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DEPARTMENT OF HEALTH AND MD 20740, 240–402–5429, email: f. How Total Appears on the HUMAN SERVICES [email protected]. g. Calculation of From SUPPLEMENTARY INFORMATION: and Drug Administration Table of Contents 2. 21 CFR Part 101 a. Definition Executive Summary b. Mandatory Declaration [Docket No. FDA–2012–N–1210] Purpose of the Regulatory Action c. Changing ‘‘Sugars’’ to ‘‘Total Sugars’’ Summary of the Major Provisions of the d. DRV RIN 0910–AF22 Regulatory Action in Question e. Seasonal Variation in Sugars Content Costs and Benefits 3. Added Sugars Food Labeling: Revision of the I. Background a. Declaration Nutrition and Supplement Facts A. Legal Authority (i) Comments on the Rationale for B. Need To Update the Nutrition Facts and Requiring Mandatory Declaration of AGENCY: Food and Drug Administration, Supplement Facts Labels Added Sugars HHS. II. Comments to the Proposed Rule and the (ii) Evidence on Added Sugars and Risk of ACTION: Final rule. Supplemental Proposed Rule, Our Chronic Disease Responses, and a Description of the Final (iii) New Evidence Presented in the 2015 SUMMARY: The Food and Drug Rule DGAC Report Administration (FDA or we) is A. Introduction b. The 2015 DGAC Analysis of Dietary amending its labeling regulations for B. General Comments Patterns and Health Outcomes conventional and dietary 1. Comments Seeking an Education c. Authority for Labeling supplements to provide updated Campaign or Program (i) Statutory Authority nutrition information on the label to 2. Comments Linking the Nutrition Facts (ii) Material Fact assist consumers in maintaining healthy Label to Specific Diseases (iii) Regulations Must Bear a Reasonable 3. Use of Household Measures Relationship to the Requirements and dietary practices. The updated 4. Impact on Other Regulations Purposes of the Statue information is consistent with current 5. Consumer Research d. Density data on the associations between C. Comments on Legal Issues e. Reformulation and chronic diseases, health- 1. First Amendment f. Calories from Solid and Added related conditions, physiological 2. Administrative Procedure Act Sugars endpoints, and/or maintaining a healthy 3. Federal Food, Drug, and Cosmetic Act g. Consumer Research and Consumer Use dietary pattern that reflects current 4. Recordkeeping Authority of Added Sugars Declaration public health conditions in the United 5. Miscellaneous Comments h. Voluntary Labeling States, and corresponds to new D. Factors for Mandatory or Voluntary i. How Added Sugars are Declared Declaration of Non-Statutory Nutrients (i) Changing ‘‘Sugars’’ to ‘‘Total Sugars’’ information on consumer understanding E. Calories (ii) Declaration of Added Sugars in and consumption patterns. The final 1. Calories From Teaspoons rule updates the list of nutrients that are 2. Calories From (iii) Distinguishing Between Naturally required or permitted to be declared; 3. Two Thousand Calories as the Reference Occurring and Added Sugars on the provides updated Daily Reference Caloric Intake Level Label Values and 4. Percent DV Declaration for Calories (iv) Replacing ‘‘Sugars’’ With ‘‘Added values that are based on current dietary F. Fat Sugars’’ recommendations from consensus 1. Total Fat (v) Distinguishing Between Different Types reports; amends requirements for foods a. Definition of Sugars or Sweeteners b. Mandatory Declaration (vi) Warning Statements represented or purported to be c. DRV j. Variability in Content specifically for children under the age of d. Declaration of Total Fat k. Non-Enzymatic Browning and 4 years and pregnant and lactating 2. Saturated Fat Fermentation women and establishes nutrient a. Definition l. Impact on Nutrient Databases reference values specifically for these b. Mandatory Declaration m. International Labeling Guidelines population subgroups; and revises the c. DRV n. Definition of Added Sugars format and appearance of the Nutrition 3. Trans Fat (i) and Vegetable Juice Concentrates Facts label. a. Definition (ii) Intended Purpose of Sweetening b. Mandatory Declaration (iii) The ‘‘No Added Sugars’’ Nutrient DATES: Effective date: The final rule c. DRV Content Claim becomes effective on July 26, 2016. d. Declaring the Amount of Trans Fat (iv) Fruit Jellies, Jams, and Preserves Compliance date: The compliance date 4. Monounsaturated Fat and (v) Dried of this final rule is July 26, 2018 for Polyunsaturated Fat (vi) Other Sugars/Sweeteners manufacturers with $10 million or more a. Voluntary Declaration (vii) Other Comments in annual food sales and July 26, 2019 b. DRV o. Establishing a DRV and Mandatory for manufacturers with less than $10 c. Declaration of Individual Declaration of the Percent DV for Added million in annual food sales. See section Polyunsaturated Fatty Acids Sugars G. (i) Mandatory Declaration of a Percent DV III, Effective and Compliance Dates, for 1. Mandatory Declaration and Whether a DRV Should be more detail. The incorporation by 2. DRV Established reference of certain publications listed H. Carbohydrate (ii) DRV of 10 Percent of Total Calories in the rule is approved by the Director 1. Total Carbohydrate From Added Sugars of the Federal Register as of July 26, a. Calculation of Total Carbohydrate (iii) Food Pattern Modeling 2016. b. Classification of Carbohydrates Based on (iv) The Te Morenga et al. Meta-Analysis a Chemical Definition or Physiological (v) The IOM Suggested Maximum Intake FOR FURTHER INFORMATION CONTACT: Effect Level of 25 Percent or Less of Energy Blakeley Fitzpatrick, Center for Food c. Separate Declaration of Additional From Added Sugars Safety and Applied Nutrition (HFS– Individual Types of Carbohydrates (vi) DRV of 10 Percent of Total Calories 830), Food and Drug Administration, d. Mandatory Declaration (vii) Education 5100 Paint Branch Pkwy., College Park, e. DRV p. Records

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4. Sugar Alcohols c. Terms Used to Declare Insoluble Fiber, Sugars, Added Sugars, a. Voluntary Declaration 4. A, D, and E and Sugar Alcohols b. Use of the Term ‘‘Sugar Alcohols’’ a. General Comments d. c. DRV b. Specific Comments on the Units of e. Fluoride d. Caloric Value Measure for Individual Vitamins f. Vitamins and Minerals 5. 5. P. Dietary Supplements a. Dietary fiber O. Labeling of Foods for Infants, Young 1. Mandatory Dietary Ingredients (i) Definition Children, and Pregnant or Lactating 2. Folate and Folic Acid (ii) Mandatory Declaration Women 3. Units of Measure (iii) Analytical Methods 1. Age Range for Infants and Young 4. Order of Nutrients Declared on the Label (iv) DRV Children 5. Subpopulations b. Soluble and Insoluble Fiber 2. Mandatory Declaration of Calories and 6. Footnote (i) Definition Statutorily Required Nutrients 7. Miscellaneous Comments (ii) Voluntary Declaration a. Declaration of Saturated Fat and 8. Compliance Requirements for Dietary (iii) Analytical Methods Cholesterol Supplements (iv) DRV b. Percent DV Declaration Q. Format (v) Caloric Value 3. Declaration of Non-Statutory Nutrients 1. General Comments 6. Other Carbohydrate Other Than Essential Vitamins and 2. Increasing the Prominence of Calories I. Protein Minerals and Serving Size 1. Mandatory and Voluntary Declaration a. Voluntary Declaration of Calories From 3. Changing the Order of the ‘‘Serving 2. Analytical Methods Saturated Fat, and the Amount of Size’’ and ‘‘Servings Per Container’’ 3. DRV Polyunsaturated and Monounsaturated Declarations and Increasing the 4. Miscellaneous Comments Fat Prominence of ‘‘Servings Per Container’’ J. b. Voluntary Declaration of Soluble Fiber, 4. Right-Justifying the Quantitative 1. Mandatory Declaration Insoluble Fiber, and Sugar Alcohols Amounts Declared in the ‘‘Serving size’’ 2. DRV c. Mandatory Declaration of Trans Fat Statement K. Fluoride d. Mandatory Declaration of Added Sugars 5. Changing the ‘‘Amount per Serving’’ 1. Voluntary Declaration e. Voluntary Declaration of Fluoride Statement 2. DRV 4. Declaration of Essential Vitamins and 6. Declaration of ‘‘Calories From Fat’’ 3. Miscellaneous Comments Minerals 7. Presentation of Percent DVs L. Essential Vitamins and Minerals of a. Mandatory Declaration of and 8. Placement of ‘‘Added Sugars’’ Public Health Significance 9. Declaration of Absolute Amounts of 1. General Comments b. Mandatory Declaration of D and Vitamins and Minerals 2. Essential Vitamins and Minerals That 10. Single and Dual Column Labeling Are Mandatory c. Voluntary Declaration of and 11. The Footnote a. Calcium 12. Use of Highlighting With a Type b. Iron d. Voluntary Declaration of Other Vitamins Intermediate Between Bold or Extra Bold c. Vitamin A and Vitamin C and Minerals and Regular Type 3. Essential Vitamins and Minerals That 5. DRVs and RDIs for Infants Through 12 13. Addition of a Horizontal Line Beneath Are Voluntary Months of Age the Nutrition Facts Heading a. a. General Comments 14. Replacing ‘‘Total Carbohydrate’’ With b. Potassium b. Calories ‘‘Total Carbs’’ 4. Other Essential Vitamins and Minerals c. Total Fat 15. Alternative Visual Formats/Fonts a. d. Saturated Fat, Trans Fat, Cholesterol, 16. Miscellaneous Comments b. Dietary Fiber, and Sugars a. Size and Space Issues c. e. Polyunsaturated Fat, Monounsaturated b. Conversion Factors d. Fat, Insoluble Fiber, Soluble Fiber, R. Compliance e. Added Sugars, and Sugar Alcohols 1. Level of Variance Allowed for the Label M. Reference Daily Intakes for Vitamins f. Total Carbohydrates Declaration of Specific Nutrients and Minerals g. Protein 2. Methods Used To Determine 1. Need to Update RDIs h. Sodium Compliance 2. Approach to Setting RDIs: EAR Versus i. Fluoride 3. Records Requirements RDA j. Other Vitamins and Minerals 4. Inclusion of Potassium as a 3. Approach to Setting RDIs: Adequate 6. DRVs and RDIs for Children 1 Through 5. Requirements for Other Carbohydrate, Intake 3 Years of Age Soluble and Insoluble Fiber, Added 4. Approach to Setting RDIs: Tolerable a. General Comments Sugars, and Sugar Alcohols Upper Intake Level b. Calories 6. Miscellaneous Comments 5. Approach to Setting RDIs: Population- c. Total Fat S. Technical Amendments Weighted Versus Population-Coverage d. Saturated Fat, Trans Fat, and Cholesterol 1. Changing the Name of the Program 6. Declaration of Absolute Amounts of e. Polyunsaturated Fat, Monounsaturated Office Vitamins and Minerals Fat, Sugars, Insoluble Fiber, Soluble 2. Changing the Publication Date of Report 7. Issues Concerning Specific Vitamins or Fiber, Added Sugars, and Sugar Alcohols Incorporated by Reference Minerals f. Total Carbohydrates 3. Plain Language Edits a. Vitamin K g. Dietary Fiber 4. Correcting § 101.9(c)(8)(iii) To Provide b. Chloride h. Protein Instructions for Rounding Percent DVs c. Potassium i. Sodium 5. Miscellaneous Changes d. Choline j. Fluoride T. Miscellaneous Comments e. Vitamin B12 k. Other Vitamins and Minerals III. Effective and Compliance Dates N. Units of Measure, Analytical Methods, 7. DRVs and RDIs for Pregnant Women and IV. Economic Analysis of Impacts and Terms for Vitamins and Minerals Lactating Women V. Paperwork Reduction Act of 1995 1. General Comments a. Calories A. Recordkeeping Requirements 2. Sodium, Potassium, , and b. Total Fat, Saturated Fat, Cholesterol, B. Reporting Requirements Chloride Total Carbohydrate, Sodium, and Dietary C. Third-Party Disclosure Requirements 3. Folate and Folic Acid Fiber D. Third-Party Disclosure Burden for a. Units of Measure c. Trans Fat, Polyunsaturated Fat, Manufacturers b. Analytical Methods Monounsaturated Fat, Soluble Fiber, VI. Analysis of Environmental Impact

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VII. Federalism and permits, rather than requires, the compliance date of 3 years after the final VIII. References declaration of vitamins A and C; rule’s effective date. (For more details, • Executive Summary Updating certain reference values see part III.) used in the declaration of percent DVs The final rule is the result of Purpose of the Regulatory Action of nutrients on the Nutrition Facts and significant stakeholder engagement. We We are amending our regulations for Supplement Facts labels; • Revising the format of the Nutrition received nearly 300,000 comments, the nutrition labeling of conventional conducted several consumer studies and foods and dietary supplements to help Facts and Supplement Facts labels to increase the prominence of the term made those studies publicly available, consumers maintain healthy dietary and, in light of new scientific practices. Section 403(q) of the Federal ‘‘Calories;’’ • recommendations (particularly for Food, Drug, and Cosmetic Act (the Removing the requirement for the added sugars), issued a supplemental FD&C Act) (21 U.S.C. 343(q)) specifies footnote table listing the reference notice of proposed rulemaking. certain nutrients to be declared in values for certain nutrients for 2,000 and 2,500 calorie diets; Elsewhere in this issue of the Federal nutrition labeling, and authorizes the • Secretary of Health and Human Services Requiring the maintenance of Register, we have published a final rule to require other nutrients to be declared records to support the declarations of that amends the definition of a single- if the Secretary determines that a certain nutrients under specified serving container, requires dual column nutrient will provide information circumstances. For example, because labeling for certain containers, updates regarding the nutritional value of such there are no analytical methods that can the reference amounts customarily food that will assist consumers in distinguish between dietary fiber consumed and serving sizes for several maintaining healthy dietary practices. (soluble and insoluble fiber) and food product categories, and amends the The Secretary also has discretion under nondigestible carbohydrates that do not serving size for breath mints. section 403(q) of the FD&C Act to meet the definition of dietary fiber; Costs and Benefits remove, by regulation and under certain added and naturally occurring sugars or the various forms of ; or folate circumstances, nutrient information that We have developed one final is otherwise explicitly required in food and folic acid, the final rule requires manufacturers to make and keep certain regulatory impact analysis (FRIA) for labeling under this section. this final rule as well as the final rule The final rule revises our regulations written records to verify the declarations of dietary fiber, added entitled ‘‘Food Labeling: Serving Sizes to provide updated nutrition of Foods That Can Reasonably Be information on the label and to improve sugars, vitamin E, and folate and folic acid in the labeling of the food Consumed at One Eating Occasion; how the nutrition information is Dual-Column Labeling; Updating, presented to consumers. associated with such records. The final rule requires these records to be kept for Modifying, and Establishing Certain Summary of the Major Provisions of the at least 2 years after introduction or Reference Amounts Customarily Regulatory Action in Question delivery for introduction of the food Consumed; Serving Size for Breath The final rule revises the Nutrition into interstate commerce. A similar Mints; and Technical Amendments.’’ Facts label by: requirement exists with respect to The FRIA discusses key inputs in the • Removing the declaration of added sugars in foods subject to non- estimation of costs and benefits of the ‘‘Calories from fat’’ because current enzymatic browning and fermentation changes finalized by the rules and science supports a view that the type of because there are no analytical methods assesses the sensitivity of cost and fat is more relevant than overall total fat that can determine the amount of added benefit totals to those inputs. The two intake in increased risk of chronic sugar in specific foods containing added nutrition labeling rules—which have a diseases; sugars alone or in combination with compliance date of 2 years after the final • Requiring the declaration of the naturally occurring sugars, where the rule’s effective date for manufacturers gram amount of ‘‘added sugars’’ in a added sugars are subject to non- with $10 million or more in annual food serving of a product, establishing a enzymatic browning and fermentation. sales, and 3 years after the final rule’s Daily Reference Value (DRV), and However, for manufacturers of such effective date for manufacturers with requiring the percent Daily Value (DV) foods who are unable to reasonably less than $10 million in annual food declaration for added sugars; approximate the amount of added sales—have impacts, including the sign • Changing ‘‘Sugars’’ to ‘‘Total sugars in a serving of food to which the on net benefits, that are characterized by Sugars’’ and requiring that ‘‘Includes ‘X’ records requirements apply, the final substantial uncertainty. The primary g Added Sugars’’ be indented and rule allows manufacturers to submit a sensitivity analysis shows benefits declared directly below ‘‘Total Sugars’’ petition to request an alternative means having the potential to range between on the label; of compliance; and $0.2 and $2 or $5 billion, and costs • Updating the list of vitamins and • Establishing a compliance date of 2 ranging between $0.2, $0.5 and $0.8 minerals of public health significance. years after the final rule’s effective date, billion (annualized over the next twenty For example, the final rule requires the except that manufacturers with less than years, in 2014 dollars, at seven percent declaration of vitamin D and potassium $10 million in annual food sales have a interest).1

TABLE 1—SUMMARY OF THE PRIMARY SENSITIVITY ANALYSIS OF THE COSTS AND BENEFITS OF THE FINAL RULES [in billions of 2014$]

Benefits Benefits Benefits Costs Costs Costs (Low) (Mean) (High) (Low) (Mean) (High)

Present Value 3% ...... $2.8 $33.1 $77.7 $2.3 $4.8 $8.6

1 There is substantial uncertainty regarding the full discussion of the uncertainty, please see the Welfare Estimates—Primary Sensitivity Analysis impacts of the two nutrition labeling rules. For a section of the regulatory impact analysis.

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TABLE 1—SUMMARY OF THE PRIMARY SENSITIVITY ANALYSIS OF THE COSTS AND BENEFITS OF THE FINAL RULES— Continued [in billions of 2014$]

Benefits Benefits Benefits Costs Costs Costs (Low) (Mean) (High) (Low) (Mean) (High)

7% ...... 1.9 22.3 52.5 2.2 4.5 8.3 Annualized Amount 3% ...... 0.2 2.2 5.2 0.2 0.3 0.6 7% ...... 0.2 2.1 5.0 0.2 0.4 0.8 Notes: Costs estimates reflect an assumption that the rules have the same compliance date. Compliance period is 36 months for small busi- nesses and 24 months for large businesses. For purposes of this analysis, we consider a small business to be a business with annual food sales of less than $10 million, and a large business to be a business with annual food sales of $10 million or more. Costs include relabeling, record- keeping, fiber study, additional labeling, future UPC growth labeling, and reformulation costs. Annualized Amount = Amount/Annualizing Factor. Three percent annualizing factor = 14.88. Seven percent annualizing factor = 10.59. The annualizing factors are calculated by summing the in- verse of 1 plus the discount rate to the power of the year (t = 1 through t = 20).

I. Background our authority in section 403(q) of the significance in a total daily . In general, under section 403(q) of the FD&C Act. Section 403(q)(1) of the Furthermore, section 2(b)(1)(C) of the FD&C Act, a food is deemed misbranded FD&C Act states that a food shall be NLEA requires that the regulations unless its label or labeling bears deemed to be misbranded if, with permit the label or labeling of food to nutrition information for certain certain exceptions, it fails to bear include nutrition information which is nutrients. To implement section 403(q) nutrition labeling and identifies specific in addition to the information required of the FD&C Act, we have issued nutrient and calorie information by section 403(q) of the FD&C Act and regulations related to: required in labeling. Section ‘‘which is of the type described in • Declaration of nutrients on food 403(q)(2)(A) of the FD&C Act gives the subparagraph (1) or (2) of such section labeling, including nutrients that are Secretary, and by delegation, FDA, the . . . .’’ We are changing the voluntary required or permitted to be declared and discretion to require, by regulation, declaration of certain nutrients in the the format for such declaration; nutrition information about nutrients consistent with • Label reference values for use in other than those specified in section this authority. declaring the nutrient content of a food 403(q)(1) of the FD&C Act to assist Other relevant authorities include on its label or labeling; consumers in maintaining healthy sections 701(a), 403(a)(1) and 201(n) of • Two types of reference values, dietary practices. Section 403(q)(2)(B) of the FD&C Act (21 U.S.C. 371(a), 21 Reference Daily Intakes (RDIs) for the FD&C Act permits the Secretary, and U.S.C. 343(a)(1), and 21 U.S.C. 321(n), vitamins and minerals and DRVs for by delegation, FDA, to remove respectively). Under section 701(a) of certain nutrients, which are used to information relating to a nutrient the FD&C Act, we may issue regulations declare nutrient contents as percent DVs required by section 403(q)(1) or for the efficient enforcement of the on the Nutrition Facts label; 403(q)(2)(A) of the FD&C Act if the FD&C Act to ‘‘effectuate a congressional • Exemptions for certain specified Secretary determines that it is not objective expressed elsewhere in the products; and necessary to assist consumers in Act’’ (Association of American • A simplified form of nutrition maintaining healthy dietary practices. Physicians and Surgeons, Inc. v. FDA, labeling and the circumstances in which Consistent with these authorities, we are 226 F. Supp. 2d 204 (D.D.C. 2002) such simplified nutrition labeling can revising certain nutrient declarations in (citing Pharm. Mfrs. Ass’n. v. FDA, 484 be used. the Nutrition Facts label and F. Sup. 1179, 1183 (D. Del. 1980)). These regulations are at § 101.9 (21 CFR Supplement Facts label. In addition, We are relying on our authority under 101.9). FDA’s authority includes section 2(b)(1) sections 403(q), 403(a), 201(n) and Elsewhere in this issue of the Federal of the Nutrition Labeling and Education 701(a) of the FD&C Act to establish Register, we are publishing a final rule Act of 1990 (NLEA) (21 U.S.C. 343 record requirements to support nutrient that amends the definition of a single- note). Specifically, section 2(b)(1)(A) of declarations in labeling for added serving container, requires dual column the NLEA requires nutrition label sugars, dietary fiber, soluble fiber, labeling for certain containers, updates information be conveyed in a manner insoluble fiber, vitamin E, and folate/ the reference amounts customarily that enables the public to readily folic acid, under certain circumstances, consumed and serving sizes for several observe and comprehend the so that we can determine compliance food product categories and amends the information and to understand its with labeling requirements and take serving size for breath mints. relative significance in the context of a enforcement action as needed. For these In addition, section 403(q)(5)(F) of the total daily diet. Section 2(b)(1)(A) of the nutrients, there is no official method of FD&C Act imposes specific NLEA also states that such information analysis of the Association of Official requirements that relate to the labeling should be consistent with current Analytical Chemists (AOAC) of products. scientific knowledge about nutrients International or other reliable or Accordingly, our food labeling and health. We are changing DVs (RDIs appropriate analytical procedure, regulations, at §§ 101.9(j)(6) and 101.36, and DRVs, as applicable) for some otherwise required by § 101.9(g), establish requirements for nutrition nutrients, and these values are used to available for us to quantify the declared labeling of dietary supplements. calculate the percent DV for use on food amount of the nutrient, under certain labels. The use of reference values based circumstances. Section 101.9(g) sets A. Legal Authority on current science and the use of such forth the standards for accuracy of the We are updating the Nutrition Facts values to calculate the percent DV can amount statements of nutrients on food label and Supplement Facts label, as set help consumers understand the labels. Failing to accurately state the forth in this final rule, consistent with nutrition information and its relative amounts of nutrients on the label under

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§ 101.9(g) would result in a product 201(n) of the FD&C Act not only statement in conjunction with claims to being misbranded. Under section 403(q) includes the authority to establish enhance consumer understanding about of the FD&C Act, a food must bear, in records requirements, but also includes cholesterol-raising lipids and how to its label or labeling, the amount of the access to such records. Without such use the information to make healthy nutrient the food contains. Moreover, authority, the nutrient declarations for food choices (68 FR 41507, July 11, the nutrient declaration must be truthful these specific nutrients that we have 2003). We later extended the comment and not misleading under sections determined are necessary to assist period (69 FR 20838, April 19, 2004) to 403(a)(1) and 201(n) of the FD&C Act. consumers in maintaining healthy receive comments that considered the Thus, when a food product contains dietary practices under section information in the 2004 meeting of the dietary fiber (whether soluble, 403(q)(2)(A) of the FD&C Act are, Nutrition Subcommittee of the Food insoluble, or a combination of both) and practically speaking, not enforceable. Advisory Committee which addressed added non-digestible carbohydrate(s) Without access to such records, we whether the available scientific that does not meet the definition of would not know whether the amount evidence supported listing the percent dietary fiber, we are requiring declared on the label or in the labeling DV for saturated fat and trans fat manufacturers to make and keep certain of these nutrients, under the together or separately on the Nutrition written records to verify the amount of circumstances described, is truthful and Facts label and what the maximal daily added non-digestible carbohydrate that not misleading under sections 403(a)(1) intake of trans fat may be; does not meet the definition of dietary and 201(n) of the FD&C Act. The • The prominence of calories on the fiber. When vitamin E is present in a introduction or delivery for introduction food label (70 FR 17008, April 4, 2005) food as a mixture of all rac-a- into interstate commerce of a (the 2005 ANPRM). We took this action acetate and RRR-a-tocopherol, we are misbranded food is a prohibited act in response to recommendations from requiring manufacturers to make and under section 301(a) of the FD&C Act the Working Group established keep written records to verify the (21 U.S.C. 331(a)). Thus, to determine by the Commissioner of Food and Drugs amount of all rac-a-tocopherol acetate whether the food is misbranded and the to develop an action plan to address the added to the food and RRR-a-tocopherol manufacturer has committed a growing incidence of obesity in the in the finished food. When a mixture of prohibited act, we must have access to . The 2005 ANPRM, in folate and folic acid is present in a food, the manufacturer’s records that we are part, requested comments on whether we are requiring manufacturers to make requiring be made and kept under giving more prominence to the and keep records to verify the amount sections 403(q), 403(a)(1), 201(n) and declaration of calories per serving of folic acid added to the food and folate 701(a) of the FD&C Act. Failure to make would increase consumer awareness of in the finished food. When added sugars and keep records and provide the the caloric content of the packaged food as well as naturally occurring sugars are records to us, as described in and whether providing a percent DV for present in a food, we are requiring § 101.9(g)(10) and (11), would result in total calories would help consumers manufacturers to make and keep records the food being misbranded under understand the caloric content of the to verify the declared amount of added sections 403(q) and 403(a)(1) of the packaged food in the context of a 2,000 sugars in the food. Finally, we are FD&C Act. calorie diet. We also requested requiring manufacturers to make and comments on questions concerning the B. Need To Update the Nutrition Facts keep records to verify the declared declaration of ‘‘Calories from fat;’’ and and Supplement Facts Labels amount of added sugars in specific • The revision of reference values and foods, alone or in combination with We first issued regulations related to mandatory nutrients (72 FR 62149, naturally occurring sugars, where the the Nutrition Facts label in 1993 and November 2, 2007) (the 2007 ANPRM). added sugars are subject to non- amended them in 1995 (to establish new The 2007 ANPRM requested comment enzymatic browning and/or DVs and to update the DVs (60 FR on various aspects of nutrition labeling, fermentation. 67164, December 28, 1995)) and in 2003 including new reference values we The final rule’s record requirements (to address the declaration of trans fats should use to calculate the percent DV for these nutrients are designed to (68 FR 41434, July 11, 2003)). From July in the Nutrition Facts and Supplement ensure that the nutrient declarations are 2003 to November 2007, we also issued Facts labels and factors we should accurate, truthful, and not misleading, three advance notices of proposed consider in establishing such new based on information known only to the rulemaking (ANPRMs) seeking public reference values. We also requested manufacturer, and to facilitate efficient comment on issues relevant to updating comments on whether we should and effective action to enforce the the Nutrition Facts label. These require that certain nutrients be added requirements when necessary. Our ANPRMs sought comment on: or removed from the Nutrition Facts and authority to establish records • Data that could be used to establish Supplement Facts labels. requirements has been upheld under new nutrient content claims about trans Additionally, between 1993 and 2013, other provisions of the FD&C Act where fatty acids; to establish qualifying we received 12 citizen petitions asking we have found such records to be criteria for trans fat in nutrient content us to make various changes to the necessary (National Confectioners claims for saturated fatty acids and Nutrition Facts and Supplement Facts Assoc. v. Califano, 569 F.2d 690, 693– cholesterol, lean and extra lean claims, labels. For example, some petitions 94 (D.C. Cir. 1978)). The records we are and health claims that contain a asked us to permit the use of a different requiring are only for foods for which an message about cholesterol raising lipids; term on the Nutrition Facts label, while adequate analytical method is not and, in addition, to establish disclosure others sought changes in definitions, available. The records will allow us to and disqualifying criteria to help values (such as caloric values or the DV verify the declared amount of each consumers make heart healthy food for a specific nutrient), or the inclusion nutrient and that such amount is choices. We also requested comments of more information on the Nutrition truthful and not misleading. Thus, the on whether we should consider Facts label. records requirements will help in the statements about trans fat, either alone Yet, as we considered the issues efficient enforcement of the FD&C Act. or in combination with saturated fat and raised in the ANPRMs and the citizen The authority granted to FDA under cholesterol, as a footnote in the petitions, the public health profile of the sections 701(a), 403(q), 403(a)(1) and Nutrition Facts label or as a disclosure U.S. population changed, and new

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information became available about evidence to calculate an EAR for that rule discussed, among other things, the nutrient definitions, reference intake nutrient, and therefore insufficient frequency at which consumers use food values, and analytical methods. New evidence on which to establish an RDA. labels and the purposes for which they dietary recommendations also were AIs can be based on a variety of data, consulted food labels (id.). The published. We reconsidered what including scientific evidence about the preamble to the proposed rule also nutrients we should require or permit to essentiality of a nutrient (i.e., choline, noted that consumer research data be listed on the Nutrition Facts label , fluoride), experimental data on suggested that, despite widespread use and what nutrient reference intake risk reduction of chronic disease (i.e., of food labels, certain elements of the values we should use as a basis for dietary fiber, potassium), and median Nutrition Facts label ‘‘may need calculating the percent DVs in food intakes of a nutrient using national improvement’’ (such as consumer labeling. We also considered survey data (i.e., vitamin K, pantothenic understanding of the concept of percent corresponding changes to the acid, , , linoleic DVs) (id.). We also stated that we Supplement Facts labels. Consequently, acid, and a-linolenic acid). Although intended to continue performing in the Federal Register of March 3, 2014 there is less certainty about an AI value research during the rulemaking process (79 FR 11879), we issued a proposed than about an RDA value, the AI is to evaluate how variations in label rule to amend our labeling regulations similarly designed to cover the needs of format may affect consumer for conventional foods and dietary nearly all individuals. The UL is the understanding and use of the Nutrition supplements to provide updated highest average daily intake level likely Facts label as well as to help inform nutrition information on the label and to to pose no risk of adverse health effects consumer education (id.). • help consumers maintain healthy for nearly all people in a particular Other considerations, including the dietary practices. The preamble to the group. The UL is not intended to be a focus of the Nutrition Facts label itself proposed rule discussed, in some detail, recommended level of intake, but is and practical limitations (id. at 11887 the reasons why we felt it necessary to used to assess the risk of adverse health through 11888). For example, we noted update the Nutrition Facts and effects from excessive nutrient intake. that the Nutrition Facts label Supplement Facts labels (see 79 FR As intake above the UL increases, so information is to help consumers make 11879 at 11884 through 11889). In brief, does the potential for risk of adverse more informed choices to consume a the preamble to the proposed rule health effects (id. at 11885 through and not intended for the discussed: clinical management of an existing • 11886). The preamble to the proposed Rates of chronic disease, such as rule also discussed the Dietary disease. However, we also said that we , diabetes, and Guidelines for Americans (DGA); the were considering the large proportion of cancer, and changes in obesity rates (79 DGA is developed jointly by the U.S. the U.S. population that is at risk for FR 11879 at 11885); Department of Agriculture and the U.S. chronic disease as we proposed changes • Dietary recommendations, Department of Health and Human to the Nutrition Facts label’s content consensus reports, and national survey Services and provides key and format (id. at 11887). data, such as the Institute of Medicine recommendations on dietary patterns Simultaneously, we recognized that (IOM) Dietary Reference Intakes Reports and quantitative intake there is not room on the label for all (which resulted in the development of recommendations with respect to information that may be related to a set of reference values known and macronutrients (id. maintaining healthy dietary practices collectively as Dietary Reference Intakes and that space constraints on the label at 11886). Although the preamble to the (DRIs) (id. at 11885 through 11887). The of most foods make it impractical to proposed rule discussed the DGA that DRIs themselves consist of four declare all essential nutrients (id. at was issued in 2010, in February 2015, categories of reference values: (1) The 11888). We added that having a large the Scientific Report of the 2015 Dietary Estimated Average Requirement (EAR); amount of information on the label Guidelines Advisory Committee (DGAC (2) Recommended Dietary Allowance could interfere with consumers’ abilities Report) became publicly available. (RDA); (3) Adequate Intake (AI); and (4) to use the information that has the While the DGAC Report is not a DGA Tolerable Upper Intake Level (UL) (id.). greatest public health significance and itself (because the Federal government The preamble to the proposed rule that, given the amount and format of must determine how to use the explained that the EAR is the average information that we require on the label, daily nutrient intake level that is information in the DGAC Report to limits to the voluntary information on estimated to meet the requirements of develop the 2015–2020 version of the the label are necessary so that voluntary half of the healthy individuals in a DGA), the DGAC Report contains information does not clutter the label, particular life stage and gender group scientific information on specific does not mislead, confuse, or and that EARs are used for assessing the nutrients and vitamins as well as a overwhelm the consumer, and does not statistical probability of adequacy of review of the underlying scientific take away prominence of and emphasis nutrient intakes of groups of people. evidence. For example, the DGAC on the required information (id.). The RDA is an estimate of the average Report contains scientific evidence The preamble to the proposed rule intake level that meets the nutrient related to a daily intake also discussed the citizen petitions and requirements of nearly all (97 to 98 recommendation for added sugars. In ANPRMs (id. at 11888 through 11889) percent) healthy individuals in a the Federal Register of July 27, 2015 (80 as influencing our development of the particular life stage and gender group FR 44303), we issued a supplemental proposed rule. Additionally, as stated and is set using the EAR. In general, the proposed rule with respect to the earlier in part I.B, in the Federal RDA is the EAR plus two times the scientific evidence in the DGAC Report Register of July 27, 2015 (80 FR 44303), standard deviation of the EAR. The RDA pertaining to added sugars and the we issued a supplemental proposed rule is used to plan nutrient intakes for possible inclusion of added sugars to to establish a DRV of 10 percent of total individuals to ensure a low probability the Nutrition Facts and Supplement energy intake from added sugars, of inadequacy. The AI is the level Facts labels. require the declaration of the percent determined for an essential nutrient or • Consumer use and understanding of DV for added sugars on the label, and a nutrient that is beneficial for human the Nutrition Facts label (79 FR 11879 to provide text for the footnotes to be health when there is insufficient at 11887). The preamble to the proposed used on the Nutrition Facts label. The

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supplemental proposed rule also the product label in the context of the the proposed rule, as well as the provided additional data and total diet. We considered revisions to proposed rule on serving size information to support the declaration the DVs based on scientific evidence requirements, and to solicit oral of added sugars on the label and made related to recommendations published stakeholder and public comments and our consumer research regarding the by the IOM and other reports such as to respond to questions about the footnote text and added sugars the DGA. In addition to changing some proposed rules. Additionally, as we declarations publicly available. DVs, the proposed rule would change stated in part I.B, in the Federal the units used to declare vitamins A, E, Register of July 27, 2015 (80 FR 44303), II. Comments to the Proposed Rule and and D from ‘‘international units,’’ or we issued a supplemental proposed rule the Supplemental Proposed Rule, Our ‘‘I.U.’’ to a metric measure, milligrams to establish a DRV of 10 percent of total Responses, and a Description of the or micrograms, and also would include energy intake from added sugars, to Final Rule the absolute amounts in milligrams or require the declaration of the percent A. Introduction micrograms of vitamins and minerals, in DV for added sugars, and to provide text for the footnotes to be used on the The proposed rule would amend our addition to the % DV, on the label. Nutrition Facts label. The supplemental labeling regulations for conventional The proposed rule also would change proposed rule also provided additional foods and dietary supplements to the appearance of the label itself by information to support the declaration provide updated nutrition information highlighting key parts of the label that of added sugars on the label and made on the label. In brief, the proposed rule are important in addressing current public health problems. For example, our consumer research regarding added would (among other things): sugars declarations and the footnote text • Require the declaration of ‘‘Added the proposed rule would: • Highlight the caloric content of publicly available. We also reopened the Sugars’’ on the label. ‘‘Sugars’’ include foods by increasing the type size and comment period for the purpose of both ‘‘added sugars’’ and sugars that are placing in bold type the number of inviting public comment on two naturally occurring in food. The calories and servings per container; consumer studies we added to the proposed rule would require the • Shift to the left of the label % DV. administrative record (80 FR 44302). declaration of ‘‘Added Sugars’’ indented The % DV is intended to help The two consumer studies pertained to under ‘‘Sugars’’ so that both would be consumers place nutrient information in proposed changes to the format of the listed; • the context of a total daily diet; Nutrition Facts label and to consumers’ Remove the requirement for • Declare the actual amount, in interpretations of information on the declaring ‘‘Calories from fat.’’ Current addition to % DV, for all vitamins and Nutrition Facts label. Collectively, with research shows that the total fat in the minerals when they are declared; respect to the proposed rule, the diet is less important than the type of • Change ‘‘Amount Per Serving’’ to supplemental proposal, and the related fat. In addition, our consumer research ‘‘Amount per ___’’, with the blank filled Federal Register documents, we shows that removal of the declaration of in with the serving size in common received nearly 300,000 comments from ‘‘calories from fat’’ has no effect on household measures, such as ‘‘Amount consumers, foreign governments, consumers’ ability to judge the per 1 cup’’; industry, trade associations, healthfulness of a product; • Replace the listing of ‘‘Total • professional societies, academia, health Revise the nutrients of public Carbohydrate’’ with ‘‘Total Carbs’’ and professionals, and other government health significance that must be add an indented listing of ‘‘Added agencies. declared on the label. The proposed rule Sugars’’ directly beneath the listing for We discuss the issues raised in the would require the declaration of vitamin ‘‘Sugars;’’ comments on the proposed rule and D and potassium. Vitamin D is • Right justify the actual amounts of supplemental proposed rule and also important for its role in bone the serving size information; describe the final rule, in part II. We development and general health, and • Reverse the order of ‘‘Serving Size’’ preface each comment discussion with intakes among some population groups and ‘‘Servings Per Container’’ a numbered ‘‘Comment,’’ and each are inadequate. Adequate potassium declarations; and response by the word ‘‘Response’’ to intake is beneficial in lowering blood • Remove the existing footnote that make it easier to identify comments and pressure, and intakes of this nutrient are describes the DVs for 2,000 and 2,500 our responses. We have numbered each also low among some population calories to provide more space to better comment to help distinguish among groups. The proposed rule also would explain the percent dietary value. different topics. The number assigned is no longer require mandatory labeling for The proposed label changes were for organizational purposes only and vitamin C or vitamin A because data intended to help consumers maintain does not signify the comment’s value, indicate that deficiencies are not health dietary practices, and we based importance, or the order in which it was common. Voluntary labeling for the updated information on current data received. vitamins C and A would be allowed; on associations between specific and nutrients and chronic diseases or Incorporation by Reference • Revise DVs for certain nutrients that health-related conditions in the United Additionally, the final rule are either mandatory or voluntary on the States and on new information incorporates by reference the ‘‘Official label. Examples include calcium, regarding consumer understanding of Methods of Analysis of the AOAC sodium, dietary fiber and vitamin D. the label and consumption patterns. International,’’ 19th Edition. The Some DVs are intended to guide We provided a 90-day comment ‘‘Official Methods of Analysis of AOAC consumers about maximum intake— period for the proposed rule. In the International’’ (AOAC Methods) is a saturated fat, for example—while others Federal Register of May 27, 2014 (79 FR comprehensive collection of chemical are intended to help consumers meet a 30055), we extended the comment and microbiological methods of nutrient requirement—iron, for period by 60 more days after receiving analysis. The AOAC Methods have example. DVs are used to calculate the multiple requests to extend the undergone rigorous scientific review percent Daily Value (% DV) on the comment period. In the Federal Register and validation to determine the label, which helps consumers of May 29, 2014 (79 FR 30763), we performance characteristics for the understand the nutrient information on announced a public meeting to discuss intended analytical application and

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fitness for purpose. Each method declaration of trans fatty acids and the information on the label,’’ and that includes specific instructions for declaration of food allergens) have been ‘‘some racial groups . . . are less likely performing the chemical analysis of a made to nutrition labeling since . . . to use and understand nutrition substance in a particular matrix. implementation of the NLEA, there have labels, primarily because of lack of time Although the 19th Edition of the not been changes to the label of the to read labels and lack of understanding AOAC Methods was available for magnitude in the proposed rule. The of the nutrition information.’’ The purchase from AOAC when we drafted comments said, therefore, that public comment stated that working with other the proposed rule, the reference has outreach, through avenues such as health departments and organizations since been sold out at AOAC Webinars, town hall meetings, and could help extend our educational INTERNATIONAL. Copies, however, social media, will be a key component resources to all rural and urban can be obtained or downloaded from of the nutrition labeling modernization communities. Another comment secondary sources, and the final rule effort. A few comments suggested that suggested that, to be most effective, we identifies one such source. However, we the consumer education program should should incorporate lessons learned on do not endorse any particular secondary be informed by any relevant consumer how individuals from various source or reseller and note that other research. Several comments noted that subpopulations interpret the new label resellers also may have the 19th Edition there is consumer confusion over the design. The comment noted that such of the AOAC Methods for sale. meaning of percent DV and consumer education needs to accommodate individuals at various levels of B. General Comments research had found that consumers do not understand or know how to use the educational achievement and with Some comments raised issues that DVs; thus, the percent DV should be a cultural and ethnic diversity. were general in nature or affected key area in which to focus consumer A few comments suggested that we multiple parts of the rule. education efforts. One comment conduct the education campaign after Additionally, one foreign government specifically stated that percent DV/ the final rule’s publication and before agency, Health , provided factual added sugars disclosure will create the rule’s compliance date. One information and comments on various substantial consumer confusion that comment suggested that our aspects of its review and update of does not exist today and that we would recommendations be publicized to nutritional information on the Canadian need to provide consumer education in groups who interact with the public at food label. Health Canada did not attempt to overcome the confusion. least 3 months before implementation of advocate a particular outcome or did not Several comments stated that education the new Nutrition Facts label style and provide comments on possible changes is needed to help consumers understand elements to allow for preparation of or suggestions to our proposed rule. the meaning of percent DVs, with curricula and development of local 1. Comments Seeking an Education inclusion of a brief footnote on educational and media efforts. One comment suggested that, similar Campaign or Program packages, but additional consumer to our earlier public service campaigns education should be done online. (Comment 1) Several comments such as ‘‘The Real Cost’’ campaign suggested that we develop a well- Several comments suggested that, targeting youth tobacco use, we have a funded, coordinated, multi-component although the education campaign is unique ability to get the attention of the consumer education campaign to important for all consumers to know public and shape understanding about promote and explain the new Nutrition about, understand, and use the revised the risks of lifestyles habits and choices. Facts label, the changes to the label, and Nutrition Facts label, an education Other comments suggested that we the use of the label to help consumers campaign should primarily be designed integrate the education campaign with to make healthier food and beverage to reach consumers who are least likely preexisting consumer education choices. Many comments suggested that to understand and use the label, programs and initiatives, including the we coordinate our consumer education including lower income consumers, USDA’s Supplemental Nutrition campaign with other Federal communities with diverse languages Assistance Program Education (SNAP- government Agencies including the and literacy levels who are also more Ed) (the nutrition promotion and obesity Centers for Disease Control and likely to suffer from many obesity- and prevention component of SNAP), Prevention (CDC), other parts of the nutrition-related chronic diseases than school-based nutrition education Department of Health and Human those with higher incomes and programs, and grocery store labeling and Services, the U.S. Department of education. The comments stated that we education initiatives, such as the Boston Agriculture (USDA), State health should use multiple and culturally Public Health Commission’s ‘‘Re-Think departments, and non-government relevant communication channels and Your Drink’’ campaign. One comment entities, including food manufacturers, messengers, and we should field test our suggested that we develop a similar retailers, and non-profit organizations messages to ensure they are relevant and outreach campaign as ‘‘Read the Label’’ with an interest in nutrition and health. compelling for audience segments. One to enable Americans to understand the Several comments suggested that our comment noted that a Canadian study revised label and its uses. education campaign emphasize calories (Ref. 1) found that participants were One comment noted that, while because knowledge of calories is significantly less likely to correctly nutrition education has been shown to important for rolling back the obesity assess the Nutrition Facts label for have a positive impact on consumers’ epidemic. Other comments would focus calorie and nutrient information if they dietary choices and patterns, multiple on sodium because of its contribution to reported lower educational attainment, studies suggest that education alone is cardiovascular disease or on nutrients lower income, or non-white ethnicity. not adequate to change consumer (such as added sugars) that would be on The comment also stated that the 2012 behavior around healthy eating for a the Nutrition Facts label for the first IOM report on front-of-pack labeling sustained amount of time. The comment time and nutrients (such as total fat) for (Ref. 2) found that ‘‘a lack of nutrition suggested that, for education efforts to which the science has changed knowledge is a major barrier to effective be effective and sustainable, they should significantly. use of the [Nutrition Facts label] and be combined with policy, systems, and Several comments noted that, may actually lower the motivation of environmental changes that support although some revisions (such as the some consumers to use the nutrition healthful choices. For example, food

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environmental changes, such as capable of developing and evaluating may be helpful to persons with an increased availability of and access to labeling education targeted to the existing acute or chronic disease (e.g., healthful foods, combined with dietary needs of diverse populations, heart disease, chronic kidney disease, education efforts, have been found to be such as low literacy consumers, lower diabetes). According to the comments, significantly more effective in changing incomes, minorities, and various mandatory declaration of the specific consumer behavior in the long run. subpopulations (e.g., children, older nutrient would be helpful for the (Response) We agree that a consumer subpopulation, women of childbearing management of specific diseases or education and outreach campaign will age) as well as to the general public. conditions. assist in making the new food label a As for the comments stating that the (Response) While the Nutrition Facts successful tool in continuing to help percent DV should be a key area to focus label information has never been, nor is consumers to make healthy food and consumer education efforts, and that the it now, targeted to individuals with beverage choices. Currently, we have disclosure of ‘‘% DV/Added sugars’’ acute or chronic disease (e.g., diabetes, available a collection of various will create substantial consumer chronic kidney disease or educational materials (e.g., videos, an confusion, we will continue to provide cardiovascular disease (CVD)), array of public education materials and education and outreach to consumers consumers with these types of diseases brochures (in English and Spanish)) on about using the Nutrition Facts label to may be able to use quantitative numerous nutrition topics, including make healthful dietary choices. (We also information on the label to follow materials on the Nutrition Facts label note that the comments’ use of the term advice they have received from a health ‘‘confusion’’ is, itself, misplaced; a more care professional concerning their (e.g., ‘‘Read the Label,’’ Make Your appropriate characterization would be conditions. However, the nutrient Calories Count, Sodium: Look at the whether some consumers we tested declaration and percent DVs on the Label) (Ref. 3). These materials are ‘‘understand’’ or ‘‘misunderstand’’ the label are to help consumers make more intended for educators, teachers, health declaration of added sugars. However, informed choices to consume a healthy professionals (e.g., dietitians, because the comments used the term diet and not intended for the clinical physicians, and nurses) as well as for ‘‘confusion,’’ for convenience, we will management of an existing disease. general consumers. Our intent is to use the same term in this response as update our existing educational 3. Use of Household Measures well as in other responses on the subject materials and create new educational of added sugars, consumer research, and (Comment 3) Many comments opportunities to explain how to use the education, in reference to the findings recommended that the amount of total label to help consumers make healthy that some consumers we tested seemed fat, carbohydrate, sugars, added sugars, dietary choices, with an emphasis on to misunderstand that the term ‘‘added protein, and sodium be declared in each of the new changes of the label. We sugars’’ referred to a subcomponent of common household measurements (e.g. intend to continue to work on and to total sugars on the label.) The changes teaspoons) instead of or in addition to create new partnership opportunities in the ‘‘new’’ label will be highlighted grams (g). The comments said that the with other Federal government Agencies and clarified through these education metric system has not been widely including other parts of the Department and outreach endeavors. We are not adopted in the United States, and the of Health and Human Services, USDA, planning to focus educational activities average consumer is more familiar with State health departments, health on the ‘‘% DV/Added Sugars’’ household measurements than with professional organizations, food disclosure of the Nutrition Facts label in grams. The comments also said that, if manufacturers, retailers, and non-profit isolation. Instead, education and the purpose of the information on the organizations that have an interest and outreach will focus on a number of label is to help consumers understand responsibilities in nutrition education aspects of the label to enhance its use the actual amount of nutrients in a food and health promotion. These and understanding by consumers. product, the declaration of these partnerships will help us develop and As for the comment stating that nutrients in grams defeats the intended disseminate our educational materials education efforts should be combined purpose of the label because consumers that will ease the transition to the with policy, systems, and food cannot conceptualize gram amounts. revised nutrition label and help environmental changes that support One comment suggested that we include consumers to understand and use the healthy dietary choices, we understand an icon that would allow the consumer label to make well-informed dietary that combining the Nutrition Facts label to visualize a gram and that we could choices. Through our work with both education efforts with other policies use a teaspoon for such an icon. government and non-government may be more effective in supporting Another comment suggested using entities, our continued goal is to healthy dietary choices; however, many ounces instead of or in addition to increase consumers’ knowledge and policies, such as consumer access to or grams because consumers can effective use of the new Nutrition Facts increased availability of healthful foods, understand this information more easily label and to ensure that consumers have are not under our purview and are than gram amounts. The comment also accurate and adequate resources, outside the scope of this rulemaking. As recommended stating on the label that materials, and information for making part of supporting access to healthy there are 28 grams in an ounce and 448 healthy food and beverage choices. foods, we continue to encourage food grams in a pound. Furthermore, we intend to continue a product reformulation, such as reducing (Response) We decline to require the variety of activities such as conduct and sodium content in the food supply. declaration of total fat, carbohydrate, report on existing and planned food sugars, added sugars, protein, and labeling research; to develop education 2. Comments Linking the Nutrition sodium in household measurements or initiatives at the national and local Facts Label to Specific Diseases in ounces. Using a volume measure levels; to build labeling education (Comment 2) Many comments rather than a weight measurement for exchanges; and to integrate food recommended mandatory declaration of total fat, carbohydrate, sugars, added labeling education into existing specific nutrients (e.g., phosphorous, sugars, and protein would provide programs (e.g., USDA-school-based added sugars, potassium) on the inaccurate information. The gram is a nutrition education programs). We plan Nutrition Facts label because, according measure of mass or weight while a to continue to build partnerships to the comments, these nutrients are or teaspoon is a measure of volume. The

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gram weight of different carbohydrates, (such as juices and dairy products) that 5. Consumer Research fats, and is different. For are now eligible to make nutrient In the preamble to the supplemental example, a teaspoon of sucrose or table content claims for nutrients that are proposed rule (80 FR 44303 at 44305 sugar weighs 4.2 grams, but a teaspoon increasing (such as potassium, calcium, through 44306), we discussed, among of corn syrup weighs 7.3 grams (Ref. 4) vitamin D, and vitamin C) would no other things, information on two and has 1.5 grams of water and 5.1 longer be able to do so. Other comments consumer studies (80 FR 44303), and in grams of sugar. expressed concern that standards of the Federal Register of July 27, 2015 (80 Additionally, many ingredients identity for , milk, and FR 44302), we reopened the comment provide multiple nutrients, so it may might need to be updated. Other period for the proposed rule for inviting not be possible for manufacturers to comments noted that food additive public comments on two additional determine the volume contribution that regulations for the addition of calcium consumer studies. These four consumer each ingredient provides towards the and vitamin D to juice would need to be studies, conducted in 2014 and 2015, various macronutrients. For example, reevaluated; some comments suggested were randomized controlled is composed of sodium and that we delay finalizing the rule until experimental studies with English- chloride. Other ingredients, such as we update our rules on nutrient content speaking adult consumers: (1) The baking soda, contain sodium. It would claims. Experimental Study on Consumer be very difficult for a manufacturer to (Response) We will address, as Responses to Nutrition Facts Labels determine the volume of sodium appropriate and as time and resources with Declaration of Amount of Added contributed by both salt and baking soda permit, the impact on our other Sugars (‘‘the added sugars study’’); (2) in a food such as a cookie. regulations that are outside the scope of the Experimental Study on Consumer We also reiterate that the gram weight this rulemaking in separate rulemaking is a more precise measurement. When it actions. While we do intend to revisit Responses to Nutrition Facts Labels comes to some nutrients, particularly our regulations for nutrient content with Various Footnote Formats (‘‘the added sugars and sodium, most claims at a later date to determine if footnote study’’); (3) the Experimental products contain a fraction of a changes are necessary, we recognize that Study of Proposed Changes to the teaspoon. changes to the list of nutrients declared Nutrition Facts Label Formats (‘‘the Additionally, dietary on the Nutrition Facts label or the RDIs format study’’); and (4) the Eye-tracking recommendations for total fat, total or DRVs of nutrients could affect the Experimental Study on Consumer carbohydrate, sugars, added sugars, ability of some products to bear certain Responses to Modifications to the protein, and sodium are provided in nutrient content or health claims. We Nutrition Facts Label Outlined in the grams and milligrams (mg) (Ref. 5). The also recognize that changes to the RDIs Food and Drug Administration’s declaration of these nutrients in for calcium, for example, may impact Proposed Rulemaking (‘‘the eye-tracking household measurements would make it certain other regulations, including our study’’). All study participants were more difficult for consumers to compare food additive regulations in § 172.380 adults 18 years of age or older. The the amount of the nutrient in a serving (21 CFR 172.380), where the use of overarching purpose of these studies of a product to current dietary vitamin D is based on a product was to explore how and to what extent recommendations. containing a certain percentage of the different presentations of the label and As for the comments suggesting the RDI for calcium. its components (e.g., different formats of declaration of teaspoon amounts in We also do not agree to delay the entire Nutrition Facts label or addition to grams, there is limited space finalizing this rule until we provide any different formats of how added sugars available on the label, especially for updates to our rules on nutrient content may be declared on the label) may affect small packages and dual column claims. The RDIs are based on how consumer responses to the labeling (see part II.Q). Adding a much of a nutrient should be consumed presentations. In addition, the added teaspoon amount before or after the to meet nutrient needs and not based on sugars study was conducted to enhance gram declaration of the nutrients could eligibility to make a nutrient content our understanding of how inclusion of make it more difficult to read the claim. added sugars declarations on the information on the label. Therefore, we (Comment 5) One comment said we Nutrition Facts label may affect how decline to allow for voluntary should try to finalize all the anticipated consumers perceive a product or a label declaration of household measurements changes to the food package labels and how to better educate people in of total fat, carbohydrate, sugars, added simultaneously, including Nutrition using the Nutrition Facts label in sugars, protein, and sodium. Facts label, a front-of package panel, general. In the following paragraphs, we Finally, with respect to declaring and health claims so that a consumer briefly describe the methodology and nutrients in ounces or pounds, we education program about the revised key findings of each study and discuss decline to revise the rule as suggested Nutrition Facts label also could explain the characteristics and proper use of the by the comment. Many products contain all changes at one time, thereby study data and findings. an ounce or less of food per serving. If minimizing consumer confusion and The added sugars study was a ounces or pounds were declared on the maximizing resources available for randomized, controlled, Web-based label for these nutrients, fractions would education. experiment conducted in July and have to be declared. The gram weight of (Response) We do not agree that the August of 2014 to enhance our a nutrient is a more precise rule should be delayed until we provide understanding of how inclusion of measurement than ounces or pounds. any updates to rules on health claims or added sugars declarations on the any possible rule on front of pack Nutrition Facts label may affect how 4. Impact on Other Regulations labeling. The pace at which each consumers perceive a product or a label (Comment 4) Several comments individual rulemaking activity proceeds and how to better educate people in expressed concern that revision of the may be affected by our resources and using the Nutrition Facts label in RDIs would necessitate revisions to other priorities; consequently, it would general. At the time the research was other regulations for nutrient content be impractical to defer action on this designed, we were not aware of any claims and health claims. Several final rule until we complete other previous studies of consumer responses comments noted that many products possible regulatory actions. to added sugars information. We

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engaged in this research to help inform format appeared to help participants understand than the current footnote. our potential consumer education better comprehend the total amount of Footnote 1 was perceived to be more efforts if added sugars were declared on sugars in a food than the ‘‘Added believable than the current footnote. the Nutrition Facts label. The research Sugars’’ format. More details about the Footnote 1 stated the following: ‘‘2,000 design did not include a percent Daily study methodology, tested label formats, calories a day is used for general Value for added sugars on the food label and results can be found in an nutrition advice. * The % Daily Value or the ingredient listing that will appear Administrative File entitled tells you how much a nutrient in a on packages and therefore did not ‘‘Experimental Study on Consumer serving of food contributes to a daily provide data on how those pieces of Responses to Nutrition Facts Labels diet.’’ More details about the study information would affect consumer with Declaration of Amount of Added methodology, tested label formats, and responses to an added sugars Sugars (OMB No. 0910–0764)’’ (Docket results can be found in an declaration. Nevertheless, the study FDA–2012–N–1210). Administrative File entitled achieved its intended objectives of The footnote study was a randomized, ‘‘Experimental Study on Consumer providing an initial understanding of controlled, Web-based experiment Responses to Nutrition Facts Labels potential consumer reactions to added conducted concurrently with the added with Various Footnote Formats (OMB sugars declarations on Nutrition Facts sugars study. The footnote study No. 0910–0764)’’ (Docket FDA–2012–N– labels. included 3,866 participants who were 1210). Participants (n = 6,480) self- different participants from those in the The format study was a Web-based administered the study on their own added sugars study but selected from study conducted in February–March, computers and were randomly assigned the same online consumer panel using 2015, to explore consumer responses to: to view mock-ups of one of three the same sampling methodology as that (1) Three different formats of the formats of the current Nutrition Facts used in the added sugars study. The Nutrition Facts label (the Current label: (1) The ‘‘Added Sugars’’ format, in purpose of the footnote study was to format, the Proposed format, and the which an added sugars declaration was explore consumer responses to various Alternative format discussed in the indented below a ‘‘Sugars’’ declaration; formats for the footnote area of the proposed rule) (80 FR 11879), with each (2) the ‘‘Total Sugars + Added Sugars’’ Nutrition Facts label, including those format embodying all current label format, in which an added sugars that provide information such as various elements or most of the potential declaration was indented below a ‘‘Total definitions for percent Daily Value, a changes to them as outlined in the Sugars’’ declaration; and (3) the succinct statement about daily caloric proposed rule (e.g., the prominence of ‘‘Current’’ format, in which ‘‘Sugars,’’ intake, and general guidelines for high the calorie declaration, the position of but not added sugars, was declared on and low nutrient levels. Participants the percent Daily Value column); (2) the the label. While viewing their assigned self-administered the study on their location of the percent Daily Value label images, participants answered own computers and were randomly column (right or left side of the label); questions on their ability to recognize assigned to view a mock-up of one of (3) column type (single-column, dual- and compare nutrient amounts on the seven Nutrition Facts label formats. Five column, and dual-calorie); (4) location Nutrition Facts label and their of these Nutrition Facts formats of sodium declaration on the Proposed judgments about the foods’ overall included modified footnotes; one single column label; and (5) the healthfulness and relative nutrient included the current footnote, and one declaration of voluntary vitamins and levels. The Nutrition Facts label images included no footnote at all. The fats (voluntary vitamins, voluntary fats, were accompanied by a product identity footnotes displayed variations of and both vitamins and fats). A total of caption (e.g., ‘‘Frozen Meal’’ or information such as a description of 5,430 consumers participated in the ‘‘Cereal’’), but no front panel or brand percent Daily Value, a succinct format study; they were recruited from name, either fictitious or real. The study statement about daily caloric intake, or the same online consumer panel with was designed as a controlled a general guideline for interpreting the same sampling methodology as in experimental study that employed percent Daily Values, or noted nutrients the added sugars and the footnote random assignment in order to establish whose daily intake should be limited. studies. As in the added sugars study causal relationships between test While viewing a label, participants and the footnote study, participants conditions and consumer responses. answered questions about their were randomly assigned to view Because the study was not intended to judgments of the foods’ overall different Nutrition Facts label mock-ups generate population estimates, healthfulness and levels of vitamin A, and answer questions about their: (1) participants were selected from vitamin C, dietary fiber, fat, and sodium. Perceptions of the healthfulness and members of an online consumer panel After rating the product’s nutritional levels of nutrients of a product; (2) in the United States. To recruit a diverse attributes, participants who viewed identification of which product in a pair study sample, quotas were constructed labels that included one of the five of products was considered healthier; with the aim of making the sample’s modified footnotes or the current (3) accuracy of identifying the amount distributions of age, gender, education, footnote were asked to rate the footnote of nutrients per serving and per race/ethnicity, and census region statement’s understandability, container and number of servings per resemble that of the U.S. population as usefulness, believability, and container; and (4) perceptions of the closely as possible. helpfulness for the following dietary understandability, usefulness, The added sugars study found that, tasks: Comparing products, planning a believability, and helpfulness of the while added sugars declarations healthy diet, determining the label for various dietary tasks such as increased the ability of some healthfulness of a food, and deciding comparing products and deciding how participants to identify those products how much of a food to eat. much of a food to eat. with less added sugars and to determine The footnote study found that all five We did not find many significant or the quantity of added sugar in a food, footnote options produced similar consistent effects of these label the declarations decreased the ability of perceptions and judgments relative to variations on the answers to the some participants to correctly identify the current footnote and the no-footnote questions we asked. However, there the quantity of total sugars in a food. control. Nevertheless, all five modified were some notable and statistically The ‘‘Total Sugars + Added Sugars’’ footnotes were rated as easier to significant differences when comparing

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the current, single-column Nutrition demographic characteristics and demonstrate how the study design will Facts label with the % DV on the right experience with the Nutrition Facts allow the Agency to determine causality (the ‘‘Current label’’), the single-column label. Due to an unexpected issue (Ref. 6). Nutrition Facts label with the % DV on during recruiting, the eye-tracking study We chose to conduct the added the left (which we had proposed (the did not include any participants who sugars, the footnote, and the format ‘‘Proposed label’’)), and an alternative, were 35 years of age or younger. We studies using a Web-based approach single-column label with the % DV on asked study participants to come to a with mock-ups of the Nutrition Facts the left (the ‘‘Alternative label’’). central location in each city to view label and footnote. The Web-based Respondents were more accurate in mock-ups of three label formats (the approach is quicker in administration identifying the grams of saturated fat Current format, the Proposed format and and data collection and more efficient in and the % DV for sodium using the the Alternative format) (80 FR 11879) on including participants from many single-column Proposed label (% DV a computer screen, recorded different parts of the country than other left) compared to the single-column participants’ eye-movement data to modes of data collection such as in- Current label (% DV right). Respondents examine and compare the degree of person interviews. The approach also were more accurate in identifying the attention paid to some of the possible reduces administrative errors in terms of grams of sugars per serving using the label changes and the level of effort assignment of labels for different single-column Current label (% DV participants used to perform three participants. We used mock-ups of the right) compared to the single-column categories of task (browsing a label, label and footnote rather than real food Proposed (% DV left) or single-column searching for specific information on a packages because the approach helps Alternative label (% DV left), and they label such as the amount of sodium per the studies accomplish their goal of were more accurate in identifying the serving in a product, and identifying exploring consumer responses to grams of sugars per container using the which of a pair of products they would differences in the presentation of the single-column Current label (% DV choose for a given purpose such as if label rather than of a food package, right) compared to the single-column they were to buy a healthier product for which includes other components such Proposed label (% DV left). Finally, themselves). Labels used in this study as the front panel, the ingredient list, respondents were more accurate in were borrowed or adapted from the and imageries. The presence of these identifying the grams of added sugars format study. other label elements can weaken a with the single-column Proposed label The eye-tracking study showed few study’s ability to obtain key information (% DV left) as compared to the single- statistically significant differences on the label and the footnote to answer column Alternative label (% DV left) between the Current and the Proposed its research questions. (respondents assigned to view the formats or between their variants. All studies used non-probability samples recruited from either members Current label were not asked this Among these differences, no one single of the public at selected geographic question). Among the Proposed labels format or variant consistently stood out locations with a certain degree of with % DV on the left (single-column, as the ‘‘best’’ format in terms of degree diversity in sociodemographic dual-column, and dual-calorie), we of participant attention to label characteristics (i.e., age, gender, found that dual-column labeling information, level of effort in using label education, race/ethnicity), as in the eye- significantly improved respondents’ information, or accuracy of information tracking study, or members of a ability to identify the amount of search or dietary choices. Many of the format differences pertained to two commercial online consumer panel with nutrients in the entire container. More specific label components: (1) Sodium, the sample’s sociodemographic details about the study methodology carbohydrate, and protein; and (2) characteristics matched to that of the and results can be found in an vitamins and minerals. There was little general population, as in the added Administrative File entitled evidence that the Proposed format led sugars, the footnote, and the format ‘‘Experimental study of proposed participants to re-allocate their attention studies; in all these cases, an changes to the Nutrition Facts label to or effort spent on different label individual’s probability of being formats (OMB No. 0910–0774)’’ (Docket components while browsing a label or selected into a sample was unknown. In FDA–2012–N–1210). making the dietary choices. More details particular, the online panel recruitment The eye-tracking study, conducted in about the study methodology and methodology was based on the opt-in January–March, 2015, was to explore results can be found in an approach, a non-probability sampling whether and to what extent most of the Administrative File entitled ‘‘Eye- technique. In contrast to probability potential label changes as outlined in tracking experimental study on sampling in which every individual has the proposed rule (80 FR 11879), in consumer responses to modifications to some chance of being selected to their totality, may increase consumer the Nutrition Facts label outlined in the participate in a study, not all attention to various label elements (e.g., Food and Drug Administration’s individuals have some chances of being calories, number of servings) and lessen proposed rulemaking (OMB No. 0910– selected in a study. To ensure consumer effort in searching for specific 0774)’’ (Docket FDA–2012–N–1210). representativeness of selected label information. In addition, the eye- For all four studies, we employed a participants of the population, it is tracking study explored how the randomized controlled experimental necessary that everyone has a known difference in the location of the percent approach. According to the Office of probability and that no one is left out Daily Value column may cause any Management and Budget (OMB), when (Ref. 7). In addition, according to OMB’s changes in consumer attention to Federal Agency research questions Guidance on Agency Survey and various label elements. A total of 160 involve trying to determine whether Statistical Information Collections, for English-speaking adult consumers in there is a causal relationship between the purpose of making estimates with four cities (Washington, DC, Chicago, IL, two variables or whether a program measurable sampling error that Boston, MA, and San Francisco, CA) caused a change for participants, the represent a population, the sample must participated in the eye-tracking study. Agency will need to employ an be selected using probability methods, They were recruited by telephone and experimental or quasi-experimental where a subset of the population is the sample was composed of some design (rather than other approaches chosen randomly such that each unit degree of diversity in socio- such as population surveys) to has a known nonzero probability of

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selection (Ref. 6). Therefore, none of the that we conduct additional consumer nation. The comments stated that such studies could provide nationally research on selected changes outlined in representativeness was important for representative population estimates of the proposed rule. The comments felt assessing the effects of the proposed consumer understanding, behaviors, or further research is needed because it is label format changes on consumer perceptions, nor could their data be difficult to examine the effects of understanding and use of the label. In considered nationally representative. individual proposed changes based on particular, the comments were The samples of our studies were not our studies. concerned that the lack of such selected using a probability sampling (Response) One of our missions is to representativeness, for example, the method and the samples came from assist in providing the public with the absence of participants 35 years of age consumers in selected locations or an accurate, science-based information it and younger in the eye-tracking study, opt-in online consumer panel. needs to use medicines and foods to would render results imprecise or Therefore, based on the AAPOR and maintain and improve health (Ref. 8). misleading. Some comments also OMB guidelines, we do not consider the The objective of the Nutrition Facts encouraged us to obtain nationally findings of any of the four studies label is to provide nutrition information representative samples of the projectable to the general population. about products to help consumers in population for future consumer research The overarching purpose of our maintaining healthy dietary practices. studies. research was to explore how and to Therefore, as part of our continuing (Response) While we recognize that what extent different presentations of effort to enable consumers to make our study samples are not nationally the label and its components may affect informed dietary choices and construct representative, we disagree that the use consumer responses to the healthful diets, we intend to, subject to of such samples would render our presentations. The added sugars study program priorities and resource findings imprecise or misleading. The also was conducted to enhance our availability, conduct more consumer purpose of our studies was to understanding of how inclusion of research to help enhance the usefulness investigate and compare how different added sugars declarations on the and understandability of the label. presentations of label information may Nutrition Facts label may affect how In the format and the eye-tracking cause different responses by consumers. consumers perceive a product or a label experimental studies, we chose to In other words, we sought to understand and how to better educate people in examine the combined effects of most of the causal relationships between the using the Nutrition Facts label in the changes outlined in the proposed label presentations and consumer general. We did not aim to use these rule, in totality. Nevertheless, in both response rather than develop nationally studies to help us develop a label that studies, we also examined selected representative estimates of the will be understood by all consumers. individual changes where we thought prevalence or extent of various We recognize that, regardless of how original consumer research would be responses. Therefore, our primary well a label is designed, there is always helpful. For example, we were consideration in the study design was a certain proportion of consumers who interested in the effect of the location of internal validity (i.e., the validity of the encounter challenges in understanding the percent Daily Value (left or right) causal relationships) rather than and using the label. independent of other format elements external validity (i.e., the extent that the In the Federal Register of July 27, and therefore studied that change on all results can be generalized to the 2015 (80 FR 44302), we added a three label formats (Current, Proposed, population or to presentations other description and our findings of these and Alternative) (in both the format and than those studied). Even though we four studies to the administrative the eye-tracking studies). We also were focused on internal validity, we record, and we reopened the comment interested in the effect of column type recognized that, to make the study period for the sole purpose of inviting (single-column, dual-column, and dual- findings more robust, it was important public comments on the eye-tracking calorie) independent of other label that the studies included participants and the format studies. We also format changes and therefore studied from different segments of the published a supplemental proposed rule that on all three label formats (in the population in terms of education, that discussed, among other things, format study). We also were interested gender, race/ethnicity, and geographic information on the added sugars and the in some other possible label format regions. Moreover, the causal footnote studies (80 FR 44303). In changes and therefore chose to study the relationships we examined were not response, many comments discussed effects of moving the location of sodium necessarily particular to certain our studies’ findings, methodologies, declaration on the Proposed single segments of the population, and our and implications. Some comments column label (in the format study), as samples included consumers with a provided new consumer research well as the declaration of voluntary wide range of label reading and use information related to issues examined vitamins and fats (voluntary vitamins, practices. in our studies, particularly the added voluntary fats, and both vitamins and We doubt the absence of study sugars declaration. To the extent that fats) (in both the format and the eye- participants aged 35 years and under in the comments pertained to general tracking studies). We believed the the eye-tracking study, which was due issues involving our study results and original consumer research on these to an unexpected issue in recruiting methodologies, we address them here. topics was more useful than on other participants from this segment, would We respond to comments related to topics. Therefore, we took a have led us to reach noticeably different research implications that are specific to approach of studying the differences conclusions about the label formats. the added sugars declaration or to between the Current, Proposed, and While all of the eye-tracking format issues, such as the footnote, Alternative formats in totality and as participants were over age 35, they were elsewhere in this document (see, e.g., well as in isolation for selected diverse in many other important factors part II.H.3, ‘‘Added Sugars,’’ and part individual changes. that the literature suggests may be II.Q, ‘‘Format’’). (Comment 7) Some comments related to label viewing and use, such as (Comment 6) While many comments questioned whether participants in our gender, education, race/ethnicity, label referred to our research findings as part studies generally or as assigned in reading practices, attitudes toward the of the evidence used to support their individual conditions were label, and nutritional interest (Refs. 9– positions, some comments suggested representative of the consumers in the 11).

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(Comment 8) One comment said that have more reliable data that can label formats to participants in the eye- the use of terms such as ‘‘healthy’’ and contribute to a more successful solution. tracking study could have affected the ‘‘healthier’’ in our studies represented a (Response) The comment did not participants’ responses. The comments misuse of a defined nutrient content explain why data collected non- attributed the concern to the design that claim. The comment also noted that electronically are more reliable than showed all participants the Current consumers have different interpretations data collected electronically. We believe label in the first set of tasks and showed of the term ‘‘healthy’’ and that these the Web-based approach is appropriate the Proposed or Alternative labels interpretations may be based on for the purposes of our studies. randomly in the second set of tasks, considerations that are different from Furthermore, the comment did not rather than showing the three labels to those defined for the claim ‘‘healthy’’ in assert that our study results were three randomly assigned groups of FDA regulations. In addition, the necessarily flawed because we collected participants in one set of tasks. The comment said that the use of the term data electronically. comments further stated that the design ‘‘healthy’’ in the eye-tracking study was (Comment 10) One comment asked us choice was not explained. a cue to participants that there is a to clarify a conclusion reported in the (Response) We acknowledge that the correct answer and the criterion was preamble to the supplemental proposed design could potentially have yielded ‘‘healthy.’’ rule that when participants viewing different results than a design that (Response) In the consumer studies Nutrition Facts labels without added randomly assigned participants to the we conducted for informing this sugars declarations could not accurately three formats. We chose our design rulemaking, research participants were determine the amount of added sugars because the Current Nutrition Facts presented with and asked to respond to in the products and that many label has been on products for a Nutrition Facts label. Neither the front participants who viewed Nutrition Facts approximately 20 years and most, if not panel of a package nor the ingredient labels without added sugars all, consumers have had exposure to or list was provided to participants. In our declarations assumed that the more used the label. Consumers have likely studies, the questions that asked nutritious products in the study had less developed their own patterns of reading participants to assess products’ added sugars (80 FR 44303 at 44306). and use of the Current label. healthfulness served as one type of The comment asked us to clarify the Furthermore, the objective of the study measure of potential consumer reactions preceding statement because it further was to explore whether and how much to the tested Nutrition Facts label noted that another document, namely, the two label formats outlined in the formats and content modifications. ‘‘Experimental Study of Proposed proposed rule would help raise These questions were not connected to Changes to the Nutrition Facts Label consumer attention to certain label the regulatory meaning of a ‘‘healthy’’ Formats,’’ stated that ‘‘respondents elements and reduce reading efforts. claim, which usually appears on the assigned to view the Current label were The design we chose recognized that front panel of a package, and we not asked to identify the grams of added participants would carry their own disagree that the healthfulness questions sugars.’’ The comment questioned how patterns of reading and using the in our studies reflect ‘‘a misuse,’’ as we were able to arrive at the conclusion Current label into tasks based on the asserted in the comments, which referenced in the supplemental Proposed and the Alternative labels. To mischaracterize the purpose of the proposed rule, reasoning that the two the extent that the patterns could have healthfulness questions in the studies statements appear contradictory, as varied between participants, each we conducted. participants in the format study who participant’s responses to the Current We agree, in part, and disagree, in viewed the Current label were not asked label in the first set of tasks was used part, that the use of the term ‘‘healthy’’ questions regarding the amount of as her/his own baseline when we in the eye-tracking study was a cue to added sugars. examined the responses to the Proposed participants that there was a correct (Response) The two statements are not or the Alternative labels in the second answer and the criterion was ‘‘healthy.’’ contradictory because the two set of tasks. This approach, in turn, We agree that this term was used in the statements refer to different studies. Due could minimize the within-subject study to prompt participants to use to the different purposes of the studies, differences between study participants ‘‘healthy’’ as the criterion in deciding the format study did not ask and help reveal the true differential their response to the task of choosing participants who were assigned to the effects of label format on attention and which of two products they thought was Current label about the amount of added efforts. Correspondingly, we applied the healthier for themselves. The primary sugars, whereas the added sugars study difference-in-difference analysis for this purpose of this design was to examine did. We used results from the added purpose. Therefore, although our design whether and how different label sugars study, rather than findings from could have produced different results presentations would lead to differences the format study, to arrive at the than a design that randomly assigned in participant attention to various parts conclusion stated in the supplemental participants to the three label formats, of a label if participants were proposed rule. we believe our design is appropriate considering a healthy dietary choice. (Comment 11) One comment asked if under the particular circumstances. The accuracy of choice was of less we balanced the sample for (Comment 13) One comment said that interest in this design. In addition, one demographic characteristics in the the sample size of the eye-tracking study of the products presented to the added sugars and format studies. was too small to produce reliable participants always had lower content (Response) In the added sugars and empirical evidence. The comment also of calories, total fat, saturated fat, format studies, we did balance our said that, despite the study’s claim that sodium and sugars than the other, so the samples on key demographic the sample represented a wide variety of ‘‘correct’’ choice was unambiguous. characteristics. We selected our samples demographics, the claim is misleading Therefore, we do not believe that the by matching their key demographic because the South and Midwest regions study design would have biased the characteristics (i.e., age, gender, were not included and 69 percent of the answers participants gave in this task. education, race/ethnicity, and census sample had a college or advanced (Comment 9) One comment suggested region) to that of the U.S. population. degree. that we conduct studies that are not (Comment 12) Some comments said (Response) We disagree with the electronically based so that we may that the order in which we assigned comment. Our sample size calculations

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suggested that the numbers of size. In addition, one comment said that container and number of servings per participants included in various the study report did not include container; and (4) perceptions of the statistical tests were sufficient to respondents’ perceptions of each label’s understandability, usefulness, achieve the conventional degree of ‘‘helpfulness.’’ believability, and helpfulness of the statistical power of at least a medium (Response) The main purpose of the label for various dietary tasks such as effect size for the non-parametric format study was to compare consumer comparing products and deciding how analyses we conducted. This is use and understanding of Current, much of a food to eat. particularly true in terms of key Proposed, and Alternative label formats Lastly, we disagree with the comment outcome measures during label (in their totality). Additionally, the that we did not report on respondents’ browsing (proportion of participants study was designed to test the effects of perceptions of label ‘‘helpfulness.’’ We who noticed a label component at least the location of Percent Daily Value, reported on respondents’ perceptions of once, length of time it took participants column type (single- vs. dual-column ‘‘helpfulness’’ for each set of label to notice a label component for the first vs. dual-calorie), location of sodium comparisons in the ‘‘Label preference’’ time, proportion of total label viewing declaration on the Proposed single- rating. time spent on a label component, column label, and declaration of (Comment 15) Some comments asked proportion of total number of notices voluntary vitamins and fats on the us to conduct additional analyses with spent on a label component), during Proposed label. Given the priorities the format experimental study on the information search (proportion of chosen, we carefully designed the study, Nutrition Facts label formats data. Some participants who identified target including the necessary number of test comments requested that we provide an information, length of time it took labels, to ensure that the study could analysis specifically comparing the participants to find target information, provide adequate statistical power to single-column Current label format to number of notices of target information test hypotheses related to the priority the dual-column Proposed label format. before it was found), and during product topics. Thus, the overall study design Another comment asked us to provide identification (length of time it took and number of labels were appropriate. the results related the effect of adding participants to enter a choice, Moreover, we disagree with the absolute values to the vitamins and proportion of participants who selected comment stating the questions about minerals as was found on the Proposed a given label, proportion of participants calories per serving and number of and Alternative labels. One comment who noticed a label component at least servings appeared later in the asked why we did not include an once on either of a pair of labels, questionnaire and were less important. analysis of the number of servings per proportion of total number of notices These questions appeared in the first container. spent on a label component, and half of the questionnaire. In addition, (Response) In the notice on Food proportion of total label viewing time with respect to the comment on the Labeling: Revision of the Nutrition and spent on a label component). order of questions related to subjective Supplement Facts Labels; Reopening of Additionally, as shown in the study numeracy, we conducted the cognitive the Comment Period as to Specific report, the participants varied in interviews with the subjective numeracy Documents (80 FR 44302), we reported education attained, gender, race/ questions at the beginning of the study on the results of our consumer study ethnicity, and geographic locations. and found that the overall flow of the ‘‘Experimental Study of Proposed Thus, contrary to what the comment questionnaire was working well. We did Changes to the Nutrition Facts Label said, the sample did include a wide not use these questions to screen Formats’’ related to key aspects of the variety of demographics. participants in or out of the study. changes we proposed to the format of (Comment 14) Some comments With respect to comments related to the nutrition label. The comparisons questioned certain design aspects of questions not included in the format suggested by the comments could be how the format experimental study study, we narrowed our questions to the made through additional analyses of the tested the different Nutrition Facts label purpose of the study. For example, data we collected. While we reported formats. In particular, some comments although we did not include specific the effects of the format types within the said that the overall study design was questions to assess consumer same column type and the column-type complex and that 29 labels were too understanding of the terms ‘‘% DV’’ and within the same format type, we did not many to test at once and recommended ‘‘% Daily Value, ’’ we assessed the report the comparison between the a simpler design. One comment said effects of the location of Percent Daily Current single-column format and that questions related to calories per Value through a question that used the Proposed dual-column format. Such an serving and number of servings were definition of % Daily Value as part of analysis would not have provided us comparatively less important because the question. Specifically, we included with information on the differences in they appeared later in the questionnaire. a question asking respondents the formats in which we were most In addition, the comment asked why the percentage of sodium for the day in a interested. However, for our own subjective numeracy questions, which serving of a product to see how the interest, we have since conducted that asked participants to self-rate their labels compared in helping respondents analysis and the results do not provide aptitude for working with fractions and find the % Daily Value. In addition, the any new information related to our percentages, appeared at the beginning focus of this study was not on consumer consideration of the format of the of the questionnaire. use and understanding of the meaning nutrition label. The results of this Other comments questioned why of serving size and therefore did not analysis seem to corroborate our main certain topics were not included as part include a specific question about it. finding related to the effects of dual- of the questionnaire. For example, one Instead, we focused on how the label column labeling compared to single- comment noted that, although the term formats affected consumers’: (1) column labeling as described in table 7 ‘‘% DV’’ was used in place of ‘‘% Daily Perceptions of the healthfulness and of our June 30, 2015 memo to the file Value’’ in the Proposed and Alternative levels of nutrients of a product; (2) (Ref. 12). As reported in that memo, the label formats, there were no questions identification of which product in a pair Proposed dual-column label (% DV left) specific to this change in the study. The of products was considered healthier; scored higher than the Proposed single- comment also asked why there were not (3) accuracy of identifying the amount column label (% DV left) on the Total more direct questions about serving of nutrients per serving and per correct per container measure.

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Similarly, in the new comparison, the vitamins and mineral section nor in also noted that, in Appendix A of the Proposed dual-column label (% DV left) healthful food choices made. The FDA study report about the results of scored higher than the Current single- comment also stated that moving the the added sugars study (Ref. 14), the column label (% DV right) on that same percent Daily Value column to the left ‘‘most nutritious’’ frozen meal had more measure. The new comparison side of the label reduced participants’ calories, sodium, fat, and saturated fat, demonstrates that the Proposed dual- attention to the percent Daily Value and lower iron and vitamin C than the column (% DV left) also scored higher information. In addition, the comment ‘‘least nutritious’’ frozen meal. on the Total Correct per serving measure suggested that more noticeable changes (Response) Because the comment does than the Current single-column (% DV to the label format, such as using traffic not specify what was ‘‘unbalanced’’ in right) label. light colors, or descriptors, such as the experimental conditions and what In addition, the purpose of our ‘‘high’’ or ‘‘low,’’ may have a greater specific inferences were therefore evaluation of consumer views about impact on attention and choice than the precluded, we do not have sufficient how high or low the product is in a changes we proposed. information to respond to this comment. vitamin or mineral when absolute (Response) We decline to comment on We disagree that the study did not values were provided, compared to a the findings because the comment did isolate the effect of added sugars label without this information, was to not provide sufficient details about how declarations separately from the effect of understand how some consumers the study was designed and analyzed. calories because that is in fact what the perceive different numbers associated As for other possible changes of the experimental design achieved. In other with various units of measure. In label that the comment speculated words, by randomly assigning response to the comment on our might affect consumer attention and participants to different experimental findings on absolute amounts, we did food choices, e.g., traffic light colors or conditions, we were able to compare complete a review of that aspect of the text descriptors, such issues are outside participant responses in experimental data, and the results do not provide any of the scope of this rulemaking. conditions that were treated identically new information related to our (Comment 17) One comment said that in all respects other than the display of consideration of the declaration of FDA’s added sugars study seemed to be added sugars information, thus isolating absolute amounts for some or all unduly focused on whether consumers the effect of added sugars declarations nutrients (Ref. 13)). The study did not could correctly identify added sugars from the effect of other experimental address how consumers use or and how identification of added sugars factors, such as calorie information. understand absolute amounts for affected overall judgment of the Regarding Appendix A of the FDA following dietary advice. Participants product. The comment also stated that study report (Ref. 14), there was a who viewed the different label the study design steered participants to typographic error on the nutrition conditions were asked to rate on a 5- think specifically about added sugars profiles for the frozen meals. Meal 1 point scale (1 = none or very little; 5 = throughout the survey, potentially should have been labeled the ‘‘least a lot) how much of various nutrients leading them to judge the labels on the nutritious,’’ whereas Meal 3 should they thought were in one serving of the amount of added sugars. have been labeled the ‘‘most nutritious.’’ product. Because the questions asked (Response) We disagree that the This typographic error, however, did participants to offer their subjective design of the added sugars study unduly not in any way affect the rest of the perception, rather than report the emphasized, or otherwise steered study description or reported findings. absolute amount for a nutrient, no rating participants to focus on, added sugars (Comment 19) One comment noted offered could be judged as correct or beyond a level necessary to meet the key that in table 8 of the added sugars study incorrect. Instead, the ratings simply objectives of the study. A primary focus report (Ref. 14), the mean ‘‘usefulness’’ provided information about how pairing of FDA’s added sugars study was to score for those viewing the control the correct absolute nutrient amount explore participants’ understanding of format was 3.93, whereas the mean with the correct % DV affected Nutrition Facts labels that include ‘‘usefulness’’ score for those viewing the participants’ perceptions. added sugars declarations relative to added sugars declaration format was Further analysis found that there was participants’ understanding of Nutrition 3.97. The comment stated that the report no difference in correctly identifying the Facts labels that do not include added noted a significant difference between number of servings per container sugars declarations. Although the these scores and requested clarification. between the single-column labels, the primary objectives of the study (Response) The comment is incorrect. dual-column labels, or between the pertained to added sugars declarations, The report indicated that there was no Current single-column (% DV right), we used a variety of measures to assess statistically significant difference and the Proposed dual-column (% DV a range of participant reactions to the between the two means in question. left) (Ref. 13). Thus, none of these different labels. For example, we asked (Comment 20) One comment stated formats had any influence on how participants to evaluate foods’ overall that the voluntary responses from study participants identified the number of healthfulness as well as the levels of participants during the debriefing phase servings per container, and therefore, various nutrients such as saturated fat, of the eye-tracking study showed that did not provide any new information sodium, dietary fiber, and others, in consumers had difficulties using the related to our consideration of the addition to added sugars. Current label and did not understand servings per container. (Comment 18) One comment noted terms such as saturated fat and trans fat. (Comment 16) One comment that the added sugars study varied the (Response) We disagree that the mentioned an eye-tracking study that experimental conditions in an indicated responses showed that the comment did to examine and unbalanced way, making it difficult to consumers have difficulties using the compare participants’ attention to the make inferences about the experimental Current label and do not understand Nutrition Facts label either in its current conditions. The comment also said that terms such as saturated fat and trans fat. format or in the proposed format. The we did not keep the caloric value The comment did not interpret this comment stated that the study did not consistent across products and, finding in context. The full statement in find significant differences between the therefore, did not isolate the effect of the our study report is ‘‘When asked, most two formats either in attention to the added sugars declarations separately participants did not report having label in its totality or in terms of the from the effect of calories. The comment difficulties using the Current format as

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long as they knew what to look for on statements or statements that are subject accurate disclosures of factual the label (table 25) (Ref. 15). Some, to misinterpretation. Other comments commercial information about the however, mentioned that they did not said that because there is already a amount of added sugars contained in a understand some of the information on declaration for total sugars and there is food. The required disclosure requires the label, such as fats and trans fat, or no material difference, or scientific only facts about the product (Am. Meat had problems with the small font size of rationale, for distinguishing between Inst. v. United States, 760 F.3d 18 (D.C. the information’’ (eye-tracking study added and intrinsic sugars, including no Cir. 2014) (‘‘country-of-origin labeling memo in the re-opener, July 27, 2015, p. ‘‘sufficient nexus to consumer health,’’ qualifies as factual, and the facts 25). Contrary to the comment, the report the declaration of added sugars is not conveyed are directly informative of states that most of the study participants purely factual and uncontroversial intrinsic characteristics of the product did not have difficulties using the information for which the First AMI is selling’’)). This required labeling Current label, and only some said they Amendment test in Zauderer would will help facilitate the free flow of did not understand fats and trans fat. apply. One comment stated that because commercial information by providing a added sugars are not chemically distinct declaration of added sugars on food C. Comments on Legal Issues from natural sugars and do not have labels, and does not ‘‘prescribe what Several comments addressed legal different health effects, the declaration shall be orthodox in politics, issues. Some comments asserted that of added sugars would be false and nationalism, religion, or other matters of FDA cannot compel an added sugars misleading and the Agency could not opinion’’ (Zauderer, 471 U.S. at 651 declaration in nutrition labeling under compel it under the First Amendment. (quoting W. Va. State Bd. of Educ. v. the First Amendment. We also received Several comments stated there are no Barnette, 319 U.S. 624, 642 (1943))). comments that questioned whether our physiological distinctions between As for the comments stating that there proposed requirement for an added added and naturally occurring sugars, is no material difference or scientific sugars declaration and certain other and therefore, no connection to rationale for distinguishing between proposed requirements are consistent consumer health on which to compel total sugars and added sugars, or with the requirements in the such speech. between added sugars and naturally Administrative Procedure Act (APA) (Response) The disclosure of added occurring sugars, these comments relate and our authority under the FD&C Act. sugars is factually accurate nutrition to our rationale for why an added sugars In addition, we received comments information and industry’s interest in declaration will assist consumers to questioning our authority to require and not disclosing such factual information maintain healthy dietary practices and access records related to the is minimal. In Zauderer, the Supreme not to whether the declaration is factual declarations for added sugars, dietary Court explained that ‘‘[b]ecause the and accurate information. We address fiber, soluble fiber, insoluble fiber, extension of First Amendment these comments in part II.H.3.i. The vitamin E, and folate/folic acid. Other protection to commercial speech is added sugars declaration conveys comments raised miscellaneous legal justified principally by the value to factual and accurate information about issues. consumers of the information such the amount of added sugars in a serving 1. First Amendment speech provides, [a speaker’s] of food. constitutionally protected interest in not Second, the required added sugars Many comments on the proposed providing any particular factual declaration is not unduly burdensome. requirement to include an added sugars information in his advertising is Factual nutrition information for a declaration on food labels related to our minimal’’ (see 471 U.S. at 651 (internal number of other nutrients is currently ability to compel such speech under the citations omitted)). Providing required to be provided on packaged First Amendment. Some comments consumers the amount of added sugars foods. The space that is occupied by the supported our proposed requirement for in a serving of food ‘‘does not offend the indented line for the ‘‘Includes ‘XX’ g the declaration of added sugars as core First Amendment values of Added Sugars’’ declaration, below the factual, uncontroversial information, promoting efficient exchange of ‘‘Total Sugars’’ declaration does not based on the application of the First information’’ and ‘‘furthers, rather than increase the size of the existing Amendment test set forth in Zauderer v. hinders, the First Amendment goal of Nutrition or Supplement Facts label, Office of Disciplinary Counsel of the discovery of the truth and given changes made elsewhere to the Supreme Court, 471 U.S. 626 (1985). contributes to the efficiency of the label, such as reducing the size of the Most comments raising First ‘marketplace of ideas’ ’’ (Nat’l Elec. Mfrs. footnote in the label. We also note that, Amendment arguments did not support Ass’n v. Sorrell, 272 F.3d 104, 113 as discussed in our economic analysis the proposed declaration, but differed in through 114 (2d Cir. 2001). As a result, (Ref. 16), the cost to manufacturers is their assertion of the applicable First government requirements to disclose reduced from that in the proposed rule Amendment test. Many comments factual commercial speech are subject to under the compliance timelines in the asserted that the proposed declaration a more lenient constitutional standard final rule which will allow most did not satisfy the Zauderer test, while than that set forth under the Central manufacturers to make revisions to the other asserted that it failed under the Hudson framework (Zauderer, 471 U.S. label during regularly scheduled label test set forth in Central Hudson Gas & at 651). Under Zauderer, the changes for their products. Electric Corp. v. Public Service Comm’n, government can require disclosure of Third, the required added sugars 447 U.S. 557 (1980). Still others asserted factual information in the realm of declaration is reasonably related to our that the proposed declaration was commercial speech as long as the government interests in promoting the subject to, and failed to satisfy, strict disclosure provides accurate, factual public health, preventing misleading scrutiny review. information; is not unjustified or unduly labeling, and providing information to (Comment 21) Some comments said burdensome; and ‘‘reasonably relate[s]’’ consumers to assist them in maintaining the added sugars declaration is not to a government interest (id.). healthy dietary practices, and thus subject to the test in Zauderer, or, even The required added sugars declaration amply satisfies the remaining element of if subject, does not meet such test. readily satisfies the Zauderer test. First, the Zauderer test. Providing consumers Specifically, one comment stated that the declaration of added sugars, which with information about the added sugars Zauderer does not apply to misleading is being finalized in this rule, provides content of food would promote the

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public health by ensuring they have recommendations, leading to for weight maintenance. Because added information to assist them in meeting overconsumption, for the nutrients sugars are in such a wide variety of nutrient needs within calorie limits and sodium and saturated fat and the food foods in the food supply, consumers to assist them in constructing a healthy components refined grains, solid fats, need to have information on the label so dietary pattern that is limited in added and added sugars.’’ While intake levels that they can consider the amount of sugars to reduce the risk of CVD. As of added sugars still remain high at an added sugars in both foods that supply explained in the preamble to the average of 13.4 percent of calories large amounts of added sugars as well proposed rule (79 FR 11879 at 11903), among the U.S. population, the amount as those that supply smaller amounts Americans consume too many calories of added sugars available for the calorie when constructing a healthy dietary from solid fats and added sugars, which ranges covered by the USDA Food pattern that contains less than 10 makes it difficult for consumers to meet Patterns (1,000 to 3,200 calories) ranges percent of calories. nutrient needs within their calorie from only 4 to 9 percent (Ref. 19). Without the declared amount of limits. The 2010 DGA noted that solid The scientific evidence, and other added sugars, consumers would be fats and added sugars contribute a data and information, supports the need denied access to the information they substantial portion of calories (35 for an added sugars declaration to need to reduce the intake of added percent) in the American diet, with 16 promote the public health. sugars to the recommended daily limit. percent on average from added sugars. In addition, the declaration of added As discussed in our response to Recommended calorie limits for most sugars provides information that is comment 159, added sugars is a material consumers, as set forth in the 2010 material because, without the fact, within the meaning of section DGA, can only reasonably accommodate declaration of added sugars, consumers 201(n) of the FD&C Act. Mandatory 5 to15 percent of calories from solid fats would not have access to information labeling that provides information about and added sugars combined (id.). While about the amount of added sugars in a the contribution to daily caloric intake it is true that excess calorie serving of food. The current ‘‘Sugars’’ of added sugars is necessary to ensure consumption from any source can lead declaration on the label does not that full, factual information is imparted to weight gain, the statistics on calorie provide information on how much to consumers so they have access to the consumption from solid fats and added added sugars are present in a food, nor information needed to follow a healthy sugars suggest that, for many does the ingredient listing. The dietary pattern and will not be misled consumers, added sugars contribute to contribution of naturally occurring in purchasing decisions because they excess calorie intake. In fact, the 2010 sugars and added sugars cannot be have no information about added sugars DGA also noted that excess calories determined based on the ‘‘Sugars’’ content and further could not calculate from solid fats and added sugars have declaration that includes both types of it based on the other information on the sugars. In addition, although ingredients implications for weight management label—total sugars content or ingredient are listed in order of predominance by (id.). Moreover, there is strong evidence labeling. weight (21 CFR 101.4), the ingredient Furthermore, the declaration of added showing that children who consume information is not a substitute for the sugars is also reasonably related to the more sugar-sweetened beverages have gram amount of added sugars. An government’s interest in providing greater adiposity (body fat) compared to ingredient listing would not enable the information needed to assist consumers those with a lower intake (id.). consumer to understand the amount of in maintaining healthy dietary practices The 2015 DGAC report further added sugars in grams and therefore, the by providing them with information contributed to the scientific support for contribution of the food to the daily about added sugars content in a serving the added sugars declaration. For the dietary recommended limit of less than of food to construct diets containing first time, the 2015 DGAC conducted a 10 percent of calories from added more nutrient-dense foods and reduce systematic review of the relationship sugars. calorie intake from added sugars by between dietary patterns and health Added sugars are found in many reducing consumption of added sugars outcomes. The DGAC found a strong foods in the marketplace. Consumers are to less than 10 percent calories. Survey association of a dietary pattern likely to be aware that added sugars are data show that consumers use the characterized, in part, by lower present in some sweet foods, such as Nutrition Facts label and the percent consumption of sugar-sweetened foods sugar-sweetened beverages and candy, Daily Value at point-of-purchase and and beverages relative to a less healthy but in other foods, such as sweetened review the nutrient contribution of food dietary pattern and reduced risk of CVD. grains, mixed dishes, condiment, (Refs. 21–23) products. Thus, by We reviewed and considered the gravies, spreads, and salad dressings, requiring the added sugars declaration evidence that the 2015 DGAC relied the presence of added sugars is not as on the Nutrition Facts label, we will upon, including an existing review from obvious. The majority of food sources of give consumers a tool they need to the Nutrition Evidence Library (NEL) added sugars are beverages (excluding include added sugars as part of a Dietary Patterns Systematic Review milk and 100 percent fruit juice), healthy dietary pattern that avoids Project as well as the NHLBI Lifestyle snacks, and sweets; however, 22 percent excess calories from added sugars and is Interventions to Reduce Cardiovascular of food sources of added sugars are from associated with a reduced risk of CVD. Risk: Systematic Evidence Review from other categories of foods such as grains, Some comments asserted that the Lifestyle Work Group (‘‘NHLBI mixed dishes, dairy, condiments, Zauderer is limited to cases where the Lifestyle Evidence Review’’) (Ref. 17) gravies, spreads, salad dressings, fruits government interest is in preventing and the associated American Heart and fruit juice, and vegetables (Ref. 20). consumer deception. Case law Association (AHA)/American College of Small amounts of added sugars that are interpreting Zauderer clarifies that the Cardiology (ACC) Guideline on Lifestyle contributed to diet by a wide variety of government need not establish that Management to Reduce Cardiovascular foods can add up over the course of the compelled disclosure will prevent Risk (‘‘Lifestyle Management Report’’) day and can make it difficult for an consumer deception for the Zauderer (Ref. 18). The diet quality of the general individual to eat sufficient amounts of standard to apply. In American Meat U.S. population ‘‘does not meet foods from the basic food groups to meet Institute, the court held that ‘‘[t]he recommendations for vegetables, fruit, nutrient needs without exceeding the language with which Zauderer justified dairy, or whole grains, and exceeds amount of calories they need in a day its approach . . . sweeps far more

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broadly than the interest in remedying to obesity or heart disease and there is also stated that we articulated a rational deception’’ 760 F.3d 18, 22 (D.C. Cir. no recommended daily allowance. basis for requiring consumers to 2014) (en banc). In reaching the (Response) As explained in our maintain healthy dietary practices conclusion that the applicability of response to comment 21, the required (citing N.Y. State Rest. Ass’n v. N. Y. Zauderer extends beyond regulations in added sugars declaration assists City Bd. of Health, 556 F.3d 114, n.21 which the government is attempting to consumers in maintaining healthy and at 136 (2d Cir. 2009), and Pharm. mandate a disclosure to remedy dietary practices and is reasonably Care Mgmt. Ass’n v. Rowe, 429 F.3d 294 deception, the court focused on the related to our government interests in (1st Cir. 2005)). ‘‘material differences between promoting the public health, preventing (Response) We agree that the disclosure requirements and outright misleading labeling, and providing disclosure of added sugars is factually prohibitions on speech,’’ (id. at 21 information to consumers to assist them accurate nutrition information and that (quoting Zauderer, 471 U.S. at 650)), the in maintaining healthy dietary practices. industry’s interest in not disclosing fact that ‘‘the First Amendment interests Furthermore, we disagree with the such factual information is minimal. We implicated by disclosure requirements comment suggesting that the added also agree that Congress imposed are substantially weaker than those at sugars declaration is unjustified and nutrition labeling requirements to help stake when speech is actually unduly burdensome because ‘‘no consumers have access to information suppressed,’’ (id. (quoting Zauderer, 471 scientific evidence exists to support that would assist them in choosing U.S. at 652 n.14)), and the fact that FDA’s assumption that added sugars healthy diets. Congress prescribed that ‘‘[b]ecause the extension of First contribute to obesity or heart disease’’ foods subject to the nutrition-label Amendment protection to commercial and due to the lack of a DV for added requirements are ‘‘deemed to be speech is justified principally by the sugars. To the extent the comment misbranded’’ if they do not provide value to consumers of the information suggests we were relying on a specific nutrition labels as required (see section such speech provides, [a] nutrient-disease relationship between 403 and 403(q) of the FD&C Act). constitutionally protected interest in not added sugars and obesity or heart Congress also has indicated that providing any particular factual disease in the general population, the labeling’s failure to provide certain information in his advertising is comment misunderstands our rationale material information is to be taken into minimal,’’ (id. (citing Zauderer, 471 for the declaration. We stated that our account in determining whether such U.S. at 651)). The court found that, ‘‘[a]ll scientific basis for the added sugars labeling is misleading (see section told, Zauderer’s characterization of the declaration, in fact, differed from our 201(n) of the FD&C Act). We do not speaker’s interest in opposing forced rationale to support other mandatory respond to the portion of the comment disclosure of such information as nutrients related to the intake of a on Congress’ intent with respect to ‘minimal’ seems inherently applicable nutrient and risk of chronic disease, a allergen labeling under FALCPA beyond the problem of deception’’ (id.). health-related condition or a because it is outside the scope of this Several other circuits concur (see physiological endpoint (see 79 FR 11879 rule. (Comment 24) One comment stated Pharm. Care Mgmt. Ass’n v. Rowe, 429 at 11904). Although we recognized that the added sugars labeling is not to F.3d 294, 297 through 298, 310, 316 (1st U.S. consensus reports do not support a provide purely factual information to Cir. 2005); N.Y. State Rest. Ass’n v. N.Y. cause and effect relationship between prevent consumer deception, but to City Bd. of Health, 556 F.3d 114, 133 (2d added sugars consumption and risk of obesity or heart disease (id.), we shape consumer behavior. Cir. 2009); Nat’l Elec. Mfrs. Ass’n v. considered, in the preamble to the (Response) As explained in the Sorrell, 272 F.3d 104, 115 (2d Cir. 2001) proposed rule (79 FR 11879 at 11902 preamble to the proposed rule (see 79 (affirming use of the ‘‘reasonable- through 11908) and the supplemental FR 11879 at 11905), the added sugars relationship Zauderer standard when proposed rule (80 FR 44303 at 44307 declaration will provide information to the compelled disclosure at issue . . . through 44309), the contribution of consumers on the amount of added was not intended to prevent ‘consumer added sugars to healthy dietary patterns, sugars in a serving of food. We confusion or deception’ ’’); Disc. and the impact to public health from recognize that added sugars can be a Tobacco City & Lottery, Inc. v. United such patterns. In the latter, we included part of a healthy dietary pattern when States, 674 F.3d 509, 556 (6th Cir. 2012) a proposed DV for the added sugars not consumed in excess amounts. The (holding that ‘‘Zauderer’s framework declaration. purpose of the added sugars declaration can apply even if the required (Comment 23) One comment stated is not to discourage the consumption of disclosure’s purpose is something other that the disclosure of added sugars is the class of foods that contain added than or in addition to preventing disclosure of factually accurate sugars, but rather to increase consumer consumer deception’’)). nutritional data and analogized the understanding of the quantity of added (Comment 22) One comment stated disclosure to the disclosure of allergens sugars in foods to enable the consumer the proposed declaration of added under the Federal Food Allergen to understand the relative significance sugars violates the First Amendment Labeling and Consumer Protection Act of the contribution of added sugars from because the requirement is not (FALCPA). The comment said that a serving of a particular food in the reasonably related to a legitimate Congress imposed requirements for context of the total daily diet. A regulatory interest. Another comment nutrient and allergen disclosures so consumer may or may not elect to asserted that an added sugars consumers can make ‘‘safer, healthier, reduce the consumption of certain foods declaration would not assist consumers and more informed choices about the with added sugars, based on his or her in maintaining healthy dietary practices. foods they eat’’ and not because food individual need and dietary choice. The Another comment stated that even if the labels were deceptive without the declaration provides purely factual declaration of added sugars was purely information. The comment cited information so that consumers will have factual and not controversial, the Zauderer and Nat’l Elec. Mfrs. Ass’n v. access to the information they need declaration is ‘‘unjustified and unduly Sorrell, 272 F.3d 104, 113 through 114 about the amount of added sugars in a burdensome’’ (citing Zauderer, 471 U.S. (2d Cir. 2001) for support that industry’s food, and that they are not able to obtain at 651), where there is no scientific interest in not disclosing such factual from the current nutrient declaration of evidence that added sugars contributes information is minimal. The comment ‘‘Sugars’’ or ‘‘Total Sugars’’ alone.

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Through our consumer education, we content of a food to learn how to manufacturer may submit a petition to plan to help consumers understand the understand and use the information in request an alternative means of changes we are making in the final rule planning a healthy dietary pattern. compliance. and how the information can assist Furthermore, the term ‘‘unhealthful’’ (Comment 27) One comment stated them to include a variety of foods in when describing a food with added that, even if the added sugars their daily diet so that they understand sugars is a relative term and must be declaration is not false or misleading, how to achieve a healthy dietary viewed in the context of the day’s total Zauderer still would not apply to the pattern. dietary intake. For example, a food with requirement to include a % DV for the (Comment 25) One comment stated a high amount of added sugars may be declaration of added sugars because the the added sugars declaration would understandably viewed as % DV is not designed to prevent compel misleading labeling because it ‘‘unhealthful’’ because, if consumed, it consumer fraud or deception. The would mislead consumers into believing may result in overconsumption of added comment stated it is not clear whether that a sweetened dried is less sugars for the day. We need to correct consumers know what the % DV healthy than a naturally sweetened the misperceptions consumers may have represents. The comment suggested that dried fruit, due to the cranberry’s added about added sugars and provide them the mere declaration may lead a sugar content. with information they need to include a consumer to consider added sugars as (Response) The comment seems to variety of foods in their diet, as part of ‘‘inherently dangerous.’’ refer to the consumer research data a healthy dietary pattern, so they can (Response) We disagree with the related to consumer perceptions of understand how to include added suggestion that, if the % DV is not ‘‘healthful’’ that we discuss in our sugars in their diets at levels less than designed to prevent consumer fraud or response to comment 184. We do not 10 percent of calories to avoid deception, Zauderer would not apply. agree that the results in our added overconsumption. We intend to educate As we explained in our response to sugars study or the results submitted by consumers on the changes to the food comment 21, the Zauderer test is not comments on consumer perceptions label, and in particular, to the limited in this way. Moreover, we are support the assertion that an added declaration of added sugars so that unclear as to the comment’s basis for its sugars declaration would compel consumers can expand their food assertion that consumers would misleading labeling. As we have stated, choices to include nutrient dense foods, consider added sugars as ‘‘inherently a consumer’s belief, opinion, or such as with added sugars, dangerous.’’ The comment provided no previous exposure to information about and still achieve a healthy dietary data or information for its assertion. We added sugars and their impact to health, pattern. consider that view, should it exist, to be whether based on science or not, may (Comment 26) Another comment a consumer misperception. We plan to affect how a consumer may view a food stated that an added sugars declaration address consumer misperceptions about with an added sugars declaration. These and percent DV will compel false added sugars as part of our consumer factors can influence how a consumer information on the label because the education effort. perceives the factual statement about amount of added sugars will need to be (Comment 28) Some comments the amount of added sugars on a label overstated on yeast-leavened products, asserted that the test in Zauderer is not and may result in some consumer in violation of the First Amendment. applicable to the added sugars confusion and misunderstanding about (Response) We disagree that an added declaration and that Central Hudson the food containing the added sugars sugars declaration on yeast-leavened provides the appropriate test with that is not based on the declaration products will need to be overstated and which to evaluate the declaration under itself, but instead, on the consumer’s therefore compel false information on the First Amendment. own misperceptions. For example, a the label. We allow for reasonable (Response) While we disagree that the consumer may erroneously think a food, deficiencies in foods generally for label required added sugars declaration which can be part of a healthy dietary amounts of calories, sugars, added should be subject to the Central Hudson pattern, is not ‘‘healthful’’ because it sugars, saturated fat, trans fat, standard, it would nonetheless be contains some amount of added sugars. cholesterol and sodium, within current Constitutional under the standard set This is likely not unique to added good manufacturing practices (see final forth in Central Hudson. If the Central sugars. Consumers obtain information § 101.9(g)(6)). Furthermore, as we have Hudson standard were applicable to the from a number of sources, previous stated in our response to comment 200, required added sugars declaration, we experiences, or in response to specific we recognize that labeling of added would need to identify a ‘‘government health concerns. For example, there is a sugars in products that undergo interest [that] is substantial,’’ establish large body of data and information on fermentation and non-enzymatic that ‘‘the regulation directly advances other nutrients to limit, e.g., saturated browning may not be exact, but that the government interest asserted,’’ and fat, cholesterol, and sodium, which may manufacturers of most products that show that the regulation ‘‘is not more influence consumer perception of how participate in these reactions should be extensive than is necessary to serve that ‘‘healthful’’ a food may be. A consumer able to provide a reasonable interest’’ (Central Hudson, 447 U.S. at may choose to avoid all or most sources approximation of the amount of added 566). Under the Central Hudson test, we of food with sodium or saturated fat sugars in a serving of their product have the discretion to ‘‘judge what present, or present in a certain amount, based on information in the literature manner of regulation may best be based on their beliefs or specific dietary and their own analyses. To the extent a employed’’ to serve the substantial needs. manufacturer has reason to believe the government interest (see City of A consumer’s lack of understanding amount of added sugars in a serving of Cincinnati v. Discovery Network, Inc., about what added sugars are or how to food may be significant enough to 507 U.S. 410, 416 n.12 (1993) (citing Bd. use the added sugars declaration to limit impact the label declaration by an of Trustees v. Fox, 492 U.S. 469, 480 added sugars intake does not mean the amount that exceeds the reasonable (1989))). factual declaration of the amount of deficiency acceptable within current (Comment 29) Some comments stated added sugars in a serving of food is manufacturing practice, and is unable to there is no substantial government misleading. Consumers need more, not reasonably approximate the amount of interest for which we can require an less, information about the added sugars added sugars in a serving of food, the added sugars declaration under Central

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Hudson because there is no material associated with it’’ through posting of consumer interest. We are requiring an difference between added and intrinsic calorie content information on menus to added sugars declaration to provide sugars in food. One comment stated that be a substantial government interest)). information to assist consumers with ‘‘scientific studies have not sufficiently We also disagree that there is no food purchases that can reduce their shown that FDA has a substantial material difference between added and intake of added sugars and enable them interest in preventing consumer intake intrinsic sugars for purposes of to achieve a healthy dietary pattern. A of added sugars.’’ Another comment achieving a healthy dietary pattern to healthy dietary pattern, characterized in stated that FDA’s interest in compelling avoid excess discretionary calories from part by lower amounts of added sugars an added sugars declaration is not added sugars and reduced risk of than that found in the U.S. general substantial where there is no causal chronic disease. As we discuss in our population’s dietary pattern, is strongly relationship between added sugars and response to comment 143, there is a associated with a reduced risk of risk of chronic disease, but only strong association with respect to the chronic disease (Disc. Tobacco & evidence of a strong association between consumption of a healthy dietary Lottery, Inc. v. United States, 674 F.3d a dietary pattern characterized, in part, pattern characterized, in part, by a lower 509, 564 (6th Cir. 2012) (finding a by a reduced intake of sugar-sweetened intake of sugar-sweetened foods and reasonable relationship between tobacco foods and beverages and a reduced risk beverages, and a reduced risk of CVD, warning statements and a government of CVD. The comment further stated compared to less healthy dietary interest in ‘‘promoting greater public that, just as there is no substantial patterns with higher intakes of added understanding of the risks’’); Sorrell, government interest for added sugars, sugars. Foods that are composed of 272 F. 3d at 115 (finding a rational there is no such interest for total sugar naturally occurring or intrinsic sources relationship between the state’s goal of content or for the percent DV for added of sugars, e.g., fruits and vegetables, are reducing mercury contamination and sugars; the comment stated there is no distinct from the category of sugar- required label disclosures on mercury- material health or safety difference sweetened foods and beverages and are containing light bulbs). The required between a food with added sugars as not food categories recommended to be declaration of added sugars is consistent compared to naturally occurring sugars. reduced as part of the healthy dietary with the First Amendment and our pattern. Furthermore, evidence and authority in sections 403(a), 201(n), (Response) We disagree that we have conclusions from the 2010 DGA support 403(q)(2)(A) and 701(a) of the FD&C Act. no substantial government interest to the conclusion that consumption of (Comment 31) Some comments support the declaration of added sugars. excess calories from added sugars can questioned how an added sugars We have an interest in promoting the lead to a less nutrient-dense diet. With declaration would directly advance the public health, preventing misleading respect to the comments related to the government interest related to consumer labeling, and providing information to scientific support for the added sugars health. One comment stated that, even consumers to assist them in maintaining declaration, we disagree that a causal if FDA had a substantial government healthy dietary practices. Promoting the relationship must be shown between interest, FDA has not shown that the public health is part of our mission to added sugars and a risk of chronic declaration directly advances that ensure, in part, that foods are properly disease (e.g., a dose-response interest (citing Central Hudson, 447 U.S. labeled (section 1003 of the FD&C Act relationship between a nutrient and risk at 566) and to a ‘‘material degree’’ (21 U.S.C. 393)). In addition, for over 20 of disease) before we can make the (citing Florida Bar v. Went For It, Inc., years, we have had a substantial requisite finding under section 515 U.S. 618, 626 (1995)) because FDA government interest in ensuring that 403(q)(2)(A) of the FD&C Act that added has not shown there would be any consumers have access to information sugars would assist consumers in ‘‘discernable effect on consumer about food on the nutrition label that is maintaining healthy dietary practices behavior’’ and that FDA must truthful and not misleading, and an (see part II.H.3.a). No such dose- demonstrate that an added sugars interest in ensuring that nutrition response requirement exists in section declaration is related to ‘‘its desired information will assist consumers in 403(q) of the FD&C Act or in change in consumer behavior or an maintaining healthy dietary practices. implementing regulations. Furthermore, improvement in consumer health.’’ Based on the more recent scientific the comment’s characterization that Another comment cited Edenfeld v. evidence on reducing added sugars ‘‘scientific studies have not sufficiently Fain, 507 U.S. 761 at 770 through 771 consumption as part of a healthy dietary shown that FDA has a substantial (1993), stating that FDA will not be able pattern, we have a substantial interest in interest in preventing consumer intake to carry the burden to ‘‘demonstrate that ensuring the accuracy and completeness of added sugars’’ mischaracterizes the the harms it recites are real and that its of added sugars information in labeling. purpose of the nutrient declaration. We restriction will in fact alleviate them to Our government interests are substantial are not ‘‘preventing’’ consumer intake of a material degree.’’ The comment stated and supported as such (Rubin v. Coors added sugars. Instead, we are providing that we have not and cannot Brewing Co., 514 U.S. 476, 485 (1995) factual, accurate information to the demonstrate a concrete harm in the (recognizing that the government has a consumer about the amount of added absence of a mandatory added sugars substantial interest in promoting the sugars in serving of food to enable declaration. health of its citizens); see also, Am. consumers to understand and use the (Response) The added sugars Meat Inst. v. U.S. Dep’t Agric., 760 F.3d information to make informed dietary declaration directly advances our 18 (D.C. Cir. 2014) (en banc) (finding the choices and construct their daily diets. government interests in promoting context and history of disclosures in (Comment 30) One comment said that consumer health, preventing misleading labeling by USDA one of several consumer interest alone does not make labeling, and assisting consumers in interests to support a substantial information material and consumer maintaining healthy dietary practices. government interest under Central interest is not a substantial government As we explain in our response to Hudson); N.Y. State Rest. Ass’n v. N.Y. interest, and therefore, the added sugar comment 137, Americans consume too City Bd. of Health (556 F.3d 114, 134 declaration cannot be compelled under many calories from solid fats and added (2d Cir. 2009) (finding the promotion of the First Amendment. sugars, which replace nutrient-dense ‘‘informed consumer decision-making (Response) We are not requiring the foods and make it difficult for so as to reduce obesity and the diseases declaration of added sugars based on consumers to achieve the recommended

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nutrient intake while controlling their risk of CVD. Therefore, the added sugars demonstrate that an added sugars calorie intake. Consumers can only declaration is required to ensure that the declaration is related to a ‘‘desired reasonably accommodate 5 to 15 percent labeling is not misleading. change in consumer behavior or an of calories from solid fats and added Consumers need to understand the improvement in consumer health.’’ sugars combined, yet the 2015 DGAC amount of added sugars in food to Achieving specific changes in consumer found intakes from added sugars alone understand the relative contribution of behavior and/or health are not the at approximately 13.4 percent. Excess the food to total dietary intake. The government interests we assert, and the calories from solid fats and added percent DV provides information on law does not require that these specific sugars have implications for weight how much added sugars in a serving of showings be made. We note that, to the management. Moreover, there is strong food contributes to the recommended extent the comment suggests we need a evidence showing that children who limit of less than 10 percent calories connection to consumer health for consume more sugar-sweetened from added sugars. As we explain in our purposes of the added sugars beverages have greater adiposity (body response to comment 21, consumers use declaration, we have described that fat) compared to those with a lower the Nutrition Facts label at point-of- relationship in the proposed rule, the intake. purchase and review the nutrient supplemental proposed rule, and the The scientific evidence shows that, contribution of food products to help final rule. although there is moderate evidence of them choose products and compare (Comment 32) One comment an association with healthy dietary products. By providing this information, acknowledged the strong association patterns (with lower added sugars) consumers can have the information between a dietary pattern characterized, compared to less healthy patterns and they need to achieve a healthy dietary in part, by a reduced intake of sugar- measures of increased body weight or pattern that is characterized by lower sweetened foods and beverages and obesity, type 2 diabetes, cancer, and levels of added sugars through a lower reduced CVD risk. However, most congenital anomalies, there is a strong total consumption of sugar-sweetened comments questioned how an added association of a dietary pattern foods and beverages. A healthy dietary sugars declaration would directly characterized, in part, by lower pattern is also characterized by a higher advance our government interest to consumption of sugar-sweetened foods consumption of vegetables, fruits, whole assist consumers to maintain healthy and beverages, relative to a less healthy grains, low-fat dairy, and seafood, and dietary practices and focused on health dietary pattern found in the general U.S. lower consumption of red and outcomes for which they say there is population, and reduced risk of CVD. processed meat and refined grains. In only moderate or no direct evidence of Thus, the scientific review supports that addition, the declaration of added an association between added sugars a healthy dietary pattern that is sugars on the nutrition label would consumption and a disease or health- characterized by a lower consumption assist consumers in maintaining healthy related condition. For example, some of added sugars, not a lower dietary practices by providing them comments stated there is no evidence consumption of naturally occurring with information necessary to meet the that added sugars has an impact on sugars, is strongly associated with a key recommendations to construct daily obesity, and therefore, a declaration reduced risk of CVD. diets containing nutrient-dense foods would not assist consumers to maintain The declaration of added sugars and reduce calorie intake from added healthy dietary practices. Another would provide consumers with sugars by reducing consumption of comment said that a link to added information about the amount of added added sugars to less than 10 percent sugars intake and health based on the sugars in a food product that is calories. Thus, by providing this 2010 DGA is flawed, citing to a currently absent from the label. The information on the food label, we can statement in the preamble to the failure to disclose the amount of added directly and materially advance an proposed rule that added sugars do not sugars in a product is an omission of a interest in promoting public health, contribute to weight gain more than any material fact. The reasonable consumer preventing misleading labeling, and other source of calories (79 FR 11879 at would expect that the information on assisting consumers in maintaining 11904) even though the 2010 DGA the label would give them the most healthy dietary practices. We have recommendation is to reduce the intake important nutrition information, relative sufficient support to demonstrate that of calories from added sugars. Other to the need to construct a healthy the declaration directly advances our comments focused on the evidence in dietary pattern that limits the excess government interests, including Chapter 6 of the DGAC Report, which consumption of added sugars. The scientific support for the added sugars the comments describe as ‘‘moderate’’ omission of added sugars runs counter declaration, evidence to support evidence, to support a specific to that expectation, impeding rational consumer use of the label, and expert relationship between added sugars and consumer choice. A healthy dietary opinion to support consumer disease risk. The comments appeared to pattern, when compared to the current understanding of the added sugars suggest that we are relying only on dietary pattern in general U.S. declaration based on changes made to evidence in Chapter 2 Part D of the 2015 population, is associated with a reduced the proposed declaration (see Florida DGAC Report to support our basis for risk of CVD and avoids excess Bar v. Went For It, Inc., 515 U.S. 618, the added sugars declaration, and not discretionary calories from added sugars 628 (1995) (justifying speech restrictions the moderate evidence in Chapter 6. and solid fats. Consumers need ‘‘by reference to studies, and anecdotes One comment suggested the moderate information about added sugars in all pertaining to different locales altogether evidence provides a lower level of foods, not just those that contain a . . . or even, in a case applying strict scientific certainty to support a certain threshold level or that are found scrutiny, to justify restrictions based reasonable fit between the disclosure in select food categories (e.g., beverages) solely on history, consensus, and and FDA’s government interest. to reduce overall intake of added sugars ‘simple common sense’ ’’) (citations (Response) The comments focusing on in the diet. Consumers can use the omitted)). evidence related to a specific declared amount of added sugars to We disagree with the comment’s relationship between added sugars compare products and make food assertion that we must show a intake in the general U.S. population selections to achieve a healthy dietary ‘‘discernable effect on consumer and a direct link to obesity to support pattern that is associated with a reduced behavior’’ and that we must a mandatory declaration of added sugars

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may have overlooked the discussion in the FD&C Act, we disagree for the our response to comment 33). Our the preamble to the proposed rule (79 reasons we set forth in our response to government interest does not rest on the FR 11879 at 11904). We are not comment 58. Furthermore, the analysis notion that there must be some percent establishing or relying on a direct link that was conducted related to dietary of consumers who we know will modify to obesity from added sugars intake for patterns and health outcomes that is their diet to consume more or less of a the general population. There is discussed in Chapter 2 of the 2015 nutrient before we can compel a label adequate evidence that the U.S. DGAC Report is not based on modeling declaration for that nutrient or the population consumes excess calories of dietary patterns, but rather on a percent DV. Consumers do not know the from added sugars, above the review of diet quality studies where amount of added sugars in foods discretionary calories permitted within dietary quality indices were used to without a required declaration. a recommended caloric intake (id. at assess how adherence to a healthy Furthermore, the comment may 11903). The 2010 DGA supports the dietary pattern is associated with health misunderstand that the nutrition need for an added sugars declaration to outcomes (Ref. 19). Therefore, information on Nutrition Facts label is provide the information necessary for statements that we have made in the to assist consumers in understanding consumers to identify the contribution past related to food pattern modeling do the relative significance of the of discretionary calories from added not apply to the evidence that we information in the context of a total sugars, which are consumed in excess considered related to healthy dietary daily diet and does not require a by the general U.S. population based on patterns that are characterized, in part, threshold level of a change in consumer recommended calorie limits, to their by lower intakes of sugar-sweetened behavior before the nutrient can then be daily diet in order to reduce their intake foods and beverages relative to less required on the nutrition label. The final of added sugars to within recommended healthy dietary patterns and CVD risk. rule does not define when a food is calorie limits. While it is true that (Comment 34) One comment stated ‘‘healthy’’ based on the amount of added excess calories from any source leads to that consumer research demonstrates sugars in a serving of the food; instead, weight gain, we know that the U.S. that, while an added sugars declaration through the Nutrition Facts label, we are general population consumes added may allow consumers to determine the providing information about the amount sugars in excess of the recommended amount of added sugars in a product of added sugars so that consumers can limit of less than 10 percent of calories. accurately and compare products based understand the relative significance of a Moreover, we have additional support on the amount of added sugars and food’s contribution to the total added for the declaration of added sugars, as percent DV contribution, the evidence sugars intake in the context of the total lower intakes of sugar-sweetened foods does not demonstrate that consumers daily diet and use that information to and beverages were part of a healthy would maintain healthy dietary decide what foods to choose as part of dietary pattern that was found to be practices or that consumer that dietary intake for the day. strongly associated with a decreased understanding of a product’s (Comment 35) One comment stated risk of CVD (see part II.H.3.a and healthfulness is improved. Another the added sugars declaration must be II.H.3.b). Furthermore, we disagree we comment suggested that we must understandable to directly advance the are mischaracterizing the evidence on demonstrate that a % DV disclosure for government interest to assist consumers which we rely because we do not cite added sugars would have a ‘‘direct and to maintain healthy dietary practices. to moderate evidence in the 2015 material effect on consumer behavior.’’ The comment said the added sugars DGAC. Although the evidence The comment said there is no evidence study provides only weak evidence that concerning a cause and effect that consumers understand the % DV consumers understand the declaration. relationship between added sugars and how to use the information for the The comment cited our statements in intake and reduced risk of a disease is added sugars declaration. the supplemental proposed rule and still emerging, there is a strong (Response) We interpret the study memorandum that acknowledge association found for a healthier dietary comments as questioning how an added that a number of participants were pattern, characterized in part by a sugars declaration (and percent DV) confused about the distinction between reduced intake of overall added sugars would directly advance our government sugars and added sugars on the labels compared to less healthy dietary interest to assist consumers to maintain studied and that some participants patterns like those consumed by the healthy dietary practices. The comments identified a more nutritious product general U.S. population, and reduced may misunderstand our authority under with more added sugars as less healthy. risk of CVD. section 403(q)(2)(A) of the FD&C Act. (Response) We considered the results (Comment 33) One comment said that Section 403(q) of the FD&C Act gives us from our consumer research on the we have not identified any direct the discretion to require a nutrient added sugars declaration, in addition to relationship between the added sugars declaration when we determine that the consumer research on the declaration declaration and an interest in helping information is necessary to assist submitted in comments (see part II.B.5). consumers to maintain healthy dietary consumers to maintain healthy dietary As a result of the findings showing that practices by reducing added sugars practices. The determination is based on some consumers may be confused by consumption. The comment questioned a review of the scientific evidence and the juxtaposition of total sugars the strong association found between other available data and information followed by added sugars indented dietary patterns and risk of CVD in the related to the need for the nutrition below total sugars, we revised the 2015 DGAC Report, based on criticisms information to be available to the declaration to address those concerns. by FDA of menu modeling to establish consumer as part of the Nutrition Facts We now include the word ‘‘Total’’ DRVs in the preamble to the proposed label. The declaration places the before ‘‘Sugars’’ and use the phrase rule (79 FR 11895 at 11896). information in the hands of the ‘‘Includes ‘‘XX’’ g Added Sugars’’ (Response) To the extent the comment consumer so that the consumer can indented below ‘‘Total Sugars’’ to asserts we must have a direct make a judgment about whether to mitigate the observed misunderstanding relationship between a nutrient and a purchase a given food based on the by some consumers to add the total and reduced risk of disease before the nutrient content and can understand the added sugars values together. With the nutrient is eligible for mandatory relative significance of the information change to the declaration, we expect labeling under section 403(q)(2)(A) of in the context of a total daily diet (see that consumers will understand that

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added sugars are a component of total (Response) We disagree. The required and how the contribution of added sugars (see our response to comment added sugars declaration is no more sugars from a food fits into the daily 188). We also considered results extensive than necessary to serve its diet. showing that some consumers may purpose (see Central Hudson, 447 U.S. (Comment 38) One comment perceive products with more added at 566). Again, this standard does not questioned whether the use of the sugars as less healthy (see our responses require the government to employ ‘‘the Nutrition Facts format was too to comments 55 and 184) and plan to least restrictive means’’ of regulation or restrictive under the First Amendment address consumer perceptions as part of to achieve a perfect fit between means for conveying nutrition information our consumer education. The factual and ends, but rather a ‘‘reasonable’’ fit about a product, noting that Congress declaration of the amount of added by adopting regulations ‘‘‘in proportion did not prescribe a particular format or sugars in a serving of food is not to the interest served’’’ (Bd. of Trustees means by which to convey nutrition misleading based on consumer v. Fox, 492 U.S. 469, 480 (1989)). information. The comment stated that perceptions about whether a food with Moreover, the required disclosure does section 403(q) of the FD&C Act provides added sugars is ‘‘unhealthful.’’ more to advance our interests to that a food will be misbranded ‘‘unless (Comment 36) One comment said that promote public health, prevent its label or labeling bears nutrition we must identify the public harm misleading labeling, and assist information.’’ The comment suggested caused by not declaring added sugars, consumers in maintaining healthy that nutrition information conveyed demonstrate how the declaration will dietary practices than a disclosure that through labeling that does not alleviate this harm, and show this is the was limited to a subset of foods. Added physically accompany the product, such as at the point of purchase, on the least intrusive approach to comport sugars are used in a variety of foods Internet, or through a smart phone with a company’s constitutional from all food categories. For example, application, would be a less prescriptive protection of its right to free speech. The although some foods, such as sugar- means of conveying the required comment also said that we must show sweetened beverages, may contain more there is a different or greater harm from information. added sugars relative to other beverages, (Response) To the extent the comment added sugars that is not present for the that does not mean that a consumer is suggests a completely different same level of naturally occurring sugars. going to consume only those sugar- approach to conveying nutrition (Response) We discuss how the added sweetened beverages that contain the information that is separated from, and sugars declaration comports to the most added sugars, and therefore, would not on, the food label itself, by use of Central Hudson analysis, including why only need added sugars information on a smart phone, Internet, or posted added sugars are distinguished from the foods that contain some higher somewhere in the store, the comment naturally occurring sugars, in our threshold of added sugars. Furthermore, provided no data or information to response to comment 29. Central the percent DV of less than 10 percent support why those approaches would Hudson requires the regulation to be no of calories from added sugars pertains to assist consumers as well as, if not better, more extensive than necessary to serve all calorie sources of added sugars, not than having the information on the label the asserted government interest just those categories that contain a itself at point-of-purchase. Not all (Central Hudson, 447 U.S. at 566). This certain higher amount of added sugars consumers own smart phones or standard does not require the per serving of food relative to other computers, or even if they did, would government to employ ‘‘the least foods in the same or similar food necessarily take these electronic devices restrictive means’’ of regulation or to category. Therefore, a consumer needs to the store to research the nutrient achieve a perfect fit between means and to understand the contribution of all profile of each food they are considering ends (see Bd. of Trustees v. Fox, 492 sources of added sugars in his or her to purchase. It also is unclear how U.S. 469, 480 (1989)). Instead, it is diet to reduce calories from added added sugars and other nutrient sufficient that the government achieve a sugars to less than 10 percent of the information in the Nutrition Facts label ‘‘reasonable’’ fit by adopting regulations total. Those foods with fewer added would be accessed by posting in the ‘‘ ‘in proportion to the interest served.’ ’’ sugars consumed over the course of a aisles or somewhere else in the store for (id. (quoting In re R.M.J., 455 U.S. at day can add up to levels that may meet the number of foods stocked within 203)). The requirement of narrow or exceed 10 percent of total calories. each area or how a consumer would tailoring is satisfied ‘‘so long as the . . . Moreover, for some food categories, find the information that matched the regulation promotes a substantial consumers may not even recognize the product picked up off the shelf. The government interest that would be food as one that contributes added Nutrition Facts label provides product- achieved less effectively absent the sugars to the diet (e.g., condiments, specific information that is readily regulation’’ (United States v. Albertini, sauces, canned fruits and vegetables, accessible to the consumer at point-of- 472 U.S. 675, 689 (1985)). The added and some snacks), much less, the purchase in the store, when consumers sugars declaration will give consumers relative contribution. Limiting the would use the information to a tool they need to include added sugars required disclosure to only certain foods understand the nutrient content and as part of a healthy dietary pattern— that exceed a certain level of added compare products for purposes of information that would not be readily sugars before a declaration is required deciding whether to purchase the available absent the regulation. would undermine our efforts in getting product. Because the comment’s (Comment 37) One comment took information needed for making suggested alternative would be less exception to the fact that the informed food purchases into the hand effective than the required disclosure in requirement for added sugars labeling is of consumers to enable them to achieve advancing the relevant government for all foods and not limited to a smaller a healthy dietary pattern. In addition, interests, we disagree with the subset of foods that account for the the required disclosure is not unduly comment. majority of added sugars consumption burdensome in that it is a factual (Comment 39) One comment stated (e.g., sweetened beverages), and thus, is disclosure confined to one line on the the compelled disclosure of added ‘‘more extensive than necessary to serve Nutrition Facts label and will enable sugars is more extensive than necessary [the government] interest’’ (citing consumers to understand the to serve ‘‘a speculative interest by Central Hudson, 447 U.S. at 566). information in the Nutrition Facts label FDA.’’ The comment suggested that an

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interest to help consumers select diets sugars declaration directly advances our (‘‘[A]s the Supreme Court has that are nutrient rich, where foods high substantial government interests. We emphasized, the starting premise in all in solid fats and added sugars do not also explained, in our response to commercial speech cases is the same: displace food with greater nutrient comment 39, why the added sugars The First Amendment values density, could be served by consumer declaration is not more extensive than commercial speech for different reasons education and not a listing of added necessary to serve our government than non-commercial speech, and sugars. interests. We disagree that the current nothing in its recent opinions, including (Response) We disagree our interest is label provides information on nutrient Reed, even comes close to suggesting speculative. We have substantial density because, although the current that that well-established distinction is government interests in promoting the label provides information on total no longer valid.’’); Chiropractors United public health, preventing misleading sugar content, it does not provide for Research & Educ., LLC v. Conway, labeling, and assisting consumers to information on added sugars content 2015 U.S. Dist. LEXIS 133559 (W.D. Ky. maintain healthy dietary practices. which is information consumers need to Oct. 1, 2015) (‘‘Because the New These interests are supported by the understand to avoid the excess Solicitation Statute constrains only science and our 20-plus year history of contribution of empty calories. To the commercial speech, the strict scrutiny the use of the Nutrition Facts label to extent the comment suggests that we analysis of Reed is inapposite.’’); San convey accurate, truthful, non- would need consumer research showing Francisco Apt. Ass’n v. City & Cnty. of misleading information about the that consumers understand the meaning San Francisco, 2015 U.S. Dist. LEXIS nutrient content of a food to the and role of added sugars before we 150630 (N.D. Cal. Nov. 5, 2015) (‘‘Reed consumer at point-of-purchase. We do require a declaration of added sugars, is inapplicable to the present case, for not consider consumer education alone we disagree. The FD&C Act does not several reasons, including that it does to be a reasonable alternative to the require us to establish that consumers not concern commercial speech.’’); Cal. declaration on the label because have a level of understanding about a Outdoor Equity Partners v. City of consumers need to know the amount of nutrient before we can compel Corona, 2015 U.S. Dist. LEXIS 89454 added sugars in specific foods, not disclosure of that nutrient on the label. (C.D. Cal. July 9, 2015) (‘‘Reed does not simply general concepts, and to In fact, the label is the means by which concern commercial speech’’); Timilsina understand how to incorporate added the consumer can access new nutrition v. West Valley City, 2015 U.S. Dist. sugars into a healthy dietary pattern. information that we have determined is LEXIS 101949 (D. Utah June 30, 2015) Providing the gram amount of added necessary to maintain healthy dietary (‘‘Because the parties agree this case sugars in a serving of food on the label, practices. concerns commercial speech and the which is the same information provided (Comment 41) One comment stated Central Hudson applies, the Court need for other nutrients on the label, is that added sugars declaration is subject not address how the regulation would sufficiently narrowly tailored to to strict scrutiny (citing Reed v. Town of fare under [Reed]’’)). Moreover, Reed advance our interests in providing Gilbert, 135 S. Ct. 2218 (2015)) because involved review of ‘‘content-based nutrition information to promote the of discrimination between added and restrictions on speech’’ (Reed, 135 S. Ct. public health, prevent misleading naturally occurring sugars. The at 2231). Here, we are requiring the labeling, and assist consumers in comment stated that the two categories disclosure of factual information, which maintaining healthy dietary practices. of label declarations for added sugars is properly reviewed under the The nutrition information will be and naturally occurring sugars is a standards articulate in Zauderer and its readily available to consumers at point- content-based regulation of speech. In progeny (Sorrell, 272 F.3d at 113 to 114 of-purchase which is the time and place particular, the comment stated that (‘‘Commercial disclosure requirements that is critical to a consumer’s cranberries and other fruit to which are treated differently from restrictions purchasing decision and considering the sugar is added are nutritionally on commercial speech because relative significance of the information comparable to fruit that contains only mandated disclosure of accurate, in the context of their total daily diet. natural sugars, so a declaration of added factual, commercial information does Because the proposed alternative would sugars would mislead consumers into not offend the core First Amendment be less effective than the required believing the products without added values of promoting efficient exchange disclosure in advancing the relevant sugars are healthier. The comment said of information or protecting individual government interests, we disagree with there is no compelling government the comment. interest, and the declaration is not liberty interests. Such disclosure (Comment 40) One comment stated an narrowly tailored, where the added furthers, rather than hinders, the First added sugars declaration does not seem sugars are listed in the ingredient Amendment goal of the discovery of to fit the requirements under Central statement. The comment said a footnote truth and contributes to the efficiency of Hudson to directly advance the could be provided to clarify the sugars the ’marketplace of ideas.’ ’’)). The government interest asserted or not be are added for palatability. added sugars declarations, together with more extensive than necessary to serve (Response) We disagree that the the other nutrient declaration on the that interest because: (1) The current added sugars declaration is subject to nutrition label, contribute to the label already provides information on strict scrutiny under Reed v. Town of marketplace of ideas by providing nutrient density and total sugar content; Gilbert. Reed involved a town sign code, information that may help consumers to (2) there is no consumer research which involves ‘‘quintessential public use and understand the amount of showing that consumers understand the fora’’ (McLaughlin v. City of Lowell, added sugars, along with the other meaning and role of added sugars; (3) 2015 U.S. Dist. LEXIS 144336 (D. Mass. nutrients listed, in constructing a there is no nutritional or physiological Oct. 23, 2015)). Reed does not apply to healthy dietary pattern to reduce the difference between added and naturally commercial speech, which is the only risk of chronic disease and achieve a occurring sugars; and (4) other sources type of speech at issue here (see, e.g., calorie intake that limits excess intake of excess calories would contribute to CTIA—The Wireless Ass’n v. City of of empty calories from unhealthy types weight gain. Berkeley, Cal., Civ. No. 15–2529 (EMC), of fats and from added sugars. (Response) We have explained, in our 2015 U.S. Dist. LEXIS 126071 *31 With respect to the comment’s response to comment 39, why the added through 33 (N.D. Cal. Sept. 21, 2015) assertion that products with different

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added sugars content would mislead judgmental, or a matter of opinion. (Response) We disagree that we do consumers into believing the products Courts have rejected similar arguments not have a sufficient scientific basis to without added sugars are healthier, we from industry attempting to assert that support an added sugars declaration. As explain in our discussion of consumer heightened scrutiny should be applied we stated in our response to comment research in part II.H.3.g why the to regulation of commercial speech (see, 21, a physiological distinction between findings of some consumer perceptions e.g., N.Y. State Rest. Ass’n v. N.Y. City added and naturally occurring sugars is about what is ‘‘healthy’’ does not mean Bd. of Health, 556 F.3d 114, 134 (2d Cir. not a prerequisite to mandatory that the added sugars declaration is 2009) (rejecting argument that menu declaration under section 403(q)(2)(A) misleading. Furthermore, we also calorie content disclosures be subject to of the FD&C Act. Nor is an analytical explain, in our response to comment 21, strict scrutiny review); Discount method specific to added sugars a why the ingredient listing is not Tobacco, 674 F.3d at 525–27 (rejecting prerequisite to mandatory declaration sufficient to convey the amount of argument that strict scrutiny applied to under this section (see the discussion in added sugars in serving of a product. tobacco warnings, as a compelled our response to comment 45). With respect to the use of a footnote or ‘‘ ‘subjective and highly controversial’ Furthermore, we explained in the other language on the palatability of a marketing campaign expressing its preamble to the proposed rule that our food without added sugars, we are not disapproval of their lawful products’’)). scientific basis for the added sugars setting forth requirements in this final In contrast, United Foods (533 U.S. 405 declaration for the general population, rule on labeling information about this at 411), which concerned the payment in fact, differed from our rationale to practice, and any labeling information of subsidies for speech that was support other mandatory nutrients must be truthful and not misleading. disfavored, has no bearing on the related to the intake of a nutrient and Lastly, as we explain in our response to nutrient declaration for added sugars. risk of chronic disease, a health-related comment 28, we disagree that we do not The scientific evidence on which we condition or a physiological endpoint have a substantial government interest rely relates to dietary patterns and (see 79 FR 11879 at 11904). Rather than or that the added sugars declaration is impact to health from consumption of a relying on a causal relationship between not narrowly tailored. healthy dietary pattern characterized, in added sugars to obesity or heart disease, (Comment 42) One comment stated part, by a reduced added sugars intake. we considered, in the preamble to the that an added sugars declaration is Added sugars are distinguishable from proposed rule (79 FR 11879 at 11902 inconsistent with the First Amendment naturally occurring sugars when through 11908) and the preamble to the because it would send a message with consumed as part of a healthy dietary supplemental proposed rule (80 FR which the manufacturer disagrees. The pattern compared to the current U.S. 44303 at 44307 through 44309), the comment said it is the total number of general population’s dietary pattern. contribution of added sugars as part of calories consumed, not the type of Indeed, the declaration of added sugars healthy dietary patterns and the impact calories consumed, which determines is not based on a specific relationship to public health from such patterns. the potential for weight gain. Another between added sugars and disease risk, Thus, the comments erroneously comment stated that a strict scrutiny test contrary to what the comments suggest. focused on the nutrient, added sugars, should be applied to the added sugars We made that distinction clear in the and its independent relationship to declaration because the declaration is preamble to the proposed rule (79 FR health in the general population rather ‘‘an inherently subjective, judgmental 11879 at 11904) when we stated that our than our rationale for mandatory statement in the guise of a purely factual rationale to support an added sugars declaration of added sugars as part of a declaration.’’ The comment stated that mandatory declaration in labeling is healthy dietary pattern. the declaration is ‘‘designed to convey different from our rationale to support (Comment 44) One comment stated the unsupported opinion that added other mandatory nutrients to date which the added sugars declaration appears to sugars are somehow more adverse to generally relates to the intake of a be arbitrary and capricious because the health than sugars that occur naturally.’’ nutrient and a risk of chronic disease. rationale to support the added sugars Another comment stated that an added declaration is dramatically different 2. Administrative Procedure Act sugars declaration would compel food from the rationale to support other producers to tell their consumers that (Comment 43) One comment said that mandatory nutrients and the added avoiding added sugars is a meaningful we do not have the required reasonable sugars content of a food does not always factor in maintaining healthy dietary basis to mandate the added sugars reflect a food’s nutritional value (such practices, which producers do not declaration because, unlike the as yogurt) or convey information that is believe to be true, and requires a higher differences between saturated fats and not otherwise available from the total level of scrutiny to support (citing trans fat, there is no physiological sugars declaration. Another comment United States v. United Foods, 533 U.S. distinction between added and naturally suggested that the supplemental 405, 411 (2001)). Some comments said occurring sugars, no analytical methods proposed rule does not provide that we have conceded that the to distinguish these sugars, inadequate adequate notice and explanation for the declaration is not meaningful based on evidence to support a direct departures from established precedent statements we made in the preamble to contribution of added sugars to obesity and must acknowledge the change and the proposed rule (79 FR 11879 at 11903 or heart disease, and that our rationale provide a reasoned explanation for the through 11904) about added sugars, e.g., does not relate to the intake of a nutrient change (citing Prevor v. FDA, 895 F. that added sugars are not chemically and risk of chronic disease, health- Supp. 2d 90 (D.D.C. 2012) and different than natural sugars, and there related condition or physiological Paralyzed Veterans of Am. v. DC Arena is lack of scientific agreement on the endpoint. Another comment cited L.P., 117 F.3d 579, 586 (D.C. Cir. 1997)). effects from added sugars to health specific statements we made related to (Response) We disagree with the outcomes and contribution to weight added sugars and their link to obesity comments that suggest the required gain compared to other calorie sources. and other statements in which we have added sugars declaration is arbitrary (Response) The declaration of added stated there is inadequate evidence to and capricious under the APA. For each sugars is an assertion of fact in the support the direct contribution of added nutrient we require be declared on the context of a commercial sugars to obesity, suggesting that this is nutrition label, we consider whether the communication; it is not subjective, a reversal of the Agency position. nutrient will assist consumers in

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maintaining healthy dietary practices, evidence and how nutrition information requiring the mandatory declaration of a consistent with our statutory authority may impact human health. nutrient where the nutrient is in section 403(q) of the FD&C Act. We Moreover, with respect to the chemically distinct from other nutrients consider the scientific evidence related comment that the added sugars or when there is an available analytical to that standard for each nutrient we declaration conveys no more method to test the presence of the consider for mandatory declaration. The information than one could obtain from nutrient in a food. The comment cited scientific evidence on which we rely to the total sugars declaration, we disagree. particular statements in the preamble to make that determination for a particular As we explain in our response to the proposed rule in which we made nutrient may differ. With respect to comment 161, the added sugars reference to a nutrient’s chemical added sugars, we considered the declaration does convey information definition, composition, or structure. evidence related to a healthy dietary that is not otherwise available from the However, the statements cited in the pattern that is associated with a reduced total sugars declaration. Furthermore, it comment do not support the risk of CVD, consumption data showing is not clear why the comment suggests propositions asserted by the comment. the added sugars content does not that Americans are consuming too many We consider the need for a mandatory reflect a food’s nutritional value (such calories from added sugars, evidence declaration based on whether the as yogurt). The added sugars declaration showing that it is difficult to meet nutrient is necessary to assist consumers reflects the contribution of that nutrient to maintain healthy dietary practices, nutrient needs within calorie limits if in a serving of the food. We agree that one consumes too many added sugars, consistent with our authority under a food, such as yogurt, can provide section 403(q)(2)(A) of the FD&C Act, and evidence showing that increased nutritional value to the overall diet even intake of sugar-sweetened beverages is whereas the statements cited by the though it contains added sugars. The comment concern characteristics of associated with greater adiposity in added sugars declaration is one piece of children. Specifically, we explained that nutrients that are not necessarily related information on the nutritional label to to whether the nutrient can assist we were reconsidering whether to help inform the consumer about how consumers to maintain healthy dietary require the declaration of added sugars the food fits into the overall dietary practices. For example, as part of our based on new data and information, pattern so that the consumer can use discussion of stearic acid in the including U.S. consensus reports and that information to help achieve a preamble to the proposed rule (79 FR recommendations related to the healthy dietary pattern. The cases cited 11879 at 11894), we did not agree to consumption of added sugars, a citizen by the comment (Prevor v. FDA, 895 F. declare stearic acid as a nutrient rather petition, and public comments (79 FR Supp. 2d 90 (D.D.C. 2012) and than as part of the saturated fat 11879 at 11902). We explained our Paralyzed Veterans of Am. v. D.C. Arena declaration because saturated fat intake rationale for requiring an added sugars L.P., 117 F.3d 579, 586 (D.C. Cir. 1997) is based on scientific evidence related to declaration in the preambles to the (overruled in part by Perez v. Mortg. the intake of all saturated fatty acids, proposed rule (79 FR 11879 at 11904 Bankers Ass’n, 135 S. Ct. 1199 (2015))) including stearic acid, and the potential and the supplemental proposed rule (80 involve questions related to effects to human health from changes in FR 44303 at 44308)). The evidence in interpretative rules. Therefore, we do the dietary intake of stearic acid on the the 2015 DGAC report, through the use not consider them to be applicable to risk of CVD remain unclear (79 FR of studies on diet quality, supports this final rule, which is a legislative 11879 at 11894 through 11895). evidence of a strong association between rule, for which we provided notice and Furthermore, we discussed, in response an opportunity to comment. a dietary pattern characterized, in part, to a request in a petition requesting FDA (Comment 45) Some comments stated by a reduced intake of sugar-sweetened to define total fat to exclude acetic, that the declaration of added sugars is foods and beverages and a reduced risk propionic, and butyric acids, based on of CVD. We also set forth in the inconsistent with FDA’s approach on whether to declare other nutrients, the chemical differences of these acids supplemental proposed rule our from other fatty acids comprising total rationale for use of the reference amount specifically stearic acid, acetic, propionic and butyric acids, dietary fat, that these acids were not chemically for added sugars of less than 10 percent fiber, and carbohydrates, and cited distinct based on the reasons set forth total daily caloric intake (id.). Thus, we statements in the preamble to the by the petitioner (79 FR 11879 at provided the requisite showing, proposed rule related to chemically 11893). We further explained that the consistent with our obligations under distinct nutrients. The comments stated petitioner did not explain why we the APA, for why an added sugars that our rationale for not labeling these should define total fat based on declaration is necessary to assist other substances separately is based on physiological differences, even if such consumers in maintaining healthy the fact that these are not chemically differences existed (id.). Thus, we dietary practices (see Home Care Ass’n distinct or are based on whether examine, on a case-by-case basis, of Am. v. Weil, 799 F.3d 1084 (D.C. Cir. analytical techniques are available to whether a nutrient is necessary to assist 2015) (stating the APA imposes ‘‘no verify the declared amount on the label. consumers to maintain healthy dietary special burden when an Agency elects The comments said that we did not practices. to change course’’ and the ‘‘reasoned explain why we departed from our Similarly, the statements the explanation’’ under the APA for an traditional approach for the added comment included for dietary fibers and alternative approach includes an sugars declaration, and, therefore, our carbohydrate classification are taken out Agency awareness of the change in decision regarding the declaration of of context and do not support the position and good reasons for the added sugars appears arbitrary and comment’s proposition. We discussed change (citing FCC v. Fox Television capricious under the APA (citing the reasons for separating dietary fiber Stations, Inc., 556 U.S. 502, 515 (2009)). Atchison, T. & S. F. R. v. Witchita Board from the definition of total carbohydrate We are not limited to one body of of Trade, 412 U.S. 800 (1973) and and determined, for several reasons, it scientific evidence when exercising our Allentown Mack Sales and Serv. v. was not necessary to change the discretion under section 403(q)(2)(A) of NLRB, 522 U.S. 359 (1998)). calculation of carbohydrate by the FD&C Act; instead, we have broad (Response) We disagree with the difference (79 FR 11879 at 11900). We discretion to consider the new scientific suggestion that we only consider also referenced the 2007 ANPRM in

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which we were considering whether to is completed (citing Doe v. Rumsfeld, comment suggested, the consumer classify carbohydrates by chemical 341 F. Supp. 2d 1 (D.D.C. 2004); Service research studied consumer reactions to definition or physiological effect (79 FR v. Dulles, 354 U.S. 363 (1957); Conn. the declaration to help inform our future 11878 at 11901). While we recognized Light & Power Co., v. Nuclear educational efforts related to food that analytical methods would Regulatory Com, 673 F.2d 525, 530 labeling and was not conducted for the distinguish carbohydrates based on through 531 (D.C. Cir. 1982); and purpose of determining whether we had chemical structure and not American Iron & Steel Inst. v. OSHA, the requisite scientific basis to declare physiological effects, we determined 939 F.2d 975, 1009 through 1010 (D.C. added sugars under section 403(q)(2)(A) that given the various components of Cir. 1991); Small Refiner Lead Phase- of the FD&C Act (80 FR 44303 at 44306). total carbohydrate and different types of Down Task Force v. Environmental We consider consumer research helpful physiological effects of these Protection Agency, 705 F.2d 506, 540 to understand how to best utilize our components that, for the class of total through 541 (D.C. Cir. 1983); Sierra Club consumer education efforts when carbohydrates, a definition based on v. Costle, 657 F.2d 298, 398 (D.C. Cir. changes to the label are made. physiological effects would not be a 1981)). Moreover, in response to our findings better approach than a chemical (Response) We disagree that a from the ‘‘Experimental Study on definition (id.). We did not consider an consumer study related to the added Consumer Responses to the Nutrition analytical method to be a necessary sugars declaration is required before we Facts Labels with Declaration of prerequisite to the declaration for can finalize a requirement to compel the Amount of Added Sugars’’ that showed carbohydrate. Thus, we have not limited declaration under section 403(q)(2)(A) some participants were confused by the ourselves to the need for a chemical of the FD&C Act. Our discretionary total sugars declaration when added distinction for a nutrient before we authority to require an added sugars sugars was indented below total sugars, would consider the mandatory declaration can be exercised if we we considered these findings and declaration of the nutrient under section determine the declaration is necessary comments received on the consumer 403(q)(2)(A) of the FD&C Act. For these to assist consumers to maintain healthy research in making changes to the reasons, we disagree with the dietary practices. Our rationale for the declaration of added sugars to reduce comment’s apparent assertion that we declaration is supported by sufficient the potential for consumer confusion. departed from a traditional approach evidence set forth in the 2010 DGA and With respect to the comment that we related to requiring a nutrient be the 2015 DGAC Report, in part, related failed to provide an adequate notice and chemically distinct for mandatory to the role of sugar-sweetened foods and opportunity for comment on the results labeling, and that therefore the added beverages as part of a healthy dietary of the consumer research study, we note sugars declaration is somehow arbitrary pattern compared to less healthy dietary that this comment was submitted in and capricious under the APA. patterns, and the relationship between response to the proposed rule published healthy dietary patterns and risk of in March 2014, before the publication of (Comment 46) One comment stated chronic disease. In addition, the the consumer research results in July that we would violate section 706(2) of evidence and conclusions from the 2010 2015 and raw data in September 2015. the APA if we finalized a declaration for DGA support that consumption of Therefore, the cases to which the added sugars because the proposed excess calories from added sugars can comment cites, concerning the need for declaration of added sugars was not lead to a less nutrient-dense diet and notice and opportunity for comment, are reasoned decision making, where we that current consumption data show moot. Furthermore, we are not relying did not complete the consumer study that Americans are consuming too many on a defective or discredited study to before proposing the required calories from added sugars. Moreover, support a rule or one where the study declaration. The comment cited there is strong evidence that greater authors do not agree with the use of the references that would analogize this intake of sugar-sweetened beverages is research for a particular application situation to one where an Agency relied associated with increased adiposity in relied on by the Agency and therefore on a defective or discredited study to children. Furthermore, section 403(q) of do not need to address the cases cited support a rule (e.g., St. James Hospital the FD&C Act does not require us to in comments on these issues. v. Heckler, 760 F. 2d 1460, 1468 (7th complete a consumer study before we (Comment 47) One comment asserted Cir. 1985); Almay, Inc. v. Califano, 569 can make the finding in section that we did not provide an adequate F.2d 674 (D.C. Cir. 1977), or where the 403(q)(2)(A) of the FD&C Act to require legal justification for why we were not study authors did not agree with the use a nutrient declaration. relying on the IOM DRI Report with of the research for a particular We explained why we were respect to developing a DRI for added application relied on by an Agency conducting consumer research in the sugars and instead relying on evidence (Humana of Aurora, Inc. v. Heckler, 753 preamble to the proposed rule. We in the DGAC Report. F.2d 1579 (10th Cir. 1985)). With discussed, in the context of the (Response) We disagree that we did respect to the consumer research we placement of added sugars on the label, not provide an adequate explanation for conducted on added sugars, the our plan to conduct a consumer study the DRV for added sugars, nor did the comment asserted that, ‘‘FDA in this to help enhance our understanding of comment further explain the basis for its situation recognized that such a study how consumers would comprehend and assertion. We explained why we were was essential’’ and that without a use the new information and to publish not relying on the IOM DRI Report in consumer study, the factual basis for the the results of the consumer research the preamble to the proposed rule (79 requirement would be lacking (citing when available (79 FR 11879 at 11952). FR 11879 at 11906). Specifically, we Motor Vehicle Mfrs. Ass’n of United We published the results of our explained that the IOM did not establish States v. State Farm Mut. Auto. Ins. Co., consumer research in a supplemental a DRI, such as a UL, for added sugars, 463 U.S. 29, 43 (1983)). The comment proposed rule to present those study nor did the IOM define an intake level also said we failed to provide an findings (80 FR 44303; July 27, 2015), at which an inadequate adequate notice and opportunity for and provided the raw data for the intakes occur. Thus, there was no level comment on the results of the consumer consumer study in response to requests for added sugars, based on the IOM research study because the comment for such data (80 FR 54446; September review, on which we could rely for a period would be closed before the study 10, 2015). Contrary to what the reference amount. In the preamble to the

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supplemental proposed rule (80 FR ‘‘blatant abuse of discretion.’’ The because there were no scientific studies 44303 at 44308), we discussed the comment stated that we are reviewed by the DGAC on consumer availability of the data and information mischaracterizing the evidence related comprehension of an added sugars from the 2015 DGAC Report to support to a specific relationship between added declaration, and therefore, the a DRV for added sugars to below 10 sugars and CVD as ‘‘strong’’ rather than recommendation for added sugars percent of total energy intake based on ‘‘moderate’’ and described this outcome labeling was not based on a the modeling of dietary patterns, current as arbitrary and capricious and an abuse preponderance of the scientific and added sugars consumption data, and a of discretion in violation of the APA. medical knowledge required under published meta-analysis on sugars Other comments stated that the section 301(a) of the NNMRRA for intake and body weight (id.). We ‘‘moderate’’ evidence does not meet our information and guidelines in the tentatively concluded that the scientific standard of ‘‘significant scientific report. The comment stated that FDA’s information in the 2015 DGAC Report consensus’’ or the ‘‘factual basis’’ reliance on the DGAC report for added provided the basis on which we could standard required (citing Motor Vehicle sugars labeling therefore violates section rely to support a DRV reference point Mfrs Ass’n v. State Farm Mut. Auto. Ins 706(2) of the APA in that it lacks a for the added sugars declaration (id.). Co., 463 U.S. 29 (1983) and A.L. factual basis and is thus arbitrary and We respond to comments in this final Pharma, Inc. v. Shalala, 62 F.3d 1484, capricious in violation of the APA. The rule to further explain the basis for the 1491 (D.C. Cir. 1995)). One comment comment also stated that the HHS and added sugars declaration under our further stated the specific relationship USDA violated section 5 of the Federal authority in section 403(q)(2)(A) of the between added sugars and CVD is Advisory Committee Act (FACA) in FD&C Act. moderate, and as such, the evidence is creating the 2015 DGAC because the (Comment 48) One comment mixed and inconclusive and therefore committee was not ‘‘fairly balanced.’’ questioned whether we provided such a change in policy will be The comment said that our reliance on stakeholders with an opportunity to overturned (citing AFL–CIO v. Dole, 745 the DGAC Report is arbitrary and provide meaningful comments. F. Supp. 18, 21 (D.D.C. 1990) rev’d on capricious in violation of section 706(2) Specifically, the comment seemed to other grounds, 923 F.2d 182 (DC Dir. of the APA. Another comment said the object to the period provided for 1991)). proposed added sugars declaration and comment on the raw data for the (Response) The comments may not DRV violate FACA because the DGAC consumer studies, and the limited scope have considered or appreciated the Report and the science supporting the of the comment on the supplement evidence on which we rely for the requirements are not sufficiently proposed rule to the issues presented in added sugars declaration. There is reliable or objective. that document. The comment stated that scientific evidence demonstrating a (Response) We disagree that the we have no authority to propose rules strong association between a healthy required declaration of added sugars in a ‘‘piecemeal fashion’’ and must dietary pattern characterized, in part, by violates section 706(2) of the APA based consider comments that address the a lower amount of sugar-sweetened on independent authorities in NNMRRA impact of the final rule as a whole. foods and beverages and the reduced and FACA with respect to the 2015 (Response) We consider the comment risk of CVD. The scientific evidence in DGAC Report. The mandatory added periods provided for the supplemental Chapter 6 of the 2015 DGAC report, sugars declaration in nutrition labeling proposed rule (80 FR 44303; July 27, concerns an entirely different body of is based on our authority in section 2015) and the raw data on the consumer evidence based on an independent 403(q)(2)(A) of the FD&C Act and not on studies (80 FR 5446; September 10, relationship of added sugars with the separate and independent authority 2015), to October 13, 2015 to be chronic disease risk. The comments do in NNMRRA. Contrary to what the sufficient. The comment did not provide not address the evidence of the strong comments stated, we considered and any basis for why the comment period association between a healthy dietary relied on the scientific evidence in the did not provide a sufficient time during pattern (including, with regard to added DGAC Report for the purpose of which meaningful comments could be sugars, lower intakes of sugar-sweetened determining whether an added sugars submitted, nor did the comment provide foods and beverages), relative to less declaration will assist consumers in a basis to support its assertion that we healthy dietary patterns, and reduced maintaining healthy dietary practices, lack authority to issue a supplement to risk of chronic disease, set forth in and did not rely on a DGAC Report the proposed rule. The supplemental Chapter 2 Part D of the 2015 DGAC recommendation. The comment proposed rule (80 FR 44303) provided report. Our reliance on this scientific concerning whether the 2015 DGAC notice and an opportunity for comment evidence does not mean we abused our Report violated section 301(a) of on relevant new data and information discretion, nor does it mean we are NNMRRA is separate and distinct from for consideration in the final rule, mischaracterizing the evidence. We are our authority under section 403(q)(2)(A) including the findings of the consumer not relying on the scientific evidence of the FD&C Act and outside the scope study on the added sugars declaration with regard to the independent of this rule. and footnote. Thus, there was adequate relationship of added sugars and Moreover, with respect to the notice and an opportunity for comment specific chronic diseases as the basis to comments expressing concerns about on the issues. We considered the require an added sugars declaration, and section 5 of FACA in relation to the comments we received in response to we have described the basis for our 2015 DGAC Report, we reviewed the the proposed rule and supplemental required added sugars declaration and available scientific evidence to proposed rule when developing the the evidence we rely on in the preamble determine whether to require an added final rule. to the proposed rule (79 FR 11879 at sugars declaration, based on our (Comment 49) One comment 11902 through 11905), the supplemental authority in section 403(q)(2)(A) of the suggested that we are ignoring the proposed rule (80 FR 44303 at 44307 FD&C Act. We included, in our review, section of the DGAC Report that focuses through 44308) and this final rule. evidence from the 2015 DGAC Report, on scientific studies about the specific (Comment 50) One comment asserted the 2010 DGA, NHANES data on U.S. relationship between added sugars and the DGAC report violates the National consumption patterns, and other data CVD, for which there is moderate Nutrition Monitoring and Related and information. The DGAC selection evidence, and referred to this as a Research Act of 1990 (NNMRRA) and review process is an interagency

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process that includes HHS and USDA we select for a nutrient for purposes of nutrition label would be misleading to and is outside the scope of this rule. nutrition labeling to ensure the consumers. (Comment 51) One comment stated information will assist consumers in (Response) The declaration of added that we should further consider the maintaining healthy dietary practices is sugars is a material fact under sections effects of the definitions (such as dietary distinct from, and would precede a 403(a) and 201(n) of the FD&C Act, as fiber) and Daily Values on existing decision on, how to define a term for a we explain in our response to comment nutrient content and health claims nutrient content claim or establish an 159. Under section 201(n) of the FD&C authorized under section 403(r) of the eligibility criterion for a . Act, labeling is misleading if it fails to FD&C Act. The comment stated that Therefore, we are not obligated to reveal facts that are material with claims for certain foods that currently consider changes to the requirements for respect to consequences which may qualify for a claim may no longer nutrient content claims or health claims result from the use of the article to qualify, and the comment stated it in this final rule (see Home Box Office, which the labeling relates under the anticipated that restrictions may include Inc. v. FCC, 567 F.2d 9, 36 n. 58 (D.C. conditions of use prescribed or under claims that are part of brand names and Cir. 1977), cert. denied, 434 U.S. 829 conditions of use as are customary or trademarks, and therefore, implicate (1977) (‘‘In determining what points are usual. First Amendment and Fifth Amendment significant, the ‘arbitrary and capricious’ Here, we have determined that the ‘‘takings’’ issues. The comment further standard of review must be kept in mind evidence shows that healthy dietary stated that, without a thorough . . . only comments which, if true, raise patterns associated with a decreased evaluation of these ‘‘collateral points relevant to the agency’s decision risk of chronic disease are lower in implications’’ the final rule ‘‘would fall and which, if adopted, would require a added sugars, consumption of too much short of administrative law change in an agency’s proposed rule added sugars can impact the nutrient requirements’’ (citing Prometheus Radio cast doubt on the reasonableness of a density of the diet, and consumption of Project v. FCC, 373 F.3d 372, 420–21) position taken by the agency.’’)). sugar-sweetened foods and beverages (3d Cir. 2004) and Sprint Corp. v. FCC, For example, we have established a are associated with increased adiposity 315 F.3d 369, 377 (D.C. Cir. 2003)). number of defined terms for nutrient in children. Furthermore, the scientific (Response) In the preamble to the content claims based on the percent of evidence supports limiting added sugars proposed rule (79 FR 11879 at 11889), the DV provided in a reference amount intake to less than 10 percent of total we recognized that changes to the list of customarily consumed for food that calories. We note that this limit was nutrients declared on the label and bears the claim (e.g., ‘‘high’’ and ‘‘good adopted as a recommendation in the changes to the RDIs and DRVs of source’’ in 21 CFR 101.54). Any changes 2015–2020 DGA. The current intake of nutrients could affect whether some we may consider to the definition of discretionary calories from added sugars foods that contained a nutrient content those terms based on changes made to in the U.S. population is excessive. The or a health claim prior to the the DV in this final rule would be in a excess intake of calories from added publication of the final rule would no separate rulemaking, consistent with sugars displaces the calories from other longer meet a defined term or eligibility our authority in section 403(r) of the foods that are needed as part of a requirement to make the claim. We FD&C Act. We plan to evaluate the healthy dietary pattern in order to stated that we plan to evaluate the impact of any changes on other FDA reduce the risk of CVD. Without impact of any changes in a final rule on regulations and address, as appropriate, information on the amount of added other FDA regulations and address those impacts in a future rulemaking. sugars in a serving of a food, consumers them, as appropriate, in a future Furthermore, the comment suggesting would not be able to determine the rulemaking (id.). To the extent the there may be restrictions in using claims amount of added sugars in particular comment suggests we must consider that include brand names and foods, and therefore would not have the impacts to food products that currently trademarks did not provide any further information they need to place a declare certain non-digestible explanation. To the extent there are particular food in the context of their carbohydrates as dietary fiber, but that such circumstances, those would be total daily diet to construct a healthy may no longer be able to declare these considered in a separate rulemaking dietary pattern that contains less than carbohydrates as dietary fiber based on where we consider such claims. Lastly, 10 percent of calories from added the definition of ‘‘dietary fiber’’ in the the cases cited by the comment concern sugars. Thus, the amount of added final rule, we provided notice and an the distinction between an interpretive sugars in a food is a material fact with opportunity to comment on the rule and a legislative rule and are respect to the consequences which may proposed definition and have responded inappropriate to this final rule, which is result from the use of the article under to comments in this final rule. a legislative rule for which we provided the conditions of use prescribed or To the extent the comment suggests notice and an opportunity to comment. under conditions of use as are we must enlarge the scope of this customary or usual. rulemaking to consider what specific 3. Federal Food, Drug, and Cosmetic Act Moreover, section 403(q) of the FD&C food products may no longer qualify for We are updating the Nutrition Facts Act gives us the authority to require a nutrient content or health claim, or label and Supplement Facts label, as set nutrient declarations that we have may include claims that are part of forth in this final rule, consistent with determined provide information that brand names, we disagree. The final rule our authorities in sections 403(q), will assist consumers to maintain concerns changes to the nutrient 403(a)(1) and 201(n), and 701(a) of the healthy dietary practices. declarations in the Nutrition Facts label FD&C Act. (Comment 53) Some comments said and Supplement Facts label under our (Comment 52) Some comments the declaration of added sugars is itself authority in section 403(q) of the FD&C questioned whether the declaration of misleading. The comments highlighted Act. The final rule does not include added sugars to limit consumption of statements in the preamble of the within its scope nutrient content claim added sugars was a material fact under proposed rule that there is no or health claim regulations we sections 403(a) and 201(n) of the FD&C physiological difference between added promulgated under our independent Act. One comment stated that we must sugars and those sugars that are intrinsic authority in section 403(r) of the FD&C demonstrate that the absence of a to food and there is no scientifically Act. Our decision on what RDI or DRV declaration of added sugars on the supported quantitative intake

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recommendation for added sugars on focus on the added sugars declaration all naturally occurring sugars. The which a DRV for added sugars can be and not the total sugars declaration. comment suggested an alternative derived and that U.S. consensus reports (Response) The listing of added method for labeling to ensure the added have determined that inadequate sugars, which is a subset of the amount sugars declaration is no longer evidence exists to support the direct of total sugars, is not misleading. It is misleading. The alternative method contribution of added sugars to obesity the factual statement of the amount of would apply to ‘‘nutritious products or heart disease (79 FR 11879 at 11905 added sugars in a product and the made from unpalatable fruits’’ and through 11906). Another comment declaration of added sugars is one of a would remove the indented Added stated that because added sugars are not number of nutrient declarations on the Sugars declaration such that ‘‘The grams chemically distinct from natural sugars label which consumers can use to assist and percent of daily value for added or have different health effects, the them in maintaining healthy dietary sugars in a dried unpalatable fruit (a declaration of added sugars would be practices. We disagree that the fruit in its raw state has total sugars of false and misleading. declaration of added sugars is less than 5 percent and an average Brix- (Response) We disagree that the equivalent to the need to clarify that all to-acid ration of six or less), and a juice declaration of added sugars is is fat-free when making a fat- product made with at least 27 percent misleading. The statutory basis for free claim about broccoli. First, the juice of an unpalatable fruit, that is requiring an added sugars declaration is declaration of the amount of added sweetened for fruit palatability and whether the Secretary, and by sugars is not a claim, it is a required contains total sugars comparable to delegation, FDA, determines that the declaration. A package of broccoli naturally sweetened dried fruits and 100 nutrient should be included in the would be required to declare 0 grams of percent fruit juices, may be declared by labeling of food for the purpose of fat on the Nutrition Facts label without an asterisk next to the declaration of providing information regarding the any additional explanation total sugars with a footnote at the nutritional value of such food that will (§ 101.9(c)(2)). Furthermore, the two bottom of the nutrition facts panel that assist consumers in maintaining healthy cited cases cited by the comment are not shall state: ‘**Total sugars include dietary practices. The statutory relevant to the requirement to state the sugars added for fruit palatability.’ ’’ framework does not require that the factual declaration of the amount of (Response) We disagree with the nutrient be linked in isolation to any added sugars in a product. The Supreme comment stating that the lack of particular chronic diseases nor does it Court in Ninety-Five Barrels was difference in the way the body processes specify that the nutrient must be discussing a label of an imitation added versus naturally occurring sugars physiologically unique. Furthermore, product that claimed to contain the is a material fact with regard to the we have determined that there is a actual ingredient. The Manischevitz Diet rationale for the added sugars scientifically supported basis for Thins case was addressing a product declaration. The added sugars requiring a DRV of 10 percent for added using the name ‘‘diet’’ that had the same declaration is intended to assist sugars. We address questions as to the calories and overall nutritional profile consumers in maintaining healthy specific scientific basis for that DRV in as the regular non-diet product. Both dietary practices based on the part II.H.3. The inclusion of this DRV cases found these specific terms used recommendation to decrease and the other issues described by the were misleading and noted that the consumption of added sugars and the comment do not make the declaration of FD&C Act condemned statements that impact of a diet that includes high added sugars misleading. The mislead about the make-up of the amounts of added sugars on chronic declaration of added sugars is a factual product. The declaration of added disease measures. We have addressed statement of the amount of this nutrient sugars provides more information to the consumer research on cranberry in the product. consumers about the nutritional make- juice in our response to comment 184 (Comment 54) One comment said that up of the product to use to help them and disagree that the added sugars the declaration of added sugars, as maintain healthy dietary practices. declaration on applied to cranberry juice products that Consumers may have perceptions or misbrands the product. While we have are nutrient dense and sweetened for preferences about a number of nutrients, modified the declaration of added palatability, presents the same issue and which nutrients they focus on in sugars in the final rule, we have related to misleading labeling under choosing food may vary. As we discuss determined that no additional labeling section 403(a)(1) of the FD&C Act, in our response to comment 184, is needed, as discussed in our response where foods naturally free or low in a whether consumers regard a product as to comment 184. nutrient that bear a claim of ‘‘free’’ or healthy can be a combination of many (Comment 56) One comment stated ‘‘low’’ must be labeled as a food that is factors, and we intend to engage in that the term ‘‘nutrient’’ is not defined low in that nutrient (‘‘broccoli, a fat free education and outreach efforts to help in the FD&C Act or FDA regulations and food’’) to avoid implying the food has consumers understand the role of the that it is reasonable for Congress to have been altered as compared to foods of the added sugars declaration and other intended the term to refer to substances same type. The comment said that aspects of the revised Nutrition Facts that are chemically and structurally requiring an added sugars declaration and Supplement Facts labels. distinct from each other, with different on a cranberry juice product that has (Comment 55) One comment stated physiological effects, and not based on fewer total sugars than juice containing that the declaration of added sugars on whether the substance is added or all natural sugars is misleading because cranberry juice, even if true, is ‘‘grossly inherent to a food. For these reasons, the it implies the cranberry product with misleading’’ under sections 403(a)(1) comment suggested added sugars are added sugars is less nutritious and and 201(n) of the FD&C Act because of not an additional nutrient within the generally unhealthy (citing United a failure to reveal the material fact that context of section 403(q)(2)(A) of the States v. Ninety-Five Barrels, 265 U.S. the human body processes added sugars FD&C Act. The comment referred to the 438, 442–443 (1924) and United States and naturally occurring sugars in the listing of nutrients in section 403 of the v. An Article of Food . . . ‘‘Manischevitz same way. The comment said that FD&C Act (e.g., total fat, saturated fat, . . . Diet Thins,’’ 377 F.Supp. 746 consumers will falsely regard the cholesterol, sodium) as scientifically or (E.D.N.Y. 1974)). The comment cranberry juice as less healthy when chemically distinct substances and that expressed concern that a shopper would compared to other fruit juices that have the nutrients listed in section

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403(q)(1)(D) and (E) of the FD&C Act are added sugars are considered to be a of added sugars is associated with not distinguished based on whether nutrient under the FD&C Act. greater risk of CVD than a healthy they are added or inherent to a product. Also, we disagree that, because dietary pattern that includes less added Furthermore, the comment said that the records would be needed to enforce the sugars. Therefore, inclusion of added fact that verification of the added sugars added sugars declaration, Congress did sugars above and beyond what is declaration cannot be achieved through not intend that added sugars be naturally present in foods that are part objective testing and requires records is considered a nutrient. Congress did not of a healthy dietary pattern is a public another reason why Congress did not include any reference to ‘‘objective health concern. The declaration is intend added sugars to be a nutrient testing’’ or how enforcement would needed for consumers to be able to (citing Util. Air Regulatory Group v. occur in the statutory language with identify the amount of added sugars in EPA, 134 S. Ct. 2427 (2014)). Another regard to what nutrients should be a serving of a product in order to fit that comment stated that we do not have the declared on the label. The only criterion product into their total daily diet. statutory authority to require the discussed in the statutory provision for Added sugars are not chemically declaration of added sugars because adding a nutrient to the label is whether different than sugars that are naturally they are not ‘‘additional nutrients’’ and it will assist consumers in maintaining present in foods, and one should not are part of total sugars. healthy dietary practices. Thus, the avoid all foods that are relatively higher (Response) We disagree with the comment’s reference to Util. Air in added sugars than others. Consumers comments that added sugars is not Regulatory Group v. EPA, where the can eat a healthy diet that includes compatible with the term ‘‘nutrient’’ in Supreme Court determined that an added sugars, but, in order to carefully sections 403(q)(2) and 403(q)(1)(D) of Agency had applied a more general choose foods so that the overall diet is the FD&C Act. With regard to the definition to a statutory provision with not high in added sugars relative to argument that it cannot be an additional a more narrow meaning given the calorie needs, it is important to consider nutrient if it is a component of total context of the program, is also the amount of added sugars in a serving sugars or if it is not chemically distinct misplaced in this context. There is no of a product and how the added sugars from total sugars, section 403(q)(1)(D) of context in the specific statutory content of that product should be the FD&C Act includes several nutrients provision about which nutrients should balanced with other food choices. (Comment 58) One comment stated that are subcomponents of other be declared on the label that indicates that an added sugars declaration is not nutrients on the list, so the comments’ that it should be limited to nutrients that can be ‘‘objectively measured.’’ related to the purpose of the NLEA arguments that each nutrient currently (Comment 57) Some comments stated because it does not help consumers required is chemically distinct or that the added sugars declaration does not reduce the risk of a diet-related disease each nutrient is not a subcomponent of assist consumers in maintaining healthy (citing House Committee Report 101– another listed nutrient is simply not dietary practices under section 538, 101st Congress, 2nd Sess., 13 correct. Total fat includes saturated fat, 403(q)(2)(A) of the FD&C Act because it through 14 and the Congressional and total carbohydrates include sugars misleads consumers into believing that Record (136 Cong. Rec. H5836 101st and dietary fiber. As these nutrients products without added sugars, but with Cong. 2nd Sess. (July 30, 1990 at 19 and were all required by Congress to be the same or greater calories and total 21)), S. 16610 Cong. Rec. (Oct. 24, declared on the label, we further sugars, are healthier if the product 1990)). The comment referenced disagree that Congress intended the contains naturally occurring sugars. statements from the preamble to the nutrients to all be chemically and Some comments considered our past proposed rule related to our rationale structurally distinct from each other and statements, including that added sugars for other mandatory nutrient to have distinct physiological effects. are not chemically distinct from declarations that relate to the intake of Furthermore, the House committee naturally occurring sugars and added a nutrient that is specifically related to report for the NLEA (H.R. 3562) (Report sugars are not independently and the risk of chronic disease, health- 101–538, June 13, 1990 at page 14) directly linked to any disease, health- related condition, or a physiological states that the Secretary may provide related condition such as obesity, or endpoint. Another comment stated that definitions of the nutrients required physiological endpoint, to support the the purpose of our added sugars under 403(q)(1)(D) or 403(q)(2) of the proposition that the added sugars declaration is to help consumers with FD&C Act, and we have done so declaration would not assist consumers dietary planning and is not reasonably consistent with the public health and in maintaining healthy dietary practices related to the requirements and purpose based on sound scientific principles. by providing consumers information to of the statute. Additionally, the specific concerns construct diets that are nutrient dense (Response) First, we note again that and recommendations about added and reduce calorie intake from added the statutory language in section sugars’ contribution to the daily diet sugars. 403(q)(2) of the FD&C Act is that a that are distinct from total sugars has (Response) We do not agree that the nutrient can be required for the led to the requirement for the declaration of added sugars misleads purposes of providing information declaration of added sugars, consistent consumers based on our consumer regarding the nutritional value of such with the stated statutory purpose of research results and those results food that will assist consumers in assisting consumers to maintain healthy submitted in the comments in response maintaining healthy dietary practices. dietary practices. Nutrient content to questions about how ‘‘healthy’’ a This statutory basis is how we claims are defined in § 101.13(b) as product is that contains added sugars. determined to propose the mandatory claims that expressly or implicitly The declaration of added sugars declaration of added sugars. characterize the level of a nutrient of the provides information about the amount Furthermore, the statements cited by the type required to be in nutrition labeling of a single nutrient that consumers can comment relating to the Congressional under § 101.9 or under § 101.36. We use as part of their decisions in building history of the NLEA are taken out of have a ‘‘no added sugar,’’ ‘‘without a healthy dietary pattern. We are context and inappropriately limit the added sugar,’’ or ‘‘no sugar added’’ requiring the declaration of added scope of the NLEA and its nutrient nutrient content claim regulation sugars because a dietary pattern declaration requirements. The purpose (§ 101.60(c)(2)), supporting the fact that characterized, in part, by larger amounts statement at the beginning of the House

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Committee Report that the comment CFR 101.65(d)(2). The comment seemed legislative history to support its referenced actually states, ‘‘The purpose to assert that finalizing a requirement position. The reference to the National of this legislation is to clarify and to for an added sugars declaration, where Academy of Science report in this strengthen the Food and Drug the term ‘‘healthy’’ requires no context also is misplaced. As stated in Administration’s legal authority to limitation on added sugars content, is the comment itself, the House require nutrition labeling on foods, and arbitrary and capricious under section Committee’s reference in 1990 was to a to establish the circumstances under 706(2) of the APA (5 U.S.C. 706(2)) and specific National Academy of Science which claims may be made about a violation of section 403(q)(1)(D) the report that had been commissioned at nutrients in foods’’ (House Committee FD&C Act (also citing Frisby v. HUD, the time. The report stated that the Report 101–538, 101st Congress, 2nd 755 F.2d 1052, 1055 through 1056 (3d ‘‘Committee expects the Secretary to Sess., 7). The comment’s reference to Cir. 1985) for the proposition that the consider the hearing record before the the statements on the House floor by Agency must follow its own Subcommittee and the NAS study on Congressman Madigan excluded the regulations). Another comment stated nutrition labeling, if that study is most relevant point about his more that added sugars content is not available in sufficient time to meet the narrow bill with respect to specific included in the nutrient content claim statutory deadline’’ (H.R. Rep. No. 101– chronic disease outcomes, that for ‘‘healthy,’’ and, therefore, an added 538, at 17). If the report was not ‘‘Chairman Waxman has graciously sugars declaration would not assist completed, it did not need to be taken included much of the language in my consumers in maintaining healthy into consideration. Furthermore, this bill in this comprehensive nutrition dietary practices. statement in the report did not labeling bill’’ (136 Cong. Rec. H5836 (Response) We are relying on our constitute a limiting statement as to 101st Cong. 2nd Sess. (July 30, 1990, at authority in section 403(q)(2)(A) of the future decisions regarding other H5843). The statement from Senator FD&C Act to require the declaration of nutrients and what they should be based Hatch seemingly focused on chronic added sugars, and the only on. In addition, the comment only disease also follows the more general consideration for that statutory stated that the decision with regard to statement by his co-sponsor Senator provision is whether the declaration the DRV for added sugars is based on an Metzenbaum that described the broader will assist consumers to maintain impermissible source and did not focus on healthy dietary practices, healthy dietary practices. The Frisby dispute the entire decision to require stating, ‘‘By providing the public with case cited by the comment is not the declaration of added sugars. better nutrition information, this bill relevant because the definition of the The reference to the NLRB case is makes a major step forward in enabling voluntary ‘‘healthy’’ claim under section similarly misplaced. The case refers to consumers to select foods to protect and 403(r) of the FD&C Act does not bear on an Agency changing the standard it is improve their health’’ (136 Cong. Rec. the determination of whether to require applying to a determination of the No. 147, S. 16607 101st Cong. 2nd Sess. a declaration on the nutrition facts label, evidence without describing any (Oct 24, 1990, at S. 16608)). and we plan to revisit claims, including reasoned basis for the change. Here, we While the preamble to the proposed the healthy claim, after we finish this have provided a reasoned explanation rule discussed a different framework rulemaking. Furthermore, our finalizing for requiring the declaration and DRV than an independent relationship a requirement for an added sugars for added sugars, and have done so between the nutrient and a risk of declaration and any separate throughout the rulemaking process. The chronic disease, a health-related consideration of the healthy claim science on the contributions of dietary condition, or a physiological endpoint under section 403(r) of the FD&C Act do patterns has evolved, and the 2015 in the general population, added sugars not violate the APA, as discussed in our DGAC Report contains evidence with are part of a dietary pattern linked to response to comment 51. regard to the effect of a diet that health effects and has been discussed in (Comment 60) One comment stated includes lower amounts of added sugars the recent DGA. In 2010, the scientific the proposed added sugars declaration compared to a diet that includes higher evidence supported a key DGA and DRV violate the NLEA because the amounts of added sugars. This evidence recommendation to reduce consumption 2015 DGAC Report and the science on supplements the growing scientific of added sugars because of their effect which we rely are not sufficiently evidence from the 2010 DGA and on health due to the inability to eat reliable or objective. Another comment concern about added sugars and their excess added sugar and consume suggested that the declaration of added impact on public health and the ability necessary nutrients within sugars violates the FD&C Act and the to maintain healthy dietary practices by recommended calorie limits. In 2015, APA because the DRV for added sugars consuming a diet sufficient in nutrients the DGAC Report included evidence is not based on a NAS report, which the within calorie limits, which we that diets that included high amounts of comment stated ‘‘the House Committee included in our rationale for the added sugars were linked to increased Report urged’’ FDA to rely on for proposed declaration for added sugars. risk of CVD compared to dietary nutrients listed on the label, and The ability of a nutrient declaration to patterns that included lower therefore, presents impermissible and assist consumers in maintaining healthy consumption of added sugars. The inconsistent Agency reasoning that is dietary practices remains the declaration of added sugars squarely fits arbitrary and capricious (citing determination upon which a new within the statutory framework to assist Allentown Mack. Sales & Serv., Inc. v. nutrient declaration is based. consumers to maintain healthy dietary NLRB, 522 U.S. 359, 374 through 375 (Comment 61) One comment said that practices. (1998)). The comment considered the we have not adequately explained our (Comment 59) One comment said we use of the 2015 DGAC Report as the departure from what the comment cannot rely on section 403(q)(2)(A) of basis for the DRV to be a departure from characterized as the 2010 DGA’s focus the FD&C Act to support an added past practice that is not sufficiently on added sugars labeling, stating further sugars declaration where we do not rely explained and without ‘‘sufficient that we relied on the 2015 DGAC Report on an added sugars content of a food to scientific consensus.’’ for a strong association between a determine if the food is ‘‘healthy’’ (Response) The comment conflates dietary pattern characterized, in part, by consistent with the nutrient content several arguments and statements and is a reduced intake of sugar-sweetened claim requirements for ‘‘healthy’’ in 21 incorrect in its reliance on the NLEA’s foods and beverages and reduced risk of

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CVD, which the comment stated is Furthermore, a healthy dietary enforce the requirements when contrary to the law (citing Motor Vehicle pattern, characterized in part by a necessary. Furthermore, the records Mfrs. Ass’n v. State Farm Mut. Auto. reduced amount of sugar sweetened would allow us to verify the declared Ins. Co., 463 U.S. 29, 42 (1983) and Nat’l foods and beverages, is strongly amount of each of these nutrients and Ass’n of Home Builders v. EPA, 682 associated with a reduced risk of CVD that such amount is truthful and not F.3d 1032, 1037 (D.C. Cir. 2012)). The compared to less healthy dietary misleading. Thus, the proposed records comment suggested that NLEA does not patterns. Thus, we disagree with the requirements would help in the efficient authorize us to rely on this basis for comment’s statement that there is no enforcement of the FD&C Act. We also labeling, and, instead, we must rely on reliable correlation between added sugar noted that our authority to establish the presence or absence of a specific content in food and healthy dietary records requirements has been upheld nutrient and disease relationship choices or patterns. The studies cited by under other provisions of the FD&C Act between added sugars and CVD before the comment that looked at nutrient where we have found such records to be requiring such labeling, for which the content claims and the data underlying necessary, and cited National comment states only moderate evidence a 2002 IOM suggested maximum intake Confectioners Assoc. v. Califano, 569 is available. The comment cited studies level of 25 percent or less of added F.2d 690, 693 through 694 (D.C. Cir. to suggest there is no reliable correlation sugars are not relevant to the basis for 1978)) (79 FR 11879 at 11884 and between added sugar content in food our declaration of added sugars. One 11957). In addition to having the and healthy dietary choices or patterns. study cited by the comment described authority to require the maintenance of (Response) First, this comment how small amounts of added sugars may such records, we further stated that our misrepresents the 2010 DGA, citing and increase the palatability of nutrient- authority also provided for FDA to have quoting a line from Appendix 4 that dense foods. We acknowledged this access to such records because in order lists the current nutrients that are finding in the preamble to the proposed to determine whether the food is displayed on the Nutrition Facts label rule (79 FR 11879 at 11905), and it is misbranded and the manufacturer has and saying that this statement is the consistent with the requirement to committed a prohibited act, we must focus of the 2010 DGA recommendation declare added sugars and the percent have access to the manufacturer’s with regard to added sugars, rather than DV so that consumers can understand records that we are requiring be made the key recommendation and how to incorporate such amounts of and kept under sections 403(q), substantive chapter of the 2010 DGA. added sugars into their daily diets. 403(a)(1), 201(n) and 701(a) of the FD&C Act. Without such authority to access The comment also mistakenly states that 4. Recordkeeping Authority the records supporting the declarations, the proposed rule and the supplemental The preamble to the proposed rule (79 proposed rule rely on the findings in the these nutrient declarations that have FR 11879 at 11884 and 11956 through been determined to be necessary to 2015 DGAC Report. As we stated in the 11957) discussed our legal authority for preamble to the supplemental proposed assist consumers to maintain healthy the proposed recordkeeping dietary practices would be rule (80 FR 44303 at 44307 through requirements. We stated that we were 44308), the science underlying the 2015 unenforceable. relying on our authority under sections (Comment 62) While several DGAC Report provides further support 403(q), 403(a), 201(n) and 701(a) of the comments supported our proposed for the declaration of added sugars, FD&C Act, to propose record requirement, many comments broadly which was supported in the proposed requirements to support nutrient asserted that we do not have the rule in part by the scientific evidence in declarations in labeling for added authority to require recordkeeping. the 2010 DGA related to reducing sugars, dietary fiber, soluble fiber, (Response) The FD&C Act requires calories from added sugar. Thus, insoluble fiber, vitamin E, and folate/ foods to bear truthful and not contrary to what the comment seemed folic acid, under certain circumstances, misleading information about the to suggest, we are not departing from the so that we can determine compliance amount of nutrients in the food to assist science set forth in the 2010 DGA that with labeling requirements and take consumers in maintaining health dietary is included in the evidence on which enforcement action, as needed. We practices (sections 403(q), 403(a)(1), and we rely for added sugars, but are also described how the records requirements 201(n) of the FD&C Act). As we stated including additional evidence from the would apply only to the narrow in the preamble to the proposed rule (79 2015 DGAC Report to further support circumstances where there are not any FR 11879 at 11956), under section the added sugars declaration, so the appropriate reliable analytical methods 701(a) of the FD&C Act, we may issue cases cited regarding the level of that can be used to verify the regulations for the efficient enforcement explanation that is necessary to explain compliance of a nutrient declaration. of the FD&C Act in order to ‘‘effectuate a change in policy are not relevant. We noted that failing to accurately a congressional objective expressed The comment suggested that reliance state the amounts of nutrients on the elsewhere in the Act’’ (Association of on a rationale other than a specific label under § 101.9(g) would result in a American Physicians and Surgeons, Inc. disease relationship between added product being misbranded. Under v. FDA, 226 F. Supp. 2d 204 (D.D.C. sugars and CVD is not permitted by the section 403(q) of the FD&C Act, a food 2002) (citing Pharm. Mfrs. Ass’n. v. NLEA. The NLEA and FD&C Act state must bear, in its label or labeling, the FDA, 484 F. Supp. 1179, 1183 (D. Del. that nutrient declarations can be added amount of the nutrient the food contains 1980))). The recordkeeping if determined to assist consumers in and, moreover, the nutrient declaration requirements are intended to ensure that maintaining healthy dietary practices. must be truthful and not misleading the nutrient declarations, which would There is no further restriction on the under sections 403(a)(1) and 201(n) of be based on information known only to evidence that can be used to support a the FD&C Act. Thus, we stated that the the manufacturer, are truthful and not declaration in the statute. Both the proposed recordkeeping requirements misleading, and to facilitate efficient preamble to proposed rule and the are designed to ensure that the nutrient enforcement of the requirements for preamble to the supplemental proposed declarations are accurate, truthful and nutrient declaration when necessary. rule thoroughly explain the rationale for not misleading, based on information The recordkeeping requirements are the required declaration for added known only to the manufacturer, and to only for foods for which official AOAC sugars. facilitate efficient and effective action to or other reliable and appropriate

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analytical methods are not available. the end is required, appropriate means administering the delegated authority in FDA access to information, in the form are given and every grant of power section 403(q) of the FD&C Act to of a record, required to support an carries with it the use of necessary and require truthful and not misleading added sugars, dietary fiber, soluble lawful means for its effective execution) labeling and accurate nutrition labeling fiber, insoluble fiber, vitamin E, and/or and Weinberger v. Bentex for the purpose of assisting consumers folate/folic acid declaration, where the Pharmaceuticals, Inc., 412 U.S. 645, 653 to maintain healthy dietary practices. In information is known only to the (1973) (Some Agency authority is essence, it is a requirement simply to manufacturer, is a practical alternative ‘‘implicit in the regulatory scheme, not document how the manufacturer means by which we can verify that the spelled out in haec verba’’ in the complied with the substantive nutrient declarations comply with statute)). requirements in certain circumstances. section 403(q) of the FD&C Act and Furthermore, we disagree that the The cited cases support the thus, assist in the efficient enforcement express grant of records authority in requirement of records to simply of the FD&C Act. Moreover, such other contexts means that it was document how the manufacturer information would also be necessary for expressly contemplated and rejected complies with the rule in this context. the manufacturer to maintain in order to under the circumstances proposed here. The court in Califano even cites case ensure the accuracy of the label. The provision for efficient enforcement law that specifically addresses the (Comment 63) Several comments of the FD&C Act in section 701(a) of the relevance of remedying enforcement stated that the FD&C Act does not give FD&C Act, along with the authority to problems, which is the basis for the us express authority to require require or voluntary permit these recordkeeping requirement here, stating recordkeeping for nutrition labeling. nutrient declarations under section that ‘‘. . . whether statutory scheme as Other comments specifically argued that 403(q) of the FD&C Act to prevent a whole justified promulgation of the sections 403(q), 403(a) and 201(n) of the misleading labeling, provides the ability regulation . . . will depend not merely FD&C Act do not provide for to require such records to effectuate the on an inquiry into statutory purpose, recordkeeping authority and that goal of enforcing nutrition labeling for but concurrently on an understanding of Congress had exercised care in defining those limited products covered by the what types of enforcement problems are the scope of our recordkeeping authority recordkeeping requirements. encountered by FDA, the need for in the statute. Additionally, some (Comment 64) Several comments various sorts of supervision in order to comments said that Congress has not stated that courts have repeatedly effectuate the goals of the Act, and the given FDA general records authority and explained that FDA cannot create safeguards devised to protect legitimate Congress must grant specific authority records access using section 701(a) of trade secrets’’ (Califano, 569 F.2d at 693 to FDA to access manufacturing records the FD&C Act, citing Association of (citing Toilet Goods Association, Inc. v. but declined to do so for nutrition American Physicians & Surgeons v. Gardner, 387 U.S. 158, 163 (1967))). As labeling. Several comments pointed out FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) we have discussed, in the case of the instances in the FD&C Act that provide and National Confectioners Association Nutrition Facts rule, the purpose of the express recordkeeping authority, v. Califano, 569 F.2d 690, 695 (D.C. Cir. statute is to ensure truthful and not arguing that the fact that Congress 1978). misleading labeling as well as to assist provided it in certain contexts means (Response) The comments’ reading of consumers to maintain healthy dietary that it was not intended here. these cases is not correct. First, while practices by providing nutrition (Response) Courts have not found that the cited cases state that section 701(a) information on the labels of food. The a specific grant of authority from of the FD&C Act is not an unlimited or requirement to maintain these records Congress is necessary in order to stand-alone provision, neither case would effectuate that purpose by promulgate every portion of every found that maintenance of records was allowing enforcement of the regulation (see, e.g., American Trucking not a proper exercise of authority declarations of certain required Ass’ns, Inc. v. United States, 344 U.S. related to section 701(a) of the FD&C nutrients. 298, 308–313 (1953) (‘‘the promulgation Act, when combined with authority (Comment 65) One comment argued of these rules . . . falls within the provided in other substantive sections that section 701(a) of the FD&C Act Commission’s power, despite the of the FD&C Act. In fact, maintenance of cannot be reasonably construed to absence of specific reference to leasing records was one requirement that the authorize records access because it does practices in the Act [citation omitted]. court in Califano upheld, stating, ‘‘In not constitute a separate grant of The grant of general rulemaking power our opinion however the coding and authority and cannot be read to necessary for enforcement compels this record-keeping requirements here at authorize recordkeeping authority if that result.’’) and Permian Basin Area Rate issue clearly do not distend the scope of authority is not already included in the Cases, 390 U.S. 747, 780 (1968) (‘‘We regulation authorized by the Act’’ other sections being used for authority, are, in the absence of compelling (Califano, 569 F.2d at 695). One section such as sections 403(q), 403(a), and evidence that such was Congress’ in Assn. Amer. Physicians & Surgeons 201(n) of the FD&C Act, in this case. intention, unwilling to prohibit that the comment quoted is ‘‘Section (Response) We agree that section administrative action imperative for the 371 [701(a)] does not constitute an 701(a) of the FD&C Act does not achievement of an Agency’s ultimate independent grant of authority that constitute a completely separate grant of purposes.’’)). This was also held to be permits FDA to issue any regulation the authority to promulgate any regulation true in Califano, where the court found Agency determines would advance the to protect the public health, but we that Congress had not intended to public health. Rather, 371 permits FDA disagree that it cannot be used to immunize the manufacturers from to use rules as a means of administering authorize records access for the nutrient requirements, including recordkeeping, authorities otherwise delegated to it by declarations identified when there is no by not having an express recordkeeping the Congress.’’ Unlike the separate express authority in section 403(q) of provision in the statute (Califano, 569 requirement to do testing and include the FD&C Act to require and access F.2d at 693; see also Morrow v. Clayton, labeling that were discussed in Assn. these specific records, as the comment 326 F.2d 36, 44 (10th Cir. 1963) (Powers Amer. Physicians & Surgeons, the argues. If there had to be an express of an Agency are not limited to those limited records requirement discussed provision in every relevant substantive expressly granted by statutes—where here is for the express purpose of provisions of the statute, such as section

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403(q) of the FD&C Act, reference to records bears on whether we have the apply only to the narrow circumstances section 701(a) of the FD&C Act and its authority to require records under the where there are not any appropriate use to effectuate the efficient statute. Section 301(e) of the FD&C Act, reliable analytical methods that can be enforcement of the FD&C Act would regarding prohibited acts, refers to the used to verify the compliance of a never be necessary, and it would be express recordkeeping requirements in nutrient declaration. rendered superfluous. the FD&C Act. Moreover, a prohibited Where there are appropriate reliable Furthermore, as discussed in greater act violation in section 301(e) of the analytical methods, we would not need detail in our response to comment 64, FD&C Act is separate and distinct from to access manufacturing records in order this notion was explicitly rejected in a misbranding violation in section to enforce the FD&C Act. However, the Califano, where the court stated that it 403(q) of the FD&C Act. It is a narrow circumstances where we do was rejecting the idea that the regulation prohibited act under section 301(a) of have the authority and are exercising must stand or fall on the substantive the FD&C Act to introduce, or deliver the authority here are those section alone and found that Congress for introduction, a misbranded food into circumstances where we do not have had not intended to immunize the interstate commerce. Thus, the fact that access to appropriate reliable analytical manufacturers from requirements, there is not a prohibited act violation for methods. including recordkeeping, by not having access to, and copying of, records (Comment 69) While one comment an express provision in the statute related to the nutrient declarations for pointed out that § 101.9(g)(9) already (Califano, 569 F.2d at 693; see also these select nutrients under section contemplates and provides a Morrow v. Clayton, 326 F.2d 36, 44 403(q) of the FD&C Act does not mean mechanism for the use of an alternative (10th Cir. 1963) and Weinberger v. that we do not have authority under means of compliance for nutrition Bentex Pharmaceuticals, Inc., 412 U.S. sections 403(q) and 701(a) of the FD&C labeling, supporting our use of an 645, 653 (1973)). In the current context, Act to require these records under these alternative means to enforce compliance records access is necessary to efficiently circumstances. As we explained earlier, here, a few comments took exception to enforce the statutory requirements in express authority in section 403(q) of the preamble to the proposed rule’s certain limited circumstances. the FD&C Act is not needed for these reference to situations where our (Comment 66) One comment argued records (see Califano, 569 F.2d at 693). regulations already provided for that the case law we cited did not Maintenance of and access to records for maintenance of records in the nutrition support our records access authority certain nutrition labeling declarations context. The comments stated that those because the cases were not specific to only under certain circumstances is instances regarding aeration to reduce nutrition labeling and were related to necessary for the efficient enforcement fat and caloric content of foods (58 FR drug labeling. The comment said that of the Nutrition Facts labeling 2229 at 2271, January 6, 1993) and the cases have no bearing on the issues requirements, whether or not caloric content of new products with here. Another comment argued that we compliance with the those requirements reduced digestibility (58 FR 2079 at should not have relied on National are included as prohibited act under the 2111) were optional recordkeeping in Confectioners Association v. Califano statute. instances where a manufacturer chooses because it was decided before the NLEA (Comment 68) Several comments to depart from the established was enacted. referenced a statement in the preamble regulations or to support a voluntary (Response) We first note that many to the 1993 nutrition labeling final rule claim, rather than the broad regulations cases cited by these and other comments stating that, to support a misbranding we proposed here for all manufacturers. are not specific to nutrition labeling and charge for inaccurate nutrient content (Response) These examples were were decided well before the NLEA was information, we must have accurate, provided as illustrations of the use of enacted. We disagree with these reliable, and objective data to present in records in a compliance context, not to comments and find the cases, which a court of law and that, to obtain that demonstrate our authority. Any many comments also cited, to be both information, we rely upon the work discussion of these other regulatory applicable and the best indication of the performed by our trained employees examples does not affect our authority proper reading of the FD&C Act. While because we do not have legal authority with regard to this particular records it is rare to find case law that directly in most instances to inspect a food requirement. We do not agree that these mirrors the situation at issue, Califano manufacturing firm’s records (58 FR are broad regulations; rather, they are is striking in that it specifically affirms 2079 at 2110, January 6, 1993). The for a quite limited purpose and scope— our authority to promulgate a comments asserted that this statement only required when the manufacturer is recordkeeping requirement for certain was evidence that we recognized that including a mixture of products that food products when needed to be able we do not have the authority to access cannot be distinguished by the to effectuate the statutory purpose. manufacturing records as part of our analytical methods detailed in the Congress has not acted to overturn that enforcement of the nutrition labeling regulations. The requirements also are decision, which was the applicable requirements. quite flexible, not requiring any existing legal framework when Congress (Response) We do not agree with this particular records and allowing the was enacting the NLEA. characterization of the statement in the manufacturer to determine the best (Comment 67) Several comments 1993 final rule. The cited statement was records to establish and maintain in referenced section 301(e) of the FD&C part of a discussion of why we perform order to comply. Furthermore, we Act, regarding what recordkeeping our own laboratory analyses and use disagree with the comment that the violations constitute a prohibited act, as those results for enforcement, rather cited existing regulations with reliance an exclusive list of what recordkeeping than looking at or verifying laboratory on records for compliance purposes are provisions are authorized and as analysis results kept in the records of a all optional or voluntary. In the context evidence that sections 403(q), 403(a), manufacturer. When there are available of calculating appropriate caloric 201(n), and 701(a) of the FD&C Act do reliable laboratory analyses in order to content of new products with reduced not authorize recordkeeping provisions. test for a specific nutrient, we still rely digestibility, the caloric declaration is a (Response) We disagree that the on those analyses for compliance required declaration, and products absence of the specified provisions in purposes. As we have described, the wishing to adjust the declared amount the list of prohibited acts regarding records requirements in this final rule because they are using certain novel

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ingredients would need to submit for a description of the variety of information, and we discuss safeguards documentation of their calculations to records that manufacturers can establish for such information in part II.R.3, FDA. or maintain to meet the requirements. practically, we need to be able to copy (Comment 70) Several comments We discuss other comments regarding the records and access them at FDA stated that, because they believed we the proper handling and confidentiality headquarters in order to fully evaluate did not have a scientific basis for of any proprietary information that is them to determine compliance or the requiring the declaration of added submitted in part II.R.3. need for any further regulatory action or sugars, our authority to require records (Comment 72) Some comments said enforcement proceedings (see FDA to verify the added sugars declaration that the recordkeeping authority Regulatory Procedure Manual, section was questionable. previously given to FDA, as in the case 4–1–4, regarding Center concurrence for (Response) Please see part II.H.3 for a of the Public Health Security and labeling violations). Such full more detailed discussion of our Bioterrorism Preparedness and evaluation by us is not possible onsite scientific basis for requiring the Response Act of 2002 (Pub. L. 107–188), at the facility. declaration of added sugars. Because the were unrelated to nutrition labeling. (Comment 75) One comment added sugar declaration is necessary to (Response) We agree that the BT Act suggested that the inspectional authority assist consumers in maintaining healthy authority is unrelated, and we disagree in section 704 of the FD&C Act did not dietary practices, which is the statutory that the scope of recordkeeping provide for access to these records. mandate, the recordkeeping authority in the BT Act limits our ability (Response) Section 704 of the FD&C requirements are necessary and to require records. Section 306 of the BT Act states that the inspection ‘‘shall’’ authorized for the efficient enforcement Act states that it shall not be construed extend to records when section 414 of of the FD&C Act. to limit the ability of the Secretary to the FD&C Act applies. We do not (Comment 71) Multiple comments require records under other provisions interpret this as an exclusive extension. argued that our authority excludes of the FD&C Act. Section 414 of the FD&C Act specifically access to ‘‘recipes for food,’’ among (Comment 73) Some comments stated states that it does not limit the authority other proprietary information. Some that we did not need records access to of the secretary to inspect records under comments stated that we may not access enforce the nutrition declarations other provisions of the FD&C Act. This or that we lack authority to access because companies are already required specific grant of authority applies to a recipes for food, or that recipes were to ensure that their labels are not false single specific statutory provision protected by Congress. Another or misleading under section 403(a)(1) of regarding , and does not comment stated that it is ‘‘beyond the the FD&C Act and § 101.9(g). address false and misleading labeling. It scope of the Agency to inspect records (Response) While we agree with the does not prevent us from accessing related to product formulation.’’ Other comment that manufacturers are already records that we can require by other comments noted that the Public Health required to ensure that their labels are regulations. Security and Bioterrorism Preparedness not false or misleading, we are requiring and Response Act of 2002 (Pub. L. 107– that records be maintained that can 5. Miscellaneous Comments 188) (BT Act), as well as section 414 of specifically support certain declarations Several comments raised other legal the FD&C Act, expressly carve out required under § 101.9(g) because issues with respect to various parts of recipes as a record that we cannot without access to those records, we are the rule. access even in food safety emergency not able to verify the accuracy of the Dietary Fiber situations. required declared amounts. (Response) The exclusion of recipes (Comment 74) Some comments (Comment 76) One comment stated that several comments referred to is argued that, even if we had the authority the definition of dietary fiber, which found in the BT Act, and there is no to access records, we did not have the requires a dietary fiber to have a more general protection of recipes by authority to copy records, stating that physiological effect beneficial to health, Congress. We further disagree that the copying of records is not required for would ‘‘prohibit the use of accurate, parameters of the recordkeeping the efficient enforcement of the FD&C well substantiated dietary fiber authority in the BT Act affect our ability Act and that inspectors should be able determinations in nutrition labeling for to require records here. The purpose of to inspect and evaluate records onsite at many foods.’’ The comment said that the review of records under the BT Act the manufacturing facility without the restriction is not adequately justified is distinct from the purpose of the copying them. to advance FDA’s labeling objectives, record review for nutrition labeling, and (Response) We disagree with this nor is adequately tailored, to satisfy the section 306 of the BT Act says that it comment. As we stated in the preamble First Amendment. shall not be construed to limit the to the proposed rule (79 FR 11879 at (Response) We disagree that, by ability of the Secretary to require 11957), in order to determine whether defining ‘‘dietary fiber,’’ we are records under other provisions of the the food is misbranded and the prohibiting the use of ‘‘accurate, well FD&C Act. manufacturer has committed a substantiated dietary fiber Furthermore, the final rule’s prohibited act, we must have access to determinations’’ as the comment recordkeeping requirement is flexible the manufacturer’s records that we are suggests. As we explain in our response and does not require any specific requiring be made and kept under to comment 252, the definition includes document to support the declarations. sections 403(q), 403(a)(1), 201(n) and dietary fibers that have been shown to While the preamble to the proposed rule 701(a) of the FD&C Act. Without the have a physiological effect beneficial to provided some examples of records that authority to access the records human health, and therefore, the manufacturers may choose to maintain supporting the declarations, the nutrient declared amount of dietary fiber will (see, e.g., 79 FR 11879 at 11956), they declarations that we have determined to include information about the amount are not required to maintain any be necessary to assist consumers in of fibers in a serving of food that are particular record and would also be maintaining healthy dietary practices necessary to maintain healthy dietary permitted to maintain redacted would be unenforceable. While we practices, consistent with our authority documents if they established the understand the concerns with in section 403(q)(2) of the FD&C Act. necessary information. See part II.R.3 confidentiality of certain corporate Manufacturers will be able to petition

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FDA to request that we amend the section 403(q)(1)(C) and (D) of the FD&C are reference intake levels provided in definition to include additional fibers, Act, nutrition information in food consensus reports that can be used to set as appropriate. If a substance is a fiber, labeling must include the total number a DRV or RDI. We expect these but not a ‘‘dietary fiber’’ that has a of calories, derived from any source and consensus reports to be published for physiological effect beneficial to human derived from the total fat, and the the purpose of setting quantitative health (such that the fiber is not eligible amounts of total fat, saturated fat, intake recommendations (e.g., the IOM to be, and not listed as, a ‘‘dietary fiber’’ cholesterol, sodium, total carbohydrates, DRI reports), but, if DRIs are not in the codified definition of ‘‘dietary complex carbohydrates, sugars, dietary available for nutrients, other than fiber’’), a manufacturer may still declare fiber, and total protein. We referred to essential vitamins and minerals, then the substance as part of total the nutrients that are explicitly required we consider the scientific evidence from carbohydrate. Furthermore, a by the FD&C Act to be declared on the other U.S. consensus reports or the manufacturer may make a statement Nutrition Facts label as ‘‘statutorily DGA. Public health significance refers to about the amount of these other fiber required nutrients.’’ Section 403(q)(2)(B) two elements. First, we consider substances in the food, provided the of the FD&C Act permits us to remove whether there is evidence of a statement is truthful and not a statutorily required nutrient from the relationship between the nutrient and a misleading. The comment did not label or labeling of food, by regulation, chronic disease, health-related provide further explanation for why our if we determine the information related condition, or health-related definition for dietary fiber is not to that nutrient is not necessary to assist physiological endpoint. This can be adequately justified or adequately consumers in maintaining healthy demonstrated either by well-established tailored under the First Amendment dietary practices. evidence (in the form of U.S. consensus and, based on the reasons we provide, Section 403(q)(2)(A) of the FD&C Act reports) or, for essential vitamins and we are not making any changes in also gives us the authority to require, by minerals, the health consequences of response to this comment. regulation, other nutrients to be inadequacy of the nutrient. Second, we declared if the we determine that a consider whether there is evidence of a D. Factors for Mandatory or Voluntary nutrient will provide information problem related to health in the general Declaration of Non-Statutory Nutrients regarding the nutritional value of such U.S. population. This is demonstrated The preamble to the proposed rule (79 food that will assist consumers in by both evidence of a problem with the FR 11879 at 11890 through 11891) maintaining healthy dietary practices. intake of the nutrient in the general U.S. discussed the factors that we primarily The preamble to the proposed rule population and evidence of the considered in requiring the declaration explained that we consider such prevalence of the chronic disease, of most non-statutory nutrients or nutrients that are not statutorily health-related condition, or health- providing for the voluntary declaration required, but subject to our discretion related physiological endpoint that is of such nutrients. Our discussion of under section 403(q)(2)(A) of the FD&C linked to that nutrient in the general these factors in the proposed rule Act, to be ‘‘non-statutory nutrients’’ to U.S. population. related to the nutrients for which there distinguish them from the ‘‘statutorily For mandatory declaration of this type is an independent relationship between required nutrients’’ (79 FR 11879 at of non-statutory nutrient, in general, we the nutrient and risk of a chronic 11889). Thus, insofar as ‘‘non-statutory consider mandatory declaration disease, health-related condition, or nutrients’’ are concerned, previously we appropriate when there is public health physiological endpoint. We did not have: (1) Required the declaration of significance and scientific evidence to consider these factors for added sugars certain essential vitamins and minerals support a quantitative intake (which, for because our rationale for the declaration (such as vitamins A and C, iron, and purposes of convenience, we will refer of added sugars differs and is not based calcium) for which an RDI was to as ‘‘a quantitative intake on an independent relationship between established and that were determined to recommendation’’) that can be used for added sugars and risk of chronic have public health significance; and (2) setting a DV (DRV or RDI). However, we disease, health-related condition, or permitted the declaration of the have also considered mandatory physiological endpoint. Thus, to help remaining essential vitamins and declaration based, in part, on evidence clarify when we refer to a nutrient for minerals for which there was an highlighting the role of a nutrient (e.g., which there is such an independent established RDI or DRV (i.e., vitamin E) trans fat) in chronic disease risk. relationship, we refer to the nutrient as or that had public health significance, For voluntary declaration of a non- ‘‘this type of’’ or ‘‘this category of’’ or, and permitted the declaration of certain essential vitamin or mineral (e.g., if plural, ‘‘these types of’’ nutrient(s), or subcategories of macronutrients for fluoride, soluble and insoluble fiber, similar phrase. We discuss our rationale which a DRV was not established monounsaturated fatty acids and for requiring added sugars separately (including monounsaturated fat, polyunsaturated fatty acids), we because our rationale for added sugars polyunsaturated fat, soluble fiber, consider voluntary declaration to be is distinct from the factors that applied insoluble fiber, sugar , and other appropriate when the nutrient either has more generally to these other types of carbohydrate) (id.). a quantitative intake recommendation, nutrients. In general, we continue to The preamble to the proposed rule but does not have public health consider mandatory declaration (id. at 11890) explained that, to help us significance, or does not have a appropriate for these types of nutrients determine whether a non-statutory quantitative intake recommendation when there is public health significance nutrient, for which there is an available for setting a DRV but has and a quantitative intake independent relationship between the public health significance. In addition, recommendation that can be used for nutrient and risk of chronic disease, we permit voluntary declaration for setting a DV (DRV or RDI). However, we health-related condition, or essential vitamins or minerals that we also have considered mandatory physiological endpoint, should be a determine do not fit within our declaration based, in part, on evidence required or permitted declaration, we considerations for mandatory highlighting the role of a nutrient (e.g., consider: (1) The existence of declaration, but that have an RDI. trans fat) in chronic disease risk. The quantitative intake recommendations; The preamble to the proposed rule preamble to the proposed rule (79 FR and (2) public health significance. also noted that we continue to be 11879 at 11889) explained that, under Quantitative intake recommendations mindful of factors such as the number

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of nutrients that can be listed in information in the DGA when the IOM the preamble to the proposed rule (79 nutrition labeling, the possibility that does not provide a quantitative intake FR 11879 at 11891), we acknowledged some individuals could interpret a long recommendation. The preamble to the that eliminating the declaration of list of nutrients as implying that a food proposed rule stated that we will ‘‘Calories from fat’’ may appear to be a has greater nutritional significance than consider quantitative intake loss of information on the amount of fat is the case, and that there is limited recommendations from the IOM report, being consumed, but noted that the space for nutrition information on the but if DRIs are not available for amount of fat being consumed can still label (id.). nutrients (other than essential vitamins be obtained from the total fat (Comment 77) The preamble to the and minerals), we will consider science- declaration elsewhere on the Nutrition proposed rule (id. at 11891) invited based recommendations from other U.S. Facts label, and consumers can still use public comment on our factors for consensus reports or the DGA policy the percent DV for total fat to put fat mandatory and voluntary declarations reports (id. at 11890). content in the context of a total daily of these types of nutrients. Some diet, compare products, and plan diets. E. Calories comments supported the factors. One Thus, the proposed rule would remove comment, however, also suggested that, Under section 403(q)(1)(C)(i) of the § 101.9(c)(1)(ii), which requires if the 2015–2020 DGA is released before FD&C Act, nutrition information in food declaration of calories from fat, and we publish a final rule, the vitamins and labels or labeling must include the total redesignate § 101.9(c)(1)(iii) as minerals considered to be of public number of calories derived from any § 101.9(c)(1)(ii). health significance should be based on source. Our preexisting regulations (Comment 79) Several comments the most recent version of the DGA. require the total caloric content of a supported removing the declaration of (Response) As discussed in the food to be declared on the Nutrition ‘‘Calories from fat’’ because current preamble to the proposed rule (79 FR Facts label (§ 101.9(c)(1)), and the dietary recommendations emphasize 11879 at 11890 and 11918), the factors proposed rule would not modify the that the intake of total calories and the that we consider for determining the requirement to declare total calories. type of fat consumed are more essential vitamins and minerals with the However, in the preamble to the important than information on calories greatest public health significance to be proposed rule (79 FR 11879 at 11891), from fat in maintaining healthy dietary those for which the IOM based DRIs on we stated that we were reconsidering a practices. a chronic disease risk, or health related number of other requirements related to Many comments opposed removing condition, or a nutrient deficiency with the declaration of information about the declaration of ‘‘Calories from fat’’ clinical significance. Additionally, we calories. The other requirements related because of the importance of knowing consider whether nutrient intake data, to ‘‘Calories from fat,’’ ‘‘Calories from this information for consumers who are and/or, when available, biomarkers of saturated fat,’’ the 2,000 reference diabetic, overweight, have high blood nutrient status, provide evidence of calorie intake level, a percent DV for pressure, or are at risk of heart disease. inadequate intakes in the general calories, and requirements related to Several comments also noted that, in healthy U.S. population (ages 4 years prominence of the calorie declaration general, the information was useful to and older) and whether a substantial and the footnote statement and table of monitor the amount of calories from fat prevalence of a disease, or health related DVs for 2,000 and 2,500 calorie diets. consumed in packaged foods. These condition or a nutrient deficiency with comments noted that some people use 1. Calories From Fat clinical significance exists that was the ‘‘Calories from fat’’ information to linked to the particular nutrient. Our Our preexisting regulations, at make a choice between similar products intake and status biomarker analysis is § 101.9(c)(1)(ii), require the declaration and that, because of fat’s caloric density, conducted for the U.S. general of ‘‘Calories from fat’’ on the label. This consumers need to be informed population, ages 4 years and older, requirement stems from section regarding the amount of calories they which is the focus of the label, while the 403(q)(1)(C)(ii) of the FD&C Act which, were getting from fat. Other comments DGA focuses on the U.S. population in turn, requires total calories from fat also suggested that we require the ages 2 years and older. The 2015 DGAC to be declared on the label or labeling declaration of ‘‘Percent of calories from (Ref. 19) used a three-pronged approach of food. However, section 403(q)(2)(B) of fat,’’ and some comments supported similar to our factors for determining the FD&C Act gives us the discretion to removing the ‘‘Calories from fat’’ the nutrients of public health concern, remove the requirement by regulation if declaration if a declaration of including analysis of intake data, we determine that the requirement is monounsaturated and polyunsaturated available valid biochemical indices from not necessary to assist consumers in fats was mandatory. NHANES dietary survey, and data on maintaining healthy dietary practices. A few comments opposed to removing the prevalence of health condition in The preamble to the proposed rule (79 the ‘‘Calories from fat’’ declaration the U.S. population. Based on the FR 11879 at 11891) explained that we stated that this information remains scientific evidence in the 2015 DGAC reviewed current scientific evidence useful to consumers; the comments, approach, vitamin D, calcium, and consensus reports in determining however, did agree that the total number potassium, iron, and fiber were whether information on calories from fat of calories and types of fatty acids considered as nutrients of public health is necessary to assist consumers in consumed are more important than total concern for under consumption. maintaining healthy dietary practices. fat consumption in maintaining healthy (Comment 78) Another comment Current dietary recommendations no dietary practices and reducing agreed with the factors, but suggested longer emphasize total fat. Certain fatty cardiovascular risk. One comment that we use the 2010 DGA or the 2015– acids are understood to be beneficial, stated that it is important for total fat 2020 DGA (if it became available) when while others are understood to have consumption to be within the a quantitative intake recommendation negative health effects, particularly acceptable range (i.e., 20 to 35 percent by the IOM is not available and can be related to cardiovascular disease. of daily caloric intake) established by supported by a ‘‘Nutrition Evidence Consequently, the proposed rule would the IOM, and that ‘‘Calories from fat’’ Library Review system.’’ no longer require, nor would it allow provides valuable information to help (Response) We agree that it is often voluntarily, the declaration of ‘‘Calories consumers put the Dietary Guidelines appropriate to consider the scientific from fat’’ on the Nutrition Facts label. In into action. Another comment disagreed

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with our assessment that removing required on the Nutrition Facts label. Facts label and because consumers can ‘‘Calories from fat’’ does not constitute We discuss monounsaturated and still use the percent DV for saturated fat a loss of information to consumers polyunsaturated fats in greater detail in to put saturated fat content in the because there is presently no other part II.F.4. context of a total daily diet, compare means for conveying differences in We disagree that the declaration of products, and plan diets, we decided nutrient density between ‘‘Calories from fat’’ should be voluntary that, due to the strong evidence macronutrients on the Nutrition Facts on the Nutrition Facts label. Based on associating higher intakes of saturated label. One comment indicated that, as current scientific evidence and dietary fat with higher low-density lipoprotein long as the ‘‘Calories from fat’’ recommendations, we have concluded (LDL) cholesterol levels, information on declaration is truthful and not that the declaration of ‘‘Calories from ‘‘Calories from saturated fat’’ can assist misleading, the information is protected fat’’ is not necessary to assist consumers consumers in maintaining healthy commercial speech under the First in maintain health dietary practices. dietary practices. Therefore, the Amendment and that there is no legal Information on total calories, the proposed rule would not change the basis to prohibit it. The comment said quantitative and percent DVs for total current voluntary labeling of ‘‘Calories that ‘‘Calories from fat’’ should continue fat and saturated fat, and quantitative from saturated fat’’ in the Nutrition to be allowed on the Nutrition Facts amount of trans fat provides consumers Facts label as specified in label on a voluntary basis. with information to maintain healthy § 101.9(c)(1)(iii). However, considering (Response) We disagree that the dietary practices and to put total fat and our proposal to eliminate the labeling of ‘‘Calories from fat’’ is saturated fat in the context of a total declaration of ‘‘Calories from fat’’ on the required for specific health conditions daily diet, to compare products, and to Nutrition Facts label (see part II.E.1.), or that it is necessary for consumers to plan diets. the proposed rule would revise monitor their calories from total fat. The (Comment 80) Some comments § 101.9(c)(1)(iii) and (d)(5) to specify Nutrition Facts label is intended to supporting the continued declaration of that the statement ‘‘Calories from provide nutrition information to the ‘‘Calories from fat’’ suggested requiring saturated fat,’’ when declared, must be general U.S. population and not for a declaration only for certain foods that indented under the statement of specific populations with specific contained above a specified level of calories. In addition, the proposed rule diseases. Current dietary total fat or if the food contained more would redesignate § 101.9(c)(1)(iii) as recommendations no longer emphasize than a certain amount of saturated and proposed § 101.9(c)(1)(ii). total fat. Consumers already have trans fat. We did not receive comments on this information on the quantitative amount (Response) We decline to revise the topic and have finalized the revisions of total fat on the label as well as rule as suggested by the comments. To without change. information of its DV on the label. The require a declaration for ‘‘Calories from 3. Two Thousand Calories as the extra emphasis of calories from fat is not fat’’ only on certain products would not Reference Caloric Intake Level needed based on the new science for be consistent with our conclusion that total fat. As we stated in the preamble information on ‘‘Calories from fat’’ is Our preexisting regulations, at to the proposed rule (79 FR 11879 at not necessary to help consumers in § 101.9(c)(9), establish a reference 11891), U.S. consensus reports maintaining healthy dietary practices. calorie intake level of 2,000 calories to recognized that there are benefits to Furthermore, the quantitative amounts set DRVs for total fat, saturated fat, total consuming moderate amounts of fat and and percent DV for total fat and carbohydrate, protein, and dietary fiber. that different types of fat have different saturated fat are already provided, as In addition, the preexisting regulation roles in chronic disease risk, so the well as the quantitative amount of trans requires a footnote on the Nutrition additional emphasis of ‘‘Calories from fat. Finally, the DGAs and other Facts label that states, ‘‘Percent Daily fat’’ is not warranted. The results of consensus reports emphasize the Values are based on a 2,000 calorie diet. these reports and dietary importance of total calories rather than Your daily values may be higher or recommendations also establish why a the amount of calories from any lower depending on your calorie declaration of ‘‘Percent of Calories from particular macronutrient. needs,’’ followed by a table with certain DVs based on 2,000 and 2,500 calorie Fat’’ is not necessary to assist 2. Calories From Saturated Fat consumers in maintaining healthy diets. dietary practices, because the reports Under our preexisting regulations at The preamble to the proposed rule (79 emphasize the intake of ‘‘total calories’’ § 101.9(c)(1)(iii), the declaration of FR 11879 at 11892) discussed and the type of fat consumed. We also ‘‘Calories from saturated fat’’ is recommendations from the IOM note that the information required for voluntary. The preamble to the macronutrient report that provided fats in the Nutrition Facts label, in the proposed rule noted that saturated fat is estimated energy requirements (EERs) absence of a declaration of ‘‘Calories known to increase the risk of and the IOM labeling report (Refs. 24– from Fat,’’ provides consumers with the cardiovascular disease and, unlike 25), as well as comments (Ref. 26) information to compare similar products ‘‘Calories from fat,’’ which could received in response to the 2007 and make healthy dietary choices. include calories attributable to fatty ANPRM, in which we asked whether Information on monounsaturated and acids that decrease or increase the risk 2,000 calories should continue to be polyunsaturated fats is voluntary on the of certain diseases, ‘‘Calories from used as the reference calorie intake level Nutrition Facts label due to their role in saturated fat’’ would provide and asked questions related to the use health, and information on saturated fat information about calories from a source of the EERs. The preamble to the will still be required. Ultimately, we do known to increase disease risk (79 FR proposed rule explained that an EER is not think mandatory information on the 11879 at 11892). Although we a DRI set by the IOM for energy intake amounts of monounsaturated and tentatively concluded that mandatory and is defined as the dietary energy polyunsaturated fats is necessary to help declaration of ‘‘Calories from saturated intake that is predicted to maintain consumers maintain healthy dietary fat’’ is not necessary because the amount energy balance in a healthy adult of practices because information on the of saturated fat being consumed can be defined age, gender, weight, height, and quantitative amount and the percent DV obtained from the total saturated fat level of physical activity consistent with of total fat and saturated fat will still be declaration elsewhere on the Nutrition good health. The IOM set EERs for all

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life-stage and gender groups and based We also use 2,000 calories because a defined age, gender, weight, height, and these EERs on normal weight rounded value is easier for other level of physical activity. It would be individuals (i.e., Body Mass Index (BMI) consumers to use and is less likely difficult to combine the EERs into a < 25) (Ref. 24). The IOM Labeling suggest an inappropriate level of single reference calorie level applicable Committee considered whether there precision as would 1,500 calories, 1,800 to the general population because was a basis to use the EERs for calories, or 2,350 calories. The calorie needs vary based on many developing a new reference calorie comments supporting a different factors. intake level for macronutrients in reference caloric intake level did not As for the comments suggesting that nutrition labeling. The IOM Labeling provide evidence to support these a DV could help consumers with the Committee found that the data values for our consideration; relationship between portion size and necessary to use the EER concept as the consequently, we do not have sufficient calorie intake and to make informed basis for a reference calorie intake level information to determine the advantages food selections, we note that the for nutrition labeling were incomplete or disadvantages associated with a declaration of ‘‘Calories’’ can by itself and that retaining the current 2,000 different value or how the values alert consumers to the amount of reference calorie intake level would be compare against the 2,000 calorie value calories in a serving of a food and assist the best approach as it would provide used now. consumers to make informed decisions continuity and would not encourage about their food selections based on the 4. Percent DV Declaration for Calories higher calorie intake and calorie content. overconsumption of energy (Ref. 25). Our preexisting regulations do not As for the comments suggesting The proposed rule would not suggest provide for a DRV for calories. The different percent DVs for calories, the any changes to the current use of 2,000 preamble to the proposed rule (79 FR comments did not indicate what those reference calorie intake level as the 11879 at 11892 through 11893) DVs would be or how we might basis for setting DRVs for total fat, explained that setting a DRV for calories calculate them. Therefore, for the same saturated fat, total carbohydrate, dietary would necessitate determining a reasons we expressed earlier in this fiber, and protein. quantitative intake recommendation for response, we do not have sufficient (Comment 81) Many comments calories, but also noted that there is no information to set a DV or multiple DVs, supported using 2,000 calories as the appropriate quantitative intake and so the final rule does not establish reference caloric intake levels based on recommendation and that we were not a percent DV for calories. However, we the same rationale provided by U.S. aware of any other data or information consider that a statement about daily consensus reports and the IOM labeling on which a DRV for calories could be calorie intake (2,000 calories) should be report mentioned in the preamble to the determined. Thus, the proposed rule a necessary part of the footnote in the proposed rule and agreed that the EER would not set a DRV for calories and, as Nutrition Facts label because 2,000 was not an appropriate way to set a a result, neither require nor permit a calories is consistent with widely used reference caloric intake level. percent DV declaration for calories. food plans and will serve as a basis for In contrast, many other comments (Comment 82) Many comments agreed menu labeling (79 FR 71156, December opposed using 2,000 calories as a with our rationale for not providing a 1, 2014). Likewise, the second sentence reference caloric intake level. The percent DV for calories. Some comments of the footnote will state: ‘‘2,000 calories comments said that many individuals said that a percent DV for calories a day is used for general nutrition do not consume 2,000 calories (i.e., would be misleading, not accurate, or advice’’ (see part II.Q.11). individuals may need more or less not useful because not all individuals depending on age, sex, weight, height consume 2,000 calories a day. F. Fat and physical activity level). Other In contrast, other comments The preamble to the proposed rule (79 comments wanted us to use a different supported a declaration for percent DV FR 11879 at 11893 through 11899) reference calorie intake level (i.e., 1,400 because, according to the comments, discussed considerations related to calories, 1,800 calories or more than this information would be useful to definitions, declaration, and DRVs for 2,000 calories) or to eliminate the consumers by allowing them to learn total fat, saturated fat, trans fat, concept of a reference calorie intake about the relationship between portion monounsaturated fat, and level because, according to the size and calorie intake. Another polyunsaturated fat. comments, it is not useful or accurate comment noted that an optional because all individuals do not consume declaration of a percent DV for calories 1. Total Fat 2,000 calories per day. would allow consumers to make more a. Definition. Our preexisting (Response) We agree that an informed decisions regarding selection regulations at § 101.9(c)(2) define ‘‘fat, individual’s caloric needs can vary; of processed foods. Some comments total’’ or ‘‘total fat’’ as a statement of the however, we disagree that the reference suggested having different percent DVs number of grams (g) of total fat in a caloric intake level should be a value for calories (i.e., one for men and serving defined as total lipid fatty acids other than 2,000 calories or that there woman, or one for growing children and and expressed as triglycerides. should not be one at all. As we stated adults, or two DVs of 1,500 and 2,000 In the preamble to the proposed rule in the preamble to the proposed rule, calories). (79 FR 11879 at 11893), we discussed a the reference calorie intake level is not (Response) We do not agree that a DV 1997 citizen petition submitted by used as a target for caloric intake, but for calories, for purposes of nutrition Nabisco, Inc. (Docket No. FDA–1997–P– rather to set DVs for total fat, saturated labeling, should be set at any caloric 0476) asking us to amend the definitions fat, total carbohydrate, protein, and level. We continue to believe that, to of ‘‘total fat’’ and ‘‘saturated fat’’ to dietary fiber (see 79 FR 11879 at 11892). provide a DV, a DRV based on clarify that acetic, propionic, and We agree with the IOM labeling report quantitative intake recommendations for butyric acids may be excluded when (Ref. 25) that a reference caloric intake calories would need to be set. calculating the amount of fat in a food level of 2,000 calories provides Quantitative intake recommendations product. We tentatively concluded that continuity and would not encourage for calories are called estimated energy the petitioner did not provide a higher calorie intake and requirements (EERs), and they are based scientific basis on which we could rely overconsumption of energy (id.). on normal weight healthy individuals of to propose to exclude acetic, propionic,

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and butyric acids from the definition of between 1 and nearly 30 carbon atoms a diet low in total fat, we tentatively total fat based on differences in (79 FR 11879 at 11893). The final rule, concluded in the preamble to the chemical composition. We therefore, therefore, does not change our pre- proposed rule that mandatory did not propose any changes to the existing definition of ‘‘total fat.’’ declaration of total fat on the Nutrition definition of ‘‘total fat’’ found in The comment noted that acetic acid is Facts label continues to be necessary to § 101.9(c)(2). most commonly found in the human assist consumers in maintaining healthy To clarify what we consider to be a diet in vinegar, either separately or as an dietary practices (id.) for the following fatty acid, we proposed to define ‘‘fatty ingredient, and is responsible for its reasons: acids’’ in § 101.9(c)(2) as ‘‘aliphatic distinctive odor and . The comment • Total fat is a calorie-yielding carboxylic acids consisting of a chain of noted that propionic acid is used in macronutrient and an important piece of alkyl groups and characterized by a food as a stabilizer, anti-microbial agent, the macronutrient profile of a food; terminal carboxyl group.’’ We explained and as a taste additive. The comment • Consumption of a low fat, high that this definition is consistent with used this information to explain why carbohydrate diet can increase the risk other similar definitions found in these acids are not functionally fatty of chronic diseases such as CHD and nutrition and chemistry references (79 acids rather than explaining how the type 2 diabetes; and FR 11879 at 11893). function of acetic and propionic acids Increased fat intake, as a result of (Comment 83) Several comments differ from those of other fatty acids. increased saturated fat intake, has been supported our current definition of Therefore, the comment did not provide shown to increase LDL cholesterol ‘‘total fat’’ and our proposed definition sufficient information for us to consider concentrations, and therefore risk of of ‘‘fatty acids.’’ The comments also in determining whether acetic and CHD. agreed with our tentative conclusion propionic acid should be excluded from (Comment 85) Several comments that acetic, propionic, and butyric acids the declaration based on their functional supported the mandatory declaration of should continue to be included in the attributes, and we have finalized the total fat on the Nutrition Facts label. definition of total fat because they are definition of ‘‘fatty acids’’ in The comments suggested that retaining short-chain fatty acids and that the basic § 101.9(c)(2) without change. the declaration of total fat also would chemical group (i.e., the terminal (Comment 84) One comment help consumers who are trying to carboxyl group attached to a chain of recommended that consumer education consume foods with a lower calorie alkyl groups containing carbon atoms) is warranted to make consumers aware density because foods higher in fat have should remain the main defining factor that the physiological effects of acetic, a higher caloric density. (Caloric density of a fatty acid. propionic, and butyric acids are is the amount of calories per unit of However, one comment suggested that different from the health effects that food weight.) Some comments provided acetic and propionic acids should not be have been linked to longer-chain fatty evidence to show that consumption of a considered fatty acids, but that butyric acids. lower-fat, lower-calorie diet promotes acid should be considered both a fatty (Response) The health effects of weight loss, weight maintenance, and acid and a saturated fatty acid. The acetic, propionic, and butyric acids have the reduction in risk of diabetes. Other comment cited the International Union not been well established in the comments stated that consumers can of Pure Applied Chemistry (IUPAC) scientific literature. Therefore, it would use a food’s total and saturated fat definition of fatty acids, which indicates be premature to provide consumer content to estimate its unsaturated fat that ‘‘natural fatty acids commonly have education on acetic, propionic, and content. As discussed in part II.F.4, a chain of 4 to 28 carbons’’ (Ref. 27). butyric acids until more is known about replacing saturated fats with The comment noted that acetic and these acids. unsaturated fats can lower LDL propionic acid have 2 and 3 carbon b. Mandatory declaration. Section cholesterol levels and the risk of CVD. chains, respectively, so the comment 403(q)(1)(D) of the FD&C Act requires Other comments disagreed with our said extending the definition of fatty the declaration of the amount of total fat conclusion and suggested that, rather acids to these two substances is on food labels. Consequently, the than listing total fat on the label, we unjustified. Furthermore, the comment Nutrition Facts label includes the should require the declaration of the said that acetic and proprionic acids are mandatory declaration of the gram amount of each type of fat (i.e., saturated not functionally fatty acids because amount for total fat in § 101.9(c)(2). fat, trans fat, polyunsaturated fat, and acetic acid is a primary component of The preamble to the proposed rule (79 monounsaturated fat). The comments vinegar and propionic acid is most FR 11879 at 11893) stated that the 2010 noted that total fat consumption is no commonly used as a food stabilizer or DGA recognizes that the types of fatty longer emphasized in the DGA. Instead anti-microbial agent in the form of acids consumed are more important in consumers are advised to limit their sodium or ammonium , and is also influencing the risk of CVD than the consumption of saturated and trans fats, used in its free form as a taste additive. total amount of fat in the diet. It also and replace them with monounsaturated (Response) We agree that butyric acid stated that current dietary and polyunsaturated fats. One comment should be considered both a fatty acid recommendations and clinical questioned whether including total fat and a saturated fatty acid. However, we guidelines encourage replacing on the label may inadvertently disagree that acetic acid and propionic saturated and trans fatty acids with discourage consumers from selecting acid should be excluded from the beneficial fats, such as polyunsaturated foods that appear to be high in fat declaration of total fat based on their and monounsaturated fatty acids, and without regard to the source of fat. carbon chain length. The IUPAC that a high intake of most types of (Response) We agree, in part, and definition provided says that fatty acids saturated fatty acids, trans fatty acids, disagree, in part, with the comments. As ‘‘commonly’’ have a chain length of 4 to and cholesterol can increase LDL we stated in the preamble to the 28 carbons, but this definition does not cholesterol levels, which in turn may proposed rule (79 FR 11879 at 11893), exclude the possibility that there may be increase the risk of CHD (id.). Although we agree with the recommendations of fatty acids with carbon chain lengths of we concurred with the 2010 DGA that the 2010 DGA that the types of fatty less than 4 carbons. Furthermore, other consuming a diet low in saturated fatty acids consumed are more important in definitions of fatty acids include acids and cholesterol is more important influencing the risk of CVD than the monocarbonic acids with chain lengths for reducing CVD risk than consuming total amount of fat in the diet. However,

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we decline to remove the declaration of compared to the cost and effort required declaration of the percent DV for total total fat from the label as some to educate consumers about the fat because we have concluded that the comments suggested. Total fat continues rationale for the change and its declaration of the amount of total fat is to be associated with the risk of chronic significance related to dietary choices. necessary to assist consumers in disease and so a declaration of total fat One comment said we should reduce maintaining healthy dietary practices provides important information about the DRV for total fat to 40 grams/day (18 and the percent DV declaration can help the nutrient profile of a food (79 FR percent of calories based on a 2,000 consumers put the gram amount of total 11879 at 11893). Increased fat intake, as calorie diet), but the comment did not fat declared on the label into the context a result of increased saturated fat intake, provide a rationale or other information of their total daily diet. Furthermore, the has been shown to increase LDL to support the recommended change. comment did not explain how removing cholesterol concentrations, and Another comment suggested that we the declaration of the percent DV for therefore risk of CHD. eliminate the DRV for total fat to allow total fat from the label will help As for the comment asserting that consumers to focus on replacing consumers focus on replacing saturated including total fat on the label may saturated fats with unsaturated fats. The fats with monounsaturated fats, inadvertently discourage consumers comment stated that the types of fat especially if the total gram amount of from selecting healthful foods because consumed are more important in total fat in a serving of a product is still of the amount of total fat declared on influencing the risk of heart disease declared on the label. Therefore, we the label, the comment did not provide than is the total amount of fat. The decline to remove the declaration of the any data or other information to support comment noted that current dietary percent DV for total fat from the label. the assertion. We recognize that how a recommendations and clinical We also disagree that the DRV for total fat declaration may be understood guidelines recommend replacing total fat should be decreased from 65 and used by consumers could have saturated and trans fats with grams/day to 40 grams/day. The important implications for how we polyunsaturated and monounsaturated comment did not provide a basis for the focus our consumer education. fats to reduce the risk of heart disease. change, so, absent data or evidence to c. DRV. The DRV for total fat is 30 (Response) Since we published the support decreasing the DRV, we do not percent of calories (65 grams/day) proposed rule in the Federal Register, have sufficient information to support (§ 101.9(c)(9)). The proposed rule would new information and evidence has the change and also are unable to not change the DRV. The preamble to become available that corroborates the determine if the change would be the proposed rule (79 FR 11879 at position that the types of fats consumed appropriate. 11894) discussed the absence of an AI are more important in influencing the Although we disagree with the and RDA for total fat and how the IOM risk of heart disease than is the total comment suggesting that we eliminate established an AMDR for total fat intake amount of fat. The 2015 DGAC the percent DV declaration for total fat, of 20 to 35 percent of energy for adults concluded that strong and consistent we are reconsidering our position that and an AMDR of 25 to 35 percent of evidence from randomized controlled increasing the DRV for total fat to 35 energy for children age 4 to 18 years. trials shows that replacing saturated percent, which is the upper end of the (The AMDRs are associated with fatty acids with unsaturated fats, AMDR range, would provide no reduced risk of chronic diseases, such as especially polyunsaturated fatty acids, meaningful health benefit. The scientific CHD, while providing for adequate significantly reduces total and LDL community continues to focus on the intake of essential nutrients.) We noted cholesterol. The 2015 DGAC also types of fats consumed and less on the that the 2010 DGA acknowledged the concluded that there is strong evidence total amount of fat consumed. Current IOM’s AMDR and indicated that total fat that dietary patterns that are lower in clinical guidelines and dietary intake should fall within the AMDRs set saturated fat, cholesterol, and sodium recommendations do not include by the IOM. We explained that the IOM and richer in fiber, potassium, and guidance or recommendations to limit Labeling Committee recommended a unsaturated fats are beneficial for total fat. We do not place limitations on population-weighted midpoint of the reducing CVD risk. The 2015 DGAC the total amount of fat. We are AMDR because AMDRs vary with age; noted that, in low-fat diets, fats are often concerned that keeping the DRV for thus, a population-weighted mid-point replaced with refined carbohydrates and total fat of 30 percent of calories may be of the AMDR for adults, i.e., 20 to 35 this is of particular concern because misinterpreted as advising consumers to percent, yields a DRV of 28 percent or such diets are generally associated with limit their intake of total fat to 30 62 grams of total fat. However, we changes in blood cholesterol levels percent or less. It is also conceivable declined to adjust the DRV because we associated with an increased risk of that consumers could view foods which concluded, in the preamble to the disease. The 2015 DGAC suggested that are good sources of mono and proposed rule (79 FR 11879 at 11894), dietary advice should put the emphasis polyunsaturated fats negatively because that the upper level of the AMDR of 35 on optimizing types of dietary fat their percent DV declaration for total fat percent of 2,000 calories as the basis for consumed and not on reducing total fat is high. Given that current dietary a DRV would provide no meaningful intake. The 2015–2020 DGA did not recommendations and clinical health benefit and that a population- include a recommendation that guidelines corroborate our action to not weighted mid-point of 28 percent of the Americans should reduce their intake of place limitations on the total amount of AMDR (28 percent of calories) as the total fat, but did recommend that fat which should be consumed and basis for the DRV is not significantly sources of saturated fat should be acknowledge that replacing total fat in different from a public health outcome replaced with unsaturated fat, the diet with carbohydrates can have standpoint than the current value of 30 particularly polyunsaturated fatty acids negative health effects, we have percent of calories. (Ref. 28). These recommendations and reconsidered our statement that the (Comment 86) One comment agreed conclusions are supported by the upper level of the AMDR of 35 percent that we should not change the DRV for Lifestyle Management Report and the would provide no meaningful health total fat. The comment noted that there evidence reviewed for the NHLBI benefit compared to the current value of is little or no advantage to making a Lifestyle Evidence Review (Refs. 17–18). 30 percent calories. Thus, we are change on this basis because the actual We disagree with the comment increasing the DRV for total fat from 30 change in the DRV amount is minimal recommending the elimination of the percent of calories to 35 percent of

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calories, which results in a DRV of 78 product or as a percentage of calories in that ‘‘natural fatty acids commonly have grams. a serving of the product. One comment a chain of 4 to 28 carbons’’ (Ref. 27). d. Declaration of total fat. The expressed concern that some (Response) We decline to exclude proposed rule would not change the manufacturers are making false claims acetic and propionic acid from the preexisting requirement for mandatory about the percentage of fat in a product, declaration of saturated fat based on the declaration of total fat on the Nutrition and the comment suggested that length of the carbon chains for reasons Facts label. knowing the percentage attributed to the already discussed in part II.F.1. (Comment 87) Several comments total weight of the food by the fat in the b. Mandatory declaration. Section recommended decreasing the product would be beneficial for 403(q)(1)(D) of the FD&C Act requires prominence of total fat on the label consumers. The comment also stated the declaration of the amount of while increasing the prominence of that most calculations of body fat and saturated fat on food labels. saturated and trans fatty acids because daily intakes are expressed as Accordingly, our preexisting regulations the scientific evidence shows that the percentages. require mandatory declaration of the type of fat consumed is more important (Response) We decline to require the gram amount for saturated fat than the total amount consumed. The declaration of total fat as a percentage of (§ 101.9(c)(2)). We did not propose any comments stated that more emphasis on the weight of the food or as a percentage changes to the mandatory declaration of saturated and trans fatty acids could of calories in a serving of the product. the gram amount for saturated fat. help consumers reduce their intake of We disagree that declaration of the (Comment 90) Most comments these types of fats. One comment amount of fat as a percentage of weight supported our decision not to change recommended that the total fat or as a percentage of calories would be the mandatory declaration of saturated declaration should be listed right after helpful to consumers in maintaining fat. protein and carbohydrate on the label to healthy dietary practices. Information Other comments opposed listing reduce its prominence. The comment found on the label can be used to saturated fats because, the comments suggested that this change is necessary determine the amount of a nutrient in a said, saturated fats are not detrimental because high fat diets have been proven food so that it can be used for product to health. One comment that suggested to reduce body weight, normalize blood comparison or to determine how the we should break down saturated fat sugars for diabetics, improve cardiac food contributes towards recommended further into medium chain and long risk profiles, and reduce the risk for amounts of nutrients (see part I.B). The chain saturated fatty acids because other comorbidities, such as the risk of declaration of a percentage of weight medium chain saturated fatty acids are stroke. that is attributable to the total fat beneficial to health, while long chain (Response) We decline to change the content of a food product would not saturated fatty acids are not. order of nutrients on the label to allow for easy product comparison and (Response) We disagree that the decrease the prominence of total fat. Fat would not allow a consumer to Nutrition Facts label no longer needs to is one of three major macronutrients in determine how the product compares to list saturated fats and also decline to the diet. The listing of the amount of dietary recommendations for total fat. break down saturated fat further into total fat in a product provides valuable Dietary recommendations for total fat medium chain and long chain saturated information to the consumer about the are provided in grams rather than in fatty acids. Section 403(q)(1)(D) of the nutrient profile of a food. While we percentages (Ref. 29). FD&C Act requires the declaration of the agree that it is important for consumers Additionally, as discussed in part amount of saturated fat on food labels, to consider the amount of saturated and II.E.1, we are removing calories from fat and, in the preamble to the proposed trans fat in a product, these fatty acids from the label because the type of fat rule (79 FR 11879 at 11895), we are components of total fat. They are consumed is more relevant in reducing described how dietary indented and listed below total fat on the risk of CHD than overall total fat recommendations continue to recognize the Nutrition Facts label so that intake. Therefore, the declaration of a the well-established relationship consumers can see that they are part of percentage of calories from fat also is between consumption of saturated fat, the total fat declaration. If the unwarranted. which include all saturated fatty acids declaration of the amount of total fat in chain lengths, and its effect on blood a product is separated from the 2. Saturated Fat cholesterol levels. In addition, the 2010 declaration of its components, as a. Definition. Our preexisting DGA provided scientific evidence suggested in the comment regulations define ‘‘Saturated fat’’ in supporting a quantitative intake recommending its placement below § 101.9(c)(2)(i) as the sum of all fatty recommendation for saturated fat which carbohydrate and protein, it could acids containing no double bonds. We likewise, include all saturated fatty acid appear as though saturated and trans fat did not propose to change the chain lengths. are not part of the total fat declaration. definition. The comments suggesting that As for the comment suggesting that (Comment 89) Most comments saturated fat did not need to be declared high fat diets have been proven to be supported our decision not to revise the or should be further broken down by beneficial for weight loss and to have definition of saturated fat. However, one chain length did not provide any other beneficial health effects, the comment argued that we should exclude information that could be used to comment did not provide evidence the short-chain fatty acids, acetic acid contradict the dietary recommendations, related to how the order of nutrients on and proprionic acid, from the definition nor did they provide information that the label may impact consumers of both total fat and saturated fat, but would enable us to determine that the wishing to follow a high fat diet. another short-chain fatty acid, butyric nutrient information is no longer Without such evidence, we are unable acid, could remain in the definitions. necessary to assist consumers in to evaluate the impact of the suggested The comment argued that both acetic maintaining healthy dietary practices change in the order of nutrients acid and proprionic acid have carbon (as section 403(q)(2)(B) of the FD&C Act declared on the label. chains shorter than four carbons and requires when removing nutrient (Comment 88) Some comments that the International Union of Pure information). Thus, based on the science recommended declaring total fat as a Applied Chemistry (IUPAC) has a and dietary recommendations and the percentage of the total weight of a definition of fatty acids which indicates absence of evidence indicating that the

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information is no longer necessary to end up being left out of the calculation 3. Trans Fat assist consumers in maintaining healthy for the percent DV. a. Definition. Our preexisting dietary practices, we are retaining the (Response) We decline to revise the regulations, at § 101.9(c)(2)(ii), define declaration of saturated fat in the DRV for saturated fat. As we discussed ‘‘Trans fat’’ or ‘‘Trans’’ as the sum of all Nutrition Facts label. in the preamble to the proposed rule (79 unsaturated fatty acids that contain one c. DRV. Under our preexisting FR 11879 at 11895), current consensus or more isolated (i.e., non-conjugated) regulations at § 101.9(c)(9), the DRV for reports reviewing the scientific evidence double bonds in a trans configuration. saturated fat is 20 grams, which is 10 related to saturated fatty acid intake The proposed rule would not change the percent of calories based on a 2,000 continue to support saturated fat intakes definition. reference calorie intake level. In the of no more than 10 percent of calories, (Comment 92) Most comments preamble to the proposed rule (79 FR based on risk of CVD. For example, the supported our decision to retain the 11879 at 11895), we discussed how scientific evidence in the 2010 DGA definition of trans fat. current consensus reports, such as the (Ref. 30) supports reducing saturated One comment, however, said that the IOM DRIs, the 2010 DGA, and a 2002 fatty acid intake to less than 10 percent physiological effects of trans fat from report from the National Cholesterol of calories, and the scientific evidence ruminant sources differs from the effects Education Program of the NIH National in the 2015 DGAC supports retaining of trans fat from industrial sources (i.e., Heart, Lung, and Blood Institute, the 10 percent upper limit for saturated partially hydrogenated oils). The continue to recommend saturated fat comment said we should exclude trans intakes of no more than 10 percent of fat intake. These guidelines apply to intake levels for the general population. fat from ruminant sources from the calories, based on risk of CVD. definition of trans fat. Additionally, the scientific evidence in Other guidelines that support lower than 10 percent of calories do exist for (Response) We decline to exclude the 2015–2020 DGA supports limiting trans fat from ruminant sources from the calories from saturated fat which therapeutic uses, which would apply to specific populations in need of, for definition of trans fat. Trans fat is corroborates the consensus reports. generally understood to be any example, lowering of LDL cholesterol Consequently, we did not propose to unsaturated fatty acid that contains a levels in the blood (Ref. 31). These are change the DRV for saturated fat in double bond, regardless of source (Ref. specific populations such as those with § 101.9(c)(9). 29). Additionally, as we stated in the diagnosed heart disease or type 2 (Comment 91) Many comments preamble to the proposed rule (79 FR diabetes, those with family histories of supported our decision to keep the 11879 at 11896), the chemical definition existing saturated fat DRV of 20 grams, high blood cholesterol, and others with is consistent with how we define but some comments would have us high risk for CVD (Ref. 32). polyunsaturated fat as cis, cis- lower the DRV to 6 or 7 percent of As for the comment claiming that the methylene-interrupted (§ 101.9(c)(2)(ii)). calories. The comments indicated that DRV for saturated fat is too low, the We also note that, in the Federal this range would calculate to a DRV of comment did not provide evidence for Register of June 17, 2015 (80 FR 34650), approximately 13 to 15 grams of increasing the DRV, and we are unaware we issued a declaratory order making a saturated fat. Other comments noted of current scientific information that final determination that there is no that recent guidelines published by the would support an increase. The current longer a consensus among qualified American Heart Association and dietary recommendations for intake of experts that partially hydrogenated oils American College of Cardiology, in saturated fatty acids, of less than 10 (PHOs), which are the primary dietary collaboration with the National Heart, percent of calories, are still applicable to source of industrially produced trans Lung, and Blood Institute, concluded the general U.S. population. Thus, the fatty acids (IPTFA) are generally that no more than 5 to 6 percent of existing DRV of 20 grams is consistent recognized as safe (GRAS) for any use in calories should come from saturated fat. with the scientific evidence supporting human food. The major provisions of One comment also argued that the a maximum intake level that covers the our declaratory order were that: saturated fat DRV was too low and that general U.S. population. • PHOs are not GRAS for any use in human diets, both historical and among human food; We also disagree with comments that different cultures, are consistent with • Any interested party may seek food diets higher in saturated fat and that would exclude stearic acid from the additive approval for one or more current science supports higher levels of calculation of an individual food’s specific uses of PHOs with data intake. percent DV for saturated fat. The demonstrating a reasonable certainty of Two comments suggested that we scientific evidence supporting the no harm of the proposed use(s); and remove stearic acid from any calculation current dietary recommendations for • For the purposes of the declaratory of the percent DV. The comments saturated fat, does not differentiate order, FDA defined PHOs as those fats argued that the DRV is based on adverse among the individual saturated fatty and oils that have been hydrogenated, physiological effect and that each acids. The scientific evidence relates to but not to complete or near complete saturated fatty acid should be the intake of all saturated fatty acids saturation, and with an value (IV) considered individually regarding these combined, and this would include greater than 4. effects. The comments suggested that a stearic acid. We note that the 2015–2020 We established a compliance date of percent DV for saturated fat of an DGA recommendation to consume less June 18, 2018 for the declaratory order. individual food could be calculated than 10 percent of calories from b. Mandatory declaration. Our using different weighting factors for saturated fatty acids makes no specific preexisting regulations, at saturated fatty acids dependent on the exclusion of stearic acid and, instead, § 101.9(c)(2)(ii), require the declaration level of adverse effect of each individual relates to the intake of total saturated of trans fat on the Nutrition Facts label fatty acid. The comments also argued fatty acids (Ref. 28). Because the DRV is (§ 101.9(c)(2)(ii)). In the preamble to the that, because stearic acid is neutral in based on the intake of all saturated fatty proposed rule (79 FR 11879 at 11896), regard to effects on levels of serum total acids, determination of percent DV is we tentatively concluded that and LDL-cholesterol compared to other also based on content of all saturated information on the amount of trans fat saturated fatty acids, stearic acid would fatty acids in the individual food. in food products allows consumers to

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reduce their intake of trans fat, and Register of June 17, 2015 (80 FR 34650), (Comment 93a) Most comments thus, reduce the risk of CHD, so we did we published a declaratory order stating agreed that the scientific evidence is not propose to change this requirement. that PHOs are not GRAS for any use in insufficient to set a DRV. In contrast, However, we also stated that, in the human food. Although we have made two comments said we should set a DV Federal Register of November 8, 2013 this determination regarding PHOs, for trans fat, but did not provide (78 FR 67169), we had published a some trans fats will continue to be information that would enable us to tentative determination that partially present in foods. For example, the establish a DRV. hydrogenated oils (PHOs), the source of declaratory order provided a (Response) We decline to revise the industrially produced trans fat, may not compliance date of June 18, 2018; this rule to establish a DV for trans fat. The be generally recognized as safe (GRAS), gives manufacturers up to 3 years to comments did not provide information and we invited comment on whether remove PHOs, and the accompanying that would enable us to establish a DV, mandatory labeling of trans fat would trans fats in PHOs, from foods. The 3 and, as we discussed in the preamble to still be necessary if we finalized our years also provides time for the proposed rule (id.), consensus determination (79 FR 11879 at 11896). manufacturers to petition us for reports were unable to determine a (Comment 93) Regarding the approval of PHOs as food additives, specific level of trans fat intake that mandatory declaration of trans fat, all which could allow PHOs to be included would likely pose no risk of adverse comments supported our decision to in food in certain circumstances. health effects. The IOM, for example, continue requiring the declaration of Moreover, trans fat will always be said that a DV for trans fat could not be trans fats. naturally present in foods from established because ‘‘any increase in With respect to the GRAS ruminant sources (e.g., products trans fat intake increases CHD risk but determination of PHOs, the comments and dairy foods). Using the latest data because trans fats are unavoidable in were divided. Some comments from the Gladson database (data current ordinary diets, consuming zero percent supported requiring the declaration of as of March 2015), we calculate that, of calories would require significant trans fats on the label regardless of the based on the Gladson values, there changes in dietary intake patterns that final GRAS determination; other could potentially be more than 5,000 may introduce undesirable effects and comments supported removing the foods remaining with declarable levels unknown and unquantifiable health declaration of trans fat from label if of trans fat, after removal of PHOs. risks’’ (Ref. 29). We continue to adhere PHOs are no longer GRAS. Thus, it is premature to consider to the recommendation from the IOM The comments supporting the removing trans fat from the Nutrition declaration of trans fat on the label, that trans fatty acid consumption be as Facts label at this time. We expect there even if PHOs are no longer declared low as possible while consuming a to be a great deal of reformulation of GRAS, discussed the continued nutritionally adequate diet. products over the next 3 years, and we presence of trans fat in products even d. Declaring the amount of trans fat. will need to evaluate the remaining after PHOs are removed from foods. The Our preexisting regulations, at trans fat content in foods, both from comments explained that trans fat could § 101.9(c)(2)(ii), state that, if the serving come from both natural sources, such as approved or potentially approved food contains less than 0.5 grams, the content the trans fat in dairy products, and from additive uses of PHOs and from declared on the Nutrition Facts label uses of oils that are either currently naturally occurring trans fat, after the must be expressed as zero. For most allowed as food additives or could expected reformulations have occurred. nutrients, the maximum amount potentially be permitted in the future. We will then be able to consider permitted for a zero declaration is The comments said that trans fat whether, in light of any remaining trans governed by the limitations associated content is still information that fat content in foods, declaring trans fat with analytical methods available, and, consumers need even if total overall on the label continues to assist in the preamble to the proposed rule (79 presence in the food supply is reduced. consumers in maintaining healthy FR 11879 at 11896), we said that Other comments supporting removal dietary practices. Until such time, validated analytical methodologies that of the trans fat declaration if PHOs are however, the scientific evidence provide sensitive and reliable estimates no longer GRAS said that, if PHOs are continues to support the need to inform of trans fatty acids in all foods at levels no longer GRAS, most foods would not consumers about the continued below 0.5 grams per serving are have any trans fat, except for the trans presence of trans fat in foods. currently not available. Thus, we did fat that comes from animal sources. c. DRV. Our preexisting regulations not propose to change the requirements Thus, to these comments, few foods do not provide a DRV for trans fat. In for a zero declaration of trans fat. would have declarable levels of trans the preamble to the proposed rule (79 (Comment 94) Several comments fat, and most foods would indicate a FR 11879 at 11896 through 11897), we asked us to lower the maximum amount trans fat content of zero. Because so few described various efforts (such as the permitted for a zero declaration. The foods would contain trans fat, the use of ANPRMs) to consider comments provided several different comments stated, a trans fat declaration determining a DRV for trans fat, values, such as 0.0 grams, 0.05 grams, would no longer be needed on the label. including the use of food composition 0.1 grams, and 0.2 grams, as alternatives Some comments also noted that animal data, menu modeling and data from to the preexisting value of 0.5 grams. products, such as dairy, are considered dietary surveys, and a potential joint The comments argued that even very part of normal, healthful diets, and trans percent DV for trans fat and saturated small amounts of trans fat in a food (i.e., fat information on those products is not fat. We described how a number of less than 0.5 grams) could be harmful to necessary. Some comments, however, evaluations of the existing scientific consumers’ health, and consumers did suggest that if trans fat from animal evidence were not able to set a should know if foods contained any sources exceeded a certain level, such as definitive quantitative intake trans fat at all. Most comments did not 1.0 g per serving, then we should recommendation for trans fat. We address the issue of a lack of validated require its disclosure on the label. tentatively concluded that there was not analytical methodologies. One comment (Response) Based on the available a basis for setting a DRV for trans fat, did, however, state that a validated scientific evidence and the findings of and so we did not propose a DRV for analytical methodology did exist to expert scientific panels, in the Federal trans fat. detect trans fat below 0.5 grams per

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serving and cited AOAC 996.06 (Ref. (Response) While it is possible that information in addition with total fat 33). omitting unsaturated fats would reduce DV to maintain healthy dietary (Response) We agree that consumers label clutter, our reason for not practices. The scientific evidence for should be informed of trans fat content requiring the declaration of added sugars (and solid fats) is based on in foods. With the current analytical monounsaturated or polyunsaturated the modeling of dietary patterns to methodologies, however, quantification fats is due to the lack of a DRV and our ensure adequate consumption of of trans fat content in foods is limited. consideration of the factors for nutrient dense foods and avoidance of When determining the maximum mandatory and voluntary declaration for excess empty calories that can lead to amount permitted for a zero declaration, these types of nutrients. We consider weight management issues and obesity. we need to consider, for compliance voluntary declaration to be appropriate (Comment 97) One comment purposes, whether the trans fat content when the nutrient either has a supporting mandatory declaration noted at those low levels can be reliably and quantitative intake recommendation, that the 2010 DGA stated that there is accurately measured in all foods by an but does not have public health well established evidence that replacing analytical method(s) that has been significance or does not have a saturated fat with monounsaturated and validated to do so. Currently, there are quantitative intake recommendation polyunsaturated fat lowers LDL no validated analytical methods to available for setting a DRV, but has cholesterol and has health benefits. determine trans fat content at levels less public health significance. (Response) We agree that there is well than 0.5 grams for all foods. (Comment 96) Some comments established evidence that replacing With respect to the comment that supported voluntary declaration of saturated fat with monounsaturated and cited AOAC 996.06 as a methodology to monounsaturated and polyunsaturated polyunsaturated fats lowers LDL detect trans fat, AOAC 996.06 does not fats because, according to the cholesterol and therefore reduces the provide validation data for trans fatty comments, they were a key risk of heart disease, and the preamble acids. AOAC 996.06 does provide recommendation in the 2010 DGA, to the proposed rule (79 FR 11879 at validation data for total fat, saturated ‘‘Consume less than 10 percent of 11897 through 11898) discussed how fat, and monounsaturated fat (Ref. 33). calories from saturated fatty acids by replacing saturated fatty acids with We are aware of ongoing efforts for replacing them with monounsaturated monounsaturated or polyunsaturated validation of improved analytical and polyunsaturated fatty acids.’’ fats reduced blood LDL cholesterol Other comments supporting methods for trans fat (Ref. 34), and if levels. A quantitative intake mandatory declaration of new validated methods become recommendation, however, is not monounsaturated and polyunsaturated available, we may reevaluate the available for either monounsaturated or fats also referred to the 2010 DGA threshold for a zero declaration of trans polyunsaturated fat. Therefore, in recommendation. Some comments fat. considering the factors for mandatory or asserted that being a key voluntary declaration, we determined 4. Monounsaturated Fat and recommendation was sufficient for Polyunsaturated Fat mandatory listing of added sugars and that monounsaturated and a. Voluntary declaration. Our claimed that we were being inconsistent polyunsaturated fat warrants voluntary preexisting regulations, at with the use of dietary guidance declaration. § 101.9(c)(2)(iii) and (iv), permit, but do recommendations, especially because An FDA health claim is available for not require, the declaration of the scientific evidence is stronger for the labeling of foods: ‘‘Replacing monounsaturated fat (defined as cis- monounsaturated and polyunsaturated saturated fat with similar amounts of monounsaturated fatty acids (e.g., oleic fats than for added sugars. unsaturated fats may reduce the risk of acid)) and the declaration of (Response) We proposed to retain the heart disease. To achieve this benefit, polyunsaturated fat (defined as cis, cis- voluntary declaration of total daily calories should not increase’’ methylene-interrupted polyunsaturated monounsaturated and polyunsaturated (see ‘‘Health Claim Notification for the fatty acids) on the Nutrition Facts label. fats based on the factors identified for Substitution of Saturated Fat in the Diet The preamble to the proposed rule (79 the mandatory and voluntary listing of with Unsaturated Fatty Acids and FR 11879 at 11897 through 11899) these types of non-statutory nutrients. Reduced Risk of Heart Disease’’) (Ref. described how we considered While added sugars is not a statutory 35). recommendations in current consensus nutrient, we are requiring the (Comment 98) One comment reports, as well as comments received in declaration of added sugars based on the supported mandatory declaration of response to the 2007 ANPRM in which need for consumers to have this polyunsaturated fat because, according we requested comment on whether information, which relates to a dietary to the comment, polyunsaturated fat declaration of monounsaturated fat and pattern, to assist consumers to maintain includes essential nutrients. polyunsaturated fat should remain healthy dietary practices and not based (Response) We agree that voluntary or be made mandatory. We on a specific relationship of added polyunsaturated fat includes essential noted that we have been unable to set sugars to chronic disease risk. Thus, the fatty acids (i.e., linoleic and alpha a DRV for monounsaturated fat and basis for requiring the declaration of linolenic acid). We disagree, however, polyunsaturated fat due to the absence added sugars differs from that for that the listing of polyunsaturated fat of DRIs for both (id.) monounsaturated and polyunsaturated should be mandatory for this reason. Consistent with the 2010 DGA, the fats. We acknowledge that the 2010 Essentiality of a nutrient is not factor 2015–2020 DGA recommends that foods DGA provided a key recommendation considered for the mandatory or high in saturated fats should be replaced for monounsaturated and voluntary labeling of these types of non- with foods high in unsaturated fats (Ref. polyunsaturated fats because of the statutory nutrients, other than essential 28). strong evidence (79 FR 11879 at 11898); vitamins and minerals. The basis for (Comment 95) One comment however, some evidence supporting this proposing voluntary declaration of supported voluntary declaration of is replacing saturated fat with polyunsaturated fat was because of its monounsaturated and polyunsaturated monounsaturated and polyunsaturated role in reducing the risk of CVD when fats and said that omitting unsaturated fats. Because saturated fat is on the replacing saturated fat, which has fats would reduce label clutter. label, we believe consumers can use that public health significance.

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(Comment 99) One comment setting DRVs (79 FR 11879 at 11897, (Response) While humans may have a supporting mandatory declaration noted 11899). limited capability to elongate and that the 2002 IOM report (Ref. 29) (Comment 100) One comment agreed desaturate ALA to EPA and DHA, we do concluded that the type of fat, rather with not setting a DRV for not have evidence to demonstrate that than total fat, was relevant to health and monounsaturated or polyunsaturated fat biosynthesis of EPA and DHA is the 2010 DGA shifted the focus from because there is no agreed upon insufficient in the general population total fat to the type of fat. Another scientific basis for establishing a DV due such that EPA and DHA are essential in comment noted that we were no longer to diverse nature of these fatty acids. the diet. Therefore, there is no basis on requiring ‘‘Calories from fat’’ because (Response) We maintain that there is which we can rely to support a the focus is more on the type of fat. an insufficient basis to set a DRV for voluntary declaration. Several comments supporting either monounsaturated or (Comment 102) Other comments mandatory declaration of polyunsaturated fat, so the final rule supporting the voluntary declaration of monounsaturated and polyunsaturated does not establish a DRV for either n-3 and n-6 polyunsaturated fatty acids fats noted that it is not possible to monounsaturated or polyunsaturated noted that monounsaturated fat, identify these types of fats which have fat. polyunsaturated fat, sugars, soluble health benefits, and, therefore, it is not c. Declaration of individual fiber, insoluble fiber, sugar alcohols, possible to differentiate from unhealthy polyunsaturated fatty acids. and added sugars are being allowed or fats. One comment said that listing these Polyunsaturated fats represent two required on the label but do not have a fats can help people distinguish general categories: n-6 and n-3 DV. Therefore, the comments argued, between fatty foods that can be eaten polyunsaturated fatty acids. The most we should treat n-3 and n-6 more often compared to those with common n-6 and n-3 polyunsaturated polyunsaturated fatty acids in the same higher saturated fat content to be eaten fatty acid in food is linoleic acid and a- manner. (Response) There is well-established less often. linolenic acid, respectively. Other n-3 evidence for the role of sugars, Other comments supporting fatty acids found in foods, particularly monounsaturated fat, polyunsaturated mandatory declaration claimed that in fish, are the long chain fatty acids, fat, soluble fiber, insoluble fiber, and consumers need to be able to compare eicosapentaeneoic acid (EPA) and sugar alcohols in reducing the risk of products and select foods that are not docosahexaenoic acid (DHA). chronic disease or providing a beneficial only lower in saturated fat but contain The preamble to the proposed rule (79 physiological effect. Therefore, these monounsaturated and polyunsaturated FR 11879 at 11898) discussed the nutrients have public health relevance, fats. possibility of establishing separate DRVs which is the basis for voluntary (Response) We agree that the four for linoleic acid and a-linolenic acid, labeling. Specifically, there is strong chemically defined categories of type of and, if so, whether the declaration of evidence for sugars increasing the risk fat (i.e., saturated, trans, these nutrients should be voluntary or of dental caries (see 79 FR 11879 at monounsaturated fat, and made mandatory. We decided that, 11902), as well as reducing the risk of polyunsaturated fat), rather than total because of the lack of well-established dental caries when sugar alcohols fat, are relevant to health, specifically evidence for a role of n-3 or n-6 replace sugar in the diet (id. at 11908). CVD risk. Current dietary polyunsaturated fatty acids in chronic There also is well established evidence recommendations no longer emphasize disease risk and the lack of a that replacing saturated fat with total fat. Certain categories of fatty acids quantitative intake recommendation, the monounsaturated and polyunsaturated are beneficial, while others categories declarations of n-3 and n-6 fat reduces the risk of CVD (Ref. 35). have negative health effects, particularly polyunsaturated fatty acids are not There is strong evidence that soluble related to CVD (see 79 FR 11879 at necessary to assist consumers to fibers reduce the risk of CHD (see 79 FR 11891). We recognize that maintain healthy dietary practices. 11879 at 11911). There is well monounsaturated and polyunsaturated Thus, the proposed rule would not established evidence that insoluble fat have public health relevance when provide for the individual declaration of fibers can improve laxation, a beneficial they replace saturated fat (id. at 11898). either n-3 or n-6 polyunsaturated fatty physiological effect (Ref. 36). Moreover, There is not a quantitative intake acids on the Nutrition Facts label. the scientific evidence for added sugars recommendation available, however, Similarly, because of the lack of well- differs from that for n-3 and n-6 that identifies how much established evidence for a role of EPA polyunsaturated fatty acids. There is a monounsaturated and polyunsaturated and DHA in chronic disease risk and the strong association between a healthy fat must replace saturated fat, and there lack of a quantitative intake dietary pattern characterized by a lower is no dose-response relationship recommendation, the proposed rule intake of sugar sweetened foods and between mono- and polyunsaturated would not provide for the declarations beverages, as compared to less healthy fats to risk of CHD, independent of of EPA and DHA. dietary patterns, and a reduced risk of saturated fat, similar to the relationship (Comment 101) Although some CVD. A DV is being provided for added between trans fat and risk of CHD. comments agreed with our decision not sugars (see part II.H.3). Therefore, we decline to require the to require the declaration of n-3 or n-6 In contrast, there is supportive, but declaration of monounsaturated and polyunsaturated fatty acids, other not conclusive, evidence to suggest that polyunsaturated fat. A quantitative comments would revise the rule to n-3 polyunsaturated fatty acids reduce intake recommendation is a factor we allow for the voluntary declaration of the risk of CHD (Ref. 37). Furthermore, considered for mandatory declaration of the n-3 polyunsaturated fatty acids, there is no conclusive evidence for an these types of non-statutory nutrients eicosapentaeneoic acid (EPA), and independent role of n-6 polyunsaturated (79 FR 11879 at 11890). docosahexaenoic acid (DHA). One fatty acids in reducing blood cholesterol b. DRV. The proposed rule would not comment supported the voluntary levels, and consequently, risk of CHD establish DRVs for either declaration of EPA and DHA because (see 79 FR 11879 at 11898). Therefore, monounsaturated or polyunsaturated fat humans have a limited capability to we disagree that there is a sufficient because quantitative intake synthesize, elongate, and desaturate a- basis to treat n-3 and n-6 recommendations are not available for linolenic acid (ALA) to EPA and DHA. polyunsaturated fatty acids the same as

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the other nutrients discussed in the preexisting CVD. A DGA key populations. Furthermore, there are a comment, so the final rule does not recommendation was not provided for number of nutrients for which there is provide for voluntary declaration of n- EPA and DHA, but rather for seafood. It suboptimal intake which was 3 and n-6 polyunsaturated fatty acids. is not clear whether EPA and DHA per considered as part of the factors for (Comment 103) One comment se, or other substances in fish contribute mandatory or voluntary declaration. supporting the voluntary declaration of to cardiac deaths. The qualified health However, we did not rely on suboptimal n-3 polyunsaturated fatty acids said that claim on EPA and DHA and CVD risk intake alone for such voluntary we could have reached the same is supportive, but not conclusive, declarations in the Nutrition Facts label. conclusion for n-3 polyunsaturated fatty evidence to suggest that n-3 (Comment 106) Other comments acid in the same way that we did for polyunsaturated fatty acids reduce the supporting the voluntary declaration of vitamin D. The 2010 DGA risk of CHD (Ref. 37). The factors for n-3 polyunsaturated fats cited published recommendation to increase the amount mandatory and voluntary labeling of articles or gave Web site addresses to and variety of seafood in place of some these types of non-statutory nutrients on discuss the health benefits of these fatty meat and poultry was made to increase the Nutrition Facts label depend on acids. EPA and DHA in the American diet, as strong (rather than moderate or (Response) We have reviewed the well as the total package of benefits inconclusive) evidence. Therefore, we articles and Web sites and, based on our seafood provides, including vitamin D. disagree that the information provided review, decline to revise the rule to (Response) We disagree that n-3 in the 2010 DGA report is sufficient to provide for the voluntary declaration of polyunsaturated fatty acids were warrant the voluntary declaration of n-3 polyunsaturated fats. handled differently than vitamin D. EPA and DHA. • Many articles were review articles There is strong evidence for a (Comment 105) One comment or meta-analyses that included studies relationship between vitamin D intake supporting the voluntary declaration of that tested individuals who had a and risk of osteoporosis (see 79 FR n-3 polyunsaturated fatty acids noted previous coronary event; therefore, the 11879 at 11921). Furthermore, the IOM that an article on a summary of a studies were evaluating the effect of the provided a quantitative intake workshop stated that, ‘‘National public n-3 polyunsaturated fatty acids on recommendation (i.e., RDA) for vitamin health initiatives to increase n-3 fatty secondary prevention of CVD (Refs. 42– D (Ref. 38). We considered the scientific acid consumption are needed: The 47). Furthermore, some articles evidence for this recommendation when working group believes that data are included observational studies on the setting an RDI (see our response to currently sufficient to indicate that association between the intake of comment 372). In contrast, the evidence intake of n-3 fatty acids is suboptimal polyunsaturated fatty acids and CVD for n-3 polyunsaturated fatty acids is not and a national and international risk. Scientific conclusions from such well-established, and a quantitative initiative should be launched to shift n- studies are not sufficient to support intake recommendation is not available 3 fatty acid intake upward’’ (Ref. 39). conclusions about the causal role of (see 79 FR 11879 at 11897 through Another comment cited a which these n-3 polyunsaturated fatty acids on 11899). concluded that a large percentage of the CHD risk in the general population. (Comment 104) Several comments U.S. adult population is not meeting • One article (Ref. 48) was a one-page supporting the voluntary declaration of recommendations for omega-3 fatty acid abstract from a meeting. The Web site n-3 polyunsaturated fatty acids stated consumption set forth by the 2010 DGA address that was cited (http:// that not providing information on n-3 (Ref. 40). One comment cited an article www.goedomega3.com/healthcare) is a polyunsaturated fatty acids affords the that evaluated intakes of ALA, EPA, and general resource for health care consumer little opportunity to apply DHA intake in children 4 to 8 years of professionals. Another Web site important dietary guidance as in the age (Madden et al., 2009). provided a list of organizations that 2010 DGA. The comments said that, (Response) We disagree with the have intake recommendations for EPA while the IOM did not set a DRI for EPA comments’ interpretation of the cited and DHA (http://www.goedomega3. and/or DHA, this is an insufficient articles. With respect to the cited com/index.php/files/download/304). reason for disallowing the voluntary articles, we note that the Akabas and None of the citations provided declaration of these essential fatty acids Decklebaum article did not provide information that we would consider for on the Nutrition Facts label. The information to explain the basis for voluntary declaration of EPA and DHA comments said that the DGA concluded concluding that the intake of n-3 related to a relationship between these that moderate evidence indicates that polyunsaturated fatty acids is nutrients and risk of CHD. 250 mg EPA and DHA daily is suboptimal. The Papanikolaou article • One article (Ref. 49) evaluated the associated with reduced cardiac deaths used 250 mg/day to assess adequacy of relationship between plasma among individuals with and without intake, however, the value was not a phospholipid EPA and DHA as a preexisting CVD and this recommendation put forth by the 2010 biomarker of intake and mortality. recommendation contributes to DGA. The article by Madden et al. Figure 2 of this article showed that the prevention of heart disease. The (2009) used the AI of 900 mg/day to dose-response relationship between comments also noted that, while we assess adequacy of ALA, and 10 percent EPA and DHA intake and plasma have not authorized a health claim of this value (90 mg/day) was used to phospholipid EPA and DHA was not regarding EPA and DHA and CVD risk, assess intake adequacy for EPA and linear and plateaued at around 0.5 we have allowed the use of qualified DHA. We disagree with how Madden grams/day. Therefore, plasma health claims for 10 years. (Ref. 41) assessed nutrient intake for phospholipid EPA and DHA is not a (Response) The 2010 DGA concluded EPA and DHA because the IOM did not reliable indicator of EPA and DHA that moderate evidence shows that the set an AI or EAR for EPA and DHA. The consumption, and scientific conclusions consumption of 8 ounces per week of a IOM only noted that EPA and DHA could not be drawn from such as study. variety of seafood, which provides an contribute approximately 10 percent of • One article (Ref. 50) was on an average consumption of 250 mg per day the total n-3 polyunsaturated fat intake animal study that tested the effect of of EPA and DHA, is associated with (Ref. 29). There is no quantitative intake DHA on melanoma. The article did not reduced cardiac deaths among recommendation (i.e., EAR) available for present the totality of the evidence on individuals with and without assessing inadequate intake in DHA and risk of melanoma.

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Furthermore, we would not rely on risk CHD, not all n-3 polyunsaturated we do not have sufficient information to animal data for evaluating the efficacy fatty acids are equal. evaluate those aspects of the comments. of DHA to reduction of risk to Other comments said that, while G. Cholesterol melanoma in humans to establish a manufacturers may express the content nutrient declaration. of EPA and DHA in a product bearing 1. Mandatory Declaration • One article (Ref. 51) was a meta- a claim, doing so outside the Nutrition analysis on EPA and DHA intake and Facts label denies the consumer an Section 403(q)(1)(D) of the FD&C Act blood pressure. There are several opportunity to recognize if a meaningful requires the declaration of the amount limitations of this meta-analysis amount of these fatty acids are provided of cholesterol on food labels, and including: (1) Not providing all of the relative to the other fats in the product. cholesterol content must be declared on relevant studies on EPA and DHA and (Response) We recognize that the the Nutrition Facts label in accordance blood pressure; (2) including studies 2014 IFIC survey concluded that 21 with § 101.9(c)(3). In the preamble to the that lacked an appropriate control percent of consumers are trying to proposed rule (79 FR 11879 at 11899), group; and (3) including studies that increase their consumption of omega-3 we explained that current dietary conducted inappropriate statistical fats. We also recognize that the majority recommendations continue to recognize analyses. of polyunsaturated fats in foods are in the well-established relationship • One article (Ref. 52) was an the form of n-6 polyunsaturated fatty between consumption of cholesterol and European Food Safety Association acids and that not all n-3 its effect on blood cholesterol levels, (EFSA) scientific opinion on a labeling polyunsaturated fatty acids have the which are a surrogate endpoint for CHD reference value for n-3 and n-6 same effect on CHD risk. However, risk and that we were unaware of polyunsaturated fatty acids in which because of the lack of well-established evidence that would support a change to EFSA provided a recommended intake evidence for a role of n-3 or n-6 the requirement for mandatory level of 250 mg/day of EPA and DHA. polyunsaturated fatty acids in chronic declaration of cholesterol on the disease risk and the lack of a The article did not discuss the scientific Nutrition Facts label in § 101.9(c)(3). quantitative intake recommendation, the evidence in detail to show how this Consequently, we did not propose any declarations of n-3 and n-6 quantitative intake recommendation changes to the requirement for polyunsaturated fatty acids are not was determined. Furthermore, while the mandatory declaration of cholesterol. necessary to assist consumers to scientific opinion cited several Relying on information provided in maintain healthy dietary practices. references to support 250 mg/day, a the NHLBI Lifestyle Evidence Review Because neither of these factors for number of these included observational (Ref. 17), the 2015 DGAC Report voluntary declaration for these types of data in which information was obtained concluded that cholesterol is not a nutrients has been met, and the on fish consumption. The IOM did not nutrient of public health concern (Ref. comments provided no scientific basis set a DRI for EPA or DHA because much 19). The 2015–2020 DGA noted that, on which we could rely to support the while adequate evidence is not available of the observational evidence measured declaration, we disagree that meaningful fish or fish oil intake as a proxy for n- for a quantitative limit for dietary amounts of EPA and DHA should be cholesterol specific to the Dietary 3 polyunsaturated fat intake, and other voluntarily listed to provide its amount components in fish may have effects Guidelines, individuals should eat as relative to the other fats in the product. little dietary cholesterol as possible that are similar to n-3 fatty acids and (Comment 108) Some comments while consuming a healthy dietary therefore may confound the results of supporting the voluntary declaration of pattern that includes eggs and shellfish the observational studies (Ref. 29). n-3 polyunsaturated fatty acids stated (Comment 107) Some comments that the recognition of only (Ref. 28). supporting the voluntary declaration of polyunsaturated fat may have Much of the published evidence, as individual polyunsaturated fatty acids unintended consequences of consumers was analyzed and reported by the IOM discussed consumer use or consumer failing to understand differences in (Ref. 53), has demonstrated a positive understanding as reasons for allowing biopotency of n-3 long-chain association between cholesterol intake voluntary declaration. polyunsaturated fatty acids compared to and total cholesterol in the blood. The One comment cited the 2014 IFIC other polyunsaturated fatty acids. IOM conducted a dose-response Food and Health survey data to assert According to the comments, not analysis of clinical trials to evaluate the that the data suggests that voluntary declaring n-3 polyunsaturated fatty relationship between dietary cholesterol declaration of individual acids may confuse consumers who are and blood total cholesterol because most polyunsaturated fatty acids is necessary not aware of differences among of the available evidence was on total for the consumer to make the purchase individual polyunsaturated fatty acids cholesterol (Ref. 53). From this IOM decisions that they intend. The with respect to their ability to reduce analysis, it was concluded that, on comment indicated that 21 percent of heart disease risk. average, an increase of 100 mg/day of consumers are looking to increase their (Response) We disagree that potential dietary cholesterol is predicted to result omega-3 intake. differences in biopotency of n-3 in a 0.05 to 0.1 mmol/L increase in total Some comments stated that a polyunsaturated fatty acids is a basis for serum cholesterol, of which distinction between the different n-3 voluntary declaration. While there may approximately 80 percent is in the LDL polyunsaturated fatty acids is necessary be differences in biopotency with fraction. The IOM cited evidence so that consumers seeking specifically respect to CHD risk, there is insufficient showing that the majority of the EPA or DHA are not misled by scientific evidence and information to increase in serum total cholesterol with voluntary declaration of warrant voluntary declaration. increased dietary cholesterol was due to polyunsaturated fat, because the levels With respect to possible consumer an increase in LDL cholesterol (rather are inflated by the presence of n-6 confusion and unintended than HDL) concentration, therefore polyunsaturated fatty acids and ALA. consequences, the comments did not adversely affecting the cholesterol The comments said that, while 85 describe the extent to which consumers profile. The IOM analysis was the basis percent of Americans are aware the n- might be confused or what the for the IOM concluding that cholesterol 3 polyunsaturated fatty acids reduce the unintended consequences might be, so consumption should be as low as

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possible while consuming a dependent relationship between the and total cholesterol in the blood. While nutritionally adequate diet. intake of dietary cholesterol with blood the 2015 DGAC concluded that there Data from NHANES (2007–2010) LDL cholesterol concentrations, the was no appreciable relationship show that, for all individuals over 1 year main dietary determinant of blood LDL between the consumption of dietary of age, 32 percent consume cholesterol cholesterol concentrations is saturated cholesterol and serum cholesterol, the in excess of the DRV of 300 mg. For men fat.’’ Other comments said there is not only information the DGAC considered and women 19 years of age and older, enough evidence on the effect of dietary was that in the NHLBI Lifestyle 59 percent and 17 percent consume in cholesterol on blood cholesterol, the Evidence Review, which was specific to excess of 300 mg/day of cholesterol, relationship between cholesterol studies that measured LDL cholesterol. respectively. These findings are consumption and blood cholesterol (Comment 112) One comment indicative that a significant portion of levels is weak and has been opposed to mandatory declaration of the U.S. population consumes amounts overestimated, and cholesterol intake cholesterol stated that clinical trials of cholesterol in excess of the DRV of does not raise blood cholesterol levels. have identified individuals across all 300 mg. Some comments cited several meta- ages who have very limited or no We do not consider there to be new analyses that concluded that there were increase in plasma cholesterol as a information that alters the conclusions small, modest reductions in serum result of additional dietary cholesterol. of the 2002 IOM report. Therefore, we cholesterol with reductions (e.g., 100 The comments said that, even among conclude that the declaration of mg/day) in dietary cholesterol (Refs. 55– hyper-responders (high response in cholesterol on the Nutrition Facts label 57). blood cholesterol to dietary cholesterol), can assist consumers in maintaining (Response) We agree that saturated fat the response is an increase in both LDL healthy dietary practices and therefore has a larger impact on raising blood and HDL cholesterol levels, such that should remain mandatory. cholesterol levels. We disagree that the LDL/HDL ratio, a key marker of CHD (Comment 109) One comment there is not enough evidence or that the risk, does not change (Refs. 58–61). supporting mandatory declaration of evidence for the cholesterol-raising Furthermore, the comments said, the cholesterol noted that the 2002 IOM effects of dietary cholesterol is weak or amounts of cholesterol provided in report (Ref. 53) showed a strong positive does not exist. Numerous clinical clinical trials are well in excess of relationship between cholesterol intake studies have reported a cholesterol- normal consumption. and increased LDL cholesterol levels. raising effect of dietary cholesterol (Ref. (Response) We agree that individual’s The comment cited a meta-analysis of 53). Using such studies, the IOM blood cholesterol levels respond clinical studies in which people illustrated a curvilinear relationship differently to dietary cholesterol; this consumed eggs or a cholesterol-free egg between change in dietary cholesterol difference in individual response is true substitute found that LDL cholesterol and change in serum total cholesterol for most nutrients when they are rose by 2 mg/dL for every 100 mg of levels ranging from 0 to 4,500 mg/day, associated with chronic disease risk. We cholesterol consumed (Ref. 54). with the greatest change (increase) in disagree that differences in individual (Response) While the 2002 IOM report serum cholesterol occurring with an response is a basis for not considering provided its own analysis that evaluated increased cholesterol intake of up to 50 the numerous studies showing that the relationship between dietary mg/day. cholesterol intake raises average blood cholesterol and cholesterol levels, it The comments about EFSA support cholesterol levels. The reported findings specifically evaluated total cholesterol mandatory listing of both cholesterol on blood cholesterol levels from clinical levels, rather than LDL cholesterol and saturated fat because EFSA trials usually represent the averages of levels. The IOM reported a positive recognizes that intake of both nutrients these blood levels of the study subjects, association between change in have a positive association with blood including those who respond and those cholesterol intake and change in total cholesterol levels. who do not respond. Assessment of the cholesterol levels which supports our The final rule, therefore, does not average findings from clinical studies is position for mandatory listing. We change the pre-existing requirement for more relevant because the Nutrition recognize that the meta-analysis cited in mandatory declaration of cholesterol. Facts label is intended for the general the comment (Weggemans et al. 2001 (Comment 111) Some comments U.S. population. (Ref. 54)) estimated that each additional opposed to mandatory declaration of We also disagree that the ratio of LDL 100 mg of dietary cholesterol would cholesterol noted that the NHLBI cholesterol to HDL cholesterol is a key increase serum LDL cholesterol by 0.036 Lifestyle Evidence Review (Ref. 17) marker of CHD risk. We do not consider (1.4 mg/dL) in the studies with a states that there is insufficient evidence HDL cholesterol, and therefore the background diet low in saturated fat and to determine whether lowering dietary LDL:HDL cholesterol ratio, to be a key by 0.061 (2.4 mg/dL) in the studies with cholesterol reduced LDL cholesterol in marker (i.e., surrogate endpoint) of CHD a background high in saturated fat (P = the blood. risk. Blood HDL cholesterol has not 0.03). However, this study only (Response) While we recognize the been qualified as being a strong evaluated the effect of cholesterol from conclusion of the NHLBI Lifestyle predictor of CHD risk. Therefore, the eggs rather than total dietary Evidence Review in addition to blood evidence on LDL cholesterol outweighs cholesterol. Thus, this meta-analysis, by LDL cholesterol being a surrogate any evidence on the LDL:HDL itself, is insufficient to evaluate the endpoint for CHD risk, blood total cholesterol ratio with respect to effect of total cholesterol intake on cholesterol is also considered a valid evaluating the role of cholesterol in blood cholesterol levels, and therefore predictor of CHD risk as approximately CHD risk. CVD risk. 80 percent of total cholesterol is LDL (Comment 113) Some comments (Comment 110) Some comments cholesterol (Ref. 29). The NHLBI opposed to the mandatory declaration of opposed mandatory declaration of Lifestyle Evidence Review did not cholesterol said that the 2010 DGA cholesterol because, the comments said, review the findings for blood total stated that an egg a day does not saturated fat has the biggest negative cholesterol. Much of the evidence, as increase blood cholesterol levels, that impact on blood cholesterol. The was analyzed and reported by the IOM eggs are not associated with greater risk comments said that the EFSA concluded (2002), demonstrated a positive of CVD, and that eggs are nutrient- that, ‘‘Although there is a positive-dose- association between cholesterol intake dense. Other comments cited a number

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of studies and meta-analyses (Refs. 62– support an association between dietary 2010) show that, for all individuals over 66) concluding that there was not an cholesterol and CHD events. However, 1 year of age, 32 percent consume association between egg consumption we put greater reliance on clinical trials cholesterol in excess of 300 mg/day. For and CVD or CHD risk. when substantiating nutrient and men and women 19 years of age and (Response) We recognize that the disease relationships. Observational older, 59 percent and 17 percent 2010 DGA noted that evidence suggests studies measure associations between consume in excess of 300 mg/day of that one egg (i.e., egg yolk) per day does foods/nutrients and diseases without cholesterol, respectively. These findings not result in increased blood cholesterol demonstrating that the food or nutrient are indicative that a significant portion levels, nor does it increase the risk of caused, in part, the change in risk of a of the U.S. population consumes cardiovascular disease in healthy chronic disease. The IOM (2002) (Ref. amounts of cholesterol in excess of the people. The 2010 DGAC, however, 29) noted that the lack of consistency in DRV of 300 mg. Therefore, we decline noted that, while eggs are a major source observational studies on dietary to make changes in response to this of cholesterol in the American diet, eggs cholesterol may be due to many factors, comment. and egg mixed dishes provide 25 including inaccuracies of dietary intake (Comment 117) Other comments percent of total cholesterol intake. data, and to the limited ability to opposed the mandatory declaration of Therefore, we do not consider studies distinguish the effects of dietary cholesterol for several reasons. The involving only eggs to be sufficient to cholesterol, independent of energy comments said that: understand the role of total cholesterol intake and other dietary variables that • Consumers who want to take care of intake on CVD risk. may be positively (e.g., saturated fat) or their blood cholesterol levels may orient As for the comments stating that eggs negatively (e.g., dietary fiber intake) their food choices only towards foods are nutrient-dense, the mandatory associated with dietary cholesterol and that contain low amounts of cholesterol, declaration of cholesterol relates to the heart disease risk. Individual studies, as regardless of their saturated fat content. relationship between cholesterol intake well as an analysis of a number of these A focus on saturated fat may lead to from consumption of all food sources, as studies (Ref. 29), have demonstrated a better results in terms of public health. part of the total daily dietary intake, and positive association between cholesterol • Listing cholesterol could have a risk of CHD. Therefore, the comment intake and total cholesterol, which is a negative impact on protein intake. does not change our conclusion about risk factor of CHD. Therefore, we rely on According to the comments, because the scientific basis for the mandatory the best available data and use clinical most meat and other protein rich foods declaration of cholesterol. As we stated trial data more heavily than also contain cholesterol, cholesterol in the preamble to the proposed rule (79 observational data when they are declaration will likely dissuade FR 11879 at 11899), current dietary available for evaluating the role of consumers from eating protein-rich recommendations continue to recognize dietary cholesterol in CHD risk. These foods. The result will be an increase in the well-established relationship two review articles (Refs. 67–68) also the consumption of carbohydrate-rich between consumption of cholesterol and cited clinical trial data and noted that, foods, causing delayed satiety and its effect on blood cholesterol levels, while dietary cholesterol raises LDL contributing to increased caloric which are a surrogate endpoint for CHD cholesterol, it also raises HDL consumption. risk. We continue to believe that cholesterol and therefore does not (Response) We require declaration of information regarding cholesterol is change the LDL:HDL ratio. While LDL cholesterol on the Nutrition Facts label necessary to assist consumers in cholesterol is considered a surrogate pursuant to section 403(q) of the FD&C maintaining healthy dietary practices. endpoint for CHD risk, HDL is not. Act. Cholesterol intake is related to the As for the studies cited in the Therefore, the LDL:HDL ratio is not risk of CHD. The comments did not comments, the studies do not imply that relied on for evaluating CHD risk. provide information on the impact of total cholesterol intake (from all dietary (Comment 115) One comment the mandatory declaration of cholesterol sources) does not contribute to CHD opposed to the mandatory declaration of on the consumer’s intake of saturated risk. Consequently, rather than view cholesterol stated that the evidence is fat, protein or carbohydrate-rich foods. eggs and cholesterol content in eggs in questionable for an association between We are not aware of information isolation, our Nutrition Facts label cholesterol intake and risk of type 2 indicating that mandatory listing of provides information to help the diabetes. cholesterol over the past 20 years has consumer understand the ‘‘relative (Response) Whether or not the resulted in more focus on cholesterol, significance’’ of eggs and their evidence supporting cholesterol’s role less focus on saturated fat, and reduced cholesterol content in the context of a in type 2 diabetes risk may be intake of protein-rich foods. We ‘‘total daily diet’’ (see section 2(b)(1)(A) questionable, the basis for mandatory consider the declaration of cholesterol is of the NLEA). declaration of cholesterol on the label is necessary to assist consumers maintain (Comment 114) Some comments because of its role in CHD risk. healthy dietary practices and are making opposed to mandatory declaration of (Comment 116) One comment no changes in response to this comment. cholesterol stated that dietary opposed to the mandatory declaration of (Comment 118) One comment said cholesterol has been proven to be cholesterol said that overconsumption that mandatory declaration of unrelated to CVD and CVD mortality. of cholesterol is not a concern in the cholesterol was not necessary because The comments cited review articles United States. The comment said that cholesterol consumption has not been a (Refs. 67–68) to assert such studies do the average dietary cholesterol intake concern for a long time in treating not support a connection between reported by CDC is 307 mg/day for men patients with high cholesterol levels. dietary cholesterol and CHD events. The and 225 mg/day for women and that, (Response) The Nutrition Facts label review articles summarized among men, the average consumption is intended for the general U.S. observational studies, as well as some exceeds 300 mg/day by only 2 percent population, and nutrient declarations clinical trials, that questioned an while, among women, the average and percent DVs on the label are to help association between cholesterol intake consumption is 25 percent below 300 consumers make more informed choices and risk of CHD. mg/day (NHANES 1999–2000). to consume a healthy diet and there is (Response) We agree that some (Response) We disagree with the a strong relationship between dietary observational studies have failed to comment. Data from NHANES (2007– cholesterol intake and total serum

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cholesterol which is a marker of CVD (Comment 120) One comment did not The comment further stated that risk (see 79 FR 11879 at 11887 and part support a DRV for cholesterol because nutrient databases can easily exclude II.C.). cholesterol is made in the body. dietary fiber from the calculation of (Comment 119) One comment (Response) We agree that cholesterol carbohydrate because analytical opposed to the mandatory declaration of is made in the body and is therefore not laboratories are easily able to determine cholesterol said that the U.S. essential in the diet. However, the basis total carbohydrate by excluding protein, government’s advice to reduce for the DRV is an intake level not to total fat, moisture, dietary fiber, and ash cholesterol intake is unusual compared exceed to reduce the risk of CHD, rather from the total weight of the food and to other countries in focusing on dietary than an intake level to achieve (e.g., a nutrient composition tables will cholesterol. The comment said that DV for essential vitamins and minerals). continue to change on a regular basis to dietary recommendations in other Therefore, we decline to revise provide new and updated data. countries, such as Canada, do not have § 101.9(c)(9) insofar as a DRV for (Response) We decline to change the an upper limit for cholesterol intake cholesterol is concerned. current method of calculating carbohydrate by difference. Total and, instead, focus on saturated and H. Carbohydrate trans fat. carbohydrate is one of the (Response) There is a strong 1. Total Carbohydrate macronutrients and includes starch, sugars, sugar alcohols, and fiber. As relationship between dietary cholesterol a. Calculation of total carbohydrate. intake and total serum cholesterol discussed in the preamble to the Under our preexisting regulations, at proposed rule (79 FR 11879 at 11900), which is a marker of CVD risk. Section § 101.9(c)(6), total carbohydrate content dietary fibers, with the exception of 403(q)(2)(B) of the FD&C Act authorizes is calculated by subtracting the sum of lignin, are considered carbohydrates us to remove, by regulation and under protein, total fat, moisture, and ash from and are listed as a subset of total certain circumstances, nutrient the total weight of the food. This carbohydrate on the label. Individuals information. We would need a scientific calculation method is called who are interested in knowing the basis about the relationship between ‘‘carbohydrate by difference’’ and is amount of carbohydrate in a serving of total cholesterol intake and CVD risk to described in A.L. Merrill and B.K. Watt, a product less the amount of dietary no longer require the mandatory ‘‘Energy Value of Foods—Basis and fiber may determine this information declaration of cholesterol. While other Derivation,’’ in the USDA Handbook No. based on what is currently declared on countries may not require the listing of 74 (Ref. 69). Total carbohydrate includes the label. Because dietary fibers are a cholesterol on their food labels, section starch, sugars, sugar alcohols, and type of carbohydrate, to maintain 403(q)(1)(D) of the FD&C Act requires dietary fiber. consistency with how components of the declaration of the amount of We did not propose to change the macronutrients are declared on the cholesterol on the food label. The fact method for calculating carbohydrate label, we decline to remove dietary fiber that other countries lack cholesterol content. from the calculation of total recommendations is, alone, an (Comment 121) While some carbohydrate, as suggested by the insufficient reason for us to no longer comments agreed with our decision to comments. require the mandatory listing of retain the calculation method for total With respect to comments suggesting cholesterol. carbohydrate content, other comments that dietary fiber should be excluded suggested that dietary fiber should not 2. DRV from the calculation of total be included in the declaration of total carbohydrate because such a change Our preexisting regulations, at carbohydrate. The comments stated that would be helpful to diabetics when § 101.9(c)(9), provide a DRV for a significant number of consumers, managing their blood sugar levels, we cholesterol of 300 mg. In the preamble especially individuals who have disagree that this should be a reason to to the proposed rule (79 FR 11879 at diabetes, want to know the amount of remove dietary fiber from the 11899), we discussed how the IOM carbohydrates excluding dietary fiber declaration of carbohydrate. The Labeling Committee had recommended (also known as ‘‘net carbs’’) because it information found in the Nutrition Facts that the DV for cholesterol (along with is helpful to know when trying to and Supplement Facts labels is not saturated fat and trans fat) be set at a control blood glucose. One comment targeted to individuals with acute or level that is as low as possible in recommended that carbohydrate should chronic diseases, such as diabetics (see keeping with an achievable health- be calculated by difference, but that part II.B.2; 79 FR 11879 at 11887). promoting diet and how, in the 2007 moisture, fat, protein, dietary fiber, and We also disagree that removal of ANPRM, we asked for public comment ash should be excluded from the dietary fiber from the declaration of on whether the current DRV for declaration of carbohydrate. The total carbohydrate would allow cholesterol of 300 mg should be comment suggested that the benefits of consumers to compare products that do retained. We also noted that, although such an approach include easy and do not contain dietary fiber more the 2010 DGA recommended that comparison of carbohydrates between easily. It is not clear how the cholesterol intake levels should be less food choices that do or do not contain comparison would be made easier by than 200 mg/day for individuals at high dietary fiber, easy calculation of calories removal of dietary fiber from the total risk of CVD, we considered the DGA from carbohydrates with a value of 4 carbohydrate declaration because, if the recommendation of 300 mg/day for calories per gram, and easy calculation consumer is interested in knowing how maintaining normal blood cholesterol of calories from dietary fiber with a much dietary fiber is in a product, the levels as an appropriate basis for setting value of approximately 2 calories per consumer can take that information into a DRV because it represents the gram. In addition, the comment stated consideration by looking for the maximum intake level that covers the that such an approach would encourage declaration of the amount of dietary general U.S. population 4 years of age manufacturers to increase the dietary fiber on the label. and older (id.). Consequently, we did fiber content of their product without Calories from total carbohydrate may not propose changes to the DRV for increasing the carbohydrate content of be declared voluntarily on the label. We cholesterol of 300 mg specified in their product and that it would simplify discuss calculation of calories from total § 101.9(c)(9). consumer education and understanding. carbohydrate in greater detail later in

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this part. We agree that additional steps interpret and use information on the We have allowed for voluntary are necessary to calculate calories from label. However, we are not aware of a declaration of ‘‘other carbohydrate’’ on total carbohydrates when dietary fiber is specific need, and the comment did not the Nutrition Facts label included in the declaration. However, specify how this information could aid (§ 101.9(c)(6)(iv)). Our regulations we did not receive any comments that consumers. Therefore, we decline to define ‘‘other carbohydrate’’ as the the calculation of total carbohydrate conduct these studies. We will consider difference between total carbohydrate when dietary fiber is included in the conducting such studies if we have and the sum of dietary fiber, sugars, and declaration would be unnecessarily information showing that there is a need sugar alcohol, except that if sugar burdensome or difficult for for these studies and we have the alcohol is not declared, ‘‘other manufacturers to perform. The resources available to conduct such carbohydrate’’ is defined as the calculation would not require additional studies. difference between total carbohydrate laboratory analysis or expense. b. Classification of carbohydrates and the sum of dietary fiber and sugars We disagree that exclusion of dietary based on a chemical definition or (§ 101.9(c)(6)(iv)). Thus, the category of fiber from the declaration of total physiological effect. The preamble to the ‘‘other carbohydrate’’ includes what are carbohydrate would encourage proposed rule (79 FR 11879 at 11900 typically considered to be complex manufacturers to raise dietary fiber through 11901) discussed how the 2007 carbohydrates. As discussed in part values independent from raising ANPRM invited comment on whether II.H.6, the final rule does not permit the carbohydrate values. So long as the carbohydrates should be classified and category of ‘‘other carbohydrate’’ to be dietary fiber added to a product meets declared in nutrition labeling based on declared on the label. our definition of dietary fiber, the their chemical definition (which is the c. Separate declaration of additional additional fiber added by the current method) or on their individual types of carbohydrates. In the manufacturer would be reflected in the physiological effect (e.g., attenuation of preamble to the proposed rule (79 FR dietary fiber declaration. Consumers blood sugar or laxation), and whether 11879 at 11901), we discussed how the who are interested in consuming more additional types of carbohydrates (e.g., 2007 ANPRM asked whether additional dietary fiber may use the dietary fiber starch) should be listed separately on types of carbohydrates (e.g., starch) declaration to determine which the Nutrition Facts label. We explained should be listed separately on the products they purchase. Therefore, it is that carbohydrates include starch, Nutrition Facts label. We stated that the not clear how removing dietary fiber sugars, sugar alcohols, and dietary fibers comments we received in response to from the declaration of carbohydrate on and that different carbohydrates have the 2007 ANPRM did not support the the label would encourage different physiological effects (id. at declaration of additional types of manufacturers to add dietary fiber to 11901). Within the different types of carbohydrates (e.g., starch). Thus, the proposed rule would not require the their products. carbohydrate (i.e., starch, sugars, sugar With respect to the assertion that separate declaration of additional types alcohols, and dietary fibers), too, exclusion of dietary fiber from the of individual carbohydrates, such as specific carbohydrates may have calculation of total carbohydrate starch, on the Nutrition Facts label. simplifies the education process and different physiological effects (e.g., (Comment 124) Several comments understanding for consumers, absent different types of dietary fibers) making discussed Allulose. Allulose (also additional information, we are unable to it difficult to apply a definition that is known as psicose) is a monosaccharide judge whether such a change would based on physiological effects across a that is derived from fructose. According lead to better understanding of the total category of carbohydrates. Furthermore, to the comments, Allulose is carbohydrate and/or dietary fiber analytical methods for measuring approximately 70 percent as sweet as declaration on the label, and thus, different types of carbohydrates are sucrose, but contributes less than 0.2 whether consumers would benefit from based on chemical structure rather than calories/gram to the diet. The comments such a change in how carbohydrate is physiological effect. Given the various said that Allulose is added to foods and calculated. components of total carbohydrate and beverages as a partial replacement for With respect to the comment asserting different types of physiological effects of sugars and/or high-fructose corn syrup that nutrient databases can easily each, we decided not to change our because of its low, near zero, calorie exclude dietary fiber from the provisions for the classification or content and other organoleptic calculation of carbohydrate, we disagree declaration of carbohydrates specified properties (e.g. mouthfeel, texture, etc.). that this is a reason to exclude dietary in § 101.9(c)(6). One comment said we should not fiber from the calculation of total (Comment 123) One comment include Allulose in the declaration for carbohydrate. Although nutrient recommended that complex total carbohydrate and added sugar. In databases may be updated, we decline carbohydrates should be listed contrast, another comment said Allulose to exclude dietary fiber from the separately under total carbohydrate on should be included in the declaration of calculation of total carbohydrate the label. The comment stated that ‘‘total carbohydrate’’ for nutrition because dietary fiber is a carbohydrate people do not understand that they have labeling purposes, but should not be and should be declared as such to to subtract in order to get an idea of how included in the declaration of ‘‘sugars’’ maintain consistency with how other much good carbohydrates are in a food or ‘‘added sugars.’’ The comments macronutrients are determined and product. suggested that Allulose does not have declared on the label. (Response) We decline to list complex the metabolic properties of fructose or (Comment 122) One comment carbohydrates separately on the label. other sugars and does not contribute encouraged us to conduct consumer The comment did not provide any calories or raise blood sugar levels like studies to examine if the separation of information to explain what is other sugars do. The comments said dietary fiber from total carbohydrate on considered to be a ‘‘complex’’ or ‘‘good that, upon ingestion, approximately 70 the label would benefit the overall use carbohydrate,’’ and it did not explain percent of Allulose is unabsorbed in the of the Nutrition Facts label as a tool for what subtraction method can be used to small intestine, passes into the nutrition literacy and education. calculate ‘‘good’’ or ‘‘complex’’ bloodstream and is then excreted in the (Response) We are always interested carbohydrates from information found urine, without significant ; in understanding how consumers on the label. the other 30 percent that is not absorbed

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is transported to the large intestine total carbohydrates should continue to (Comment 127) One comment where it is not fermented. Allulose is be declared on the label is because the supported maintaining the current DRV then excreted without being absorbed information is used by individuals who for total carbohydrate of 300 grams. The (Refs. 70–71). have diabetes to ‘‘count carbs.’’ comment stated that it falls within the One comment stated that, when (Response) While we agree that total AMDR range. In addition, the comment Allulose is used in food, there should be carbohydrates should continue to be said, although there is an EAR and RDA a reduction in the amount of calories declared on the label, we disagree with for total carbohydrate, neither is declared of 4 calories/gram. the comments’ rationale for the appropriate or needed to serve as the (Response) On April 10, 2015, we continued mandatory labeling of total basis for the DRV because relevant received a citizen petition from Tate & carbohydrates. As discussed in part public health concerns are the ratio of Lyle Ingredients Americas LLC (Docket II.B.2, the information on the label is carbohydrate to total fat and the source Number FDA–2015–P–1201) requesting intended for the general healthy and type of carbohydrate in the diet. that Allulose be exempt from being population rather than individuals with Other comments suggested that the included as a carbohydrate, sugars, or chronic diseases such as diabetes. In the DRV of 300 grams is too high and that added sugar in the Nutrition Facts label preamble to the proposed rule (79 FR we should take a different approach to on foods and beverages. The petition 11879 at 11901), we explained that setting the DRV for total carbohydrate. provided data and other information carbohydrates are an essential part of One comment stated that, even though suggesting that Allulose is different the diet because they provide energy to the DRV should not be viewed as an from other sugars in that it is not the cells in the body, especially the intake requirement, but rather as a metabolized by the human body, has brain, which is dependent on reference amount, consumers often negligible calories (0.2 calories per gram carbohydrate for proper functioning. perceive it as recommended amount. or less), does not contribute to increases Thus, the declaration of carbohydrates The comment recommended using the in blood glucose or insulin levels, and, on the Nutrition Facts label continues to population-weighted mid-point of the if included as carbohydrates and sugars be necessary to assist consumers in AMDR for adults and children of 275 (added sugars) on the Nutrition Facts maintaining healthy dietary practices, grams to encourage reduction in label, would lead to consumer and so the final rule does not change the carbohydrate consumption. The confusion, particularly consumers with requirement in § 101.9(c)(7) for comment suggested that the current diabetes or consumers otherwise mandatory labeling of total DRV of 300 grams is excessive given concerned with accurately monitoring carbohydrate. that the RDA for carbohydrate for adults blood glucose. The petition, which was 19 years of age and older is 130 grams/ e. DRV. The DRV for total submitted after the comment period for day, and that excessive carbohydrate carbohydrate is 300 grams the proposed rule had ended, provided intake is a central cause of the American (§ 101.9(c)(9)). Consistent with new evidence that was not previously obesity epidemic. submitted in comments to the proposed calculating total carbohydrate ‘‘by Another comment recommended rule. We need additional time to fully difference,’’ the proposed rule would reducing the DRV for total carbohydrate consider the information provided in not change the approach to calculate the because the American population is the comments and the citizen petition. percent DV for carbohydrate ‘‘by sedentary and prone to metabolic Therefore, the final rule does not reach difference’’ as well. In addition, the syndrome. The comment also referred to a decision as to whether Allulose proposed rule would not change the the current DRV of 300 grams as a should be excluded from the labeling of DRVs for fat or protein (see parts recommended intake level for a daily carbohydrate, sugars and/or added II.F.1.c, II.F.2.c, II.F.3.c, II.F.4.b, and energy intake of 2,000 calories. sugars, and Allulose, as a II.I.3), which are used to derive the DRV (Response) We agree with the monosaccharide, must be included in for total carbohydrate. The DRV for total comments recommending a reduction in the declaration of each pending any carbohydrate would remain at 300 the DRV for total carbohydrate, but for future rulemaking that would otherwise grams/day. We note that the RDA for different reasons. We disagree with the exclude this substance from the carbohydrate for men and women 19 comment that recommended decreasing declaration. years of age and older is 130 grams/day. the DRV for total carbohydrate because d. Mandatory declaration. Section Therefore, the DRV should not be the American population is sedentary 403(q)(1)(D) of the FD&C Act requires viewed as an intake requirement, but as and prone to metabolic syndrome. It is the declaration of total carbohydrate, a reference amount. unclear, based on the comment, what and our preexisting regulations, at (Comment 126) One comment said we the comment is suggesting regarding the § 101.9(c)(6), require the declaration of should no longer require a percent DV relationship between consumption of the amount of total carbohydrate on the declaration for total carbohydrate carbohydrates and a sedentary lifestyle Nutrition Facts label. In the preamble to because consumption of some or risk of metabolic syndrome. the proposed rule (79 FR 11879 at carbohydrates, such as naturally Furthermore, we disagree with the 11901), we said that carbohydrates are occurring sugars from fruit and milk, are comment that the current DRV is a an essential part of the diet because they not a public health concern. recommended intake level. As stated in provide energy to the cells in the body, (Response) We disagree with the the preamble to the proposed rule (79 especially the brain, which is dependent comment that the percent DV FR 11879 at 11901), the DRV should not on carbohydrate for proper functioning, declaration for total carbohydrate be viewed as an intake requirement, but and we tentatively concluded that the should no longer be required. Total as a reference amount. declaration of carbohydrates on the carbohydrate is one of the three major We agree that neither the EAR or RDA Nutrition Facts label continues to be macronutrients in the diet. It provides values for total carbohydrate are necessary to assist consumers in basic information about a food’s appropriate to serve as the basis for a maintaining healthy dietary practices. nutrient profile. The percent DV DRV, but we agree for different reasons (Comment 125) Many comments declaration for total carbohydrate helps than those stated in the comment. As supported the continued mandatory consumers put the amount of total discussed in the preamble to the declaration of total carbohydrates; some carbohydrate in a serving of a food into proposed rule (79 FR 11879 at 11901), comments stated that the reason that the context of their total daily diet. the EAR and RDA values set by the IOM

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do not include sugar alcohols or dietary next to ‘‘Total Carbs’’ or place ‘‘Total those known to meet the definition of fiber. Our calculation of total Carbs’’ in parentheses next to ‘‘Total dietary fiber. To ensure that all soluble carbohydrate, for the purposes of Sugars.’’ and insoluble non-digestible nutrition labeling, accounts for all types (Response) We disagree that carbohydrates are excluded from the of carbohydrates, including sugar carbohydrates are chemically sugars. calculation of calories from alcohols and dietary fiber. Therefore, Although the body converts carbohydrate, we proposed to amend using the EAR and RDA to set a DRV for carbohydrates to sugars, the chemical § 101.9(c)(1)(i)(C) to require that calories total carbohydrate would result in a structure of some carbohydrates (e.g., from carbohydrate be calculated using a reference value that is based on starches) differs from the chemical general factor of 4 calories/g of total recommendations specifically for sugars structure of sugars. Sugars are a subset carbohydrate less the amount of non- and starches. As we stated in the of carbohydrates and are declared as digestible carbohydrates and sugar preamble to the proposed rule (id.), if such on the label. Some examples of alcohols, and the caloric value of each the midpoint of the AMDR range is used carbohydrates include sugars, such as (the non-digestible carbohydrates and as the basis for the DRV, there would be sucrose and lactose, and sugar alcohols) is then added to the sum a discrepancy in what carbohydrates are polysaccharides, such as cellulose, of the carbohydrates. encompassed in the information glycogen, and starch. Therefore, we We did not receive any comments on provided on the label for the absolute decline to change the label’s format as this proposed amendment, and so we gram amount versus the percent DV. suggested by the comment. have finalized the rule without change. The current DRV for total (Comment 129) Some comments 2. Sugars carbohydrate of 300 grams is calculated would move ‘‘Total Carbohydrates’’ to based on 60 percent of a 2,000 calorie the top of the list of declared nutrients a. Definition. Our preexisting diet ((0.60 × 2,000 calories)/4 calories on the label. The comments cited the regulations, at § 101.9(c)(6)(ii), define per gram of carbohydrate = 300 grams). significant rise in diabetes and the need sugars as a statement of the number of The percentage of calories contributed to make the declared amount of total grams of sugars in a serving. They are by total fat, total carbohydrate, and carbohydrates more prominent on the the sum of all free mono and protein add up to 100 percent on the label. disaccharides (e.g., glucose, fructose, label. The DRV for carbohydrate of 60 (Response) We disagree that the lactose, and sucrose). We considered percent of a 2,000 calorie diet is increase in diabetes in the United States whether we should continue to require determined by the difference of what is is a reason to move total carbohydrates mandatory declaration of sugars on the left over by the DRVs for total fat and to the top of list of declared nutrients on label in the proposed rule, but protein and 100 percent. As discussed the label. As stated in part II.B.2, the tentatively concluded that the in part II.F.1, we are increasing the DRV intended purpose of information on the declaration of sugars continues to be for total fat from 30 to 35 percent. Nutrition Facts label is to assist the necessary to assist consumers in Therefore, in order for the percentages general healthy population in maintaining healthy dietary practices, of calories contributed by total fat, total maintaining healthy dietary practices. and thus did not propose to change the carbohydrate, and protein to add up to (Comment 130) One comment current requirement for mandatory 100 percent, either the percentage of recommended listing the amount of declaration of sugars (79 FR 11879 at calories contributed by the DRV for total total carbohydrate in a product in 11902). carbohydrate or protein needs to teaspoons rather than grams. The As discussed in the total decrease. Some comments suggested comment said that people do not carbohydrates section at part II.H.1, that the DRV for total carbohydrates be understand what gram of carbohydrate some comments and a citizen petition decreased, and the DRV for total would look like and providing the said we should exclude Allulose from carbohydrate is significantly greater information in teaspoons would be more the declaration of sugars. We discuss than the RDA for carbohydrate for helpful for consumers. those comments in part II.H.1 (see adults 19 years of age and older of 130 (Response) We decline to revise the comment 124). grams/day. Reducing the DRV for rule as suggested by the comment. We b. Mandatory declaration. Section protein to 5 percent of calories to address arguments regarding the use of 403(q)(1)(D) of the FD&C Act requires account for the 5 percent increase in the household measures, rather than in the declaration of sugars, and our DRV for fat would result in a DRV value gram amounts on the label, in part preexisting regulations, at of 25 grams of protein, which is below II.B.3. § 101.9(c)(6)(ii), require the declaration the RDA for protein for children and g. Calculation of calories from of sugars on the Nutrition Facts label. adults 9 years and older. Therefore, we carbohydrate. Our preexisting We did not propose to change this conclude that the DRV for total regulations, at § 101.9(c)(1)(i)(C), require requirement. carbohydrate should be decreased from that the calories from total carbohydrate (Comment 131) Several comments 60 percent of calories to 55 percent of be calculated by using the general factor supported the continued mandatory calories for a DRV of 275 grams. of 4 calories/gram of carbohydrate less declaration of sugars. One comment f. How total carbohydrates appears on the amount of insoluble dietary fiber. stated that sugars should continue to be the label. The proposed rule also would revise the labeled as part of total carbohydrate (Comment 128) Several comments definition of dietary fiber so that only because they are a type of carbohydrate. discussed the placement of those dietary fibers that we have The comment added that the amount of carbohydrates on the label itself. One determined to have a physiological declared sugar is possible to quantify, comment said that consumers need to effect that is beneficial to human health easy to verify using analytical methods, be made aware of the fact that would be considered to be ‘‘dietary and is information that is easily carbohydrates are sugars chemically fiber’’ on the Nutrition Facts label. For understood by consumers, nutritionists, because, according to the comment, the purposes of calculating calories from and health professionals. most consumers believe that carbohydrate, when it is voluntarily In contrast, other comments asked us carbohydrates and sugars are two declared, all soluble and insoluble non- to remove sugars from the label or distinct nutrients. The comment would digestible carbohydrates should be replace it with a declaration of added place the word ‘‘sugars’’ in parentheses excluded from the calculation, not just sugars or ‘‘fruit & milk sugars.’’ The

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comments recommending replacement of sugars because the comment did not percent DV for sugars. One comment of sugars with added sugars said that provide data or information, and we are stated that such information would help consumers, including individuals who not aware of such data or information, consumers choose food and beverages have diabetes, focus on the sugars to support this assertion. that are low in sugar. Another comment instead of the total carbohydrate amount We disagree with the comment which said that, with ‘‘skyrocketing’’ declared on the label. One comment would replace ‘‘Sugars’’ with ‘‘Fruit & overweight, obesity, and their co- suggested that, when registered Milk Sugars’’ on the Nutrition Facts morbidities, a percent DV for sugar dietitians provide Medical Nutrition label. Total sugars continue to be would be a useful tool for informing Therapy for diabetics, the sugars line is associated with risk of dental caries. consumers of sugar content and would not valuable and contributes to Furthermore, our definition of added help consumers make better choices. information overload. The comment sugars includes (see part II.H.3.n) some The comment said that the declaration also stated that the sugars declaration fruit and milk sugars, such as sugars could help consumers to visually makes consumers reluctant to eat foods, found in concentrated fruit juice that is understand approximately how much such as fruit and milk, which contain not reconstituted to 100 percent fruit sugar they should be getting each day sugars as their source of carbohydrates. juice. and how much sugar they are actually One comment would replace sugars c. Changing ‘‘Sugars’’ to ‘‘Total consuming. One comment suggested with fruit and milk sugars and place the Sugars’’. In the preamble to the that a declaration of a percent DV for new heading directly under dietary proposed rule (79 FR 11879 at 11902), sugars would allow consumers to fiber; the comment said this change we said that we were considering compare products more easily. would clearly distinguish added sugars whether to use the term ‘‘Total Sugars’’ Other comments said that a DRV for from naturally occurring sugars in instead of ‘‘Sugars’’ on the label if we sugars could be based on whole fruit and from sugars from dairy finalize a declaration of added sugars. recommendations from the World ingredients and also eliminate the need We also said that we planned to conduct Health Organization or the American for a double indentation (for declaration consumer research that would include, Heart Association. One comment said of added sugars) under the ‘‘Total among other things, questions regarding that the National Institutes of Health Carbs’’ heading. The comment cited the declaration of added sugars on the should ask the IOM to set a suggested data from an online survey of 500 Nutrition Facts label in order to help or limit on how much sugar one should participants showing that, when enhance our understanding of how consume on a daily basis. ‘‘Sugars’’ is replaced with ‘‘Fruit & Milk consumers would comprehend and use (Response) We decline to set a DRV Sugars’’ on the Nutrition Facts label, this new information, and to inform for sugars or to require the declaration significantly more individuals were able education efforts (id.). In the of a percent DV for sugars. We are not to correctly identify the amount of supplemental proposed rule (80 FR aware of data or information related to naturally occurring sugars in one 44303 at 44306, 44308), we discussed a quantitative intake recommendation serving of the food (Ref. 72). the results of our consumer research for sugars that we could use as the basis (Response) We decline to remove the which showed that when an ‘‘Added for a DRV for total sugars. declaration of sugars from the label Sugars’’ declaration was indented below With respect to the comments because consumption of sugars a ‘‘Total Sugars’’ declaration on the suggesting that the World Health continues to be associated with an label, participants appeared to be better Organization (WHO) or the American increased risk of dental caries; thus, the able to comprehend the total amount of Heart Association (AHA) could give us information continues to be necessary to sugars in a food than if an ‘‘Added a basis to establish a DRV, we assist consumers in maintaining healthy Sugars’’ declaration was indented below acknowledge that the WHO recently dietary practices. We agree that sugars a ‘‘Sugars’’ declaration. In the released guidelines for sugars intake for should continue to be labeled as part of supplemental proposed rule (id. at adults and children (Ref. 73). The WHO total carbohydrate and that the amount 44304), we asked for comment on recommends reducing the intake of free of total sugars can be quantified using whether the term ‘‘Total Sugars’’ should sugars to less than 10 percent of total existing analytical methods. be declared on the label instead of energy intake in both children and Similarly, we disagree with the ‘‘Sugars.’’ adults. It also provided a conditional comments suggesting that the total The final rule uses the term ‘‘Total recommendation which suggested sugars declaration should be removed Sugars’’ to replace the declaration of further reduction of the intake of free from the label because consumers, ‘‘Sugars.’’ We explain our rationale and sugars to below 5 percent of total energy especially individuals with diabetes, respond to comments on this change in intake. The WHO defines ‘‘free sugars’’ focus on the sugars declaration rather part II.H.3. as monosaccharides and disaccharides than the total carbohydrate declaration d. DRV. Our preexisting regulations added to foods and beverages by the and may be overwhelmed by the do not specify a DRV for sugars. In the manufacturer, cook, or consumer, and information. The comments did not preamble to the proposed rule (79 FR sugars naturally present in honey, provide data or other evidence, nor are 11879 at 11902), we explained that syrups, fruit juices and fruit juice we aware of such data or evidence, to consensus reports did not set dietary concentrates (Ref. 73). The WHO support this assertion. The total reference values based on which we definition of ‘‘free sugars’’ is not carbohydrate and sugars declaration has could derive an appropriate DRV for consistent with our definition of been on the label for over 20 years. total sugars. Therefore, we did not ‘‘sugars’’ because the WHO definition Furthermore, as noted in part II.B.2, the propose to establish a DRV for total does not include all free mono and information on the label is intended for sugars. disaccharides. It excludes some the general healthy population and not (Comment 132) Some comments naturally occurring sugars, such as for individuals with chronic diseases, submitted in response to the proposed lactose. Therefore, we disagree that the such as diabetes. rule agreed that there is insufficient WHO’s recommendations could be used Likewise, we are unable to evaluate information to establish a DRV for to establish a DRV for sugars. The AHA whether the sugars declaration results in sugars. However, others comments recommended limits for intake of added a reluctance to consume foods, such as recommended establishing a DRV and sugars and not total sugars (Ref. 74). fruit or milk, which are natural sources requiring mandatory declaration of a Therefore, it would not be appropriate

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to use the AHA recommendations to needed based on the total sugar content statements if a product contains an establish a DRV for total sugars. and the amount of sugars or sugar insignificant amount of added sugars As for the comment suggesting that alcohols added to standardize the and for when the added sugars content the IOM could set a maximum intake profile of the food. may be expressed as zero, as proposed, recommendation, the IOM reviewed the The declaration of the amount of in § 101.9(c)(6). evidence on this topic in the sugar alcohols on the Nutrition Facts Because our preexisting regulations Macronutrient report (Ref. 75). As label is voluntary, so if a manufacturer do not define ‘‘added sugars,’’ the discussed in the preamble to the uses sugar alcohols to account for the proposed rule would define ‘‘added proposed rule (79 FR 11879 at 11902), variation in the sugar content of the sugars’’ as sugars that are added during the IOM found an association between product, the label would only need to the processing of foods, or are packaged sugar consumption and risk of dental change if the amount of sugar alcohol is as such, and include sugars (free, mono- caries, but, due to the various factors voluntarily declared on the label. and disaccharides), syrups, naturally that contribute to dental caries, the IOM However, if a food product does not occurring sugars that are isolated from could not determine an intake level of typically contain a certain sugar alcohol a whole food and concentrated so that sugars that is associated with increased which is added to adjust for the sugars sugar is the primary component (e.g. risk of dental caries and, therefore, did content of fruit, that sugar alcohol fruit juice concentrates), and other not have sufficient evidence to set a UL would need to be declared in the caloric sweeteners. A summary of the for sugars. ingredient list. comments regarding our proposed e. Seasonal variation in sugars definition of added sugars, and our 3. Added Sugars content. responses to those comments, can be (Comment 133) One comment noted In the preamble to the proposed rule, found in part II.H.3.a. that, depending on the time of year, the we explained that current regulations In February 2015, the 2015 DGAC sugar content of fruit changes, which neither define the term ‘‘added sugars’’ submitted the 2015 DGAC Report to the could impact the sugar content of nor require or permit the declaration of Secretaries of the U.S. Department of products to which fruit is added. The added sugars on the label. We Health and Human Services and the comment questioned whether the considered requiring the declaration of U.S. Department of Agriculture. The product labels have to change added sugars taking into account new 2015 DGAC reaffirmed throughout the year to reflect the information. We tentatively concluded recommendations in the 2010 DGA, seasonal variation in sugar content of that the declaration of added sugars on which included recommending the the fruit or fruit juice in a product. The the label is necessary to assist reduction of added sugars intake. For comment also questioned if the seasonal consumers to maintain healthy dietary the first time, the 2015 DGAC conducted variation in the sweetness of fruit is practices, and we proposed to require a systematic review of the evidence compensated for by adjusting the the declaration of the amount of added related to dietary patterns and health amount of sugar alcohols in the product sugars in a serving of a product (79 FR outcomes, including cardiovascular and whether a label change would be 11879 at 11905). We are finalizing the disease (CVD), body weight and type 2 required. Another comment suggested requirement for mandatory labeling of diabetes, cancer, congenital that sugars may be added to fruits and added sugars in § 101.9(c)(6)(iii), and abnormalities, neurological and vegetables to achieve a standard flavor our rationale for doing so is discussed psychological illness, and bone health. profile and said that the amount of in this section below. The 2015 DGAC concluded that there is sugars added to the food may change We have requirements for label strong and consistent evidence that throughout the year. statements that must be made if a healthy dietary patterns characterized, (Response) Our compliance product contains an insignificant in part, by lower intakes of sugar- requirements in § 101.9(g)(5) state that a amount of many nutrients on the label sweetened foods and beverages relative food with a label declaration of calories, such as carbohydrate, sugars, and to less healthy patterns, are associated sugars, total fat, saturated fat, trans fat, dietary fiber. We also have requirements with a reduced risk of CVD. We cholesterol, or sodium shall be deemed for when the nutrient content can be considered the evidence that the 2015 to be misbranded under section 403(a) expressed as zero. We proposed that a DGAC relied upon in making its of the FD&C Act if the nutrient content statement of added sugars content determinations, and tentatively of the composite is greater than 20 would not be required for products that concluded, in the preamble to the percent in excess of the value for that contain less than 1 gram of added sugars supplemental proposed rule (80 FR nutrient declared on the label. However, in a serving if no claims are made about 44303), that this information provides no regulatory action will be based on a sweeteners, sugars, or sugar alcohol further support for our proposal to determination of a nutrient value that content and we are finalizing this require the mandatory declaration of the falls above this level by a factor less requirement, as proposed, in amount of added sugars in a serving of than the variability generally recognized § 101.9(c)(6)(iii). We proposed to require a product on the label. for the analytical method used in that that the phrase ‘‘Not a significant source The proposed rule would not food at the level involved. This of added sugars’’ be placed at the establish a DRV for added sugars. We approach takes into account seasonal bottom of the table of nutrient values if explained, in the preamble to the variability as well as variability due to a statement of the added sugars content proposed rule (79 FR 11879 at 11906), the analytical method used. Therefore, is not required, and as a result, is not that the USDA Food Patterns specify the so long as the variability in the sugars declared. Alternatively, we proposed to maximum amount of calories from solid content of the fruit does not cause the permit the use of the alternative fats and added sugars that can be total sugars comment to be greater than statements ‘‘Contains less than 1 g’’ and consumed at each calorie level, while 20 percent in excess of the declared ‘‘less than 1 g’’ to be declared. We also staying within calorie limits. A 2,000 value, the manufacturer of a product proposed to permit the added sugars calorie diet could contain containing fruit would not be in content to be expressed as zero if a approximately 260 calories from solid violation of the regulation. The serving of food contains less than 0.5 fats and added sugars (id.). The limit of manufacturer is in the best position to grams of added sugars. We are finalizing 260 calories served as a reference to determine if and when a label change is the requirements for when label ensure the selection of a nutrient dense

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diet without excess discretionary by lower amounts of sugar-sweetened are associated with a decreased risk of calories from added sugars and solid foods and beverages are associated with CVD. The scientific evidence from the fats. These limits established for calories a reduced risk of CVD supports a 2010 DGA supporting that consumption from solid fats and added sugars in the mandatory declaration of added sugars. of excess calories from added sugars can USDA Food Patterns are based on food Both the USDA Food Patterns and the lead to a less nutrient-dense diet, pattern modeling. Because the limits are dietary patterns and health outcomes current consumption data showing that not based on any biomarker of risk of analysis that were discussed in the 2015 Americans are consuming too many disease from an independent DGAC Report provide information about calories from added sugars, and the relationship between a nutrient and healthy dietary patterns. Therefore, the strong evidence that greater intake of chronic disease risk we stated that we DRV of 10 percent of calories and the sugar-sweetened beverages is associated did not have a quantitative intake mandatory declaration of the amount of with increased adiposity in children recommendation upon which a DRV for added sugars in a serving of food are also support mandatory declaration of added sugars could be derived. The related to providing information that added sugars. statement was not intended to suggest a will assist consumers in constructing a We reviewed and considered the limitation for when we can mandate a healthy dietary pattern. evidence that the 2015 DGAC relied nutrient declaration in the nutrition On January 7, 2016, the Secretaries of upon for its conclusion that healthy label, as some comments seem to the U.S. Department of Health and dietary patterns characterized, in part, suggest. The 2015 DGAC further Human Services and the U.S. by lower intakes of sugar-sweetened evaluated limits for added sugars in the Department of Agriculture released the foods and beverages are associated with diet based, in part, on food pattern 2015–2020 DGA (Ref. 28). The 2015– a decreased risk of CVD relative to less modeling and recommended that 2020 DGA focuses on eating patterns in healthy dietary patterns, which Americans limit their intake of added addition to nutrients and foods because included an existing review from the sugars to a maximum of 10 percent of healthy dietary patterns may be more NEL Dietary Patterns Systematic Review total daily caloric intake. The 2015 predictive of overall health status and Project as well as the NHLBI Lifestyle DGAC said that its recommendation was disease risk than individual foods or Evidence Review and the associated supported by a food pattern modeling nutrients. A key recommendation of the Lifestyle Management Report (Refs. 17– analysis conducted by the 2015 DGAC 2015–2020 DGA is to limit calories from 18). We have concluded that it is and the scientific evidence review on added sugars and saturated fats and appropriate to rely on evidence that added sugars and chronic disease risk. reduce sodium intake. In order to considered not only added sugars but In the preamble to the supplemental achieve this recommendation, the 2015– also sugar-sweetened foods and proposed rule (80 FR 44303 at 44308), 2020 DGA says that Americans should beverages to support the mandatory we reconsidered our tentative consume an eating pattern that is low in declaration of added sugars on the label conclusion that a DRV for added sugars added sugars. Another key because sugars are added to sugar- could not be established and proposed recommendation of the 2015–2020 DGA sweetened foods and beverages and to establish a DRV for added sugars of is to consume less than 10 percent of provide extra calories in those foods. 10 percent of total energy intake from calories per day from added sugars. The When those foods are consumed in added sugars and to require the 2015–2020 DGA is consistent with the excess, they are not consistent with declaration of the percent DV for added recommendations and the science healthy dietary patterns. We also note presented in the 2015 DGAC Report. We that the strong and consistent sugars on the label. considered the scientific evidence in the association with CVD risk was seen Thus, we have scientific evidence to 2015 DGAC Report related to dietary when healthy dietary patterns were support a limit for added sugars that can patterns, as well as evidence related to compared with less healthy dietary serve as the basis for a DRV for added limiting calories from added sugars that patterns. As discussed in the 2015 sugars. The limit for calories from added served as our basis for proposing a DRV DGAC Report, dietary patterns of the sugars to less than 10 percent of calories for added sugars of 10 percent of total American public are suboptimal and are is a reference value that is appropriate calories. causally related to poor individual and for use as a DRV for added sugars. The Throughout this part, we refer to the population health and higher chronic DRV is used to calculate the percent DV, underlying scientific evidence that we disease rates. On average, the U.S. diet and a percent DV provides information have reviewed and considered which is low in vegetables, fruits, and whole that Americans can use to determine supports our basis for the mandatory grains, and high in sodium, calories, how the amount of added sugars in a declaration of the amount of added saturated fat, refined grains, and added serving of food contributes to his or her sugars in a serving of a product, the sugars. Underconsumption of the individual total daily diet. The food DRV, and the declaration of the percent essential nutrients vitamin D, calcium, pattern modeling used to support a limit DV for added sugars. The need for a potassium, and fiber are public health in the intake of added sugars to less mandatory declaration of added sugar is concerns for the majority of the U.S. than 10 percent of calories was used to supported by strong and consistent population, and iron intake is of create the USDA Food Patterns. The evidence that dietary patterns concern among adolescents and USDA Food Patterns provide suggested characterized by higher consumption of premenopausal females (Ref. 19). amounts of food to consume from the vegetables, fruits, whole grains, low-fat There were many statements made in basic food groups, subgroups, and oils dairy, and seafood, and lower the 2010 DGA related to consuming a to meet recommended nutrient intakes consumption of red and processed meat, dietary pattern that is nutrient dense. at 12 different calorie levels. They can and lower intakes of refined grains, and Those statements included the concepts be used by Americans to construct a sugar-sweetened foods and beverages that added sugars displace other healthful dietary pattern that is relative to less healthy dietary patterns; nutrient-dense foods in the diet and that consistent with current regular consumption of nuts and as the amount of solid fats and added recommendations. We have concluded ; moderate consumption of sugars increase in the diet, it becomes that evidence on dietary patterns and alcohol; lower in saturated fat, more difficult to also eat foods with health outcomes showing that healthy cholesterol, and sodium and richer in sufficient dietary fiber and essential dietary patterns characterized, in part, fiber, potassium, and unsaturated fats vitamins and minerals, and still stay

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within calorie limits. The 2010 DGA considered when determining which (Response) Our determination under relied on food pattern modeling done non-statutory (those that are not section 403(a)(2)(A) of the FD&C Act of for the USDA Food Patterns to support explicitly required by the FD&C Act) whether a nutrient is necessary to assist statements in the 2010 DGA related to nutrients should be declared on a consumers in maintaining healthy nutrient density. We considered these mandatory and voluntary basis on the dietary practices is not limited to the statements and evidence from the IOM label (79 FR 11879 at 11889). We factors we have used when assessing macronutrient report (Ref. 75) showing considered whether a quantitative nutrients for which there is an that decreased intake of some intake recommendation existed and independent relationship between the micronutrients occurs when individuals whether there is public health nutrient and risk of disease, a health- consume in excess of 25 percent of significance when determining which related condition, or a physiological calories from added sugars. nutrients should be declared on the endpoint (see our response to comment The 2015 DGAC said that current label. We considered mandatory 45). Our rationale for requiring the intake of added sugars remains high at declaration to be appropriate when mandatory declaration of added sugars 268 calories, or 13.4 percent of total there is public health significance and a is different from that of nutrients for calories per day among the total quantitative intake recommendation which such an independent relationship population ages 1 year and older (Ref. that can be used for setting a DV for a exists. Rather than basing a declaration 19). Intake data from the What We Eat nutrient (79 FR 11879 at 11890). For of added sugars on an association with In America, 2007–2010 (Ref. 76), the nutrients that are not essential vitamins risk of chronic disease, a health-related dietary component of NHANES was and minerals, we considered voluntary condition, or a physiological endpoint, used by the 2015 DGAC to answer declaration to be appropriate when the for the purposes of the general questions related to current intake of nutrient either has a quantitative intake population (see part II.H.3), we are added sugars. We also considered how recommendation but does not have considering a declaration of added this current intake data relates to public health significance, or does not sugars in the context of how it can assist recommendations from the 2015 DGAC have a quantitative intake consumers in maintaining healthy when concluding that Americans are recommendation available for setting a dietary practices by providing consuming too many calories from DRV but has public health significance information to help them limit added sugars. (79 FR 11879 at 11891). We also consumption of added sugars, and to We considered the scientific evidence considered the scientific evidence from consume a healthy dietary pattern. in the 2010 DGAC Report supporting the the 2010 DGA related to the intake of Instead of considering an association conclusion related to consumption of added sugars in the diet and the role of with risk of chronic disease, for the sugar-sweetened beverages and such information in assisting consumers purposes of the general population, our adiposity in children when determining to maintain healthy dietary practices. review for the proposed rule was based that the evidence supports the We noted that our review for added on information which supported the mandatory declaration of added sugars. sugars was not based on the factors we need for further information about The 2010 DGAC conducted a full NEL have traditionally considered for added sugars on the label to assist search to evaluate the association mandatory declaration that are related consumers to maintain healthy dietary between sugar-sweetened beverages and to an independent relationship between practices and the need for consumers to adiposity in children. Results of this the particular nutrient and a risk of be able to readily observe and review, covering 2004–2009 were chronic disease, health-related comprehend the information and to supplemented by the findings of condition, or health-related understand its relative significance in prospective studies included in an physiological endpoint. the context of a total daily diet (79 FR earlier evidence review conducted by (Comment 134) Many comments 11879 at 11891). We relied on multi- the American Dietetic Association addressed our rationale for requiring the faceted evidence showing that added (ADA) (1982–2004). Although we have declaration of added sugars on the label sugars consumption in the United States concluded that this body of evidence in relation to the risk of chronic disease. is a public health concern. We cited provides further support for a One comment recognized that our information from the 2010 DGA mandatory declaration of added sugars rationale for proposing to require the indicating that a high intake of calories on the label, it is limited to children. mandatory declaration of added sugars from excess solid fats and added sugars Therefore, we refer to the general is atypical and is not based on a can decrease the intake of nutrient- population, which includes both traditional nutrient health-outcome dense foods in the diet and can increase children and adults, when we discuss linkage. In contrast, other comments the overall caloric intake, which could the evidence on dietary patterns suggested that we not require the lead to weight management issues (79 characterized, in part, by lower intakes declaration of added sugars on the label FR 11879 at 11904). We considered of sugar-sweetened foods and beverages because they do not meet the factors evidence related to excess consumption and decreased risk of CVD because the outlined in our criteria for mandatory of calories from added sugars. For many healthy dietary pattern components labeling. One comment also objected to years, added sugars have contributed a described in the literature for adults are voluntary declaration of added sugars significant amount of calories to the reaffirmed with the USDA Food because, according to the comment, it American diet. The 2010 DGA cited Patterns, which aim to meet nutrient does not meet either of our proposed intake data showing that Americans needs across the lifespan, including factors. Another comment said that we consumed approximately 16 percent of children 2 years of age and older. have not shown that a public health calories from added sugars (Ref. 77). a. Declaration significance exists for added sugars More recent data shows that labeling through well-established consumption of added sugars has (i) Comments on the Rationale for scientific evidence. The comments also decreased to approximately 13.4 percent Requiring Mandatory Declaration of noted that our rationale for requiring the of calories in recent years; however, the Added Sugars declaration of added sugars differs from intake still remains high and exceeds 10 In the preamble to the proposed rule, our rationale for declaring other percent of total calorie intake. In the we identified the factors that we nutrients on the label. preamble to the proposed rule, we also

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cited to the strong evidence reviewed by and diet-related cancers, have become comment is considering the guidance the 2010 DGAC that shows that children much more prevalent in the population we have given related to determining who consume sugar-sweetened (Ref. 19). Dietary patterns and their food public health significance in our beverages have increased adiposity and nutrient characteristics were at the proposed factors for mandatory and (increased body fat) (79 FR 11879 at core of the conceptual model that voluntary labeling, which are focused 11904). guided the 2015 DGAC’s work and on nutrients for which there is a The evidence we considered when resulted in scientific evidence relationship with a risk of a chronic determining that the amount of added supporting the recommendations from disease, a health-related condition, or a sugars in a serving of a product must be both the 2015 DGAC Report and the physiological endpoint. However, we declared on the label includes the 2015–2020 DGA related to healthy are using a different paradigm for the scientific evidence from the 2010 DGA dietary patterns (Refs. 19, 28). For the labeling of added sugars for the general and the 2015 DGAC Report related to first time, the 2015 DGAC completed a population (see part II.H.3) than has limiting calories from added sugars. The systematic review to examine the been used traditionally. We have 2015–2020 DGA also includes this relationship between dietary patterns established that there is public health scientific evidence. and health outcomes. The data related significance of added sugars through A recommendation to limit the intake to dietary patterns and health outcomes, other evidence and recommendations of added sugars has been long-standing which was reviewed by the 2015 DGAC, related to a healthy dietary pattern low in the various editions of the DGA, focused on specific health outcomes in sugar-sweetened foods and beverages although the terminology and specificity including: CVD, measures of body that is associated with reduced risk of of the guidance has evolved over time. weight or obesity, type 2 diabetes, CVD, through consumption data In fact, we considered requiring the cancer, congenital anomalies, showing that Americans are consuming declaration of added sugars on the label neurological and psychological too many calories from added sugars, in the January 6, 1993 final rule for the illnesses, and bone health. The 2015 through evidence showing that it is Mandatory Status of Nutrition Labeling DGAC concluded that the overall body difficult to meet nutrient needs within and Nutrient Content Revision, Format of evidence examined by the 2015 calorie limits if one consumes too many for Nutrition Label (58 FR 2079 at 2098). DGAC identifies that a healthy dietary added sugars, and through evidence The comments that we received to a pattern is higher in vegetables, fruits, showing that increased intake of sugar- 1990 proposed rule recommended whole grains, low- or non-fat dairy, sweetened beverages is associated with mandating the declaration of added seafood, legumes, and nuts; and greater adiposity in children. sugars only, rather than total sugars, moderate in alcohol (Ref. 19). The 2015 We disagree with the comments that because dietary recommendations urged DGAC also concluded that dietary suggested that added sugars should not the use of sugar in moderation, while at patterns characterized, in part, by lower be required to be declared on the label the same time recommending increased consumption of sugar-sweetened foods because they do not meet the factors we consumption of fruits, which are and beverages relative to less healthy consider for mandatory labeling of sources of naturally occurring sugars. dietary patterns were strongly and nutrients for which there is an Though the terminology ‘‘added sugars’’ consistently associated with a reduced independent relationship between the was not introduced into the DGA until risk of CVD (Ref. 19). Evidence for nutrient and a risk of chronic disease, a 2005, when Americans were advised to dietary patterns and the other health health-related condition, or a ‘‘choose and prepare foods and physiological endpoint. We must outcomes that were included in the beverages with little added sugars or evaluate the current nutrition science analysis was moderate or limited. The caloric sweeteners, such as amounts and determine whether a nutrient will new evidence from the systematic suggested by the USDA Food Guide and assist consumers in maintaining healthy review examining the relationship the DASH eating plan,’’ the DGA has dietary practices. We are not bound by between dietary patterns and health included key recommendations advising certain factors when determining if any outcomes provide further support for a Americans to limit their intake of and all nutrients should be declared on mandatory declaration of added sugars ‘‘sugar’’ since the first report in 1980 the label now or in the future (see part because consumers need to know how (Refs. 30, 78–83). Even in the 1980 DGA, II.C.3). Americans were advised to ‘‘avoid much added sugars are in their foods in The final rule, therefore, at excessive sugars’’ by using less of all order for them to construct an overall § 101.9(c)(6)(iii), requires the mandatory sugars, including white sugar, brown healthy dietary pattern and to limit declaration of added sugars. sugar, raw sugar, honey, and syrups. consumption of added sugars. The (Comment 135) Many comments said Consumers were also advised to reduce scientific evidence also was included in we should not require the declaration of their consumption of foods containing the 2015–2020 DGA. Furthermore, added sugars on the label because they these sugars such as candy, soft drinks, consumers need to know how much do not have a unique role in causing ice cream, cakes, and cookies. All of the added sugars are in a serving of a weight gain or increasing the risk of ingredients that consumers were product so that they can avoid chronic disease when compared to other advised to limit in their diet in the 1980 consuming excess calories from added macronutrients. Many comments cited DGA would meet our current definition sugars, at the expense of calories from the 2010 DGA’s conclusion that added of an added sugars, and the foods that other components as part of a healthy sugars are no more likely to contribute Americans were advised to limit are dietary pattern within calorie limits, to weight gain or obesity than any other some of the largest contributors to such as fruits, vegetables, fat-free and source of calories (Ref. 30). Some added sugars intake today. low-fat dairy, grains, protein foods, and comments also cited the conclusion in Over the past century the health oils. the IOM DRI report for macronutrients profile of Americans has changed. We disagree with the comment that that there is no clear and consistent Deficiencies of essential nutrients have added sugars should not be required on association between increased intake of dramatically decreased, and chronic the label because we have not shown added sugars and BMI (Ref. 75). The diseases that are related to poor quality that a public health significance exists comments noted that studies have dietary patterns and physical inactivity, for added sugars labeling through well- shown that with respect to weight loss, such as obesity, CVD, type 2 diabetes, established scientific evidence. The reducing total caloric intake is more

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important than the source of calories. insulin, and LDL cholesterol. The concluded that an increased intake of The comments asserted that excess comments suggested that the findings sugar-sweetened beverages is associated energy in any form will promote body indicate that diets high in fructose with greater adiposity in children. Since fat accumulation. increase markers or risk factors for heart 2010, additional evidence on sugar- (Response) We agree that excess disease, diabetes, non-alcoholic fatty sweetened beverages and their calories from any source can contribute liver disease, and metabolic syndrome. association with risk of disease has to weight gain. However, Americans are The comments noted that randomized, emerged. The 2015 DGAC concluded consuming too many calories from controlled clinical trials to test the that there is strong and consistent added sugars, and those calories hypothesis that added sugars increase evidence that intake of added sugars typically are not accompanied by other disease risk would violate ethical from foods and/or beverages is beneficial nutrients. The comments are standards, and therefore, are impossible associated with excess body weight in considering the evidence that we have to conduct. children and adults (Ref. 19). We note used to support a declaration of added In contrast, many comments argued that the majority of the evidence that the sugars against our proposed factors for that there is no association between 2015 DGAC relied on for this conclusion mandatory and voluntary declaration of consumption of added sugars and risk of was from studies on the relationship non-statutory nutrients for which there chronic disease, and therefore, there is between intake of sugar-sweetened is an independent relationship between a lack of a scientific basis to require the beverages and body weight. Although the nutrient and a risk of chronic mandatory declaration of added sugars the evidence on sugar-sweetened disease, a health-related condition, or a on the label. One comment stated that beverages and body weight/adiposity is physiological endpoint. Rather than evidence available since the 2010 DGA strong and consistent, sugar-sweetened considering a direct relationship is conflicting and inconclusive. In beverages represent only 39 percent of between consumption of added sugars reference to the evidence showing that food sources of added sugars. As noted and risk of a chronic disease, health- all sugars contribute to dental caries, in the comments, sugar-sweetened related condition, or physiological one comment suggested that there are beverages may not be an appropriate endpoint, for the purposes of the general many factors that can contribute to proxy or surrogate for total added sugars population (see part II.H.3), we have dental caries, including oral bacteria, intake. focused on how added sugars found in salivary flow, oral hygiene behavior, Research on the health effects of total sugar-sweetened foods and beverages and susceptibility of the tooth. The added sugars continues to emerge. One contribute to a dietary pattern, and how comment stated that it was not aware of difficulty that researchers face when the contribution of added sugars to the any evidence showing that added sugars designing studies on added sugars from total diet impacts health. The evidence presents a unique risk for causing dental all food sources is that there are many points to the need for consumers to caries. ingredients containing added sugars by know how much added sugars are in a Some comments criticized studies on different names, and no single serving of a product to assist them in added sugars and risk of disease. The definition of added sugars has been achieving a healthy dietary pattern and comments suggested that scientific adopted by the scientific community. In maintaining healthy dietary practices. consensus groups have found difficulty § 101.9(c)(6)(iii) of the final rule, we are in determining any relationship establishing a regulatory definition of (ii) Evidence on Added Sugars and Risk between added sugars intake and health added sugars. We expect that, by of Chronic Disease outcomes due to a variety of complex requiring the declaration of the amount (Comment 136) Many comments reasons. The reasons cited included lack of added sugars in a serving of a product suggested that, if we are using the of harmonization within the scientific on the label, and by establishing a traditional relationship between a literature of the definition and inclusion definition of added sugars, additional nutrient and risk of chronic disease, a of ingredients considered to be added research on the health effects of added health-related condition, or a sugars, difficulty comparing studies sugars from food and beverages will be physiological endpoint when where the primary health outcomes conducted in the future that will further determining if added sugars should be measured are not consistent across clarify the direct relationship of added declared on the label, there is specific studies, systematic reviews draw sugars with risk of chronic diseases, scientific evidence on added sugars and conclusions across multiple studies health-related conditions, and risk of disease that we should consider. with various inclusion criteria and physiological endpoints. Many comments suggested that a designs, excess energy intake may not Although we are not basing a declaration of added sugars is necessary be controlled for in the analysis, much mandatory declaration of added sugars because consumption of added sugars is of the information about added sugar for the general population on an associated with an increased risk of content of products is proprietary, and independent relationship between chronic disease or markers for chronic methodological problems with added sugars and risk of chronic disease. Some comments provided observational studies which have disease, we are, instead, basing an evidence that increased consumption of suggested detrimental associations of added sugars declaration on the need to sugar-sweetened beverages, which are added sugars intake with health provide consumers with information to the primary source of added sugars in outcomes. The comments also noted construct a healthy dietary pattern that the American diet, is associated with that sugar-sweetened beverages are often is low in added sugars. We intend to increased body weight, an increase in inappropriately used as a proxy or monitor the evidence in this area and body mass index (BMI), adiposity (body surrogate for total added sugars intake. will consider how any new evidence fat), increased blood pressure leading to (Response) Added sugar in the diet is may impact our regulations in the increased incidence of hypertension, an area that is of particular interest in future. and in increased risk of metabolic the nutrition community. A substantial (Comment 137) In the preamble to the syndrome, type 2 diabetes, and gout. amount of research has been conducted proposed rule (79 FR 11879 at 11904), Other comments provided evidence that on the association between we suggested that the disclosure of high intakes of fructose-containing consumption of sugar-sweetened saturated fat and trans fat on the label sugars can raise levels of triglycerides, beverages and risk of chronic disease, as not only provides information to visceral fat, liver fat, blood glucose, noted in the comments. The 2010 DGAC consumers for managing their risk of

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CVD, but the declaration of these reduced in isolation; in fact, sodium and grains, seafood, legumes, and nuts; nutrients also could provide a marker saturated fats are also recommended to moderate in low- and non-fat dairy for foods that contain solid fats (fats be reduced in order to achieve a healthy products and alcohol (among adults); which are solid at room temperature dietary pattern that is balanced, as lower in red and processed meat; and and contain a mixture of saturated and appropriate, in calories (Ref. 19). These low in sugar-sweetened foods and unsaturated fatty acids but tend to considerations have led us to conclude beverages and refined grains. One contain a high percentage of saturated that consumers need information on the comment noted that the dietary patterns and trans fats). We suggested that there amount of added sugars in a serving of that are now recommended for CVD is not currently information on the label a product as well as a percent DV reduction by the American Heart that could serve as a marker for added declaration to help them maintain Association and the American College sugars. healthy practices and determine how a of Cardiology and the new part 2 Some comments took issue with serving of a product fits into the context recommendations of the National Lipid comparisons made between fats and of their total daily diet. Furthermore, the Association all refer to a dietary pattern sugars in the proposed rule. The declaration of added sugars will be low in sweets and sugar-sweetened comments noted that there are included with other nutrient beverages. significant health differences between declarations on the label. This is one of Many comments supported the 2015 fats in general and solid fats. The many pieces of nutrition information DGAC’s recommendation that comments asserted that those that consumers should use when Americans reduce their intake of added differences provide a defensible basis making food choices. sugars and said that the for delineating the types of fats on the recommendation is consistent with the label, and there are no similar (iii) New Evidence Presented in the American Cancer Society’s nutrition functional health differences between 2015 DGAC Report and physical activity guidelines, the sugars and added sugars. Therefore, the After publication of the 2010 DGA, recent guidelines from the World Health comments said we do not have a basis the USDA NEL completed a systematic Organization on added sugars intake, for requiring a separate declaration for review project examining the and recent lifestyle guidelines from the added sugars on the label. relationships between dietary patterns American Heart Association and the (Response) Our basis for requiring the and several health outcomes, including American College of Cardiology. declaration of added sugars for the CVD, body weight, type 2 diabetes, and (Response) We have reviewed and general population (see part II.H.3) is dental caries. In addition, the DGAC considered the data and information not related to an independent reviewed the NHLBI Lifestyle Evidence underlying the 2015 DGAC’s relationship between added sugars and Review and the Lifestyle Management recommendations and have concluded a risk of chronic disease, but rather on Report. Based on the information that the declaration of added sugars is the contribution of added sugars to an provided in the NEL report, the 2015 necessary to assist consumers in overall dietary pattern. Added sugars DGAC made conclusions about the maintaining healthy dietary practices. consumption among the general U.S. association of healthy dietary patterns The declaration would enable population exceeds what can reasonably and the risk of the named health consumers to limit added sugars as part be consumed within calorie limits and outcomes. In particular, the 2015 DGAC of a healthy dietary pattern. can have a negative impact on health. concluded that strong and consistent (Comment 140) Although we did not The declaration of added sugars will evidence demonstrates that dietary propose to rely on the analysis assist consumers in maintaining healthy patterns characterized by higher conducted by the 2015 DGAC (Ref. 84) dietary practices. In the preamble to the consumption of vegetables, fruits, whole on the relationship between the intake proposed rule, we were not making a grains, low-fat dairy, and seafood, and of added sugars and CVD, body weight/ comparison between the level of lower consumption of red and obesity, type 2 diabetes, and dental evidence related to an independent processed meat, and lower intakes of caries, some comments addressed the relationship between the intake of fats refined grains, and sugar-sweetened analysis and whether it supports a and sugars and chronic disease risk. foods and beverages relative to less mandatory declaration of added sugars. Instead, we were describing whether healthy patterns; regular consumption Some comments said that it is information on the label for certain fats of nuts and legumes; moderate appropriate for us to rely on information and sugars would allow the consumer to consumption of alcohol; lower in from the 2015 DGAC Report as well as use the label to reduce their saturated fat, cholesterol, and sodium, the robust science upon which that consumption of calories from solid fats and richer in fiber, potassium, and report is based regarding the health risks and added sugars. unsaturated fats is associated with a of added sugars. The comments said (Comment 138) Some comments decreased risk of CVD. We reviewed and that the DGAC comprehensively likened the public interest in added considered the evidence that the DGAC reviewed the current scientific literature sugars to that in total fat in previous relied on for making this conclusion, and concluded that added sugars years and suggested that we consider and determined that it supports our increase the risk of multiple health the unintended consequences associated basis for requiring the mandatory outcomes, including excess body with a single nutrient-type approach. declaration of the gram amount of added weight, type 2 diabetes, CVD and dental (Response) We disagree with the sugars on the label. We requested caries. According to the comments, the comment’s suggestion that we are taking comment on this new information in the evidence, which was graded either as a single nutrient-type approach to the supplemental proposed rule. ‘‘strong’’ or ‘‘moderate’’ by the DGAC, labeling of added sugars. We are (Comment 139) Some comments further supports the mandatory considering how added sugars interact supporting our inclusion of the new declaration of added sugars on the label with other components in the diet and information on dietary patterns and and supports the addition of a percent make it difficult for individuals to meet CVD risk in our rationale for the DV declaration on the label. The nutrient needs within calorie limits and declaration of added sugars said that the comments cited additional scientific to construct a healthful dietary pattern. U.S. population should be encouraged evidence supporting an association As noted in the 2015 DGAC Report, and guided to consume dietary patterns between consumption of added sugars added sugars are not intended to be that are rich in vegetables, fruit, whole and/or sugar-sweetened beverages and

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the risk of the health outcomes named (Comment 141) Some comments disease risk to determine the association in the 2015 DGAC Report or endpoints suggested that our review is inconsistent between a single component of the such as serum triglycerides, LDL and selective. The comments said that mixture to disease risk in our Guidance cholesterol, and blood pressure. the particular dietary pattern related to on Evidenced Based Review (Ref. 85). Other comments suggested that the CVD was singled out from the DGAC The comments said that the existing evidence related to Report of dietary patterns and other extrapolation does not establish a public consumption of added sugars and the chronic diseases (e.g. cancer, type 2 health endpoint to justify mandatory risk of various chronic diseases and diabetes) in the supplemental proposed declaration added sugars. Some health-related conditions is limited and rule because it was the only chronic comments also said that the evidence on does not demonstrate a clear, causative disease for which the evidence was dietary patterns is not nutrient specific relationship or direct contribution of considered to be strong and, as such, we and a dietary pattern is defined as the added sugars to obesity, heart disease, consider strong evidence to be necessary quantities, proportions, variety or or other diseases or conditions. for requiring added sugars on nutrients combinations of different foods and Some comments questioned why we in the proposed rule. beverages in diets, and the frequency are relying on evidence related to (Response) We have strong and with which they are habitually dietary patterns and risk of disease to consistent evidence that dietary patterns consumed. support a mandatory declaration of associated with a decreased risk of CVD (Response) This type of analysis that added sugars when a review was done are characterized by higher was conducted to examine the by the DGAC that specifically looked at consumption of fruits, vegetables, whole relationship between healthy dietary consumption of added sugars and risk of grains, low-fat dairy, and seafood, and patterns and health outcomes is CVD and the DGAC concluded that the lower consumption of red and appropriate to answer questions about evidence was moderate rather than processed meats, and lower intakes of how dietary patterns, as a whole, impact strong. The comments noted that the refined grains and sugar-sweetened disease risk. This type of analysis also evidence reviewed by the DGAC in foods and beverages relative to less takes into account relationships healthy dietary patterns. The dietary between components of a healthy chapter 6 (clinical trials and pattern approach focuses on dietary intake, which cannot be observational studies on sources of components of the diet and how they determined when looking at specific added sugars and CVD risk) provides a contribute to an overall healthy dietary associations with a nutrient and risk of more direct and specific evaluation on pattern that is associated with a disease. Other analyses are more added sugars and CVD risk than from decreased risk of disease. Although this appropriate for answering questions data on dietary patterns and CVD risk. is the first time that the 2015 DGAC has related to a direct cause and effect (Response) As discussed in part conducted a systematic review of the relationship between a nutrient and the II.H.3.a, we are requiring an added evidence related to dietary patterns and risk of a disease or health-related sugars declaration so that consumers health outcomes, analysis of diet quality endpoint. can limit calories from added sugars as using scoring indices is an accepted The evidence considered by the 2015 part of a healthy dietary pattern lower scientific method that has been used for DGAC related to dietary patterns and in sugar-sweetened foods and beverages years to assess diet quality. The CVD risk provides us with information which is associated with a reduced risk evidence that the 2015 DGAC about the components of a healthy of chronic disease and can meet nutrient considered related to dietary patterns dietary pattern and how those needs within calorie limits. We do not and CVD risk adds to information that components, when taken in need to limit our review of the science we provided in the proposed rule to combination, make up a dietary pattern to the moderate evidence related to an support an added sugars declaration and that is associated with the reduced risk independent relationship between is not the only evidence that we are of CVD. As noted by the 2015 DGAC, it added sugars and risk of chronic relying on to support the declaration. is often not possible to separate the disease; instead, we can include in our Evidence related to an independent effects of individual nutrients and review the strong and consistent association between consumption of foods. The 2015 DGAC Report says that association between the healthy dietary added sugars and risk of chronic disease the components of the eating pattern pattern with lower amounts of sugar- continues to emerge. Although science can have interactive and potentially sweetened foods and beverages, related to the independent relationship cumulative effects on health (Ref. 19). compared to less healthy dietary between total added sugars and risk of The 2015–2020 DGA also says that patterns, and reduced risk of CVD (see chronic disease is not conclusive at this people do not eat food groups and added sugars introduction). Although point, it does not mean that we cannot nutrients in isolation but rather in the 2015 DGAC concluded that strong and should not rely on the evidence that combination, and the totality of the diet and consistent evidence shows that we currently have related to healthy forms an overall eating pattern. intake of added sugars from food and/ dietary patterns characterized, in part, The dietary pattern analysis as well as or sugar-sweetened beverages are by a reduced intake of sugar-sweetened information from the USDA food associated with excess body weight in foods and beverages and reduced risk of patterns showing how much added children and adults, the evidence CVD, which is strong and consistent. sugars individuals can reasonably reviewed by the 2015 DGAC was (Comment 142) Some comments cited consume in their diet while meeting primarily on sugar-sweetened beverages, reasons why the type of analysis which nutrient needs, and consumption data which only represent 39 percent of food was conducted to examine the showing that consumption of added sources of added sugars. The relationship between healthy dietary sugars among Americans remains high consumption of added sugars and their patterns and health outcomes cannot be supports limiting consumption of added impact on health continues to be an area used to make conclusions regarding sugars. In order for consumers to limit of great interest to the scientific single nutrients, food components, or consumption of added sugars in the community and to consumers. We foods. The comments noted that we diet, it is necessary for information to be intend to monitor future research that have stated that we do not accept this provided on the label that allows may impact the labeling of added type of extrapolation from an consumers to determine how much sugars. association of a complex mixture with added sugars is in a serving of food, so

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they can determine whether and how quintile of scores) across scoring Dietary Approaches to Stop that food fits into their total daily diet. indices, and that higher diet quality is Hypertension adherence index included Therefore, information about what significantly and consistently associated soda, sugar sweetened beverages or a constitutes a healthy dietary pattern that with a reduced risk of death due to all broader ‘‘sweets’’ category depending on is associated with a decreased risk of causes, CVD, and cancer compared to the scoring method used. The comments disease supports a label declaration of the lowest quintile of scores (Ref. 86). said that none of these indices added sugars even though conclusions Therefore, it is very unlikely that the specifically address added sugars about a nutrient-specific association majority of the population can consume independently. One comment stated with risk of disease cannot be drawn a high quality diet that incorporates the that not one of the Mediterranean from this type of evidence. proper amounts from food groups to dietary pattern studies cited by the (Comment 143) Some comments meet nutrient needs as well as a DGAC had a sugars or added sugars noted that the 2010 DGA said that significant amount of added sugars and criterion. individuals can achieve a healthy diet still stay within calorie limits. The Other comments singled out studies in multiple ways and preferably with a research suggests that there is a high from the 55 that were included in the wide variety of foods and beverages. level of consistency between different NEL review based on whether they Optimal nutrition can be attained by scoring indices in what is considered to included a measure of added sugars in many different dietary patterns, and a be a healthy diet. Furthermore, as the study. The comments suggested that single dietary pattern approach or shown in the USDA Food Patterns for studies with scoring indices that did not prescription is unnecessary. The three patterns of health eating (a include a measure of added sugars comments said that dietary patterns Healthy U.S.-Style Eating Pattern, a should be excluded from our analysis. other than those evaluated in Chapter 2 Healthy Mediterranean-Style Eating Some comments suggested that, when of the 2015 DGAC Report might not Pattern, and a Healthy Vegetarian Eating only the studies in which dietary have necessarily shown that reduced Pattern (Ref. 19)), in order to eat a pattern scoring indices were used that added sugars intake was associated with dietary pattern that includes the included a measure of added sugars are increased risk of CVD. amounts of other healthy dietary considered, the evidence related to CVD (Response) While individuals can components, it is not possible to risk is not strong and consistent. The follow a number of different healthful consume large amounts of empty comments noted that the 2015 DGAC dietary patterns, the NEL review on calories. Report says that ‘‘certain scores also dietary patterns and CVD risk did not included added sugars or sugar- specifically look at studies where b. The 2015 DGAC Analysis of Dietary sweetened beverages as negative individuals were placed on a particular Patterns and Health Outcomes components.’’ diet or were instructed to follow a (Comment 144) In the analysis of (Response) While a number of index specific diet. The 2015 DGAC did dietary patterns and health outcomes, studies did not include a direct measure consider evidence from DASH trials dietary quality indices were used to of added sugars or sugar-sweetened where participants were placed on the evaluate adherence to certain dietary foods and/or beverages, the scoring DASH diet. With the exception of the patterns. An individual’s score is systems in the study were measuring DASH trials, the analyses included free- derived by comparing and quantifying adherence to an overall dietary pattern, living individuals who were following their adherence to the criterion food such as the Mediterranean diet, that is many dietary patterns. Certain scoring and/or nutrient component of the index typically low in added sugars. indices were then applied to intake data and then summed over all components Furthermore, research shows that there to look at how closely the diets of study (Ref. 19). A population’s average mean is consistency in scoring as well as participants matched certain types of and individual component scores can be association with health outcomes across healthy dietary patterns. Scores were similarly determined. Some examples of dietary quality indices, including two then given based on adherence to the the dietary quality scores used for the that do not typically include a sugar- dietary pattern of interest. The dietary analysis include: The Health Eating sweetened food and beverages quality analyses included individuals Index (HEI)–2005 and 2010, the component (i.e. aHEI and AMED) (Ref. that did not closely adhere to a Alternate HEI (AHEI) and updated 86). particular dietary pattern of interest. In AHEI–2010, the Recommended Food The Dietary Patterns Methods Project looking at all reports, which included Score (RFS), the Mediterranean Diet conducted standardized and parallel an analysis of adherence to multiple Score (MDS), and the Alternate analyses of the prospective association types of healthy dietary patterns, the Mediterranean Diet Score (aMed). of select dietary patterns characterized 2015 DGAC concluded that closer Some comments took issue with the by dietary quality indices and mortality adherence to the healthy dietary various scoring algorithms used to outcomes in three large cohort studies patterns of interest, which tended to evaluate adherence to certain dietary conducted in the United States. The include less sugar-sweetened foods and patterns as well as with the studies investigators selected four commonly beverages, resulted in a decreased risk included in the analysis. One criticism used dietary quality indices including of CVD. Therefore, the analysis included of the scoring algorithms was that the the HEI–2010, the AHEI–2010, the individuals who followed a wide variety majority of dietary pattern index studies aMED, and the DASH (Ref. 86). The of dietary patterns, some of which were cited by the 2015 DGAC did not include comments noted that the AHEI and determined to be more strongly an added sugars criterion. The aMED dietary quality indices do not associated with chronic disease risk comments noted that the MDS, the have a specific measure of added sugars. than others. Although it is possible that aMed, the AHEI, and the RFS do not Liese et al. found that the indices were some dietary patterns including include a ‘‘sweets or sugar products’’ highly correlated, which means that substantial amounts of sugar-sweetened component. The comments said the individuals with the highest scores of foods and beverages are associated with HEI–2005 included sugar in a combined adherence were likely to be scored a decreased risk of CVD, research category of solid fats, alcoholic similarly across all of the four dietary conducted across cohorts using multiple beverages and added sugars, the AHEI– quality indices. They also found that dietary pattern indices show that there 2010 included sugar-sweetened higher diet quality (highest quintile of is a high degree of correlation (highest beverages and fruit juice, and the scores) was associated with lower all-

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cause, CVD, and cancer mortality when undergo chemical processes that reduce hamper cross-study comparisons and compared to lower diet quality (lowest the amount of sugar in a product. limit reproducibility. quintile of scores) across the diet quality (Response) To the extent that the (Response) Some studies included indices. Similar findings have been seen comments are suggesting that it is not only sugar-sweetened beverages, while across dietary quality scoring indices appropriate for us to rely on evidence others included ‘‘sugar’’ or ‘‘sweets.’’ and large prospective cohort studies related to dietary patterns and health The scoring algorithms also did vary (Refs. 87–89). These results suggest that outcomes to support a mandatory from study to study. However, research dietary quality scoring indices declaration of added sugars, we shows that different dietary quality consistently determine diet quality, disagree. The scientific evidence related indices are very comparable in what regardless of whether they include a to dietary patterns and health outcomes they consider to be a high quality versus component for sugar-sweetened foods that was presented in the 2015 DGAC a low-quality diet (Ref. 86). The and/or beverages. The research also Report, and more specifically the different dietary quality indices also are suggests that, because the diet quality evidence related to a healthy dietary very consistent in their association with indices are so comparable in what they pattern that is associated with a health outcomes (Ref. 86). Although the measure as a high quality diet, it is very decreased risk of CVD relative to less studies included different types of likely that the diets of individuals with healthy dietary patterns does show that added sugars as components of their higher diet quality scores will have a there are certain characteristics of a analysis, when taken as a whole, the lower intake of sugar-sweetened foods healthy dietary pattern that consumers data generally shows that healthy and/or beverages. Furthermore, it is very need when selecting foods to eat and dietary patterns that are associated with unlikely that participants with high diet when determining how much of those a decreased risk of CVD relative to less quality scores across the various scoring foods they should eat. The information healthy dietary patterns are indices would be able to consume that we are relying upon related to characterized, in part, by lower amounts enough of the other components of a healthy dietary patterns characterized, of sugar-sweetened foods and beverages. healthy dietary pattern to receive a high in part, by lower amounts of sugar- Additionally, it would be extremely score if they were consuming large sweetened foods and beverages and difficult for individuals consuming large amounts of sugar-sweetened foods and CVD risk is directly related to the need amounts of empty calories from sugar- beverages. for consumers to have information on sweetened foods and beverages to be We also note that the dietary pattern the label, which they do not currently able to consume enough of the other have in the case of added sugars, so that components of a healthy dietary pattern scoring indices were modified by study they can construct a healthy dietary to be able to receive a high diet quality investigators, so it is necessary to review pattern that is associated with a score. each study to determine whether the decreased risk of disease and maintain We also recognize that the scoring diet quality index used in a particular healthy dietary practices. algorithms used in the studies included study included a component that In response to the comment’s in the analysis differ from study to measured added sugars. Table 4–B–I–1 suggestion that an added sugars study. However, despite having from the 2015 DGAC Report shows a declaration is potentially false and different ways to evaluate many comparison of the dietary components misleading for certain foods which different types of healthy diets, a strong across some of the major diet scoring undergo chemical processes that reduce and consistent pattern emerged from the indices (Ref. 19). The comment noting the amount of sugar in a product, we evidence. We view the variety of scoring that the MDS, the aMed, the AHEI, and have concluded that, generally, algorithms to be a strength of the review the RFS do not include a ‘‘sweets or manufacturers of foods that undergo because, despite the differences in sugar products’’ component was likely non-enzymatic browning and scoring algorithms, there was referring to the information in Table 4– fermentation are able to determine a consistency in what constituted a diet B–I–1. However, to determine if the reasonable approximation of the amount that would receive a high dietary quality scoring index used in a particular index of added sugars in a serving of their score and there was consistency in the study included a measure of sugars- finished product (see part II.H.3.k). association between higher dietary sweetened foods or beverages, it is Therefore, added sugars declarations on quality scores and CVD risk versus necessary to go to the study report foods that undergo non-enzymatic lower diet quality scores. because investigators did include browning and fermentation are not (Comment 147) Some comments measures of types of sugar-sweetened potentially false and misleading. noted that none of the definitions of foods and/or beverages in most of the (Comment 146) Some comments added sugars used in the studies studies included in the analysis. For noted that the studies that did include included in the analysis of dietary example, Trichopoulou et al. evaluated an assessment of sugar sweetened foods patterns and CVD risk are consistent adherence to a Mediterranean diet by and/or beverages did not include an with our proposed definition since it using the MDS, but included sweets as assessment of everything that we would was not released until 2014 and the a component of the scoring algorithm. consider to be added sugars. One studies were conducted prior to that (Comment 145) One comment noted comment said that some of the studies date. One comment suggested that many that, if a company wanted to make a only assessed sugars-sweetened more sources of sugar are included in voluntary claim that there is a strong beverage intake, and some considered our proposed definition than in the association between diets low in added fruit juices to be sugar-sweetened studies cited in the 2015 DGAC Report. sugars and a decreased risk of CVD, we beverages. The studies included no (Response) The studies included in would not consider the underlying assessment of intake of sugar-containing the analysis on dietary patterns and evidence that the DGAC relied upon as foods. CVD risk assessed the intake of foods sufficient to support such a claim, yet Other comments noted that the that are part of an eating pattern rather we are relying on this same level of scoring algorithms used to evaluate than intake of specific nutrients. evidence to require that companies dietary pattern adherence may differ Therefore, we would not expect, nor include a mandatory claim on their and may affect the results of studies would it be necessary for, our proposed labels that is potentially false and examining specific health outcomes. definition of added sugars to be misleading for certain foods which The comments said that this factor may consistent with how sugar-sweetened

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foods and beverages were defined for noted in the comments, when taken association between a dietary pattern the purposes of this type of analysis. together with other studies included in and a health outcome was inconsistent, Furthermore, we would not anticipate the analysis, the body of evidence which shows that the methodology used that researchers would have used our supports the conclusion that there is is imprecise. proposed definition as a guide when strong and consistent evidence dietary (Response) For the first time, the 2015 determining what foods include added patterns characterized by higher DGAC conducted a systematic review of sugars because, at the time the studies consumption of vegetables, fruits, whole the evidence related to dietary patterns were conducted, we had not finalized grains, low-fat dairy, and seafood, and and health outcomes. The analysis was the rule. lower consumption of red and included because people do not eat (Comment 148) One comment cited processed meat, and lower intakes of nutrients or foods in isolation. Rather several epidemiological studies which refined grains, and sugar-sweetened than focusing on specific nutrients, the evaluated the DASH dietary scoring foods and beverages relative to less 2015 DGAC and the 2015–2020 DGA pattern and CVD outcomes. The healthy patterns; regular consumption focused on eating patterns and shifts comment said that, in one study of nuts and legumes; moderate that Americans need to make in order to included in the 2015 DGAC analysis consumption of alcohol; lower in move towards a healthier diet that is (Ref. 90), the range of sweetened saturated fat, cholesterol and sodium associated with a decreased risk of beverage intake across the DASH score and richer in fiber, potassium, and chronic disease. The 2015–2020 DGA quintile was narrow (0.3 servings per unsaturated fats are associated with said that the key recommendations for day in the lowest quintile and 0.2 decreased CVD risk. healthy eating patterns should be servings per day in the highest quintile). applied in their entirety, given the (Comment 149) Some comments cited The comment noted that the authors of interconnected relationship that each a number of studies where an the study concluded that a diet that dietary component can have with others association with higher adherence resembles the DASH eating plan was (Ref. 28). The 2015 DGAC Report said, scores and CVD risk, CHD risk, or significantly associated with lower risk and we agree, that it is often not ischemic stroke was found, but when an of CHD and stroke, but they made no possible to separate the effects of analysis of sugar sweetened foods and/ mention of reduced consumption of individual nutrients and foods and that or beverages was done in the same data sweetened beverages as part of the diet. the totality of the diet-the combinations set, an association with the outcome of The comment also referred to a and quantities in which foods and interest was not found. The comments subsequent study in the Women’s nutrients are consumed may have Health Study cohort which evaluated referred to component analyses that synergistic and cumulative effects on the relationship between adherence to a were conducted as part of some of the health and disease (Ref. 19). It is with DASH dietary pattern score and risk of studies included in the analysis of the this information in mind that we CVD. In this study, an apparently strong evidence related to dietary patterns and reviewed the evidence related to dietary association of adherence to the DASH CVD risk. In these component analyses, patterns and health outcomes presented diet with incidence of CVD was the data for intake of certain dietary in the 2015 DGAC Report. attenuated upon control for components, such as fruits and We disagree with the comments confounding variables. The comment vegetables, were looked at more closely stating that studies that included a noted that, Folsom et al. found that to see if they were associated with the component analysis for added sugars adherence to the DASH diet, where outcome of interest (CVD risk) when and CVD risk that did not show a sweets were evaluated as a broad looked at in isolation. The comments favorable association cannot be used to category, did not have an independent said that ‘‘added sugars’’ intake was not support an added sugars declaration. long-term association with hypertension a factor in the observed differences in Investigators use component analyses as or CVD mortality after adjustment for CVD risk in some of the studies where an exploratory measure to see if the confounding variables in a cohort of component analyses were performed. result seen is mainly due to one women (Ref. 91). Additionally, the comments said that component or another. How these (Response) Although study authors sugars are only one of many dietary component analyses are conducted may not have mentioned sweetened factors included in the scoring indexes, varies from study to study because there beverages as part of the DASH eating and interplay between multiple factors is not consensus within the scientific plan, the DASH diet is typically lower in the dietary patterns cannot be community yet on what methods should in the category of food called ‘‘sweets.’’ excluded. Some comments said that the be used for component analyses. For Therefore, it is appropriate to rely on analysis is limited because not all of the example, in some studies, the effects of studies where a DASH scoring index studies included in the NEL review individual components of the diet are was used because the scoring algorithm included a component analysis. The looked at separately without controlling is based on a diet that is low in sweets. comments pointed to the statement in for the effects of other components of We considered all 55 articles the 2015 DGAC Report which says the diet, while in other studies reviewed by the NEL, which ‘‘although a large number of the studies investigators control for other variables summarized evidence from 52 assessed food group components and in the diet when looking at the effect of prospective cohort studies and 7 their association with CVD outcomes, an individual dietary component. randomized-controlled trials (RCTs), many did not, and more precise Because the methodology related to and the NHLBI Lifestyle Evidence determination of the benefits and risks dietary pattern component analyses is Review and the associated Lifestyle of individual components (e.g., alcohol) still evolving and there is a great deal of Management Report, which included would be helpful for policy variability between studies in how the primarily RCTs. Although some studies recommendations. One comment noted component analyses are performed, we where a DASH dietary quality scoring that the 2015 DGAC Report fails to believe that it would not be appropriate index was used did not show an mention all of the individual to conclude that sugar-sweetened association with CVD risk, and some components that were tested that had no beverages have no responsibility for the DASH dietary quality scoring indices effect on CVD (e.g., added sugars). overall relationship that is seen with did not include a direct measure of Another comment noted that throughout CVD risk just because a component sugar-sweetened foods and beverages, as the studies, the impact of dairy on the analysis indicates that there is no

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independent effect of sugar-sweetened grains, low-fat dairy, and seafood, and is becoming more widely accepted in beverage consumption on CVD risk in lower consumption of red and the scientific community because there the data set. Instead, we have processed meat, and lower intakes of has been a shift in recent years from considered the evidence related to the refined grains, and sugar-sweetened focusing on nutrients and their totality of the dietary pattern. By foods and beverages. association with disease risk to a dietary considering the makeup of the entire The comments that said that the data pattern approach that considers the fact healthy dietary pattern, we can take into does not support a strong and consistent that individuals do not eat nutrients or account connections that foods and relationship with CVD risk were looking foods in isolation. The 2015 DGAC dietary components may have with one at the data in more limited way than we based their conclusions and another. have. They focused their review on a recommendations on the results of this As noted in the 2015 DGAC Report, specific nutrient-disease relationship type of analysis to look at dietary the analysis of dietary patterns and whereas we considered the whole of the patterns as a whole rather than specific health outcomes captures the dietary pattern. Some comments nutrient and disease relationships, and relationship between the overall diet included conclusions from their own the DGAC uses scientifically valid and its constituent foods, beverages and review of the evidence. In those approaches that are widely accepted in nutrients in relationship to outcomes of comments, studies were excluded based the scientific community. interest and quality, thereby overcoming on whether the dietary quality index Other comments suggested that the the collinearity (closely aligned used in each study included a measure use of dietary pattern indices to assess relationship) among single foods and of added sugars, whether the studies the relationship between dietary nutrients (Ref. 19). Therefore, we agree were conducted in the United States, patterns and health outcomes is flawed with the comment that said that whether a component analysis for a for specific reasons. We address those interplay between multiple factors in measure of added sugars was issues in our responses to comment 143. dietary patterns cannot be excluded. conducted, and whether that analysis (Comment 152) Several comments The dietary pattern should be looked at showed an association with CVD risk. cited a number of limitations of how the as a whole rather than a sum of its parts As previously discussed in our dietary intake data was collected in because there is interplay between the responses to comments 147 and 148, we studies included in the analysis. The multiple factors. When certain nutrients do not agree that it is appropriate to comments cited a number of criticisms or foods are looked at individually discount studies from the body of of the use of Food Frequency without taking into account the evidence considered based on these Questionnaires (FFQs), which were relationships that the nutrient or food factors and have looked at the data and used in the observational studies component has with other pieces of the the dietary pattern as a whole rather included in the analysis to assess dietary pattern, the effects of those than a sum of its parts. adherence to scoring patterns. The relationships are lost. Information that (Comment 151) One comment comments suggested that added sugars would allow consumers to understand questioned the scientific validity of are poorly measured by FFQs. Another how a food fits into their overall dietary using hypothesis-based dietary pattern limitation of FFQs mentioned in pattern is therefore important to be scores for determining health outcomes. comments is that they are based on self- declared on the label. The comment said that the use of report and may introduce levels of In addition, investigators often adherence scores, cluster or factor report bias that can attenuate diet-health analyze data using different methods, analysis as a science-based measure for relationships. The comments stated that depending on the research question, and predicting health outcomes is flawed the extent to which data from FFQs are not all articles include a report of all of and not an accepted scientific valid measures of dietary patterns is not the study findings. Therefore, it is methodology. The comment provided well established. One comment said that possible that sugar-sweetened foods and an example where an analysis based on FFQs are not designed to assess absolute beverages could have been measured or dietary pattern scores showed that intakes of foods, and when used only at that a component analysis was individuals with higher adherence to baseline, the assumption is that intake conducted for sugar-sweetened foods the dietary pattern of interest compared does not change over several years, and/or beverages, but the findings were to individuals with lower adherence when health outcome is measured. The not reported in a particular published actually had an almost 300 percent comment also said that FFQs provide article. increased chance of dying from CVD, little information on how the food was (Comment 150) Some comments said which is an incorrect conclusion (Ref. prepared. that the evidence related to healthy 92). Other comments said that the dietary dietary patterns characterized, in part, (Response) The use of this type of patterns do not assess the frequency of by lower intakes of sugar-sweetened scientifically valid approach to looking meal and snack consumption, specific foods and beverages is not strong and at complex relationships between combinations of foods consumed questioned whether we relied on the dietary patterns at health endpoints is together, and aspects of food purchase DGAC’s analysis and conclusion rather being used by well-established scientific and preparation, all of which may than doing our own analysis of the bodies. In fact, some of the dietary influence an overall dietary pattern. studies. quality scoring indices were developed One comment said that fats and oils (Response) We reviewed and by Federal Agencies (e.g., the HEI). are spread across food groups, making considered the evidence that was Although this is the first time that the them difficult to account for. considered by the 2015 DGAC when DGAC has conducted a systematic (Response) FFQs are a relatively making their conclusions in Chapter 2 review of the evidence related to dietary efficient and cost effective way to of the 2015 DGAC Report. We patterns and health outcomes, the use of collect information about usual intakes concluded based on that review and diet quality indexes to look at an in a large population study, which is consideration of the evidence that association between dietary patterns why they are often used to assess intake strong and consistent evidence and health outcomes is not new. For in large-scale cohort studies. FFQs are demonstrates that healthy dietary example, the USDA’s Center for often used in studies because they are patterns are characterized by higher Nutrition Policy and Promotion created inexpensive, can be self-administered, consumption of vegetables, fruits, whole the HEI in 1995. Dietary pattern analysis take less time for participants to

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complete compared to other dietary dietary pattern and health outcomes association between increased assessment methods, and can be read by analysis. adherence to a healthy dietary pattern machines rather than being hand- (Comment 153) One comment said and decreased risk of CVD. The NEL entered and analyzed (Ref. 93). that the observational data used in these considered the results of all 55 studies Although there may be more precise studies, and the way that they are rather just a subset where score ways to assess dietary intake patterns, analyzed, make the findings highly adherence was associated with a other intake methods, such as multiple subjected to residual confounding (error decreased CVD risk. 24-hour recalls are often less practical that can occur when either the c. Authority for Labeling for use in large population studies. categories of the variables related to the There are many advantages to having a outcome of interest (e.g. CVD risk), (i) Statutory Authority larger sample size when evaluating called confounding variables, are too (Comment 156) Many comments habitual intake, which can provide broad or when some confounding addressed our authority to require the variables are not accounted for). The robust results (Ref. 94). FFQs have been mandatory declaration of added sugars comment said that even with shown to be reasonably accurate in on the label. We discuss our authority adjustment for confounders, residual reporting food use (Ref. 93). FFQs also under the FD&C Act and our confounding cannot be eliminated from provide a better estimate of usual recordkeeping authority in parts II.C.3 observational studies. More specifically, intakes that can be used to assess and C.4. higher/better dietary index scores were dietary patterns because they assess Many other comments questioned our associated with a number of factors, intake over a longer period of time than authority to require added sugars on the such as higher education, increased other dietary assessment techniques, label because the purpose of the physical activity, non-smoker, such as 24-hour recalls, diet histories, Nutrition Facts label is to help multivitamin use, hormone therapy and dietary records. FFQs are also consumers reduce their risk of diet- almost always used in retrospective (women), and being married vs. single. (Response) Residual confounding is a related disease and added sugars are not reports about diet (Ref. 95). We accept associated with risk of disease. One the use of data from FFQs in general limitation of all observational studies and is not specific to just this comment noted that each of the observational studies used to support an nutrients currently on the label relate to association between a substance and a type of analysis. The comment did not provide specifics about individual a disease or serious health condition. disease or health-related condition for Other comments said that we lack the health claims (Ref. 85). studies for which confounders were not appropriately adjusted. Therefore, the authority to require the disclosure of We recognize that there are some comment does not change our added sugars because our rationale for limitations to the use of FFQs, and that consideration of the data. requiring labeling, which is related to one limitation is that in many of the (Comment 154) Some comments said encouraging consumers to eat a more studies FFQs were only administered at that the patterns may be population- nutrient-dense diet or dietary planning, baseline. FFQs do not assess the specific and therefore, are not is by our own admission not related to frequency of meal and snack generalizable. The comments also noted a disease or health-related condition, consumption, specific food that some studies were not conducted in such as obesity. combinations, and food preparation. the United States and suggested that One comment suggested that, because Dietary pattern analysis considers these studies cannot be used to draw there is no scientifically supported combinations of foods and how they conclusions about the general U.S. quantitative intake recommendation for relate to health outcomes, but questions population. added sugars upon which a DRV can be about the frequency of meal and snack (Response) We agree that patterns derived and because no authoritative consumption, specific food may be population-specific; however, scientific body has found a public combinations, and food preparation care was taken to include studies health need to set an Upper Level (UL) would require a more specific analysis. conducted in populations that were very for added sugars intake, we have not Like other types of dietary assessment, similar to the U.S. population (e.g. sufficiently shown that there is a public this type of analysis can only be used countries in the E.U.) and that data was health need to monitor added sugars to draw general conclusions about what collected in populations that would be intake through labeling for consumers to components are included in a dietary generalizable to the U.S. population maintain healthy dietary practices. The pattern that is associated with risk of (Ref. 19). comment further stated that our disease and the relative contribution (Comment 155) Some comments said admission in the proposed rule that we (higher or lower) of that dietary that the NEL project based its cannot establish a DV for added sugars component to the overall dietary conclusions only on those studies where further indicates that added sugars is pattern. Further analyses would be score adherence was associated with not the type of nutrition disclosure that required to answer questions related to decreased CVD risk, leaving all of the Congress intended for the Agency to frequency of meal and snack studies showing no effect out of the require on the label. consumption, specific food analysis. (Response) As discussed in part II.C.3, combinations that may associated with (Response) We disagree with the under section 403(q)(2)(A) of the FD&C disease risk, and specific aspects of food comment that the NEL and the 2015 Act, the Secretary of the Department of preparation. DGAC based their conclusions only on Health and Human Services may Fats and oils are spread across food studies where score adherence was require, by regulation, that information groups, which make them more difficult associated with decreased CVD risk. As related to additional nutrients be to account for; however, we are most stated in the 2015 DGAC Report, after included in the label or labeling of food, interested in sugar-sweetened food and the exclusion criteria were applied, a if the Secretary determines that beverages and how they fit into the total of 55 studies met the inclusion providing information regarding the dietary pattern. Sugar-sweetened foods criteria for the systematic review. The nutritional value of such food will assist and beverages can be isolated from the NEL found that the majority of the 55 consumers in maintaining healthy diet by the dietary assessment tools studies that assessed CVD incidence or dietary practices. The FD&C Act used in the studies included in the mortality reported an inverse requires that nutrition information on

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the label be conveyed to the public in intake recommendation for added disagree. We are not requiring the a manner which enables the public to sugars has been addressed. public disclosure of formulations or readily observe and comprehend such (Comment 157) Some comments said recipes. We are requiring, for all information and to understand its that a stronger case can be made for products, the declaration of specific relative significance in the context of including whole grains or stearic acid nutrients that have been determined to the total daily diet. There is evidence on the label. assist consumers to maintain healthy that excess consumption of added (Response) The FD&C Act gives us the dietary practices (cf. Philip Morris, Inc. sugars is a public health concern. authority to add and remove nutrients v. Reilly, 312 F.3d 24 (1st Cir. 2002)). It Healthy dietary patterns characterized, from the label based on whether we would be unreasonable for in part, by lower intakes of foods and determine the nutrients are necessary to manufacturers to expect that the beverages which contain added sugars assist consumers in maintaining healthy nutrients on the Nutrition Facts label are associated with a decreased risk of dietary practices. We did not consider would never change based on updated CVD. Current scientific evidence whether it would be appropriate to scientific evidence and the need to supports limiting consumption of added consider whole grains as a nutrient, nor provide information that will assist sugars. Without a label declaration of propose a declaration of whole grains on consumers to maintain healthy dietary added sugars, consumers are unable to the nutrition label, in the context of this practices (see, e.g., Ruckelhaus v. determine how much added sugars a rulemaking. Whole grains are made up Monsanto Co., 467 U.S. 986 (1984), Corn serving of a particular food would of a variety of different grains (e.g. Products Refinery Co. v. Eddy, 249 U.S. contribute to their diet and how to fit , , , whole 427 (1919)). kernel corn, , , , , that food within an overall healthy (ii) Material Fact eating pattern. We have concluded that , sorghum, teff, triticale, , and the declaration of added sugars will wild rice), and we would need to give (Comment 159) Some comments said assist consumers in maintaining healthy further consideration about whether it that a declaration of added sugars is not dietary practices, as required under the would be appropriate to consider whole a material fact because a declaration FD&C Act. grains as a nutrient for purposes of does not appear to be necessary for nutrition labeling. consumers to make healthy dietary We disagree with the comment that In the preamble to the proposed rule choices and that, absent a declaration of asserted that added sugars is not the (79 FR 11879 at 11894), we considered added sugars, the label is not false or type of nutrient disclosure Congress whether the labeling of stearic acid misleading to consumers. intended for FDA to require because should be mandatory or voluntary on (Response) Under section 403(a)(1) of there is no scientifically supported the label and concluded that the the FD&C Act, a food is misbranded if quantitative intake recommendation for evidence for a role of stearic acid in its labeling is false or misleading in any added sugars upon which a DRV can be human health (e.g. changes in plasma particular. Section 201(n) of the FD&C derived. We are not limited to LDL cholesterol levels) is not well- Act further defines misleading labeling. establishing a quantitative intake established. We tentatively concluded In determining whether labeling is false recommendation to circumstances in that the individual declaration of stearic or misleading, we take into account which there is a biomarker of risk of acid is not necessary to assist consumers representations made or suggested in disease. Instead, we are relying on other in maintaining healthy dietary practices. the labeling and the extent to which the evidence to support a mandatory We also have declined to exclude stearic labeling fails to reveal facts material in declaration of added sugars for the acid from the calculation of an light of the representations or with general population which is not based individual food’s percent DV for respect to consequences that may result on an independent relationship with a saturated fat elsewhere in this document from the use of the food to which the chronic disease, health-related (see part II.F.2) because current dietary labeling relates under the conditions of condition, or physiological endpoint, recommendations for saturated fat, such use prescribed in the labeling, or under but is based, instead, on constructing an as those of the DGA, do not differentiate such conditions of use as are customary overall healthy eating pattern that is low among the individual saturated fatty or usual (id.). In the context of nutrition in added sugars. acids in providing the recommended labeling, we have considered the As discussed in part II.H.3.o.(i), new intake levels. In addition, the DGA declaration of meaningful sources of evidence has become available since recommendation to consume less than calories or nutrients to be a material fact publication of the proposed rule in 10 percent of calories from saturated (see 55 FR 29487 at 29491 through March 2014 related to limiting intake of fatty acids makes no specific exclusion 29492, July 19, 1990 and 68 FR 41434 added sugars to less than 10 percent of of stearic acid, and instead, relates to at 41438, July 11, 2003). Nutritive value calories (Ref. 19). We have considered the intake of total saturated fatty acids. cannot be determined without a the underlying scientific evidence in the Therefore, we have determined that declaration. Thus, the final rule will 2015 DGAC Report and have stearic acid should not be specifically ensure that information that relates to determined that the evidence supports listed on the label and should not be the added sugars content of a serving of establishing a DRV of 10 percent of total excluded from the calculation of an food, which is fundamental to people’s calories. The DRV for added sugars of 10 individual food’s percent DV for food choices, is available on the food percent of calories is based on the saturated fat. label. The added sugars declaration will amount of added sugars that can be (Comment 158) One comment provide consumers with information reasonably accommodated within a discussed how the declaration of the that is material with respect to the healthy dietary pattern. As discussed in amount of added sugars in a product consequences of consuming a particular part II.H.3, the evidence that we are ‘‘could compromise legitimate trade food (see 55 FR 29487 at 29491 through relying on for a mandatory declaration secrets’’ based on the declared amount 29492). of added sugars for the general being made public. We have determined that there is population and for the DRV is based on (Response) To the extent that the adequate evidence to demonstrate that information related to healthy dietary comment argued that the declaration of consumption of added sugars is a public patterns. Therefore, the comment’s the amount of added sugars could health concern because evidence shows concern about a lack of a quantitative compromise legitimate trade secrets, we that heathy dietary patterns associated

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with a decreased risk of chronic disease sugars has been pronounced with an also high in females. The usual median are lower in sugar-sweetened foods and approximate decrease of about 25 intake exceeds 15 teaspoons and 300 beverages that have been sweetened percent on a per person basis between calories per day in females aged 9 with added sugars, consumption of too 1999 and 2010 (Ref. 96). One comment through 30 years (Ref. 97). At the much added sugars can impact the noted that sugar/sucrose consumption highest calorie level of 3,200 calories nutrient density of the diet, and has declined by 33 percent in the per day in the USDA Food Patterns consumption of sugar-sweetened foods United States and that per capita added described in the 2015 DGAC Report, the and beverages is associated with sugars consumption has declined since empty calorie limit available for added increased adiposity in children. 1970 when obesity was not a public sugars is 275 calories (Ref. 98). This Furthermore, the scientific evidence health concern. means that the median usual intake for supports that consumers limit their One comment suggested that the most age groups based on 2007 to 2010 intake of added sugars to less than 10 contribution from added sugars to the intake data exceeds the highest empty percent of total calories. Without increase in total calories over the past calorie limits available for added sugars information on the amount of added 30 years is relatively minor. The in the USDA Food Intake Patterns. This sugars in a serving of a food, consumers comment cited evidence from USDA information shows that added sugars would not have the information they that between 1970 and 2009 there was intake in the U.S. population continues need to construct a healthy dietary an increase of 425 calories per person to be excessive. Knowing the amount of pattern that contains less than 10 per day, and added sugars contributed added sugars in the foods that we eat percent of calories from added sugars. less than 10 percent (38 calories) of this may help Americans limit their intake Therefore, we have concluded that this increased caloric intake. of calories from added sugars and evidence is adequate to compel a label One comment suggested that the reduce their overall consumption of declaration of added sugars on the problem of increasing added sugars calories. Nutrition and Supplement Facts labels. consumption has mainly been a problem with beverages, not food. The (B) Comments on Whether an Added (iii) Regulations Must Bear a Reasonable comment said that almost all of the Sugars Declaration Is Necessary To Relationship to the Requirements and increase in consumption of sugars Assist Consumers in Limiting Their Purposes of the Statute between the late 1970s and about 2005 Added Sugars Consumption (A) Consumers Are Eating Too Many has been in beverages. The total amount (Comment 161) Many comments Added Sugars of added sugars consumed in sweet supported mandatory declaration of pastry, dairy and non-dairy desserts, added sugars on the label because the (Comment 160) Some comments candy, and other sugars-containing information is necessary to assist suggested that an added sugars foods has remained almost constant, but consumers in limiting their intake of declaration would be beneficial for the added sugars contributed by added sugars. The comments argued consumers because evidence shows that sweetened beverages has doubled. Total that consumers have no way of knowing Americans are consuming too many sugars consumption increased from the quantity of added sugars in a added sugars. The comments cited about 59 grams per person per day to product unless they are listed on the survey data showing that from 2003 to about 84 grams per person per day, and label, and such a declaration would 2006, added sugars, on average, added sugars in sweetened beverages help consumers avoid the consumption provided about 14 percent of total increased from about 17.5 to 41.5 grams of too much added sugars. The calories in the American diet, and 25 per person per day. Twenty-four of the comments stated that, in reading percent or more of total calories for over twenty-five grams of increase were in ingredient labels, consumers may not 36 million Americans. The comments sweetened beverages. know all forms of added sugars that can argued that Americans consume an (Response) Although added sugars be in a food, such as concentrated fruit average of 152 pounds of sugar per year, consumption has decreased in recent juice, and they may not understand that the average 6- to 11-year-old American years, consumption of added sugars still ingredients are listed in order of boy consumes 22 teaspoons of added remains high at an average of 13.4 predominance. One comment noted sugars per day, and the average girl of percent of calories among the U.S. that, for many programs across the that age consumes 18 teaspoons of population (Ref. 19). The scientific country in schools and other added sugars per day. The comments evidence supports Americans limiting institutions, the preexisting label makes also cited data on the average per-capita their intake of added sugars to no more it difficult for those developing program loss-adjusted food availability data from than 10 percent of calories (Ref. 19). The guidelines to follow the DGA’s 2012 showing that, on average, scientific evidence also is included in recommendations and limit the amount Americans consumed between 18 to 23 the 2015–DGA. Current consumption of added sugars in provided foods. To teaspoons (about 300 to 390 calories exceeds the recommended limit for date, limiting total sugars has been the worth) of added sugars per day. added sugars. Usual intake data shows only option, which results in complex Other comments suggested that the that added sugars consumption among standards with detailed exemptions for declaration of added sugars is not some populations, especially children foods with naturally occurring sugars, necessary because current evidence and young adults, is even higher. Based such as fruit and dairy. shows that consumption of added on food intakes in the U.S. population In contrast, many other comments sugars is declining in the United States. from 2007 to 2010, the usual median opposed to the mandatory declaration of One comment noted that the American intake of added sugars exceeded 15 added sugars on the label argued that a public is already reducing its percent of calories and 300 calories for label declaration of the amount of added consumption of sugar-sweetened males 4 to 50 years old. For males 14 to sugars is not necessary because it does beverages, especially carbonated 18 years old, the usual median intake not convey information that consumers sweetened beverages, and it is doing so was 22.2 teaspoons per day and 492.3 cannot already obtain from total sugars without having an added sugars calories per day. The usual median and calorie declarations or from the declaration on the Nutrition Facts label. intake of added sugars for males 19 to ingredient list. One comment said that Some comments provided evidence that 30 years was 21.2 teaspoons per day and we are already addressing how to help the decrease in the intake of added 454.6 calories per day. Consumption is consumers maintain appropriate caloric

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balance through increasing the fits into a healthy diet. Furthermore, the product that is not currently available prominence of calories on the Nutrition calorie declaration reflects calories from on the label. We anticipate that Facts label, and the DGAs are already all macronutrients, and the total sugars providing a declaration of the amount of providing consumers with declaration would only be a reflection of added sugars in a serving of a product recommended food choices to increase the amount of added sugars in a product would assist government programs, consumption of nutrient dense foods. if all of the sugars are added rather than schools, and other institutions in Other comments stated that we did not naturally occurring. limiting the amount of added sugars in show how an added sugars declaration Consumers would not be able to foods they provide. would provide consumers with any determine the relative amount of added (Comment 162) Some comments additional information to help sugars in a serving of a product from the suggested that added sugars should be consumers maintain healthy dietary ingredient list for several reasons. There declared on the label because this is practices or enhance the information are many different types and forms of information that consumers have the that the Nutrition Facts label already sugar that may be added to a food right to know. provides, and therefore, the added during processing and preparation. (Response) While we appreciate sugars declaration fails to assist Consumers also may not recognize the consumers’ interests, the statutory consumers in maintaining healthy names of some types of sugars to be a framework for the declaration of a dietary practices. One comment sugar (e.g. trehelose). Finally, nutrient under section 403(q)(2) of the suggested that an added sugars consumers may also not know that the FD&C Act is whether the declaration declaration will not help consumers ingredients are listed in order of will provide information that will assist select a nutrient-dense diet because predominance by weight, and no consumers in maintaining healthy information on total calories and quantitative information is provided in dietary practices, not whether nutrient content already allows for the the ingredient list. consumers want access to the identification of other nutrient-dense Although the DGA already provides information. Furthermore, consumer foods. Other comments noted that foods information on recommended food interest or demand alone does not that are major sources of added sugars choices to increase consumption of constitute a material fact under section are products for which all or virtually nutrient dense foods, the DGA does not 201(n) of the FD&C Act and is not a all sugar is added and the current sugars provide the amount of added sugars in sufficient basis upon which we can declaration already reflects the amount a serving of food that nutritional require additional labeling for foods of added sugars. labeling provides. While some added (see, e.g., Stauber v. Shalala, 895 F. sugars can be part of a healthy dietary Supp. 1178, 1193 (W.D. Wisc. 1995) and (Response) The calorie declaration, pattern, without a label declaration for Alliance for BioIntegrity v. Shalala, 116 the total sugars declaration, and the added sugars, consumers will not have F. Supp. 2d 166, 179 (D.D.C. 2000)). ingredient list do not provide the the information they need to limit Although consumer interest alone is consumer with the amount of added added sugars to less than 10 percent of not sufficient to require mandatory sugars in a serving of a product. An calories. Information about the amount labeling, we have discussed in part II.C added sugars declaration is necessary to of added sugars in a serving of food and that the amount of added sugars in a provide consumers with a measure to how to put that amount of added sugars serving of food is a declaration that assess the relative contribution of the into the context of the total daily diet meets the statutory framework in added sugars from a serving of food as can further assist consumers in reducing section 403(q)(2) of the FD&C Act and, part of a healthy dietary pattern and their intake of calories from added furthermore, it is a material fact because enable consumers to avoid a dietary sugars. added sugars is a public health concern pattern containing excess calories from With respect to the comments that and knowing the amount of added added sugars. In some foods that are suggested we did not show how added sugars in a serving of food will assist high in added sugars, such as sugar- sugars would provide consumers with consumers in maintaining healthy sweetened beverages, virtually all sugars any additional information to help them dietary practices. in the products are added sugars. In maintain healthy dietary practices or (Comment 163) In our Preliminary these types of foods, it would be enhance what the Nutrition Facts label Regulatory Impact Analysis (PRIA), we possible for the consumer to determine already provides, we are not required to extrapolated from the welfare effects the amount of added sugars in the show that consumers will use new estimated in a retrospective study on the product by looking at the (total) sugars information on the label to change their impact of the Nutrition Labeling and declaration. However, many other foods behaviors or dietary practices before Education Act of 1990 (Ref. 99) to contain a mixture of naturally occurring requiring the declaration of information quantify benefits of the proposed rule. and added sugars. Based on information on the label. Furthermore, our consumer Some comments suggested that it was that is currently declared on the label, research shows that without an added inappropriate for us to rely on a paper the consumer is unable to determine sugars declaration, consumers are written by a graduate student, which what portion of the total sugars unable to determine the amount of was not peer-reviewed, as the basis for declaration is naturally occurring and added sugars in a serving of a product our proposal to require the mandatory what portion of the total sugars (Ref. 14). Further, the current label declaration of added sugars. Another declaration is added sugars. Small provides only information on total comment argued that we provided no amounts of added sugars found in many carbohydrates and total sugars. A basis to require the mandatory different foods and ingredients can add declaration of added sugars on the label declaration of added sugars on the label up throughout the day and can would provide the needed information other than the Abaluck paper. contribute empty calories in the diet at about the added sugars content of a (Response) We note that we did not levels that exceed what would food. rely on the information provided in the otherwise be reasonable within A declaration of the amount of added Abaluck paper as the basis for our recommended calorie limits. Therefore, sugars in a serving of a product will proposal to require the mandatory an added sugars declaration allows provide more specific quantitative declaration of added sugars on the label. consumers to better compare products information about the amount of all The information in the Abaluck paper and assess whether a particular product added sugars found in a serving of a was used to estimate economic benefits

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of our proposal for the PRIA. We are are requiring the declaration of added suggested that it would be challenging relying on information related to sugars on the label to provide one to require a declaration of added sugars overconsumption of added sugars, the additional piece of information to on the label because they are not reduction of the nutrient density of the consumers to assist them in selecting chemically or physiologically distinct diet when substantial amounts of added foods that contribute to a healthy from naturally occurring sugars (Ref. sugars are present, evidence showing dietary pattern. Therefore, we do not 100). the consumption of sugar-sweetened agree that an added sugars declaration is However, other comments suggested beverages is associated with increased unnecessary because the total amount of that there is evidence that not all sugars body weight and adiposity, and calories in a serving of a food is already are chemically the same. The comments evidence showing that consumption of displayed on the label. suggested that different sugars are health dietary patterns characterized, in (Comment 166) One comment stated metabolized differently in the body. One part, by lower consumption of sugar- that by mandating declaration of both comment stated that naturally occurring sweetened foods and beverages is total sugars and added sugars, we are sugars have more nutritional value than associated with a decreased risk of CVD. creating an arbitrary distinction between those added to foods. Another comment (Comment 164) One comment noted two types of sugars which will not lead stated that sugars that are found that the FD&C Act only gives us the to any nutritional differences for naturally in foods are consumed in authority to add nutrients to the consumers. combination with all other ingredients Nutrition Facts label to help consumers (Response) We do not agree with the and nutrients in that food and that the maintain healthy dietary practices, but comment that the distinction between body reacts to inherent sugars in such our definition of ‘‘healthy’’ excludes any total and added sugars is arbitrary and combinations. The comment noted that consideration of sugars content. will not lead to any nutritional emerging studies suggest that inherent (Response) The comment is referring differences in the foods that consumers sugars in combination with to our regulation for implied nutrient select. The addition of added sugars to nutrients, for example, behave content claims (§ 101.65). Section foods provides additional calories differently in the body than added 101.65(d)(1)(ii)(2) provides which can make it difficult for sugars without such accompanying requirements for the use of the term consumers to meet nutrient needs nutrients. These comments indicated ‘‘healthy’’ or related terms on the label within calorie limits and can lead to that it is important for consumers to or in the labeling of foods. The issues with weight management. Sugars, know how much added sugars are in regulation requires that a food must added in excess, do not provide any their products because they are meet requirements for fat, saturated fat, health benefits. In addition, foods high inherently different from naturally cholesterol, and other nutrients, but in added sugars tend to be lower in occurring sugars. does not include limitations on the beneficial nutrients. By providing a (Response) A physiological or amount of total or added sugars that a declaration of added sugars on the label, chemical distinction between added and food may have if it bears an implied consumers will have additional naturally occurring sugars is not a ‘‘healthy’’ nutrient content claim. Our information about a product that can prerequisite to mandatory declaration authority in section 403(r) of the FD&C assist them in determining how much under section 403(q)(2)(A) of the FD&C Act to define a term, by regulation, to sugars have been added to a food. Act. We explained in the preamble to characterize the level of a nutrient in the Moreover, the intake of added sugars the proposed rule that our scientific label or labeling is distinct from our from sugar-sweetened foods and basis for the added sugars declaration, authority in section 403(q) of the FD&C beverages needs to be reduced as part of in fact, differed from our rationale to Act to require the declaration of a a healthy dietary pattern. A healthy support other mandatory nutrients nutrient in nutrition labeling. As dietary pattern, when compared to less related to the intake of a nutrient and previously discussed in part II.B.4, we healthy dietary patterns, such as the risk of chronic disease, a health-related intend to revisit our other regulations dietary pattern of the current U.S. condition, or a physiological endpoint for nutrient content claims at a later general population, is strongly (see 79 FR 11879 at 11904). Rather than date to determine if changes are associated with a reduced risk of CVD. relying on a causal relationship between necessary. The intake of foods with naturally added sugars to obesity or heart disease, (Comment 165) One comment said occurring sugars, such as fresh fruits we considered, in the preamble to the that sources of sugar contribute the and vegetables, is encouraged as part of proposed rule (79 FR 11879 at 11902 same number of calories per gram a healthy dietary pattern and not through 11908) and the preamble to the weight of food, and calories should be recommended to be reduced. supplemental proposed rule (80 FR the principal nutrient of concern of a 44303 at 44307 through 44309), the (C) Comments on a Lack of a Chemical population striving to achieve desired contribution of added sugars as part of weight and control obesity. The or Physiological Distinction Between healthy dietary patterns and the impact comment suggested that giving Naturally Occurring and Added Sugars to public health from such patterns for consumers a false impression that (Comment 167) In the preamble to the the purposes of the general population. reducing added sugars without reducing proposed rule (79 FR 11879 at 11905), Thus, the comments did not focus on calories may actually delay finding a we recognized a lack of a chemical or added sugars as a component of sugar- real solution to the problem. physiological distinction between added sweetened foods and beverages that (Response) We have increased the and naturally occurring sugars. Many have been found to have health prominence of calories on the label comments agreed that naturally implications as part of a dietary pattern, because of its importance for consumers occurring and added sugars are the same or as a nutrient that provides a source to consider for the purposes of weight and argued that, because there is no of empty calories consumed by the U.S. management. We are not suggesting that chemical or physiological distinction, population in excess, which make it consumers should ignore or consider we should not require the mandatory difficult for consumers to meet nutrient information about the amount of labeling of added sugars. One comment needs within calorie limits. Providing calories in a serving of a food to be cited a paper by Murphy and Johnson consumers with information about the secondary to the amount of added (2003) that discusses added sugars in amount of added sugars in a serving of sugars in a serving of food. Instead, we the context of the 2000 DGA and a product will assist consumers in

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planning a healthy diet. We have of added sugars provides factual, (D) Comments Questioning our Reliance concluded that the consumption of accurate information about the amount on Conclusions and Information From added sugars is related to health for a of added sugars in a serving of food, and the 2010 DGA and the 2015 DGAC number of reasons, and consumers will we are requiring the declaration (Comment 171) Many comments benefit from information about the consistent with our authority in section questioned our reliance on conclusions added sugars content of a food on the 403(q) of the FD&C Act. The added and information in the 2010 DGAC label. sugars declaration is not inherently Report and 2010 DGA. One comment (Comment 168) Many comments did misleading as the comments suggest, as asserted that it is a gross expansion of not support an added sugars declaration is addressed further in part II.C.3. the law governing the DGA to use because added sugars are not chemically (Comment 169) Some comments selective dietary guidance from a single or physiologically distinct from suggested that we are being inconsistent edition to promulgate food labeling naturally occurring sugars, and a in our treatment of the evidence for regulations. Some comments suggested separate declaration of added sugars nutrients because we are considering that the evidence cited by the 2010 implies that there is a distinction. The whether certain dietary fibers have a DGAC and 2010 DGA was not strong comments suggested that an added beneficial physiological effect, but we enough to support a declaration of sugars declaration would arguably be are not considering whether added false and misleading because it would sugars have a separate and distinct added sugars. One comment stated that convey to the reasonable consumer that physiological effect in our neither the 2010 DGA nor the 2010 added sugars are chemically different determination that added sugars should DGAC Report provided a preponderance than naturally occurring sugars and/or be declared on the label. of scientific information or conclusive, that added sugars has different health (Response) In the case of dietary fiber, documented, or strong scientific effects than naturally occurring sugars. we are requiring that a dietary fiber have evidence to support these suppositions. One comment further asserted that a beneficial physiological effect to The comments asserted that we did not implying superiority of one source of a human health for the purposes of address the strength of the evidence that nutrient versus another, when they are declaration because there are dietary the 2010 DGAC reviewed as the basis for not materially different and are fibers currently present in foods that are their recommendations. One comment chemically, nutritionally, and being declared on the label indicating to also noted that the 2010 DGAC functionally equivalent, is inherently consumers that they have the same addressed few or limited questions misleading. Another comment suggested beneficial physiological effects to related to impact of added sugars on that a separate declaration for added human health as other fibers, when in health due to lack of available evidence. sugars could cause consumers to believe fact, they do not. We previously have The comment stated that what evidence that naturally occurring sugars are more discussed in this section that added there was at the time that the 2015 beneficial. sugars, independent of sugars naturally DGAC Report was published was not (Response) As we explained in our present in foods, can have a negative conclusive. response to comment 167, a impact on health. A decision to not (Response) We note that we did not physiological or chemical distinction require a separate declaration of added specifically rely on conclusions or between added and naturally occurring sugars on the label would not allow recommendations made by the 2010 sugars is not a prerequisite to mandatory consumers to determine the additional DGAC Report or in the 2010 DGA. We declaration under section 403(q)(2)(A) sugars which have been added above considered the information and of the FD&C Act. In fact, some nutrients and beyond what is naturally present in underlying data presented in the 2010 currently declared on separate lines in a food which are contributing extra DGAC Report and 2010 DGA that was the Nutrition Facts label may be related calories to their diet and could also used as the basis for their conclusions to the same chronic disease risk or contribute to a dietary pattern that is and recommendations and determined physiological endpoint (e.g., saturated associated with disease risk. that, for the purposes of nutrition fat and trans fat and risk of CVD). (Comment 170) One comment stated labeling, the evidence in the 2010 DGAC Therefore, we disagree that a separate that the Nutrition Facts label must and 2010 DGA, along with other data declaration necessarily implies a remain a source of information about and information we considered, chemical or physiological distinction. nutrients that are chemically distinct supports the declaration of added sugars Furthermore, the comments may not based on analysis. The comment on the Nutrition and Supplement Facts have considered the basis for why the asserted that we have not provided a labels (79 FR 11879 at 11902 through declaration of added sugars is necessary reasonable basis for defining added 11908). The DGAs have recommended to assist consumers in maintaining sugars based on source rather than that Americans reduce their intake of healthy dietary practices. A dietary chemical composition. what we are defining to be added sugars pattern characterized, in part, by larger (Response) We disagree with the since the early 1980s, so the amounts of sugar-sweetened foods and comment that a chemical distinction recommendation to limit consumption beverages is associated with greater risk must be a requirement for declaration of of added sugars is not new. Since of CVD than a healthy dietary pattern a nutrient on the label. Section publication of the 2010 DGA and 2010 that includes less sugar-sweetened foods 403(q)(2)(A) of the FD&C Act provides DGAC Report, new evidence has and beverages. Moreover, added sugars discretion to the Secretary, and by become available on added sugars and provide excess calories in the U.S. diet delegation, to FDA, to determine dietary patterns that we have (see our responses to comment 29 and whether providing nutrition information considered. We have determined that comment 177), and these additional regarding a nutrient will assist this evidence further supports a empty calories make it difficult for consumers in maintaining healthy declaration of added sugars on the label. consumers to meet nutrient needs dietary practices and when to require The comment suggesting that the within their calorie limits and can lead information relating to such additional evidence on added sugars is not to issues with weight management. nutrient be included in the label or conclusive, documented, or strong is Therefore, the intake of added sugars in labeling of the food. This section does referring to the factors that we the current U.S. dietary pattern is a not include limitations on chemical considered for mandatory declaration of public health concern. The declaration distinctions. nutrients on the label for which there is

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an independent relationship between impact of added sugars on nutrient in assisting consumers to maintain the nutrient and chronic risk of disease. density and on their implications for healthy dietary practices and the need Our determination that added sugars weight management (Ref. 77). for consumers to be able to readily should be declared on the label for the Furthermore, the fact that the USDA observe and comprehend the general population (see part II.H.3) was food patterns were not studied for information and to understand its not based on the factors used to health effects until recently, does not relative significance in the context of a determine mandatory or voluntary lessen our reliance on the information total daily diet (79 FR 11879 at 11891). declaration for these other non-statutory as part of our basis for a mandatory Therefore, whether the 2015 DGAC nutrients that have an independent declaration of added sugars. Since Report is or is not a consensus report is relationship related to a chronic disease, publication of the proposed rule, the not relevant for the added sugars a health-related condition, or health- USDA Food Patterns have been studied declaration. Furthermore, we related physiological endpoint. Instead, for their association with disease risk considered the underlying evidence our review is based on the need for the (Ref. 101). We also have evidence that related to added sugars that supported declaration of nutrient information on dietary patterns characterized, in part, the recommendation to limit the labels to assist consumers in by lower intakes of sugar-sweetened consumption of calories from solid fats limiting their consumption of calories foods and beverages are associated with and added sugars and did propose to from added sugars found in sugar- a reduced risk of CVD that further require a declaration of the amount of sweetened foods and beverages and supports a mandatory declaration of added sugars in a serving of a product consuming a healthy dietary pattern that added sugars on the label for the general on the label because of the 2010 DGA is associated with a reduce risk of CVD. U.S. population. It is not clear what is recommendation related to calories from (Comment 172) Many comments took meant by the comment which stated solid fats and added sugars. We issue with the 2010 DGA’s use of food that the extremely low suggested intakes considered the evidence in the 2010 pattern modeling to support the of 6 to 12 teaspoons of added sugars in DGAC Report and 2010 DGA, along with recommendation to reduce the intake of the USDA Food Patterns have no other data and information in the calories from added sugars. One historical basis and lack context. To the proposed rule to support a declaration comment stated that the amount of solid extent the comment disagrees with the of added sugars on the Nutrition Facts fats and added sugars in the USDA food suggested intakes of 6–12 teaspoons of and Supplement Facts labels (79 FR patterns is the outcome of using the added sugars, we note that there is 11879 at 11902 through 11908). remaining calories in that pattern rather evidence showing that Americans are (Comment 174) One comment said than the evidence-based research. Other consuming too many calories from that the proposed rule incorrectly comments said that the USDA Food added sugars as well as evidence that it assumes that reduced consumption of Patterns lack the scientific is difficult to meet nutrient needs added sugars will reduce the problem of underpinning on which to base official within calorie limits when excessive obesity, but noted that we recommendations. amounts of added sugars are consumed. acknowledged in the proposed rule that Some comments said that the same (Comment 173) In the preamble to the solid fats and added sugars do not issues that prevent FDA from using food proposed rule (79 FR 11879 at 11890), contribute to weight gain any more than consumption data, menu modeling, and we discussed the factors that we another source of calories. dietary survey data to determine DRVs considered for mandatory and voluntary (Response) We have not changed our are also applicable when considering declaration of non-statutory nutrients. position with regard to the effect of the mandatory declaration of non- We considered the scientific evidence calories from solid fats and added statutory nutrients. One comment noted from other U.S. consensus reports or sugars on weight gain. However, as that we have concluded that menu DGA policy reports (79 FR 11879 at noted in the 2010 and 2015–2020 DGAs, modeling is not related to disease risk 11890). We also listed the DGA policy consumption of excess solid fats and and is not suitable for determining reports among other reports that we added sugars make it difficult to meet recommended intakes. would consider to be U.S. consensus nutrient needs within calorie limits Some comments also noted that the reports. (Refs. 28, 30). Because sugars added to 2010 DGA clearly states that the USDA One comment questioned whether the foods during processing increase the Food Patterns are only one example of DGA is a consensus report because it is calorie content of the food without suggested eating patterns and that the a report that is issued jointly every 5 increasing other nutrients in the food, USDA Food Patterns have not been years by the USDA and HHS. The added sugars as an ingredient could specifically tested for health benefits. comment said that the DGAC Report is conceivably lead to weight gain if a Another comment said that the an advisory report, and the Secretaries consumer striving to meet their nutrient extremely low suggested intakes of 6 to of USDA and HHS have sole needs does so by consuming foods 12 teaspoons of added sugars in the responsibility and discretion as to the containing too many added sugars. USDA Food Patterns have no historical final content of the DGA. The comment Further, we stated in the proposed rule basis and lack context. also noted that the DGAC Report does that we know that foods containing (Response) We disagree with not undergo independent external solid fats and added sugars make up a comments that questioned the use of review. significant percentage of the American evidence based on food pattern (Response) In the preamble to the diet and are a source of excess calories modeling to support the added sugars proposed rule (79 FR 11879 at 11885 (79 FR 11879 at 11904). declaration so that consumers can use through 11887), we listed new dietary (Comment 175) Some comments said the information to reduce calories from recommendations, consensus reports, that we are not being consistent with the solid fats and added sugars. While the and national survey data as sources of dietary recommendations we use for food pattern modeling used to create the information that we considered when requiring nutrients on the label because USDA Food Patterns was used to developing the proposed amendments the 2010 DGA also recommended compare current consumption data with to the regulations. Furthermore, our replacing saturated fats with mono and recommended intakes from the USDA review of the scientific evidence in the polyunsaturated fats, yet the labeling of Food Patterns, the 2010 DGA also 2010 DGA relates to the intake of added mono and polyunsaturated fats is considered information about the sugars and the role of such information voluntary on the label.

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(Response) We do not rely on the than the median intakes of those noted in comments, additional evidence 2010 DGA recommendation to reduce nutrients for someone consuming 0 to 5 has become available since the IOM DRI calories from solid fats and added percent of their calories from added reports were published, which supports sugars. Instead, we examined the sugars (Ref. 102). Another comment their conclusion (Ref. 102). Therefore, underlying evidence and concluded that noted that IOM recommends that the although the 2010 DGAC did not added sugars should be declared on the intake of added sugars not exceed 25 conduct an evidence-based review on label. Furthermore, the 2010 DGA percent of energy to ensure adequate this topic, there is documented evidence recommendations related to mono and intake of essential micronutrients that that increased consumption of added polyunsaturated fats are about replacing are typically not present in foods high sugars can make it difficult for saturated fats with the mono and in added sugars (Ref. 75). One comment individuals to meet nutrient needs. polyunsaturated fats, because reduction said that consumers who eat less added We disagree with the suggestion of saturated fats is associated with sugars consume fewer calories and more added sugars consumption is not reductions in blood LDL cholesterol foods rich in essential nutrients. contributing to poor nutrient intake in and, therefore, the risk of CVD. The In contrast, many comments said that the U.S. population as a whole and thus 2015 DGA corroborates this finding. a declaration of added sugars on the should not be required on the label Saturated fats are already declared on label will not assist consumers in because only a small proportion of the the label, so consumers have the constructing a more nutrient dense diet. population is consuming large amounts information they need to reduce their The comments said that there is a lack of added sugars. The 2015 DGAC found intake of saturated fat. In addition, of science to support the contention that that the general U.S. population is current evidence does not show that added sugars intake displaces nutrients consuming 13.4 percent of its calories there is an inherent benefit to or causes a decrease in the intake of from added sugars. As the comments consumption of mono and nutrient-rich foods in the diet of the noted, Marriott et al. found that median polyunsaturated fats by themselves. The general population, at current intake nutrient intakes were lower when added benefit comes from reduction of levels. One comment cited the 2010 sugars intake was 10 to 15 percent of saturated fats in the diets by way of DGA conclusion that added sugars calories (Ref. 102). Therefore, even at replacement. Furthermore, the scientific replace nutrient-dense foods and intake levels below 25 percent of evidence supports consuming a healthy beverages and make it difficult for calories, nutrient intake can be dietary pattern that is low in saturated people to achieve the recommended negatively impacted by increased fats. A healthy eating pattern limits nutrient intake while controlling their consumption of added sugars. saturated fats, and the scientific calorie intake, but noted that no Furthermore, based on NHANES data evidence supports consumption of evidence-based review was conducted from 2007 to 2010, males aged 9 to 50 added sugars to to less than 10 percent on this topic, and no conclusive, are consuming more than 300 calories of calories per day from saturated fats documented, or strong evidence was per day from added sugars, and females (Ref. 19). Therefore, Americans cited to support that added sugars aged 9 to 30 are consuming more than currently have the information on the intake causes nutrient displacement, or 250 calories per day from added sugars label which will allow them to limit decreased consumption of nutrient-rich (Ref. 104). Males between the ages of 14 saturated fats in their diet. foods. Another comment noted that to 18 years old consumed almost 400 although a recent analysis of NHANES calories per day from added sugars (Ref. d. Nutrient Density data (Ref. 102) reaffirmed the 104). Although these subpopulations (Comment 176) Many comments conclusion of the 2002 IOM report (Ref. may not make up a majority of the suggested that including a declaration of 75), individuals with intakes of greater population, these groups include the amount of added sugars in a serving than 25 percent of calories from added children and young adults who are of a product can help consumers select sugars appear to be at greater risk for growing and need nutrients for proper foods that contribute to a more nutrient- nutrient inadequacy based on growth. Therefore, the impact of added dense diet. The comments noted that comparison with the DRIs. The sugars consumption on nutrient density the 2010 DGA suggested that reduced comment said that the authors of the in these specific populations is an intake of added sugars allows for study also clarify the real-world impact important consideration for the increased intake of nutrient-dense foods from these higher intake amounts, and declaration of added sugars. which may help individuals to control stated ‘‘However, high levels of added As for the comment which said that their total caloric intake and better sugars intake occur among only a small consumers who eat less added sugars manage their weight. The comments proportion of the population and cannot consume fewer calories and more foods also said that sugars intrinsic to foods explain the existing problem of poor rich in essential nutrients, the comment are accompanied by nutrients, whereas nutrient intake in the U.S. population as did not provide evidence to support this added sugars are not. The comments a whole.’’ statement. Therefore, we are unable to referred to the discussion in the (Response) We agree that a determine if this information adds to proposed rule related to intake of added declaration of the amount of added other evidence we have, which suggests sugars and its association with a lower sugars can assist consumers in selecting that added sugars can decrease the intake of essential nutrients (79 FR foods that contribute to a more nutrient nutrient density of the diet. 11879 at 11903) and suggested that most dense diet. The IOM did not establish a (Comment 177) Many comments major sources of added sugars are high UL for sugars or added sugars, however suggested that the added sugars in calories and fats, but lack meaningful they did conclude that increased declaration does not assist consumers in amounts of dietary fiber, essential consumption of added sugars can result constructing a nutrient dense diet vitamins or minerals. The comments in decreased intakes of certain because there are nutrient dense foods said that, when added sugars intake is micronutrients based on their review of which contain added sugars, and the 10 to 15 percent of calories, the median the evidence available at the time that declaration may obscure the fact that intakes of nine nutrients (vitamin A, the IOM Dietary Reference Intakes for some foods with added sugars may vitamin E, vitamin C, folate, energy, carbohydrate, fiber, fat, fatty actually be good sources of beneficial magnesium, potassium, vitamin K, fiber, acids, cholesterol, protein, and amino nutrients. One comment argued that the and total choline) are significantly lower acids were published (Ref. 103). As added sugars declaration does not meet

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the proposed rule’s stated goal to a natural combats the threat foods with small amounts of added convey information necessary to meet of mold and yeast contamination. sugars, such as whole-grain breakfast recommendations to construct diets Several comments noted that USDA cereals or fat-free yogurt, as long as the containing nutrient-dense foods because grants an exemption, which is similar to calories from added sugars do not the declaration does not provide that which the comments requested for exceed 10 percent per day, total consumers with any means to the labeling of added sugars on carbohydrate intake remains within the differentiate between foods that will cranberry products, for cranberry AMDR, and total calorie intake remains contribute phytonutrients to their diet products offered for sale in our nation’s within limits (Ref. 19). from foods with empty calories. The schools. One comment noted that the The added sugars declaration is just comments provided examples of IOM, in its report titled ‘‘Nutrition one piece of information that consumers nutrient-dense foods, such as yogurt, Standards for Foods in Schools: Leading can use to help them construct a cranberries, tart , and cereal, the Way Toward Healthier Youth,’’ healthful dietary pattern that may which contain added sugars. made recommendations for nutrition include some added sugars. We Some comments from the cranberry standards for competitive foods offered acknowledge that some consumers may industry asked that we make an in schools, and has made an exception focus in on the amount of added sugars exception to added sugars labeling for for yogurt from its recommended in a product and may judge it to be a cranberries, which require sweetening general sugar standard of 35 percent or less nutritious product even though it for palatability. The comments noted less of calories from total sugars. contains beneficial nutrients. The added that cranberries are a nutrient-dense One comment suggested that the sugars declaration on the label is new fruit with many known health benefits. added sugars declaration will not help information that consumers will not Unlike other fruits, cranberries have consumers select foods that contribute have seen before. In collaboration with little natural sugar and, therefore, have to a nutrient dense diet because Federal and other partners, we plan to information on total calories and a uniquely tart taste. The comments engage in educational and outreach nutrient content (e.g. fiber plus vitamins expressed concern that cranberry activities for consumers and health and minerals) already allows for the products would be considered professionals about the use of identification of nutrient-dense foods. ‘‘unhealthy’’ based solely on their added (Response) Consumers now have information on the Nutrition Facts and sugars content. The comments said that access to nutrient information provided Supplement Facts labels. Part of that the evidence shows that cranberries are on the nutrition label that they can use education will include information rich in polyphenols, specifically to plan a nutrient dense diet. We have about added sugars. A key message , and have a positive impact required those nutrients that are of the related to added sugars will be that on urinary health. The comments also greatest public health significance be consumers should consider all of the cited evidence that the addition of sugar declared in nutrition labeling (58 FR information on the label when to cranberry products does not decrease 2079, 2107). An added sugars constructing a healthful dietary pattern the polyphenol content. Furthermore, declaration is an important piece of and not focus in on one specific according to the comments, the calorie information because consumers need to nutrient, such as added sugars. The content of each serving of dried ensure their diet does not contain excess message related to consumption of cranberries is similar to that of other calories from added sugars which can added sugars is not to eliminate added dried fruits, and cranberry juice cocktail make it difficult for consumers to meet sugars or foods high in added sugars (27 percent juice) is the standard nutrient needs within calorie limits and from the diet; instead, the message is to equivalent to other 100 percent juices can lead to issues with weight limit overall consumption of added with similar total calorie and sugar management. sugars in the diet to less than 10 percent levels. The comments also noted that As mentioned in the 2010 DGA, many of total calorie intake. Therefore, if they contribute to recommended fruit foods that contain added sugars often consumers choose to eat foods with intake amounts in the DGA. supply calories, but few or no essential sugars added to them for palatability, The comments said that requiring the nutrients, and no dietary fiber (Ref. 77). such as cranberries, they may do so in declaration of added sugars on However, there are some foods, such as moderation, and cut back on added cranberry products may mislead dried fruits, yogurt, and cereal, that sugars elsewhere in the diet. consumers to believe that nutrient- contain significant amounts of We decline to exempt certain nutrient dense foods, such as cranberries, with beneficial nutrients as well as added dense foods containing added sugars their proven health benefits, are sugars. The declaration of added sugars from the requirement to declare the somehow less nutritious than foods will enable consumers to understand amount of added sugars in a serving of with the same amount of naturally the relative significance of the added a product on the label. If such products occurring sugar, or even those with sugars content in a serving of dried fruit, are exempt from added sugars labeling, more total sugars. The comments yogurt, cereal, and other foods that may consumers may assume incorrectly that expressed concern that a focus on added contribute beneficial nutrients to the they contain no added sugars. Providing sugars may have the unintended diet and determine how to incorporate added sugars information on the label consequence of driving consumers away those foods into a healthy dietary for all foods allows consumers to from nutrient dense products with pattern and meet their nutrient needs compare foods and make informed moderate amounts of sugar. within calorie limits. As discussed in choices. It allows them to also make Many comments said that a the 2015 DGAC report, there is room for trade-offs in their diet to achieve an mandatory declaration of added sugars Americans to include limited amounts overall healthy dietary pattern that could be damaging for the cranberry of added sugars in their eating patterns, contains less than 10 percent of total industry or for the tart industry. including to improve the palatability of calories from added sugars. As part of One comment noted that the drying some nutrient-dense foods, such as our education and outreach activities, operation used by the tart cherry fruits and vegetables that are naturally we plan to educate consumers that the industry reduces the moisture content tart (e.g. cranberries and ). amount of added sugars in a serving of while simultaneously increasing the Healthy eating patterns can also a product should be considered along percentage of sugar. The use of sugar as accommodate other nutrient dense with other information on the label

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when constructing a healthy dietary sweeteners. In our efforts to educate information is not available on the label pattern. consumers and health professionals for calories from added sugars (id.). While other government programs about the use of the label, we intend to Several comments disagreed that the and consensus bodies have excluded encourage consumers to consider all of declared amounts of saturated and trans cranberries and yogurt from their the information on the label when fats can be used as markers for solid fats programs or recommended limits on making decisions about what foods to in the diet. The comments stated that sugars, the purpose of those programs eat and how much rather than focusing the calculation of calories from SoFAS and reports are different than the on one specific nutrient, such as added is not feasible based on the information purpose of the information on the sugars. If consumers take all label that is proposed for the label, and the Nutrition and Supplement Facts labels. information into consideration when nature of the calculation that consumers The purpose of the Nutrition and making dietary choices, they will would need to perform would not be Supplement Facts labels is to provide recognize when a product is low in consistent with our objectives to make nutrition information to consumers to added sugars, but still contains a the label more usable and allow them to make informed choices significant amount of calories and understandable for consumers. The about the foods that they eat. Therefore, carbohydrate or fat per serving. They comments noted that it is not feasible to although some nutrient-dense foods can also see if low-calorie sweeteners determine the amount of solid fats from containing added sugars have been have been added to a product by looking the saturated and trans fat declarations excluded from government programs or at the ingredient list. alone because the label does not provide recommendations, the same approach With respect to the comment which the quantity of solid fat that USDA used does not apply to the Nutrition and suggested that low-calorie sweeteners in its menu modeling analysis. The Supplement Facts labels. may be harmful to health, as noted in comments further stated that, while With regard to the comment that said our Overview of Food Ingredients, saturated fat and trans fat may be that the drying operation used by the Additives & Colors, there is no components of solid fats, those values tart cherry industry reduces the convincing evidence of a cause and alone cannot be used to determine the moisture content while simultaneously effect relationship between these solid fat content of a food because it is increasing the percentage of sugar, we sweeteners and negative health effects not known what portion of these would not consider sugars that naturally in humans. We have monitored declarations would be identified in the exist in the tart cherries prior to the consumer complaints of possible menu modeling program used by USDA. drying process to be added sugars. Only adverse reactions for more than 15 years One comment said that the sugars that have been added to the fruit (Ref. 105). declaration of saturated and trans fat would be required to be declared as (Comment 179) One comment asked declarations are for the purposes of added sugars on the label. what studies we used to suggest that lowering risk of CVD and not for declaring added sugars on the label will estimating the SoFAS content of a food. e. Reformulation result in firms reducing the amount of The identification of SoFAS is for the (Comment 178) While some added sugars in products and result in purposes of developing the USDA Food comments said that an added sugars an overall reduction of sugar Patterns and is not a suitable approach declaration will be an incentive for food consumption. for mandating an added sugars manufacturers to reformulate, other (Response) In the preamble to the declaration. comments said that reformulation of proposed rule (79 FR 11879 at 11904), Another comment suggested that the products to reduce the added sugars we said that the mandatory declaration sugars declaration on the label can serve content may not result in products that of added sugars may prompt product as a marker for added sugars in the same are healthier. Some comments said that reformulation of foods high in added way that saturated fats serves as a an added sugars declaration may lead to sugars like what was seen when trans marker for solid fats. The comment also reformulation or changes in consumer fat labeling was mandated. We do not suggested that saturated fats in certain behavior that would not improve overall know whether or how manufacturers foods are not solid fats (such as in nuts) nutritional profile or nutrient density of will reformulate their foods as the result in the same way that sugars in certain the diet and may result in of a mandatory added sugars foods are not added sugars (such as fruit overconsumption of other declaration. juice and milk). macronutrient sources (e.g. fat) without (Response) We used the term a reduction of calories. The comments f. Calories From Solid Fats and Added ‘‘marker’’ in the preamble to the said that added sugars could be replaced Sugars proposed rule to mean that the amount with bulking agents, which provide (Comment 180) The 2010 DGA of saturated and trans fats on the label calories and carbohydrate. Another provided a key recommendation that would give consumers a very good idea comment said that reformulation of Americans should reduce their intake of or a reasonable estimate of the quantity products containing added sugars could calories from solid fats and added of solid fats in a serving of a food. result in an increased use of artificial sugars (SoFAS). In the preamble to the Although many fat containing foods sweeteners (i.e. low calorie sweeteners), proposed rule (79 FR 11879 at 11904), have a mixture of fats, such as nuts and which could be bad for health. Other we concluded that the disclosure of oils that may contain some solid fats comments noted that consumers have saturated fat and trans fat on the label and some unsaturated fats, the saturated many food and beverage choices that are not only provides information to fat and trans fat declarations would reduced in total and added sugars. consumers which can be used to reduce account for these differences. In (Response) Absent data, we do not their intake of these nutrients, and thus addition, even though one would need know whether manufacturers will reduce their risk of CVD, but the more information on how saturated fats reformulate their products if we require declaration of saturated and trans fats were quantified for the development of the declaration of added sugars on the on the label could also provide a marker the USDA Food Patterns to determine label. Likewise, absent data, we do not for foods that contain solid fats that are the exact amount of calories from solid know whether consumers will select abundant in the diets of Americans and fats, such specificity would not be reformulated products that may be contribute significantly to excess calorie needed to obtain a reasonable estimate higher in fat, calories, or low-calorie intake. We stated that similar of solid fats using the declared value of

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saturated fat and trans fat combined. beneficial. The comments noted that the Individuals (CSFII) was used to model Furthermore, unlike solid fats, there is total number of calories in a serving of total consumption of added sugars and no information currently on the label food is prominently displayed in the the Diet and Health Knowledge Survey that could give consumers an estimate proposed format. The comments said conducted by the USDA was used to of the amount of added sugars in a that a declaration of calories from added determine usage of labeling information serving of food when the food contains sugars could cause consumer confusion, on total sugars (Ref. 106). both naturally occurring and added particularly for consumers who are (Response) Although the results of the sugars. In such a case, the amount of unable to readily understand the study showed that regular use of sugar total carbohydrate or total sugars in a distinction between a gram value and information on nutrition labels is serving of a food cannot be used as a calories from added sugars. The associated with a significantly lower reasonable estimate of the amount of comments noted that consumers are density of added sugar in the diet, the added sugars in a serving of the food. already familiar with the gram unit from results of this study cannot be used to We disagree with the comment the total sugars declaration. The determine whether there is a causal suggesting that the total sugars comments said there is no evidence effect between including added sugars declaration can serve as a marker of from consumer research that a information on the Nutrition Facts label added sugars in the same way that the declaration of calories from added and decreased added sugars intake. The saturated fat and trans fat declaration sugars in lieu of grams would lead study did not assess use of labeling can serve as a marker for solid fat. When consumers to greater reductions in information on added sugars, but rather both naturally occurring and added intake of added sugars. use of information on total sugars. sugars are present in a food, the (Response) Evidence shows that (Comment 183) One comment noted consumer has no way of knowing from heathy dietary patterns associated with that the use of the ‘‘no added sugars’’ or the total sugars declaration what portion a decreased risk of chronic disease are ‘‘without added sugars’’ nutrient of that total sugars declaration lower in sugar-sweetened foods and content claim focuses on ingredients represents the amount of added sugars beverages. Consumption of too much used in a product (§ 101.60(c)). The in a serving of the food. added sugars can impact the nutrient comment said that manufacturers must Since the publication of the proposed density of the diet, and consumption of put a disclaimer on the label of their rule, the 2015 DGAC Report became sugar-sweetened beverages are product if the food is not low or reduced available. In that report, the solid fats associated with increased adiposity in in calories so that consumers are not and added sugars were divided within children. Thus, the added sugars misled about the calories associated the ‘‘empty calories’’ category with 45 declaration is information that is with such products. The comment percent of the empty calorie allowance necessary for consumers to construct a suggested that consumers could allocated to added sugars and 55 healthy dietary pattern lower in added potentially be misled because when the percent of the empty calorie allowance sugars and that is less than 10 percent amount of added sugars in a serving of allocated to solid fats. Furthermore, the of calories from added sugars. The a product is declared on the label, scientific evidence in the 2015 DGAC information on the label includes the manufacturers who are currently using Report for limiting calories from added gram amount of added sugars in a a ‘‘no added sugars’’ or ‘‘without added sugars is separate from that for limiting serving of a food product and the sugars’’ claim would be less likely to saturated fats, which are a key percent DV declaration for added use the claim because the amount of contributor of solid fats to the diet. sugars. There is no need for consumers added sugars is stated on the label, and There is adequate information available to be able to determine the amount of thus, a disclaimer with regard to the to consumers on the label to assist them calories from added sugars in a serving calorie content of a product would not in meeting the key recommendation to of a food because we are establishing a be declared. limit calories from saturated fats to less DV that is based on 10 percent of total (Response) We do not have data or than 10 percent of total calories; calories (50 grams in children and information about whether however, there is no such information adults 4 years of age and older and 25 manufacturers may elect to use a on the label to help consumers limit grams for foods purported to be for voluntary nutrient content claim once their consumption of added sugars to no children 1 through 3 years of age). they are required to declare the amount more than 10 percent of total calories. Consumers can use the percent DV of added sugars in a serving of their Whether there is adequate information declaration to determine what product. Consequently, we also cannot on the label to assist consumers in percentage of total calories a serving of determine whether consumers might be limiting solid fats is not related to an a food contributes. They can also use misled, so we decline to revise the rule added sugars declaration. the gram declaration of added sugars to in response to this comment. (Comment 181) The comments were construct a diet that is low in added (Comment 184) Several comments divided on whether calories from added sugars by comparing the amount of addressed additional consumer research sugars should be declared on the label. added sugars between products and by on Nutrition Facts labels that include One comment said that, if added sugars using trade-offs in the diet if they added sugars declarations. One are declared on the label, we should choose to include certain foods which comment included two reports that require the declaration of calories from have a large amount of added sugars. described methods and results of two added sugars. Another comment stated studies, including one controlled that concerns about the scientific g. Consumer Research and Consumer experiment and one cross-sectional evidence on the health effects of added Use of Added Sugars Declaration survey study, both on cranberry and sugars and the usefulness of a (Comment 182) One comment said other fruit products. Both studies declaration to improve food choices that research does not substantiate a included, among other formats of the apply to whether the declaration of causal effect between including added Nutrition Facts labels, Nutrition Facts added sugars is in gram units or sugars information on the Nutrition labels with declarations of the gram declared as calories from added sugars. Facts label and decreased added sugars amount of added sugars in a serving of Other comments suggested that a intake. The comment cited a study in the product and the percent Daily Value declaration of calories from added which data from the 1994–96 for added sugars displayed below a sugars is unnecessary and not Continuing Survey of Food Intakes by ‘‘Total Sugars’’ declaration. Regarding

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the experiment on cranberry and other content for the . In the same likely to consume or purchase the fruit products, the comment described study, a subset of participants also cranberry juice cocktail after viewing an online study conducted in a sample completed a ‘‘forced choice task’’ in the FDA-proposed nutrition label, of 1,448 adults age 18 or older in the which they were shown Nutrition Facts versus 29 percent for the juice and United States At the start of the study, labels for two products presented, 18 percent for the juice. participants were shown a set of five displayed in FDA’s proposed label Participants were also asked to identify statements, including two statements format, side-by-side, and were asked to ‘‘how many grams of sugar’’ were in that referred to added sugars: choose which of the two products was each juice. The comment said that 30 ‘‘Americans should reduce consumption ‘‘better described’’ by eight different percent of participants could not answer of sodium, saturated fat, refined grains phrases. Some participants were shown the question correctly when viewing the and added sugars;’’ and ‘‘Too much a Nutrition Facts label for dried label for cranberry juice cocktail, versus added sugar in a person’s diet can be cranberries plus a Nutrition Facts label 7 percent for the grape juice and 7 bad for them and their total added sugar for raisins, both in FDA’s proposed percent for the apple juice. After intake should not exceed 10 percent of format. The report submitted in the answering questions about the grams of their total calorie intake.’’ comment said that among those who sugar in each juice, participants who The comment described selected completed this task, statistically indicated that they would be less likely results including, but not limited to, significantly more participants selected to consume or purchase cranberry juice findings related to study participants the dried cranberries as being ‘‘better cocktail were asked, ‘‘Why do you say who viewed a single Nutrition Facts described’’ as containing ‘‘more sugar’’ that?’’ The comment said that the ‘‘main label, in FDA’s proposed format, either and ‘‘more calories,’’ whereas reason’’ for most of the participants who for cranberry juice cocktail or 100 statistically significantly more answered this question was ‘‘sugar percent grape juice. The cranberry juice participants selected the raisins as being content.’’ The comment reported similar cocktail label showed 110 calories, 28 ‘‘better described’’ as ‘‘healthy.’’ research findings for participants who grams of total sugars, and 25 grams (50 The same comment described selected viewed Nutrition Facts labels, in our proposed format, for dried cranberries percent DV) of added sugars. The 100 results from a cross-sectional survey versus raisins. percent grape juice label showed 140 study on cranberry products. The survey Based on the research findings from was conducted online in September calories, 36 grams of total sugars, and 0 the two cranberry studies, the comment grams (0 percent DV) of added sugars. 2015 and included 1,000 adults of 18 said that consumers misunderstood the The comment noted that when both and over in the United States. The study sugar content of cranberry juice cocktail groups of participants were asked to participants were asked how likely they and dried cranberries, and believed that describe ‘‘the amount of sugar’’ that the are to consume or purchase cranberry cranberry products contain more product contains on a scale of 1 to 10, juice cocktail, apple juice, and grape calories and more sugars and are less where 10 equaled ‘‘extremely high,’’ the juice for their household on a regular healthy than competitive products, average rating of the sugar content for basis. Participants were then asked how when presented with FDA-proposed the cranberry juice cocktail was strongly they agreed or disagreed with labels for each, both alone and as statistically significantly higher than the four statements: (1) ‘‘Too much added compared to competitive products. average rating of the sugar content for sugar in a person’s diet can lead to Therefore, the comment said that the grape juice. The comment also obesity and risk of chronic health requiring a naturally unpalatable fruit described findings from a group of problems;’’ (2) ‘‘Many Americans do not product that has been sweetened to participants who viewed a single meet dietary recommendations for label the gram amount and percent DV Nutrition Facts label, in FDA’s proposed servings of fruit;’’ (3) ‘‘One should for added sugars, in comparison with format, for dried cranberries, and reduce consumption of sodium, naturally sweetened fruit products another group of participants who saturated fat, refined grains and added labeled as having zero grams and zero viewed a single nutrition label, in FDA’s sugar;’’ and (4) ‘‘Dried fruits and fruit percent DV for added sugars, is proposed format, for raisins. The dried juices can form a nutritious part of a misleading because it implies that a cranberries label showed130 calories, 3 well-balanced diet and help provide sweetened unpalatable fruit with the grams (12 percent DV) of dietary fiber, nutrients and servings of fruit.’’ same or fewer total calories and sugars 29 grams of total sugars, 26 grams (52 Participants were then shown nutrition as the naturally sweetened fruit product percent DV) of added sugars; 0 percent information for three juice products, is less nutritious and ‘‘generally DV of vitamin D, calcium, and iron; and displayed in FDA’s proposed label unhealthy.’’ 1 percent DV of potassium in a serving format, in a rotating order. One product Both cranberry studies also tested an of the product. The raisins label showed was cranberry juice cocktail of which alternative label format in which the 130 calories, 2 grams (8 percent DV) of label showed 110 calories, 28 grams of declaration of the grams and percent DV dietary fiber, 29 grams of total sugars, 0 total sugars, and 25 grams (50 percent for added sugars was replaced by a grams (0 percent DV) of added sugars, DV) of added sugars. One product was double asterisk symbol on the 0 percent DV of vitamin D, 2 percent DV grape juice of which the label showed declaration of ‘‘Total Sugars,’’ (instead of calcium, 6 percent DV of iron, and 9 140 calories, 36 grams of total sugars, of ‘‘Sugars’’), and a footnote placed at percent DV of potassium. The comment and 0 grams (0 percent DV) of added the bottom of the label that stated, said that when both groups of sugars. One product was apple juice of ‘‘** Total sugars include sugars added participants were asked to describe ‘‘the which the label showed 120 calories, 24 for fruit palatability.’’ The comment said amount of sugar’’ and ‘‘the amount of grams of total sugars, and 0 grams (0 that the alternative label format calories’’ that the product contains by percent DV) of added sugars. As each alleviated the confusion regarding the rating each item on a scale of 1 to 10, product label was shown, participants sugar content of cranberry juice cocktail where 10 equaled ‘‘extremely high,’’ the were asked, ‘‘How does the information compared to grape juice and the average ratings of the sugar and calorie on this label affect your likelihood to confusion regarding the sugar content of content for the dried cranberries were consume or purchase [name of juice] for dried cranberries compared to raisins. statistically significantly higher than the your household?’’ The comment said Another comment described a average ratings of the sugar and calorie that 39 percent of participants were less separate, online experiment that tested

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Nutrition Facts labels for fictitious Many comments referenced a study view a label with an added sugars products without any product identities. that was initially submitted as a declaration, whether the belief, opinion, The study, co-sponsored by five trade comment and report to the proposed or information is grounded in scientific associations, was conducted in October, rule and subsequently published in evidence or not. These factors can 2015, among a sample of 2,014 U.S. 2015 (Ref. 107). The report provided influence how a consumer perceives adult consumers aged 18 years or older. qualitative and quantitative results of a information on a label and may result in Half of the sample saw ‘‘Control labels’’ study conducted with 1,088 U.S. adults some consumer confusion and that included only gram amounts of recruited from an online consumer misunderstanding, e.g., when a ‘‘Sugars.’’ The other half of the sample panel. The report said that study consumer thinks a food, which can be saw ‘‘Added Sugars labels’’ that featured participants generally did not part of a healthy dietary pattern for the gram amounts of added sugars and the understand the term ‘‘added sugars’’ day, is not ‘‘healthful’’ simply because percent Daily Value for added sugars and had difficulty correctly identifying it has a certain amount of added sugars. displayed below a ‘‘Total Sugars’’ the amount of ‘‘sugars’’ on the label We want to ensure, through our declaration. All participants performed when ‘‘added sugars’’ were declared. consumer education, that consumers two product comparison tasks. In the Some study participants perceived that understand how to include a variety of first product comparison task, products with an ‘‘Added Sugars’’ foods in their diet as part of a healthy participants who saw the ‘‘Control declaration had a higher sugar content dietary pattern and focus on providing labels’’ were shown two labels side-by- than was actually present. The consumers the tools they need to side that displayed identical nutrition published paper of the study also said understand how to include added profiles, whereas participants who saw that participants were shown three sugars in their diets and where calories ‘‘Added Sugars labels’’ saw two labels Nutrition Facts labels, side-by-side, for from added sugars can be included side-by-side which were almost three products that were nutritionally within calorie limits. FDA’s consumer nutritionally identical, except that one identical, except that two of the three research on added sugars suggests that declared 4 grams of added sugars labels included ‘‘Added Sugars’’ in comparison to participants who saw whereas the other declared 0 grams of declarations whereas one of the three the current label without any added included only a ‘‘Sugars’’ declaration. added sugars. All participants were sugars declarations, some study The paper said that, when participants asked to indicate which of the two participants’ perceptions of the were asked to rank in order of products was: (1) The ‘‘healthier’’ healthfulness of a given product varied descending preference which product choice and (2) the ‘‘best choice for when added sugars declarations were they would buy based on the label maintaining weight.’’ The comment said included on the Nutrition Facts label. information, 76 percent of the that the results showed that compared Specifically, the study showed that participants gave the highest preference to those who saw two ‘‘Control labels’’ when participants compared two to the label that included only a side-by-side, participants who saw two products that declared added sugars, ‘‘Sugars’’ declaration. ‘‘Added Sugars labels’’ side-by-side and the more nutritious product had (Response) The findings from the more added sugars, some participants were less likely to say that the product research submitted in the comments and declaring 4 grams of added sugars was had difficulty assessing the relative from our own added sugars study healthfulness of the more nutritious equally healthy to, or equally helpful in suggest more limited conclusions than maintaining a healthy weight as, an product. This variation in healthfulness the comments assert. Regarding the perceptions suggests that, when identical product that declared 0 grams findings that some study participants presented with Nutrition Facts labels of added sugars. In the second product appeared to have overestimated the that included added sugars declarations, comparison task, participants were sugar content of the products included some FDA study participants may have shown two labels side-by-side that in the study as a result of summing total applied their own understanding of displayed different nutrition profiles. and added sugar amounts, we address added sugars in deciding how to One product contained 190 calories, 2 this issue in our response to comment evaluate this new information, relative grams (3 percent DV) of total fat, 37 188. Regarding the comments’ assertions to other, more familiar nutrients shown grams (12 percent DV) of total that the study findings demonstrate that on the label, which may have, in turn, carbohydrates, 7 grams (28 percent DV) our proposed label declaration of the affected these participants’ perceptions of dietary fiber, 16 grams of total sugars, percent Daily Value and grams of added and, in the ‘‘Added Sugars labels’’ but sugars would ‘‘mislead’’ consumers about the healthfulness of a given food. not the ‘‘Control labels,’’ 0 grams (0 based on study participants’ responses A variety of factors may account for percent DV) of added sugars. The other to questions posed (which reflect some of the product perceptions (e.g., product contained 190 calories, 3 grams participant perceptions), we disagree healthfulness of a product) found in our (5 percent DV) of total fat, 35 grams (12 that the results support such a research, including but not necessarily percent DV) of total carbohydrates, 10 conclusion (see our response to limited to: (1) Dietary advice grams (40 percent DV) of dietary fiber, comment 35). disseminated since 1980 about limiting 8 grams of total sugars, and, in the Our consumer study on added sugars ‘‘sugar’’ intake, particularly from ‘‘Added Sugars labels’’ but not the was conducted to help inform our sources of added sugars; (2) preexisting ‘‘Control labels,’’ 8 grams (16 percent consumer education. In particular, we perceptions and knowledge (both DV) of added sugars. All other nutrients were interested in better understanding correct and incorrect) about ‘‘sugars’’ were declared in identical amounts for how the inclusion of added sugars and ‘‘added sugars;’’ and (3) potential both products. In this case, the comment declarations on the Nutrition Facts label confusion among some consumers about said that of the participants who saw might influence consumer perceptions the fact that the existing ‘‘Sugars’’ ‘‘Control labels,’’ 56 percent selected the of various products and comprehension declarations on the current Nutrition product with 10 grams (40 percent DV) of the label. A consumer’s belief, Facts label refers to the components of of dietary fiber and 8 grams of total opinion, or previous exposure to ‘‘sugars,’’ which include both naturally sugars as the healthier choice, versus 32 information about added sugars and the occurring and added sugars. percent of participants who saw the impact added sugars may have on The information on the Nutrition ‘‘Added Sugars labels.’’ health may affect how a consumer may Facts label provides consumers with

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information they need to maintain The studies submitted in comments cranberry experiment would not healthy dietary practices. Our consumer demonstrate the same issue we have provide consumers with essential research on added sugars was noted with respect to some consumers information about the quantity of added informative with respect to the need for adding total and added sugar sugars in a food or what that amount of information about the amount of added declarations together, which led to our added sugars contributes to a daily diet. sugars in a serving of food to enable revisions to the final declaration of Without this information, consumers consumers to incorporate added sugars added sugars to clarify that added will not be able to consume less added into a healthy eating pattern. Our sugars is a subcomponent of total sugars sugars or put the added sugars consumer research on added sugars (‘‘included’’ in total sugars). declaration in the context of their daily demonstrated that, without the added Furthermore, due to a number of diet. Finally, although we acknowledge sugars declaration, consumers will not deficiencies in the information provided that the cranberry experiment showed have information they need to construct about the cranberry studies as well as in that statistically significantly more a dietary pattern that is low in added the described study methodologies, we participants selected raisins as being sugars. Not all consumers understand are not able to assess the merits of any ‘‘better described’’ as ‘‘healthy’’ in the distinction between ‘‘Sugars’’ and conclusions described in the comments comparison to the dried cranberries, we ‘‘Added Sugars,’’ and, therefore, some related to cranberry products. For note that there were other differences consumers do not understand that example, in the cranberry experiment, between the dried cranberries and the added sugars, along with naturally one dietary statement that participants raisins besides the amount of added occurring sugars, are components of were shown at the beginning of the sugars. For example, the raisins ‘‘Sugars.’’ We found that some study study about added sugars said: ‘‘Too contained more protein, iron, potassium participants think a food with added much added sugar in a person’s diet can and calcium than cranberries. It is sugars is less ‘‘healthful,’’ even though be bad for them and their total added unclear from the study results if the the food could be included as part of a sugar intake should not exceed 10 participants solely chose raisins based healthy dietary pattern. percent of their total calorie intake.’’ A on their lack of added sugars or if the Without the factual information about DRV for added sugars of less than 10 increased levels of these other nutrients the amount of added sugars in a serving percent calories suggests that some may have impacted the participant’s of food and percent DV declaration, added sugars can be part of a healthy choice for the ‘‘healthy’’ product. consumers would not be able to choose diet. In fact, the food pattern modeling In the cranberry survey study, from a variety of foods for a healthy that was part of the basis for selective reporting of the verbatim dietary pattern and would not be establishing the DRV for added sugars results that were used to identify the provided with information about included 4 to 9 percent of calories from reported reasons for the decreases in appropriate limits on calories from added sugars. Therefore, some study purchase or consumption intentions, the added sugars in their diet. It is findings in the cranberry experiment absence of a baseline assessment of how important to provide consumers with may be attributable to participants participants would respond to the study the information on the amount of added having seen the negative dietary questions using the current Nutrition sugars in a serving of food so they can statement before evaluating the label Facts label, and the sequence and nature better manage their daily intake of formats tested in the study. of the questions described preclude a added sugars, rather than having Additionally, it is not clear whether determination of the extent to which the consumers avoid foods with added the cranberry experiment tested how findings produced in the study are sugars in the ingredient list or participants would have evaluated the attributable to the FDA-proposed label conversely consume excess amounts of cranberry juice cocktail versus grape or to added sugars declarations. For added sugars because they are juice, or dried cranberries versus raisins example, the cranberry survey study uninformed about the contribution of when using the current Nutrition Facts first asked participants to express added sugars in a serving of food. label and, more importantly, the agreement or disagreement with a Information about added sugars on the proposed Nutrition Facts label without statement, ‘‘Too much added sugar in a nutrition label will provide material the proposed declaration of added person’s diet can lead to obesity and information to the consumer to better sugars. Without such test results, it is risk of chronic health problems.’’ Given enable them to construct a healthy not possible to ascertain whether the that 91 percent of the study sample said dietary pattern from a variety of foods. reported results could be attributed, as that they strongly or somewhat agreed In addition to our consumer study on the comment asserted, to the added with this statement, it is reasonable to added sugars, the comments provided sugars declaration or were influenced by infer that the study participants’ consumer research on added sugars other label elements. Moreover, preconceived beliefs and/or heightened related to consumer perceptions. The although the comment said that the attention on added sugars may account research provided in the comments was cranberry experiment reduced for many of the cranberry survey study designed to show differences in how confusion with an alternative label in findings reported in the comment, people view added sugars on the label, which the declaration of the grams and rather than the declaration of added but did not discuss the need for the percent DV for added sugars was sugars. Given that study participants added sugars declaration and its replaced by a footnote that stated, have various preconceived perceptions importance in enabling consumers to ‘‘** Total sugars include sugars added about added sugars, it is not surprising construct healthy dietary patterns. If we for fruit palatability,’’ based on findings that participants have different purchase do not include added sugars on the from eye-tracking studies (Refs. 15, 108), intentions or perceptions. Furthermore, label, based on how consumers may we suspect that the reduced confusion because the cranberry survey study led misperceive added sugars or be is related more to participants participants through a sequence of confused about how to include it as part overlooking the information in the questions where they answered of a healthy dietary pattern on intake, footnote, which is located at the bottom questions about grams of sugar in the consumers could be harmed by not of the label. Regardless of the findings products before viewing an alternative having critical information needed to described in the comment, the label that was advocated by the authors maintain healthy dietary practices. alternative label format included in the of the comment, the study methods

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deliberately led participants to focus on fruit and juices made with at least 27 education level, or both. Based on the information that they may not have percent juice of an unpalatable fruit findings from the reanalysis and prior naturally focused on in other includes a proposed definition for an published research that has examined circumstances, therefore calling into unpalatable fruit. We note that there are how nutrition label use varies with question whether the alternative label other fruits, such as and limes, education level and ethnic minority would produce less confusion while which contain nutrients, but have a low status, the comment said that the also producing better comprehension Brix value. When the juices of such presence of added sugars information on about the added sugars content of the fruits are consumed, they typically have the label produced misperceptions and tested foods if a different set or sugar added to them for palatability. It confusion, and that low-education sequence of questions had been is not clear what the impact of this consumers and ethnic minorities employed. approach suggested in the comment, seemed especially prone to ‘‘unintended In the experiment that was co- which includes a definition of dried consequences’’ when added sugars was sponsored by five trade associations, we unpalatable fruit as well as use of a displayed on the label. The comment are unable to conclude that added Brix-to-acid ratio that is not defined by said that more research is needed to sugars declarations were the reason for regulation, would have on other dried thoroughly understand how the the findings in the second product fruit products or products made from provision of added sugars on the comparison task because the juices of other fruits that typically have Nutrition Facts label would affect ‘‘at- experimental conditions included sugars added to them. An alternative risk segments’’ of the population. variations in total fat and dietary fiber approach provided in comments (Response) We agree that some values, in addition to varying added includes the use of a footnote in the findings suggest the potential for sugars. For example, in the second Nutrition Facts box to explain that consumer responses to labels vary product comparison task, in which added sugars are added to increase the depending on race, ethnicity, and respondents viewed ‘‘nutritionally palatability of the food. However, we are education level; this type of variation different’’ products, 50 percent of concerned about the use of the Nutrition has been shown in prior published participants who selected the product Facts label to convey this type of research. On the other hand, because the that declared 0 grams of added sugars as information and the precedent such an reanalysis ventured beyond the primary ‘‘better for maintaining healthy weight’’ approach may set for other possible objectives of what the study was indicated ‘‘it was low in fat’’ as a reason statements related to a nutrient declared designed to explore and because some for their selection; in addition, our on the label, such as the purpose for its findings reported in the comment were analysis of the raw data submitted by addition, and information related to the based on fewer than five participants, the commenter shows that, 36 percent characteristics or use of the nutrient. We many findings of the reanalysis are indicated ‘‘has no grams of added consider it important to maintain the unreliable. We also disagree with the sugars’’ as a reason for their selection. consistency of the information comment’s basis for asserting a need for On the other hand, our analysis of the contained within the Nutrition Facts additional research as discussed in our raw data shows that among participants label, which provides factual response to comment 40. Due to the who selected the product that declared information about the amount of a limitations of the sample, limitations 8 grams of added sugars as ‘‘better for nutrient in a serving of food. This which the comment acknowledged, we maintaining healthy weight,’’ 55 percent ensures that consumers can continue to view the reanalysis as exploratory and inconclusive, although potentially indicated ‘‘is higher in fiber’’ as a reason readily use the Nutrition Facts label to for their selection, and 39 percent informative for future education efforts. make comparisons across all packaged indicated ‘‘contains less sugar’’ as a Furthermore, as addressed in our foods. Manufacturers who are interested reason. As for the findings from the first responses to comments 1 and 244, we in communicating, through labeling, comparison task, in which participants have considered, and will continue to how products made from fruits that viewed two labels that were almost consider, a variety of educational efforts have sugars added to them in order for nutritionally identical, we do not agree to assist consumers in comprehending the product to be acceptable to that participants ‘‘misjudged’’ the and using the Nutrition Facts label to consumers are free to make a statement healthfulness or weight-related maintain healthy dietary practices. elsewhere on the label or in labeling, attributes of the foods in the presence of h. Voluntary labeling. In the preamble outside of the Nutrition Facts box, to added sugars information, because the to the proposed rule (79 FR 11879 at difference in added sugars content explain the purpose for which the 11905), we considered the between the foods meant that the two sugars has been added, provided the appropriateness of the voluntary foods were, in fact, nutritionally information is consistent with other declaration of added sugars. However, different. Without added sugars labeling requirements, e.g., is truthful we said that we were concerned that declarations, participants were unable and not misleading. Thus, for example, voluntary declaration of added sugars to discern that such a difference existed. manufacturers could include a truthful may not ensure that consumers have the Similarly, in the paper by Laquatra et and not misleading statement information that will allow them to al., participants who expressed a explaining that total sugars include follow the current dietary purchase preference for the label that sugars added for fruit palatability. recommendations (id.). We also said included only a ‘‘Sugars’’ declaration (Comment 185) One comment that added sugars declared voluntarily may not have understood that the food described a reanalysis of the raw data by manufacturers could be confusing to contained added sugars and may have from our added sugars study, the consumers and would not provide based their preference on that mistaken availability of which we announced in consumers with the information they understanding. the Federal Register of September 10, need to plan their dietary pattern to Some research referenced different 2015 (80 FR 54446). The reanalysis reduce consumption of calories from approaches for the labeling of added confirmed some of the findings reported added sugars (id.). sugars for certain nutrient-dense fruit in an FDA memo (see part II.H.3.g), but (Comment 186) Several comments products that are high in acid. The also found that participant perceptions disagreed with our tentative conclusion proposed alternative approach to added of the products in the study were that the labeling of added sugars should sugars labeling for dried unpalatable inconsistent depending on race, be mandatory and provided a number of

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reasons why the declaration of added consumers need to know how much determined before we can require the sugars should be voluntary rather than added sugars is in a serving of a product declaration of added sugars, that is not mandatory. Most comments suggested in order to consume a healthy dietary consistent with our authority for when that labeling of added sugars should be pattern that is low in added sugars we can require a nutrient declaration, as voluntary rather than mandatory for the because we have evidence that healthy discussed in our response to comment same reasons that they opposed dietary patterns characterized, in part, 156. mandatory labeling of added sugars. The by lower intakes of sugar-sweetened Concerning the comments raised with comments, and our responses to the foods and beverages when compared to the TBT Agreement, the comments have comments, are provided in part II.H.3.a. less healthy dietary patterns are not explained why we would be acting Other comments, which recommended associated with a decreased risk of CVD. inconsistently with our WTO that if we determine that added sugars We have the authority to require the obligations if we require the declaration should be declared on the label, the declaration of a nutrient on the label if of added sugars, as compared to other label declaration should be voluntary we determine the declaration will assist countries that allow for the voluntary rather than mandatory, provided the consumers in maintaining healthy declaration of added sugars on their following reasons: dietary practices. Our discretion labels. As we have explained, our • One comment referred to our includes whether to permit the objectives will not be fulfilled by discussion of voluntary labeling of voluntary declaration or require the voluntary labeling. Rather, the scientific added sugars in the proposed rule (79 mandatory declaration of a nutrient (56 evidence supports the mandatory FR 11879 at 11905), and said that FR 60366, November 27, 1991). disclosure of the amount of added whether declaration of a nutrient on the With respect to the comment which sugars in the nutritional labeling of Nutrition Facts label is mandatory or noted that the only nutrient which has food. The dietary pattern of the general voluntary does not correspond to its been added to the label by regulation is United States population contains bearing on maintaining healthy dietary trans fat, which was based on its excessive calories from solid fats and practices; relationship to CVD risk, our basis for added sugars. The consumption of • The sole macronutrient made requiring the declaration of added excess calories above calorie needs can mandatory by regulation is trans fat due sugars for the general population is not lead to overweight and obesity. There is to its established relationship to risk of its independent association with the public health need to reduce excess chronic diseases and health-related risk of chronic disease, a health-related calories from solid fats and added conditions; condition, or a physiological endpoint. sugars to ensure that nutrient needs are • Other voluntary nutrients, such as Instead, we are requiring the mandatory met within calorie limits. Moreover, a polyunsaturated fat, monounsaturated declaration of added sugars because healthy dietary pattern that is fat, potassium, soluble fiber, and sugar evidence shows that heathy dietary characterized, in part, by lower intakes alcohol, are the subject of authorized patterns associated with a decreased of sugar-sweetened foods and beverages health claims; risk of chronic disease are lower in relative to less healthy dietary patterns • Executive Order 13563 requires us added sugars, consumption of too much is associated with a reduced risk of to consider less burdensome added sugars can impact the nutrient CVD. Thus, we have determined that alternatives; density of the diet, and consumption of there is a public health need for • Consumers’ understanding of the sugar-sweetened beverages are Americans to be able to determine the differences between added and associated with increased adiposity in amount of added sugars in a serving of naturally present sugars should be children. foods and to be able to put that amount determined before becoming mandatory; With respect to the comment that into the context of their total daily diet • Voluntary labeling would be suggested that a declaration of added so that they can consume a healthy consistent with the labeling of added sugars should be voluntary because it is dietary pattern that is lower in added sugars in the United Kingdom, Canada, not the subject of an authorized health sugars. We have a legitimate regulatory Australia, and New Zealand, and would claim, our authority to add additional objective to provide nutrition not run afoul of the World Trade nutrients to the label under section information to consumers that includes Organization’s Agreement on Technical 403(q) of the FD&C Act is distinct from the added sugars content in a serving of Barriers to Trade (‘‘TBT Agreement’’); our authority to authorize health claims. food to protect the health of United and With respect to the comment States consumers. The scientific • Manufacturers of foods containing a suggesting that we should consider less evidence indicates that requiring significant amount of added sugars burdensome alternatives as directed by disclosure of added sugar content is would likely be disinclined to declare Executive Order 13563, we did consider necessary to achieving this objective. added sugars if labeling is voluntary, voluntary labeling of added sugars in We address comments related to however manufacturers of foods the preamble to the proposed rule (79 international trade in part II.H.3.m. containing an insignificant amount of FR 11879 at 11905) and determined that We have considered the comment added sugars would likely use the a voluntary declaration would not about the possible inclination of added sugars declaration to highlight provide the information consumers manufacturers to declare added sugars the added sugars content by juxtaposing need to understand the relative on their labels as a basis for determining sugars and added sugars declarations on contribution of added sugars from all whether to require or permit the the label. food in the context of a total daily diet declaration of added sugars on the label (Response) Since the publication of and achieve a healthy dietary pattern and consider the required declaration of the proposed rule, additional evidence that is associated with a reduced risk of added sugars to be necessary to assist has become available that further chronic disease. The 2015 DGA consumers in maintaining healthy supports the need for a mandatory provides further support for this dietary practices. If consumers do not declaration of added sugars. The conclusion. have information on the amount of scientific evidence supports Americans With respect to the comment that added sugars in foods available in the limiting their calories from added sugars consumers’ understanding of the marketplace, they will not be able to by consuming an eating pattern low in differences between added and compare products so that they can avoid added sugars. We explained that naturally present sugars should be excess calories from added sugars and

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construct an overall healthy dietary heading ‘‘Total Sugars’’ would provide sugars (see part II.H.2.c). Therefore, we pattern that has less than 10 percent of interpretive data that is consistent with are replacing ‘‘Sugars’’ with ‘‘Total calories from added sugars. the need to make information clearer for Sugars’’ throughout §§ 101.9 and 101.36. i. How added sugars are declared. consumers with lower levels of health (Comment 188) Many comments Many comments provided literacy, numeracy, and English raised concerns about our proposal to recommendations for how information language limitations. One comment said require added sugars declarations due to about added sugars in products should that an analysis of our research findings from consumer research be conveyed to consumers on the label. indicates that replacing the term conducted by FDA and others. The comments said consumer research (i) Changing ‘‘Sugars’’ to ‘‘Total Sugars’’ ‘‘Sugars’’ with ‘‘Total Sugars’’ on the label will enhance the consumers’ showed that added sugars declarations In the preamble to the proposed rule ability to discern the overall nutritional decreased the ability of some (79 FR 11879 at 11902), we said that we value and compare nutrient density of participants to correctly identify the were considering whether to use the food products at the point of selection quantity of total sugars in a food. term ‘‘Total Sugars’’ instead of ‘‘Sugars’’ (Ref. 109). Specifically, FDA’s studies as well as on the label if we finalize a declaration Other comments provided evidence other studies cited in the comments of added sugars. We also said that we that consumer’s understanding of label showed that when viewing nutrition planned to conduct consumer research information about sugars is improved labels with added sugars declarations, that would include, among other things, when the ‘‘Sugars’’ term is replaced some participants mistakenly summed questions regarding the declaration of with ‘‘Total Sugars.’’ One comment the value for total sugars and the value added sugars on the Nutrition Facts provided the results of a qualitative and for added sugars when they were asked label in order to help or enhance our quantitative study that it conducted to identify the total amount of sugars in understanding of how consumers would showing that, when ‘‘Total Sugars’’ was a serving of a product. Some comments comprehend and use this new declared on a label rather than also said that the research suggests that information, and to inform our ‘‘Sugars,’’ participants were more likely the proposed label is more likely than education activities and outreach. In the to understand that the sugars in an the current label to mislead or confuse preamble to the supplemental proposed ‘‘Added Sugars’’ line would be included consumers with regard to total grams of rule (80 FR 44303 at 44306), we in a ‘‘Total Sugars’’ line (Ref. 107). sugars in the product; the comments discussed the results of our consumer These results are consistent with our would exclude an added sugars research which showed that when an findings. Another comment cited a declaration from the label. Another ‘‘Added Sugars’’ declaration was study by Laquatra et al., which the comment suggested that FDA should indented below a ‘‘Total Sugars’’ comment said suggests that consumers’ conduct additional research to find declaration on the label, participants understanding of the amount of sugar other ways to present added sugars and appeared to be better able to indicated on a food label was improved total sugars declarations to reduce comprehend the total amount of sugars when the term ‘‘total sugars’’ was used consumer confusion. in a food than if an ‘‘Added Sugars’’ rather than ‘‘sugars’’ (Ref. 107). (Response) We acknowledge that our declaration was indented below a One comment said that our consumer consumer research and those referenced ‘‘Sugars’’ declaration. In the preamble to research results are ambiguous, and in the comments showed statistically the supplemental proposed rule (id. at requested that we undertake sufficient significant decreases in participants’ 44304), we asked for comment on education activities to ensure that understanding of total sugars in a whether the term ‘‘Total Sugars’’ should consumers understand that ‘‘Added serving of a product when a label be declared on the label instead of Sugars’’ are included in the ‘‘Total included an added sugars declaration, ‘‘Sugars.’’ Sugars’’ declaration. Another comment either with or without the (Comment 187) Many comments to also said that it is premature to corresponding percent Daily Value of both the proposed rule and the comment on using the term ‘‘Total added sugars, compared to when a label supplemental proposed rule addressed Sugars’’ instead of ‘‘Sugars’’ on the label did not include an added sugars this topic. The comments generally because additional consumer research declaration. Our study showed that the preferred the term ‘‘Total Sugars’’ rather that includes a label format that most common error was for our study than ‘‘Sugars’’ on the label. Although represents our proposed added sugars participants to overestimate the quantity some comments did not support a labeling declarations (including a of total sugars in the product by declaration of added sugars on the label, percent DV declaration) is needed to summing the product’s ‘‘total sugars’’ the comments said that, if we require gauge consumer understanding and (or just ‘‘sugars,’’ depending on which the declaration of added sugars in the usage of the new label information. label format was used) and ‘‘added final rule, the term ‘‘Total Sugars’’ (Response) Since the publication of sugars.’’ We note, however, that in our should be used on the label rather than the supplemental proposed rule, our study and in a study conducted by IFIC, ‘‘Sugars.’’ The comments said that such finding that participants appear have including ‘‘total’’ in front of ‘‘sugars’’ a change to the terminology used will better comprehension of the total helped study participants better likely increase consumer understanding amount of sugars in a food when comprehend the total amount of sugars that ‘‘Added Sugars’’ are included in the ‘‘Sugars’’ is replaced with ‘‘Total in a serving of a product. Therefore, the ‘‘Total Sugars’’ declaration. The Sugars’’ on the label has been replicated final rule includes ‘‘total’’ in front of comments would change the ‘‘Sugars’’ by others, as noted in some comments. ‘‘sugars’’ to better enable consumers to declaration to ‘‘Total Sugars’’ to provide We disagree that additional consumer correctly assess the quantity of total a clearer distinction between total and research testing the proposed label sugars in a product. added sugars and to prevent consumers format with a percent DV declaration for We also note that in our research, from adding the ‘‘Added Sugars’’ and added sugars is needed before we can when compared to the control group ‘‘Sugars’’ declarations together. The finalize a change to the label which viewing the current label with no comments said that this change would replaces the term ‘‘Sugars’’ with ‘‘Total ‘‘added sugars’’ declaration, some study be consistent with the declarations for Sugars.’’ ‘‘Total Sugars’’ will help participants still did not report the ‘‘Total Fat’’ and ‘‘Total carb.’’ Other improve comprehension of information correct amount of ‘‘sugars’’ in one comments suggested that using the on the label related to total and added serving of the product, even when the

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word ‘‘total’’ was included in front of The expert also suggested that use of the however the understanding of tabular ‘‘sugars.’’ It is also important to note word ‘‘includes’’ should reinforce for information and understanding of that when using the sugars declaration consumers that ‘‘added sugars’’ is a textual information share similar on the current label, some participants component of ‘‘total sugars’’ and not psychological processes (Ref. 116). The were unable to determine the total merely a complement. The expert also literature thus lends support that a amount of sugars, even when only noted that any lingering confusion with linking word such as ‘‘includes’’ may ‘‘sugars’’ was listed on the label. the format related to determining total help consumers better comprehend that Additionally, our research found that amount of sugars in a serving of a ‘‘added sugars’’ are a sub-component of the majority of study participants could product should dissipate over time as ‘‘total sugars.’’ not identify the correct amount of users of the Nutrition Facts label Furthermore, in the previous final ‘‘added sugars’’ on the label when it was become accustomed to the new label. rule implementing the NLEA (57 FR not declared, thereby not giving The second expert in risk 32070 at 32071), we noted that several participants a key piece of information communication noted that the presence comments suggested using terms such needed to maintain healthy dietary of the word ‘‘includes’’ provides clarity as ‘‘includes,’’ ‘‘including,’’ and ‘‘of practices. that she expects will reduce confusion which,’’ before the subcomponent for We plan to include ‘‘added sugars’’ in among those consumers who summed fats and carbohydrates to indicate that our consumer education and outreach ‘‘Added Sugars’’ and ‘‘Total Sugars’’ and the subcomponent is a part of a broader efforts on the Nutrition Facts label. This allow consumers to determine the total classification. We agreed that these will address some consumer confusion. amount of sugars in one serving of a words would add clarity to the label but However, to the extent some confusion product. declined to include them at that time was identified in the studies, we want In addition to the expert opinion, because they could ‘‘clutter’’ the label. to correct this potential confusion by some literature suggests linking terms While label clutter is a concern, adding the word ‘‘includes’’ in front of (words or phrases that reveal decreasing potential consumer added sugars. The added sugars relationships between ideas in content) confusion outweighs any cluttering of declaration will now read ‘‘Includes X are useful for increasing the label that would result from the g Added Sugars’’ below the ‘‘Total comprehension, indicating that using addition of a word before ‘‘added Sugars’’ line. The addition of ‘‘includes’’ the word ‘‘includes’’ may help sugars.’’ We also note that the European will enable consumers to understand consumers understand that ‘‘added Union, in its new nutritional labeling that ‘‘added sugars’’ are a sub- sugars’’ are a subcomponent of ‘‘total requirements, is requiring ‘‘of which’’ to component of ‘‘total sugars.’’ We also sugars.’’ Comprehension of information help denote the sub-components of fats are minimizing the hairline between in text takes place when the reader can and carbohydrates, which is a similar total sugars and added sugars to help identify new text information and relate linking phrase. denote that ‘‘added sugars’’ are a it to the information already given or With regard to the comment that subcomponent of ‘‘total sugars.’’ known. The more information that asked us to conduct further consumer Minimizing the hairline between the coincides with what readers already research on this topic, we decline to do two sugars will ‘‘chunk’’ the sugars know, the easier it will be for them to so at this time. While we may consider together instead of them being distinct integrate new information into their additional consumer research in the and separate. We base our decision on existing knowledge base, hence coming future to help inform consumer the expert opinion of two scientists in to understand the material presented in education regarding the ‘‘added sugars’’ the fields of consumer research and risk the information (Ref. 112). One or other declarations, we have communication and a review of principle commonly used to facilitate incorporated changes intended to literature as explained below comprehension is to make each minimize consumer confusion regarding surrounding the use of connecting sentence explicitly related to the next. the ‘‘added sugars’’ declaration on the words to clarify relationships between One possible approach to implement label and have finalized this subject matter. this principle is to use sentence requirement. We have sufficient We enlisted the aid of two connectors to clarify relationships information to move forward with the independent FDA experts, one whose between sentences. Similarly, requirement for the added sugars expertise is in consumer research and Spyridakis 1989 (Ref. 113) suggested declaration based on a review of the the other whose expertise is in risk that because comprehension of text scientific evidence and other available communication. These experts were not requires readers to make inferences, a data and information which support the affiliated with our current consumer text that provides clues to the links need for added sugars information to be studies work on added sugars and were between discrete units of information available to the consumer as part of the asked to evaluate whether using the can help readers make appropriate nutrition label. word ‘‘includes’’ as well as minimizing inferences and therefore contribute to the line between ‘‘total sugars and overall learning of the content of the (ii) Declaration of Added Sugars in ‘‘added sugars’’ are likely to ameliorate text. There are different types of Teaspoons the consumer confusion found in our ‘‘connector’’ or ‘‘signal’’ words, phrases, (Comment 189) While one comment consumer research as well as the or statements that preannounce content said that a gram disclosure for added research of others. The experts and/or reveal a relationship between sugars would be more readily independently agreed that these changes ideas in content (Ref. 114). The latter, understood by consumers because it is should help consumers better sometimes called logical connectors, consistent with the manner in which understand that ‘‘added sugars’’ is a can be words or phrases such as ‘‘first,’’ total sugars are disclosed on the label, subcomponent of ‘‘total sugars’’ (Refs. ‘‘moreover,’’ ‘‘because,’’ ‘‘for example,’’ a number of comments suggested that 110–111). The consumer research expert and ‘‘in other words.’’ The literature has added sugars should be declared in noted that including the word ‘‘total’’ in demonstrated that logical connectors teaspoons or in teaspoons as well as front of ‘‘sugars’’ should be particularly can be helpful in improving text grams. The comments said Americans helpful to regular label users since this comprehension (Refs. 113–115). We understand household measures better format is consistent with what is used acknowledge that text and tables are than they do the metric system because for ‘‘total fat’’ and ‘‘total carbohydrate.’’ different formats of presentation, they use household measures at home.

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The comments said that listing the Additionally, the USDA Food Patterns the label. The comments did not amount of added sugars in both grams provide limits for added sugars that can provide a basis upon which we can rely and teaspoons would improve the be reasonably consumed while meeting to support a separate declaration of clarity of the information provided all other nutrient and food group naturally occurring sugars, and so we about added sugars. The comments also requirements that are listed in grams decline to revise the rule as suggested suggested that a gram and teaspoon rather than in teaspoons. The by the comments. declaration for added sugars would help declaration of added sugars in teaspoons (Comment 191) One comment consumers readily observe and rather than in grams would make it recommended that we propose a comprehend the information on sugars difficult for consumers to determine Nutrition Facts label format that clearly and to understand its relative how their consumption of added sugars distinguishes added sugars from significance in the context of a total relates to the recommended limits in the naturally occurring sugars in whole fruit daily diet. USDA Food Patterns. and from sugars from dairy ingredients. The comments provided the results of There is limited space on the label, so The comment also recommended survey data to support an added sugars the declaration of both gram and replacing ‘‘sugars’’ with ‘‘fruit & milk declaration in teaspoons. One comment teaspoon amounts of added sugars on sugars’’. provided the results of a 2010 telephone the label could cause clutter and make (Response) We address this comment survey which it said showed that 72 the label more difficult to read. We have in part II.H.2. percent of respondents favored listing determined that the amount of other nutrients on the label should not be (iv) Replacing ‘‘Sugars’’ With ‘‘Added teaspoons of sugar on the label. Another Sugars’’ comment referenced the results of a declared in teaspoons, so if added 2012 survey of readers by Consumer sugars were declared in both grams and (Comment 192) Some comments World, an Internet-based publisher of a teaspoons, it could draw the reader’s would replace ‘‘Sugars’’ with ‘‘Added consumer resource guide. The comment attention to the added sugars Sugars.’’ One comment said that foods said that, when exposed to label declaration and make it appear as like fruits have natural sugars in them, information in which the amount of though the information should be more but when people see the amount of added sugars in a product was important or considered in a different sugars they may think the food is bad expressed in grams, up to 80 percent of way than declarations of other nutrients for them. (Response) We decline to revise the survey participants could not accurately when the declarations of other nutrients rule as suggested by the comment. The say how much sugar was contained in are just as important to consider when consumption of sugars continues to be a product, and many participants constructing a healthful dietary pattern. While we take into consideration associated with an increased risk of underestimated the actual amount of consumer preference, manufacturers dental caries (Ref. 75); thus, a sugar in the product. must provide information on the label declaration of the total amount of sugars (Response) We decline to revise the that is as accurate as possible. Although in a serving of a product continues to be rule as suggested by the comments. We consumers may prefer the declaration of necessary to assist consumers in address issues regarding the use of added sugars in teaspoons because maintaining healthy dietary practices. household measures (such as teaspoons) household measures are more familiar in part II.B.3. (v) Distinguishing Between Different to them than gram amounts, the need for Types of Sugars or Sweeteners Additionally, we note that there are accurate labeling of added sugars is of many ingredients that supply added greater importance. (Comment 193) One comment sugar, so it would be difficult, if not We have conducted our own research, suggested listing all sugars separately on impossible, for a manufacturer to and that research showed that when the the label. determine the volume contribution that gram amount of added sugars is (Response) We decline to revise the each ingredient provides towards the declared on the label, study participants rule as suggested by the comment. There added sugars declaration. For example, are able to determine the amount of are many different kinds of sugars and a cookie made with white added sugars in a serving of a product. ingredients containing sugars. The chips and dried fruit would have added Furthermore, the percent DV declaration declaration of the amount of each type sugars in the form of sugar in the batter for added sugars is also required. of sugar in a serving of a product would as well as in the white chocolate chips Therefore, we disagree that consumers result in a very large and cluttered and the dried fruit. are unable to determine the amount of Nutrition Facts label. While all nutrient Because many products would not added sugars when the gram amount is declarations are important to build have amounts of added sugars in a declared on the label. healthy dietary patterns, current science serving of a product that would result in focuses on added sugars in total rather the declaration of an even teaspoon or (iii) Distinguishing Between Naturally than focusing on specific sugars. If multiple thereof, the requirement to Occurring and Added Sugars on the consumers are interested in knowing declare added sugars in teaspoons rather Label whether certain sugars are in a product, than in grams would result in fractional (Comment 190) Some comments specific sugars are listed in the declarations of teaspoons of added thought that we proposed to require ingredient list. sugars. Indeed, under § 101.9(c)(6)(iii) of both a declaration for naturally (Comment 194) One comment the final rule, a statement of added occurring and added sugars. Other requested that we allow the inclusion of sugars content is not required for comments suggested that the Nutrition ‘‘nutritive sweetener’’ in a parenthetical products that contain less than 1 gram Facts label include separate declarations after added sugars so manufacturers of added sugars in a serving if no claims for naturally occurring and added sugars could identify the name of the added are made about sweeteners, sugars, or so that consumers could clearly identify sugar. The comment also requested that, sugar alcohol content. The final rule the amount of both naturally occurring if the added sugar is high fructose corn also states that if a product contains an and added sugars on the label. syrup, we allow manufacturers to insignificant amount of added sugars, (Response) We did not propose to identify the percentage of fructose on the added sugars content may be require separate declarations for the Nutrition Facts label (e.g., high expressed as zero. naturally occurring and added sugars on fructose corn syrup-42 or high fructose

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corn syrup-55). The comment said that require a warning statement that says carefully construct a healthful diet that listing ‘‘nutritive sweetener,’’ the name ‘‘WARNING: THIS PRODUCT includes calories from added sugars. of the added sugar, and the percentage CONTAINS A SIGNIFICANT AMOUNT Finally, regarding a statement on the of fructose in high fructose corn syrup OF ADDED TEASPOONS OF SUGAR label with limits for the amount of is essential for the consumer to make a WHICH STUDIES HAVE LINKED TO added sugars that the average man or fully informed choice about the caloric OBESITY, TYPE II DIABETES, woman should consume, we do not contribution of sweeteners and the CARDIOVASCULAR DISEASE AND provide this information for any other composition of ingredients in the CERTAIN CANCERS. CONSULT YOUR nutrients which are to be limited in the product they are consuming. PHYSICIAN ABOUT AN diet, and it is not clear what the Other comments supported the APPROPRIATE DIET WITH A scientific basis is for the suggested declaration of the amount of fructose in REDUCED AMOUNT OF ADDED limits. a serving of a product on the label. One SUGAR.’’ Another comment suggested j. Variability in sugar content. comment said that the information is that we should require a (Comment 198) One comment noted needed because metabolizing fructose that says ‘‘IT [added sugar] IS that manufacturers may add varying puts an extra load on the liver. The ADDICTIVE. IT CAN LEAD TO amounts of sugars due to variation in comment suggested that adding fructose OBESITY. OBESITY CAN LEAD TO maturity of a fruit or vegetable and deleting added sugars in the DIABETES, HEART DISEASE, ETC.’’ ingredient during the course of a quantitative information would add One comment suggested that we growing season to attain a consistent value without adding complexity. require, or offer an incentive for, a level of soluble solids and a consistent (Response) We decline to revise the disclaimer about added sugars and taste profile of the food. The comment rule as suggested by the comments. sodium. The disclaimer would explain further said that food manufacturers and Added sugars are nutritive sweeteners, the health effects on the body and marketers would not prepare multiple so it is not clear why ‘‘nutritive connections to disorders such as labels for different batches, so the sweetener’’ needs to be declared in diabetes and hypertension. The declared amount would reflect the parentheses behind the words ‘‘added comment said that, similar to cigarette highest possible amount of added sugars sugars’’ on the label. As previously packets, consumers should be warned of and may overstate the actual amount. discussed in our response to comment the health effects of added sugars. (Response) Variation in the sugar 193, current science focuses on added (Response) We decline to revise the content of fruits and vegetables due to sugars in total rather than focusing on rule as suggested by the comments. The growing conditions is something that specific sugars. statements are not consistent with our manufacturers have had to take into (Comment 195) One comment review of the evidence (see our response account with their labeling of total objected to the use of the term ‘‘added to comments 136 and 137), and we do sugars since 1993. Manufacturers are in sugars’’ because, according to the not require warning labels or the best position to determine how comment, it improperly combines disclaimers for other nutrients on the much of a nutrient is in their product compositionally and metabolically label. Furthermore, some added sugars given the variability of the nutrients in distinct caloric sweeteners. can be included as part of a healthy their product. They are also in the best (Response) We are not basing our dietary pattern. position to determine when a label declaration of added sugars on an (Comment 197) Several comments change is needed because the independent relationship between suggested that we use wording to declaration would no longer be in added sugars, or different types of convey that the DRV of 10 percent of compliance with our requirements added sugars, and risk of chronic calories from added sugars is a under § 101.9(g). disease. To the extent that the comment maximum amount rather than a k. Non-enzymatic browning and is suggesting that different types of recommended amount. One comment fermentation. In the preamble to the sugars are chemically distinct, so the would include language to state that ‘‘no proposed rule (79 FR 11879 at 11906), term added sugars is inappropriate, consumption is recommended. But if we recognized that sugars in some foods there are different types of naturally you choose to consume, then this may undergo changes mediated by occurring sugars as well as different absolute maximum should be observed chemical reactions from non-enzymatic types of carbohydrates, but we use the to avoid increasing adverse health browning (i.e. Maillard reaction and terms ‘‘total sugars’’ and ‘‘total exposure.’’ Another comment would caramelization) and fermentation that carbohydrate’’ to capture all sugars and require a statement on the label that the would result in compounds that are no all carbohydrates respectively. average woman should consume no longer recognizable or detectable as Therefore, using one broad term to more than 24 grams of sugar per day, sugars through conventional analytical capture all sugars that have been added and the average man should consume methods. We tentatively concluded that to a food is consistent with the approach no more than 34 grams of sugar per day. the amount of added sugars transformed that we have taken for other nutrients. (Response) We decline to revise the during non-enzymatic browning Furthermore, caloric sweeteners that rule as suggested by the comments. In reactions is insignificant relative to the have been added to a food are added response to the comment that would initial levels of sugars. We also sugars, therefore we do not agree that it include language to convey that the tentatively concluded based on the is inappropriate to use the term added DRV is a maximum amount rather than information available to us that the sugars to include caloric sweeteners that a recommended amount, such language amount of added sugars present in foods have different chemical structures. would not be appropriate because we do prior to undergoing fermentation, with not require this information for other the exception of yeast-leavened bakery (vi) Warning Statements nutrients with DRVs or RDIs that are products, wines with less than 7 percent (Comment 196) Several comments based on an amount not to exceed. alcohol by volume, and that do suggested that we require various As for a statement regarding ‘‘no not meet the definition of a ‘‘malt warning statements on the label related consumption,’’ the current evidence beverage’’ as defined by the Federal to added sugars to warn consumers of does not support a need to eliminate all Alcohol Administration Act (27 U.S.C. the negative health effects of added added sugars from the diet. In fact, the 211(a)(7)) with sugars added during the sugars. One comment suggested that we USDA Food Patterns show that one can formation process, will not be

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significantly affected by virtue of the added sugars are not chemically distinct percent alcohol by volume, and beers food having undergone fermentation (79 from naturally occurring sugars and are that do not meet the definition of a malt FR 11879 at 11907). We acknowledged not associated with health or the risk of beverage to make and keep records of that we do not have adequate disease, we respond to such issues in scientific data and information to information to assess the degradation of part II.H.3.i. We also have stated, in part demonstrate the amount of added sugars added sugars during fermentation for II.H.3.a, that added sugars consumption remaining in the finished food, when yeast-leavened bakery products, wine is a significant public health concern that amount is less than the initial with less than 7 percent alcohol by which warrants mandatory declaration. amount of added sugars, be extended to volume, and beers that do not meet the (Comment 200) Several comments all food manufacturers that must declare definition of a malt beverage with sugars suggested that there are a wide variety added sugars in the labeling of their added before fermentation. We of fermented foods (e.g., fermented products. requested the submission of available vegetables, beverages, fruits, Other comments disagreed with our data and information on our tentative condiments, products made with grains tentative conclusion that the amount of conclusions as well as the submission of and/or pulses, dairy replacement added sugars transformed by non- data on the amount of variability that products, and meat products) and enzymatic browning reactions will be occurs among various types of products ingredients (e.g., vinegars, enzymes, insignificant relative to the initial levels where added sugars are transformed vitamins, and amino acids in pure form of sugars. One comment provided the into other compounds as a result of or in mixtures) to which sugars are example of the manufacture of caramel. chemical reactions during food added, and where the sugars content is The comment suggested that this processing. significantly diminished or entirely process converts sugars into thousands The proposed rule, at removed through fermentation. The of new chemical compounds that § 101.9(g)(10)(v), would require a comments also disagreed with our include oligomers, dehydration and manufacturer of yeast-leavened bakery tentative conclusion that the amount of hydration products, disproportionation products, wines with less than 7 percent added sugars transformed by products, and colored aromatic alcohol by volume, and beers that do fermentation will be insignificant products. The comment noted that the not meet the definition of a malt relative to the initial levels of sugars in decrease in added sugars in a wide beverage with sugars added before and foods and ingredients other than yeast- variety of products undergoing such during the fermentation process to make leavened bakery products, wines with chemical reactions may depend on the and keep records of added sugars less than 7 percent alcohol by volume, ingredients, moisture levels, presence of necessary to determine the amount of and beers that do not meet the acids or bases, exposure to heat, etc., but added sugars present in the finished definition of a malt beverage. The that the decrease is not uniformly food. The proposed rule would require comments noted that the effect of insignificant. manufacturers of such foods to make fermentation is variable. According to (Response) Although comments said and keep records of all relevant the comments, the net effect can depend that the amount of added sugars scientific data and information relied on details of the starting materials, converted to other compounds during upon by the manufacturer that fermentation process, and length of fermentation and non-enzymatic demonstrates the amount of added fermentation. browning is significant in a wide variety sugars in the food after fermentation and Several comments noted that there are of foods, few comments provided data a narrative explaining why the data and many processing and ingredient to support their conclusions. One information are sufficient to variables that influence the fermentation comment provided information about demonstrate the amount of added sugars process in yeast-leavened bakery the amount of sugars which are declared in the finished food, provided products. The comments said that our converted to other compounds in the data and information used is assumption that manufacturers have kimchi, a fermented vegetable product specific to the type of fermented food information about reduction of added (Refs. 117–118). Another comment manufactured. Alternatively, under the sugars in yeast-leavened bakery provided information about caramel proposed rule, manufacturers would be products is incorrect. One comment candy (Ref. 119). In a memo to the file able to make and keep records of the stated that, because manufacturers for the proposed rule (Ref. 120), we amount of added sugars added to the would be unable to determine the tentatively concluded that the amount food before and during the processing of amount of added sugars consumed of added sugars which are converted to the food and, if packaged as a separate during fermentation in yeast-leavened other compounds through Maillard ingredient, as packaged. We said that bakery products, manufacturers would browning, a type of non-enzymatic the amount of added sugars declared have to declare the amount of sugars browning, is insignificant. Although the should not exceed the amount of total added before leavening under the comments generally disagreed with our sugars on the label (79 FR 11879 at proposed rule, resulting in an conclusion that all products 11908). overstatement of the amount of added participating in non-enzymatic (Comment 199) One comment said sugars in the finished product, which is browning have an insignificant that we have not demonstrated why false and misleading. reduction in the amount of added distinguishing between a fermented Other comments suggested that added sugars, no comments specifically added sugar and a fermented naturally sugars that are converted through disagreed with our conclusion about occurring sugar or why the type of sugar fermentation to other compounds products that participate in Maillard that participates in reactions due to heat should be subtracted from the added browning. Therefore, in products treatment improves the health of sugars declaration, and any sugars affected by Maillard browning, the consumers. The comment questioned produced during fermentation should be amount of sugars added before Maillard what the compelling government omitted from the declaration of added browning is a reasonable approximation interest is in knowing which molecule sugars. of the amount of added sugars in the of sugar participates in these reactions. One comment suggested that finished product in most, if not all, (Response) To the extent that the proposed § 101.9(g)(10)(v), which would products. comment is suggesting that our focus on permit manufacturers of yeast-leavened With the exception of the comment added sugars is misplaced because bakery products, wines with less than 7 which cited caramelization as an

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example of a non-enzymatic browning serving of the finished food product is through non-enzymatic browning and/ process where the reduction in the significantly less (i.e., where the or fermentation, manufacturers must: amount of added sugars present in a reduction in added sugars after • Make and keep records of all finished food could be significant, we fermentation may be significant enough relevant scientific data and information did not receive any other specific data to impact the label declaration for added relied upon by the manufacturer that or information about foods that undergo sugars) than the amount added prior to demonstrates the amount of added non-enzymatic browning to support the non-enzymatic browning and/or sugars in the food after non-enzymatic comments’ position that the amount of fermentation, and the manufacturer has browning and/or fermentation and a added sugars converted to other no way to reasonably approximate the narrative explaining why the data and compounds is significant. Therefore, we amount of added sugars in a serving of information are sufficient to expect that the amount of sugars added the finished food. Therefore, we have demonstrate the amount of added sugars before non-enzymatic browning in these revised § 101.9(g)(10)(v)(C) to state that declared in the finished food, provided foods would be a reasonable manufacturers may submit a petition, the data and information used is approximation of the amount of added under § 10.30 (21 CFR 10.30), to request specific to the type of food sugars in the finished product. We also an alternative means of compliance. The manufactured; or expect that manufacturers of such petition must provide scientific data or • Make and keep records of the products would be able to make and other information for why the amount of amount of sugars added to the food keep documentation to show a added sugars in a serving of the product before and during the processing of the reasonable basis for how they is likely to have a significant reduction food, and if packaged as a separate determined the declared value for added in added sugars compared to the ingredient, as packaged (whether as part sugars. amount added prior to non-enzymatic of a package containing one or more We recognize that there may be a browning and/or fermentation. A ingredients or packaged as a single larger amount of variability in significant reduction would be where ingredient) and in no event shall the fermented products with respect to the reduction in added sugars after non- amount of added sugars declared exceed amount of added sugars that are enzymatic browning and/or the amount of total sugars on the label; converted to other compounds. fermentation may be significant enough or Although the comments provided to impact the label declaration for added • Submit a petition, under § 10.30, to examples of products that participate in sugars by an amount that exceeds the request an alternative means of fermentation, the comments provided reasonable deficiency acceptable within compliance. The petition must provide very little data or information to support current good manufacturing practice scientific data or other information for the assertion that the added sugars under § 101.9(g)(6). In addition, the why the amount of added sugars in a content is significantly reduced in a scientific data or other information must serving of the product is likely to have large number of fermented foods. We are include the reason that the a significant reduction in added sugars aware of only a small number of manufacturer is unable to determine a compared to the amount added prior to fermented foods where the reduction in reasonable approximation of the amount non-enzymatic browning and/or added sugars may significant (where the of added sugars in a serving of their fermentation. reduction in added sugars after finished product and a description of A significant reduction would be fermentation may be significant enough the process that they used to come to where reduction in added sugars after to impact the label declaration for added that conclusion. non-enzymatic browning and/or sugars) after fermentation. Therefore, we We recognize that labeling of added fermentation may be significant enough expect that the majority of sugars in products that undergo to impact the label declaration for added manufacturers would be able to use the fermentation and non-enzymatic sugars by an amount that exceeds the amount of added sugars added as an browning may not be exact, but reasonable deficiency acceptable within ingredient as a reasonable manufacturers of most products that current good manufacturing practice approximation of the amount of added participate in these reactions should be under § 101.9(g)(6). In addition, the sugars in a serving of their product. able to provide a reasonable scientific data or other information must If a manufacturer has a basis on which approximation of the amount of added include the reason that the to support a declaration of added sugars sugars in a serving of their product manufacturer is unable to determine a based on the amount of added sugars based on information in the literature reasonable approximation of the amount present in a food after non-enzymatic and their own analyses. Most of added sugars in a serving of their browning or fermentation, the label manufacturers should be able to provide finished product and a description of declaration must be supported by documentation to support the value that the process that they used to come to records demonstrating the accuracy of they declare on the label. Therefore, the that conclusion. the declared amount. The records majority of manufacturers of such foods (Comment 201) One comment noted should include all relevant scientific will be able to provide a reasonable that sugar content of products can be data and information relied upon by the approximation of the amount of added increased through hydrolysis and manufacturer that demonstrates the sugars in a serving of their product as enzymatic reactions using carbohydrate amount of added sugars in the food after well as documentation showing a containing ingredients. The comment non-enzymatic browning and/or reasonable basis for how they questioned what the classification fermentation and a narrative explaining determined the declared value. would be of the sugars (natural or why the data and information are As some comments recommended, we added) produced by such reactions sufficient to demonstrate the amount of agree that it is appropriate to allow during . The comment added sugars declared in the finished manufacturers of all products which also noted that the possibility of having food. undergo non-enzymatic browning and/ sugars produced ‘‘in situ’’ (meaning in There may be a small number of foods or fermentation to make and keep place or in position) shows the which undergo non-enzymatic records of the type that we proposed. difficulty of drawing a clear line browning and/or fermentation for which Therefore, we have revised § 101.9(g)(v) between the two types of sugars. manufacturers have reason to believe to say that when the amount of sugars (Response) Sugars content can be that the amount of added sugars in a added to food products is reduced increased through acid, heat, or

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enzymatic hydrolysis of complex approved database that has been support for labeling only total sugars: (1) carbohydrates (e.g. starch). Sometimes, computed following FDA guideline The body cannot differentiate between the increase is incidental as a procedures and where food samples added sugars and total sugars in consequence of other food have been handled in accordance with physiologic response; (2) the absence of manufacturing processes, such as current GMPs to prevent nutrition loss. any analytical differentiation between acidification, heating, and/or Our Guidance for Industry: Nutrition added and inherent sugars, which fermentation. For example, during yeast Labeling Manual—A Guide for would create difficulties for bread fermentation, natural enzymes Developing and using Data Bases, the enforcement; and (3) the importance of present in the flour can hydrolyze starch manual provides generic instructions for declaration of total sugars for certain into maltose. Other than sugar syrup developing and preparing an acceptable populations including diabetics. The types of products where the sugars are database, as well as the recommended comment also said that the WHO specifically and purposely produced via statistical methodology to develop advised that ‘‘total sugars is the only hydrolysis, we do not have information nutrition label values. The guide is practical way of labeling the sugars suggesting that sugars produced through based on doing laboratory analyses of content of food since sugars cannot be incidental hydrolysis of complex food samples. Because added sugars and distinguished analytically from intrinsic carbohydrates results in a significant naturally occurring sugars are not sugars.’’ increase in the sugar content of foods. chemically distinct, it is not possible to Other comments said that no other Sugars which are produced through do a laboratory analysis to determine country has adopted mandatory added incidental hydrolysis would be captured the amount of added sugars in a product sugars declarations as part of nutrition in the total sugars declaration, but we that contains both naturally occurring labeling of foods and beverages. The do not have any comments or other sugars and added sugars. If a product comments noted that the purpose of the information suggesting that these sugars contains only added sugars, the Codex Guidelines on Nutrition Labeling should be captured under the added procedures outlined in our guidance is to promote fair trade through sugars declaration. Therefore, they are could be used by manufacturers to international harmonization in the not included in our definition of added develop a database of values for added approach to nutrition labeling. sugars and would not be declared as sugars. However, if both naturally Other comments said that we need to added sugars on the label. In the occurring and added sugars are present, be in compliance with the TBT previous example of the enzymatic manufacturers will have to use other Agreement, which insures that technical hydrolysis of maltose from starch during information that they have to determine regulations ‘‘do not create unnecessary bread fermentation, we would not a label value. They will also have to obstacles to international trade.’’ require the maltose formed during this make and keep records to support the Some comments referred to previous process to be declared as added sugar. declared value, as discussed in part positions that we have taken with However, sugar present in corn syrup II.H.3.p. respect to Codex and said that our produced from hydrolysis of corn starch With respect to calculating the proposal to require the mandatory would be considered added sugar varying sugar content of foods that declaration of added sugars is a total because the hydrolysis was specifically contain naturally occurring and added reversal from those previous positions. done to generate mono- and di- sugars given seasonal variability and (Response) The Codex standards are glycerides. In addition, if a variability due to other growing recommendations for voluntary manufacturer purposely employs a conditions in products containing application by countries. For nutrition hydrolysis step as part of a food naturally occurring sugars, such as fruits labeling, the Codex Guidelines on manufacturing process to increase the and vegetables, manufacturers should Nutrition Labeling provide that where a sugar content of a food product (e.g. know how much sugars they add to a nutrient declaration is applied, the enzymatic hydrolysis of corn starch to product to account for the variability in declaration of total sugars should be make corn syrup in the same facility as the sugars naturally present in a food. mandatory. Although Codex does not part of the cookie-making process), we They should be able to use the amount state or imply that the declaration of would consider the sugar generated that they add to determine the value added sugars should be mandatory, the from the hydrolysis step to be added that they declare on the label. The guidelines provide for mandatory sugars, since hydrolysis was purposely variability in naturally occurring sugar declaration when ‘‘The amount of any used by the manufacturer to increase the content would not be a new variable for other nutrient [is] considered to be sugar content of the product. manufacturers to consider. relevant for maintaining a good l. Impact on nutrient databases. m. International labeling guidelines. nutritional status, as required by (Comment 202) One comment said (Comment 203) Some comments national legislation or national dietary that we failed to provide a framework noted that Codex Alimentarius guidelines.’’ ((Ref. 121) at section and/or an approved database that Guidelines on Nutrition Labeling 3.2.1.4). We have determined that the harmonizes implementation across require the labeling of total, but not declaration of added sugars in necessary industry. The comment also said that it added sugars (Ref. 121). The comments to assist consumers in maintaining is unclear how FDA-approved databases said that our proposal to require the healthy dietary practices, consistent would be revised in order to be used to mandatory declaration of added sugars with our authority in section 403(q) of calculate added sugars or to distinguish is not in line with international the FD&C Act for when the labeling of between amounts of naturally occurring guidelines on nutrition labeling. The a nutrient is required. The provision of sugars and added sugars, such as how comments said that a revision of the such information is necessary to achieve to calculate the varying sugar content of Guidelines was undertaken by a our legitimate objective of protecting a food that contains naturally occurring working group within the Codex human health. We have established and added sugars given the common Committee on Food Labeling (CCFL) elsewhere in this section that the fluctuations in foods containing and discussed at the 38th Session of the mandatory declaration of the amount of naturally occurring sugars. CCFL (2010). The comments also said added sugars in a serving of a product (Response) Under § 101.9(g)(8), we that, based on reports from that CCFL is necessary to protect human health allow for compliance with § 101.9(g)(1) meeting, the Codex Committee because scientific evidence supports through (g)(6) by use of an FDA considered the following evidentiary that healthy dietary patterns

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characterized, in part, by lower intakes the relevance of these circumstances juice concentrate. However, many other of added sugars are associated with a with respect to our objectives and the comments disagreed with the inclusion decreased risk of CVD, sugar-sweetened scientific evidence before us. of both fruit juices and fruit juice beverage consumption is associated With respect to the comments on the concentrates in the definition of added with adiposity in children, added sugars evidentiary support considered by the sugars. The comments said that 100 can lead to displacement of nutrient- CCFL on the reporting of added sugars, percent fruit juices, and 100 percent dense foods in the diet, and intake data we have addressed these points in juice reconstituted from concentrate shows that Americans, on average, are response to comments in this final rule. should not be considered to be added exceeding the recommended limit for Furthermore, we require records, as sugars. The comments suggested that added sugars consumption. As such, our appropriate, to verify the declaration of fruit juice concentrates should be requirements to include the declaration added sugars, and do not rely on considered an added sugar only if they of added sugars in nutrition labeling analytical methods, as addressed by the are not brought back to single strength and for manufacturers to make and keep WHO. In the six years since that by dilution with water in the product or records of the amount of sugars they add decision, the evidence that has by the end-user. One comment stated to their products do not constitute an developed indicates that reporting of that 100 percent juice from concentrate unnecessary obstacle to trade. Firms, added sugars is of clear benefit in terms and 100 percent juice not from whether domestic or foreign, must of public health. concentrate are nutritionally identical, include an added sugars declaration on n. Definition of added sugars. Added and there is no reason to require the label and must make and keep sugars are not currently defined by declaration of the added sugar content records, as appropriate, to verify the regulation. We proposed to define differently. One comment questioned amount of added sugars in a product. added sugars in § 101.9(c)(6)(iii) as why we are proposing to require Manufacturers already know how sugars that are either added during the different labeling for fruit juice much sugar is added to their product processing of foods, or are packaged as depending upon whether it is a stand- based on the formulation or should be such, and include sugars (free, mono- alone product or an ingredient in able to reasonably estimate the amount and disaccharides), syrups, naturally another product. Another comment of sugars added in products that occurring sugars that are isolated from stated that a juice product formulated undergo non-enzymatic browning and a whole food and concentrated so that with juice that is reconstituted from a fermentation. We also do not consider sugar is the primary component (e.g. juice concentrate would appear as if it that the records we are requiring would fruit juice concentrates), and other is making a greater calorie contribution be unnecessarily burdensome for caloric sweeteners. We also clarified in because the juice concentrate would be manufacturers to make and keep (see preamble to the proposed rule (79 FR deemed an ‘‘added sugar’’ when in fact, part II.C.1). 11879 at 11906) that the definition the calorie contribution of these two Our position on requiring the labeling would include single ingredient foods products is exactly the same. The of added sugars has developed in such as individually packaged table comments argued that, if a juice product response to additional information that sugar, and that sugar alcohols are not is sweetened with added sugars, the we did not have in the past. At the time considered to be added sugars. We underlying juice before sweetening that previous statements with respect to provided the following examples of should not be considered an added our official position on labeling of names for added sugars: , sugar. added sugars were made, the 2010 DGA corn sweetener, corn syrup, dextrose, (Response) Single strength or 100 and 2015 DGAC Report were not yet fructose, fruit juice concentrates, percent fruit juices (which, for purposes available. Based on information glucose, high-fructose corn syrup, of this document, we will refer to provided in the 2010 DGA and the 2015 honey, invert sugar, lactose, maltose, collectively as 100 percent fruit juice) DGAC Report, such as the underlying malt sugar, , raw sugar, contribute calories from sugars as well evidence used to support the 2015 turbinado, sugar, trehalose, and sucrose. as nutrients. The comments did not DGAC conclusion that there is strong We note that this is not an exhaustive provide data or other information to evidence that healthy dietary patterns list of all added sugars. demonstrate that exclusion of characterized, in part, by lower intakes Although some comments supported information on sugars from fruit juices of sugar-sweetened foods or beverages the proposed definition, other would be scientifically unjustified, are associated with a decreased risk of comments said that the proposed potentially disadvantageous for CVD and evidence that it is difficult to definition is ambiguous, confusing, and consumers, and inconsistent with meet nutrient needs within calorie will lead to inconsistent application growing expert opinion and limits when individuals consume large across the . As discussed international approach. We note that amounts of added sugars, we had reason in the following responses to comments sugars from 100 percent fruit juices have to revisit the requirement for a on the definition of added sugars, the never been considered to be added declaration of added sugars on the final rule revises the definition of added sugars in the DGA. In fact, the USDA Nutrition and Supplement Facts labels sugars in § 101.9(c)(6)(iii) that is specific Food Patterns include 100 percent fruit in the proposed rule and in the and provides clarity on issues raised in juices in the fruit group, and the DGA supplemental proposed rule. We the comments. As such, the definition of has recommended increased considered comments to the proposed added sugars can be applied by the food consumption of fruits for many years rule and the supplemental proposed industry in a consistent manner. (Refs. 28, 30, 78–83). It was not our rule and have concluded that the intent to include the sugars from 100 evidence supports the mandatory (i) Fruit and Vegetable Juice percent fruit and vegetable juices in the declaration of added sugars on the label Concentrates definition of added sugars in the to fulfill the legitimate objective of (Comment 204) Many comments proposed rule. Therefore, the final rule protecting human health. related to the inclusion of juices and does not include 100 percent fruit or With respect to the comments that juice concentrates in the definition of vegetable juices in the added sugars suggest no other country has adopted added sugars. Some comments definition. mandatory labeling of added sugars, we suggested that the definition include While fruit or vegetable juice note that the comments do not address sugars from fruit juice as well as fruit concentrates can supply the same

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nutrients as single strength or 100 be added sugars. For example, if 15 be expected in the same type of 100 percent fruit juice, they are a highly grams of concentrated apple juice, percent juice is considered added sugar. concentrated source of sugar. They may which has 6 grams of sugars, is added However, concentrated juice cocktails, be used in small quantities for purposes to sweeten an applesauce and the same drinks, or beverages do not reconstitute other than to sweeten a food; however amount (15 grams) of 100 percent apple to 100 percent juice and often contain they are increasingly added to foods for juice contains 1.7 gram of sugar, we sweeteners, such as sugar and syrup. sweetening purposes. They are would consider 4.3 grams of the sugars For these types of products, all sugar identified in the ingredient list as contributed to the applesauce (6 grams except the sugar from the juice concentrated fruit or vegetable juice. sugar in 15 grams apple juice ingredients should be declared as added Some consumers could assume that the concentrate 1.7 gram sugar in 15 grams sugar on the label. sugars that a concentrated fruit or 100 percent apple juice = 4.3 grams We note that we are also excluding vegetable juice contributes to a product added sugars) by the apple juice fruit juice concentrates which are used are beneficial because they come from concentrate to be added sugars. Another to formulate the fruit component of fruits or vegetables rather than from a example to consider is an apple juice jellies, jams, or preserves in accordance more refined source. While foods concentrate added to 100 percent pear with the standard of identities set forth sweetened with concentrated fruit or juice for the purposes of sweetening. If in § 150.140 and § 150.160 as discussed vegetable juices can be a part of a 30 grams of apple juice concentrate, in our response to comment 211. healthful diet, the sugars contributed by which contributes 10 grams of sugars is As for juice concentrates, juice the concentrated fruit or vegetable juice present in a serving of the finished concentrates may be added for many provide additional calories to a product product, the amount of added sugars different purposes and they may have just as another source of refined sugar which should be declared can be multiple functions in a food. For would provide additional calories. Over calculated by subtracting the amount of example, an juice concentrate the course of the day, small amounts of sugars present in 30 grams of 100 could be added to a muffin batter to give calories in sugar-sweetened foods and percent apple juice (3.4 grams) from the it orange flavor, to add vitamin C, and beverages can add up and can make it amount of sugars present in 30 grams of to provide sweetness. If one purpose of difficult to balance the amount of the fruit juice concentrate (10 grams of adding the juice concentrate to a calories consumed with the amount of sugar in 30 grams apple juice product is to provide sweetness, calories expended. We consider foods concentrate 3.4 grams sugar in 30 grams manufacturers should declare the sweetened with concentrated fruit or 100 percent apple juice = 6.6 grams amount of sugar provided from the juice vegetable juices to be sugar-sweetened added sugars). which is in excess of what would be foods. The 2015 DGAC concluded that Fruit juice concentrates made from provided from the same volume of the same type of 100 percent juice as added healthy dietary patterns characterized, 100 percent juice that are sold directly sugars on the label. in part, by lower intakes of sugar- to consumers (e.g. in grocery stores or We are aware that there are syrup-like sweetened foods and beverages are on the Internet) are typically reconstituted with water by consumers products made by concentrating fruit associated with a reduced risk of CVD. juice that has been processed Therefore, it is important for consumers before consumption. The packaging of these fruit juice concentrates typically specifically to remove organic acid, to be aware that when products are minerals, and insoluble fruit materials. sweetened with concentrated fruit or provides information about the amount of water that consumers should use to These types of products are not fruit vegetable juices; the extra sugars and reconstitute the juice. Concentrated juice concentrates, but are fruit syrups. calories that they contribute to products juice products must bear a percentage All of the sugar contents in these types are like any other source of added juice declaration and that declaration of ingredients should be declared as sugars. When added to foods for the may not be greater than 100 percent added sugars on the label. purpose of sweetening, we consider the (Ref. 122). The label may explain that We proposed to require manufacturers sugars in a fruit juice concentrated when the product is diluted according to make and keep records to verify the which are used for sweetening purposes to label directions, the product yields a amount of added sugars in a serving of to be added sugars. ‘‘ll percent juice from concentrate,’’ a product when the product contains We recognize that juice concentrates with the blank being filled in with the both naturally occurring and added may be added to food products in correct percentage based on the Brix sugars. If a juice concentrate is added to varying levels of concentration. For values set out in 21 CFR 101.30(h)(1), as a food and is not brought back to 100 example, a product may use juice applicable (Ref. 122). We expect that percent juice, we are unable to concentrate as an ingredient to achieve consumers will reconstitute these types determine how much of the sugars equivalent juice percentage as discussed of fruit juice concentrates to 100 percent provided by the juice is in excess of in this section (e.g. a juice drink with 50 juice based on the instructions provided what would be expected for the same percent juice) or at 100 percent juice on the label for reconstituting frozen volume of the same type of 100 percent (e.g. 100 percent juice, from fruit juice. Therefore, we do not juice, therefore, manufacturers of such concentrate) based on our juice consider 100 percent juice concentrate products must include a calculation of percentage declaration regulation in sold directly to consumers as added how they determined the amount of § 101.30 (also see our response to sugar. sugars from the juice concentrate that comment 205). An applesauce may have Accordingly, we have revised the contribute to the added sugars concentrated fruit juice added which definition of added sugars to exclude declaration. Because juice concentrates has not been reconstituted at all. frozen fruit juice concentrates from 100 contain naturally occurring sugars, all Because the nutrient profiles of fruit percent juice and to include only manufacturers of products containing juice concentrates are the same as 100 additional sugars contributed by fruit juices that are not brought back to 100 percent fruit juices, we consider the juice concentrates not reconstituted to percent strength in the finished food amount of sugars above and beyond full strength to be declared on the label. must make and keep records to verify what would be contributed by the same This approach is consistent with our how they arrived at their determination volume of the same type of juice which position that only the amount of sugar of the amount of added sugars which are is reconstituted to 100 percent juice to which is above and beyond what would contributed by the concentrated juice.

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(Comment 205) Some comments sugars that are isolated from a whole sugars, we have considered the presence noted that juice concentrates are food and concentrated so that sugar is of added sugars as a component of commonly used to adjust the Brix levels the primary component (e.g., fruit juice dietary intake and whether it is of directly expressed juice, and these concentrates)’’ are added sugars. We consistent with the concept of empty juice concentrates are not required to be recognize that there could be fruit juice calories, as discussed in the 2015 DGAC reflected in the common or usual name concentrates that do not have sugar as Report. of such juices under the regulation for the primary component. Therefore, we (Comment 208) One comment beverages that contain fruit or vegetable have revised the definition of added recommended that mono and juice (§ 102.33(g)(2)). The comments sugars to remove the language regarding disaccharides from any pure (i.e. with said that fruit juice concentrates are not naturally occurring sugars that are no added sugars) fruit ingredient, such added sugars if they qualify to be isolated from a whole food and as juices, concentrates, fruit pieces, included in the percent juice concentrated so that sugar is the pulps, and purees should not count as declaration found on beverage labels. primary component (e.g., fruit juice added sugars if these ingredients are not The comments asked us to clarify that concentrates), and instead specifically added for sweetening purposes. added sugars do not include fruit or listing the types of fruit juice (Response) We decline to revise the vegetable juice concentrates used to concentrates that we consider to be rule as suggested by the comment. We formulate 100 percent juice or 100 added sugars. agree that whole fruit, fruit pieces, percent juice blends, or dilute juice pulps, purees, 100 percent fruit juices, (ii) Intended Purpose of Sweetening beverages, and do not include juice and certain fruit juice concentrates concentrates that are added to juices (Comment 207) Many comments should not be considered added sugars and dilute juice beverages to adjust argued that sugars are an ingredient because they are nutrient rich and soluble solids content in accordance which may have multiple functions in maintain the basic properties of a fruit, with § 102.33 (21 CFR 102.33) and the a food. The comments recommended which is not considered to be an added standards of identity in parts 146 and that we exclude certain ingredients sugar. We have, in the final rule’s 156 (21 CFR parts 146 and 156). which are not added for the intended definition of added sugars, excluded (Response) We do allow for the use of purpose of sweetening a food. Most whole fruits, fruit pieces, pulps, purees, juice concentrates in the formulation of comments suggested defining added and certain concentrated fruit juices that 100 percent juice, 100 percent juice sugars based on the intended use of the are reconstituted to full strength or that blends, and diluted juice beverages sugar which has been added and not may be added to other fruit juices, under § 101.30 (percentage juice exclusively on the nature of the product. jellies, jams, and preserves under our declaration for foods purporting to be The comments would define added standards of identity. However, we beverages that contain fruit or vegetable sugars as the sum of all mono- and consider other mono and disaccharides juice), § 102.33 (beverages that contain disaccharides that are added to a food from fruit ingredients to be added fruit or vegetable juices), part 146 for purposes of sweetening the food. sugars. Sugars from fruits as well as fruit (requirements for specific standardized Other comments said that, even when juices can be isolated (removed from the canned fruit juices and beverage), and added as an ingredient in foods (as fruit), concentrated (decreased in part 156 (vegetable juices). For opposed to beverages), fruit juice volume by removing water), and consistency with our current concentrates are not always used for a stripped of nutrients such that they are regulations, we agree that juice sweetening purpose. One comment essentially sugars that provide a concentrates should be exempt from the stated that apple juice concentrates can concentrated source of calories to a food definition of added sugars if they are: (1) be added to produce a browning color without other redeeming qualities (e.g. Counted towards percentage juice as the food is heated and the sugars in fruit syrups). Therefore, we are not declaration in accordance with § 101.30 the concentrate are caramelized. Many excluding all mono and disaccharides for 100 percent juice and juice beverages yogurt manufacturers, for example, use from any pure fruit ingredient. (§ 102.33); and (2) used to standardize small amounts of fruit juice (Comment 209) Many comments the Brix values of a single species juice concentrates (such as juice opposed the inclusion of dried and consisting juice directly expressed from concentrate) in their yogurt products for concentrated dairy ingredients in the a fruit or vegetable in accordance with purposes of coloring or flavoring. The definition of added sugars. The § 102.33(g)(2). Therefore, we have comments suggested that fruit juice comments explained that a number of revised the definition of added sugars to concentrates which are not used to dairy-based ingredients are isolated make an exception for juice sweeten a food not be counted as from milk and concentrated such that concentrates which contribute to the ‘‘added sugars’’ given that they: (1) Are lactose, the naturally occurring sugar in percentage juice label declaration under not being used as a sweetener; (2) do not milk, is the primary component. § 101.30 and for Brix value materially sweeten the product when Examples of such ingredients include standardization under § 102.33(g)(2). used in the amounts necessary for their non-fat dry milk powder, dry whole (Comment 206) One comment noted intended purpose of coloring or milk, some forms of concentrated whey that, under the proposed definition for flavoring; and (3) only contain naturally and dried whey, and milk and whey added sugars, a fruit juice concentrate occurring sugars derived from fruit. permeate. According to the comments, that is 45 percent sugar, 50 percent (Response) We acknowledge that fruit under the proposed definition of added water, and 5 percent other components juice concentrates, sugars, honey, or sugars, the lactose in these dried and would not be considered an added sugar syrups may be added for many reasons concentrated dairy ingredients would be because sugar would not be the primary to a food, and they may have many considered an added sugar because it is component. The comment said that this affects in a food other than adding the ‘‘primary ingredient.’’ is a potential loophole that sweetness. As previously discussed in The comments also explained that manufacturers could exploit. this part, we have evidence that excess lactose is not added to foods for the (Response) The comment is calorie consumption from added sugars purpose of sweetening, and is instead referencing the language in our is a public health concern. In added for other functional properties. proposed added sugars definition which determining which sugars should be Lactose contributes viscosity and would state that ‘‘naturally occurring included in the definition of added mouthfeel, serves as a fermentation

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source in yogurt, increases shelf-life, dairy ingredients as sources of ‘‘added dairy ingredients, except lactose as provides foaming properties which are sugars.’’ defined in § 168.122, are not included in beneficial for cakes and frozen desserts, The comments noted that dairy the definition of added sugars. and serves as an emulsifier in sausages, ingredients containing lactose may be (iii) The ‘‘No Added Sugars’’ Nutrient soups, sauces, beverages, and salad added so that a dairy product meets the Content Claim dressing. Milk and whey protein standards for identity. One comment concentrates, some of which contain stated that California’s standard for fluid (Comment 210) Many comments lactose as the primary component, are milk mandates higher milk solids than argued that the proposed definition is typically used to increase the protein the Federal standard of identity, inconsistent with the regulation for the content of foods or as salt replacers to requiring the addition of nonfat dried ‘‘no added sugars’’ nutrient content reduce the amount of sodium in a broad milk or condensed skim milk containing claim in § 101.60(c)(2) because the range of foods because of their unique lactose. The comment said that the regulation recognizes that ingredients salt enhancement characteristics. lactose in these milk solids should not that contain sugars do not preclude the The comments said that it would not be considered an added sugar because it use of the claim unless the ingredients be possible to make foods if lactose were is not added for sweetening purposes. ‘‘functionally substitute for added used as the sole sweetener in the The comments also noted that for sugars.’’ The comments noted that, if the formulation, replacing the traditional standardized dairy products such as definition of added sugars is not sugar (e.g., sucrose). Lactose has about milk and yogurt, current regulations do consistent with the ‘‘no added sugars’’ one sixth of the sweetness of sucrose. not require that a sweetener be added. nutrient content claim regulation, The amount of lactose required to The comments said that the exclusion of products could conceivably bear ‘‘no achieve the same level of sweetness dairy-based ingredients as sweeteners in added sugars’’ claims but have a gram would compromise basic attributes of the standards is acknowledgement by amount of added sugars declared on the the product itself. For example, if FDA that the lactose in these dairy- Nutrition Facts label, which would be lactose were added to a typical ice derived ingredients is not primarily confusing and misleading. One cream, the amount of lactose that would added to provide sweetness. comment provided the example of a have to be added to sweeten the product (Response) Lactose is a major juice that is reconstituted from juice would either depress the freezing point component of milk solids. Many concentrate which meets the Brix of the ice cream mix such that the common concentrated or dried dairy standard for single-strength juices. The product would not be able to freeze ingredients, such as nonfat dry milk and comment said that such a product can under normal conditions, or if it did whey powder contain lactose as the factually claim that it is ‘‘unsweetened’’, freeze, would result in an extremely primary component. We agree that but the manufacturer would have to gritty texture defect which would make many dairy ingredients, even though disclose the amount of added sugars the product unacceptable to consumers. high in lactose, are not considered a under the proposed rule. One comment said that the common source of added sugars. Dairy Other comments noted that in the and usual names for dairy ingredients ingredients and nutritive carbohydrate 1993 preamble to our rule defining the would cause confusion with added sweeteners are often considered to be in ‘‘no added sugars’’ nutrient content sugars declarations. For example, two separate ingredient categories claim, we clarified that sugars inherent according to the comment, we allow during food formulation. The proposed in a product, such as those found in manufacturers to identify skim milk, definition of added sugars captured fruit juices, would not disallow a no concentrated skim milk, and nonfat dry such dairy ingredients because it added sugars claim. One comment milk as ‘‘skim milk’’ or ‘‘nonfat milk’’ in included naturally occurring sugars that further noted that we advised that ‘‘the an ingredients listing. In addition, two are isolated from a whole food and addition of water to a juice concentrate nonfat yogurt products could be concentrated so that sugar (in this case to produce a single strength juice would formulated to the same final product lactose) is the primary component. We not preclude the use of a ‘‘no added composition, and the ingredient did not intend to capture dairy sugar’’ claim; however the other statements for both could read ‘‘nonfat ingredients under this portion of the conditions for the claim must still be milk and culture.’’ However, under the definition. Therefore, we have removed met’’ (see 58 FR 2328). The comment proposed definition of added sugars, a the language from the definition of said that this statement makes it clear yogurt made using fluid skim milk as added sugars stating that naturally that the presence of a fruit juice the sole dairy ingredient would have no occurring sugars that are isolated from concentrate in a food does not prevent added sugars, while a yogurt made a whole food and concentrated so that the use of a no added sugar claim. using nonfat dry milk powder as the sugar is the primary component are Another comment suggested that, in sole source of dairy solids would have added sugars. addition to fruit juice concentrates that to declare added sugars on the Nutrition FDA regulations, at § 168.122, are reconstituted to single strength in Facts label. establish a standard of identity for 100 percent juices, juice blends, juice One comment said that, when dry lactose. The standard of identity for drinks, and juice drink blends also milk ingredients are added, consumers lactose states that it must contain not should be excluded from the definition may be confused about the source of less than 98 percent lactose, mass over of added sugars because doing so would added sugar in the food if the food mass (m/m), calculated on a dry basis. align with the current definition of no contains no obvious sweetener. For We have historically considered added sugars. example, if a food with a dairy-based purified lactose as a sweetener as it is (Response) The comments expressed ingredient, such as nonfat dry milk or included in 21 CFR part 168 under concern that fruit juice concentrates whey protein concentrate, would be sweeteners and table syrups. We added to a single strength juice or dairy required to declare the inherent lactose consider lactose as defined in § 168.122 ingredients that are not added for the as added sugars on the Nutrition Facts to be an added sugar. Lactose, as intended purpose of sweetening can label and the food contained no easily defined under § 168.122 would be currently bear the ‘‘no added sugars’’ identifiable source of added sugars, captured under the definition of added claim, but sugars from the concentrated consumers reading the ingredient list sugars because it is a free disaccharide. fruit juice or dairy ingredient would likely would not expect or recognize Therefore, with the revised definition, have to be declared as added sugars

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under the proposed definition. We have certain fruit juice concentrates fall (Response) We have recognized revised the rule to exclude certain fruit within what we consider to be added through our health claim for juice concentrates that are added to sugars. Because fruit juice concentrates noncariogenic carbohydrate sweeteners juices and that dilute juice beverages to may be used as ingredients in fruit and dental caries that the sugars D- adjust soluble solids content in jellies, jams, and preserves, we have tagatose and isomaltulose may reduce accordance with § 102.33 and the excluded those fruit juice concentrates the risk of dental caries (tooth decay). standards of identity in parts 146 and that are used in accordance with the However, D-tagatose and isomaltulose 156. We are also excluding fruit juice standards of identity in § 150.140 and are chemically sugars. Because these concentrates that are reconstituted to § 150.160 from the definition of added sweeteners are chemically sugars, and 100 percent single strength juice. In sugars. However, any additional sugars other substances are included or addition, we have removed the language that are added to the jelly, jam, or excluded from the definition of sugars from the definition of added sugars preserve would need to be declared as and added sugars based on whether they which states that naturally occurring added sugars on the label. are a free mono or disaccharide rather sugars that are isolated from a whole than on their physiological effects, food and concentrated so that sugar is (v) Dried Fruits including D-tagatose and isomaltulose is the primary component are added (Comment 212) Some comments said consistent with how we have sugars. Therefore, dairy ingredients that dried fruit added to a product characterized other sugars. As such, we containing lactose, except lactose as should not be considered to be an added are not excluding D-tagatose and defined in § 168.122, are no longer sugar. isomaltulose from the added sugars captured under the definition of added (Response) We agree that dried fruits declaration. However, manufacturers sugars. With these revisions to the which have not had any sugar added to may still use the noncariogenic definition of added sugars, there is no them should not be considered to be an carbohydrate sweeteners and dental longer a conflict between the definition added sugar because they are essentially caries health claims on their products to of added sugars and the requirements a dehydrated whole fruit and still retain make consumers aware that sugars for use of the ‘‘no added sugars’’ the nutrients and other components of contained in a food may reduce the risk nutrient content claim. a whole fruit. However, if additional of dental caries. We decline to define added sugars (Comment 214) Some comments sugar is added to a dried fruit, the sugar based on the intended purpose of the would exclude Allulose (psicose) from added to the dried fruit must be ingredient as suggested by the the definition of added sugars because declared on the label as added sugars. comments because we are providing ketohexose sugars, such as Allulose, do specifics of what we consider to be (vi) Other Sugars/Sweeteners not provide calories, are not added sugars in the definition. In metabolized, and do not raise blood addition, in determining which sugars (Comment 213) One comment would sugar levels. should be included in the definition of exempt isomaltulose and D-tagatose (Response) As discussed in our added sugars, we have considered the from labeling as added sugars due to response to comment 124, we received presence of added sugars as a their effect on reducing the risk of a petition on this subject after the component of dietary intake and dental caries. The comment said that the comment period closed. We intend to whether it is consistent with the proposed declaration for added sugars address this issue at a later date when concept of empty calories, as discussed would not allow for adequate we have had time to consider the in the 2015 DGAC Report. information to be provided to the information presented in the petition. consumer about carbohydrates such as (Comment 215) Some comments (iv) Fruit Jellies, Jams, and Preserves isomaltulose (a disaccharide) and D- stated that the proposed language, (Comment 211) Several comments tagatose (a monosaccharide) that are which states that ‘‘other caloric suggested that fruit jellies, jams, and ‘‘sugars’’ from a regulatory standpoint, sweeteners’’ are considered added preserves not be considered as added but at the same time have very different sugars, is confusing and unclear. One sugars. The comments noted that fruit and beneficial physiological properties comment provided the example of jellies, jams, and preserves are subject to than traditional ‘‘sugars.’’ The comment applesauce, which can be used to standards of identity set forth in noted that isomaltulose and D-tagatose replace oil in baking. In this example, § 150.140 and § 150.160 and are are noncariogenic carbohydrate unsweetened applesauce contains no manufactured using certain fruit and sweeteners, and products containing added sugars, but can be used to both fruit juice ingredients in combination these sweeteners can bear the dietary replace an oil and sweeten baked goods. with added sugars. One comment noncariogenic carbohydrate sweeteners (Response) We agree that the language suggested that it is appropriate for such and dental caries health claim if they that states that ‘‘other caloric’’ ingredients, regardless of whether they meet the requirements of § 101.80. The sweeteners are considered to be added are derived from cane sugar, fruit juice comment also stated that these dental sugars may not be clear to syrup, fruit juice concentrates, etc., to health benefits of isomaltulose and D- manufacturers or consumers. We have count towards an added sugars tagatose can also be the subject of a removed this language from the declaration when used as sweeteners. health claim under EU regulation 432/ definition of added sugars because The comment said that characterizing 2012. The comment said that, aside caloric sweeteners, which are fruit and fruit juices in jellies, jams, and from the dental health benefits, chemically sugars, are free mono or preserves (before the addition of isomaltulose and D-tagatose are low- disaccharides and are captured sweeteners) should be excluded from glycemic carbohydrate(s) resulting in a elsewhere in the definition. the definition of added sugar because reduced blood glucose response and they do not serve as sugar substitutes, that this health effect is the subject of (vii) Other Comments and are not ‘‘added’’ to a food for EU health claim 432/2012. The (Comment 216) Some comments purposes of sweetening a food. comment argued that such a health noted that ingredients such as fruit juice (Response) The definition of added benefit provides the basis for a concentrates, high fructose corn syrup, sugars excludes fruits and 100 percent structure-function claim under the honey, and molasses contain significant fruit juices. However, sugars from FD&C Act. amounts of water (e.g., 30 percent). The

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ingredients may contain a range of these foods are nutrient rich. However, need to collect nutrient information for naturally occurring constituents besides products such as maple syrups or honey ingredients in their products from sugars (e.g., polysaccharides, are included in the ‘‘empty calories’’ or suppliers. Manufacturers have the , vitamins, minerals, etc.). ‘‘calories for other uses’’ category in the ability to select which suppliers they Therefore, to avoid overstating the USDA Food Patterns. Therefore, we use. If a supplier is not willing or able amounts of added sugars, the comments decline to exclude sugars from honey to provide information about the added said that it is important to take into and maple syrup from the added sugars sugars content of an ingredient, the account the actual ‘‘sugars’’ content of definition. manufacturer may wish to consider the ingredients. The comments (Comment 218) One comment stated another supplier. suggested adding language to clarify that that consistency is needed in the With respect to the comment the quantity of added sugars declared in definition of added sugars across suggesting that manufacturers may have labeling will include only the actual Federal Agencies as well as by difficulty obtaining information about ‘‘sugars’’ portion of the ingredient. scientists, health professionals, the added sugars content of ‘‘better for (Response) We agree that some manufacturers, and others. The you’’ formulated foods, manufacturers ingredients containing sugars, such as comment identified fruit juice need to obtain information about the syrups, contain water and other concentrate as one example of added sugars content of all ingredients components that are not sugars, and that inconsistency among Federal Agencies. in order to provide accurate labeling, those components should not be The comment cited a paper on the regardless of whether they are used to considered as part of the added sugars development of USDA estimates of formulate ‘‘better for you foods.’’ declaration. Therefore, when such added sugars (Ref. 123). (Comment 221) One comment would ingredients are included in foods, only (Response) When establishing a expand the added sugars definition to the sugar portion of the ingredient regulatory definition for the purposes of encompass all added sweeteners. should be declared on the label. The nutrition labeling, we consider other (Response) It is not clear from the definition of added sugars states that regulatory aspects such as the impact on comment which sweeteners that the free mono and disaccharides are other regulations. We expect that comment is suggesting are not included considered added sugars, thus water establishing a regulatory definition of in an added sugars declaration. and other components of sugar- added sugars for the purpose of Therefore, we are not revising the added containing ingredients are not added nutrition labeling will help other sugars definition in response to the sugars and should not be declared as Federal Agencies and the scientific comment. such. We have also revised the community in determining a definition o. Establishing a DRV and mandatory definition to say ‘‘sugars from syrups’’ for added sugars for Federal guidelines, declaration of the percent DV for added to clarify that only the sugars programs, and research. sugars. component of the product should be (Comment 219) One comment would (i) Mandatory Declaration of a Percent declared as added sugars. not consider incidental additives or DV and Whether a DRV Should Be (Comment 217) Several comments containing sugars, such as Established would not consider natural sources of dextrose, which are not added for sugar (e.g., honey or maple syrup) to be sweetness as added sugars. (Comment 222) Many comments both added sugars. One comment would (Response) The comment did not to the proposed rule and the exempt natural, unrefined honey and explain what ‘‘incidental additives’’ are. supplemental proposed rule discussed other natural liquid or semi-liquid, However, we disagree that dextrose establishing a DRV that can be used to unrefined, un-concentrated, whole-food should be excluded from the definition calculate a percent DV for added sugars sweetening agents because they are of added sugars. Dextrose is a sugar, as well as a mandatory declaration of a whole food products in an unrefined, and, when added to a food, it acts in the percent DV for added sugars on the un-concentrated, whole-food form. same manner as other types of added label. Most comments favored Conversely, the comment suggested that sugars. establishing a DRV and requiring the other sweeteners which are extracted, (Comment 220) Some comments said percent DV declaration of added sugars. refined, and concentrated such as agave it will be difficult for manufacturers to Many comments to the proposed rule syrup, maple syrup, and evaporated obtain information about added sugars recommended establishing a DRV for cane juice syrup should be considered content of sourced ingredients that they added sugars of 10 percent of calories, added sugars. get from suppliers. The comments and provided several rationales to (Response) We disagree that all questioned whether ingredients used in justify the suggested DRV. The natural sources of sugar which have not the formulation that are not an isolated comments said that, since the 1977 been processed or refined should not be sugar but are part of a compound Dietary Goals, health officials have considered added sugars. In ingredient must be labeled. One consistently recommended an upper determining which sugars should be comment noted that, aside from the limit of 10 percent of calories from included in the definition of added ingredients used in traditional food added sugars. The comments referred to sugars, we have considered the presence processing, there are ingredients that are the WHO recommended limit of 50 of added sugars as a component of used in ‘‘better for you’’ formulated grams or 10 percent of total calories dietary intake and whether it is foods that would be required to be listed from added sugars and the American consistent with the concept of empty on the label. Heart Association recommendation to calories, as discussed in the 2015 DGAC (Response) The added sugars limit added sugars consumption to 25 Report. The processing history (e.g., declaration in the finished product grams per day for women and 37.5 concentration or refinement) does not includes added sugars present as sub- grams per day for men. The comments entirely determine whether or not sugar ingredients. For example, if a cookie also noted that the 1992 USDA Food in an ingredient is added sugar. For product uses jams as an Guide Pyramid suggested an upper limit example, natural sources of sugar ingredient, the added sugar present in of 6, 12, and 19 teaspoons of sugars, present in foods, such as whole fruits, the strawberry jam would count towards respectively, for diets of 1,600, 2,200, 100 percent juice, and dried fruits, are the added sugars declaration for the and 2,800 calories, respectively. This not considered added sugars because finished cookie product. Manufacturers comes to 7, 10, and 13 percent of calorie

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intake, respectively, for an average of 10 Literacy and Health Numeracy proposed value, if the value is percent of total calories from added documents that most Americans have determined to be incorrect at a future sugars. One comment said that the 2010 limited numeracy skills, and disparities date, it will remain in the public’s mind DGA stated that no more than 5 to 15 exist in those skills. The comment long after it has been proven to be percent of calories should come from a further stated that providing simpler, incorrect. combination of solid fats and added clearer food labeling information is (Response) Consumers need to know sugars. The comment stated that this needed to reach a larger segment of the how much added sugars are in a serving implies that added sugars should be less population, and suggested that of a product in order to maintain than 10 percent of calories. Another providing a percent DV declaration may healthy dietary practices. As discussed comment quoted a pediatric be an easier way for consumers with in part II.H.3, our rationale for the endocrinologist who says that a ‘‘dose’’ limited numeracy skills to understand declaration of added sugars for the of added sugars of up to 50 grams a day an added sugars declaration. general U.S. population is focused on poses little risk for metabolic or chronic In contrast, many comments opposed assisting consumers in maintaining disease, but that the amount consumed establishing a DRV for added sugars and healthy dietary practices by providing by Americans is toxic. the mandatory declaration of a percent the information that consumers need to One comment to the proposed rule DV for added sugars. The comments construct a healthful dietary pattern that suggested that the discretionary calorie said there is no scientific basis upon meets nutrient needs within calorie allowance from the USDA Food Patterns which to base a DRV for added sugars. limits and is associated with a presented in the 2005 DGA could serve Other comments said that we should not decreased risk of chronic disease. While as a basis for a DRV. The comment establish a DRV for added sugars or the gram declaration for added sugars suggested that, using the food patterns require the percent DV declaration for gives consumers the information that provided in the 2005 DGA at the 2,000 added sugars because the declaration of they need to construct a healthy dietary calorie level, one would have a limit of any information related to added sugars pattern that is low in added sugars, it 267 discretionary calories to use on is not scientifically supported. The does not provide the information that solid fats and added sugars (assuming comments’ rationale relates to our basis they need in order to put the amount of no alcohol consumption). The for requiring an added sugars added sugars in a serving of a product discretionary calorie allowance could be declaration, and we address those topics in the context of their total daily diet. divided equally between solid fats and are provided elsewhere in this part. The gram amount of added sugars also added sugars resulting in a limit of no The comments also opposed the does not give consumers the more than 133 calories, 33 grams, or 8 mandatory declaration of a percent DV information that they need to determine teaspoons of added sugars per day. This for added sugars because sugars are if a food is relatively high or relatively would result in a DRV for added sugars converted to other products during low in added sugars or a frame of of 6 percent of total calories. processing (caramelization, Maillard reference that they can use to determine Other comments in favor of a percent browning, and fermentation), and thus how to include a food in their overall DV declaration suggested that a percent the amount declared on the label may be diet. The percent DV declaration DV declaration is necessary for inaccurate for some products. (We provides that missing piece of consumers to be able to put the amount respond to comments pertaining to non- information that will allow consumers of added sugars in a serving of a food enzymatic browning and fermentation to more easily compare products and into the context of their total daily diet. in part II.H.3.k and have determined determine the relative contribution that The comments said that, without a DV, that it is possible for manufacturers of a serving of a food will provide towards consumers could only compare the products which undergo these chemical their diet. relative amounts of added sugars among reactions to provide a reasonable After publication of the proposed products, but would not know how approximation of the amount of added rule, the 2015 DGAC recommended that much of a day’s worth of added sugars sugars in a serving of their product.) Americans limit their consumption of a food contains. The comments said that Many comments also said that added added sugars to a maximum of 10 the percent DV advises the consumer of sugar is not a necessary nutrient and percent of total calories (Ref. 19). The how much of a recommended intake of should be avoided or should not be 2015 DGAC based this recommendation that nutrient is provided by a particular consumed in any amount. The on modeling of dietary patterns, current food. The comments also suggested that comments said that it is inappropriate added sugars consumption data, and a a percent DV declaration could help for us to recommend the consumption published meta-analysis on sugars parents and other caregivers make of any amount of added sugars in the intake and body weight. We considered informed decisions about the food diet. One comment suggested that added the evidence that the 2015 DGAC relied products children consume and be more sugars should be viewed similarly to on in making this recommendation, and confident that their intake of added trans fats because they are not essential tentatively concluded in the sugars does not exceed healthy daily in the diet and are detrimental to health. supplemental proposed rule that limits. One comment provided survey The comment said that we should not limiting consumption of added sugars to data showing that consumers would like set a recommended level of added 10 percent of daily calories is a to have a DV for added sugars on the sugars because, like trans fats, reasonable goal for consumers to label. Americans should be consuming as achieve and would assist consumers in Many comments supporting a little added sugars as possible in their choosing and maintaining a healthful mandatory declaration of a percent DV diet. dietary pattern. We proposed to require of added sugars also suggested that the One comment said that a percent DV the mandatory declaration of a percent information is necessary because added declaration for added sugars just DV for added sugars, and we proposed sugars consumption is associated with confuses the public, many of whom a DRV of 50 grams for added sugars for the risk of chronic diseases and health- have diabetes, and should be focused on children and adults 4 years of age and related conditions such as diabetes, their intake on total carbohydrates older from which the percent DV can be CVD, and metabolic syndrome. rather than sugars or added sugars. calculated. The DRV of 50 grams is One comment noted that the 2014 Another comment said that, because determined by first multiplying the IOM workshop summary on Health there are no studies which support the 2,000 reference calorie intake by 10

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percent (2,000 × 0.1 = 200 calories) and diet relative to individuals with lower With respect to the suggestion that, if then by dividing the resulting 200 calorie needs. the DRV for added sugars is determined calories by 4 calories per gram for While consumers are interested in to be incorrect later, the DRV will carbohydrates (200 ÷ 4 = 50 grams). We seeing a DV for added sugars on the remain in the public’s mind long after proposed a DRV of 25 grams of added label, as discussed in part II.C.1, it has been proven to be incorrect, a sugars for children 1 through 3 years of consumer interest alone cannot be used change in the science related to added age. A 1,000 calorie reference amount to justify a label declaration. There is a sugars in the future should not prevent would be used to calculate the DRV for need for a percent DV declaration for us from establishing a DRV at this time children under the age of 4 (1,000 added sugars so that consumers can put that is based on currently available calories × 0.1 = 100 calories and 100 the amount of added sugars in a serving evidence. Science evolves over time, calories ÷ 4 calories per gram for of a product into the context of their and it is possible that we could have carbohydrates = 25 grams). total daily diet so that they can meet additional evidence in the future that Before proposing a DRV for added nutrient needs within calorie limits and would lead us to re-evaluate the DRV for sugars, we considered the approaches construct a healthy dietary pattern that added sugars. In fact, we are updating suggested in comments to the proposed is associated with a reduced risk of DRVs and RDIs for a number of different rule for establishing a DRV of 10 percent CVD. nutrients on the label based data and of total calories for added sugars, but We disagree with the comment information that has become available declined to accept the comments’ suggesting that we should take the same since 1993. various approaches for supporting a approach that we have taken with trans (Comment 223) Some comments to DRV of 10 percent of calories from fat and not establish a DRV for added the proposed rule recommended that we added sugars because the approach sugars because Americans should be commission the IOM to review the provided a recommended limit for consuming as little added sugars in their evidence and recommend a figure that added sugars, which was not based on diets as possible. The current evidence could be used as the basis for a DV. The total added sugars information (e.g. the on added sugars does not show a linear comments suggested that a quantitative relationship with chronic disease risk, WHO recommendations which are limit will help consumers reduce added and therefore, the evidence does not based on ‘‘free sugars’’ and include fruit sugars by giving them a specific target support limiting added sugars to as little juices), because it is not clear how the or goal to work towards. in the diet as possible, similar to current recommended limits were derived and recommendations for trans fat. In fact, (Response) We have evidence that whether they were based on any individuals can carefully incorporate added sugars are a public health scientific data or evidence (i.e., AHA limited amounts of added sugars into a concern, and a percent DV declaration recommendation and recommendation healthy diet. The USDA Food Patterns that is calculated based on a DRV for from an endocrinologist), or because the suggest that individuals who need added sugars will assist consumers in 2015 DGAC provided updated USDA between 1,000 and 3,200 calories per putting the amount of added sugars in Food Patterns that are specific to added day can reasonably consume between 4 a serving of a product into the context sugars, unlike previous editions of the to 9 percent of their calories from added of the total daily diet. We also have USDA Food Patterns included in the sugars and still meet their nutrient scientific evidence to support limiting 1992, 2005, and 2010 DGAs. needs within calorie limits. calories from added sugars to less than With respect to the comments As for the assertion that a percent DV 10 percent of calories that can be used suggesting that we do not have a declaration for added sugars will to establish a DRV. We are acting on the scientific basis to establish a DRV for confuse the public, the comments did evidence that we currently have added sugars, we have a recommended not provide evidence to support the available to us because a percent DV limit for added sugars of no more than assertion. Some comments submitted declaration for added sugars is 10 percent of total calories that was consumer research that included a important to assist consumers in developed using food pattern modeling. percent DV declaration for added sugars maintaining healthy dietary practices. We address these issues later in this in the labels, and the participants were (Comment 224) Some comments part. shown the percent DV declaration. opposed establishing a DRV and We want to clarify that the DRV for However, the research did not isolate requiring the mandatory declaration of a added sugars should not be viewed as the effect of the percent DV declaration percent DV for added sugars when we a recommended amount for from that of the gram amount have not established a DRV for total consumption. The percent DV declaration, so it is not possible to sugars. The comments said that declaration for nutrients, which is determine if the effects seen in those establishing a DRV and requiring the calculated based on the DRV or RDI, studies were due to confusion about a percent DV declaration for added sugars represents a reference value that serves percent DV declaration for added sugars without a DRV or percent DV as a general guide to consumers. It or more generally about information on declaration for total sugars will cause would be inappropriate to view all the label related to added sugars. Other confusion. One comment questioned DRVs and RDIs as recommended consumer research showed that our conclusion that there is adequate amounts to consume because some are participants reported similar responses evidence to establish a DRV for added based on amounts to limit (e.g., sodium about percent DV declarations for sugars but not total sugars, especially and saturated fat) while others are based saturated fat and for added sugars, when much data used to support the on amounts that individuals should which suggests that a percent DV declaration of added sugars was based strive to consume (e.g., calcium and declaration for added sugars may not on research looking at total sugars. potassium). Furthermore, individuals have specifically caused the confusion Another comment said that a percent have varying nutrient and calorie needs, shown in the research. In both cases, it DV declaration for total sugars is more so consumers may need more or less of is unclear what conclusions related to important than one for added sugars a particular nutrient based on their confusion about a percent DV because a percent DV for added sugars specific nutrient needs. As such, declaration for added sugars can be does not represent the true caloric or consumers with higher calorie needs drawn from the evidence provided in metabolic contributions of sugars to a can consume more added sugars in their comments. food product.

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(Response) As discussed in the product makes towards the total daily participants spent statistically preamble to the proposed rule (79 FR diet. significantly less time on added sugars 11879 at 11902), we do not have a To the extent that comments are than on carbohydrate on the Proposed reference value upon which we can suggesting that we should be able to label and spent statistically the same derive an appropriate DRV for total establish a DRV for total sugars because amount of time on carbohydrate and sugars. The IOM has not set a UL for much evidence which is being used to added sugars on the Proposed label as sugars. We also do not have scientific support an added sugars declaration is that on carbohydrate on the Current evidence to support a reference value on total sugars, we disagree. Total label. The comment also asked how we for total sugars from another U.S. sugars includes both naturally occurring made the distinction between consensus report. However, we have and added sugars. Although a small participants’ attention on carbohydrate considered the scientific evidence that number of the studies that we are and on added sugars on the proposed supports the 2015 DGAC relying on to support an added sugars label. Another comment questioned recommendation (which we note is also declaration included fruit juices, which whether adding percent DV for added included in the 2015–2020 DGA) to contain naturally occurring sugars, the sugars will increase consumer attention limit calories from added sugars to no vast majority of the evidence was on to the added sugars declaration, more than 10 percent of calories. only added sugars, or on foods and including the percent DV for added Although this reference level is different beverages to which sugars have been sugars. The comment stated that, than other scientifically supported added. Furthermore, we are basing the although percent DV for added sugars quantitative intake recommendations DRV on food pattern modeling and not was not specifically tested in our eye- that have been used to establish DRVs on the Chapter 2 analysis related to tracking study, the study showed that: and RDIs for other nutrients, it was dietary patterns and health outcomes. (1) There were no statistically derived from food pattern modeling of Although we do not currently have a significant differences between the a healthy dietary pattern that is low in reference value that can be used to current and the proposed formats in the added sugars. We are focusing on what establish a DRV for total sugars, proportion of participants who noticed healthy dietary patterns look like and information could become available in percent DV information or the share of what information is needed for the future that may cause us to time they spent on the information; and consumers to construct a healthy dietary reconsider. (2) the added sugars declaration (Comment 225) One comment said pattern. The USDA Food Patterns that received relatively little attention (on that we should not require a percent DV support limiting consumption of the proposed label). The comment declaration for added sugars because calories from added sugars to less than concluded that these results suggest that other countries have evaluated added 10 percent of calories per day, are the percent DV information receives low sugars and have concluded that the examples of the type of healthy dietary priority from consumers or the declaration of added sugars should not pattern that consumers could use to information is not prominent or easy to be mandatory as there is little evidence reduce their risk of disease. Therefore, understand and it is not clear if to support such identification. although a limit of calories to no more (Response) We address similar including the percent DV for added than 10 percent of calories provides a comments related to the declaration of sugars will enhance consumer attention reference value that is different than the gram amount of added sugars on the to the added sugars declaration. other scientifically supported label in part II.H.3. (Response) We disagree that our eye- quantitative intake recommendations, it (Comment 226) Some comments tracking study findings on the percent was derived using a dietary pattern suggested that additional research needs DV information and on added sugars approach, which is consistent with our to be conducted to determine how much declaration mean that adding percent basis for requiring the declaration of added sugars is harmful before DV for added sugars will not increase added sugars on the label. establishing a DRV for added sugars or consumer attention to the added sugars In response to the comments requiring a percent DV declaration on declaration. Our study did not include suggesting that consumers will be the label. a percent DV for added sugars on any confused if there is a percent DV (Response) We disagree that labels tested, did not compare declaration for added but not total additional research on added sugars participants’ responses to a label with a sugars, the comments did not provide should be conducted before we establish percent DV declaration for added sugars data or other information to support this a DRV for added sugars or to require a and responses to a label without such a assertion. A declaration of the gram percent DV declaration on the label. declaration, and did not examine amount of sugars has been on the label Although a linear relationship has not participants’ attention to this percent for over 20 years without a declaration been established between added sugars DV information. Therefore, the cited of a percent DV for sugars, so consumers intake and risk of disease upon which findings cannot be used to infer the are familiar with the information that a UL can be based, we do have evidence amount of attention the percent DV for will be on the label for total sugars. showing that consumption of too much added sugars would receive by With respect to the comment stating added sugars is harmful to health. We consumers if and when it is present on that it is more important to require a also have scientific evidence that labels. We also disagree that one can percent DV declaration for total rather supports limiting added sugars infer from our eye-tracking study than added sugars because a percent DV consumption to less than 10 percent of findings that an added sugars for added sugars would not represent calories that includes modeling of declaration, including the percent DV, is the true caloric or metabolic healthy dietary patterns. of no value to consumers. Our decision contributions of sugars to a food (Comment 227) One comment, as part to require the declaration is not product, we have concluded that of its argument that the declaration of determined by how much attention it consumption of too many added sugars added sugars information is not material receives from the study participants. has health implications. Consumers and provides no added importance to Instead, we are requiring the declaration need specific information on how much consumer product purchase or use of added sugars on the label because added sugars is in a serving of a product decisions, stated that, based on its own consumers need the information in and the contribution that a serving of a research of our eye-tracking study data, order to maintain healthy dietary

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practices. We clarify that, in our eye- added sugars relates to consuming a upon when setting other DVs, it is not tracking study, the label element healthy dietary pattern that meets the only source of information on which ‘‘carbohydrate’’ on the Proposed label nutrient needs within calorie limits and we can rely. While we recognize that a included these areas of the label: Total is associated with a decreased risk of DRV that is derived primarily based on carbohydrate, dietary fiber, sugars and chronic disease. The food pattern food pattern modeling is different from protein. ‘‘Added sugars’’ was considered modeling that was done for the USDA a UL that is determined by IOM, a DRV in the study as a separate area on the Food Patterns provides a conceptual based on food modeling is a valid label. framework for selecting the kinds and approach that provides consumers with amounts of foods of various types, a tool that they can use to help them put (ii) DRV of 10 Percent of Total Calories which together, provide a nutritionally the amount of added sugars in a serving From Added Sugars satisfactory diet. Therefore, the of a product into the context of their In the supplemental proposed rule, scientific evidence that supports total daily diet. In response to the we proposed to establish a DRV for limiting calories from added sugars to comments suggesting that the process added sugars of 10 percent of total less than 10 percent of calories per day that is used by the IOM to set ULs is calories (50 grams for children and that was derived from food pattern more scientifically rigorous than food adults 4 years of age and older and 25 modeling is related to our basis for pattern modeling, the IOM process is grams for children 1 through 3 years of requiring the mandatory declaration of different than food pattern modeling, age). The scientific evidence from the added sugars for the general population, but we have the ability to use different 2015 DGAC Report supports Americans which is focused on consumption of a approaches to set DRVs based on the keep added sugars intake below 10 healthy dietary pattern. information we have available to us if percent of total energy intake, based on (Comment 229) Several comments the information will assist consumers in modeling of dietary patterns, current recommended that the IOM re-evaluate maintaining healthy dietary practices. consumption data, and a published the added sugars intake We also disagree with the comment meta-analysis on sugars intake and body recommendations. The comments said stating that all other DRVs were weight (80 FR 44303 at 44308). We that the IOM is the appropriate body to established based on IOM DRI reports. concluded that the scientific establish a DRI upon which to base a Some DRVs were set based on scientific information from the 2015 DGAC Report DRV for added sugars because: evidence from consensus reports or by provides a basis for FDA to establish a • The scope of work for the IOM DRI other means. In the Reference Daily DRV for added sugars. The 2015 DGAC committees is specifically to develop Intakes and Daily Reference Values relied on both food pattern modeling the DRIs, which are intended to inform proposed rule, we proposed to establish information from the USDA Food nutrition labeling; eight DRVs for persons 4 or more years Patterns as well as information from the • The DRI process provides a rigorous of age based on information presented Te Morenga et al. paper for their and methodological process to in the ‘‘Diet and Health: Implications for recommendation to limit added sugars determine nutrient values used in Reducing Chronic Disease Risk report,’’ to a maximum of 10 percent of total nutrition labeling and includes the ‘‘Surgeon General’s Report on daily caloric intake. guidance on when a percent DV may be Nutrition and Health,’’ and the ‘‘Report (Comment 228) One comment cited established; of the Expert Panel on Population work sponsored by ILSI North America • The IOM DRI considers the risks of Strategies for Blood Cholesterol that suggests a lack of strong evidence adverse effects associated with low as Reduction’’ (55 FR 29476 at 29483). The for a dietary recommendation to limit well as high nutrient intakes; DRVs were finalized in the 1993 added sugars to no more than 10 percent • The IOM adheres to a structured Reference Daily Intakes and Daily of calories. The comment cited reviews risk assessment approach to ensure that Reference Values final rule (58 FR 2206, by ILSI North America related to dental the evidence is systematically and Jan. 6, 1993). caries and BMI which led it to conclude consistently evaluated; and As new evidence emerges, we will that frequency of consumption of • The IOM ensures and fosters consider whether we need to update the fermentable carbohydrates is a driver of transparency in decision-making. DRV. In the future, there may be more dental caries along with oral hygiene, The comments said that we have information available that would allow exposure to fluoride, and salivary flow based all other DRVs on the IOM DRI us to establish a DRV for added sugars and composition and that sustained reports. The comments noted that more that is based on a linear relationship overconsumption of energy, irrespective than a decade has passed since IOM with the risk of disease. We intend to of the energy sources, leads to weight concluded in 2005 that, based on the monitor the evidence related to added gain. The comment concluded from the data available on dental caries, sugars and consider whether changes evidence reviewed that the scientific behavior, cancer, risk of obesity, and need to be made to the label based on evidence is lacking with respect to risk of hyperlipidemia, there is the evidence in the future. quantifying a level of sugar or added insufficient evidence to set a daily (Comment 230) One comment referred sugar relative to health outcomes. intake for total and added sugars or to to the DGA recommendation that (Response) The comment provided a set an upper limit for added sugars. The Americans consume fatty fish due to review of the evidence related to a comments said that the process the their omega-3 fatty acid content, but specific relationship between intake of DGAC used to develop its noted that there is no reference value for added sugars and risk of disease. As recommendations did not have the omega-3 fatty acids. The comment said discussed in our response to comment scientific rigor of the IOM process. The that added sugars are no different than 224, we are establishing a DRV for comments recommended that we defer omega-3 fatty acids and suggested that added sugars using a different type of any final rule, especially changes added sugars can be reduced in the diet, intake recommendation than what has related to the declaration of added even while there is not sufficient been used for other nutrients with a sugars, until the IOM can review the evidence to recommend that they be linear relationship with disease risk, available evidence and develop a DRI limited to a particular intake level. which was developed primarily by food for added sugars. (Response) We do not agree that pattern modeling. Our rationale for (Response) While the IOM has been omega-3 fatty acids are an appropriate requiring the mandatory declaration of the source of data that we have relied comparison to added sugars. For

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example, we do not have scientific (Response) Although we have stated We also recognize that individuals evidence to support a reference value in the past that use of food composition may be able to accommodate more or for omega-3 fatty acids. We include a data, menu modeling, or dietary survey less than 10 percent of calories in their reference value for added sugars in the data is not a suitable approach to diet while meeting nutrient needs final rule to provide information that determine DRVs, these statements were within calorie limits. The purpose of a allows consumers to put the amount of made in the context of establishing percent DV is to provide context to the nutrient into the context of the total DRVs for nutrients where a causal consumers so that they can determine daily diet. relationship between consumption of how a food fits within their diet. The the nutrient and risk of disease exists. percent DV declaration can also allow (iii) Food Pattern Modeling Added sugars are different than trans for consumers to determine if a product (Comment 231) Food pattern fats in that there is a linear relationship is relatively high or low in a nutrient modeling was used to support the 2015 between consumption of trans fats and based on a reference amount. Therefore, DGAC recommendation that Americans LDL cholesterol whereas, for added a DRV of 10 percent of total calories should limit added sugars to a sugars we do not have the type of direct should not be viewed as a maximum of 10 percent of total caloric association with risk of disease, based recommended consumption level, but intake. For the 2015 DGAC, USDA used on the evidence we are using to support rather a reference amount that a modeling process to develop new a mandatory declaration of added sugars consumers can use as a guide. USDA Food Patterns based on different for the general U.S. population, that we We disagree with the comment that types of evidence: The ‘‘Healthy do with trans fats. When a linear the USDA Food Patterns have not been Vegetarian Pattern,’’ which takes into relationship with disease risk is present, scientifically tested for health benefits. account food choices of self-identified there are other, more appropriate, ways Schroeder et al. assessed the effects of vegetarians, and the ‘‘Healthy to establish a DRV for the nutrient. a diet based on the USDA Food Patterns Mediterranean-style Pattern,’’ which Because the current evidence supports used in the 2010 DGA, a Korean diet, takes into account food group intakes more of a dietary pattern approach than and a typical American diet on blood from studies using a Mediterranean diet a specific nutrient-disease approach, it lipid (fat) levels and blood pressure in index to assess dietary patterns. The is appropriate to use methods for the overweight, non-Asian individuals in USDA Food Patterns provide suggested development of a DRV for added sugars the United States with elevated LDL amounts of foods to consume from the that are based on constructing a healthy cholesterol (Ref. 101). They found that basic food groups, subgroups, and oils dietary pattern that is low in added total cholesterol and LDL cholesterol to meet recommended nutrient intakes sugars. The food pattern modeling that significantly decreased when subjects at 12 different calorie levels. They also was done when developing the healthy were on fed a diet that is consistent with show the number of calories from solid U.S.-style, the healthy Mediterranean- the USDA Food Patterns. Although the USDA Food Patterns in the 2015 DGAC fats and added sugars that can be style, and healthy vegetarian patterns Report differ slightly from those accommodated within each calorie provides a model of what a healthy included in the 2010 DGA, they were level, in addition to the suggested dietary pattern should look like at designed in a very similar manner with amounts of nutrient-dense forms of different calorie levels. Therefore, the the goal of meeting nutrient needs foods in each food group. use of food pattern modeling to support a DRV for added sugars is closely within calorie limits. Many comments questioned the use of (Comment 233) Some comments aligned with our rationale for requiring food pattern modeling to establish a objected to the use of food pattern the mandatory declaration of added DRV for added sugars. The comments modeling to establish a DRV for added sugars for the general U.S. population noted that, when we considered sugars because, according to the on the label. establishing a DRV for trans fat using comments, it lacks a scientific basis. menu modeling, we said that we (Comment 232) Some comments The comments said that the reference continue to adhere to the approach of noted that the 2010 DGA states that the value of 10 percent of total calories that determining DRVs for a nutrient based USDA Food Patterns are only one the 2015 DGAC produced using on the nutrient’s association with a example of suggested eating patterns modeling is a mathematical calculation specific health outcome (e.g., LDL and that the USDA Food Patterns have of empty calories ‘‘left over’’ after the cholesterol levels), yet we proposed to not been scientifically tested for health recommendations for food groups and use food pattern modeling to establish a benefits. nutrients in the different dietary DRV for added sugars rather than data (Response) We acknowledge that the patterns have been met. It does not on an association with a health USDA Food Patterns are only one signify a level at which negative outcome. The comment noted that we example of a healthy eating pattern and metabolic effects occur. The comments stated previously in the proposed rule, that it is possible for individuals to asserted that the calories available for as well as in 1993, that we do not consume other patterns that are solid fats or added sugars in the ‘‘empty consider the use of food composition associated with a decreased risk of calories’’ category would completely data, menu modeling, or dietary survey disease. However, analyses using diet change based on one addition or data as a suitable approach to determine quality index scores show that there is deletion of a serving of food. DRVs. The comments explained that a great deal of consistency in what is The comments cited a number of menu modeling involves individual considered a healthy dietary pattern that limitations of food pattern modeling, foods, whereas food pattern modeling is associated with a decreased risk of such as: involves food group composites, but the disease (Ref. 86). Although it is possible • It is not evidence-based or nutrient process for menu and food pattern to eat other healthy dietary patterns, it specific so conclusions cannot be drawn modeling is similar. The comments said would be very difficult to meet nutrient with respect to health-related outcomes; that the issues that we raised for not needs within calorie limits by • It was designed to study the impact using menu modeling for setting a DV consuming enough of the other of an overall diet, not to evaluate the for trans or saturated fat are the same for components of a healthy dietary pattern effect of a single nutrient; a food pattern modeling approach and while consuming high levels of added • The nutritional adequacy was would therefore apply to added sugars. sugars. derived from a limited number of

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representative foods, limiting the ability chronic disease. However, we do have Americans ages 2 years and older within to extrapolate the nutritional adequacy evidence that added sugars are a public their calorie limits. We disagree with of the food patterns beyond these health concern, and that consumers the comment stating that the ‘‘representative foods;’’ need information about of added sugars contribution of the representative foods • Table sugar was used as a surrogate in a serving of food to maintain healthy to total daily added sugar intake was not for added sugar in the USDA Food dietary practices. Consumers also need considered or reported. About 7 percent Patterns. As such, the model only to know how that amount of added of these representative foods contain identifies how much pure sugar can be sugars in a serving of food fits into the some added sugars (Ref. 124). For all consumed after achieving nutrient context of their total daily diet. added sugars in the USDA food requirements, and not how to Although we do not have the same type patterns, the nutrients in granulated incorporate foods with added sugars of reference amount for added sugars white sugar were used for the nutrient into a dietary pattern; that we do for other nutrients that are profile; however, this does not limit the • The modeling is based on a associated with chronic disease risk, the application of the information for use as misperception that added sugars scientific evidence supporting a limit in a DRV. While sugars are added to many provide no additional nutritional value consumption of added sugars to a nutrient-dense foods, and the and are merely ‘‘empty calories.’’ Sugars maximum of 10 percent of total calories assumption is made for the purposes of are added to many nutrient-dense foods; provides a reference value that can be the USDA Food Patterns that the sugars • The contribution of the used to give context to the gram do not come along with other nutrients, representative foods to total daily added declaration for added sugars. The DRV, they provide a way to identify how sugar intake was not considered or in general, should not be viewed as a much added sugars one could consume reported; precisely defined limit, but rather a in various forms in the diet while • It presents one modeling scenario guide to help consumers when selecting meeting nutrient needs within calorie with one set of assumptions and foods and determining how much of limits. The empty calorie allotment in presents no uncertainty around their those foods they can eat within a the USDA Food Patterns gives assumptions. Micronutrient healthful diet. Americans a general sense of how many requirements in the USDA Food Pattern We recognize that empty calories calories from added sugars they can are not always based on established allotment in the USDA Food Patterns incorporate into a nutrient-dense diet intakes i.e., the USDA Food Patterns represents an amount that is left over without exceeding calorie limits. It is up calcium intakes can range from 110 once all other requirements of the diet to each individual to determine if he or percent of the RDA at the lower calorie are met. We also recognize that she wants to consume those extra range to 138 percent of the RDA at the conclusions related to health outcomes calories in the form of a food that is highest, the RDA range for iron is 110 cannot be drawn from food pattern nutrient dense (e.g., cereal, yogurt, or to 265 percent. As caloric levels modeling. However, the dietary patterns dried fruit with sugar added to them) or increase, there is a disregard for the approach to setting a DRV is consistent whether to consume it in a less nutrient- percent adequacy of micronutrients; with the dietary pattern approach that dense form such as a cola. The Nutrition • The model did not test if nutritional we are taking to the evidence that we Facts label also provides factual adequacy could be achieved at added have considered to support the information that consumers can use to sugar intake levels above 10 percent and mandatory declaration of added sugar. make choices about their diet. was not tested to assess efficacy or Rather than basing the declaration on a With respect to the suggestion that sensitivity; nutrient-disease relationship, we are micronutrient requirements in the • The USDA food modeling (with few considering how a dietary pattern that is USDA Food Patterns are not always exceptions) does not take into lower in added sugars is characterized, based on established intakes, we agree. consideration fortification in the food in part, by lower intakes of sugar- Instead, they are based on nutrient supply, which could dramatically sweetened foods and beverages. requirements for specific age and sex reduce the number of food servings in We disagree with the comment that groups. However, the nutrient profiles the USDA Food Patterns and increase said that the USDA Food Patterns were of the food groups and subgroups used the calories designated as leftover; and designed to study the impact of an to construct the USDA Food Patterns are • Food formulations and food overall diet and not to evaluate the calculated and weighted by consumption is continually changing. effect of a single nutrient. The USDA consumption of the U.S. population. It With continuing changes to food Food Patterns were not designed to is not clear what the comment meant composition databases, information study nutrient or diet/disease when it said that, as caloric levels derived from food pattern modeling relationships. They provide a increase in the USDA Food Patterns, could change frequently. Using such conceptual framework for selecting the there is a disregard for the percent changing information to update daily kinds and amounts of foods of various adequacy of micronutrients. To the values could be costly to manufacturers types, which together, provides a extent that the comment is suggesting for frequent changes to labels especially nutritionally satisfactory diet. The that at higher calorie levels, the amounts when based on an approach that has no USDA Food Patterns assist Americans of nutrients provided in the USDA Food public health relevance. The comment in meeting their nutrient requirements Patterns exceed nutrient said that we chose, in part, to not use based on different caloric needs. In recommendations, as long as the food similar type data (i.e., census data) for general, food patterns, such as the pattern does not exceed the UL for using a population weighted approach USDA food patterns, translate nutrients, it should not be a concern if for setting daily values for vitamins and recommendations on nutrient intake the USDA Food Patterns exceed nutrient minerals. into recommendations on food intake recommendations. (Response) As previously noted in our based on selective nutrient-dense foods. In developing the dietary intake response to comment 224, we do not During the modeling of the USDA patterns, USDA built nutrient adequacy have the type of quantitative intake intake patterns, 292 representative foods in its dietary pattern by selecting a recommendation for added sugars that were chosen in order to provide healthy nutrient-dense food to represent each we have for other nutrients that have an food intake patterns to meet nutrient item cluster (Ref. 19). The selection of independent association with the risk of needs for various age/sex groups of item clusters is based on the

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consumption amount of the U.S. remainder (55 percent) allocated to solid that the assignment of 45 percent of population (more than 1 percent of the fats. calories to added sugars is not weighted amount). A limited number of Some comments opposed the associated with a healthy diet. The the representative foods for an item assignment of 45 percent of empty purpose of the USDA Food Patterns is cluster were fortified foods. These calories to added sugars based on to assist consumers in putting intake fortified representative foods were current consumption data. The recommendations for nutrients, foods, selected when fortification of the food is comments said that consumption data and food groups into practice so that mandatory, such as folate in enriched changes, so the assignment of 45 percent they can construct a healthful diet. After cereal grains, the food is typically of calories to added sugars could nutrient needs are met, the left over fortified, or when the market leader for change. Furthermore, the comments calories are empty calories which the food is fortified and its consumption noted that Americans are consuming too Americans can choose to consume in in the population was consistent over many calories from added sugars, so the form of solid fats and/or added time. Most nutrients in the USDA Food using current consumption data to set a sugars. Therefore, how the empty Patterns come from non-fortified food limit for added sugars consumption is calorie allowance was derived was sources. It is possible that, if other inappropriate. One comment said that based on getting adequate amounts of fortified foods are used as representative current intake of solid fats and added nutrients from a variety of foods in the foods in the model, the quantities of sugars has no relevance to the intended diets to make up a healthy diet. foods in the USDA Food Patterns may use of the USDA Food Patterns (e.g., (Comment 235) One comment said increase or decrease thereby increasing nutrient density). The intent is for these that we should not base a DRV for or decreasing the empty calorie leftover calories to be used at the added sugars on the USDA Food allotment. The USDA Food Patterns are discretion of the individual as to how Patterns because they have not been a theoretical model that is used to help they consume these calories all added validated. The comment noted that, Americans put the dietary sugars, all solid fats, or a combination. although the 2015 DGAC Report states recommendations into practice. The The comments also said that the that an extensive effort was made to amount of added sugars that could be assignment of 45 percent of calories to validate the food patterns, the DGAC reasonably consumed while eating a added sugars in the USDA Food did not actually test the patterns in a healthy dietary pattern may be slightly Patterns is not linked to a health-related clinical study. Instead, it plotted the more or less depending on the foods outcome or a healthy diet. USDA food groups against those found included when modeling the dietary (Response) We agree that in published hypothesis-based dietary patterns; however, they show that, consumption data changes and the pattern studies on a graph. The across calorie levels, it would be very designation of 45 percent of empty comment questioned whether the data difficult to consume significantly more calories to added sugars could change. provided by USDA to support a than 10 percent of calories as added Consumption of added sugars could validation of the USDA food patterns is sugars while still consuming enough change in the future, which may prompt empirical evidence that the USDA food foods from the food groups to meet a change to the recommendations and patterns are evidence-based guides for nutrient needs within calorie limits. the how empty calories from solid fats food consumption because, the We agree that nutrient intake data can and added sugars are divided in the comment said, the majority of food be affected due to factors such as USDA Food Patterns. If changes are group intakes from the USDA Food nutrient database changes, made to the USDA Food Patterns in the Patterns do not actually fall within the reformulation, or change of dietary future related to added sugars, we will range of intakes in the published dietary behaviors. This is a limitation with the consider whether and how those pattern study recommendations and use of all intake data, and affects changes impact the DRV for added because the majority of dietary pattern evidence that we rely on for other label sugars. We also acknowledge that index studies used for the exercise did declarations as well (e.g., assessment of Americans are currently consuming too not included added sugars criteria. nutrient adequacy when determining much added sugars, so the assignment (Response) The comment is what the nutrients of public health of 45 percent of the empty calories suggesting that the USDA Food Patterns concern are). The DRV of 10 percent of allotment could reflect are not evidence based guides for food calories from added sugars is based on overconsumption. However, Americans consumption and have not been the data that we have available to us at also are consuming too many solid fats, validated because it is comparing them this time. We plan to monitor intake so the relative proportion of empty to dietary pattern studies where dietary data and other evidence and calories assigned to both solid fats and quality indices are used to evaluate information on added sugars and will added sugars reflects overconsumption dietary patterns and health outcomes. consider whether and how it affects of both components of the diet. Comparing the USDA Food Patterns, both an added sugars declaration and a Although the empty calorie allotment is which have been developed through the DRV for added sugars in the future. intended to be used by Americans based process of menu modeling, to studies (Comment 234) The 2015 DGAC on their discretion, using consumption evaluating certain dietary patterns and Report explains that, for purposes of the data to provide a percentage of empty health outcomes is not an appropriate USDA Food Pattern Food Groups, the calories from solid fats and added way to assess the validity of the USDA term solid fats and added sugars is an sugars can be consumed within a Food Patterns. The USDA Food Patterns analytic grouping, but the 2015 DGAC healthy dietary pattern reflects how have been developed to be used as an elected to use the term ‘‘empty calories’’ Americans currently are using those left example of a nutritionally adequate and for the food grouping in the USDA Food over calories. The modeling of dietary balanced diet. Although the purpose is Patterns which includes solid fats and patterns for the USDA Food Patterns is not to provide an example of a diet that added sugars. The empty calorie done for a different reason than to is associated with decreased risk of allowance in the USDA Food Patterns is evaluate a dietary pattern for health- disease, Schroeder et al. did assess the 8 to 19 percent of calories, and, based related outcomes, so the assignment of effects of the USDA Food Patterns from on current consumption patterns, 45 45 percent of calories to added sugars is the 2010 DGA and found that total and percent of empty calories were allocated not expected to be linked to a health- LDL cholesterol were significantly lower to limits for added sugars with the related outcome. However, we disagree in participants on the 2010 DGA diet

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compared to typical American diet (Ref. upper level at 2,300 mg/day based on a consuming more than 4 to 9 percent of 101). The proper assessment of the public health outcome, even though their calories from added sugars. USDA Food Patterns is to consider they said it is generally agreed this is Because Americans are consuming whether they meet current dietary not a reasonable intake level that can be approximately 13.4 percent of their recommendations. The 2015 DGAC achieved in the near future. The calories, or even more in some segments evaluated the Healthy U.S.-style, comments said that current intakes are of the population, the evidence supports Mediterranean-style, and Vegetarian- used to estimate prevalence of that Americans are consuming too many style Patterns and determined that they overconsumption by comparing to a calories from added sugars. meet nutritional goals without excess maximum intake level tied to an adverse (Comment 237) Some comments calories, and use a variety of foods (Ref. outcome rather using current intake to questioned our reliance on findings and 19). set the maximum intake level. recommendations in the 2015 DGAC (Comment 236) In the preamble to the (Response) Americans are still Report for establishing a DRV for added supplemental proposed rule (80 FR consuming 13.4 percent of their calories sugars. The comments asked whether 44303 at 44307 through 44308), we from added sugars, which is a we took the conclusions and noted that the 2015 DGAC based its significant proportion of calories. recommendations from the 2015 DGAC recommendation that Americans limit Despite the fact that consumption of at face value or whether we conducted their added sugars intake to no more added sugars may have declined in our own rigorous review of the scientific than 10 percent of total energy intake, recent years, consumption among the evidence. The comments (which were in part, on current consumption data. U.S population remains high. While submitted in response to the proposed For many of the same reasons that current consumption data was a rule before the 2015 DGAC Report comments opposed the use of current consideration in the 2015 DGAC’s became available) said that the DGAC consumption data to allocate 45 percent recommendation, it was used more to Report has not yet been sanctioned by of available empty calories in the USDA show that limiting calories from added the Secretaries of Health and Human Food Patterns to added sugars, some sugars is a reasonable goal for Service and the U.S. Department of comments generally opposed the use of Americans to strive for than it was to Agriculture, which are under current consumption data to support a establish a precise limitation. Congressional mandate to ensure that DRV of 10 percent of total calories. The Furthermore, current consumption data the general dietary guidance for the comments noted that consumption of was not the only information that was American public in the DGA is based on added sugars has been declining in used by the 2015 DGAC to support a the preponderance of scientific and recent years although the prevalence of recommendation to limit added sugars medical knowledge at the time of the overweight and obesity have increased. to a maximum of 10 percent of total report. The comments noted that the One comment said that intake data do calories. Information from the USDA Secretaries not only consider the not support ‘‘added sugars’’ intake as a Food Patterns showing that one can recommendations in this advisory major source of increased caloric intake. reasonably accommodate approximately report to ensure the Dietary Guidelines The comment said that, in the past 40 4 to 9 percent of calories in a diet that are based on the preponderance of years, U.S. per capita consumption of meets nutrient needs within calorie science and medical knowledge, but sugar/sucrose declined by 33 percent as limits as well as data information from also take into consideration public obesity and other serious diseases a published meta-analysis, also comment, a process that has not yet increased. The comment noted that a supported the 2015 DGAC’s been completed. The comments said recent analysis of U.S. National Health recommendation. that our reliance on information and and Nutrition Examination Survey We explain, in our response to other conclusions from the DGAC Report is (NHANES) data found that ‘‘added comments in part II.H.3.o, that we are setting a new precedent. sugars’’ consumption has declined to considering how added sugars interact Other comments said that the DGAC 14.6 percent of energy, which is a with other components of a healthy was not convened with the purpose and decrease of 19.3 percent over a period dietary pattern. When too many added intent of establishing specific reference of 8 years (2000 to 2008) and as the 2015 sugars are consumed, it makes it values for labeling. The comments noted DGAC noted intake continues to difficult to meet nutrient needs within that the 2015 DGAC did not include a decrease and current intake is now 13.4 calorie limits and it also makes it carbohydrate and/or ‘‘added sugars’’ percent of energy. The comment also difficult for one to consume the expert. The comments suggested that a said that, according to USDA data, recommended amount of other foods robust review by carbohydrate and Americans are consuming 425 more that make up a healthy dietary pattern sugars experts familiar with the entire calories per person per day than they that is associated with a decreased risk body of high-quality scientific literature did in 1970 and of these 425 calories of CVD. Because our basis for requiring is necessary for establishing a reference only 38 calories are attributed to ‘‘added the mandatory declaration of added value for added sugars. The comments sugars’’ intake (2009). sugars on the label for the general U.S. said that the lack of ‘‘added sugars’’ Other comments said that a maximum population is related to consumption of expertise on the DGAC not only calls limit for added sugars should not be a healthy dietary pattern that is low in into question the legitimacy of the based on consumption data but rather added sugars, it is appropriate to DGAC’s ‘‘added sugars’’ upper daily on science with meaningful endpoints. establish a DRV that is based, in part, on intake limit intake recommendation, but While current intake of added sugars (13 information derived from modeling of also disputes the validity of the 2015 percent of calories) is above but near a healthy dietary patterns. The IOM has DGAC Report as a ‘‘consensus report’’ maximum level of 10 percent of not set a UL for added sugars so we do from which we can establish a DRV. calories, suggesting that this current not have a maximum intake level tied to One comment said that the IOM intake makes 10 percent a reasonable an adverse outcome to which we can recommendations are based on thorough goal is also not a health-based approach compare current intake levels. The and systematic reviews of the scientific for setting a maximum intake level. The USDA Food Patterns show that it would literature; a process that usually takes 2 comments noted that current average be difficult for Americans to consume a to 3 years to complete by experts in the intake of sodium is approximately 3,400 nutritionally adequate diet within field of investigation. The comment said mg/day, but that the IOM panel set the calorie requirements if they are that the DGAC did not conduct a

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thorough review of the evidence to 10 percent of daily total energy intake were identified and composite results determine its recommendation to limit based on lowest versus highest intakes from those studies provided ‘‘no consumption of added sugars to less from prospective cohort studies (Ref. evidence of difference in weight change than 10 percent of calories. The 125). The Te Morenga et al. study is a as a result of difference in sugar intakes comment said that the DGAC did not systematic review and meta-analysis of when energy intakes were equivalent.’’ convene the Added Sugars Working randomized controlled trials and The comments concluded that it cannot Group until a few months before the prospective cohort studies that was be assumed that ‘‘free sugars’’ is linked DGAC process concluded. The comment commissioned by the WHO to look at to fatness when excess energy intake suggested that, because the Added the relationship between dietary sugars was not taken into consideration in the Sugars Working Group was not and body weight (Ref. 125). Several meta-analysis for non-isoenergetic established earlier on, the DGAC had comments criticized the Te Morenga studies; only 90 days to collect, review, paper, stating that: • The authors noted significant synthesize and formulate conclusions • It is a meta-analysis commissioned heterogeneity (the studies included in on the extensive body of literature on by the WHO and not a U.S. consensus the meta-analysis were not undertaken sugars, with no experts in carbohydrate report; in the same way using the same metabolism on the 2015 DGAC. • Although Te Morenga et al experimental design) and potential bias (Response) Since the publication of concluded that among free living people in some of the trials examined; the supplemental proposed rule, the consuming ad libitum diets, intake of • The authors concluded that Secretaries of the U.S. Department of free sugars or sugar-sweetened comparison of the lowest to highest Health and Human Services and the beverages is a determinant of body intakes in cohort studies was U.S. Department of Agriculture released weight, the comments noted that in the compatible (not supportive as the 2010 the 2015–2010 DGA (Ref. 28). During WHO report on sugars intake for adults DGAC Report indicates) with a the process of developing the 2015– and children, they graded their own recommendation to restrict intake to 2020 DGA, government officials evidence for free sugars intake and body below 10 percent of total energy. considered the recommendations from weight for both adults and children to However, there is no evidence of a dose- the 2015 DGAC as well as comments be of moderate quality at best; response relationship, a key component from the public. The scientific evidence • The Te Morenga et al. interpretation of elucidating potential mechanisms, in the 2015–2020 DGA related to added did not establish a reference value for was provided through the array of sugars corroborates the scientific intake of free sugars and body weight; research studies evaluated; evidence in the 2015 DGAC. The • The definition of free sugars differs • The findings are consistent with the scientific evidence supports limiting from our proposed definition of added 2010 DGA advice that states, ‘‘Foods calories from added sugars and sugars. The WHO defines ‘‘free sugars’’ containing solid fats and added sugars saturated fats and reducing sodium as all monosaccharides and are no more likely to contribute to intake. Americans can achieve this by disaccharides added to foods by the weight gain than any other source of consuming an eating pattern low in manufacturer, cook or consumer, plus calories in an eating pattern that is added sugars, saturated fats, and sodium the sugars that are naturally present in within calorie limits; and as well as by cutting back on foods and honey, syrups and fruit juices. In • The research included in Te beverages higher in these components to particular, the definition of free sugars Morenga et al. is not current. Less than amounts that fit within healthy eating includes natural sugars from fruit juices 10 percent of the studies included in the patterns. A healthy eating pattern which are not included in our proposed report were published after 2010, more accounts for all foods and beverages definition of added sugars; than 50 percent of the studies are over within an appropriate calorie level and • Te Morenga et al. investigates the 10 years old, more than 70 percent of limits saturated fats and trans fats, relationship between added sugars the trials (in children and adults) are added sugars, and sodium. The intake and body weight rather than CVD over 10 years old, and 80 percent of the scientific evidence, from the 2015 risk; randomized trials on adults are over 10 DGAC (that is corroborated by the 2015– • The authors’ conclusion that any years old. 2020 DGA) supports the role of sugars on body weight results Other comments questioned our recommendation from the 2015 DGAC from alteration in energy balance rather reliance on the Te Morenga et al. paper for Americans to consume less than 10 than a physiological or metabolic due to a number of factors and percent of calories per day from added consequence of monosaccharides or suggested that the results of this study sugars. Therefore, because the 2015– disaccharides. The paper further stated should not be extrapolated to nutrient- 2020 DGA is in agreement with the 2015 that ‘‘the extent to which population- dense foods and beverages with small DGAC, the concern related to us basing based advice to reduce sugars might amounts of added sugars. an added sugars declaration on the reduce risk of obesity cannot be The comments questioned our evidence from the 2015 DGAC have extrapolated from present findings’’ reliance on a meta-analysis for the been addressed. because few studies lasted longer than proposed DRV of 10 percent of calories 10 weeks; from added sugars and said that a meta- (iv) The Te Morenga et al. Meta- • Many studies in the meta-analysis analysis does not provide sufficient Analysis fail to provide any comparative scientific support to make an intake (Comment 238) The 2015 DGAC associations between total sugar intakes recommendation of 10 percent of reported that its recommendation to and metrics of obesity (i.e., BMI, energy. limit added sugars to a maximum of 10 adiposity measures) in comparison with One comment noted that the Te percent of total daily caloric intake is their analyses of free sugar intakes. The Morenga et al. paper was published and supported by scientific evidence on comments said that this may be a source available to us at the time of the March added sugars and chronic disease risk of bias for their conclusions that only 2014 proposed rule, but we said, in the conducted by the DGAC. The 2015 ‘‘free sugars’’ contribute to weight gain preamble to the proposed rule (79 FR DGAC Report also says that the data and fatness; 11879 at 11906), that we reviewed analyzed by Te Morenga et al. supports • Of the 77 studies evaluated for full scientific evidence and limiting added sugars to no more than review, only 11 isoenergetic studies recommendations of consensus reports

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and concluded that we could not total calories (50 grams for children and the 2015 DGAC and consumption data propose to establish a DRV for added adults 4 years of age and older and 25 supported a recommendation to limit sugars. The comment questioned why grams for children 1 through 3 years of added sugars to a maximum of 10 we now have determined that the Te age). We said that the 2015 DGAC percent of total daily caloric intake. We Morenga et al. paper provides suitable Report recommended that Americans did not propose to establish a DRV evidence to establish a DRV, but not keep added sugars intake below 10 based on recommendations from the when we developed the proposed rule. percent of total energy intake, and that WHO, nor are we finalizing a DRV for (Response) We are relying on recommendation was based on added sugars based on information from the USDA Food modeling of dietary patterns, current recommendations from the WHO. Patterns showing that it would be consumption data, and a published (v) The Iom Suggested Maximum Intake difficult for one to consume more than meta-analysis on sugars intake and body Level of 25 Percent or Less of Energy 10 percent of their calories from added weight (80 FR 44303 at 44308). We From Added Sugars sugars and still be able to consume concluded that the scientific enough of the other components of a information from the 2015 DGAC report (Comment 241) Some comments healthy dietary pattern to meet nutrient provides a basis for FDA to establish a noted that the 2005 IOM Macronutrient needs within calorie limits to support a DRV for added sugars. The 2015 DGAC Committee concluded that ‘‘based on DRV for added sugars. We are also relied on both food pattern modeling the data available on dental caries, relying on consumption data showing information from the USDA Food behavior, cancer, risk of obesity, and that, on average, Americans are Patterns as well as information from the risk of hyperlipidemia, there is consuming 13.4 percent of calories from Te Morenga et al. paper for its insufficient evidence to set a UL for added sugars. Therefore, because we are recommendation to limit added sugars total or added sugars. Although a UL is not relying on the Te Morenga et al. to a maximum of 10 percent of total not set for sugars, a maximum intake paper to support a DRV for added daily caloric intake. level of 25 percent or less of energy from sugars, we need not address specific After further consideration, we are added sugars is suggested based on the comments on the merits of the Te establishing a DRV for added sugars of decreased intake of some micronutrients Morenga et al. paper. We have 10 percent of total calories, and are of American subpopulations exceeding determined that, because we are relying on information from the USDA this level’’ (Ref. 75). The comments focusing on a healthy dietary pattern, Food Patterns as well as current asked why we did not use this 25 the interactions that sugar-sweetened consumption data for this percent level as the basis for a DRV for foods and beverages have with other determination. added sugars because it was determined components of a healthy dietary pattern, (Comment 240) Some comments said using an evidence-based approach. and how that healthy dietary pattern is it would be inappropriate to base a DRV (Response) We have concluded that associated with health outcomes, and for added sugars on recommendations using the IOM suggested maximum basing a DRV for added sugars on data from the WHO. The comments said that intake level of 25 percent or less of that takes into consideration the whole the WHO recommendation to limit energy from added sugars to set a DRV of a healthy dietary pattern, we do not intake of free sugars to 10 percent of for added sugars would be need to rely on evidence related to a energy intake was based on evidence for inappropriate. As noted in the IOM direct association between added sugars dental caries and not body weight or macronutrient report, the IOM could not and risk of disease for a DRV. It also CVD risk. In reference to the Te establish a UL for total or added sugars suggests that a DRV for added sugars of Morenga et al. paper, the comments said based on the evidence, and the less than 10 percent of total calories is not an that there was no effect of sugar and 25 percent of total energy unrealistic reference value. We note that measures of weight found in children recommendation should not be viewed the 2015–2020 DGA also bases the based on the reviews of randomized as a UL. Setting a DRV for added sugars recommendation to limit intake of controlled trials and only a minor effect that is one quarter of a 2,000 calorie diet calories from added sugars to less than was found in cohort studies with intake would result in a DRV for added sugars 10 percent per day on food pattern of sugar-sweetened beverages but no of 125 grams (2,000 × 0.25 = 500 calories modeling and national intake data on other sugar-containing foods. and 500 ÷ 4 = 125 grams). Such a DRV intakes of calories from added sugars Other comments referred to the new for added sugars would be greater than that demonstrate the public health need WHO conditional recommendation to the DRV for protein and fat, and would to limit calories from added sugars to further reduce free sugars intake to 5 be approximately 42 percent of the DRV meet food group and nutrient needs percent of total calories and said that for total carbohydrate. Although DRVs within calorie limits. The 2015–2020 this recommendation appears to be are reference values rather than precise DGA states that, for most calorie levels based solely on data from several recommended intake levels, the percent in the USDA Food Patterns, there are studies that are more than 50 years old. DV declaration, which is calculated not enough calories available after The comments noted that the findings of based on the DRV, gives the consumer meeting food group needs to consume the evidence-based review are described a general idea of how much of a nutrient 10 percent of calories from added sugars by the review authors as of ‘‘very low should be consumed (79 FR 11879 at and 10 percent of calories from quality’’ (Ref. 126). 11926). A DRV of 25 percent of calories saturated fats and still stay within (Response) Although the WHO would indicate to consumers that foods calorie limits. commissioned a systematic literature containing a significant amount of (Comment 239) One comment said review to answer a series of questions added sugars are relatively low in added that our scientific justification for relating to the effects of sugars on excess sugars. Such a DRV also would send the proposing a DRV for added sugars of 10 adiposity that resulted in the Te message to the American public that percent of total energy is not clear Morenga et al. paper, the 2015 DGAC consuming one fourth of one’s calories because it is based on menu-modeling considered the evidence discussed to in the form of added sugars is and is not included in the meta-analysis the Te Morenga et al. paper and appropriate. If a consumer chooses to conducted by Te Morenga et al. concluded that the evidence reviewed eat those added sugars in the form of (Response) We proposed to establish by Te Morenga et al., as well as food foods that contain few or little other a DRV for added sugars of 10 percent of pattern modeling analysis conducted by nutrients, it would be very difficult, if

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not impossible, to consume a healthful consume 5 percent or less of total more than 24 grams for children ages 7 dietary pattern that includes adequate calories from added sugars, those to 10. amounts from food groups, meets recommendations are not consistent (Response) We decline to revise the nutrient needs, and is within calorie with those of U.S. consensus reports. rule as suggested by the comments. limits. As such, a DRV for added sugars Furthermore, current consumption data DRVs should be viewed as reference that is 25 percent of total calories could shows that Americans, on average, are amounts that consumers can use to have negative public health consuming 13.4 percent of calories from determine how a serving of a food fits implications. Therefore, we are not added sugars, and the USDA Food within their total daily diet. A DRV for setting a DRV for added sugars based on Patterns show that it is possible to children between the ages of 4 through the IOM suggested maximum level of 25 construct a healthful dietary pattern that 11 or 7 through 10, as the comments percent of total calories. includes more than 5 percent of calories suggested, could clutter the label, cause confusion, and draw attention to the (vi) DRV of 10 Percent of Total Calories from added sugars. The USDA Food Patterns were developed using added sugars declaration because more Many comments to the supplemental representative foods with very little or space would be required for two proposed rule discussed whether a DRV no added sugars or solid fats. Even with separate percent DV declarations on the of 10 percent of total energy intake is using representative foods with little or label. In addition, the approach we have appropriate or whether another number no added sugars, the amount of calories taken for setting a DRV for added sugars should be chosen. left over that consumers can use to for children and adults 4 years of age (Comment 242) Many comments incorporate added sugars into their diet and older is consistent with that of total suggested that the DRV for added sugars was 5 percent or more for all but two and saturated fat where the DRVs are should be lower than 10 percent of calorie levels (Ref. 19). A DRV of 10 based on an amount not to exceed. calories. The comments referred to the percent of total calories provides a value 2015 WHO Guideline for Sugars intake (vii) Education that is more realistic considering current for adults and children which (Comment 244) Many comments consumption of added sugars in the recommends reducing the intake of free discussed the need for consumer United States as well added sugars in sugars to less than 10 percent of total education to help consumers the food supply. energy intake. In the report, the WHO understand the addition of an added also suggested a further reduction of the (Comment 243) Several comments sugars disclosure to the Nutrition Facts intake of free sugars below 5 percent of recommended lowering the added label and to help consumers use this total energy intake as a ‘‘conditional sugars DRV for children. The comments information to make healthy food recommendation.’’ The comments also said that a DRV of 50 grams of added choices. Other comments suggested that recommended that we follow the sugars for children 4 years of age and education should focus on total calories, recommendation of the Scientific older which is based on the 2,000 total sugars, and the ingredient list— Advisory Committee on Nutrition in the reference value is too high. The information which can already be found United Kingdom that added sugars comments said that according to USDA, on the current Nutrition Facts label. One should account for no more than 5 4 year olds should be consuming 1,400 comment suggested that we educate percent of daily energy intake. The calories per day, assuming moderate consumers about the fact that sugars are comments said that the American Heart activity. The comments said that under included in total carbohydrates, instead Association (AHA) also recommends our proposal, a 4 year old could of requiring an added sugars declaration limiting added sugars consumption to consume more than 14 percent of on the label. Many comments also said no more than 5 percent of total energy calories from added sugars and still be that Nutrition Facts labels that declare intake. The comments also said that a within the guidelines. The comments added sugars in addition to total sugars DRV of 5 percent of total energy intake noted that this disparity does not align will be confusing to consumers, suggest would align with AHA’s with the 2015 DGAC’s or WHO’s to consumers that added sugars are recommendation that no more than one- recommendations for added sugars more harmful than naturally occurring half of discretionary calories should accounting for no more than 10 percent sugars, or suggest that consumers come from added sugars. The AHA of total calories until age 11 for boys and should focus on added sugars more than recommends that most women consume age 12 for girls. The comments on other nutrients. no more than 100 calories (6 teaspoons) suggested changing the DRV to 25 grams One comment argued that consumer from added sugars per day and no more of added sugars for children aged 1 to responses to added sugars declarations than 150 calories (9 teaspoons) per day 11years, and no more than 50 grams of could lead to unintended consequences, for most men. The comments suggested added sugars for individuals 12 and citing studies that have found that ‘‘low- that a DRV of 5 percent of total energy older. The comments said that this fat’’ labels may reduce consumers’ intake would be more appropriate than change would bring our experience of guilt associated with a DRV of 10 percent of total energy recommendations more in line with the excess consumption of foods bearing intake because the 2,000-calorie stated goal of consuming less than 10 such labels or may increase what ‘‘Healthy U.S.-Style,’’ ‘‘Healthy percent of total calories from added consumers perceive to be an appropriate Mediterranean-Style,’’ and ‘‘Healthy sugars. The comments also said that for serving size of such foods. Many Vegetarian’’ dietary patterns developed products marketed to children between comments said that requiring a new line for the DGAC Report included only 6 or the ages of 1 to 11 years old, we should for added sugars could suggest to 7 percent of calories from added sugars. require the use of a DRV of 25 grams for consumers that they should give (Response) We disagree that the DRV added sugars. The comments suggested increased attention to added sugars for added sugars should be lower than criteria that could be used to identify whereas current U.S. dietary guidelines 10 percent of calories or that there is products marketed to children. do not support an overemphasis on adequate evidence at this time to set a One comment noted that in the added sugars. One comment said that an DRV for added sugars of less than 5 United Kingdom health authorities added sugars declaration could call percent of calories. While the WHO and further stratify recommendations for undue attention to added sugars as a other health organizations have children to include no more than 19 source of calories when it is no different recommended that individuals should grams for children ages 4 to 6 and no from other caloric sources. This

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comment said that emphasis on represents a ‘‘conservative estimate’’ of declaration per serving of a product reducing individual macronutrients, in the highest amount one should consume discussed in part II.Q. Focusing on the lieu of reducing total energy intake of added sugar. The comment also said totality of nutrition information on the defeats the primary goals of our Calories that if subsequent research were to show label in education activities will enable Count report (Ref. 127). Another that the current daily value for added consumers to identify foods that are comment said that the addition of added sugars is too high or too low, the nutrient rich and may contain some sugars declarations to the label may lead ‘‘incorrect’’ value may remain in the added sugars, and reinforces the consumers to opt for foods of equal total public mind long after it has been recommendations of the 2015 DGAC sugar content but lesser nutrition, and to proven to be incorrect. Report and 2015–2020 DGA to increase overlook health benefits that some foods One comment included information fruit and vegetable consumption, have to offer. from a consumer study that sampled decrease saturated fat and sodium, and In contrast, some comments said that 1,088 participants aged 18 years and to limit added sugar intake to less than listing added sugars on the Nutrition older from an online respondent panel. 10 percent of total calories. Facts label would provide vital The comment described results With regard to the comment stating information on the amount of added including, but not limited to, that no education initiative can be sugars in a food and help consumers eat participants’ understanding of the term successful in helping consumers less added sugars. ‘‘Added Sugars’’ as displayed on understand added sugars, and therefore Some comments also said that public Nutrition Facts labels used in the study. implying that added sugars should not education on the food sources and Respondents’ answers reflected a range be on the Nutrition Facts label, we health consequences of excessive added of interpretations, including, but not disagree. The requirement to declare sugars intake is needed. One comment limited to, beliefs that added sugars added sugars on the label is important suggested that we develop materials to refer to specific types of sugars (e.g., public health information based on the explain that consuming foods high in ‘‘white sugar’’) or artificial sweeteners. latest science. Not requiring this added sugars makes it difficult to meet The comment said that 30 percent of important information to be declared nutritional needs and stay within participants said they ‘‘don’t know’’ would be detrimental to public health calorie limits. The comment also what added sugars are or provided no and run counter to our mandate to suggested that we emphasize that answer. The comment said that the promote healthy dietary practices, even naturally occurring sugars in fruits, study findings indicated that there is if not all consumers understand and use vegetables, and dairy products do not confusion among consumers regarding the information immediately. pose any health problem, and that what added sugars are and that With regard to the comments people should consume more fruits, ‘‘consistent, coordinated questioning the addition of added vegetables, and low-fat dairy products. communication efforts’’ will be needed sugars to the label, we have determined One comment said that an industry- to educate consumers about the that there is a public health need for this sponsored reanalysis of FDA’s added Nutrition Facts label and added sugars. declaration and that it is necessary to sugars consumer study and a consumer (Response) Increased consumer assist consumers in maintaining healthy study commissioned by a group of education about nutrition and healthy dietary practices (see part II.H.3.a). We national food and beverage associations dietary practices would likely benefit a have the legal authority to require this showed that the ‘‘% DV/Added Sugars’’ number of consumers in the United declaration (see part II.C.3). Moreover, information will create consumer States. The updated Nutrition Facts we are not aware of any data or confusion that does not exist today. The label promulgated by this rule is an information suggests that consumers comment said that we would face important foundational tool for that will focus undue attention on added education campaign challenges such as consumer education. As noted in part sugars as a source of calories any more confusion related to the concept of II.B.1, we are committed to increasing than other nutrients on the label that are percent DV, possible misinterpretation understanding and use of the Nutrition a source of calories. Our determination of the new term ‘‘Added Sugars,’’ and Facts label to improve healthy dietary that added sugars should be declared on ‘‘unintended effects’’ of placing a patterns through consumer education, the label is consistent with the intent of percent DV next to ‘‘Added Sugars’’ and in collaboration with key Federal our Calories Count report because the not ‘‘Total Sugars.’’ The comment also partners such as USDA and CDC, health information an assist consumers in said that when misperceptions of ‘‘% professionals, and the broader public limiting their total energy intake. DV/Added Sugars’’ arise in the health community, as well as with With regard to the comments marketplace, it will be difficult to industry partners. One aspect of those questioning the confusion about a correct those misperceptions, education and outreach activities will percent DV relating to added sugars and particularly given that the new rule and be increasing understanding of new not total sugars, we address the need for label changes would be interpreted and components to the label including a percent DV for added sugars and why defined by many other communicators added sugars (e.g., definition, it is not appropriate for total sugars (see outside FDA. The comment cited relationship to total sugars), part II.H.3). examples of other campaigns that faced considerations for how to interpret the Regarding the question about similar obstacles, and concluded that information on added sugars in the consumer confusion about the concept any campaign FDA undertook related to context of a healthy diet, and how all of of the percent DV, we have updated the added sugars would not succeed. Some the information provided on the footnote explaining the percent DV (see comments said that some segments of Nutrition Facts label is important to part II.Q.11). the population may be more susceptible consider when constructing a healthy With regard to the question about to misunderstanding added sugars dietary pattern—not only information consumer confusion on the relationship information than the general on added sugars, but the nutrients between total and added sugars, as population. Another comment suggested declared, the percent Daily Value, and described in our response to comment explaining ‘‘daily values’’ better and to the importance of being mindful of total 188, we have modified the format of the clarify that the daily value for added caloric intake. Attention to calories is added sugars declaration to appear sugars does not represent a suggested highlighted by the substantially indented under total sugars using the amount one should eat, but rather, increased font size of the calorie phrasing: ‘‘Includes X g Added Sugars.’’

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p. Records. When a mixture of § 101.9(c)(6)(iii), permit the voluntary defined as the ‘‘sum of saccharide naturally occurring and added sugars is declaration of sugar alcohols on the derivatives in which a hydroxyl group present in a food, the proposed rule, at Nutrition Facts label. The preamble to replaces a ketone or aldehyde group’’ § 101.9(g)(10)(iv), would require the proposed rule (79 FR 11879 at (§ 101.9(c)(6)(iv)). The presence of the manufacturers to make and keep written 11908) discussed how, in reaction to a hydroxyl group is the basis for these records of the amount of added sugars citizen petition and in the 2007 modified sugars being called ‘‘sugar added to the food during the processing ANPRM, we considered whether to alcohols.’’ The term ‘‘sugar alcohols’’ of the food, and if packaged as a make the declaration of sugar alcohols more accurately reflects the chemical separate ingredient, as packaged on the Nutrition Facts label mandatory. composition of these compounds than (whether as part of a package containing We tentatively concluded that the ‘‘polyols.’’ Because of the difference in one or more ingredients or packaged as declaration of sugar alcohols should chemical composition, they are a single ingredient) to verify the amount remain voluntary, and so the proposed metabolized differently and have of added sugars present in the food. We rule would not revise the requirement different caloric contributions. also proposed specific recordkeeping but would, because of other changes, Analytical methods are available to requirements specific to yeast-leavened renumber the provision as measure sugar alcohols based on their bakery products, wines with less than 7 § 101.9(c)(6)(iv). chemical composition and structure (79 percent alcohol by volume, or that We did not receive any comments FR 11879 at 11901), and they are listed does not meet the definition of a ‘‘malt regarding the voluntary declaration of separately in the Nutrition Facts label. beverage,’’ as defined by the Federal sugar alcohols, and so the final rule ‘‘Sugar alcohols’’ more accurately Alcohol Administration Act (27 U.S.C. continues to provide for their voluntary describes the group of substances 211(a)(7)), if the amount of added sugars declaration. encompassed in the definition in in those products is reduced through the b. Use of the term ‘‘sugar alcohols’’. § 101.9(c)(6)(iii). ‘‘Polyols’’ includes process of fermentation. In the preamble to the proposed rule (79 non-carbohydrate polyalcohols, such as Several comments addressed the FR 11879 at 11908), we discussed our polyesters, whereas ‘‘sugar alcohols,’’ as proposed recordkeeping requirements consideration of a citizen petition and defined by FDA, includes only for added sugars. We discuss those comments to the 2007 ANPRM carbohydrates (see 79 FR 11879 at comments in part II.R.3. regarding the use of the term ‘‘polyols’’ 11908). Thus, we decline to revise As discussed in part II.H.3.n, we are (a contraction of the term ‘‘polyalcohol’’ § 101.9(c)(6)(iii) to use the term requiring manufacturers of products instead of ‘‘sugar alcohols’’). We ‘‘polyols.’’ containing fruit and vegetable juice determined that ‘‘polyols’’ could be (Comment 246) One comment concentrates as an ingredient that have potentially more confusing to supporting use of the term polyols noted not been reconstituted to 100 percent consumers than the term ‘‘sugar that our explanation in the preamble to juice in the finished food to provide alcohol,’’ but acknowledged that the proposed rule, that polyols only documentation that shows how they consumers also may not be familiar with cover non-carbohydrate polymers while determined how much of the sugars the term ‘‘sugar alcohol.’’ Nevertheless, sugar alcohols include only provided by the juice concentrate we continued to support the term ‘‘sugar carbohydrates, is not supported. The should be declared as added sugars. alcohols’’ rather than ‘‘polyols’’ because comment said that polyols are low- Also, as discussed in part II.H.3.k, we stated that ‘‘sugar alcohols’’ more digestible carbohydrates and the only when the amount of added sugars in a accurately describes the group of sugar alcohols used in foods are also product is reduced through non- substances encompassed in the considered polyols. enzymatic browning and/or definition in § 101.9(c)(6)(iii) (79 FR (Response) We disagree that polyols fermentation, we are requiring 11879 at 11908). We explained that only pertain to non-digestible manufacturers to make and keep records ‘‘polyols’’ includes non-carbohydrate carbohydrate polymers. We consider to demonstrate the amount of amount of polyalcohols, such as polyesters, polyols to include low-digestible added sugars after non-enzymatic whereas ‘‘sugar alcohols,’’ as defined by carbohydrates (i.e., sugar alcohols) that browning and/or fermentation, make FDA, includes only carbohydrates, and are used in foods, as well as non- and keep records of the amount of so the proposed rule would not change carbohydrate polyalcohols (see 79 FR sugars added to the food before and the term ‘‘sugar alcohols’’ when used on 11879 at 11908). Therefore, ‘‘sugar during the processing of the food, or the the Nutrition Facts label. alcohols’’ is a more specific description submission of a citizen petition (Comment 245) Several comments of the listing of these ingredients in the requesting an alternative means of supported using the term ‘‘polyols’’ Nutrition Facts label. compliance if the manufacturer has instead of ‘‘sugar alcohols.’’ (Comment 247) One comment said reason to believe that the amount of Some comments said that sugars are that ‘‘sugar alcohol’’ may be confusing added sugars in the finished product is mono- and disaccharides, whereas most to consumers and that ‘‘polyols’’ is less significantly less than the amount added sugar alcohols are pentoses and hexoses. likely to cause confusion. The comment prior to non-enzymatic browning and The comments said that the chemical said that ‘‘sugar alcohol’’ may mislead fermentation but they have no way to structures of sugars are rings, and the the consumer regarding health effects, determine a reasonable approximation chemical structure of sugar alcohols are given the negative health connotations of the amount in the finished food. chains. The comments also said that of the terms ‘‘sugar’’ and ‘‘alcohol’’ sugars and sugar alcohols have different separately. The comment said that we, 4. Sugar Alcohols calorie contributions. Therefore, the at the very least, should conduct Our preexisting regulations, at comments said that the term ‘‘polyols’’ consumer testing of the term ‘‘polyols’’ § 101.9(c)(6)(iii), define sugar alcohols, is more appropriate in reference to and ‘‘sugar alcohols.’’ in part, as the sum of saccharide carbohydrate-based polyalcohols. Another comment cited a 1995 survey derivatives in which a hydroxyl group (Response) We disagree with the provided to FDA in a citizen petition in replaces a ketone or aldehyde group comments. Both sugars and sugar 1995, stating that there is strong (e.g., mannitol or ). alcohols contain saccharides. Sugars are evidence that ‘‘sugar alcohols’’ is a term a. Voluntary declaration. Our defined as mono- and disaccharides widely misunderstood by consumers, preexisting regulations, at (§ 101.9(c)(6)(ii)). Sugars alcohols are with most consumers mistakenly

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believing that foods containing sugar a caloric value lower than 4 kcal/gram 5. Dietary Fiber alcohols contain both sugar and alcohol. (Refs. 129–130). In the preamble to the a. Dietary fiber. Another comment cited a 2012 survey, proposed rule (79 FR 11879 at 11908 ‘‘Adults Remain Confused about ‘Sugar through 11909), we explained that we (i) Definition Alcohol’—and Whether It Contains considered revising the energy Our preexisting regulations do not Sugar and/or Alcohol,’’ which observed contribution of sugar alcohols and also establish a definition for dietary fiber. that a majority of the 1,000 adults polled considered relevant caloric values Dietary fiber represents a heterogeneous believed that ‘‘sugar-free’’ products recommended by the Life Sciences group of compounds that vary in their containing ‘‘sugar alcohols’’ contained Research Office (LSRO). The LSRO carbohydrate composition, linkages sugar (74 percent) or alcohol (64 expert panel reports provided the between carbohydrates, and molecular percent). following caloric values for individual weight. Therefore, there is no specific (Response) We previously considered sugar alcohols: Isomalt (2.0 kcal/gram), chemical definition for dietary fiber. the use of the term ‘‘polyol’’ and lactitol (2.0 kcal/gram), xylitol (2.4 kcal/ The amount of dietary fiber that is determined that it could be potentially gram), maltitol (2.1 kcal/gram), sorbitol currently declared is based on analytical more confusing to consumers than (2.6 kcal/gram), hydrogenated starch methods such as the AOAC analytical ‘‘sugar alcohols.’’ However, we hydrolysates (3.0 kcal/gram), and methods. acknowledge that consumers may not be mannitol (1.6 kcal/gram). Consequently, In the preamble to the proposed rule familiar with the term ‘‘sugar alcohol’’ we proposed to amend § 101.9(c)(1)(i)(F) (79 FR 11879 at 11909), we explained (see 79 FR 11879 at 11908). Therefore, to establish the following general factors how the IOM had issued a report we allow for the listing of the name of for caloric values of sugar alcohols, defining ‘‘total fiber’’ as the sum of the specific sugar alcohol instead of using the values recommended by ‘‘dietary fiber’’ and ‘‘added fiber,’’ ‘‘sugar alcohols,’’ provided that only LSRO: Isomalt—2.0 kcal/gram, lactitol— where ‘‘dietary fiber’’ consists of non- one sugar alcohol is present in the food, 2.0 kcal/gram, xylitol—2.4 kcal/gram, digestible carbohydrates and lignin that because many sugar alcohols are listed maltitol—2.1 kcal/gram, sorbitol—2.6 are intrinsic and intact in , and as ingredients (e.g., sorbitol, mannitol, kcal/gram, hydrogenated starch ‘‘added fiber’’ (referred to as ‘‘functional and xylitol) and therefore may be more hydrolysates—3.0 kcal/gram, and fiber’’ in the IOM Macronutrient Report) recognizable to consumers. mannitol—1.6 kcal/gram. We also consists of isolated, non-digestible (Comment 248) One comment proposed to amend § 101.9(c)(1)(i)(C) carbohydrates that have beneficial supporting use of the term ‘‘polyols’’ such that the 4 kcal/gram value is not physiological effects in humans. We said that the EU has introduced optional applied to sugar alcohols. declaration for ‘‘polyols’’ (Ref. 128) (‘‘on (Comment 250) Several comments proposed to adopt a definition for the provision of food information to supported the proposed caloric values. dietary fiber that is equivalent to the consumers’’). Some comments, however, noted that IOM’s definition of ‘‘total fiber’’ and (Response) We acknowledge that the we did not identify a caloric value for therefore would include fibers that the EU provides for the option to declare erythritol. Some comments noted that a IOM defines as ‘‘dietary fiber’’ and ‘‘polyols’’ which is defined as ‘‘alcohols caloric value of 0.2 kcal/gram was ‘‘functional fiber.’’ Both ‘‘dietary fiber’’ containing more than two hydroxyl consistent with the EU and Health and ‘‘functional fiber,’’ as defined by the groups.’’ The EU, however, does not Canada, while other comments IOM, are considered to have beneficial allow for the optional listing of specific supported 0 kcal/gram as a value health effects, so there is little benefit sugar alcohols. ‘‘Sugar alcohols’’ more consisted with the EU. One comment for consumers in distinguishing accurately reflects the chemical provided a review of the evidence, between these two types of fiber on the composition of these ingredients than including a publication by Livesey Nutrition Facts label. In addition, the ‘‘polyols.’’ Furthermore, unlike the EU, (1992) (Ref. 131) and more recent IOM recognized analytical limitations in we allow for the listing of specific sugar evidence from human (Ref. 132) and rat distinguishing between ‘‘dietary fiber’’ alcohols because consumers may not be studies to support of a caloric value of and ‘‘functional fiber’’ and noted that familiar with the term ‘‘sugar alcohol.’’ 0 kcal/gram for erythritol. the labeling of ‘‘total fiber’’ would be c. DRV. Our preexisting regulations (Response) We agree that a caloric more practical than labeling ‘‘dietary do not provide a DRV for total sugar value for erythritol should be fiber’’ and ‘‘functional fiber’’ separately alcohols or for individual sugar considered. We generally do not (79 FR 11879 at 11909). Specifically, the alcohols. The preamble to the proposed consider animal studies for determining proposed rule would amend rule (79 FR 11879 at 11908) explained the caloric contribution of nutrients. § 101.9(c)(6)(i) to include the definition that a quantitative reference intake Livesey (1992) determined that the for dietary fiber. The proposed recommendation for sugar alcohols is caloric value for erythritol was 0.2 kcal/ definition would include: (1) Non- not available from current consensus gram in humans. Applying the factors digestible soluble and insoluble reports, so we have no basis on which that Livesey (1992) used for determining carbohydrates (with 3 or more to consider setting an appropriate DRV. the caloric value for erythritol and monomeric units) and lignin that are Therefore, we did not propose to set a considering the newer evidence using intrinsic and intact in plants; (2) DRV for sugar alcohols. radiolabelled erythritol in humans (Ref. isolated and synthetic non-digestible (Comment 249) One comment agreed 132), the review submitted as part of the carbohydrates (with 3 or more that there was no scientific basis to comment concluded that erythritol is a monomeric units) that we have granted establish a DRV for ‘‘sugar alcohols.’’ substrate that is readily absorbed, and be included in the definition of dietary (Response) Because we continue to undergoes no metabolism, therefore fiber, in response to a citizen petition lack a basis to set an appropriate DRV providing 0 calories. These methods are we received demonstrating that such for sugar alcohols, the final rule does consistent with those used for carbohydrates have a physiological not establish a DRV for sugar alcohols. establishing caloric values for the other effect(s) that is beneficial to human d. Caloric value. The caloric value for sugars alcohols determined by LSRO (79 health; or (3) isolated and synthetic non- carbohydrates, other than insoluble FR 11879 at 11909). Therefore, the final digestible carbohydrates (with 3 or more fiber, is 4 kcal/gram (§ 101.9(c)(1)(i)(C)). rule provides a caloric value of 0 kcal/ monomeric units) that are the subject of Sugar alcohols have been shown to have gram for erythritol. an authorized health claim. Our

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proposed definition for total fiber also color additives, and health and nutrient/ (Comment 253) Some comments would include a minimum degree of content claims and that section 403(q) of expressed concern about the citizen polymerization (DP) greater or equal to the FD&C Act does not provide a legal petition process with respect to the time 3 monomeric units. basis to support premarket approval. for FDA to respond and about the In the preamble to the proposed rule The comments also asserted that, under priority of review. Several comments (79 FR 11879 at 11909 through 11910), the Administrative Procedure Act, our said that, if we did not respond to a we proposed to list isolated and actions must be consistent with the citizen petition after 180 days, the synthetic non-digestible carbohydrates authority given to us under the FD&C dietary fiber should be considered to be with beneficial physiological effect(s) in Act and cannot be arbitrary or officially recognized. One comment the definition of dietary fiber. In the capricious. would change the deadline for proposed codified language, we (Response) We disagree that defining responding to a petition to 30 days or identified two ways the list of dietary the term ‘‘dietary fiber’’ to include the to 90 days. fibers could be amended to include new identification of specific isolated and (Response) Under § 10.30(e)(2), the fibers in the definition. Specifically, we synthetic non-digestible carbohydrates Commissioner is to provide a response identified the existing citizen petition is a pre-approval process for dietary to a petitioner within 180 days of process in § 10.30 that a manufacturer fibers like that for food additives, color receipt of the petition to approve the could use to request an amendment to additives, and health or nutrient content petition, deny the petition, or provide a the definition of dietary fiber and the claims. First, the listing of isolated and tentative response. In addition, under petition process for the authorization of synthetic dietary fibers in the definition § 10.30(e)(3), the Commissioner may a health claim (21 CFR 101.70) where a of dietary fiber does not constitute a pre- grant such other relief or take other fiber that is the subject of an authorized approval process related to the safety of action as the petition warrants. The claim would be considered a dietary the food as an ingredient. We are comment that requests a shorter time fiber that we could add to the list of defining dietary fiber under our period for review under § 10.30 would fibers in the definition. We would authorities in sections 403(q), 403(a), require a substantive amendment to the consider an isolated or synthetic non- 201(n) and 701(a) of the FD&C Act and existing regulation in § 10.30 and is digestible carbohydrate that meets the not under the food additive approval outside the scope of this rule. Therefore, significant scientific agreement standard provisions in section 409 of the FD&C we decline to revise the rule in response in section 403(r)(3) of the FD&C Act, for Act (21 U.S.C. 348). Moreover, the to this comment. (Comment 254) Several comments which a health claim is authorized, to definition of dietary fiber does not be a dietary fiber with a beneficial asked how we would handle more than prevent the use of an isolated or physiological effect to human health. one petition on the same added non- synthetic non-digestible carbohydrate to Two dietary fibers, for which an digestible carbohydrate. For example, if be used as an ingredient in the authorized health claim exists, i.e., b- two petitions were submitted on the manufacture of a food. The use of such glucan soluble fiber and barley b-fiber, same added non-digestible an added fiber as an ingredient must be were included in the proposed carbohydrate, but for different lawful under the relevant provisions in definition. The two types dietary fibers, endpoints, and the added non-digestible the FD&C Act. Second, our definition of for which an authorized health claim carbohydrate meets the dietary fiber dietary fiber for a label declaration does exists (i.e., b-glucan soluble fiber and definition based on one endpoint, but not constitute a health claim or a husk), are included in the not the other endpoint, would the added codified definition for dietary fiber in nutrient content claim under the non-digestible carbohydrate meet the this final rule. provisions to authorize such claims in dietary fiber definition? Another (Comment 251) Some comments section 403(r) of the FD&C Act. By comment stated that it is unlikely that stated that it would be a burden to us defining the term dietary fiber, based on a single dietary fiber source will to maintain and update an approved list beneficial physiological effects in produce all of the potential health of dietary fibers. human health rather than by chemical outcomes anticipated for dietary fiber (Response) We consider a listing of definition, we will ensure that the consumption. Some comments dietary fibers that provide a beneficial dietary fiber declared amount will assist questioned whether all manufacturers physiological effect to be an efficient consumers to maintain healthy dietary would have to submit a citizen petition way to ensure the use of a common practices, consistent with our labeling for the same fiber. definition on which all manufacturers authorities under section 403(q) the (Response) We recognize that can rely to evaluate the fiber content of FD&C Act. different isolated or synthetic non- their products for purposes of the To avoid confusion in the final rule digestible carbohydrates can have dietary fiber declaration and that we can about the citizen petition process at different beneficial physiological effects. use to evaluate compliance. Therefore, § 10.30, we removed the language that An isolated or synthetic non-digestible we decline to revise the rule in response referred to dietary fibers ‘‘that FDA has carbohydrate only needs to demonstrate to this comment. granted be included in the definition of one beneficial physiological effect. (Comment 252) Some comments dietary fiber, in response to a petition Therefore, for example, if the non- expressed concern about using the submitted to FDA under § 10.30 digestible carbohydrate attenuates blood citizen petition process in § 10.30 to demonstrating that such carbohydrates glucose levels, but not blood cholesterol amend the listing of isolated and have a physiological effect that is levels, it would meet the definition of synthetic non-digestible carbohydrates beneficial to health.’’ The language is dietary fiber. As long as one of the in the definition of dietary fiber. Some not necessary. Any interested person petitions provided sufficient evidence comments considered this aspect of the may seek to amend the listing of added for a beneficial physiological effect, we definition as creating an approval fibers through the existing citizen could add the dietary fiber to the process for dietary fiber and stated that petition process in § 10.30. We do not regulation. After an isolated or synthetic we did not have legal authority for such need to cite to that process within the non-digestible carbohydrate is included a process. The comments said our pre- codified definition of dietary fiber for in the list of such fibers in the definition approval authority is limited to the that process to be available or used to of dietary fiber in § 101.9(c)(6)(i), all premarket review of food additives, amend the definition of dietary fiber. manufacturers must list the dietary fiber

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as part of the total dietary fiber is GRAS does not necessarily meet the a submission; however, there are certain declaration if it is present in their definition of dietary fiber for purposes circumstances under which we may product. Manufacturers would not have of a nutrient declaration. A non- object to the content of the submission. to individually submit a citizen petition digestible carbohydrate that is added to For FDAMA health claims in use, for for the same fiber already listed before a food by a manufacturer must be which the 120-day period has passed, being subject to the mandatory approved as a food additive under we must issue a regulation to prohibit declaration for that fiber. section 409 of the FD&C Act or be GRAS or modify the claim or make other (Comment 255) One comment said we under the conditions of its intended use findings to prevent the use of the claim should authorize only specific (see sections 201(s) and 409 of the FD&C (section 343(r)(3)(D) of the FD&C Act). formulations of an isolated or synthetic Act). The lawfulness of the use of There are a number of factors we must non-digestible carbohydrate. The various fibers added to food is outside evaluate during the 120-day period of comment said that generic approval of the scope of this rule. review that could raise questions about many added fibers would be Moreover, a process whereby a firm the use of the claim. For example, we inappropriate because companies retains the evidence that its fiber meets may have questions about the source of produce a wide variety of each fiber. the definition of dietary fiber would not the statement and whether the statement (Response) We recognize that ensure that there is a singular definition is a health claim, whether the companies may produce a wide variety of dietary fiber for purposes of the notification contains a balanced of specific formulations of isolated or declaration in the Nutrition Facts label. representation of the scientific literature synthetic non-digestible carbohydrates, By including a list of all isolated or about the health claim and whether the and we would, as appropriate, provide synthetic dietary fibers that meet the claim is misleading. Thus, unlike the the needed specificity in a list of definition of dietary fiber, 540-day period available to publish a isolated or synthetic non-digestible manufacturers will know that, when final rule to authorize a health claim carbohydrates in the definition, they use those fibers as an ingredient in (section 403(r)(4)(A)(i) of the FD&C Act), including their source and chemical their product, they must include the we may not have adequate time during structure to ensure clarity in what fibers fibers in the declaration of dietary fiber. a FDAMA health claim review period to must be declared as ‘‘dietary fiber’’ if Consumers will have a consistent basis address additional questions about the present as an ingredient in food. We on which the declared values for dietary fiber as it relates to our authority in intend to issue a guidance document on fiber are derived and can use that section 403(q) of the FD&C Act for the information we recommend be information in making healthy dietary purposes of nutrient declaration. provided to us for scientific review, the choices and for comparing products. We Therefore, we plan to consider, on a approach we intend to use to evaluate are establishing a definition for dietary case-by-case basis, whether the the studies, including the approach for fiber that includes isolated or synthetic scientific evidence for a fiber that is the our evaluation of the strength of the non-digestible carbohydrates that have a subject of a FDAMA health claim scientific evidence, if a company beneficial physiological effect to human notification is sufficient to amend the petitions us to amend the definition of health and are to be included in the list of dietary fibers in the dietary fiber dietary fiber to include an additional declaration for dietary fibers on the definition for nutrient declaration. fiber in the definition. Nutrition Facts label. Without a (Comment 257) One comment asked (Comment 256) One comment consistent regulatory definition, we us to clarify that, when a company suggested that we use a voluntary pre- would not be able to determine the makes a structure/function claim (e.g., notification process, such as that used veracity of a dietary fiber declaration on fiber helps maintain healthy digestive for FDAMA health claims, to the Nutrition Facts label for purposes of function), the substantiation for that substantiate an added non-digestible compliance, and consumers would not claim would need to be based on a carbohydrate. Other comments be assured that the fibers declared as physiological effect. The comment said suggested the use of a voluntary GRAS dietary fiber on the label are those that that companies already must notification process that involves will assist them in maintaining healthy substantiate all claims on the label and submitting a detailed summary of a dietary practices. said we could issue a guidance determination for safety or, for Furthermore, although we consider an document to clarify how substantiation companies that have self-determined isolated or synthetic fiber that is the of a claim should be done. their ingredient as GRAS, their self- subject of an authorized health claim to (Response) Structure or function determination process. Other comments meet the definition of dietary fiber, we claims are outside the scope of this rule. said that added non-digestible are not able to make the same Therefore, we are making no clarifying carbohydrates that are GRAS should determination for such a fiber if subject statements with respect to structure or meet the dietary fiber definition. Many of a health claim notification submitted function claims in this final rule. comments suggested that we use a pre- under section 403(r)(3)(C) of the FD&C (Comment 258) One comment that market notification process, such as that Act. (We refer to this health claim as a objected to the proposed rule’s mention used for structure/functions claims, ‘‘FDAMA health claim’’ based on the of citizen petitions stated that the where the evidence is on file and the statutory language enacted as part of the evidence for meeting the dietary fiber evidence is publically available. Food and Drug Administration definition should meet the significant (Response) We decline to revise the Modernization Act of 1997, Pub. L. 105– scientific agreement (SSA) standard for rule as suggested by the comments. A 115, 111 Stat. 2296 (1997).) A FDAMA health claims and that small, short-term voluntary process, such as the GRAS health claim relates to an authoritative studies of varying quality with notification program, is not consistent statement made by a scientific body of conflicting results would not suffice. with ensuring that there is a singular the U.S. Government with official The comment also said that a health definition of dietary fiber for purposes responsibility for public health claim authorization would require us to of the declaration in the Nutrition Facts protection or research directly relating consider whether levels of an added label. Furthermore, the GRAS review to (section non-digestible carbohydrate in foods are system evaluates ingredients for their 343(r)(3)(C)(i)) of the FD&C Act). A sufficient to cause the physiological safety, rather than beneficial FDAMA health claim may be used on effect. Other comments said we should physiological effects. A dietary fiber that food in the market within 120 days of only require evidence needed to

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demonstrate the physiological effect of definition of dietary fiber in 2010 (79 FR macronutrient report (Ref. 5) that the added non-digestible carbohydrate, 11879 at 11909). Accordingly, we do not summarizes the scientific evidence and regardless of the amount in the finished consider animal or in vitro data to be where sufficient data documents their food. sufficient. The physiology of animals is beneficial physiological effect. The Another comment said that we should different than that of humans. In vitro comments said that the 2002 IOM report not expect the evidence to be equivalent studies are conducted in an artificial already included inulin and to the significant scientific agreement environment and cannot account for a oligofructose as dietary fibers in table 7– (SSA) standard required for an multitude of normal physiological 1 and pages 345 through 346. authorized health claim. Instead, the processes such as digestion, absorption, (Response) We disagree with the comment said the evidence considered distribution, and metabolism that affect comments. The IOM (Ref. 5) did not could include animal and in vitro how humans respond to the consider whether the scientific evidence studies or else the evidentiary standard consumption of foods and dietary is sufficient to support a beneficial would be the same as for structure substances (Ref. 134). Animal and in physiological effect to human health for function and health claims. The vitro studies can be used to generate specific isolated or synthetic non- comment said we should provide the hypotheses, investigate biological digestible carbohydrates, but rather evidentiary standard in the final rule. plausibility of hypotheses, or explore a identified or classified which non- (Response) The comments express mechanism of action of a specific food digestible carbohydrates would be concern about the level and sufficiency component through controlled animal considered to be a functional fiber and, of the scientific evidence necessary to diets; however, these studies do not therefore, would need to demonstrate a demonstrate a fiber provides a beneficial provide information from which beneficial physiological effect to fall physiological benefit to health and scientific conclusions can be drawn within the dietary fiber definition. For whether a certain level of such a fiber regarding the beneficial physiological example, the IOM report states that in food is needed in order to be effects of a food component, such as inulin, oligofructose, and considered a ‘‘dietary fiber’’ for added non-digestible carbohydrates. fructooligosaccharides ‘‘could be purposes of a Nutrition Facts label If a dietary fiber is the subject of an classified as functional fibers where declaration. A health claim and a authorized health claim, we would there are sufficient data to show positive nutrient declaration are distinct from consider the relationship between the physiological effects in humans’’ (Ref. each other. A health claim is a statement fiber and the chronic disease risk or 135). Table 7–1 of the IOM report about the relationship between a food or health-related condition, to provide a simply provides the general a food component and risk of chronic beneficial physiological benefit to characteristics of what could qualify as disease or a health-related condition. A health. In fact, we proposed, and a dietary fiber. The IOM did not nutrient declaration on a food label is a include in this final rule, two dietary evaluate the beneficial physiological statement of the amount of the nutrient fibers in the definition of dietary fiber effects of the individual non-digestible in a serving of a food that is necessary that are the subject of an authorized carbohydrates for the purpose of to assist consumers to maintain healthy health claim. Prospectively, if we issue identifying those that meet the dietary dietary practices. A beneficial a final rule authorizing a health claim fiber definition. Instead, the IOM physiological effect to human health for for a dietary fiber, we intend to modify provided a brief science review rather purposes of nutrition labeling may be the dietary fiber definition accordingly. than an indepth review for the various based on a relationship between the Moreover, we are not including a physiological endpoints. The IOM nutrient (e.g., dietary fiber) and a risk of requirement that an isolated or synthetic stated that it is important to note that chronic disease or a health-related non-digestible carbohydrate that has the discussions on the potential benefits condition, but that is not a prerequisite. beneficial physiological benefit be of what might eventually be classified as Not all beneficial physiological effects included at or above a certain level in functional fibers should not be are specific to chronic disease risk (e.g., food in order to be declared as dietary construed as endorsements of those attenuation of postprandial blood fiber on the Nutrition Facts label. The fibers. glucose, improved bowel function). dietary fiber declaration is not a health (Comment 260) One comment said Thus, for purposes of the Nutrition claim. We do not consider it necessary our consideration of physiological Facts label, the evidence to support a to titrate an amount of a dietary fiber in effects was arbitrarily limited to three beneficial physiological effect on human a food with the beneficial physiological endpoints. Many comments said we health may differ from that required for effect of the fiber for purposes of a should use and incorporate into a a health claim that relates to a nutrient declaration. We recognize that guidance document the endpoints relationship between an isolated or dose-response relationships may exist identified at the Vahouny Fiber synthetic non-digestible carbohydrate between certain isolated or synthetic Symposium, besides the three endpoints and a risk of chronic disease. As part of non-digestible carbohydrates and a listed in the IOM report (and the the factors for mandatory declaration, beneficial physiological endpoint. We proposed rule). the evidence for a relationship between also recognize that the amount of an (Response) We disagree that we the nutrient and a health-related isolated or synthetic non-digestible limited the physiological effects to three physiological endpoint should be ‘‘well- carbohydrate will vary in similar and endpoints. In the preamble to the established’’ which includes conclusive different marketed food products. The proposed rule (79 FR 11879 at 11910), or strong evidence (79 FR 11879 at scientific evidence from a clinical study we identified examples of physiological 11890). For evidence submitted as part to support a beneficial physiological effects that are beneficial to human of a citizen petition, we consider that effect should provide an amount of the health, such as attenuation of the strength of the total evidence should fiber that is a reasonable level to be postprandial blood glucose demonstrate a specific beneficial expected in a food and relevant based concentrations, attenuation of blood physiological effect and that the on typical consumption of dietary fiber. cholesterol concentrations, and beneficial effect should be replicated (Comment 259) Several comments improved laxation. The terms ‘‘such as’’ (Ref. 133), consistent with generally said we should accept functional fibers indicate that the subsequent list of items accepted scientific evidence to (i.e., isolated or synthetic non-digestible is merely an illustration rather than an competent authorities in the Codex carbohydrates) identified in the IOM exhaustive list.

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As for the comments’ reference to dietary fiber to include a listing of an amendment to the definition to Vahouny endpoints, at the 9th Vahouny isolated or synthetic non-digestible include an additional dietary fiber Fiber Symposium, nine physiological carbohydrate that will provide a should include all publically available health effects were identified: (1) Total/ beneficial physiological effect. In this evidence relevant to the review about a LDL cholesterol; (2) post-prandial way, there is transparency in what beneficial effect of the isolated or glucose and insulin; (3) increased fecal added fibers are included in the synthetic added non-digestible bulk and laxation; (4) colonic transit definition that will assist consumers in carbohydrate. time; (5) blood pressure; (6) colonic maintaining healthy dietary practices (Comment 262) The proposed fermentation and short chain fatty acid and certainty in what must be declared definition of dietary fiber would production; (7) modulation of the for compliance purposes. mention citizen petitions submitted to colonic microflora; (8) weight loss, Numerous studies have already been us pursuant to § 10.30. One comment weight maintenance, and reduction in conducted on many different types of said that requiring a citizen petition to satiety; and (9) increased satiety (Ref. isolated or synthetic non-digestible seek approval of currently used fibers 136). We agree that lowering total/LDL carbohydrates. We reviewed the will cause disruption in the food levels, lowering post-prandial glucose publically available studies for various supply. The comment said there could levels, reducing gut transit time and non-digestible carbohydrates. Based on be a backlog of petitions. improving laxation (fecal output), our review, we found that a number of Several comments raised concerns reduced blood pressure, and increased isolated or synthetic fibers have a that a review of new fibers that satiety associated with reduced energy demonstrated beneficial physiological manufacturers want to include as part of intake and with possible associated effect to health (Ref. 137), and we a listing of fibers within the definition outcomes on body weight are beneficial include such fibers in the definition for of dietary fiber will result in lag time to human health. We consider colonic dietary fiber (§ 101.9(c)(6)(i)). We resulting in manufacturers dropping the fermentation and short chain fatty acid consider the totality of the evidence extrinsic fiber they use in products. production and modulation of the when evaluating the beneficial With a label compliance period of 2 colonic microflora to be processes that physiological effect(s) of an isolated or years, the comments questioned may be associated with a physiological synthetic non-digestible carbohydrate. whether we could review and respond endpoint, rather than physiological We reviewed several non-digestible to citizen petitions within this time endpoints themselves. carbohydrates for which the publically period and allow manufacturers to (Comment 261) One comment said available scientific evidence indicated design and secure new packaging. Some that requiring added non-digestible mixed results, or appears to be comments said that, once we begin carbohydrates to have a beneficial insufficient. It is not clear whether there implementing the final rule, the time for physiological effect will require may be additional data or information review of subsequent petitions may be research, and funds to support such concerning the beneficial health effects unreasonable and that some added non- research, to demonstrate such an effect. of these non-digestible carbohydrates digestible carbohydrates that are The comment said this would be a that interested persons have and are not currently declared as dietary fiber may burden to firms who seek to develop yet publically available. Therefore, we have to come off the Nutrition Facts new fibers. Another comment said we decline to make a determination on label. The comments said that a lengthy should accept the existing body of whether these non-digestible petition process undermines the overall evidence as an appropriate carbohydrates meet the definition of purpose to promote the healthful demonstration of benefit, in many cases, ‘‘dietary fiber’’ without first providing consumption of dietary fibers and that without requiring new substantiation for an opportunity for comment on the industry would have to make the other a beneficial ingredient already in available scientific evidence for these label changes in response to the final common use. non-digestible carbohydrates. We intend rule without knowing the amount of (Response) The final rule does not to publish a separate notice to seek dietary fiber to declare and could lose require a firm to demonstrate that there comment on the available scientific data dietary fiber health claims. Some is a beneficial physiological effect before on these non-digestible carbohydrates to comments said that premarket review it can add an isolated or synthetic non- determine if we should consider should only apply to those fibers that digestible carbohydrate to a food and additional non-digestible carbohydrates we did not identify as dietary fiber. One declare it as part of the Total to be added to the list of dietary fibers. comment said that we should issue the Carbohydrate declaration. We recognize We also intend to publish a guidance guidance document along with the that firms may develop new fibers and document on the type of evidence we listing of the dietary fibers, including that we may not be aware of all of the recommend be provided and the the commonly used added non- added fibers that a manufacturer may be approach we plan to use to evaluate the digestible carbohydrates that we have using as an ingredient in its products. beneficial physiological effect of a non- determined to have a beneficial effect For example, there may be some fibers digestible carbohydrate. without submission of formal petitions. that a manufacturer has self-determined If a manufacturer wants to add an (Response) We recognize that there to be GRAS for which we did not isolated or synthetic non-digestible may be uncertainty about whether receive a GRAS notification. In addition, carbohydrate to the listing of fibers in certain isolated or synthetic non- isolated or synthetic added fibers may the dietary fiber definition, it can digestible carbohydrates, currently in be approved for use as a food additive. petition us to amend the definition to use by manufacturers and declared as Moreover, even if a manufacturer self- include that fiber in the dietary fiber dietary fiber, meet the dietary fiber determines that a fiber is GRAS, or there listing for these types of carbohydrates. definition. We proposed to list isolated is a food additive approval for the fiber, Under § 10.30(b), the citizen petition or synthetic non-digestible whether the fiber has a beneficial must include all relevant information carbohydrates that we have been physiological effect to health is a and views on which the petitioner determined to have a physiological separate question. Therefore, given the relies, as well as representative effect that is beneficial to human health potential uncertainties and possible information known to the petitioner in § 101.9(c)(6)(i), and the final rule inconsistencies in what fibers may be which is unfavorable to the petitioner’s includes additional dietary fibers in the declared as dietary fiber, we define position. Thus, any petition to request definition based on the review of

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publically available evidence (Ref. 137). comments did not provide data on cholesterol levels and improved These reviews identify a number of beneficial physiological effects, so we laxation) and the reference to the IOM isolated or synthetic non-digestible are unable to conduct a scientific reports (Ref. 138) (id.). We also asked for carbohydrates for which the publically review. However, we intend to publish comment on the IOM definition of available scientific evidence supports a a separate notice to seek comment on dietary and functional fibers dating back beneficial physiological effect to human the available scientific data on non- to the 2007 ANPRM (id.). Therefore, we health. digestible carbohydrates to assist us in decline to delay issuance of the final With respect to the concern about a the review of the scientific evidence. rule as suggested by the comments. possible backlog in petitions, we did not Publically available clinical trial data Furthermore, the administrative process receive any comment about numbers of will be identified and summarized for for submitting a request to amend the specific isolated or synthetic fibers used non-digestible carbohydrates, including definition of dietary fiber is in § 10.30. as an ingredient in food that would not inulin, bamboo fiber, soy fiber, pea We have not proposed changes to that otherwise have been included in our fiber, wheat fiber, cotton seed fiber, regulation in the context of this review of publically available evidence. sugar cane fiber, sugar beet fiber, and rulemaking, and, therefore, comments to Our review was necessarily limited to fiber. § 10.30 are outside the scope of this the publically available evidence on (Comment 264) Several comments rule. such fibers. Therefore, to the extent stated that we should provide guidance (Comment 265) Many comments there are uses of isolated or synthetic to industry on submissions to supported the proposed definition of fibers that are specific to a particular demonstrate physiological effects that dietary fiber, but for different reasons. manufacturer, we will need to consider are beneficial to humans before we issue Some comments supported the those case-by-case in the context of the final rule so that meaningful proposed definition because, according petition submitted under § 10.30 and comments can be provided on the to the comments, dietary fibers should consider the resources needed to process. The comments said that our show a physiological benefit, and the evaluate such requests as we receive failure to provide notice and an proposed definition would facilitate the them. opportunity to comment on a guidance development of healthier products. (Comment 263) Several comments document would violate the Other comments said the proposed said that certain added non-digestible Administrative Procedure Act. Other definition aligns with the IOM and carbohydrates meet the dietary fiber comments stated that, once we have Codex definitions for dietary fiber. definition. Some comments would add identified the dietary fibers, we should Several comments, however, asked us psyllium husk to the list of approved reopen the dietary fiber section of the for clarification. Some comments asked fibers and said that there is a wealth of proposed rule for public comment, us to clarify what we meant by ‘‘intact clinical trial data on inulin which met including the requirements for defining and intrinsic in plants’’ and ‘‘isolated the dietary fiber definition based on the dietary fiber. and synthetic.’’ 2002 IOM report and that there were (Response) We intend to issue (Response) Consistent with the IOM data to support galactooligosaccharides guidance concerning the evidence to fiber report (Ref. 138), we consider (GOS) as a dietary fiber. submit and our approach to reviewing ‘‘intact’’ as having no relevant Other comments supported the the science in a request to amend the component removed or destroyed and inclusion of bamboo fiber, soy fiber, pea dietary fiber definition to support a ‘‘intrinsic’’ as originating and included fiber, wheat fiber, cellulose, cotton seed fiber’s beneficial physiological effect to wholly within a food. Intact and fiber, sugar cane fiber, sugar beet fiber, human health. We do not consider it intrinsic fibers are naturally present and oat fiber. One comment said that necessary to publish the draft guidance such that they are integrated within the cellulose is GRAS under a ‘‘prior before the final rule is published. There plant matrix and contain other nutrients sanctioned category.’’ will be an opportunity to submit naturally present in proportions that (Response) We agree that psyllium comments to the guidance, consistent exist in the plant cell. For example, husk meets the dietary fiber definition with our good guidance practices brans, which are obtained by grinding, (§ 101.81(c)(2)(B)) and have revised the regulation at 21 CFR 10.115. are anatomical layers of the grain definition accordingly. We have To the extent the comment asserts a consisting of intact cells and substantial reviewed the publicly available failure to receive comment on the draft amounts of starch, protein and other scientific evidence for some of the guidance before the publication of the nutrients. Non-digestible carbohydrates isolated or synthetic non-digestible final rule violates the Administrative that are created during normal food carbohydrates, including cellulose (Ref. Procedure Act (APA), we disagree. The processing (e.g., cooking, rolling, or 137). Based on our review, we publication of a draft guidance milling) are intrinsic and intact (e.g., determined that the scientific evidence document is not a general notice of non-digestible (resistant) starch in supports a showing of a beneficial proposed rulemaking to which the APA flaked corn cereal). However, a resistant physiological effect to human health requirements under 5 U.S.C. 553 would starch that has been extracted and from the following fibers: Cellulose, otherwise apply. Furthermore, we isolated from the flaked corn cereal, guar gum, , locust bean gum, and provided adequate notice and such that it is no longer part of the food hydroxypropylmethylcellulose. opportunity to comment on our matrix (intrinsic) and no longer consists Cellulose was determined to improve proposed definition of dietary fiber and of relevant food components (intact), bowel function. Guar gum, pectin, provided the Codex definition that often with an increased concentration of locust bean gum and includes isolated or synthetic non- non-digestible carbohydrates, would be hydroxypropylmethylcellulose were digestible carbohydrates that have been considered an isolated non-digestible determined to lower blood total and/or shown to have a beneficial physiological carbohydrate. The term ‘‘isolated’’ is LDL cholesterol levels. Therefore, we effect to health as demonstrated by used to describe isolated non-digestible include these isolated or synthetic generally accepted scientific evidence to carbohydrates that are isolated from dietary fibers in the final rule’s competent authorities (79 FR 11879 at plant sources such that they are no definition of dietary fiber. 11909). We provided examples of longer intrinsic or intact. Some of these As for the other carbohydrates beneficial physiological effects (e.g., isolated fibers can be further modified. mentioned in the comments, the attenuation of blood glucose and The term ‘‘synthetic’’ is used to describe

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synthetic non-digestible carbohydrates isolated from foods or synthesized, and the proposed rule (id. at 11910), that are not isolated from plant sources, so we have revised the rule as suggested physiological effects that are beneficial, but rather chemically synthesized. by the comment. such as attenuation of blood glucose and We note that the distinction between (Comment 268) One comment stated cholesterol levels (i.e., total or LDL). We ‘‘intrinsic and intact’’ and ‘‘isolated or that brans, obtained by mechanical also would consider the lowering of synthetic’’ is important because foods action (grinding), are a layer of grains blood pressure to be a beneficial that contain intrinsic and intact fibers and therefore should be a dietary fiber. physiological effect. The attenuation/ include naturally occurring dietary (Response) We agree that brans that lowering of these biomarkers (lowering fibers that contain other nutrients are obtained by mechanical actions are of blood glucose and cholesterol levels normally found in foods that may be unique and, unlike other fibers subject and lowering of blood pressure) are associated with beneficial physiological to mechanical actions, are intact and associated with reduced risk of type 2 effects. Such beneficial physiological intrinsic and therefore meet the dietary diabetes or CVD. Another outcome we effects, associated with natural dietary fiber definition. is the hard outer consider a beneficial physiological fibers, cannot be assumed to exist when layer of cereal grain and is obtained by effect is increased satiety, where an non-digestible carbohydrates are mechanical processing. Bran is rich in isolated or synthetic non-digestible isolated from foods, and especially dietary fiber, as well as other nutrients carbohydrate is associated with a including starch, protein, vitamins, and when synthesized. We note that the reduced energy intake. A reduced minerals. Furthermore, naturally IOM (2002) cited an earlier IOM report energy intake can reduce the risk of occurring dietary fiber is part of the (Ref. 139), which stated that, while being overweight or obese. In addition, matrix in bran. Therefore, dietary fiber dietary fiber intake is associated with improved laxation and bowel function decreased risk or improvements in in bran is intact and intrinsic. is a beneficial physiological effect where several chronic diseases, there is no (Comment 269) One comment an isolated or synthetic non-digestible conclusive evidence that dietary fiber, opposed to the proposed definition of carbohydrate shows a reduced intestinal rather than the other components of dietary fiber stated that, as is the case transit time or an increase in the passage vegetables, fruits, and cereal products, for most dietary components, the health of stools. These outcomes result in an reduces the risk of those diseases. benefits of dietary fiber have only been increased rate of defecation to improve Furthermore, the IOM stated that there studied in clinical trials in isolated bowel function. Increased absorption of are many constituents of whole grains, forms rather than in their intrinsic and minerals, such as calcium, are in addition to dietary fiber, that may intact forms. The comment said it is considered to provide beneficial reduce the risk of CHD. These nearly impossible to separate out any statements emphasize the inherent associated health outcome from other physiological effects because increased benefits of intact and intrinsic non- bioactive components within the food absorption of calcium is associated with digestible carbohydrates. matrix. increased bone mineral density which (Comment 266) Several comments (Response) We agree that the health may reduce osteoporosis. For the would change ‘‘intact and intrinsic in benefits of non-digestible carbohydrates purposes of Nutrition Facts labeling, we plants’’ to ‘‘intact or intrinsic.’’ The have been studied in numerous clinical do not consider processes and comments said that, without this trials in isolated forms. These clinical mechanisms (e.g., fermentation) per se change, the definition would exclude trials have been used to identify those as beneficial physiological effects for almost all fiber ingredients. added non-digestible carbohydrates that determining whether an isolated or (Response) We disagree with the meet the dietary fiber definition (Ref. synthetic non-digestible carbohydrate comment. These two terms collectively 137). Fiber-containing fruits, vegetable, meets the definition of dietary fiber. require that the non-digestible and grain products have been shown to Fermentation is not a physiological carbohydrate is naturally present such have beneficial health effects via such benefit; rather, it is a process associated that it is integrated within the plant clinical trials, as well as observational with the digestion of the non-digestible matrix and contains other nutrients studies on chronic disease risk (e.g., carbohydrate itself. Unless there is naturally present in proportions that CHD). The collective information from information to support a beneficial exist in the plant cell. These conditions such studies has been used to physiological effect, such non-digestible (integration in the plant matrix and substantiate the evidence for the carbohydrates would not assist providing proportional nutrients that relationship between soluble fibers and consumers in maintaining healthy are present naturally in the plant cell) CHD risk (e.g., §§ 101.77 and 101.81), as dietary practices. As stated in the IOM are considered to be inherent in the well as the establishment of an AI for Diet and Health report (Ref. 139), while health benefits associated with naturally dietary fiber (Ref. 36). Thus, the health dietary fiber intake is associated with occurring dietary fibers. The definition benefits of foods that contain naturally decreased risk or improvements in of dietary fiber includes these intact and occurring dietary fibers have already several chronic diseases, there is no intrinsic fibers in addition to isolated or been substantiated. conclusive evidence that it is dietary synthetic fibers that have a beneficial (Comment 270) Several comments fiber, rather than the other components physiological effect. Therefore, we asked us to clarify the meaning of a of vegetables, fruits, and cereal disagree that the definition of dietary ‘‘physiological effect that is beneficial to products, that reduces the risk of those fiber would ‘‘exclude almost all fiber human health.’’ diseases. There are many constituents in ingredients’’ if we retained ‘‘intrinsic (Response) In the preamble of the whole grains, in addition to dietary and intact in plants’’ in the definition. proposed rule (79 FR 11879 at 11909), fiber, that may reduce the risk of CHD. We decline to revise the definition as we explained that a regulatory Therefore, unlike the inherent benefits suggested by the comment. definition for dietary fiber, such as those of intact non-digestible carbohydrates, (Comment 267) One comment consistent with the IOM and Codex, isolated or synthetic non-digestible suggested changing ‘‘isolated and should be one that emphasizes its carbohydrates must be independently synthetic’’ to ‘‘isolated or synthetic.’’ physiological effect that is beneficial to shown to have physiological health (Response) We agree with the human health to assist consumers in benefits, and not all such fibers have comment. Non-digestible carbohydrates maintaining healthy dietary practices. these types of benefits. One example of that are added to foods are either We also identified, in the preamble to a process that is not considered to be a

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beneficial physiological effect is considered in our science reviews that do not provide a beneficial fermentation. Another example is include those that are supported by the physiological effect. Therefore, relying changes in the microbiota in the large current scientific evidence (Ref. 137). on AOAC methods can overestimate the intestine as a result of the consumption We recognize that, as the science amount of non-digestible carbohydrates of non-digestible carbohydrates. evolves, the list of dietary fibers in the that can assist consumers in Physiological effects that are beneficial definition may change. Thus, our list is maintaining healthy dietary practices. (e.g., satiety) may be an outcome of a not exhaustive. We agree that the newer methods that process, such as fermentation and (Comment 273) One comment can measure lower molecular weight changes in the colonic microbiota. presumed that, based on the proposed non-digestible carbohydrates were not (Comment 271) One comment said factor of 2 kcal/gram, ‘‘non-digestible available when the IOM was developing that the food industry will be able to carbohydrates’’ includes partially and the dietary fiber definitions. However, demonstrate at least one physiological totally digested carbohydrates. The the availability of analytical methods effect for each type of isolated or comment said that, for this reason, we had no bearing on the IOM’s definitions, synthetic non-digestible carbohydrate should define ‘‘non-digestible and the IOM definition included the and those effects may be less significant carbohydrate’’ to mean ‘‘carbohydrates lower molecular weight non-digestible than the benefits from intact fiber. For that are partially or totally fermentable oligosaccharides as part of the definition example, the comment said, referring to by colonic microflora.’’ of dietary fiber. The focus was on EFSA, reduced post-prandial glycemic (Response) As provided in the IOM ensuring that all added non-digestible response would apply for all isolated or fiber report (Ref. 138), ‘‘non-digestible’’ carbohydrates that meet the dietary fiber synthetic non-digestible carbohydrates is an adjective that implies a substance definition have a beneficial (compared to sugar). The comment also is not broken down to simpler chemical physiological effect. Even though said that the evidence showing that compounds in the living body chiefly natural and isolated fibers can be isolated or synthetic non-digestible through the action of secretion- identical chemically, they may not carbohydrates are beneficial is often containing enzymes such as the saliva provide the same beneficial inconsistent and based on poorly and the gastric, pancreatic, and physiological effect. established biomarkers. Thus, according intestinal juices in the alimentary canal. (Comment 275) Several comments to the comment, added fiber may have Thus, non-digestible carbohydrates are supported using the American less benefit than its intact counterpart. not digested by human enzymes and Association of Cereal Chemist (Response) Without reviewing the pass into the colon where they may or International (AACCI) definition evidence on the beneficial physiological not be fermented by colonic microflora, because the AACCI definition was effects of non-digestible carbohydrates, and so we decline to revise the rule as consistent with the Codex definition it is premature for us to state whether suggested by the comment. and would support global or not at least one physiological effect (Comment 274) Many comments harmonization. The AACCI definition for each type of isolated or synthetic disagreed with the proposed definition is: non-digestible carbohydrate can be of dietary fiber. Several comments said demonstrated. We disagree with the that the amount of dietary fiber declared Dietary fiber is the edible parts of plants or analogous carbohydrates that are resistant to comment, referring to EFSA, that in the Nutrition Facts label should digestion and absorption in the human small reduced post-prandial glycemic continue to be based on AOAC methods intestine with complete or partial response would apply for all isolated or because the measured amount aligns fermentation in the large intestine. Dietary synthetic non-digestible carbohydrates. more closely to the chemical fiber includes polysaccharides, As an example, EFSA concluded that a composition and structure and is more oligosaccharides, lignin, and associated plant relationship has not been established feasible and practical. The comments substances. Dietary fibers promote beneficial between acacia gum and reduced also said that natural and isolated fibers physiological effects including laxation, and/ postprandial glycemic response (Ref. are chemically identical. or blood cholesterol attenuation, and/or blood glucose attenuation. 140). While some studies may have used Other comments argued that using the poorly established biomarkers, our more recently developed methods (e.g., (Response) We decline to revise the science reviews have included AOAC 2011.25) allows for a rule as suggested by the comment. endpoints that are reliable comprehensive isolation and While the AACCI definition measurements of physiological effects quantitation of all dietary fiber distinguishes between natural and (e.g., total and LDL cholesterol levels, ingredients, without relying on a isolated or synthetic non-digestible and intestinal transit time and definition. The comments said that the carbohydrates, it does not specify the frequency of bowel movements as a newer AOAC methods capture the more need for isolated or synthetic non- measure of laxation) (Ref. 137). highly soluble non-digestible digestible carbohydrates to demonstrate (Comment 272) One comment said carbohydrates (i.e., non-digestible a beneficial physiological effect. Foods there is an insufficient understanding of oligosaccharides) that were not captured that contain naturally occurring dietary the complex interactions among and in the methods available at the time fibers are usually a mixture of between gut microbiota and the human when the IOM considered the polysaccharides that are integral host. The comment said these definitions for dietary fiber and components of the plant cell wall or interactions are affected by total fiber therefore not considered in the 2002 intercellular structure. Naturally intake, but the effects of specific fiber IOM report. occurring dietary fibers have the three- components can be difficult to define. (Response) We disagree with the dimensional plant matrix that is Another comment said that we should comments. While the AOAC methods responsible for some of the indicate that the list of beneficial may be more feasible, practical, and physicochemical properties attributed to physiological effects is not exhaustive inclusive in measuring non-digestible dietary fiber (Ref. 138). Furthermore, and is evolving. carbohydrate compared to the amount of foods that contain naturally occurring (Response) We agree that scientific non-digestible carbohydrates that meets dietary fibers contain other nutrients knowledge of beneficial physiological the dietary fiber definition, these normally found in foods that may be effects to human health is evolving. The methods are not able to distinguish and associated with beneficial physiological physiological endpoints that we have measure non-digestible carbohydrates effects. Such beneficial physiological

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effects, associated with natural dietary scientific evidence to competent excluding certain fatty acids (i.e., stearic fibers, cannot be assumed to exist when authorities. acid) from the definition of total fat. non-digestible carbohydrates are The Codex and IOM definitions are (Response) We disagree with the isolated from foods, and especially consistent with our definition in that comments. The definition for saturated when synthesized. they specify that isolated or synthetic fat in § 101.9(c)(2)(i) includes all fatty We also disagree that the AACCI non-digestible carbohydrates that are acids without double bonds, and the definition is consistent with the Codex added to foods need to show a accepted analytical methods capture all definition. The Codex definition beneficial physiological effect. The of the saturated fatty acids, including includes the need for isolated or footnote is left up to competent stearic acid. In adopting this definition, synthetic fibers to have been shown to authorities, such as FDA, and we have we addressed the issue of the inclusion have a physiological effect of benefit to chosen to include non-digestible or exclusion of individual saturated health. oligosaccharides with a DP of 3 to 9 fatty acids and determined that a (Comment 276) One comment said we monomeric units as part of the dietary chemical definition which includes all should establish a definition that is fiber definition to include fibers with fatty acids containing no double bonds consistent with other long-recognized beneficial physiologic effects regardless was the appropriate approach to define definitions regardless of whether that of size. saturated fat (see 79 FR 11879 at 11894). definition is based on clinical evidence (Comment 278) One comment stated The scientific evidence to recommend or to include greater than DP >3. The that the dietary fiber definition should that saturated fatty acids provide no comment, however, did not identify any include non-digestible carbohydrates more than 10 percent of total calories other definitions. with a DP = 2 (e.g., non-digestible does not exclude stearic acid. As we (Response) To the extent the comment disaccharides such as galacto- discussed in the preamble to the suggests that we should not consider oligosaccharides (GOS)) to capture all proposed rule (79 FR 11879 at 11894), added non-digestible carbohydrates that clinical evidence of beneficial the scientific evidence in the 2010 DGA have a beneficial physiological effect. physiological effect or length of to consume less than 10 percent of (Response) Non-digestible calories from saturated fatty acids makes monomeric units in the dietary fiber oligosaccharides, such as GOS, vary in definition, we disagree. Consistent with no specific exclusion of stearic acid and, size. GOS is a mixture of b-linked instead, relates to the intake of total the IOM, we recognize that those non- polymers in various configurations and digestible carbohydrates that have been saturated fatty acids. Therefore, the DRV the DP ranges from 2 to 8 (Ref. 141). The that is based on 10 percent of calories isolated from foods or synthesized need currently available AOAC methods includes stearic acid. The DV of 28 to demonstrate a physiological benefit measure non-digestible carbohydrates at grams for dietary fiber is based on the in humans and may include a DP of ≥3. a DP ≥3. Furthermore, non-digestible AI set by the IOM for total fiber (Ref. Evidence of such a benefit is obtained monosaccharides and disaccharides 36). The DV reflects the IOM definition primarily through human clinical meet the definition of sugar (see part for dietary fiber which excludes those studies that have evaluated the effect of II.H.3.n). Therefore, we disagree that isolated or synthetic non-digestible isolated or synthetic non-digestible non-digestible mono- and disaccharides carbohydrates that do not provide a carbohydrates on individual should be considered as dietary fiber. beneficial physiological effect. physiological effects. (Comment 279) One comment said Furthermore, the listing of individual (Comment 277) Several comments that the IOM definition could be nutrients based on physiological effect stated that, for the sake of enhanced by including other minor is not new. Soluble and insoluble harmonization, we should adopt the substances that are intrinsic in plant dietary fibers can be voluntarily listed Codex definition, but without footnote fibers to make it more compatible with separately because of their distinct 2. Footnote 2 states that the decision on a variety of other definitions, such as physiological effects. whether to include carbohydrates from those issued by Codex and AACCI. (Comment 281) One comment that 3 to 9 monomeric units should be left (Response) The IOM (and Codex) objected to the proposed definition said to national authorities. definition did not address minor that the criteria for listing dietary fiber (Response) We decline to revise the components such as waxes, cutin, and differ from the criteria used for protein. rule as suggested by the comments. suberin, that are intrinsic in plant fibers. The comment said there are many Codex defines dietary fiber to mean However, like lignin, waxes, cutin, and sources of protein (soy protein) that are carbohydrate polymers with ten or more suberin are not carbohydrates that are used as ingredients, but they are not monomeric units, which are not closely associated with non-digestible reviewed individually for their health hydrolyzed by the endogenous enzymes carbohydrates within plants. Therefore, benefits. in the small intestine of humans and like lignin, these minor components are (Response) Protein is listed because it belong to the following categories: included in the amount of intact and is a major macronutrient category, as is • Edible carbohydrate polymers intrinsic fibers that would be declared the case for total carbohydrate. Protein naturally occurring in the food as as dietary fiber. Newer methods, such as contains amino acids that are essential consumed; AOAC 2011.25, include waxes, cutin, in the diet. Dietary fiber is not essential • carbohydrate polymers, which have and suberin in the measurement of non- in the diet and is listed because of its been obtained from food raw material by digestible carbohydrates. beneficial physiological effects, rather physical, enzymatic, or chemical means (Comment 280) Several comments than essentiality. The DV for protein is and which have been shown to have a said that the proposed requirement to based on providing a certain percent of physiological effect of benefit to health demonstrate a physiological benefit is a calories, relative to total fat and as demonstrated by generally accepted drastic shift from the analytical-based carbohydrate, whereas the DV for scientific evidence to competent approach and dietary fiber would be the dietary fiber is based chronic disease authorities; and only nutrient listed in the Nutrition risk. Therefore, the basis for declaring • synthetic carbohydrate polymers Facts label that requires a physiological protein, including protein ingredients, which have been shown to have a benefit. The comments said our is not comparable to dietary fiber. physiological effect of benefit to health approach contradicts with the rationale As for the comment’s mention of soy as demonstrated by generally accepted (chemical composition) for not protein, soy protein that is naturally

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present in a food is an intact and provide a beneficial physiological effect certain fiber sources that may not meet intrinsic protein, and thus, is a protein to assist consumers in maintaining the dietary fiber definition. One for purposes of nutrient declaration. healthy dietary practices. Under comment stated that all non-digestible (Comment 282) One comment that § 101.9(c)(6)(i) of the final rule, soluble carbohydrates have a physiological objected to the proposed definition of fiber and insoluble fiber that meet the effect by virtue of not being digested dietary fiber said that vitamins naturally dietary fiber definition may be declared and present in the colon. Another present in food and those added through voluntarily. comment questioned why there is not a fortification can work effectively As for education campaigns, we call to demonstrate physiological together to fulfill nutrient needs in the address such issues in part II.B.1. benefits of natural dietary fibers. same manner that added fibers can (Comment 285) One comment said (Response) We agree that some fiber- interact with intrinsic fibers to meet the that all insoluble non-digestible containing ingredients may have a requirement. carbohydrates should meet the proposed variety of physiological effects that do (Response) We agree that different fiber definition. The comment said that not depend on whether they are forms of naturally occurring and cellulose and lignin do not dissolve in characterized as intrinsic and intact or isolated or synthetic non-digestible water and are not digested by bacteria isolated or synthetic. The presence of a carbohydrates that meet the dietary fiber in the colon adding bulk to the stool for fiber in the colon alone is not definition can work together to assist improved laxation. Furthermore, the necessarily beneficial. While one consumers in maintaining healthy comment said that the IOM noted that comment did not provide an example of dietary practices, but this fact does not the body of evidence indicates that non- how non-digestible carbohydrates have necessitate a change to the definition. fermentable fiber sources (often isolated a physiological effect by virtue of not The comparison of different sources of as insoluble fiber) promote laxation and being digested and present in the colon, fibers to different sources of the same that improved laxation is an established not all measurements in a study vitamin, as the comment suggests, is not physiological effect that is beneficial to necessarily demonstrate a physiological accurate. Fibers represent a human health. effect, much less a beneficial heterogeneous group of compounds, and (Response) We agree that if the physiological effect. For example, not all isolated or synthetic non- scientific evidence for a particular fermentation and changes in the colonic digestible carbohydrates may provide a isolated or synthetic non-digestible microflora is a process rather than a beneficial physiological effect. carbohydrate demonstrates improved physiological effect. (Comment 283) One comment said laxation, the fiber would meet the Moreover, unlike foods that contain that we should base the listing of dietary dietary fiber definition because only isolated or synthetic non-digestible fiber on physicochemical properties improved laxation is a beneficial carbohydrate as a fiber source, foods instead of physiological benefit. The physiological effect. However, we are that contain intrinsic and intact fibers comment would define dietary fiber as not able to conclude that all isolated or contain other nutrients normally found ‘‘non-digestible soluble and insoluble synthetic non-digestible carbohydrates in foods, and the foods with these fibers carbohydrates (with 3 or more improve laxation and therefore meet the are associated with beneficial monomeric units) and lignin.’’ The dietary fiber definition. Cellulose is a physiological effects. Such beneficial comment said this definition would fiber for which the science supports its physiological effects cannot be assumed allow any review or consideration of role in improved laxation (Ref. 138). to exist when non-digestible dietary fiber to be predicated on its Therefore, we are listing cellulose in the carbohydrates are isolated from foods physicochemical characteristics. definition of dietary fiber. and thereby separated from other (Response) We disagree that the With respect to lignin, and as we nutrients found in the food. The same declaration of dietary fiber should be stated in the preamble to the proposed is true for synthetic fibers which do not based on physicochemical properties. rule (79 FR 11879 at 11900), all dietary have other nutrients present that are Although a physiochemical property, fibers, with the exception of lignin, are found in the food. such as viscosity (degree of thickness carbohydrate polymers. Although lignin (Comment 287) One comment stated and resistance to flow), is linked to is not a carbohydrate, it is tightly bound that isolated plant fibers are chemically health benefits, it is not known at what to other dietary fibers and cannot be identical to intrinsic fibers and have no level of viscosity a dietary fiber begins easily isolated using AOAC or other similarity with synthetic fibers. The to have a physiological effect (see 79 FR reliable and appropriate analytical comment said that we should not hold 11879 at 11911). Moreover, there are no procedures. It is, therefore, included in isolated fibers to the same standards as scientifically valid methods available the declaration of dietary fiber. synthetic fibers. that we could use to measure the (Comment 286) One comment stated (Response) While some isolated non- amount of various dietary fibers defined that fiber-containing ingredients can digestible carbohydrates may be by their physicochemical properties in have a variety of physiological effects chemically identical or similar to the various food matrices, whereas that do not depend on whether they are forms (including molecular weight) that scientifically valid methods to measure characterized as intrinsic and intact or occur naturally in food, the basis for soluble and insoluble fiber are available. isolated and synthetic. The comment isolated non-digestible carbohydrates (Comment 284) One comment stated said that requiring added non-digestible showing a beneficial effect is not that, instead of using the proposed carbohydrates demonstrate a chemical composition. Isolated or dietary fiber definition, we should physiological benefit falsely implies a synthetic fibers are similar in that they require the listing of soluble and nutritional superiority of fibers that are not part of the three-dimensional insoluble fiber and conduct an have not been separated from their plant matrix that is responsible for some education campaign to understand the natural source. The comment added that physicochemical properties attributed to difference which might prove to be such a distinction that is not factual dietary fiber (Ref. 138) or in foods that more beneficial for consumers. from a or physiological contain other nutrients normally found (Response) We disagree that soluble perspective. Other comments noted that in foods that may be associated with and insoluble fiber should be listed the dietary fiber definition has the beneficial physiological effects. instead of the dietary fiber definition. potential to be exclusionary and limit (Comment 288) Some comments Both soluble and insoluble fibers should the benefits that consumers realize from objecting to the proposed definition of

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dietary fiber stated that consumers will individual dietary fibers so that would be needed to be eligible for not easily understand our dietary fiber consumers can match particular claims. and functional fiber definition, and beneficial physiological effects with (Response) We recognize that some these definitions will cause consumer each, we disagree and consider such an non-digestible carbohydrates added to confusion. One comment said that approach to be unwieldy. foods may not meet the dietary fiber changing the declaration of dietary fiber (Comment 290) One comment said definition in the final rule, resulting in could cause consumer confusion when that the proposed definition of dietary a lower amount of dietary fiber being a product no longer lists dietary fiber. fiber, insofar as it states that non- declared on the Nutrition Facts label. (Response) The comments may have digestible carbohydrates have a We also recognize that the definition misinterpreted the rule. The rule does physiological effect that is beneficial to may affect the number of foods that not change the term ‘‘dietary fiber’’ on human health, will reduce the voluntarily make a nutrient content or the Nutrition Facts label, nor does it use availability of high fiber products and health claim. However, we disagree that the term ‘‘functional fiber’’ on the reduce their use as ingredients. The this is a sufficient basis for not requiring Nutrition Facts label. Consumers comment said that regulatory hurdles added non-digestible carbohydrates to generally view dietary fiber as being a will discourage manufacturers from meet the dietary fiber definition; the beneficial nutrient (Ref. 142). Including innovating fiber containing products declaration of dietary fiber should assist fibers in the definition of dietary fiber and reduce the intake of dietary fiber. consumers in maintaining healthy that do not have a beneficial Another comment stated that these dietary practices. physiological effect would be ingredients are used as thickeners, (Comment 292) One comment said misleading in that the fiber listed would bulking agents, or anti-caking agents, in that the dietary fiber definition would not assist consumers in maintaining addition to fiber fortification. encourage the food industry to market healthy dietary practices. Therefore, (Response) We agree that many non- cookies, candies, ice cream, refined ensuring that all non-digestible digestible carbohydrates are added to grains, and other highly processed and carbohydrates that are declared as foods for a technical effect other than as relatively non-nutritious foods that dietary fiber have a beneficial a source of dietary fiber. There are would compete with the fiber-rich physiological effect will provide a numerous non-digestible carbohydrates fruits, vegetables, beans, and whole consistent benchmark with respect to approved as foods additives and GRAS grains that are linked to a lower risk of the types of fibers included in the notifications submitted to FDA about disease. declaration so that consumers can manufacturers’ determinations that (Response) We disagree with the understand the relative significance of certain non-digestible carbohydrates comment. The comment did not the amount of dietary fiber declared in added to food provide a technical effect provide, and we are not aware of, a product in the context of a total daily and are safe. The final rule does not evidence to suggest that the dietary fiber diet. We expect that some dietary fiber prohibit isolated or synthetic non- definition would encourage the food label declarations will need to change to digestible carbohydrates from being industry to market cookies, candies, ice comply with the definition of dietary added to foods. cream, refined grains, and other highly fiber. Consumers may have questions Manufacturers have a responsibility to processed and relatively non-nutritious about fiber ingredients based on changes ensure that the ingredients they use are foods that would compete with the in dietary fiber declarations and will be safe and do not adulterate the food and fiber-rich fruits, vegetables, beans, and better informed as to the dietary fiber to obtain FDA pre-market approval as whole grains that are linked to a lower content of a product that provides a appropriate. Innovative non-digestible risk of disease. Furthermore, the current beneficial nutrient. carbohydrate-containing products have process of relying solely on analytical (Comment 289) One comment said been shown to provide a variety of methods does not ensure that isolated or that our rule would prevent consumers technical effects. If the isolated or synthetic non-digestible carbohydrates from knowing how much fiber in many synthetic non-digestible carbohydrate is provide any beneficial physiological foods has been linked to a lower risk of included in the listing of fibers in the effect. While we do have a fortification disease and how much fiber has some definition of dietary fiber, then the policy in place (see § 104.20), ‘‘physiological benefit’’ that may be far dietary fiber must be included in the manufacturers can and currently do add less consequential. declaration of declared as dietary fiber these non-digestible carbohydrates to a (Response) While there can be a in addition to the declaration of Total variety of foods that may or may not distinction between physiological Carbohydrate. If the added fiber is not have a beneficial physiological effect. benefit and lower chronic disease risk, included in the listing of dietary fibers The final rule’s definition of dietary a number of the endpoints for a in the definition, the added fiber is not fiber would prevent the declaration of physiological benefit also are surrogate a dietary fiber and must not be part of isolated or synthetic non-digestible endpoints for chronic disease risk (e.g., the declaration of dietary fiber; instead, carbohydrates that have no beneficial fasting blood cholesterol and glucose the added fiber would only need to be physiological effect as dietary fiber. If levels, blood pressure). Furthermore, included in the declaration of Total there were to be a change in the requiring that an added non-digestible Carbohydrate. marketing of snack foods, it would more carbohydrate meet the dietary fiber (Comment 291) Some comments said likely result in a reduction of the use of definition will better identify those that there may be a need to make isolated or synthetic non-digestible dietary fibers that have a beneficial role significant product changes to maintain carbohydrates that do not meet the in human health than the current current dietary fiber label values. The dietary fiber definition. process of declaring dietary fiber solely comments explained that a dietary fiber (Comment 293) One comment said based on analytical methods. A dietary that is now a significant source may no that the definition could result in fiber is not necessarily limited to one longer be a significant source if we unintended consequences (i.e., reduced physiological health benefit, and there change the definition of dietary fiber. dietary fiber intake) because only may be multiple types of dietary fibers The comments said that companies dietary fibers would be based on present in a particular food. Thus, to the would lose their ability to make fiber physiological function. extent the comment suggests the claims that have been marketed for (Response) We disagree with the Nutrition Facts label needs to list years and that significant reformulation comment. Those dietary fibers that

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occur naturally in food must be declared (Comment 296) Several comments consistent with section 403(q) of the as dietary fiber. Information on the said we should allow isolated or FD&C Act. amount of isolated or synthetic non- synthetic non-digestible carbohydrates As for the comments’ reference to digestible carbohydrates that identified by other governmental EFSA, in response to evidence demonstrate a beneficial physiological organizations to meet the dietary fiber submitted in a petition, EFSA conducts effect to human health can assist definition. The comments further stated premarket reviews of added non- consumers in maintaining healthy that our isolated or synthetic non- digestible carbohydrates and their role dietary practices. While the dietary fiber digestible carbohydrates that meet the in beneficial physiological effects for declaration may need to be revised to a dietary fiber definition should be health claims (claims that are similar to lower value in some foods based on the harmonized with those approved by our structure function claims). Simply definition of dietary fiber, that does Canada (e.g., inulin) or Europe so as to adopting isolated or synthetic non- mean that consumption of the various not hinder trade. Some comments noted digestible carbohydrates approved by carbohydrates will change or that that EFSA mentions physiological other countries or organizations without consumers will not seek out other foods endpoints such as improved bowel determining if they have a beneficial to achieve a desired dietary fiber intake. function, colonic fermentation, physiological effect would not ensure (Comment 294) One comment stated maintenance of cholesterol levels, and that there is a consistent basis for an that some added fibers have adverse lowered glycemic response. Other isolated or synthetic non-digestible effects (flatulence, exacerbation of comments said we should consider carbohydrate meeting the definition of irritable bowel syndrome) that outweigh Health Canada and EFSA decisions to dietary fiber for purposes of the their benefits. grandfather in our isolated or synthetic declaration in the Nutrition Facts label. (Response) While the comment did non-digestible carbohydrates that meet not provide information as to which the dietary fiber definition. (ii) Mandatory Declaration isolated or synthetic non-digestible (Response) We decline to revise the Section 403(q)(1)(D) of the FD&C Act carbohydrates have adverse effects, the rule as suggested by the comments. specifies, in part, that for each serving overall health implications of fibers in Health Canada provides a list novel size or other unit of measure of a food, the context of the daily diet have been the amount of dietary fiber must be considered. While the safety of added fibers that are ingredients manufactured to be sources of dietary fiber and consist provided. Accordingly, our preexisting fibers is outside the scope of this rule, regulations, at § 101.9(c)(6)(i), require we have approved many isolated or of carbohydrates with a DP of 3 or more that are not digested and absorbed by the declaration of dietary fiber on the synthetic non-digestible carbohydrates Nutrition Facts label. as food additives, and there have been the small intestine. Novel fibers are In the preamble to the proposed rule determinations that certain non- synthetically produced or are obtained (79 FR 11879 at 11910), we mentioned digestible carbohydrates added to food from natural sources which have no that the 2007 ANPRM did not ask any provide a technical effect and are safe. history of safe use as a dietary fiber or questions about the mandatory labeling Furthermore, natural dietary fibers also which have been processed so as to can cause flatulence. modify the properties of the fiber. of dietary fiber and that we received no (Comment 295) One comment asked Health Canada considers the following comments on this subject. Dietary fiber whether dietary fibers that are currently to be beneficial effects: (1) Improved is not an essential nutrient, although it declared in the Nutrition Facts label laxation or regularity by increasing stool has physiological effects that are would have to be removed until bulk; (2) reduced blood total and/or beneficial to human health, such as approved. The comment said we should low-density lipoprotein cholesterol attenuation of postprandial blood allow industry to continue using and levels; (3) reduced post-prandial blood glucose concentrations, attenuation of labeling fibers already on the market glucose and/or insulin levels; and (4) blood cholesterol concentrations, and during the authorization process. energy-yielding metabolites through improved laxation. The consumption of (Response) The compliance date for colonic fermentation. There are distinct certain dietary fibers, particularly those the final rule is 2 years after the differences between how novel fibers that are poorly fermented (i.e., insoluble effective date, except that the are identified and our definition of fiber), improve fecal bulk and laxation compliance date for manufacturers with dietary fiber. First, a novel fiber need and ameliorate constipation, and less than $10 million in annual food only show a physiological effect, rather soluble fiber plays a beneficial role in sales is 3 years after the final rule’s than a beneficial physiological effect. reducing the risk of heart disease (id.). effective date. After the compliance We do not consider energy-yielding Given the health benefits of dietary date, foods must declare dietary fiber in metabolites (e.g., short chain fatty acids) fiber, we did not propose any changes accordance with the requirements of the to be a beneficial physiological effect to our current requirement for the final rule. Thus, if fibers are included as but rather an end product of mandatory declaration of dietary fiber in an ingredient in a food and do not meet fermentation that may result in a § 101.9(6)(i). the definition of dietary fiber after that physiological effect that may be We received no comments on this date, the declaration of dietary fiber beneficial. Second, Health Canada does topic, and so no changes to the final must not include those fibers. We are not require that all added non-digestible rule, with respect to mandatory not aware of how many isolated or carbohydrates demonstrate a declaration of dietary fiber, are synthetic fibers may be used as an physiological effect. Isolated or necessary. ingredient in food that we have not synthetic non-digestible carbohydrates With respect to the term used to already evaluated and that are not that have a history of safe use are declare dietary fiber content on the already included in the definition of considered to be traditional fibers rather Nutrition Facts label, the preamble to dietary fiber. Thus, we have no than novel fibers and do not have to the proposed rule (79 FR 11879 at information to suggest that we would demonstrate a physiological effect. We 11910) said that the term ‘‘dietary fiber’’ receive numerous petitions or that, if we have determined that a fiber must have has been listed on the Nutrition Facts were to receive petitions, our review beneficial physiological effects to label since 1993. Thus, we did not would extend beyond the compliance human health to assist consumers in propose to change the current dates. maintaining healthy dietary practices, requirement to declare dietary fiber

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using the term ‘‘dietary fiber,’’ as soluble naturally occurring dietary carbohydrates added during processing specified in § 101.9(f). fibers are associated with CVD risk, that do not meet the definition of (Comment 297) One comment whereas insoluble naturally occurring dietary fiber (in proposed supported the current single disclosure dietary fiber, such as some forms of § 101.9(c)(6)(i)) from the value obtained of dietary fiber because, according to the cellulose, is associated with improved using AOAC 2009.01, AOAC 2011.25 or comment, all fibers have a beneficial laxation. However, we disagree that the an equivalent AOAC method of analysis effect. differences in health effects warrant as given in the ‘‘Official Methods of (Response) We agree that there should separate declarations on the Nutrition Analysis of the AOAC International’’ be a single disclosure for dietary fiber. Facts label when both categories are 19th Edition. If a product contains only While it is premature to know whether composed of a heterogeneous group of non-digestible carbohydrates that meet all isolated or synthetic non-digestible compounds with variable health effects, the proposed definition of dietary fiber, carbohydrates have a beneficial all of which assist consumers to using AOAC 2009.01, AOAC 2011.25, or physiological effect, and therefore are a maintain healthy dietary practices. We an equivalent method would be ‘‘dietary fiber’’ as defined in the final have no basis on which we could rely, sufficient to quantify the dietary fiber rule, the final rule does not affect the nor has the comment provided one, to content of a food. However, if the preexisting requirement to use the term separate the dietary fiber declaration in product contains both dietary fiber that ‘‘dietary fiber.’’ the Nutrition Facts label into two is included in the proposed definition (Comment 298) Several comments separate listings; one for intact and (e.g., naturally occurring fibers) and supported a separate disclosure (e.g., intrinsic fibers, and the other for non-digestible carbohydrates not subcategory) of added fiber. Some isolated or synthetic non-digestible included in the definition (e.g., comments said that consumers should fibers that provide a physiological synthetic fibers without a physiological know the amount of added (processed) benefit to human health. Therefore, we effect that is beneficial to human versus natural (unprocessed) non- disagree that the declaration of dietary health), neither AOAC 2009.01 or digestible carbohydrates in a product so fiber, as proposed, would mislead AOAC 2011.25 nor an equivalent AOAC that consumers who want to increase consumers, and we decline to revise the method would accurately quantify the their intake of only intact fiber are able rule in response to this comment. dietary fiber that could be declared on to do so. Other comments noted that the the Nutrition Facts label, because the (iii) Analytical Methods 2010 DGA stated that it is unclear determination of fiber by these methods whether added fibers provide the same Under our preexisting regulations, at would include the non-digestible health benefits as naturally occurring § 101.9(g)(2), compliance with the carbohydrates that do not meet the dietary fiber. Other comments said that requirement for declaration of dietary proposed definition of dietary fiber. a separate declaration of added non- fiber is determined using appropriate To verify that the quantity of dietary digestible carbohydrates would exclude AOAC analytical methods. In the fiber declared on the Nutrition Facts non-digestible carbohydrates that do not preamble to the proposed rule (79 FR label includes only those fibers that have a demonstrated health benefit. 11879 at 11910), we discussed meet the regulatory definition of dietary One comment supporting a separate comments to the 2007 ANPRM fiber, when a food contains a mixture of listing of added non-digestible regarding the use of analytical methods non-digestible carbohydrates that meet carbohydrates stated that, although the and our review of other analytical the proposed dietary fiber definition IOM concluded that functional (added) methods. We noted that while some and those that do not, we also proposed, fiber should be included in total fiber, AOAC methods, such as AOAC 985.29, in §§ 101.9(c)(6) and (g)(10), to require the IOM clearly had more confidence in 991.43 and 994.13, measure soluble and manufacturers to make and keep written the benefits of foods rich in intact fiber insoluble polysaccharides, lignin, records to verify the amount of added than in the benefits of added fiber. The higher molecular weight non-digestible non-digestible carbohydrates that do not comment said that, in the years since oligosaccharides (DP >12), and some meet the proposed definition of dietary the IOM report was issued, the evidence measure resistant starch, inulin and low fiber. The amount of non-digestible that dietary fiber lowers the risk of heart molecular weight non-digestible carbohydrate measured by AOAC disease, diabetes, and diverticular oligosaccharides (DP <10), they do not 2009.01 or AOAC 2011.25 (or an disease continues to come from studies measure all non-digestible equivalent AOAC method) minus the of people who consume foods rich in carbohydrates with a DP <10 (id.). In amount of added non-digestible intact fiber, especially whole grains and contrast, newer methods (AOAC carbohydrate which is not included in wheat bran. The comment said that 2009.01 and AOAC 2011.25) measure all the definition of ‘‘dietary fiber’’ would allowing labels to combine intact and low molecular weight non-digestible reflect the amount of dietary fiber added fiber misleads consumers into carbohydrates (i.e., non-digestible lawfully declared on the label. Only believing that added fiber has the same oligosaccharides) in addition to the those fibers that have been determined health benefits as intact fiber. The higher molecular weight non-digestible by FDA to have a physiological effect comment said we have tentatively carbohydrates, and we said that the that is beneficial to human health would concluded that there is little benefit for newer, more inclusive AOAC methods be included in the definition of ‘‘dietary consumers in distinguishing between would be more consistent with our fiber.’’ intact and added fiber on the Nutrition proposed definition of dietary fiber (id.). (Comment 299) One comment stated Facts label because ‘‘both have We acknowledged, however, that there that AOAC 2009.01 is suitable to beneficial health effects.’’ However, the is no analytical method that can measure low molecular weight non- comment said that the two types of fiber distinguish non-digestible digestible oligosaccharides, as well as do not necessarily have equivalent carbohydrates that have a beneficial the higher molecular weight non- health effects, as labels would imply. physiological effect from those that do digestible carbohydrates and (Response) We agree that intact and not (id.). quantitatively cover inulin and intrinsic (naturally occurring) dietary Thus, we proposed to amend oligofructose while the older methods fibers may have different health effects § 101.9(c)(6)(i) to indicate that dietary did not. Another comment supported than isolated or synthetic non-digestible fiber content may be determined by acceptance of the ‘‘all-inclusive’’ carbohydrates. For example, some subtracting the amount of non-digestible methods of analysis, AACCI 32–45

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(AOAC 2009.01) and AACCI 32–50 the risk of CHD. Therefore, we proposed comment said that recommendations to (AOAC 2011.25), as well as other to use 14 grams/1,000 kcal as the basis reduce calorie intake will make it more equivalent and validated AACCI and for a DRV for dietary fiber and to amend difficult to increase dietary fiber intake AOAC Approved or Official methods. § 101.9(c)(9) to set a DRV of 28 grams and to increase the DV to 28 grams will Several comments stated that AOAC (14 grams/1,000 kcal × 2,000 kcal/day) require consumers to increase their 2009.01 and 2011.25 are not the only for dietary fiber. calorie intake. methods that can be used to measure (Comment 301) Some comments (Response) We disagree with the dietary fiber. Some comments suggested supported the proposed DV (also a DRV) comments’ assertion that an AI based on that we allow for other dietary fiber of 28 grams based on most recent calories is not a sufficient basis for analytical methods, such as AOAC findings by the IOM and current dietary setting the DV. There have been a 985.29, AOAC 991.43 and AOAC recommendations. One comment number of DVs based on calories other 2001.03. One comment would revise the supported increasing the DV from 25 to than dietary fiber (e.g., total fat and rule to allow the use of alternative 28 grams after we have a better saturated fat). Furthermore, the AI was methods provided they have been understanding of consumer and shopper not set based on energy needs but rather sufficiently validated (e.g., if they are dynamics. on energy intake. While there may be noted in USP or CFR citations). The In contrast, one comment objected to recommendations to reduce calorie comment said that test methods may a DV of 28 grams; the comment said that intake for some individuals, the 2010 evolve to incorporate superior the AI is based on observational data DGA encourages consumption of fruits, measurement technologies and will rather than clinical trial data. vegetables and whole grains which are better keep pace with the science and (Response) We proposed the DV of 28 sources of dietary fiber. understanding of dietary fiber. Several grams based on the current scientific (Comment 303) Several comments comments stated that we should allow evidence evaluated by the IOM. The opposed a DV of 28 grams because, the use of methods that measure specific comments objecting to a DV of 28 grams according to the comments, some foods non-digestible carbohydrates such as did not provide a basis on which we that are a good source of dietary fiber GOS, b-glucan, fructans, polydextrose, could rely that would cause us not to would no longer qualify if the DV was trans galactose oligosaccharides, and use the current DRIs provided by the set at 28 grams. resistant starch. IOM. The AI was set by the IOM based (Response) We will address, as (Response) The proposed rule did not on three prospective cohorts that appropriate, the impact on our other specify the use of AOAC 2009.01 and consistently demonstrated that the regulations that are outside the scope of AOAC 2011.25 for measuring and greatest reduction in CVD risk could be this rulemaking, such as the regulations declaring dietary fiber. We stated that achieved when consuming 14 grams/ for nutrient-content claims, in separate dietary fiber content may be determined 1,000 kcal of dietary fiber. We agree that rulemaking actions. While some foods by subtracting the amount of non- observational data alone are insufficient may no longer qualify as a good source digestible carbohydrates added during for evaluating the causal relationship of dietary fiber, the DV is based on processing that do not meet the between a nutrient and a health evidence linking dietary fiber to definition of dietary fiber from the value endpoint, such as CVD. The IOM noted reduced risk of chronic disease. obtained using AOAC 2009.01, AOAC that there are a large number of Therefore, this DV and nutrient-content 2011.25, or an equivalent method of intervention trials on blood lipid claims based on this DV can assist analysis as given in the ‘‘Official concentrations that alter the risk of CHD consumers in maintaining healthy Methods of Analysis of the AOAC (Ref. 29). In our science review of the dietary practices. International, 19th Ed., 2012 (see 79 FR evidence to authorize a health claim for (Comment 304) One comment 11879 at 11968). The methods used dietary fiber-containing fruits, opposed to setting the DV at 28 grams must support the dietary fiber definition vegetables and grain products and CVD said that increasing the level of dietary and therefore must measure lower (§ 101.77), numerous intervention fiber to meet the increased DV will molecular weight non-digestible studies were cited that showed a present many technical and economic oligosaccharides (DP 3–9) if present in cholesterol-lowering effect (58 FR 2552 hurdles to ingredient suppliers and a food. at 2552 through 2559). Furthermore, our manufacturers. The comment said (Comment 300) One comment stated recent review of intervention studies on manufacturers would be deterred from that AOAC 2009.01 and 2011.25 do not some added fibers (e.g., pectin, guar developing products that help capture all types of resistant starch (RS) gum, hydroxypropylmethylcellulose consumers close the dietary fiber intake (e.g., RS4). and locust bean gum) has shown a gap. (Response) We agree that AOAC cholesterol-lowering effect (Ref. 138) (Response) While it is unclear how an 2009.01 and 2011.25 do not measure all Because of the available underlying increased DV would present technical forms of RS4, such as cross-linked evidence from intervention studies to and economic hurdles or deter the wheat starch (Ref. 143). In these cases, support a cholesterol-lowering effect of development of products, the DV of 28 when submitting a citizen petition or a dietary fibers, we disagree that a grams is a quantitative intake health claim petition, a more quantitative intake recommendation recommendation set by the IOM (14 appropriate method can be identified based on observational data related to grams/1,000 calories) based on reducing that can measure all of the RS4. CVD risk is inadequate for setting a DV, the risk of CVD and therefore should and the final rule sets a DRV of 28 grams inform the consumer on the (iv) DRV for dietary fiber. contribution of a food to dietary fiber to The DRV for dietary fiber is 25 grams (Comment 302) Several comments assist the consumer in maintaining (§ 101.9(c)(9)). In the preamble to the supported retaining the DV of 25 grams healthy dietary practices. Increasing the proposed rule (79 FR 11879 at 11911), rather than the proposed DV of 28 grams DV for dietary fiber (which may result we noted that, in 2002, the IOM set an for dietary fiber. One comment stated in a corresponding reduction in the AI of 14 grams/1,000 kcal for ‘‘total that 28 grams is based on an AI of 14 percent DV for some foods) tells the fiber’’ and that the AI was primarily grams/1,000 calories and is tied to consumer how much that food based on the intake level that was calories rather than reflecting the energy contributes to the overall dietary fiber associated with the greatest reduction in needs of children and women. The intake as part of a healthy diet.

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Consumers attempting to meet a certain (Response) We agree that the terms important to evaluate the physiological percent DV could increase their dietary soluble and insoluble fiber do not benefits of individual isolated or fiber intake based on the new DV and necessarily reflect physiological or synthetic non-digestible carbohydrates. based on the dietary fiber definition are nutrition functions. In the preamble to (iii) Analytical Methods assured that the percent DV reflects the proposed rule (79 FR 11879 at beneficial physiological effects. 11911), we considered physicochemical Our preexisting regulations, at (Comment 305) One comment would terms such as ‘‘viscous’’ or § 101.9(g)(2), state that compliance with keep the DV at 25 grams and noted that ‘‘fermentable.’’ The standardization of any declaration of soluble or insoluble WHO/FAO and EFSA recommend 25 the characterization of such terms, fibers is to be determined using grams/day as an amount needed for however, has not yet occurred. appropriate AOAC analytical methods. healthy laxation. Furthermore, the viscosity of a fiber In the preamble to the proposed rule (79 (Response) We disagree that a DV of does not necessarily predict FR 11879 at 11911), we said that there 25 grams should be set based on fermentability, and it is not known at are a number of traditional AOAC laxation. The WHO/FAO (Ref. 144) did what level of viscosity a fiber begins to methods available for measuring soluble not provide a recommendation for have a physiological effect. Therefore, fiber (e.g., AOAC 991.43 and 993.19) dietary fiber, but stated that the we did not propose to change the terms and insoluble fiber (e.g., AOAC 991.42 recommended intake of fruits and soluble and insoluble fiber. and 991.43), but that, as is the case with vegetables is likely to provide greater The final rule, at § 101.9(c)(6)(i)(A) dietary fiber, these methods cannot than 25 grams/day of total dietary fiber. and (c)(6)(i)(B), requires soluble fiber measure all non-digestible This amount would only reflect dietary and insoluble fiber, respectively, to carbohydrates with a DP <10. Similarly, fiber that is naturally occurring in food. meet the definition of dietary fiber in a newer method, AOAC 2011.25, can While EFSA set a Nutrient Reference § 101.9(c)(6)(i). measure low molecular weight non- Value of 25 grams/day based on (ii) Voluntary Declaration digestible carbohydrates and separately measure soluble and insoluble non- laxation, EFSA also noted that there is Our preexisting regulations permit, digestible carbohydrates, but AOAC evidence of benefit to health associated but do not require, the declaration of 2011.25 cannot distinguish soluble and with the consumption of dietary fiber soluble fiber (§ 101.9(c)(6)(i)(A)) and insoluble non-digestible carbohydrates intakes greater than 25 grams/day (e.g., insoluble fiber (§ 101.9(c)(6)(i)(B)) on that have a physiological effect that is reduced risk of CHD) (Ref. 145). the Nutrition Facts label. We did not beneficial to human health from those (Comment 306) One comment propose any changes to these provisions that do not (id.). opposed to a DV of 28 grams stated that with respect to voluntary declaration. this value represents intact dietary fiber (Comment 308) One comment The proposed rule would amend only because the IOM relied on supported voluntary declaration of § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) to evidence from studies of intact fiber to soluble and insoluble fiber. The indicate that the soluble and insoluble set the AI. comment said consumers may not know non-digestible carbohydrate content (Response) We disagree with the the difference between these two may be calculated by first using AOAC comment. The AI of 28 grams/day (14 categories of dietary fiber. 2011.25, or an equivalent AOAC method grams/1,000 calories) set by the IOM In contrast, another comment of analysis. If a food contains only non- represents total dietary fiber which supported mandatory declaration of digestible carbohydrates that meet the includes both naturally occurring and soluble and insoluble fiber. The proposed definition of dietary fiber (e.g., added dietary fiber (IOM). comment said that, while the IOM did contains naturally occurring fiber only), b. Soluble and insoluble fiber. Dietary not provide DRIs for each category of then AOAC 2011.25 or an equivalent fibers can be classified as being soluble dietary fiber, there is a recommendation AOAC method would measure the or insoluble. Soluble fibers, such as of a 3:1 ratio of insoluble fiber to soluble amount of soluble or insoluble fiber that pectin and gums, dissolve in water and fiber. Furthermore, the comment said, can be declared on the Nutrition Facts are digested by the bacteria in the large there is little burden to measure both, label. If a food contains a mixture of intestine. Insoluble fibers, such as some consumers may make more informed non-digestible carbohydrates that do forms of cellulose and lignin, do not choices that offer a balance of soluble and do not meet the proposed dietary dissolve in water and are not digested and insoluble fiber, and the solubility fiber definition, and the label of the food by bacteria in the large intestine, adding relates to physiological benefit. declares soluble or insoluble fiber bulk to the stool for improved laxation. (Response) We decline to revise the content, proposed § 101.9(c)(6)(i)(A) and rule to provide for the mandatory (c)(6)(i)(B) would require manufacturers (i) Definition declaration of soluble and insoluble to make and keep records to verify the Our preexisting regulations do not fiber. We are unaware of a amount of soluble or insoluble non- define soluble or insoluble fiber. In the recommended ratio for insoluble to digestible carbohydrates that do not preamble to the proposed rule (79 FR soluble fiber intake, and, therefore, we meet the proposed definition of dietary 11879 at 11911), we explained that, do not know on what basis such a fiber that have been added to the food because soluble and insoluble fibers are declaration would allow consumers to product during processing. components of dietary fiber, they must make more informed choices on an (Comment 309) Some comments said meet the proposed definition of dietary appropriate balance of soluble and that other analytical methods (e.g. fiber. Therefore, we proposed, in insoluble fibers. However, to meet the AOAC 991.43) are cited in a health § 101.9(c)(6)(i)(A) and (c)(6)(i)(B), that dietary fiber definition, all non- claim regulation for soluble fiber from soluble fiber and insoluble fiber, digestible carbohydrates declared as certain foods and risk of CHD (§ 101.81). respectively, must meet the definition of dietary fiber should assist consumers in One comment further stated that there is dietary fiber in § 101.9(c)(6)(i). maintaining healthy dietary practices, an opportunity to incorporate HPLC (Comment 307) One comment said regardless of the ratio of such fibers. analysis to quantify the DP 3–9 fraction that the terms soluble and insoluble While there is evidence to suggest that, which previously has not been detected fiber did not clearly identify in general, solubility relates to by the health claim-mandated method physiological or nutritional functions. physiological benefit, we consider it for psyllium husk.

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(Response) We recognize that carbohydrate less the amount of final rule retains a general factor of 2 § 101.81(c)(G)(2)(ii) states that b-glucan insoluble dietary fiber calories per gram for soluble non- soluble fiber from the whole oat and (§ 101.9(c)(1)(i)(C)) (79 FR 11879 at digestible carbohydrates. barley sources will be determined by 11912). Because the proposed rule (Comment 311) One comment AOAC 992.28 and that we will would establish a new definition of supported a caloric value of 1 kcal/gram determine the amount of soluble fiber dietary fiber that only allows for the for polydextrose. The comment said provided by psyllium husk by using a declaration of dietary fibers that are that, in 1981, FDA recognized that modification of AOAC 991.43. We added to foods that we have determined polydextrose has a biocalorie value of 1 intend to update this regulation in the to have a physiological effect that is kcal/gram and that the science future such that these soluble fibers beneficial to human health, the supporting this value has been reviewed would be required to be measured by proposed definition of dietary fiber (Ref. 146). methods that meet the dietary fiber would exclude soluble and insoluble (Response) The comment is referring definition (DP >3). However, the final non-digestible carbohydrates that do not to a 1981 letter from the Bureau of rule no longer refers to AOAC methods meet the proposed definition of dietary Foods, Division of Food and Color in § 101.9(c)(6)(i), (i)(A), and (i)(B). We fiber. Thus, to calculate calories from Additives that did not object to the discuss the omission of the AOAC soluble and insoluble non-digestible caloric value of 1 kcal/gram from methods in these provisions in our carbohydrate, the proposed factor of 2 polydextrose. This letter was in response to comment 524. kcal/gram and 0 kcal/gram, respectively, reference to food additive petition would apply to those soluble and 9A3441. We disagree that the 1981 FDA (iv) DRV insoluble non-digestible carbohydrates letter related to polydextrose is a basis Our preexisting regulations do not that both do and do not meet the for establishing a caloric value for establish DRVs for soluble fiber or proposed definition of dietary fiber. To polydextrose for the Nutrition Facts insoluble fiber. In the preamble to the ensure that soluble non-digestible label. Polydextrose is a synthetic, non- proposed rule (79 FR 11879 at 11912), carbohydrates that do and do not meet digestible carbohydrate. We are we explained that no DRIs were the proposed definition of dietary fiber establishing, in this final rule, a established for soluble or insoluble fiber are considered in the caloric definition for dietary fiber that does not during the IOM’s evaluation of a DRI for contribution of total carbohydrate, such include polydextrose as a listed dietary dietary fiber, so we have no basis on that a general factor of 2 kcal/gram is fiber. Thus, polydextrose would be which to derive an appropriate DRV. applied to these non-digestible considered a component of total Therefore, we did not propose to set a carbohydrates, we proposed to amend carbohydrate subject to the calculation DRV for either soluble fiber or insoluble § 101.9(c)(1)(i)(C) to require that calories of the value for total carbohydrate in fiber. from carbohydrate be calculated using a § 101.9(c)(1)(i)(C) and not as a dietary We did not receive any comments on general factor of 4 kcal/gram of total fiber. a DRV for soluble or insoluble fiber. The carbohydrate less the amount of non- As for the comment’s reference to a final rule, therefore, does not establish digestible carbohydrates, which specific scientific article, the a DRV for soluble or insoluble fiber. includes soluble (2 kcal/gram) and publication was a review article on studies that had evaluated the caloric (v) Caloric Value insoluble (0 kcal/gram) non-digestible carbohydrates that do and do not meet contribution of polydextrose in humans Under our preexisting regulations, at the definition of dietary fiber. The and animals (Ref. 146). We have not § 101.9(c)(1)(i)(C), the caloric content of calorie contribution of soluble non- considered all of the caloric values of a food may be calculated by, among digestible carbohydrate would be added individual components of total other methods, using the general factors to that sum to determine the total carbohydrate as part of this rule, and all of 4, 4, and 9 kcal/gram for protein, total carbohydrate calorie contribution. are subject to § 101.9(c)(1)(i)(C) for total carbohydrate less the amount of (Comment 310) Several comments carbohydrate, unless otherwise insoluble dietary fiber, and total fat, agreed with a caloric value of 2 kcal/ specified. respectively. Soluble fiber, which is gram for soluble, non-digestible 6. Other Carbohydrate encompassed within ‘‘total carbohydrates. Some comments, carbohydrate,’’ is assigned a general however, said the final rule should Our preexisting regulations, at factor of 4 kcal/gram. In the preamble to provide for exceptions when the § 101.9(c)(6)(iv), define ‘‘other the proposed rule (79 FR 11879 at difference in energy value would be carbohydrate’’ as the difference between 11912), we explained how comments to significant and has been established by total carbohydrate and the sum of the 2007 ANPRM and a citizen petition science. dietary fiber, sugars, and sugar alcohol, supported a caloric value of 2 kcal/gram (Response) We decline to revise the except that if sugar alcohol is not for soluble fiber, and so we proposed to rule to provide for exceptions. We declared, ‘‘other carbohydrate’’ is amend § 101.9(c)(1)(i)(C) to establish a recognize that fermentation of fibers can defined as the difference between total general factor of 2 kcal/gram as the yield different caloric values and that a carbohydrate and the sum of dietary caloric value of soluble non-digestible fermentable fiber is not equivalent to a fiber and sugars. Examples of ‘‘other carbohydrates. Insoluble non-digestible soluble fiber. We agree that exceptions carbohydrate’’ include starch and carbohydrates are not included in the could be considered for changing the oligosaccharides. Our preexisting caloric calculation. caloric value of a soluble non-digestible regulations, at § 101.9(c)(6)(iv), also We also proposed a corresponding carbohydrate when the difference in provide for the voluntary declaration of change to the introductory text in energy value is significant and when we the amount of ‘‘other carbohydrate’’ on § 101.9(c)(1)(i)(C) to reflect the caloric determine that the evidence is the Nutrition Facts label. value of total carbohydrate based on the established by science. We would need The preamble to the proposed rule (79 new caloric contribution of soluble to evaluate any requests for exceptions FR 11879 at 11912) explained that we fiber. We explained that our regulations case-by-case in a request to amend were reconsidering the voluntary require that the calories from total § 101.9(c)(1)(i)(C) to include the greater declaration of ‘‘Other carbohydrate’’ on carbohydrate be calculated by using the caloric value of the fiber in the total the Nutrition Facts label based on the general factor of 4 kcal/gram of carbohydrate calorie amount. Thus, the factors we consider for the mandatory

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and voluntary declaration. We stated not understand the ‘‘Other 2. Analytical Methods that ‘‘other carbohydrate’’ represents carbohydrate’’ declaration. Our preexisting regulations, at different types of carbohydrate, and, In any case, the declaration of ‘‘Other § 101.9(c)(7), state that protein may be unlike sugars and dietary fiber, carbohydrate’’ was voluntary, so most calculated on the basis of 6.25 times the carbohydrates covered under this products did not contain the nitrogen content of the food determined category have no shared physiological declaration. The FDA Food Label and by the appropriate method of analysis as effects and that there is no well- Package Survey (FLAPS) (2006–2007) given in the Official Methods of established evidence to support the role estimated that about 4 percent of Analysis of AOAC International, 15th of particular types of carbohydrate that products list ‘‘Other carbohydrate.’’ As ed. (1990), except when the official fall within the ‘‘Other carbohydrate’’ a result, consumers had limited ability procedure for a specific food requires category, such as starch and to be informed about the components of another factor. The preamble to the oligosaccharides, in human health that total carbohydrate on most products. proposed rule discussed a citizen is based on reliable and valid The contribution of ‘‘Other petition that asked us to consider other physiological or clinical endpoints (id.). carbohydrate’’ can be determined by methods of analysis as set forth in a We also noted that a quantitative intake subtracting dietary fiber and sugars from newer edition of the Official Methods of recommendation for ‘‘Other the ‘‘Total carbohydrate’’ declaration. Analysis of AOAC International, and we carbohydrate’’ is not available from The declaration of ‘‘Total agreed that we should update the relevant consensus reports, and so, carbohydrate,’’ is mandatory, so the version of the Official Methods of given the lack of public health total carbohydrate content is available Analysis of the AOAC International that significance or a quantitative intake on all products that must bear a we use for compliance purposes because recommendation for ‘‘other Nutrition Facts label. Consequently, the newer, and sometimes better, analytical carbohydrate’’ as a category, we final rule removes the provision that methods for many nutrients are tentatively concluded that ‘‘Other allows for the voluntary declaration of carbohydrate’’ should no longer be included in new or revised versions of ‘‘Other carbohydrate’’ on the Nutrition the methods (79 FR 11879 at 11913). permitted to be declared on the Facts label, and we also have revised Nutrition Facts label (id.). Thus, the The proposed rule, therefore, would § 101.9(g)(4) and (g)(6) to remove amend § 101.9(c)(7) to incorporate by proposed rule would remove the references to ‘‘Other carbohydrates.’’ provision that allows for the voluntary reference the Official Methods of declaration of ‘‘Other carbohydrate’’ on I. Protein Analysis of the AOAC International, 19th ed. (2012) by removing ‘‘15th Ed. the Nutrition Facts label, and we would 1. Mandatory and Voluntary Declaration make a corresponding revision to (1990)’’ and adding in its place ‘‘19th § 101.9(g)(4) and (g)(6) to remove Section 403(q)(1)(D) of the FD&C Act Ed. (2012).’’ references to ‘‘Other carbohydrates.’’ requires food labeling to bear nutrition We did not receive any comments on (Comment 312) Several comments information about protein, and so our the AOAC methods for the supporting the removal of ‘‘Other preexisting regulations, at determination of protein. The Official carbohydrate.’’ Some comments agreed § 101.9(c)(7)(i), require the declaration Methods of Analysis of AOAC that there is no quantitative intake of the amount of protein by weight and International, 20th Edition was recommendation and the scientific provide for voluntary declaration of the published in 2016. The 20th Edition evidence does not demonstrate public percent DV for protein on the Nutrition includes a number of new methods of health significance. Other comments Facts label (§ 101.9(c)(7)(i)). In the analysis as well as changes to current said that retaining ‘‘Other carbohydrate’’ preamble to the proposed rule, we methods. We need additional time to may be confusing and that most stated that there is strong evidence, consider the additions and changes, and consumers are not likely to understand based on valid physiological and to determine if additional public what the term ‘‘Other carbohydrate’’ clinical endpoints, that protein is an comment is necessary on the 20th represents. One comment said it was not essential nutrient that is necessary for Edition of the AOAC Methods of aware of any data or other factual human health and growth and that the Analysis. Therefore, we are finalizing information around consumer declaration of protein content remains the regulation as proposed, and are understanding of the term. necessary to assist consumers in incorporating the 19th Edition of the In contrast, some comments said we maintaining healthy dietary practices. Official Methods of Analysis of the should retain the voluntary declaration We also stated that, because protein AOAC International by reference. of ‘‘Other carbohydrate’’ because, intake in the U.S. population continues Consequently, we have finalized according to the comments, consumers to be adequate when compared to the § 101.9(c)(7), insofar as the AOAC use the information to determine the EAR, absent a mandatory percent DV methods are concerned, without change. carbohydrate content of foods that are declaration, the declaration of protein as (Comment 314) Although we did not not attributable to sugars and dietary a percent DV should remain voluntary propose any changes to how the gram fiber or because removing the voluntary (id.). Consequently, we did not propose amount of protein in a serving of a food declaration could confuse consumers. any changes to the requirement for product is calculated, several comments Some comments said that the ‘‘Other declaration of the quantitative amount addressed this subject. Our preexisting carbohydrate’’ declaration allows of protein and the voluntary declaration regulations, at § 101.9(c)(7), require that consumers to better understand the total of this amount as a percent DV on the protein content be calculated using a carbohydrates portion of the Nutrition Nutrition Facts label. factor of 6.25 times the nitrogen content Facts label because the various (Comment 313) Several comments of the food as determined by the components that constitute ‘‘Total supported the continued mandatory appropriate method of analysis in the carbohydrate’’ approximates the sum declaration of protein on the label. ‘‘Official Methods of Analysis of the when ‘‘Other carbohydrate’’ is included. (Response) Because we did not AOAC International’’ (15th Ed.), except (Response) The comments did not propose to change the preexisting when the official procedure for a provide data or information, nor are we requirement to declare the amount of specific food requires another factor. We aware of any, to support their view that protein by weight, no changes to the also state in § 101.9(c)(7)(ii) that the consumers use, are confused by, or do final rule are necessary. protein digestibility-corrected amino

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acid score (PDCAAS) must be a value for ‘‘crude protein’’ since the In recent years, a number of determined by methods given in factors are derived by applying the conversion factors have been sections 5.4.1, 7.2.1, and 8.00 in appropriate factor to the total nitrogen recalculated based on the best available ‘‘Protein Quality Evaluation, Report of present. For groups of foods for which data, including the amino acid the Joint FAO/WHO Expert a conversion factor is not provided, a composition of foods rather than the Consultation on Protein Quality general factor of 6.25 is used. This nitrogen content. Conversion factors Evaluation,’’ Rome, 1990 (which we also general conversion factor is derived calculated from the nitrogen content proposed changing the publication year from observations that many commonly provide a measure of the ‘‘crude to 1991; hereafter referred to as the 1991 occurring proteins contain about 16 protein’’ content (Refs. 147–152). FAO/WHO Protein Quality Report), percent nitrogen (i.e., (100/16 = 6.25)) However, the amino acid composition except that when official AOAC (Ref. 69). A single nitrogen-to-protein rather than the nitrogen content of a procedures described in § 101.9(c)(7) conversion factor may be sufficient if protein is increasingly viewed as the require a specific food factor other than the aim is to indicate the amount of more important quality of a protein for 6.25, that specific factor shall be used. nitrogen present and to present it as an nutrition purposes. This is because One comment noted that the language average protein content. In contrast, ‘‘protein’’ is increasingly taken to mean related to use of nitrogen to protein specific conversion factors rather than a ‘‘amino acids,’’ which is the focus of conversion factors in § 101.9(c)(7) and single general factor provide a more greatest concern to those interested in (c)(7)(ii) is inconsistent. The comment accurate indication of dietary amino human nutrition (Ref. 147). suggested that the term ‘‘official acids in a food (Ref. 147). procedure’’ is vague, and the term Theoretically, these newer factors may As for the comment’s assertion that provide a more nutritionally relevant ‘‘food’’ does not allow for the the word ‘‘food’’ does not allow for differentiation between single foods like way to estimate protein quantity and differentiation between single foods or a quality. As discussed in our response to peas, or a blend like beans and rice. The blend of foods, we disagree. Food is comment suggested revising both comment 317, other comments have defined in section 201(f) of the FD&C raised issues related to the § 101.9(c)(7) and (c)(7)(ii) to say ‘‘or if Act as articles used for food or drink for another scientifically supported factor is determination of protein for the man or other animals, chewing gum, purposes of nutrition labeling which generally accepted.’’ The comment said and articles used for components of any that this change would allow for the use require additional review and such article. Therefore, ‘‘food’’ refers to consideration. We need to evaluate the of nitrogen to protein conversion factors both single-ingredient foods, such as other than 6.25 that are commonly used use of methods which include peas, and blends such as beans and rice. throughout industry. The comment conversion factors other than those We note, however, that all of the Jones’ noted that a number of sources have specified in official AOAC procedures factors were determined for specific suggested that the factor of 6.25 does not to determine if they are appropriate and single foods and not for blends of foods reflect an accurate nitrogen level for all in context with other changes to how as suggested in the comment (Ref. 69). foods, particularly non-meat items and protein is determined for the purposes We are not aware of any conversion that other commodity-specific nitrogen- of nutrition labeling before amending factors that have been developed for to-protein conversion factors are the regulation. We therefore decline to blends of foods (e.g. a mixture of beans included in reports from USDA (Ref. allow for the use of conversion factors and rice). 69). other than those specified in the official (Response) We agree, in part, with the With respect to the comment’s AOAC procedures at this time, but will comment and disagree, in part, with the assertion regarding other, more accurate continue to monitor future comment. We agree that the language in food factors, we note that, in the 1993 developments in the determination of § 101.9(c)(7) and (c)(7)(ii) should be Final Rule for Mandatory Nutrition protein and will consider amendments consistent and have revised § 101.9(c)(7) Labeling, we responded to a comment to our requirements for protein labeling, to say ‘‘except that when official AOAC requesting that food-specific conversion as appropriate. procedures described in paragraph (c)(7) factors used by AOAC be allowed for require a specific factor other than 6.25, calculating the PDCAAS whenever such In the future, it may be possible to that specific factor shall be used’’ and factors are available (58 FR 2079 at accept factors other than Jones’ factors have made a corresponding edit to 2102). The PDCAAS is an amino acid if there is a description of methods used § 101.9(c)(7)(ii). We also agree that the scoring procedure that takes into for their determination (e.g. complete generally accepted factors (i.e., the account digestibility of a protein. The amino acid determination) and a Jones’ factors) should be used when PDCAAS provides a reasonable measure description of the foods to which such specified in official AOAC procedures. of protein quality. We acknowledged new factors are applicable. Because a We decline to allow for the use of other that the method for calculating PDCAAS nitrogen-to-protein conversion factor factors for the reasons discussed in this described in the 1991 FAO/WHO can be ‘‘calculated’’ by simply dividing response. Protein Quality Report specifies a 100 by the total nitrogen content of a For purposes of nutrition labeling, conversion factor of 6.25, but agreed to food, it will be critical that newer among others, protein is estimated by allow for the use of other food-specific factors be accompanied by publicly determining the nitrogen content of an conversion factors when the official available documentation of the amino ingredient and multiplying it by a AOAC procedures require them (58 FR acid analyses by which they were nitrogen-to-protein conversion factor. A 2079 at 2102). When amending our developed and the specific foods to number of Jones factors cited in the regulations to allow for use of such which the new factors apply. Continued USDA references provided in the conversion factors, we intended to allow use of Jones’ factors other than 6.25 comment have been in use for a wide for the use of food-specific conversion (e.g., 5.7 for wheat, 6.38 for milk, 5.46 variety of foods for about 75 years. factors that are specified in official for and Brazil nuts, 5.18 for These conversion factors for calculating AOAC procedures. The conversion ) in AOAC Official Methods is protein from nitrogen content for 43 factors specified in official AOAC appropriate. These factors are used in foods were published in 1973 by USDA procedures are commodity-specific commodity-specific analytical methods (Ref. 69). Use of Jones’ factors provides Jones’ factors. which have been replicated in

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numerous laboratories and, as a result, official procedure requires another comments addressed this subject. Our have achieved Official Method status. factor. Replacement of the term ‘‘may’’ preexisting regulations, at § 101.9(c)(7), (Comment 315) One comment stated with other terms in § 101.9(c)(7) would require the use of a PDCAAS for that, because the regulation says that prevent the use of all other means of determining whether a food contains a ‘‘protein content may be calculated on protein determination. Manufacturers significant amount of protein per the basis of the factor 6.25 times the are permitted to use other means, such serving and for calculating the percent nitrogen content of the food,’’ as databases, to determine the amount of DV for protein. When the protein in manufacturers are using various protein in a serving of their product, foods represented or purported to be for practices in calculating protein for the and the suggested change would not adults and children 4 or more years of labeling of foods (e.g., breakfast cereal, permit such practices. Therefore, the age has a PDCAAS of less than 20 meal replacement products, and dietary final rule does not prohibit the use of expressed as a percent, or when the supplements) that contain protein values derived from databases or other protein in a food represented or combined with non-protein sources of methods, but the protein value declared purported to be for children greater than nitrogen such as free amino acids and in labeling must meet the value that we 1 but less than 4 years of age has a non-proteinogenic nitrogen compounds obtain using our compliance criteria for PDCAAS of less than 40 expressed as a (e.g., L-carnitine, creatine, D- the product to not be misbranded. percent, a statement must be placed on phenalalanine, adenosine, niacinamide, Regardless of the means used to the label indicating that the food is not etc.). Two comments recommended that determine the amount of protein, a a significant source of protein or the we revise the rule so that the declared manufacturer is responsible for the percent DV for protein must be content of protein in grams does not accuracy and compliance of the declared. include non-protein nitrogen sources information presented on the label. We We also require, in § 101.9(c)(7)(ii), and to define protein as ‘‘a chain of will determine whether a product that the PDCAAS be multiplied by the amino acids connected by peptide complies with § 101.9(g) by laboratory actual amount of protein in grams to bonds.’’ One comment suggested that, if analysis. determine the ‘‘corrected amount of these changes are made, there are two We also agree that methods for the protein (gram) per serving’’. Under our means by which the appropriate label determination of non-protein nitrogen preexisting regulations, at declaration for protein may be sources may not yet be available or may § 101.9(c)(7)(i), the corrected amount of determined. The first is by subtracting not be valid for a given food matrix. We protein per serving must then be used the quantity of non-protein nitrogen are currently aware of such methods for to calculate a percentage of the RDI or sources from the total protein calculated milk, but not for other matrices. For DRV for protein, as appropriate. The based on the nitrogen content. The example, a number of AOAC Official PDCAAS must be determined by second is by measuring the total amino Methods are available, including a methods given in the 1991 FAO/WHO acids in the food and subtracting the method for TCA-precipitated protein Protein Quality Report, which is free amino acids present. The comment nitrogen in milk (AOAC Official incorporated by reference in acknowledged that methods for various Methods 991.20, 991.21, and 991.22). § 101.9(c)(7)(ii). non-protein nitrogen sources may not These methods have been validated for Some comments expressed support exist or may not be valid for a given milk and are considered to be adequate for continued use of the PDCAAS for food matrix. The comment to determine true protein and non- calculation of the percent DV for recommended that we should give protein nitrogen in milk. It may be protein. However, other comments manufacturers greater flexibility to possible to extend these methods or to recommended replacing the PDCAAS select an appropriate test method or to develop analogous methods for other method with the Digestible rely on recordkeeping to determine the food matrices in the future. Indispensable Amino Acid Score quantities of non-protein nitrogen We disagree with the comments that (DIAAS) in § 101.9(c)(7) because the sources. we should define protein as ‘‘a chain of comments believed the DIAAS to be a Another comment noted that amino acids connected by peptide more accurate method of evaluating § 101.36(b)(2) states that protein shall bonds;’’ such a definition is overly protein quality (Ref. 153). DIAAS is not be declared on labels of products simplistic and would not prevent the defined as: DIAAS percent = 100 × [(mg that, other than ingredients added solely declaration of compounds, such as di- of digestible dietary indispensable for technological reasons, contain only and tri-peptides, from being declared as amino acid in 1 g of the dietary protein/ individual amino acids. The comment protein on the label. (mg of the same dietary indispensable argued that this requirement does not Methods for the determination of such amino acid in 1 g of the reference prevent foods from containing non- compounds may not be widely protein)] (Ref. 154). Indispensable or amino acid nitrogen compounds as the available. There is also no definition of ‘‘essential’’ amino acids are those that only source of nitrogen (e.g., a dietary protein that is generally accepted by the the body cannot make and that can only supplement containing vitamins or scientific community that could be be obtained from the diet. The nucleotides, but no amino acids) from applied to a regulatory framework. The comments referred to conclusions and being labeled as containing protein. development of validated analytical recommendations from the FAO Expert (Response) We agree with comments methods for the determination of non- Consultation on Dietary Protein Quality that the term ‘‘may’’ in § 101.9(c)(7) protein nitrogen containing compounds Evaluation in Human Nutrition (Ref. could be interpreted to mean that a to match a scientifically sound 154). The 2013 FAO Protein Quality variety of different practices could be regulatory definition of protein will take Report states that for regulatory used to determine the amount of protein time. Therefore, we plan to revisit the purposes, DIAAS is the recommended in a serving of food. However, we determination of protein on the label method for dietary protein quality decline to replace the term ‘‘may’’ with once validated analytical methods and/ assessment. A key recommendation by other terms that would require or a regulatory definition for protein can the FAO Expert Consultation was to manufacturers to calculate the amount be established. replace PDCAAS with DIAAS because of protein in a serving of a product on (Comment 316) We did not propose DIAAS more accurately reflects protein the basis of 6.25 times the nitrogen any changes to how the quality of a digestion and amino acid absorption content of the food, except when the protein is determined, yet some compared to the single fecal crude

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protein values used as part of the digestibility should be used in the Report describes how the PDCAAS is PDCAAS calculation. Some comments calculation of DIAAS (Ref. 154). determined, describes the analyses noted that the 2013 FAO Protein Quality Notes from the Sub-Committee Report needed for test foods, the amino acid Report states that DIAAS should (Ref. 157) express the conclusions of the scoring pattern, and calculation of optimally be based on known values of Sub-Committee members that, while amino acid scores. The four sections ileal amino acid digestibility for human there is a sound scientific case for using from the 2007 Protein and Amino Acid foods, and such data are currently ileal digestibility, it derives almost Requirements Report include the lacking. According to the comments, the entirely from work with animals. Based following information: Current concerns FAO Expert Consultation suggested that, on limitations and the nature of data about the PDCAAS approach (sections until such data become available, currently available, a case cannot be 6.2 through 6.3), summary of adult DIAAS values could be calculated by made for changing from fecal to ileal indispensable amino acid requirements applying fecal crude protein digestibility. The Sub-Committee also (section 8.3), summary of indispensable digestibility values to dietary amino concluded that, ‘‘For an organization amino acid requirements for older acid contents. like the FAO representing the whole infants and children (section 9.4.2.) and (Response) We agree that the DIAAS World, a change will produce summaries of requirements for various is an important new method of confusion. Before the change is made, age groups (section 14.7). The comment evaluating protein quality when true sufficient data on comparisons across recommended these changes because it ileal amino acid digestibility data are animal species and humans are needed’’ said there have been advances in used. However, we decline to replace (Ref. 157). Therefore, we decline to science since the 1991 FAO/WHO the PDCAAS with DIAAS in the final propose to replace PDCAAS with Protein Quality Report was published. rule because there are insufficient data DIAAS until such time that a database The comment said that the 2007 Protein available to implement the DIAAS. The of true ileal amino acid digestibility for and Amino Acid Requirements Report digestibility of protein has traditionally humans that is widely accepted by the provides updated adult indispensable been determined from fecal digestibility, scientific community has been amino acid requirements as well as which does not take into account developed. We will continue to monitor corrections to the calculation of the metabolism of protein in the colon. future developments in the evaluation PDCAAS for food mixtures. Unabsorbed amino acids are largely of dietary protein quality, and will (Response) We decline to amend metabolized by bacteria in the colon and consider amendments to our § 101.9(c)(7)(ii) as suggested by the requirements for protein labeling based comment. The amendment sought by then converted into other compounds on new information, as appropriate. the comment would eliminate important that can be absorbed; therefore, (Comment 317) One comment information that identifies and describes determination of fecal digestibility may recommended replacing the scoring the methods and procedures for provide inaccurate measurements of pattern for PDCAAS found in the 1991 determination of the PDCAAS, would amino acids absorbed from the small FAO/WHO Protein Quality Report, remove the current preschool child intestine (Refs. 153, 155–156). which is incorporated by reference in scoring pattern used for PDCAAS, and Digestibility measured at the terminal § 101.9(c)(7)(ii), with the scoring would replace the scoring patterns with ileum (that is, at the end of the intestine) patterns found in the 2007 WHO/FAO/ newer ones that were developed in a has been suggested by some in the UNU Report ‘‘Protein and Amino Acid different manner than those in the 1991 scientific community (Ref. 153) to be Requirements in Human Nutrition, FAO/WHO Protein Quality Report. more accurate than fecal digestibility for Report of a Joint WHO/FAO/UNU None of this methods-related and determination of dietary amino acid Expert Consultation’’ (Ref. 158). procedural information is included in digestibility. The difference between Specifically, the comment would amend the 2007 Protein and Amino Acid DIAAS and PDCAAS is that true ileal § 101.9(c)(7)(ii) by removing the Requirements Report, including those amino acid digestibility for the dietary incorporation by reference of the sections mentioned specifically for indispensable amino acids is used for determination of PDCAAS by methods inclusion (i.e., sections 6.2 and 6.3, the calculation of DIAAS rather than a in sections 5.4.1, 7.2.1, and 8.00 of the section 8.3, section 9.4.2 and section single fecal crude protein digestibility 1991 Protein Quality Report and 14.7). value. incorporating by reference sections 6.2 In addition to removing important As mentioned in the comments, a key and 6.3, section 8.3 (including Table methods-related information for the finding of the 2013 FAO Protein Quality 23), section 9.4.2 (including Table 36), calculation of PDCAAS, replacement of Report is that digestibility should be and section 14.7 (including Tables 49 the 1991 FAO/WHO Protein Quality based on the true ileal digestibility of and 50) from the 2007 Protein and Report with specific sections of the 2007 each amino acid, preferably determined Amino Acid Requirements Report. Protein and Amino Acid in humans. If collection of human data Specifically, section 5.4 of the 1991 Recommendations Report would is not possible, the true ileal Protein Quality Report provides remove the current preschool child digestibility can be determined in recommended procedures for methods scoring pattern for the PDCAAS and growing pigs or in growing rats, in that for the determination of all amino acids, replace it with an adult scoring pattern. order. However, the report noted that, partial amino acid analysis, and The amino acid scoring pattern after assessment of the ileal amino acid recommendations regarding the use of currently in use by FDA is that for the digestibility dataset, the FAO Expert published amino acid data. Section 7 of preschool child (age 2 to 5 years), as Consultation concluded that currently the Protein Quality Report identifies recommended in the 1991 FAO/WHO available data are insufficient to digestibility methods and provides a Protein Quality Report. This scoring implement true ileal amino acid detailed description of the in vivo rat pattern was established by FAO/WHO/ digestibility in the calculation of assay for true protein digestibility. This UNU in 1985 for preschool children 2 DIAAS. Furthermore, until such time section also describes the composition to 5 years of age (‘‘Energy and protein that a dataset of true ileal amino acid of experimental diets to be used, rat requirements: Report of a Joint FAO/ digestibility for human foods becomes feeding protocol, collection of food and WHO/UNU Expert Consultation’’ (Ref. available, the report suggested that feces, and calculations to be performed. 159). The 1985 Report suggested values for fecal crude protein Section 8.00 of the Protein Quality separate amino acid scoring patterns for

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infants, pre-school children 2 to 5 years before we can determine which acids that are deficient in one food or of age, and adults, implying that protein approach provides a better estimation meal can be supplied by another so that quality varies with the age of the determination of protein quality. We dietary needs are met over the course of individual. The 1985 Report stated that will continue to monitor future the day. However, it is not clear, based protein and diets containing essential developments in the determination of on the information provided in the amino acids that met the greater needs protein quality and will consider comment, if the general public would of young children were also adequate amendments to our requirements for understand what a ‘‘complete’’ protein for older children and adults, whereas protein labeling based on new is and, even if consumers did the reverse may not be true (Ref. 159). information, as appropriate. understand, whether the statements In 1991, the FAO/WHO Consultation (Comment 318) One comment would be viewed differently. Therefore, evaluated the 1985 Report and recommended that, in § 101.9(c)(7), we are not replacing the statement ‘‘not recommended that the FAO/WHO/UNU when the protein in foods represented a significant source of protein’’ with amino acid scoring pattern for preschool or purported to be for adults and ‘‘not a source of complete protein’’ children be used to evaluate protein children 4 or more years of age has a when a product contains protein with a quality for all age groups except infants PDCAAS of less than 20 expressed as a low PDCAAS. (Ref. 160). The FAO Expert Consultation percent, or when the protein in a food also concluded that the PDCAAS is the represented or purported to be for 3. DRV most suitable regulatory method for children older than 1 but less than 4 Our preexisting regulations, at evaluating protein quality of foods (Ref. years of age has a PDCAAS of less than § 101.9(c)(9), set the DRV for protein at 160). We reviewed the 1991 FAO/WHO 40 expressed as a percent, the statement 50 grams, and this represents 10 percent Protein Quality Report, tentatively ‘‘not a significant source of protein’’ of the 2,000 reference calorie intake accepted its conclusions, and proposed should be changed to ‘‘not a source of level. The preamble to the proposed rule to require the use of PDCAAS as the complete protein’’ for products that (79 FR 11879 at 11913 through 11914) method for determining protein quality supply a non-trivial amount of protein discussed scientific recommendations for food intended for children over 1 but which have a low PDCAAS. The for setting the DV for protein and year of age and adults in the 1991 comment explained that many comments we received in response to proposed rule for Reference Daily consumers, especially vegetarians, are the 2007 ANPRM. The preamble to the Intakes and Daily Reference Values; familiar with the concept of complete proposed rule (79 FR 11879 at 11913) Mandatory Status of Nutrition Labeling vs. incomplete protein and, even for explained how using the IOM Labeling and Nutrient Content Revision (56 FR consumers who are unfamiliar with the Committee’s recommended approach for 60366 at 60370). concept, the statement ‘‘not a source of setting the DV for protein would result We responded to comments on this complete protein’’ provides notice that in no change to the DRV for protein and subject in the 1993 final rule for the food in question cannot be relied how the DRV of 50 grams for protein Mandatory Status of Nutrition Labeling upon as the sole source of protein in the falls within the range of the RDAs and Nutrient Content Revision, Format diet. (Complete proteins are those that calculated using reference weights. for Nutrition Label (58 FR 2079 at 2104) contain all of the ‘‘essential’’ amino We did not propose to change the and concluded that the proposed amino acids, or those amino acids that cannot DRV of 50 grams for protein. acid scoring pattern for preschool age be made by the body. An incomplete (Comment 319) Several comments children was the most suitable pattern protein is one that is low in one or more supported maintaining the current DRV for use in the evaluation of dietary of the essential amino acids (Ref. 161). of 50 grams for protein. However, other protein quality for all age groups, except The comment stated that the label for comments recommended increasing the infants. a product that contains 10 grams of DRV for protein. One comment We also decline to replace the protein per serving (which would suggested that the DRV for protein incorporation by reference of provide 20 percent of the DRV for should be 23 percent of calories, which information from the 1991 FAO/WHO adults) from low-PDCAAS proteins such is the median of the IOM’s Acceptable 1991 Protein Quality Report with the as gelatin or collagen as the sole source Macronutrient Distribution Range information cited in the comment from of amino acids will often have ‘‘10 g of (AMDR) range (Ref. 5). Taking into the 2007 Protein and Amino Acid protein’’ declared and a ‘‘not a account the average actual weight of Requirements Report. The use of the significant source of protein’’ people in the United States, which is 2007 Report’s scoring pattern for adults declaration as well. The comment 195.5 pounds (lbs) for men and 166.2 would provide significantly lower suggested that such a situation is lbs for women based on data from the amounts of specific indispensable confusing and misleading to the Centers for Disease Control and amino acids (i.e., histidine, lysine, consumer. Prevention National Center for Health phenylalanine + tyrosine, and The comment further stated that Statistics (Ref. 162), the comment said tryptophan) than those provided by use amino acids deficient in one food or an individual would need to eat 66 of the scoring pattern in the 1991 FAO/ meal can be supplied by another, so that grams/day of protein to meet the WHO Protein Report. The scoring dietary needs are met over the course of recommended grams/kilogram of patterns in the 2007 Protein and Amino the day. Therefore, according to the protein. The comment suggested that Acid Requirements Report were based comment, foods with a low PDCAAS are increasing the DRV for protein would on amino acid requirement values a valuable source of protein in the help people lose weight because it divided by the mean protein context of the overall diet, and the would allow people to increase their requirement while the scoring patterns labeling regulations should not muscle mass. However, the comment provided in the 1991 FAO/WHO Protein completely discount their value. did not provide scientific support for Quality Report were estimated by (Response) We decline to amend this statement. dividing amino acid requirements by § 101.9(c)(7) to replace the statement Other comments recommended what was considered a safe level of ‘‘not a significant source of protein’’ increasing the DRV for protein from 10 protein intake (Refs. 158, 160). Further with ‘‘not a source of complete protein’’ percent to 15 percent or a minimum 15 evaluation of the two approaches used when a product contains protein with a percent of calories. The comments to derive scoring patterns is necessary low PDCAAS. We agree that amino suggested that the current DRV of 10

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percent of energy from protein is too reference to the concern that the protein quality values as described in low considering the IOM’s AMDR for established DRV for protein does not paragraph (c)(7)(vii) of this section.)’’ to protein is 10 to 35 percent of energy cover the needs of adolescent and adult § 101.9(c)(7); (4) addition of the intake for adults. One comment stated men, recent consumption data shows statement ‘‘for foods in which the only that Americans typically consume 15 to that, on average, males 19 years and significant source of nitrogen is from 17 percent of calories from protein, so older are exceeding the RDA for protein, protein (i.e., chains of amino acids increasing the DRV for protein to 15 and thus a DRV of 10 percent has not linked by peptide bonds) followed by percent would be consistent with had a negative impact on protein information related to the calculation of protein intakes in the United States. consumption (Ref. 163). The mean protein content (moved from One comment expressed concern that a protein intake from foods and beverages § 101.9(c)(7)) to § 101.9(c)(7)(i)); (5) DRV of 10 percent of energy from in males 20 years of age and older is addition of a new § 101.9(c)(7)(ii) which protein could lead to overconsumption 98.8 grams/day and ranges from 80 includes requirements for foods of calories from other macronutrients, grams/day to 110.0 grams/day. Four containing non-protein sources of such as carbohydrates or fats. percent or less of males 19 years of age nitrogen; (6) replacement of the Another comment compared the and older are consuming below the EAR proposed language in § 101.9(c)(7)(iii) current DRV for protein to the IOM’s for protein. Therefore, regardless of the related to the DRV and RDI values for RDAs. The comment acknowledged that current DRV, males 19 years of age and protein with information related to the our DRV for protein is not based on the older are consuming well above the protein quality of foods purported to be RDA for protein, but said it is less than RDA for protein. for children and adults 4 years of age the RDA for adolescent and adult men. We also disagree that the DRV should and older and new requirements for The comment further stated that, reflect suggested values from a dietitian. when the statement ‘‘not a source of because protein is an essential nutrient There is a range of values that could be complete protein’’ or a calculated and because the RDA is set based on recommended by a dietitian depending percent DV for protein can be declared; grams/kilogram of body weight, protein on the individual or group that a (7) addition of a new § 101.9(c)(7)(iv), needs may exceed the RDA for some dietitian is counseling. Dietitians work which includes requirements for when men, especially for men who are taller in a variety of settings such as hospitals, the statement ‘‘not a significant source than average and/or have increased long-term care facilities, wellness or of protein’’ or the percent DV for protein muscle mass. The comment expressed rehabilitation centers, food industry, must be declared on foods represented concern that we are not determining the and non-profit organizations. They or purported to be for children greater DRV for protein in a similar manner to provide recommendations based on the than 1 but less than 4 years of age; (8) that for vitamins and minerals (i.e., the patient or client’s needs. The protein addition of a new § 101.9(c)(7)(v), which population coverage approach). recommendations provided by dietitians includes requirements for when the One comment suggested that the DRV vary greatly depending on the audience. statement ‘‘not a significant source of for protein should reflect dietitian- Therefore, a DRV based on values protein’’ must be declared and the suggested values (e.g., 60 grams/day), suggested by dietitians would not prohibition of the declaration of the but did not provide any basis for the necessarily be reflective of the needs of percent DV for foods represented or change. the general population. purported to be specifically for infants (Response) We decline to increase the 4. Miscellaneous Comments 7 through 12 months of age; (9) addition DRV for protein and are not making any of a new § 101.9(c)(7)(vi) which changes to the existing DRV for protein (Comment 320) One comment includes information related to the of 50 g. The preamble to the proposed recommended reorganizing § 101.9(c)(7) voluntary declaration of a percent DV rule discussed comments we had so that the regulated industry can more for protein, except that the percent DV received in response to an ANPRM and easily understand its provisions. The declaration is prohibited if a food is explained why we declined to change comment stated that the regulation is represented or purported to be for the DRV (79 FR 11879 at 11913). In written in a manner that is convoluted infants 7 through 12 months of age; (10) brief, we considered basing the DRV for and confusing, such that many readers addition of a new § 101.9(c)(7)(vii), protein on the midpoint of the AMDR have a hard time understanding its which includes all of the information in for protein 22.5 grams (79 FR 11879 at requirements. For example, the proposed § 101.9(c)(7)(ii) related to the 11913), but declined to base the DRV for comment said that readers are often calculation of the ‘‘corrected amount of protein on the midpoint of the AMDR confused as to when, how, and to what protein (gram) per serving’’; and (11) range because we had no data to show the PDCAAS correction is to be applied addition of a new § 101.9(c)(7)(viii), that protein intakes in the United States in labeling, and when declaration of the which includes all of the information in were inadequate or that setting a higher percent DV is required, prohibited, or proposed § 101.9(c)(7)(iii) related to the DRV that is based on the midpoint of optional. The comment also stated that proposed DRVs and RDIs for protein. the AMDR is needed to reduce the risk there is also confusion regarding the The comment also recommended of chronic diseases. Furthermore, the most appropriate method to determine revising § 101.36(b)(2)(iii)(B) to state DRV of 10 percent of calories from the declared quantity of protein. that the percent DV of all dietary protein falls within the AMDR range of The comment suggested revisions to ingredients declared under 10 to 35 percent of calories from protein the codified text, which included: (1) § 101.36(b)(2)(i) must be listed, except (id.). Removal of the discussion related to that the percent for protein may ‘‘or We also disagree that the DRV for protein quality and when the statement shall’’ be omitted as provided in protein should be increased to 15 ‘‘not a significant source of protein’’ § 101.9(c)(7). In addition, the comment percent of calories from protein. The must be declared from § 101.9(c)(7); (2) recommended clarifying only basis provided in comments for removal of the discussion of how § 101.36(b)(2)(iii)(B) so that the percent increasing the DRV for protein to 15 protein content may be determined from DV for protein, when present, be percent of calories from protein is § 101.9(c)(7) and placement of this calculated using the corrected amount consumption data indicating that information under§ 101.9(c)(7)(i); (3) of protein as specified in § 101.9(c)(7). Americans typically consume 15 to 17 addition of ‘‘(The quantity of protein in (Response) We decline to revise percent of calories from protein. In grams shall not be corrected based on § 101.9(c)(7) based on the comment. It is

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not clear that the suggested and blood pressure in the context of patterns. The 2015–2020 DGA also reorganization of the codified makes it dietary pattern changes; (5) sodium and made a key recommendation to easier for the reader to understand the blood pressure in the context of other consume less than 2,300 mg of sodium requirements related to when, how, and minerals; and (6) effect of dietary intake per day. This recommendation was to what the PDCAAS correction is to be of sodium on CVD outcomes. The based on the UL for individuals ages 14 applied, and when the declaration of the Lifestyle Workgroup found that the years and older set by the IOM (Ref. percent DV is required, prohibited, or strength of the evidence was high and 28)). optional. that, in adults 25 to 80 years of age with 1. Mandatory Declaration We do agree, however, that blood pressure 120 to 159/80 to 95 mm § 101.36(b)(2)(iii) should be revised for HG, reducing sodium intake lowers Under section 403(q)(1)(D) of the clarity to explicitly state that the blood pressure. The Lifestyle Work FD&C Act, nutrition information in food percentage of the RDI for protein shall Group found moderate evidence that, in labels or labeling must include, among be omitted when a food is purported to adults 25 to 75 years of age with blood other things, the amount of sodium, and be for infants through 12 months of age, pressure 120 to 159/80 to 95 mm HG, our preexisting regulations, at and we have revised the rule reducing sodium intake that achieves a § 101.9(c)(4), require the declaration of accordingly. (We explain, in our mean 24-hour urinary sodium excretion sodium content on the Nutrition Facts response to comment 441, our reasons of approximately 2,400 mg/day relative label. The preamble to the proposed rule for changing ‘‘infants 7 through 12 to approximately 3,300 mg/day lowers (79 FR 11879 at 11914) explained that months of age’’ to ‘‘infants through 12 blood pressure by 2/1 mm HG and Americans 4 years and older consume months of age.’’) reducing sodium intake that achieves a an average of approximately 3,650 mg We also agree to clarify, in mean 24-hour urinary sodium excretion sodium/day, which is more than twice § 101.36(b)(2)(iii), that the percent DV of approximately 1,500 mg/day lowers the amount required to meet their for protein should be calculated using blood pressure by 7/3 mm Hg. There adequate intake (1,500 mg/day for the corrected amount of protein as was low evidence that a reduction in individuals 9 to 50 years old). We also specified in § 101.9(c)(7). Therefore, we sodium by approximately 1,000 mg/day noted that evidence continues to have revised § 101.36(b)(2)(iii) to state reduces CVD events by about 30 percent support the association between that the percent DV for protein, when and that higher sodium intake is increased sodium consumption and present, shall be calculated using the associated with greater risk for fatal and increased blood pressure (id.). corrected amount of protein as specified nonfatal stroke and CVD. The Lifestyle Consequently, the preamble to the in § 101.9(c)(7)(ii). Work Group did not find sufficient proposed rule indicated that we would continue to require mandatory J. Sodium evidence to determine the association between sodium intake and the declaration of sodium at § 101.9(c)(4). The preamble to the proposed rule development of heart failure. (Comment 321) Several comments discussed key consensus reports and The second report was the 2015 supported the ongoing mandatory recommendations that we reviewed in DGAC. The DGAC informs the Federal declaration of sodium content on the reconsidering the DRV (79 FR 11879 at government of current scientific Nutrition Facts label. Some comments 11914 through 11915). After we evidence on topics related to diet, noted that providing this information published the proposed rule in March nutrition, and health. The 2015 DGAC will assist consumers in maintaining 2014, three new reports were issued that considered the 2010 DGAC reviews, the healthy dietary practices by helping provided corroborative evidence to our 2013 NHLBI Lifestyle Evidence Review, them identify products with less sodium proposal to set a DRV of 2,300 mg. the 2013 IOM Sodium in Populations and to follow the advice of their health The first report was the ‘‘NHLBI report, and new evidence released since care professionals, specifically those Lifestyle Interventions to Reduce 2013 for sodium intake and blood consumers who are at higher risk of Cardiovascular Risk: Systematic pressure and CVD outcomes. The 2015 cardiovascular disease (CVD) (e.g., Evidence Review from the Lifestyle DGAC recommended that the general people with chronic kidney disease, Work Group’’ (Ref. 17). In 2013, the population, ages 2 years and older, rely African Americans, people 51 years and Lifestyle Work Group evaluated on the recommendations in the 2005 older, and those with hypertension). evidence on the role of specific dietary IOM DRI Electrolytes report that set the One comment stated that consumer patterns, nutrient intake (e.g., UL at 2,300 mg/day based on evidence research indicates that sodium is one of macronutrients, sodium, and showing associations between high the top three food components potassium), and levels and types of sodium intake, high blood pressure, and Americans consider when making physical activity, through effects on subsequent risk of heart disease, stroke, decisions about buying packaged foods such modifiable CVD risk factors as high and mortality. The committee also noted or beverages (Ref. 164). Another BP and lipids, in reducing CVD risk. that, given the well-documented comment suggested that mandatory The results of this systematic review relationship between sodium intake and declaration along with the declaration of were intended to be used to establish high blood pressure, sodium intake potassium would encourage food clinical recommendations that are should be reduced and combined with manufacturers to reduce sodium that is directed at patients with CVD risk a healthful dietary pattern (Ref. 19). added to foods. However, the comment factors (i.e., abnormal lipids and/or The third report was the 2015–2020 did not provide data to support these prehypertension and hypertension). The Dietary Guidelines for Americans (Ref. assertions. Lifestyle Work Group evaluated 28). The 2015–2020 DGA made a key (Response) We agree that the evidence statements on the: (1) Overall recommendation to limit calories from declaration of sodium on the food label effect of dietary intake of sodium on added sugars and saturated fats and will provide consumers with blood pressure; (2) comparison of reduce sodium intake and to consume information on sodium content that can different levels of dietary intake of an eating pattern low in added sugars, help them make appropriate food sodium on blood pressure; (3) sodium saturated fats, and sodium. Cutting back choices to help them maintain healthy and blood pressure in subpopulations on foods and beverages higher in these dietary practices. However, with respect defined by sex, race/ethnicity, age, and components will help people achieve to the comment suggesting that hypertension status; (4) sodium intake diets that fit into healthy eating mandatory declaration of sodium, along

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with the declaration of potassium, (Comment 323) Several comments recommended no more than 2,400 mg/ would encourage food manufacturers to supported a DRV of 2,300 mg and day and that a further reduction to 1,500 reduce sodium addition to foods, the agreed that the UL established by the mg/day would be even more beneficial extent that mandatory declaration of IOM in 2005 is an appropriate basis for for adults with pre-hypertension and sodium and potassium will encourage setting a DRV. The comments also noted hypertension who could benefit from reformulation is unknown. that the 2013 IOM Sodium Intake in blood pressure lowering. While the The final rule also requires disclosure Populations, Assessment of the NHLBI report found strong evidence for of potassium. We discuss comments Evidence report (Ref. 167) concluded reducing sodium intake and lower blood regarding the mandatory declaration of that evidence on direct health outcomes pressure, the comment said that the potassium at part II.L.3.b. is not consistent and insufficient to evidence for specifying an optimal (Comment 322) One comment conclude that lowering sodium intakes intake level for sodium intake was opposed mandatory declaration of below 2,300 mg/day either increases or moderate, and the evidence for sodium sodium and asked us to look critically decreases risk of CVD outcomes or all- intake and CVD events was low. at the science behind the dietary sodium cause mortality for the general (Response) We agree with the recommendations and to consider population. The comments also noted comments supporting a DRV of 2,300 removing sodium from the list of that the IOM concluded there was no mg for sodium. The DRV is consistent mandatory nutrients. However, the evidence on health outcomes to support with the scientific evidence from comment recognized that, given the treating subpopulation groups consensus reports, such as the 2005 2010 DGA (Ref. 30) and the 2010 IOM differently from the general U.S. IOM DRI Electrolytes report (Ref. 166) Sodium Strategies Report (Ref. 165), population. A few comments noted that and the 2013 IOM Sodium Intake in FDA may feel that eliminating sodium a recent meta-analysis by Graudal et. al Populations, Assessment of the as a mandatory nutrient is not possible (2014) showed that there is a U-shaped Evidence (Ref. 167), as well as our approach for other nutrients (such as at the current time. relationship between sodium intake and health outcomes (Ref. 168). (A U-shaped saturated fat and cholesterol) that (Response) We decline to remove curve indicates that, at low levels of should be limited in the diet. The final sodium from the list of mandatory intake, there is a risk of inadequacy and, rule, therefore, establishes a DRV of nutrients. We note that section 403(q) of at high levels of intake, there is a risk 2,300 mg for sodium. the FD&C Act expressly lists sodium as of adverse events.) The comments noted To the extent the comment suggests one of the nutrients to appear on the that the Graudal et al. study extends the that the 2005 DGA implied that 1,500 Nutrition Facts label. While the FD&C IOM report by identifying a specific mg was the new UL for specific Act also provides a mechanism for us to range of sodium intake, 2,645 to 4,945 subgroups, we disagree. While the 2010 remove nutrients from the label or mg, associated with the most favorable DGA recommended reducing sodium labeling of food, we would have to health outcomes, within which intake to the AI of 1,500 mg/day for determine that the information related variation in sodium intake is not certain subpopulations at increased risk to that nutrient is not necessary to assist associated with variation in mortality. of the blood-pressure raising effects of consumers in maintaining healthy The comments stated that this analysis sodium (e.g., older persons, African- dietary practices. In the case of sodium, underscores the conclusions of the 2013 Americans, and individuals with evidence continues to support the IOM Sodium Intake in Populations, hypertension, diabetes or chronic association between increased sodium Assessment of the Evidence report (Ref. kidney disease), the 2005 IOM consumption and blood pressure. In 167) and supports setting a DRV of Electrolytes report concluded that there 2005, the IOM DRI Electrolytes Report 2,300 mg and does not support reducing was insufficient scientific evidence to noted a direct relationship between the DV to 1,500 mg. set a separate UL for these groups (see sodium intake and increased blood Other comments supporting a DRV of 79 FR 11879 at 11914 through 11915). pressure (Ref. 166). The 2010 DGAC 2,300 mg argued that a DRV based on a The AI for sodium of 1,500 mg/day was (Ref. 30) and the 2013 IOM report on UL (rather than an RDI based on an AI) based on meeting essential needs of Sodium Intake in Populations, is consistent with our current and sodium (e.g., replacing sweat losses) and Assessment of the Evidence (Ref. 167) proposed approach for other nutrients not blood pressure. We note that the concluded that a strong body of (e.g., saturated fat and cholesterol) that NHLBI Lifestyles Evidence Review evidence has been documented in should be limited in the diet and for recommendations apply to adults with adults that blood pressure decreases as which there are concerns of excess pre-hypertension and hypertension who sodium intake decreases. The 2015 intake and risk of chronic-disease or would benefit from blood pressure DGAC Report corroborates our position health-related conditions. lowering. in the proposed rule because it also Some comments supporting a DRV of (Comment 324) Some comments concluded that there is a strong body of 2,300 mg said that this value is stated that, while intake below 2,300 evidence linking increased sodium consistent with the 2010 DGA mg/day of sodium is desirable for some intake to increased blood pressure (Ref. recommendation for the general individuals, particularly those at risk of 19). Thus, the evidence continues to population. Another comment stated hypertension, the 2,300 mg/day support mandatory declaration of that scientific evidence and Federal recommendation seems most achievable sodium on the Nutrition Facts label. nutrition policy do not support given the current food supply and recommending that the general public intake levels in the general U.S. 2. DRV reduce their daily intake of sodium to population. The comments said that We proposed to revise § 101.9(c)(9) to 1,500 mg/day. The comment noted that sodium targets below 2,300 mg/day reduce the DRV for sodium from 2,400 2005 DGA report’s statement for specific would make it hard to meet other mg to 2,300 mg. The preamble to the population groups to ‘‘consume no more nutrient needs, particularly potassium. proposed rule (79 FR 11879 at 11914 than 1,500 mg’’ inadvertently implied In addition, one comment said that through 11915) explained that new that the 2005 DGA had defined a new substantially lowering the current DV to scientific data and consensus reports on UL for these groups. Furthermore, the 1,500 mg would reduce the palatability sodium highlighted the need to comments said that the NHLBI’s of foods that can be labeled as ‘‘low reconsider the DRV. Lifestyles Evidence Review sodium’’ (e.g., assuming, as FDA

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recognized, the eligibility criteria of 140 for sodium. However, if significant individuals in the general population mg/RACC) used to define low sodium changes in the science occur in the (79 FR 11879 at 11914). More recently, would likely be adjusted to remain future, we would re-evaluate the the 2013 IOM Sodium Intake in consistent with current cut points for evidence. We also note that the 2015– Populations (Ref. 167) report concluded ‘‘low’’ nutrient content claims which are 2020 DGA also supported a UL of 2,300 that evidence was insufficient and set at levels around 5 percent DV or mg/day for individuals ages 14 years inconsistent to recommend sodium less). and older. intake levels below 2,300 mg/day for the (Response) The DRV of 2,300 mg is (Comment 326) Some comments general U.S. population based on the based on clinical data on sodium and stated that consumers recognize that direct outcomes of CVD or all-cause blood pressure that is applicable to the sodium is a nutrient to limit and that it mortality. In addition, the IOM general U.S. population and represents is appropriate to use the UL of 2,300 concluded that the evidence on both an amount not to exceed. The DRV for mg/day to establish a DRV because the benefit and harm is not strong enough sodium is not based on the levels of UL is the dietary intake level of a to indicate that these subgroups should sodium in the food supply or eligibility nutrient that is recommended not to be treated differently from the general requirements for nutrient content exceed during any given day. Some U.S. population. Thus, the evidence on claims. However, we recognize that comments noted that setting a DRV of direct health outcomes does not support revisions of other regulatory 2,300 would result in less consumer recommendations to lower sodium requirements, such as nutrient content confusion than changing to an RDI of intake within these subgroups to or even claims (e.g., low sodium), would be less 1,500 mg because consumers already below 1,500 mg/day (see 79 FR 11879 at likely if the DV were updated to 2,300 understand that sodium is a nutrient to 11915). We also note that the 2015–2020 mg (see 79 FR 11879 at 11916) and that limit (Ref. 164). DGA recommended limiting sodium there may be fewer technological (Response) Results from the FDA intake to less than 2,300 mg/day for barriers and product acceptance issues Health and Diet Surveys (Refs. 169–171) individuals ages 14 years and older. (e.g., palatability) for products that meet have shown that consumers are aware (Comment 328) Some comments the current definition of ‘‘low’’ sodium. that sodium is a nutrient to limit in the supporting a DV of 1,500 mg noted that (Comment 325) A few comments diet. As we noted in the preamble to the the 2010 IOM Strategies to Reduce supported establishing a DRV of 2,300 proposed rule (79 FR 11879 at 11916), Sodium Intake in the U.S. report mg, but suggested that we should this awareness would suggest that recommended that we lower the DV for consider the 2015–2020 DGA before consumer acceptance of a DV based on sodium to 1,500 mg based on the AI. issuing a final rule. Other comments a level not to exceed would be (Response) In the preamble to the suggested that we ask the IOM to re- consistent with a DRV of 2,300 mg. proposed rule (79 FR 11879 at 11916, evaluate the DRI for sodium or conduct (Comment 327) Several comments 11917), we recognized that the 2010 our own re-evaluation to determine a objected to a DRV of 2,300 mg and IOM report recommended that we base sodium intake range. The comments supported a different level instead. the DV for sodium on the AI of 1,500 stated that a new reevaluation should Some comments supported using 1,500 mg/day, and we invited comment on consider data on biomarkers, clinical mg and said that lowering the DV for whether an RDI of 1,500 mg would be outcomes as well as the sodium and sodium from 2,400 mg to 1,500 mg/day more appropriate and why. We also potassium ratio. would align with the 2010 DGA noted that the IOM said that using the (Response) Given the extensive recommendation for the majority of AI would be consistent with the reviews already conducted by the IOM, Americans, including persons who are approach used for all other essential the 2010 DGA, and the 2015 DGAC, we 51 years or over, African-Americans, or nutrients, where the DV is based on a decline to ask the IOM to re-evaluate the individuals who have hypertension, reference value of adequacy rather than existing evidence for sodium or to diabetes, or chronic kidney disease. a reference value of safety (79 FR 11879 conduct our own re-evaluation. The UL (Response) We decline to establish an at 11916). However, the 2010 IOM set by the IOM in 2005 was based on RDI for sodium of 1,500 mg. We note report did not focus on reviewing the clinical studies on sodium intake and that the 2010 DGA recommended 2,300 scientific evidence between sodium blood pressure. Additionally, the 2005 mg/day for the general population. intake and health or with reevaluating IOM Electrolytes report evaluated the While the 2010 DGA recommended the dietary guidance levels of sodium data on the sodium and potassium ratio reducing sodium intake to the AI of that should be consumed. The AI is a and concluded that the data were 1,500 mg/day for certain subpopulations level to achieve in the diet to meet insufficient to be used to set at increased risk of the blood-pressure essential needs and is not an UL. Thus, requirements. The 2013 IOM report, raising effects of sodium (e.g., older we continue to consider that the 2005 Sodium Intake in Populations, persons, African-Americans, and IOM DRI Electrolytes report and 2013 evaluated the evidence on sodium individuals with hypertension, diabetes IOM Sodium in Populations report, intake and CVD outcomes, and the or chronic kidney disease), the 2005 which conducted extensive reviews of report’s conclusions support the UL of IOM Electrolytes report concluded that the literature on sodium intake and 2,300 mg/day. Furthermore, the 2015 there was insufficient scientific blood pressure and/or CVD outcomes, DGAC reviewed the evidence for blood evidence to set separate UL for these are the most appropriate basis for a DRV pressure and clinical outcomes and groups (see 79 FR 11879 at 11914 of 2,300 mg. recommended that the general through 11915). The AI for sodium of (Comment 329) Some comments population, 2 years and older, should 1,500 mg/day was based on meeting stated that a DV of 1,500 mg would be rely on the UL of 2,300 mg/day based essential needs of sodium (e.g., consistent with recommendations of the on evidence showing associations replacing sweat losses) and not blood 2010 DGAC, CDC, the American Public between increased sodium intake, pressure. The UL of 2,300 mg/day Health Association, and the American increased blood pressure, and applies to the majority of the U.S. Heart Association. subsequent risk of heart disease, stroke, population (persons aged 14 years and (Response) In the preamble to the and mortality (Ref. 166). Therefore, we older) and is the highest daily nutrient proposed rule (79 FR 11879 at 11890), continue to consider the UL of 2,300 intake level that is likely to pose no risk we explained the factors we consider for mg/day to be appropriate for the DRV of adverse health effects to almost all nutrients of this type: (1) Existence of

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quantitative intake recommendations, even among those in the reduced adjustment for baseline sodium particularly reference intake levels sodium group that decreased sodium excretion and body weight found a 30 provided in consensus reports that can intake by 20 to 30 percent (Refs. 172– percent lower risk (RR = 0.70 [CI: 0.53, be used to set a DRV or RDI; and (2) 173). The followup study found a 0.94], P = 0.02). The recent additional public health significance, as continued decrease in CVD events analysis conducted by Cook et al., 2014 demonstrated by either well-established among those with sodium levels as low (Ref. 174) on a subset of the TOHP evidence or evidence of a problem with as 1,500 mg/day with no evidence of a participants not in the sodium reduction the intake of the nutrient in the general J-shaped curve (increased risk of CVD at intervention group and stratified based U.S. population and evidence of the upper and lower levels of sodium on sodium intake (<2,300 mg, 2,300 to prevalence of the chronic disease, intake) (Ref. 174). Those who excreted <3600 mg, 3,600 to <4,800 mg, and health-related condition, or health- less than 2,300 mg/day had a 32 percent 4,800 mg and higher) was published related physiological endpoint that is reduction in risk; however, this after the 2013 IOM report. This linked to that nutrient in the general reduction was not statistically additional analysis showed a significant U.S. population. While the 2010 DGAC significant (Ref. 174). P for trend; however, CIs for CVD risk Report recommended that sodium be (Response) We based the DRV of were not statistically significant reduced over time to 1,500 mg/day, the 2,300 mg primarily on the UL between the lower daily intake levels 2010 DGA did not recommend 1,500 established in the 2005 IOM DRI (<2,300 mg; 2,300 to <3,600 mg) and the mg/day for the general population. The Electrolytes report. The UL is, itself, reference intake level (of 3,600 mg to CDC recommendations are consistent based on clinical studies on sodium <4,800 mg) for the three models used in with the 2010 DGA. The intake and blood pressure. Moreover, the analysis. Many studies analyze for recommendations of the American Heart the 2013 IOM Sodium Intake in the statistical significance of the linear Association and the American Public Populations report conclusions that are relationship (P for trend) between the Health Association of 1,500 mg/day did based mostly on observational studies substance and the disease. While this not persuade us to adopt a lower value on intake of sodium and outcomes for trend may be significant (P <0.05), the as the DRV for sodium for the general CVD and all-cause mortality are difference in risk between subjects at U.S. population. We determined that the consistent with a DRV of 2,300 mg. the various levels of intake (e.g., tertiles, data and information on sodium intake While the IOM included studies in quartiles or quintiles of intake) may not and health from U.S. consensus reports patients with Congestive Heart Failure be significant (Ref. 85). In this case, that support a quantitative intake (CHF), it did consider the other because the CIs are not significant, the recommendation for sodium of 2,300 subgroups separately. The IOM Cooke et al., 2014 study shows no effect mg/day provide an adequate basis on concluded that, while the current for the association of sodium intake and which we can rely to establish 2,300 literature provides some evidence for risk of CVD when stratified by intake mg/day as the DRV for sodium. adverse health effects of low sodium levels. When establishing a DRV, we intake among individuals with diabetes, (Comment 330) Several comments consider the totality of the scientific chronic kidney disease (CKD), or evidence and do not consider it said we should not use the ‘‘flawed’’ preexisting CVD, the evidence on both 2013 IOM Sodium Intake in Populations appropriate to rely on one observational benefit and harm is not strong enough study in lieu of a larger body of report to set dietary policy. According to to indicate that these subgroups should the comments, the IOM did not consider evidence that includes intervention be treated differently from the general studies on sodium and blood pressure hypertension itself as a health outcome U.S. population. Thus, the IOM and other observational studies on despite the relationship between blood concluded that the evidence on direct sodium and CVD outcomes. Therefore, pressure and cardiovascular disease. health outcomes does not support we consider the UL of 2,300 mg/day The comments also said that there are recommendations to lower sodium appropriate for establishing a DRV. methodological concerns with some intake within these subgroups to or even studies that the IOM considered, such as below 1,500 mg/day. (Comment 331) Some comments unreliable measures of sodium intake As for the comment regarding the use supporting a DRV of 1,500 mg stated and results that are not generalizable to of a ‘‘robust body of evidence,’’ our that this value would be consistent with the general population. The comments decision to use the DRV of 2,300 mg is what we had proposed for other also said that the IOM based its based on a robust body of evidence. nutrients (e.g., vitamin K, biotin, conclusions, in part, on a study with Both IOM consensus reports were , manganese) where the suspect evidence that focused on people comprehensive reviews on the evidence IOM had established an AI, but not an with heart failure who received an between sodium intake and blood RDA. aggressive treatment that is not used in pressure and/or CVD outcomes. (Response) We disagree that the DRV the United States. The comments said Additionally, the TOHP I and TOHP II for sodium should be consistent with that these methodological issues limit trials and the followup observational vitamins and other minerals. Unlike the IOM report’s usefulness in setting study (Ref. 172) cited by the comment vitamins and other minerals, the dietary recommendations that are were included in the IOM’s majority of the population consumes applicable to the general population and comprehensive review in 2013. The sodium at levels that exceed the AI and that we should base the DV for sodium 2013 IOM report noted that Cook et al. the UL. There is not a concern with on a robust body of evidence linking 2007 (Ref. 172), an observational overconsumption of these vitamins and sodium intake with elevated blood followup of the TOHP I and II sodium other minerals. This makes sodium pressure and on the few existing trials reduction trials, found a 25 percent unique in comparison to other vitamins of sodium reduction and CVD. One reduction in CVD incidence (RR = 0.75, and minerals for which people generally comment stated that among those [Confidence Interval [CI]: 0.57 to 0.99], strive to meet their daily needs. population trials is the Trials of P = 0.04) when average sodium intake (Comment 332) Some comments Hypertension Prevention Study (TOHP I decreased from approximately 3,600 to opposed to a DRV of 2,300 mg stated and II). The comment noted that the 2,300 mg/day in the intervention group that using the UL might confuse observational followup study showed a in TOHP I and from 4,200 to 3,200 mg/ consumers into thinking that it is a 30 percent reduction in the risk of CVD day in TOHP II (Refs. 167, 172). Further recommended intake level.

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(Response) The comment provided no children (1 to 4 years of age), women of level to achieve rather than a level to data to support its position, and we are childbearing age (12 to 49 years old), consume less than and also that not aware of data indicating that and pregnant women. It contrasted the consuming in excess of this level would consumers would be confused with DV for sodium as being a ‘‘UL for all of not be helpful (id. at 11916); using a DRV based on an intake level the population over 14 years of age and • Although the comment said we not to exceed. The current DRV for substantially in excess of that for used a different approach for iron, the sodium has been listed on food labels younger children.’’ The comment said comment’s comparison is misplaced. As for the past 20 years and represents an that we acknowledged that roughly one- the preamble to the proposed rule amount not to exceed. Additionally, the half of the adult population, namely noted, iron deficiency is a concern (see FDA Health and Diet Surveys (Refs. African Americans, individuals ages 51 id. at 11919), so the DV for iron 169–171) have shown that consumers years or older, and individuals with represents a level that is to be achieved. are aware that sodium is a nutrient to hypertension, chronic kidney disease, or Sodium, in contrast, is a concern due to limit in the diet. Furthermore, our diabetes, should be consuming lower overconsumption, so the DV for sodium approach for sodium is consistent with levels of sodium (Ref. 175). For those is based on a reference intake level that the approach we use for other nutrients, subgroups, 1,500 mg/day is the should not be exceeded. As we stated in such as saturated fat and cholesterol, recommended maximum intake for the preamble to the proposed rule, that should be limited in the diet (see sodium (Ref. 30). The comment claimed unlike the consumption of other 79 FR 11879 at 11915 through 11916). that the DV ‘‘will affirmatively mislead vitamins and minerals, the majority of (Comment 333) One comment said the most affected but suggesting a much the population consumes sodium at that we had indicated that consumers higher target for their consumption than levels that exceed the AI and the UL, would find it difficult to reduce their is healthy or medically appropriate.’’ and this makes sodium unique in sodium consumption to 1,500 mg/day The comment referred to the preamble comparison to the other vitamins and because of the high-sodium content in to the proposed rule where we minerals for which people generally the food supply and because of taste discussed using 1,500 mg as a possible must strive to meet their daily needs (id. preferences. The comment said that DV for sodium (79 FR 11879 at 11914 at 11916); can change as sodium levels are through 11915) and said we focused • As for the comment’s depiction of reduced and that lowering the DV for inappropriately on a ‘‘flawed’’ 2013 the 2013 IOM report as ‘‘flawed,’’ as sodium would give manufacturers IOM report to arrive at a DV of 2,300 mg discussed in our response to comment greater incentive to reduce the sodium for sodium. 330, we disagree. Furthermore, we content of their foods. (Response) We disagree with the stated, in the preamble to the proposed (Response) We are establishing a DRV comment. The preamble to the proposed rule, that a DRV of 2,300 mg, which of 2,300 mg/day for reasons unrelated to rule discussed, at some length, the represents the UL, would be consistent the sodium content in the food supply options we considered for updating the with the 2005 and 2010 DGA and taste preferences. Therefore, the DV for sodium and why we proposed to recommendations for sodium intake in issues the comment raises are no longer set a DRV of 2,300 mg for sodium based the general population (id. at 11915). relevant, and we are not making changes on the UL for individuals aged 4 years (We also note that it is consistent with in response to this comment. We note and older and how a DRV of 2,300 mg the 2015–2020 DGA and that the that we are considering other ways to for sodium is the most appropriate DV ‘‘Scientific Report of the 2015 Dietary support the reduction of sodium in the (79 FR 11879 at 11914 through 11917). Guidelines Advisory Committee’’ food supply that take into account For example, we stated that: maintains a goal of less than 2,300 mg technological challenges to sodium • A DRV of 2,300 mg represents the dietary sodium per day for the general reduction (see 76 FR 57050, September UL for the majority of the population population); 15, 2011). (persons 14 years of age and older) and • We disagree that the UL is (Comment 334) One comment said is consistent with both the 2005 and ‘‘substantially in excess of that for that not setting the DV at 1,500 mg 2010 DGA recommendations for sodium younger children.’’ The UL for children would be arbitrary and capricious. The intake in the general population as the 4 to 8 years is 1,900 mg/day and 2,200 comment said that Agency action is 2013 IOM report on Sodium Intake in mg/day for adolescents 9 to 13 years. arbitrary and capricious if the action Populations (id. at 11914); (We note that these values are the same departs from prior Agency policy • Setting the DV at 2,300 mg would in the 2015–2020 DGA.) The IOM without explanation or with disregard classify the level as a DRV (rather than derived these ULs for these age groups for factual determinations that we made an RDI) and represent a reference intake by extrapolating downward from the in the past. The comment acknowledged level not to exceed. This would be adult UL of 2,300 mg/day based on that we had presented several consistent with our approaches to using mean energy intakes because the alternatives to the DV of 2,300 mg, DRVs for other nutrients that should be evidence for sodium reduction on blood including alternative DVs of 1,500 and limited in the diet and for which there pressure in children is limited and 1,900 mg and a ‘‘tiered approach,’’ but are concerns of excess intake and risk of inconsistent and was therefore said that our proposal ‘‘lacks an chronic or health-related conditions insufficient to directly set a UL. We adequate basis in the record’’ and that (id.). Thus, although the comment reiterate that the DRV for sodium is an a DV of 2,300 mg is not protective of claimed that a DV of 2,300 mg would amount not to exceed and not a vulnerable populations. The comment mislead consumers into believing they recommended intake level. Therefore, it cited the preamble to the proposed rule should consume more sodium, we is appropriate to use the UL that to indicate that most DRVs have been reiterate that, as a DRV, it is a reference represents the majority of the based on a quantitative intake intake level not to exceed. Moreover, as population as the basis for setting the recommendation associated with we stated in the preamble to the DRV; and chronic disease risk of a health-related proposed rule, if we were to adopt a DV • We also disagree with the condition (79 FR 11879 at 11892) and of 1,500 mg, we anticipate that comment’s assertion that for subgroups that, in the case of iron, we set a DV to consumer education efforts would be the DV ‘‘will affirmatively mislead the protect population subgroups that needed to help consumers understand most affected by suggesting a much require more iron, such as young that the updated DV for sodium is a higher target for their consumption than

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is healthy or medically appropriate.’’ Assessment of the Evidence was not report which recommended reducing The 2013 IOM Sodium in Populations given the task to set a target intake level, sodium content in a stepwise manner report concluded that the evidence on the conclusions of this review that (Ref. 165). both benefit and harm is not strong examined the benefits and adverse (Response) We decline to amend the enough to indicate that these subgroups outcomes of reducing sodium intake rule to adopt a tiered approach. As we should be treated differently from the primarily in observational studies are explain in our response to comment general U.S. population. Thus, the consistent with the UL of 2,300 mg/day. 325, we have set a DV of 2,300 mg based evidence on direct health outcomes Furthermore, all of the individual on a UL. We also maintain that DVs are does not support recommendations to studies in the Graudal meta-analysis based on scientific data supporting lower sodium intake within these (2014) cited by the comments have been healthy dietary practices rather than the subgroups to or even below 1,500 mg/ considered in the IOM reports (Refs. levels of a nutrient present in the food day (see 79 FR 11879 at 11915). 166–168). In addition, this meta- supply (see 79 FR 11879 at 11914). Additionally, the 2005 IOM Electrolytes analysis does not represent the totality However, we are working on efforts to report concluded that there was of the scientific evidence. Given the reduce sodium content in various foods insufficient scientific evidence to set a extensive reviews already conducted by and encourage manufacturers to take separate UL for these groups (see 79 FR the IOM, we do not agree that it is steps towards reducing sodium content. 11879 at 11914 through 11915). necessary to convene a panel to re- (Comment 337) One comment Furthermore, consumers in these review the existing evidence at this suggested that reference to any daily subgroups may be able to use time. The scientific evidence from the nutritional intake or requirement for quantitative information on the label to 2005 IOM DRI Electrolytes report, the sodium is misleading and that we follow advice they have received from a 2013 IOM Sodium in Populations should halt any further consideration of health care professional concerning report, and the 2010 DGA report that we regulations on the sodium content of their conditions (see 79 FR 11879 at relied on in the proposed rule are a food. The comment said that neither the 11887). sufficient basis to establish a DRV of AI nor the UL established by the IOM Thus, we disagree that a DV of 2,300 2,300 mg. Furthermore, the 2015–2020 should be used to recommend intake mg for sodium is ‘‘arbitrary and DGA conclusions corroborate a DRV of levels of sodium because they are capricious,’’ departs from our past 2,300 mg. inconsistent with results from practice, or lacks an adequate basis in (Comment 336) The preamble to the populations studies on sodium intake the record. proposed rule discussed the possibility (Refs. 177–178). The comment also said (Comment 335) Several comments of using a ‘‘tiered approach’’ whereby that using the AI and UL would violate supported retaining a DV of 2,400 mg. we would set an interim DRV of 2,300 the National Nutrition Monitoring and Some comments said experts disagree mg and lower to an RDI of 1,500 mg Related Research Act, 7 U.S.C 5301 et what the recommended daily amount over time (79 FR 11879 at 11916 seq. The comment added that the 2013 for sodium should be and said that the through 11917). We explained that a IOM report concluded that there is no 2013 IOM report on Sodium Intake in tiered approach would give companies consistent evidence supporting any Populations did not recommend an more time to manufacture new foods or association between sodium intake and intake level. Some comments cited a reformulate existing products, would health outcomes and the Dietary meta-analysis by Graudal et al. (Ref. help gradually achieve an adequate Guideline of 1,500 mg sodium per day 168) that included over 250,000 intake level of 1,500 mg/day, and would and could increase health risk for participants; the comment said that be consistent with the 2010 DGAC certain population groups. The there is a u-shaped relationship between recommendation, but we stated that comment asserted that the range of sodium intake and health outcomes there was inadequate justification for sodium intake at which there is the least (Ref. 168). One comment noted that this proposing a tiered approach. negative health outcomes based on relationship could enable a more precise A few comments agreed with our mortality and measureable feedback determination of intake levels to be conclusion that there is inadequate responses (renin, aldosterone, achieved rather than relying on dietary justification in consensus reports to use catecholamines, cholesterol and modeling and a somewhat arbitrary a tiered approach. The comments noted triglycerides) is above 130 mmol cutoff on a continuous scale. Therefore, that a tiered approach would be an (approximately 3,000 mg/day) and that the comment said we should convene a unprecedented process and inconsistent this is the level that most people around panel to review the evidence, examine to the approach used for other nutrients, the world already consume (Ref. 179). the scientific evidence associating such as saturated fat and cholesterol, to The comment stated that restriction of sodium intake to measurable health limit in the diet. Another comment sodium intake stimulates the renin- outcomes, or wait for the publication of noted that a tiered approach may not angiotensin-aldosterone (RAS) response the 2015–2020 DGA report to be help consumers adjust their taste and may lead to insulin resistance, published for consideration. preferences for sodium (Ref. 176). increased mortality from diabetes, (Response) We disagree that there is Other comments, however, increased congestive heart failure risk, not agreement on a sodium intake level recommended that we consider the negative blood chemistry and increased among experts. The 2005 IOM DRI tiered option if an RDI of 1,500 mg is overall mortality (Refs. 179–182). The Electrolytes report, a U.S. consensus not used. The comments said a tiered comment also stated that the IOM had report, set a UL of 2,300 mg/day based approach would provide food agreed to re-evaluate the DRIs for on clinical trials that evaluated the manufacturers with more time to sodium. dose-response relationship between reformulate, allow consumer taste (Response) We disagree that any sodium intake and blood pressure. preferences to adjust, and be consistent reference to any daily intake is Retaining the existing DRV of 2,400 mg with the 2010 DGAC recommendation misleading, that there should be no would exceed the UL for sodium for the to reduce sodium intake to 1,500 mg/ reference to an intake recommendation majority of the population (persons 14 day over time. Some comments said a for sodium, and that we should stop years of age and older) (see 79 FR 11879 phased-in approach also would be working on ways to reduce the sodium at 11915). While the 2013 IOM Report consistent with the 2010 IOM Strategies content of food. While we agree that the on Sodium Intake in Populations to Reduce Sodium Intake in Populations AI for sodium, which was based on

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meeting essential needs, is not a suitable 11887 and part II.B.2). In addition, added sodium in labeling. Therefore, we basis for establishing a DRV, we while sodium was nominated as part of are not making changes in response to disagree that the UL should not be used the DRI nomination process that was this comment. to establish a DRV for sodium. There is developed to help Federal Agencies (Comment 339) One comment said we well-established evidence from prioritize which nutrients are reviewed, should require disclosure of ‘‘salt’’ consensus reports on the relationship the IOM has not been asked to instead of ‘‘sodium.’’ The comment said between sodium intake and blood undertake a re-evaluation of the DRI for that consumers understand ‘‘salt,’’ but pressure (Ref. 166). The UL of 2,300 mg/ sodium as asserted by the comment may not know what ‘‘sodium’’ means. day was based on clinical trials that (Ref. 183). To our knowledge, the IOM The comment also noted that most evaluated the dose-response also has not agreed to reevaluate the DRI sodium we consume is in the form of relationship between sodium intake and for sodium as asserted by the comment. salt and that other countries use the blood pressure (Ref. 166). In addition, Lastly, in response to the comment term ‘‘salt.’’ The comment stated that the 2013 IOM Sodium Intake in asserting that using the AI and UL requiring use of the term ‘‘salt’’ would Populations report concluded that would violate the National Nutrition mean that consumers would see a larger clinical outcomes primarily from Monitoring and Related Research Act number on food labels and that could observational studies are consistent (NNMRRA), to the extent the comment deter consumers from eating high with the UL of 2,300 mg/day. One suggests our establishment of a DRV of sodium foods. observational population study cited by 2,300 mg/day for sodium for purposes of (Response) We decline to revise the the comment (Ref. 177) was reviewed by labeling is somehow not consistent with rule to replace ‘‘sodium’’ with ‘‘salt.’’ the IOM in 2005 and 2013 and another nutritional monitoring and related We note that section 403(q)(1)(D) of the study done by Powles et al., 2013 (Ref. research activities related to the FD&C Act expressly refers to ‘‘sodium’’ 178) did not evaluate sodium intake to NNMRRA, we disagree. We are (rather than a specific form of sodium) CVD outcomes or blood pressure and requiring a DRV of 2,300 mg/day for as a nutrient and that ‘‘sodium’’ has only estimated sodium intakes around sodium consistent with our authority in been in the Nutrition Facts label since the world. section 403(q) of the FD&C Act to assist 1993 (see 58 FR 2079). We also note that consumers to maintain healthy dietary We also disagree with the comment our surveys suggest that consumers are practices and to enable consumers to that suggests there should be no aware that too much sodium is observe and comprehend the restriction of sodium below current unhealthy (see 79 FR 11879 at 11916 information and to understand the (referring to results from the FDA Health intake levels of 3,000 mg/day because of relative significance of the information concerns of negative health outcomes. and Diet Surveys)). in the context of a total daily diet. We Furthermore, while most sodium The 2005 IOM Electrolytes report also note that the NNMRRA was enacted reviewed the evidence on low sodium consumed in the diet comes from on October 22, 1990 and that the NLEA sodium chloride (which is the intake and blood lipid concentrations was enacted on November 8, 1990. and insulin resistance and noted that compound associated most with ‘‘salt’’), Nothing in the NLEA states or even other forms of sodium, such as sodium the Al of 1,500 mg/day exceeds the suggests that the NNMRRA imposes levels of sodium intake (typically less bicarbonate (e.g. baking soda) and limits or conditions on the declaration (MSG), used in than 700 mg/day) that have been of nutrients on food labeling or on our associated in some studies with adverse foods contribute to the intake of sodium statutory obligations under the NLEA. and can also raise blood pressure. effects of blood lipid concentrations and (Comment 338) A few comments said insulin resistance (Ref. 166). The 2005 that food labels should distinguish the K. Fluoride IOM Electrolytes report reviewed the amount of sodium that is added to food 1. Voluntary Declaration evidence for plasma renin and from the amount that is naturally concluded that, in contrast to blood occurring. The comments said we Our preexisting regulations do not pressure, there is no consensus on the proposed a similar result for added require or permit the declaration of interpretation of plasma renin activity sugar and that both sodium and added fluoride on the Nutrition Facts label. and its role in guiding therapy for high sugar cause serious health problems. Fluoride is a nonessential nutrient, but blood pressure (Ref. 166). Similar to (Response) We decline to require the there is well-established evidence for plasma renin activity, the evidence for amount of added sodium to be declared the role of fluoride in reducing the risk the role of sympathetic nerve activity separately from the amount that occurs of dental caries. As we said in the (e.g., release of catecholamines) and naturally in food. The comment did not preamble to the proposed rule (79 FR aldosterone is limited, and neither explain why we should consider a 11879 at 11917), the declaration of catecholamines, aldosterone, plasma distinction between naturally occurring fluoride content of a food can provide renin, or triglycerides are recognized as and added sodium for purposes of the consumers with information to assist validated surrogate endpoints for sodium declaration or provide a them in maintaining healthy dietary predicting CVD risk (see 79 FR 11879 at scientific rationale for that distinction. practices. However, because the 11916). Furthermore, while consumers (In contrast, the preamble to the evidence available to us did not allow with acute or chronic disease, such as proposed rule (79 FR 11879 at 11902 us to establish a DRV for fluoride, we obesity, CVD (including CHF), or through 11905) discussed why we were proposed to amend § 101.9(c)(5) to diabetes, may be able to use quantitative proposing to require the declaration of provide for voluntary declaration of information on the label to follow added sugars, and the preamble to the fluoride. In addition, consistent with advice they have received from a health supplemental proposed rule (80 FR existing provisions for voluntary care professional concerning their 44303 at 44307 through 44309) declaration of other nutrients, we conditions, the nutrient declarations explained why we were proposing to proposed that the declaration of fluoride and percent DVs on the label are to help establish a DRV of 10 percent of total would be mandatory when a claim consumers make more informed choices energy intake from added sugars and to about fluoride is made on the label or to consume a healthy diet and are not require a percent DV for added sugars.) in labeling of foods and that, when intended for the clinical management of We are not aware of any scientific fluoride content is declared, it must be an existing disease (see 79 FR 11879 at evidence to support a distinction for expressed as zero when a serving

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contains less than 0.1 mg of fluoride, to (Comment 341) One comment stated proposed rule would impose a burden the nearest 0.1 mg increment when a that declaration of fluoride should be without any consumer benefit because serving contains less than or equal to 0.8 mandatory because fluoride fluoride is already declared and all mg of fluoride, and the nearest 0.2 mg consumption is one of the safest and other nutrients would be declared as when a serving contains more than 0.8 most effective ways to help prevent zero. The comment added that, if we mg of fluoride, consistent with how we tooth decay. The comment said that required Nutrition Facts labels on all have approached incremental values for most bottled waters contain negligible foods that are otherwise exempt from other nutrients that are present in food amounts of fluoride or are fluoride-free, nutrition labeling, labels on these foods in small amounts. so displaying the fluoride content of would have to increase in size. (Comment 340) Several comments bottled water on Nutrition and (Response) We agree that a supported voluntary fluoride labeling Supplement Facts labels will help declaration of fluoride would not be and agreed that there is well-established consumers make informed decisions required on the label for bottled water evidence for the role of fluoride in about their choice of . if statements such as ‘‘fluoridated,’’ reducing the risk of dental caries. The comment noted that, without such fluoride added,’’ or ‘‘with added One comment suggested that labeling, individuals who use bottled fluoride,’’ consistent with § 101.13(q)(8), manufacturers of foodstuffs/beverages water as their primary water source are included. The use of these voluntarily label fluoride content if could unknowingly be missing the statements would, however, require use levels do not exceed 0.2 ppm from decay preventive effects of optimally of a simplified format for nutrition fluoride-contaminated materials during fluoridated water available from their labeling. In the preamble to the final product preparation or are less than 2 community water supply. rule establishing the standard of identity (Response) We decline to amend the ppm if fluoride is present naturally. The and standard of quality for bottled water rule as suggested by the comment. There comment would require foodstuffs/ (60 FR 57076 at 57079; November 13, are already quantitative limits for beverages to be labeled if fluoride is 1995), we recognized that bottled water fluoride with respect to bottled water. intentionally added to the product. may be used by some consumers as an Furthermore, labeling of fluoride on (Response) Under the final rule, alternative to community drinking water bottled water would not be sufficient to declaration of a product’s fluoride levels and that the Surgeon General’s Report inform a consumer about whether to is voluntary whether intentionally on Nutrition and Health recommends consume water from the local municipal added or present naturally. As we stated that community water systems contain water supply. The consumer would in the preamble to the proposed rule (79 need to understand the fluoride content fluoride at optimal levels to prevent FR 11879 at 11917), a DRV cannot be of the local municipal water supply (or tooth decay. Therefore, we included, as established for fluoride based on the well water, if applicable) to understand part of the standard of identity for available quantitative intake the relative contribution of fluoride bottled water (§ 165.110(a)(1)), the recommendations. Therefore, while from each. Therefore, we do not optional addition of fluoride to bottled fluoride is a nutrient with public health consider it necessary to require labeling water within the limitations established significance, consistent with the factors on the fluoride content of bottled water. in the quality standard we considered for declaration of non- We also do not expect fluorination of (§ 165.110(b)(4)(ii)). We stated that a statutory nutrients such as this, fluoride food. To the extent fluoride is approved bottled water with added fluoride declaration is voluntary in the Nutrition for use as an ingredient in a food, its would be a multi-ingredient food and, Facts label. The final rule also states form must be listed in the ingredient as such, its label must bear ingredient how fluoride content must be expressed, list, and so one can determine if there labeling (21 CFR 101.4(a)(1)) (id.). We depending on the amount of fluoride in is fluoride in food by checking the also stated that we provided for the use a specified serving. ingredient list (§ 101.4(a)(1)). of terms ‘‘fluoridated,’’ ‘‘fluoride As for the comment suggesting that (Comment 342) One comment agreed added,’’ or ‘‘with added fluoride’’ on the the declaration of fluoride be mandatory with the proposed requirements for label or in labeling of bottled water that if it is added intentionally to a product, voluntary declaration of fluoride and for contains added fluoride in 21 CFR we disagree. The comment did not mandatory declaration of fluoride if a 101.13(q)(8) (id.). By doing so, we did provide, nor do we have, a basis to claim is made about fluoride content or not define a nutrient content claim for require labeling of fluoride content the label includes a FDA health claim fluoride, and, instead, provided that a when intentionally added. The addition for fluoride and dental caries. However, statement indicating the presence of of fluorine compounds to foods that the comment objected to the need for a added fluoride could be used, but that would be subject to a voluntary fluoride fluoride nutrient content declaration on the claim cannot include a description declaration in the Nutrition Facts label bottled water when the product bears a of the level of fluoride present (e.g., includes fluoride in water that is used statement of ‘‘added fluoride’’ as part of ‘‘good source’’ or ‘‘high’’) (58 FR 2302 as an ingredient in food from the statement of identity with an at 2314). We also stated, in the preamble fluoridation of public water supplies accompanying quantitative declaration to another final rule (58 FR 2079 at and fluoridation of bottled water within elsewhere on the label. The comment 2149), that we considered the identity the limitations set forth in said that declaring fluoride in the statement ‘‘fluoridated water’’ to be § 165.110(b)(4)(ii) (see § 170.45). We are Nutrition Facts label in such a situation misleading if the product is derived not aware of added fluorinated would not help consumers. The from a source naturally containing compounds to other foods and would comment stated that including a fluoride. We concluded that the term consider such an addition to be subject statement about fluoride in the ‘‘fluoridated’’ should be used to to a food additive approval under statement of identity (e.g., spring water describe only products to which section 409 of the FD&C Act. Moreover, with fluoride added) under the bottled fluoride has been added in the mandatory declaration is required if a water standard should not be treated as manufacturing process and that such claim about fluoride content is made on a fluoride claim that triggers mandatory products must bear nutrition labeling the label or in the labeling of foods (see nutrition labeling as long as the amount that complies with the simplified format § 101.9(c)(5)). Thus, we decline to revise of fluoride is otherwise declared on the (id.). Thus, fluoride that is added to the rule as suggested by the comment. label. The comment said that the bottled water consistent with the

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standard of quality in § 165.119(b)(4)(ii) widespread, significant dental fluorosis. fluorosis could not be estimated in U.S. and that bears a statement consistent The comment said that athletes or adolescents due to few cases in the with § 101.13(q)(8) must comply with others who drink twice the average participants in a national survey (Ref. the simplified format for labeling in intake of water could easily consume 184). The PHS stated that ‘‘to lower the § 101.9(f). However, we did not require more than 2 mg of fluoride per day. fluoride concentration for community any inclusion or declaration of fluoride (Response) The level of fluoride in water fluoridation should decrease in the simplified format for Nutrition public drinking water is outside the fluoride exposure during the time of Facts label because of the regulatory scope of this rulemaking. enamel formation (birth through 8 years status of fluoride declarations and With respect to community water of age) for most permanent teeth, and fluoride claims at the time. The terms sources, we note that, on April 27, 2015, further lessen the chance for children’s ‘‘fluoridated,’’ ‘‘fluoride added,’’ or the U.S. Public Health Service (PHS) teeth to have dental fluorosis, while ‘‘with added fluoride’’ were not recommended an optimal fluoride keeping the decay prevention benefits of provided for use as nutrient content concentration of 0.7 mg/L for fluoridated water’’ (Ref. 184). The PHS claims (which would require community water systems that add and FDA recommendations or advice declaration of fluoride if defined as fluoride (see Department of Health and should reduce the risk of dental such), but rather as statements regarding Human Services, ‘‘HHS Issues Final fluorosis while still preserving the the presence of added fluoride, which Recommendation for Community Water benefit of caries prevention. were declared exempt from the nutrient Fluoridation,’’ dated April 27, 2015; content claim general requirements ‘‘U.S. Public Health Service 2. DRV (§ 101.13(q)). Moreover, even if the Recommendation for Fluoride Our preexisting regulations do not terms ‘‘fluoridated,’’ ‘‘fluoride added,’’ Concentration in Drinking Water for the provide an RDI or DRV for fluoride, and, or ‘‘with added fluoride’’ were defined Prevention of Dental Caries,’’ Public in the preamble to the proposed rule (79 as nutrient content claims at that time, Health Reports, vol. 130, pages 1 FR 11879 at 11917), we stated that we fluoride had not been included in through 14 (July–August 2015) (‘‘PHS were not proposing to establish a DRV § 101.9 as a nutrient for inclusion in Recommendation’’) (accessed on the for fluoride. Nutrition Facts label and would not Internet at http://www.publichealth (Comment 344) Some comments have been able to be included in the reports.org/documents/PHS_2015_ agreed with our decision to not establish simplified format for Nutrition Facts Fluoride_Guidelines.pdf)). PHS a DRV for fluoride. label even if those claims were used. indicated that this fluoride (Response) The final rule does not Through this final rule, we provide concentration, which replaces the establish a DRV for fluoride. previous recommended range of 0.7 to for the voluntary declaration of fluoride 3. Miscellaneous Comments in the Nutrition Facts label, but, under 1.2 mg/L, would maintain caries the preexisting regulations, statements prevention benefits while reducing the Several comments raised additional on the presence of added fluoride risk of dental fluorosis (PHS issues regarding fluoride. remain exempt from the nutrient Recommendation at 2). It also noted that (Comment 345) One comment said the content claim general requirements. We the Environmental Protection Agency fluoride declaration should be in units may evaluate our regulations for (EPA) is in the process of reviewing the of mg per liter (mg/L) rather than mg/ nutrient content claims (and health maximum amount of fluoride allowed serving. The comment stated that that claims) for any necessary changes after in drinking water (id.). the FDAMA health claim is in mg/L, publication of this final rule and the As for bottled water, although we that we mandated the amount of final rule on serving sizes. To be clear, have regulations establishing a quality fluoride in bottled water in mg/L, and with respect to labeling requirements standard for bottled water (§ 165.110), that consumers are accustomed to when statements are made on the label we issued a letter on April 27, 2015, seeing fluoride as mg/L on bottles. about added fluoride in bottled water based on the PHS recommendation, Therefore, according to the comment, to consistent with § 101.13(q)(8), we are advising manufacturers, distributors, facilitate consumer understanding and not requiring the mandatory declaration and importers of bottled water to not comparisons between the amount of of fluoride for bottled water that bears add fluoride to bottled water at fluoride in bottled water or other a statement about added fluoride. We concentrations greater than a maximum products and the recommended intake are, however, including additional final concentration of 0.7 mg/L (see levels, we should adopt mg/L as the unit language in § 101.9(c)(5) to make clear Letter from Susan T. Mayne, Ph.D., for fluoride declarations. The comment that bottled water that bears a statement F.A.C.E., Director, Center for Food further stated that if mg/serving were to about added fluoride, as permitted by Safety and Applied Nutrition, to be used as the unit, some servings of § 101.13(q)(8), must bear nutrition Manufacturer, Distributor, or Importer bottled water would need to be declared labeling that complies with of Bottled Water, dated April 27, 2015 as 0 mg fluoride, despite containing a requirements for the simplified format (available on the Internet at http://www. meaningful amount of fluoride from a in § 101.9(f). If any other fluoride claim fda.gov/Food/GuidanceRegulation/ public health perspective on a mg/L is used on the label (e.g., the FDAMA GuidanceDocumentsRegulatory basis and that consumers may be health claim for fluoride or an amount Information/BottledWaterCarbonated confused if the label said ‘‘with fluoride statement under § 101.13(i)(3)), the SoftDrinks/ucm444373.htm)). We added’’ but the Nutrition Facts label declaration of fluoride would be intend to revise our quality standard for declared 0 mg of fluoride. mandatory on the Nutrition Facts label. fluoride added to bottled water (at (Response) We decline to require the (Comment 343) One comment would § 165.110(b)(4)(ii)) to be consistent with declaration of fluoride in the Nutrition revise the rule to require the declaration the PHS recommendation. Facts label to be in units of mg/L. The of fluoride if the amount of fluoride As for the comment’s mention of declaration of fluoride in the Nutrition exceeds 0.5 mg per serving. The dental fluorosis, the majority of dental Facts label is comparable to the other comment said that fluoride is a fluorosis in the United States is the very nutrients which are declared in absolute dangerous neurotoxin and that mild form, and severe dental fluorosis is amounts per serving. Reporting mg per consumption of over 2 mg/day of not common in the United States (Ref. serving gives consumers an accurate fluoride in drinking water would cause 184). The prevalence of severe dental amount of fluoride in a serving of the

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product. Providing the amount of different category (such as an comment 343, the PHS recently fluoride per liter may confuse unapproved drug). The comment said recommended an optimal fluoride consumers because the consumer may that, if our evidence suggests benefits of concentration of 0.7 mg/L for not be aware how much fluoride will be dietary fluoride exposure in preventing community water systems that add in the amount per serving (e.g., 12 dental caries, it is reasonable to fluoride. Based on the PHS ounces of bottled water which is equal conclude that the qualified health claim recommendation, we advised to about 360 mL). should be expanded to allow the claim manufacturers, distributors, and As for the comment’s mention of the in conventional foods and dietary importers of bottled water to not add FDAMA health claim and our bottled supplements, labeled with dietary fluoride to bottled water at water regulation, the FDAMA health fluoride, and in all forms (capsule, concentrations greater than a maximum claim language did not mention a tablet, liquid). final concentration of 0.7 mg/L. specific quantity of fluoride nor did it (Response) The proposed rule did not As for the comment’s suggestion to use a specific unit of measure; the claim set forth a qualified claim with respect include language that the EPA has language is ‘‘Drinking fluoridated water to fluoride. In the preamble to the recognized fluoride as a water may reduce the risk of [dental caries or proposed rule (79 FR 11879 at 11917), ‘‘contaminant,’’ the fact that EPA has a tooth decay].’’ We acknowledge that the we explained that we received a maximum contaminant level for bottled water regulation uses units in FDAMA notification in 2006 for a health fluoride in public drinking water does mg/L, yet we also note that the bottled claim for fluoride in bottled water and not mean bottled water or other water regulation is directed at that we did not object to the claim. The products containing fluoride should manufacturers, distributors, and FDAMA health claim is limited to state that fluoride is recognized by U.S. importers of bottled water and bottled water and does not extend to EPA as a water contaminant. Fluoride, establishes a standard of identity and other foods. Under the FDAMA health as a contaminant to public drinking standard of quality for bottled water and claim, the food eligible to bear the claim water, is outside the scope of this rule. includes maximum levels of fluoride in is bottled water meeting the standards of (Comment 348) One comment stated bottled water. In contrast, the Nutrition identity and quality set forth in that labeling could promote the false Facts label information declares nutrient § 165.110, and general requirements for notion that fluoride is a nutrient and content in a serving of a product to health claims in § 101.14 with the said that any accompanying claim that assist consumers in maintaining healthy exception of the minimum nutrient fluoride has ‘‘nutritional value’’ or is a dietary practices. Thus, we decline to contribution (§ 101.14 (e)(6)). For a ‘‘dietary ingredient’’ would constitute amend the rule to require the health claim to be expanded to more false labeling and would violate the declaration of fluoride to be in mg/L. foods, a health claim petition (§ 101.70) FD&C Act. Finally, regarding the comment’s or a FDAMA notification must be (Response) We disagree with the claim that consumers would be submitted for our review (section comment. We consider fluoride to be a confused if the label said ‘‘with fluoride 403(r)(3)(C) of the FD&C Act). nutrient (specifically, a mineral) (Ref. added’’ and the Nutrition Facts label (Comment 347) One comment 185) for purposes of nutrition labeling declared fluoride content as 0 mg, we suggested that, when fluoride is in section 403(q) of the FD&C Act. We note that the use of a statement, intentionally added to foods/beverages consider a nutrient that is subject to consistent with § 101.13(q)(8) would not for ingestion by consumers, the nutrition labeling under section require fluoride be declared on the label following disclaimer/label appear before 403(q)(1) or (q)(2) of the FD&C Act also as ‘‘0 mg.’’ We are not aware of, and the listed amount: ‘‘Fluoride is not a to be a dietary ingredient in section think it would be unlikely for, a mineral nutrient, has no daily 201(ff) of the FD&C Act. manufacturer to voluntarily declare ‘‘0 allowance, and is not FDA approved for (Comment 349) One comment mg’’ for fluoride if the level of added ingestion particularly for women who suggested that, when fluoride is fluoride is at a level that must be are pregnant. Fluoride is recognized by declared over 0.5 grams per serving, the declared as zero when making U.S. EPA as a water contaminant.’’ One manufacturer declare the form of statements on its product consistent comment stated that voluntary labeling fluoride present. The comment said that with § 101.13(q)(8). Any labeling must could help because those who add this information is highly relevant given be truthful and not misleading, within fluoride and claim it as a ‘‘dietary the well-known differences between the the meaning of sections 403(a) and ingredient’’ will show fluoride content. bioavailability and pharmacokinetic 201(n) of the FD&C Act. The comment noted that consumers profiles of artificial fluorides (e.g. (Comment 346) One comment who understand that fluoride is unsafe hydrosilicic acid, sodium interpreted the proposed rule as to add to food can avoid buying the monofluorophosphate) as compared allowing fluoride claims for dental product. with naturally occurring ones caries on all food labels. The comment (Response) We decline to revise the (principally calcium fluoride). asked if these health claims will be rule to include the comment’s suggested (Response) If a nutrient is added to a permissible, beyond fluoride in bottled language. While we agree that fluoride food, the form that is added must be water products, for conventional foods is a non-essential nutrient, there is well- declared in the ingredients list and dietary supplements of any matrix established evidence for the role of (§ 101.4(a)(1)). Moreover, under because we have evidence fluoride in reducing the risk of dental § 101.4(a)(1), if the ingredient is a acknowledging fluoride’s health benefits caries, and the IOM set a quantitative dietary ingredient, the form would be in and whether we will update the current intake recommendation (AI) based on its the ingredient list, unless already qualified health claim for fluoridated role in the reduction of risk of dental labeled in accordance with § 101.36. water and reduced risk of dental caries. caries, but a DRV for fluoride has not Under the Supplement Facts label Alternatively, the comment asked if been established. Furthermore, we have requirements at § 101.36(d), the source claims for the reduction in dental caries a standard of identity and a standard for ingredient may be identified within the in the labels for conventional for bottled water that allows nutrition label in parenthesis products (other than bottled water) and voluntary addition of fluoride within immediately following or indented dietary supplements would lead us to the limitation established in § 165.110, beneath the name of a dietary ingredient regulate those products under a and, as we stated in our response to and preceded by the word ‘‘as’’ or

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‘‘from’’. Therefore, we decline to revise vitamins and minerals, namely, vitamin information that would cause us to the rule as suggested by the comment. A, vitamin C, calcium, and iron. reconsider our analysis of the factors (Comment 350) One comment rejected Vitamins and minerals that may be supporting mandatory declaration. the notion that fluoride is a safe declared voluntarily are vitamin D, Thus, we decline to revise the rule as ingredient that only provides benefit vitamin E, vitamin K, , suggested by the comment. and no harm. The comment said that vitamin B12, thiamin, , niacin, (Comment 352) Some comments said ingested fluoride is toxic and that we folate, biotin, pantothenic acid, that our nutrients of public health should cite references that address the phosphorus, iodine, magnesium, , significance (e.g., calcium and vitamin harm of ingested fluoride. Another , copper, manganese, D) are similar to nutrients of public comment stated that all synthetic chromium, , chloride, and health concern as determined by the industrial fluorides (e.g., hydrosilic potassium. 2010 DGA recommendations. The acid, sodium monofluorophosphate) are comments suggested that we wait for the toxic calcium chelators that are 1. General Comments 2015–2020 DGA decision on nutrients assimilated well. The comment said that (Comment 351) One comment of public health concern, so we can be fluoride is incorporated permanently in opposed the mandatory declaration of consistent with the 2015–2020 DGA. the bone during lifelong consumption, any vitamins or minerals other than (Response) We note that our nutrients contributes to osteoporosis, accentuates sodium and potassium. The comment of public health significance are the hypothyroidism and dysfunctional noted that all vitamins and minerals are same as the 2010 DGA and the 2015 kidneys, and can cause dental fluorosis required in the diet and said that DGAC recommendations. The 2015 in children and other effects. The singling out a few nutrients on the label DGAC used a three pronged approach comment said that natural calcium encourages unnecessary fortification similar to our factors for determining fluoride is not well assimilated and is and overconsumption. The comment whether nutrients that have a specific the fluoride source for which labeling stated that labeling potassium would relationship to chronic disease risk or a could be voluntary. The comment added encourage food manufacturers to reduce health-related condition are nutrients of that EPA’s maximum contaminant level sodium to achieve a better balance. public health concern, including an (MCL) for fluoride in drinking water (2 (Response) The comment did not analysis of intake data, available valid ppm) is derived for calcium fluoride in provide data or information to support biochemical indices from NHANES natural sources in public water supplies its argument that the inclusion of a dietary survey, and data on the and that there is no established MCL for vitamin or a mineral on the Nutrition prevalence of health condition in the synthetic fluoride where toxicity can Facts label will encourage fortification U.S. population. Based on the 2015 vary under differing environmental or overconsumption. With respect to DGAC approach, vitamin D, calcium, conditions and disease conditions of the fortification, we encourage potassium, iron, and fiber were consumers. manufacturers to follow the principles considered as nutrients of public health (Response) The preamble to the in our fortification policy at § 104.20 if concern for under-consumption. proposed rule highlighted the adverse they add nutrients to food. We issued We also note that the 2015–2020 DGA impacts of high fluoride consumption the fortification policy to promote the identifies calcium, potassium, dietary set by IOM (Ref. 185) and U.S. EPA rational addition of nutrients to foods fiber, vitamin D, and iron as nutrients of report (Ref. 186) (see 79 FR 11879 at and to preserve a balance of nutrients in public health concern. 11917 through 11918). We also stated the U.S. diet. In addition, our food additive regulations or GRAS status of 2. Essential Vitamins and Minerals That that other FDA regulations (§§ 165.110 Are Mandatory and 170.45) have limited what foods some nutrients (e.g., vitamin D and folic contain added fluoride. We reiterate that acid) may limit which foods may be a. Calcium. Our preexisting we recently advised manufacturers, fortified and at what level. For example, regulations, at § 101.9(c)(8)(ii), require distributors, and importers of bottled the food additive regulations on folic the declaration of calcium content as a water to not add fluoride to bottled acid (21 CFR 172.345) and vitamin D percent DV on the Nutrition Facts label. water at concentrations greater than a (§ 172.379 (21 CFR 172.379); § 172.380) We require the declaration of calcium in maximum final concentration of 0.7 mg/ stipulate which foods may be fortified nutrition labeling because: (1) There L. and at what level. were a limited number of calcium-rich As for the comment regarding As for the mandatory declaration of foods in the food supply; (2) calcium synthetic and natural forms of fluoride, vitamins and minerals, as we stated in intakes in the United States were the final rule does not restrict itself to the preamble to the proposed rule (79 generally marginal; (3) adequate calcium a specific source of fluoride. Absent FR 11879 at 11918 through 11922), we intakes are needed to allow for optimal data or information, we do not have a determined that iron, calcium, vitamin bone mass development during sufficient basis in the administrative D, and potassium are nutrients of public childhood and young adulthood; and (4) record on which to distinguish health significance and their mandatory calcium was identified as a nutrient of ‘‘natural’’ forms of fluoride from declaration on the label can help public health significance in the 1990 ‘‘synthetic’’ forms and to base the consumers maintain healthy dietary IOM report and in other consensus fluoride declaration in the Nutrition practices. We mentioned how we reports (58 FR 2079 at 2106). Facts label on a particular form of considered several factors, such as In the preamble to the proposed rule fluoride. intake and/or biomarker data, IOM (79 FR 11879 at 11918 through 11919), We have not made any changes to the setting a quantitative intake we discussed the benefits of adequate rule in response to these comments. recommendation for a nutrient based on calcium intake on bone health, the its relationship to a chronic disease, or relatively low intakes of calcium, and L. Essential Vitamins and Minerals of a health-related condition to determine the high prevalence of osteoporosis and Public Health Significance whether a particular nutrient was of osteopenia among the U.S. population. In addition to sodium, a statutorily public health significance for the We decided to continue requiring the required nutrient, our preexisting general U.S. population (id.). The declaration of calcium on the Nutrition regulations, at § 101.9(c)(8)(ii), require comment did not dispute our Facts label, and so the proposed rule the declaration of four essential assessment of the data or provide would not change § 101.9(c)(8)(ii).

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(Comment 353) Most comments to require the declaration of calcium serum ferritin concentration (the major supported mandatory declaration of content as a percent DV on the Nutrition iron storage compounds) less than 15 calcium on the Nutrition Facts label. Facts label, so the final rule does not ng/mL, while 10 and 14.5 percent of However, some comments supported affect the requirements for the women had inadequate stores of body mandatory declaration for different declaration of calcium. iron based on the body iron model or reasons. Some comments focused on (Comment 354) One comment noted ferritin model, respectively (see 79 FR calcium’s role in bone health, but most that adding calcium (plus vitamin D and 11879 at 11920). Additionally, about comments said that calcium is potassium) to the Nutrition Facts label 3.76 million of these women of important for dialysis and renal will be ‘‘nice’’ for those who understand childbearing age are considered to have patients. these details, but, for most consumers iron deficiency anemia, so that iron (Response) While a mandatory (except perhaps those with Chronic continues to be of public health calcium declaration may help patients Kidney Disease), information regarding significance among women of who have chronic kidney disease, this calcium is just more information to sift childbearing age and pregnant women, was not a factor we considered in through on an already-confusing food who account for 26 percent of the mandating the declaration of calcium. label. general U.S. population (id.). The Nutrition Facts label is not (Response) We consider that a vitamin We noted that iron continues to be intended to focus on individuals with a or mineral of public health significance identified as a nutrient of public health specific acute or chronic disease (see should continue to be the key factor in significance in consensus reports such part II.B.2). To evaluate the public deciding when to require mandatory as Healthy People 2020 and the 2010 health significance of essential vitamins declaration in labeling. Available DGA (see 79 FR 11879 at 11920). Thus, and minerals, we considered several quantitative evidence suggests that the we did not propose any changes to the factors in determining the mandatory declaration of nutrient of public health mandatory declaration of iron under declaration of vitamins and minerals in significance, including vitamins and § 101.9(c)(8)(ii). the Nutrition Facts label. We considered minerals, can help consumers maintain (Comment 355) Most comments the essential vitamins and minerals with healthy dietary practices (Refs. 187– supported the mandatory declaration of the greatest public health significance to 188). Additionally, we intend to work iron on the Nutrition Facts label. be those for which IOM based DRIs on with other Federal Agencies and One comment suggested that, instead chronic disease risk (e.g., osteoporosis), organizations on communication and of declaring iron as ‘‘iron,’’ we should a health-related condition (e.g., high education for health professionals and require the declaration of specific forms, blood pressure), or a nutrient deficiency consumers regarding the revised such as ‘‘reduced iron’’ or ‘‘ferrous with clinical significance (e.g., low iron Nutrition Facts and Supplement Facts sulfate,’’ on the label. The comment said storage leading to iron deficiency labels after we issue the final rule. that some people have an allergic anemia) for which inadequate intake of b. Iron. Our preexisting regulations, at reaction to added iron, but do not react these nutrients are likely to have § 101.9(c)(8)(ii), require the declaration to natural iron. important clinical consequences. We of iron as a percent DV on the Nutrition (Response) We decline to revise the also considered whether the national Facts label. We require the declaration rule as suggested by the comment. survey data on nutrient intake and/or, of iron because: (1) Iron was identified Based on our regulations, only iron can when available, biomarkers of nutrient as a nutrient of public health be used on the food labels status, provide evidence of inadequate significance in a 1990 IOM report and (§ 101.9(c)(8)(iv)), but the specific form intake of the nutrient in the general in other consensus reports; and (2) iron that is added to the food, (e.g., ferrous healthy U.S. population, and whether a deficiency was a risk for certain sulfate) must be listed in the ingredient substantial prevalence of health segments of the U.S. population (i.e., list (§ 101.4). Individuals with allergic consequences that was linked to the young children, adolescents and women reactions to added iron in food are particular nutrient exists in the general of childbearing age and pregnant advised to check the ingredient list. healthy U.S. population (see 79 FR women, especially those with low Under the Supplement Facts label 11879 at 11890). In setting DRIs for incomes) (58 FR 2079 at 2106). In the requirements at § 101.36(d), the source calcium, the IOM reviewed various preamble to the proposed rule (79 FR ingredient may be identified in endpoints (i.e., bone health, cancer, 11879 at 11919), we discussed our parenthesis immediately following or cardiovascular disease and diabetes), analysis of NHANES intake data indented beneath the name of a dietary and bone health was the only endpoint showing that 3.5 percent of the ingredient and preceded by the word with sufficient scientific evidence to set population ages 4 years and older ‘‘as’’ or ‘‘from.’’ When a source a DRI (Ref. 38). Therefore, given the (excluding pregnant and lactating ingredient is not identified within the benefits of adequate intake on bone women) have inadequate iron intakes nutrition label, it must be listed in an health, reflected in the IOM’s DRIs, from conventional foods (i.e., an intake ingredient statement in accordance with relatively low intake of calcium (about below the EAR), and about 3.3 percent § 101.4(g). However, when a source 49 percent of individuals ages 4 years have inadequate iron intakes from ingredient is identified in the nutrition and older have usual calcium intake conventional foods and dietary label, it will not be listed again in the from conventional foods below the EAR supplements. We also stated that about ingredient statement. and 37 percent have intakes from both 11.2 and 10.4 percent of women of Our preexisting regulation, at conventional foods plus supplements childbearing age (12 to 49 years old) § 101.9(c)(8)(ii), continues to require the below the EAR), and the high continue to have iron intakes below the declaration of iron content as a percent prevalence of osteoporosis and EAR, from conventional foods and DV on the Nutrition Facts label, so the osteopenia among the U.S. population, conventional foods plus dietary final rule does not affect the we concluded that calcium is a nutrient supplements, respectively. We also requirements for the declaration of iron. of public health significance, and its considered data for several status c. Vitamin A and Vitamin C. Our declaration continues to be necessary to biomarkers related to iron nutrition. preexisting regulations, at assist consumers in maintaining healthy Analyses of these data showed that § 101.9(c)(8)(ii), require the declaration dietary practices. Our preexisting about 14 percent of women of of vitamins A and C as percent DVs on regulation, at § 101.9(c)(8)(ii), continues childbearing age (12 to 49 years) had the Nutrition Facts label.

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With respect to vitamin A, we require of inadequate intake of vitamin C is comments agreed that vitamins A and C the declaration of vitamin A because: (1) high, prevalence of vitamin C deficiency deficiencies are not common in the It was found in a limited number of is not apparent in the U.S. population general population, but said vitamins A foods within the food supply; and (2) a as only about 6 percent of the general and C are extremely important and that 1990 IOM labeling report identified population had serum vitamin C the public will benefit from seeing them vitamin A as a nutrient of potential concentrations below 11.4 micromoles on the label. The comments suggested public health significance and stated (mmol)/L, a cutoff level that is used as that removing vitamins A or C from the that certain subpopulations (children an indicator of vitamin C deficiency (79 label would prevent consumers from under 5 years of age) were still at risk FR 11879 at 11921). We further noted determining the amount of each vitamin of deficiency for this vitamin (see 58 FR that the effects of vitamin C on risk of in their diet. Other comments suggested 2079 at 2106). In the preamble to the chronic diseases, such as cardiovascular keeping vitamins A and C on the label proposed rule (79 FR 11879 at 11920), disease or cancer, are not conclusive, because we also proposed eliminating we mentioned that, in response to the that, in a letter of enforcement other portions of the Nutrition Facts 2007 ANPRM, several comments discretion on qualified health claims for label; thus, the comments said there recommended retaining the mandatory vitamin C supplement intake and should be adequate room for mandatory declaration of vitamin A, but we also reduced risk of cancers, we concluded declaration of vitamins A and C. said that, even though vitamin A intakes that there was no credible evidence on (Response) We decline to amend the appear to be low, vitamin A deficiency the risk reduction from vitamin C for rule to require the disclosure of based on an assessment of vitamin A most cancers (squamous cell cancer of vitamins A and C. We base the status is rare in the U.S. population. the esophagus, colorectal, laryngeal, mandatory listing of vitamins and Consequently, we tentatively concluded lung, oral cavity, pancreatic, minerals on public health significance that vitamin A is no longer a nutrient of pharyngeal, renal cell, and salivary relative to inadequate dietary intakes public health significance for the gland cancers), and very limited and biomarkers of nutrient status, as general U.S. population, and, consistent evidence for an association between well as the possible association between with the factors for declaration of these vitamin C supplement intake and gastric the nutrients and the risk of chronic types of non-statutory nutrients, we cancer, and that the 2010 DGA does not disease. Consistent with the factors set proposed to amend § 101.9(c)(8)(ii) to include vitamin C among the list of for the declaration of essential vitamins permit, but no longer require, the nutrients of public health concern for and minerals, we concluded that declaration of vitamin A on the the general U.S. population (id.). vitamins A and C are no longer Nutrition Facts label. However, vitamin Consequently, we tentatively concluded considered nutrients of public health A declaration would remain mandatory that, while vitamin C intakes are low, significance for mandatory declaration when vitamin A is added as a nutrient vitamin C deficiency is uncommon, and on the label, and the final rule removes supplement or claims are made about it vitamin C is no longer a nutrient of vitamins A and C from the list of on the label or in labeling of foods. The public health significance for the nutrients in § 101.9(c)(8)(ii) for which proposed rule also would not change general U.S. population. Therefore, the quantitative amount by weight and the current provision for voluntary consistent with the factors we consider percent of the RDI are required in declaration of the percent of vitamin A for declaration of these types of non- nutrition labeling. However, that is present as b-carotene, as statutory nutrients, we proposed to manufacturers can declare these vitamins on the label voluntarily, and if specified in § 101.9(c)(8)(vi). The amend § 101.9(c)(8)(ii) to permit, but no vitamin A or vitamin C is added as a preamble to the proposed rule (79 FR longer require, the declaration of nutrient supplement or claims are made 11879 at 11920) did, however, invite vitamin C on the Nutrition Facts label. about the vitamin on the label or in comment on whether there is an However, vitamin C declaration would labeling of foods, then they must be appropriate alternative analysis to remain mandatory when vitamin C is added as a nutrient supplement or declared on the Nutrition Facts label. application of the factors regarding the As for the comment referring to other mandatory declaration of vitamin A. claims are made about it on the label or in labeling of foods. The preamble to the information that would be removed As for vitamin C, we require the proposed rule (79 FR 11879 at 11920) from the Nutrition Facts label, space declaration of vitamin C because: (1) A invited comment about whether there is constraints on the label were not the 1990 IOM labeling report identified an appropriate alternative analysis to reason behind the removal of these vitamin C as a nutrient of potential the application of the factors regarding vitamins from the Nutrition Facts label. public health significance and stated the mandatory declaration of vitamin C. (Comment 357) One comment stated that certain subpopulations were (Comment 356) Several comments that vitamins A and C are markers for considered at risk of deficiency (such as agreed with our proposal to amend fruit and vegetable intake, and so elderly individuals on inadequate diets § 101.9(c)(8)(ii) to allow for the declaring vitamins A and C on the label and infants fed cow’s milk exclusively); voluntary declaration of vitamins A and will promote increased intake of fruits and (2) vitamin C was thought to play C. Although we invited comment on and vegetables. Another comment noted a role in promoting the intestinal whether there is an appropriate that having vitamins A and C on the absorption of non-heme iron, meaning alternative analysis to the application of label will help consumers to figure out that vitamin C in the same food as iron factors regarding the mandatory how much real fruits and vegetables are was considered to help prevent iron declaration of vitamin A and vitamin C, in a food product. deficiency anemia, while excess vitamin we did not receive any comments on (Response) We consider whether a C was considered to increase the risk of that topic other than general agreement vitamin or mineral is of public health excessive iron absorption (55 FR 29487 with the factors we applied. significance (rather than its possible role at 29501). In the preamble to the Most comments, however, disagreed as a marker for certain food groups) to proposed rule, we noted that, in with voluntary declaration. Many be a key factor in deciding whether to response to the 2007 ANPRM, several comments did not explain why they felt require mandatory declaration on the comments recommended retaining the that mandatory declaration of vitamins Nutrition Facts label. However, the four mandatory declaration of vitamin C, but A and C is necessary, but some selected mandatory vitamins and we also noted that, while the prevalence comments provided a rationale. A few minerals plus fiber represent various

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food categories, such as fruits and functioning of the human body. The the risk of chronic disease and the vegetables. For example, potassium and comment suggested that, to determine prevalence of disease in the general U.S. fiber are found in fruits and vegetables which vitamins and minerals to list in population. and could be used as markers for fruits the Nutrition Facts label, we should (Comment 359) One comment stated and vegetables, and non-heme iron study which vitamins or minerals are that, while frank vitamin C deficiency sources come from plant foods, such as more difficult for the body to synthesize may not be common, almost 20 percent beans and and some vegetables or make on its own, and we should list of individuals 6 years of age and older such as . Paying particular those vitamins or minerals because have serum vitamin C concentrations attention to nutrients of public health consumers need to find other sources of indicative of being at moderate risk for significance on the Nutrition Facts label those vitamins or minerals help their developing vitamin C deficiency and can help consumers in selecting a body function. cited a published article as support (Ref. variety of foods in the diet and help the (Response) The preamble to the 189). The comment also said that U.S. population make healthy dietary proposed rule invited comments, individuals who smoke or who are in choices. including the submission of data and lower income categories may be more (Comment 358) One comment information on whether the mandatory likely to be deficient in vitamin C (Ref. suggested that the reason why vitamin listing of vitamins and minerals impacts 189), which may put these vulnerable A and vitamin C deficiencies are rare is practices. We did not populations at higher risk for vitamin C because they are on the Nutrition Facts receive any comments providing data or deficiency and associated morbidity. label. The comment said that if we information that inclusion of mandatory (Response) We disagree with the remove the vitamins from the label, vitamins and minerals on the label will comment. Based on our data analysis there might be deficiencies in the future increase or decrease fortification (NHANES 2003–2006), we determined because manufacturers would not fortify practices. The comments also did not that about 6 percent of people ages 6 the foods. Another comment stated that provide data to substantiate the claim years and older (including smokers) food fortification is a significant that removing vitamins A and C from have serum vitamin C concentrations contributor to the intakes of both the label will change the industry below 11.4 m mol/L. This cutoff level is vitamins A and C and is instrumental fortification practices, although one used as indictor of vitamin C deficiency for controlling vitamins A and C comment suggested that such data does (Refs. 190–191). The CDC analysis of deficiency. The comment said we not exist. Consequently, we do not have NHANES 2003–2006 showed the same should consider the impact on the evidence that would let us determine results as ours (Ref. 190). fortification and consumer access to whether removing these nutrients from As for the article cited by the vitamins A and C in foods if we do not the Nutrition Facts label will affect comment, Schleicher et al., 2009 (Ref. require declaration of these vitamins. fortification. 189), we note that the authors reported The comment said that presence of As for the claim that removing that 7.1 percent of the total population these vitamins on the Nutrition Facts vitamins A and C from the Nutrition in NHANES 2003–2004 were deficient label has encouraged fortification by the Facts label may cause deficiencies in the (using cutoff of less than 11.4 m mol/L). food industry and that a large U.S. population, we have evaluated all Additionally, in establishing the percentage of vitamins A and C in the essential vitamins and minerals intake nutrients of public health significance, diet is supplied through food (including vitamins A and C) in the U.S. while nearly 35 percent of the general fortification. Thus, if declaration of population for purposes of determining healthy U.S. population (4 years and vitamins A and C is not required, the the nutrients of public health older) have vitamin C intakes below the comment said that the industry may significance, and we will continue EAR from conventional foods, and reconsider fortifying foods with those monitoring vitamins A and C (among nearly 28 percent of the general healthy vitamins. The comment stated that there other nutrients) intake and the status (to U.S. population (4 years and older) have are no data to indicate the impact that determine both deficiency and excess) vitamin C intakes below the EAR from removing the requirement for vitamins of the U.S. population after the final conventional foods plus dietary A and C from the Nutrition Facts label rule becomes effective. We also intend supplements, vitamin C deficiency is will have on the practice of food to monitor the marketplace to determine uncommon. Thus, it is no longer fortification or on the adequacy of those the impact of requiring the declaration considered a nutrient of public health vitamins in the U.S. population. of nutrients on the Nutrition Facts label significance for the general U.S. One comment stated that it is or removing nutrients from the label on population. Similar to our findings, misleading and incorrect scientifically fortification practices. vitamin C was not considered to be a to consider any essential nutrient as As for the comment stating that it is nutrient of public health concern by the being ‘‘no longer of public health misleading and incorrect scientifically 2010 DGA and the 2015 DGAC, but significance.’’ Rather than removing two to consider any essential nutrient as these reports considered vitamin C to be nutrients from the mandatory being ‘‘no longer of public health a shortfall nutrient because intakes are declaration list to make way for two significance,’’ the fact that we do not below the recommended intake. (The new ones, the comment said it is require the declaration of a particular 2015 DGAC states that ‘‘shortfall important for consumers to know as vitamin or mineral on the Nutrition nutrients’’ are ‘‘those that may be much as possible about the micro- Facts label should not be interpreted as underconsumed either across the nutritional content of the foods they saying that these vitamins and minerals population or in specific groups relative choose to purchase and consume. One are no longer essential nutrients or do to the IOM-based standards, such as the comment asked whether one can really not need to be consumed in adequate Estimated Average Requirement (EAR) judge which vitamins and minerals are amounts each day. We base the or the Adequate Intake (AI)’’ (Ref. 192). more important to people or whether mandatory listing of vitamins and We will continue monitoring all vitamin D and potassium are more minerals on several factors that link nutrient intake (including vitamins A beneficial to people than vitamins A public health concerns relative to and C) and the status of the U.S. and C. The comment said that all inadequate dietary intakes and status population (to determine both vitamins and minerals play an biomarker levels as well as the deficiency and excess) after the final important role in the healthy association between the nutrients and rule becomes effective.

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(Comment 360) One comment said vitamin A or vitamin C status is not One comment said that consumers are that segments of U.S. population have common in the general healthy U.S. still looking for vitamins A and C and, inadequate intakes of both vitamins A population. Furthermore, the IOM did in fact, are trying to purchase more and C, so we should not remove not set a quantitative intake products containing these vitamins. The vitamins A and C from the label. The recommendation for vitamins A or C comment said that a study done by NPD comment said that provitamin A based on a public health endpoint (see reveals that 50 percent of shoppers are carotenoids provide approximately 26 79 FR 11879 at 11920 through 11921). trying to get more vitamin C, and 40 and 34 percent of vitamin A consumed We also note that, similar to our percent are trying to get more vitamin A. by men and women, respectively. findings, vitamins A and C were not Additionally, the 2013 HealthFocus Because recent data indicate a much considered to be nutrients of public Trend Report, A National Study of lower conversion rate of carotenoids to health concern in the 2010 DGA (Ref. Public Attitudes and Actions, found that vitamin A, the comment said that many 30) and the 2015 DGAC (Ref. 19). the importance of numerous label reports of vitamin A intake have been However, both 2010 DGA and 2015 claims remains relatively steady with over-estimated (Ref. 193). The comment DGAC considered these vitamins to be more than 40 percent of shoppers also said that 45 percent of American shortfall nutrients because their intakes looking for ‘‘good source claims.’’ males and females over the age of 2 are below the recommended intake Specifically, the comment said, 40 years (excluding pregnant/lactating level. percent are looking for food products women) consume less than the EAR for As for the comment regarding that are a ‘‘good source of ’’ vitamin A from food and that, even declaration of all essential vitamins and (e.g., vitamin C). when dietary supplements were minerals when present over a (Response) Besides looking at only considered, 34 percent of Americans did predetermined significant amount (10 to intake data, we also looked at biomarker not meet the EAR for vitamin A (Ref. 20 percent of DV), we must be selective data (when available) as well as the 194). The comment also said that with regard to the information to be endpoints upon which the IOM based a vitamin A intake from any source listed on the label. Therefore, we DRI and the disease prevalence (naturally in foods, fortified in food and emphasize only the essential vitamins associated with that nutrient in order to dietary supplement) were below the and minerals that meet our factors for determine public health significance of EAR in 25 percent of 9- to 13-year-old determining nutrients with the greatest nutrients. For example, in view of the girls, and over 50 percent of 14 to 18 public health significance to be declared benefits of adequate calcium intake on year olds failed to meet the EAR (Ref. on the Nutrition Facts label in order to bone health (established in the IOM’s 195). The comment added that 37 and assist consumers in maintaining healthy DRIs), low intakes of calcium, and the higher prevalence of osteoporosis and 25 percent of Americans consume less dietary practices. We permit voluntary osteopenia among the U.S. population, than the EAR for vitamin C from food declaration of other vitamins and we concluded that calcium is a nutrient or from food plus dietary supplements, minerals on the Nutrition Facts label. of public health significance and its respectively (Ref. 194). However, the declaration of these The comment said, similar to vitamin declaration continues to be necessary to vitamins and minerals will be A, vitamin C intakes are poor in assist consumers in maintain healthy mandatory when they are added as a children (2 to 18 years old) (Ref. 195). dietary practices. nutrient supplement or claims are made Another comment stated that, given For vitamin A, although our analysis about them on the label or in labeling increased awareness and knowledge showed that vitamin A intakes appears of foods. about the importance of nutrient to be low, vitamin A deficiency based interactions (e.g., between calcium and Thus, we decline to revise the rule as on assessment of vitamin A status is rare magnesium, sodium, potassium, iron, suggested by the comments. in the U.S. population. The IOM did not copper, and vitamins D, K, and A), the (Comment 361) One comment said we set a quantitative intake best approach to providing informed were being inconsistent in our recommendation for vitamin A based on choice to consumers is to require a evaluation of non-statutory nutrients for a public health endpoint (Ref. 193). declaration of all essential vitamins and mandatory declaration. The comment Thus, we concluded that vitamin A is minerals when present in a serving over said that the intake data for vitamin A no longer a nutrient of public health a predetermined significant amount, for and calcium are very comparable, and significance. We do not necessarily instance between 10 and 20 percent of so our proposal to include calcium on consider a high prevalence of nutrient the DV. the label, while removing vitamin A, is intake inadequacy by itself as a (Response) We considered whether a inconsistent. The comment compared sufficient justification of being a vitamin or mineral is of public health vitamin A to calcium consumption; it nutrient of public health significance significance to be a key factor in stated, for example, that 45 and 34 and warranting mandatory declaration deciding whether to require mandatory percent of Americans consume less than on the Nutrition Facts label (Ref. 196). declaration of that vitamin or mineral the EAR for vitamin A from food, or Vitamins A and C were not also on the Nutrition Facts label. We have food plus dietary supplements, considered to be nutrients of public done our own analyses of both intake respectively, while 48.9 and 38 percent health concern in the 2010 DGA (Ref. and status (using biomarker data when of Americans consume less than the 30) and the 2015 DGAC (Ref. 19). available in NHANES with a valid EAR for calcium from food or food plus However, both the 2010 DGA and the cutoff) data from NHANES for those dietary supplements, respectively. 2015 DGAC considered these vitamins ages 4 years and older (excluding One comment said that removing to be shortfall nutrients because their pregnant women) for all vitamins and vitamins A or C from the Nutrition Facts intakes are below the recommended minerals (including vitamins A and C). label will lead consumers to believe intake level. Based on the factors considered in these vitamins are not nutrients of As for the comment pertaining to establishing a nutrient of public health concern. The comment said the removal MyPlate, MyPlate is based on the USDA significance (see 79 FR 11879 at 11899 also may cause USDA nutrition food intake patterns, which provide a through 11891), we concluded that, programs, such as MyPlate, to recommended daily selection of foods while vitamins A and C intakes are low, reconsider their emphasis on vitamins A that is generally adequate in essential their deficiency based on assessment of and C. nutrients and moderate in food

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components often consumed in excess. Another comment noted that scurvy is importance in improving iron The USDA food intake patterns a big problem in the homeless absorption. The comment also said that emphasize eating the recommended population and in youth due to poor the WIC program has been successful in intake of all essential vitamins and diet. The comment said it would be decreasing iron-deficiency anemia, and minerals, regardless of whether those difficult for people to consume adequate this may be, in part, because of nutrition vitamins and minerals are on the amounts of vitamin C if we no longer education and the provision of easily Nutrition Facts label. required the declaration of vitamin C on identified vitamin C-rich foods, which As for consumer interest or shopping the Nutrition Facts label. aid in the absorption of iron. The patterns, we agree that many consumers (Response) We agree that adequate comment said that WIC benefits for may be interested about the levels of vitamin A intake is important for qualifying juices are issued monthly to vitamins A and C, among other normal vision and immune function 2.05 million pregnant and postpartum nutrients, on the label, but not all (Ref. 193). However, the IOM set the women who receive benefits for up to nutrient information can be mandated DRIs (EAR/RDA) based on the amount 144 fluid ounces of juice each month, on the Nutrition Facts label. We of dietary vitamin A required to and 4.58 million children ages 1 to 4 consider mandatory declaration maintain adequate liver stores in well- who receive benefits for 128 fluid appropriate, for a nutrient that has a nourished subjects, rather than on ounces of juice each month. The specific relationship to chronic disease normal vision or immune function (Ref. comment said that, to be authorized for risk or a health-related condition, when 193). Furthermore, there is no clear WIC purchase, juices must contain 30 there is public health significance and a evidence that suggests a protective mg of vitamin C per 100 mL of juice, quantitative intake recommendation association between dietary vitamin A which translates to 120 percent of that can be used for setting a DV (DRV or b-carotene and reduction of risk for vitamin C per eight ounce serving using or RDI). We consider voluntary chronic disease, such as cardiovascular the RDA for women. The comment said declaration to be appropriate when such disease and cancer (Ref. 193). Instead, that consumers can identify WIC- a nutrient either has a quantitative consistent with the factors we set forth authorized juices by reading the intake recommendation, but does not regarding mandatory and voluntary Nutrition Facts label to determine if the have public health significance, or does declaration, we have determined that juice contributes 120 percent of vitamin not have a quantitative intake vitamin A is no longer a nutrient of C per serving. Thus, according to the recommendation available for setting a public health significance and so the comment, eliminating mandatory DRV but has public health significance. final rule does not require declaration of declaration of vitamin C on food labels For vitamins A and C, the final rule vitamin A on the Nutrition Facts label. removes the mechanism for WIC clients provides for voluntary declarations, As for the comment regarding vitamin to readily identify WIC-approved juices and, if the nutrient is added to a food C and scurvy, the comment did not while shopping. This may result in WIC or a claim is made on the label or in the provide evidence to support the clients forgoing this important benefit labeling of food (e.g., good source of proposition that scurvy is high among rather than risk potential product vitamin C), the nutrient must be homeless individuals and among youth. rejection and the associated declared on the label. We do note that our regulations have embarrassment upon checkout. (Comment 362) Some comments required the declaration of vitamin C The comment added that, if we no suggested that vitamin A can be toxic in declaration on the Nutrition Facts label longer require declaration of vitamin C high levels and can cause birth defects, for over 20 years, so if we were to accept content in the Nutrition Facts label, so consumers need to know the amount the comment’s premise that scurvy is State agencies will have to review all of vitamin A on the label. high among the homeless and youth, potential eligible juices from multiple (Response) Consumption of vitamin A then it does not appear that declaring manufacturers to meet regulation each (as preformed vitamin A (retinol)) above vitamin C on the Nutrition Facts label time the food list is updated, and this the UL may pose risk of toxicity in the has affected the purchasing behavior of process would create an unnecessary population. The IOM set a UL for these subpopulations to buy products administrative burden for both the WIC preformed vitamin A based on higher in vitamin C. Instead, based on State agencies and manufacturers. teratogenicity in women of childbearing the factors considered in determining (Response) We consider whether a age or liver abnormalities in all other mandatory declaration of essential vitamin or mineral is of public health adults (Ref. 193). If a vitamin A is vitamins and minerals, vitamin C was significance to be the key factor in present at very high levels in a no longer considered as a nutrient of deciding when to require mandatory conventional food, it is most likely in public health significance for the declaration in labeling. As we explained the added form, therefore, it must be general U.S. population. in the preamble to the proposed rule (79 declared on the label, and the forms (Comment 364) One comment said FR 11879 at 11921), while vitamin C added must be listed in the ingredient that mandatory declaration of vitamins intakes are low, vitamin C deficiency is list (§ 101.4). Consumers can check the A and C is crucial for government food uncommon, so we no longer find ingredient list to learn about the forms programs and that there might be an vitamin C to be a nutrient of public of vitamin A added in the food. unintended consequence if we stopped health significance for the general U.S. Furthermore, the amount of added requiring mandatory declaration of population. Juice manufacturers who vitamin A and its form must be reported vitamin C. The comment said that the would like their products to be either on the Supplements Facts label or IOM recommended increasing vitamin C authorized for WIC purchase can the ingredient list of a dietary levels for women of reproductive age as declare vitamin C voluntarily on their supplement (§ 101.36). a priority in the revision of food product labels. (Comment 363) One comment packages under the Special All juices under the WIC suggested that vitamin A is important in Supplemental Nutrition Program for authorization must meet the vitamin C eye vision, immune function, and the Women, Infants, and Children (WIC), minimum (at least 30 mg of vitamin C prevention of other diseases, so we that vitamin C intake is important in per 100 mL), either naturally or via should continue to require the reducing the risk of iron deficiency in fortification (Ref. 197). However, many declaration of vitamin A on the women of child bearing age, and that eligible juices (e.g., pineapple, apple, or Nutrition Facts label. the 2010 DGA emphasized vitamin C’s grape juice) have to be fortified with

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vitamin C to be authorized by WIC; so, that would achieve and maintain serum Thus, given the benefits of adequate because vitamin C is added to those 25-hydroxy vitamin D (25(OH)D) vitamin D intakes on bone health, data juices, the declaration of vitamin C concentrations above a defined level (40 indicating inadequate intakes, poor would be mandatory on the label. to 50 nanomoles per liter (nmol)/L) to vitamin D status, and high prevalence of As for the comment’s statements maintain bone health and how, in 2008, osteoporosis and osteopenia among the regarding the rule’s potential impact on we authorized a health claim for general U.S. population, we tentatively WIC clients and the WIC program, such calcium and vitamin D intake and concluded that vitamin D is a nutrient issues are outside the scope of this reduced risk of osteoporosis (§ 101.72), of ‘‘public health significance,’’ and so rulemaking. signifying vitamin D’s critical role in the mandatory declaration of vitamin D is (Comment 365) One comment risk reduction of this chronic disease. necessary to assist consumers in supported voluntary declaration of Additionally, the preamble to the maintaining healthy dietary practices. vitamins A and C, but said that, because proposed rule (79 FR 11879 at 11921) Therefore, consistent with the factors these two nutrients are linked to the discussed how serum concentration of we consider for mandatory declaration minimum nutrient contribution 25(OH)D is widely considered as a of non-statutory nutrients, we proposed requirements for the nutrient content biomarker of total vitamin D nutritional to amend § 101.9(c)(8)(ii) to require the claim ‘‘healthy’’ and for health claims, status and is recommended to be used mandatory declaration of vitamin D on we should make any changes to the for assessing vitamin D total exposure the Nutrition Facts label, and we invited nutrient content and health claim from all sources, including conventional comment on whether there is an regulations at the same time when we foods, dietary supplements, synthesis appropriate alternative analysis to the finalize the rule. from sun, and conversion of vitamin D application of the factors regarding the (Response) We decline to adopt the from adipose stores in the liver. We mandatory declaration of vitamin D. comment’s suggestion. As we stated in explained that our analysis of NHANES (Comment 366) Most comments the preamble to the proposed rule (79 2003–2006 data showed that about 18 supported the mandatory declaration of FR 11879 at 11889), we plan to evaluate percent of the U.S. population 4 years vitamin D on the Nutrition Facts label, the final rule’s impact on other FDA but did not explain the reasons for their regulations and to address, as and older (excluding pregnant and lactating women) have serum 25(OH)D support. appropriate, the impact on other FDA One comment supported the levels below the 40 nmol/L (a level set regulations in future separate mandatory declaration of vitamin D by IOM as equivalent to EAR), which rulemakings. Issues related to nutrient declaration on the label, but said that a indicates an increased risk of content claims and health claims are food or beverage that is not a significant inadequate vitamin D exposure, but that outside the scope of this rulemaking source of vitamin D should declare that (see part II.B.4). this analysis might underestimate the fact as part of the ‘‘Not a significant prevalence of low serum vitamin D source of (listing the vitamins or 3. Essential Vitamins and Minerals That levels in the U.S. population (id.). Are Voluntary minerals omitted)’’ statement included Analysis of NHANES 2005–2008 dietary at the bottom of the table of nutrient a. Vitamin D. Our preexisting data showed that, about 94 percent of values. regulations, at § 101.9(c)(8)(ii), provide the U.S. population have usual vitamin (Response) We agree with the for the voluntary declaration of vitamin D intakes below the EAR from comment. Under our preexisting D content on the Nutrition Facts label, conventional foods only and 62 percent regulations at § 101.9(c)(8)(iii), if any unless vitamin D is added as a nutrient have intakes below the EAR from mandatory essential vitamin or mineral supplement or claims are made about it. conventional foods and supplements is present in amounts less than 2 In 1993, we determined that vitamin D (table 1). The IOM set the DRIs (e.g., percent of the RDI, label declaration of was not of particular public health EAR) assuming minimal sun exposure the nutrient(s) is not required if the significance in the United States (Ref. 38). statement ‘‘Not a significant source of because the human requirement for We also noted that approximately 24 .... (Listing the amount of vitamins vitamin D could be met with sufficient percent of the U.S. population ages 4 and minerals)’’ is placed at the bottom exposure to sunlight and consumption years and older have serum 25(OH)D of the table of nutrient values. No of milk and other foods that were concentrations between 30 and 50 changes to the rule, however, are fortified with vitamin D; as a result, nmol/L, levels that indicate risk for necessary as a result of this comment, deficiencies in this vitamin were very inadequacy according to the IOM and and the final rule requires the rare (58 FR 2079 at 2107). In the CDC (79 FR 11879 at 11921). mandatory declaration of vitamin D on preamble to the proposed rule (79 FR Approximately 32 percent of the U.S. the Nutrition Facts label. 11879 at 11921), however, we described population has serum 25(OH)D levels (Comment 367) Some comments how comments responding to the 2007 below 50 nmol/L (a level set by IOM as noted that vitamin D is used in ANPRM recommended vitamin D for equivalent to RDA and associated with fortification and that dietary mandatory declaration citing vitamin D optimal benefit for nearly all the supplements may be in various forms inadequacy; the relationship of vitamin population) (id.). We stated that about 8 such as vitamin D2 (ergocalciferol) or D to chronic disease risk (e.g., percent have serum 25(OH)D levels vitamin D3 (). The rheumatoid arthritis, multiple sclerosis, below IOM’s cutoff of 30 nmol/L and comments said that the form of vitamin and cancers, such as prostate, breast, may be at increased risk of vitamin D D added to foods may be important to lung, colon, and colorectal cancers); and deficiency. Vitamin D deficiency results vegetarians because the vitamin D3 the 2005 DGA, which identified vitamin in inadequate bone mineralization or commonly used in dietary supplements D as a nutrient of concern for certain demineralization of the skeleton and in fortified foods is derived from subpopulations (e.g., older adults, including rickets, osteomalacia, and lanolin from sheep’s wool and is not people with dark skin, and those osteoporosis. The 2010 DGA, too, considered to be vegan. Some comments exposed to insufficient ultraviolet band highlighted vitamin D as a nutrient of said that foods and dietary supplements radiation). We also mentioned that the concern for the U.S. population, in might list vitamin D without specifying IOM set age and gender specific DRIs general, rather than for specific the form. Thus, the comments said that (EAR and RDA) for vitamin D at a level population groups alone. requiring manufacturers to specify the

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form of vitamin D would be helpful to this reason alone, it does not belong on (Response) We disagree with the vegans and to those who prefer to use the food label. comments. To ensure that vitamin D is a specific form of vitamin D. One comment suggested vitamin D not added to the U.S. food supply at Another comment asked whether we fortification should be viewed as levels that could raise safety concerns, consider the main two forms of vitamin hormone replacement therapy and that we affirmed vitamin D as GRAS with D (D2 and D3) to be bioequivalent. The it raises questions about efficacy, dose, specific limitations as listed in comment said it would be helpful if we and side effects that should be asked § 184.1950. Under § 184.1(b)(2), an could either define them as about all such therapies. The comment ingredient affirmed as GRAS with bioequivalent or list a potency said it would be misleading, and specific limitations may be used in food conversion factor if we consider one possibly harmful, to the public to add only within such limitations, including form to be more bioactive than the this hormone to food and to promote it the category of food, functional use of other. as something that promotes better the ingredient, and level of use. Any (Response) We decline to revise the health. addition of vitamin D to food beyond rule as suggested by the comments. We (Response) We agree that vitamin D is those limitations set out in § 184.1950 note that our GRAS affirmation synthesized by the body via sunlight requires either a food additive regulation (§ 184.1950 (21 CFR exposure. However, the IOM set the regulation or an amendment of DRIs for vitamin D based on minimal 184.1950)) includes both D2 and D3 and § 184.1950. A manufacturer would have their resins. The food additive sun exposure because sun exposure is a to submit a petition to amend our regulations are specific to one form or risk factor for skin cancer (Ref. 38). regulations. Several food additive another (and even more specific, to the Considering the factors for mandatory petitions for vitamin D have been and voluntary declaration of vitamins crystalline forms or vitamin D2 baker’s submitted to FDA, resulting in food yeast) because that is what the and minerals, we determined that additive regulations. (see §§ 172.379, petitioner requested. With respect to the vitamin D is a nutrient of public health 172.380, and 172.381.) significance based on its contribution to Nutrition Facts label, only vitamin D bone health and because our analysis Furthermore, while vitamin D can be can be used on the food labels (see indicates that intake and status of produced in the body via sunlight, and § 101.9(c)(8)(iv)), but the specific form vitamin D is inadequate in the U.S. there are a number of foods that can that is added to a food (e.g., population. Therefore, vitamin D met currently be fortified with vitamin D, ergocalciferol) must be listed in the our factors for mandatory declaration, total usual intakes for vitamin D from ingredient list (§ 101.4). People who are and its inclusion on the label will assist food and dietary supplements are below interested in knowing the forms of consumers in maintaining healthy the EAR for the general U.S. population. vitamin D in the food should check the dietary practices. The total usual intakes do not exceed ingredient list. As for the comment regarding vitamin the UL for any age group at the 90th As for dietary supplements, under the D fortification and hormone percentile (Ref. 199). The percentage of Supplement Facts label requirements at replacement therapy, vitamin D is a the population that consumes vitamin D § 101.36(d), the source ingredient may vitamin (Ref. 198), and its rational above the UL is very low (0.1 to 0.4 be identified within the nutrition label addition to foods is allowed under our percent). In addition, the prevalence of in parenthesis immediately following or current food additive (§ 172.380) and high serum 25–OH–D concentration indented beneath the name of a dietary GRAS (§ 184.1950) regulations. The use (greater than 125 nmol/L) for the U.S. ingredient and preceded by the word of vitamin D as a food additive is not population aged 1 year and older is 0.9 ‘‘as’’ or ‘‘from.’’ When a source considered as hormone replacement percent (NHANES 2003–2006) (Ref. ingredient is not identified within the therapy. Under our preexisting 190). The IOM committee indicated that nutrition label, it must be listed in an regulations, vitamin D can be added in serum 25–OH–D concentration over 125 ingredient statement in accordance with specific amounts to selected foods such nmol/L may be reason for concern (Ref. § 101.4(g). However, when a source as breakfast cereals, grain products and 200). Thus, while some comments said ingredient is identified in the nutrition , fluid milks and milk products, that manufacturers would increase label, it will not be listed again in the and calcium-fortified juices. fortification of foods, we are not aware ingredient statement. (Comment 369) Some comments of evidence to support this statement. (Comment 368) Some comments objected to the mandatory declaration of We do note that, in the preamble to the objected to the mandatory declaration of vitamin D on the Nutrition Facts label proposed rule (79 FR 11879 at 11923), vitamin D on the label, although most because, according to the comments, we invited comment on whether the comments did not explain why they mandatory declaration of vitamin D will mandatory declaration of vitamins and opposed mandatory declaration. increase vitamin D fortification of foods minerals somehow impacts food Other comments objecting to the because vitamin D is found in few foods fortification practices, and we did not mandatory declaration of vitamin D said and because consumers cannot expect to receive any data to support an impact. there are not very many food sources see a significant vitamin D contribution We also do not have any data to that contain vitamin D, and they would on the vast majority of food labels. The determine whether there was an prefer retaining other vitamins on the comments said that if we require the increase in vitamin C or calcium since Nutrition Facts label instead. The declaration of vitamin D on the the time they were first required to be comments noted that most vitamin D is Nutrition Facts label, more food listed on the label. However, we know produced by the body with the aid of manufacturers would make their food that both vitamin C and calcium intake exposure to the sun. sound more nutritious by fortifying with are not above the UL set by IOM (Ref. Other comments suggested not vitamin D and promoting that on the 199). We intend to continue monitoring permitting food companies to use label. Some comments said that a the nutrients, including vitamin D, on statements such as ‘‘fortified with similar outcome occurred with vitamin the Nutrition Facts label, their intake, Vitamin D’’ or ‘‘good source of Vitamin C and calcium; other comments said and status of the U.S. population (both D’’ because, the comments said, vitamin that vitamin D can easily reach toxic deficiency and excess) through the D is a hormone synthesized by the levels in the diet and that most national survey databases. We also action of sunlight on skin, and so, for consumers do not realize this. intend to continue to monitor the

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marketplace to determine if D intakes on bone health and calcium 38). The IOM set age and gender specific inappropriate fortification is occurring. absorption, data indicating inadequate DRIs (EAR and RDA) for vitamin D to If we find that there is an inappropriate intakes, poor vitamin D status, and the maintain bone health (Ref. 38). Vitamin fortification of foods with vitamin D or high prevalence of osteoporosis and D deficiency results in inadequate bone any other nutrients, we will take steps osteopenia (Ref. 201–202) among the mineralization or demineralization of to help ensure that fortification does not general U.S. population, we concluded the skeleton including rickets, result in the imbalance of essential that this nutrient is a nutrient of public osteomalacia, and osteoporosis (Ref. nutrients in the diet of the U.S. health significance and met the factors 203). In addition, in 2008, we population. for mandatory declaration on the authorized a health claim for calcium (Comment 370) One comment Nutrition Facts label. Furthermore, the and vitamin D intake and reduced risk objected to mandatory declaration of 2010 DGA recommends increasing the of osteoporosis (§ 101.72), signifying vitamin D because, according to the amount and variety of seafood in place vitamin D’s critical role in the risk comment, vitamin D does not occur of some meat and poultry (Ref. 30). reduction of this chronic disease. In naturally in most foods and because Fish/seafood is the primary source of view of the benefits of adequate vitamin other FDA regulations would not allow naturally occurring vitamin D (Ref. 30). D intakes on bone health, data manufacturers to make a significant Data show that fish/seafood only indicating inadequate intakes, poor impact on the dietary intake of vitamin provides 9 percent of the total vitamin vitamin D status, and high prevalence of D. D intake in the United States. Therefore, osteoporosis and osteopenia among the (Response) Considering the factors for we conclude that mandatory declaration general U.S. population, we conclude mandatory and voluntary declaration of of vitamin D on the label would allow that this nutrient is a nutrient of public vitamins and minerals, we determined consumers to understand the relative health significance and meets our that vitamin D is a nutrient of public significance of the contribution of factors for mandatory declaration on the health significance based on its vitamin D from natural food sources, in Nutrition Facts label. contribution to bone health and because addition to fortified foods, in the As for the comment’s claims that our analysis indicates that intake and context of the total daily diet and also fortification will result in adverse status of vitamin D is inadequate in the is necessary to assist consumers in consequences, while vitamin D can be U.S. population. Therefore, we consider maintaining healthy dietary practices. produced in the body via sunlight and vitamin D to be a nutrient of public Also, as we stated in our response to there are a number of foods that can health significance and include vitamin comment 368, vitamin D is a vitamin currently be fortified with vitamin D, D in the list of nutrients in and its rational addition to foods is current total usual intakes for vitamin D § 101.9(c)(8)(ii) for which a quantitative allowed under our current food additive from food and dietary supplements do amount by weight and percent of the (§ 172.380) and GRAS (§ 184.1950) not exceed the UL for any age group at RDI are required in nutrition labeling to regulations. the 90th percentile (Ref. 199). The assist the consumers in maintaining (Comment 372) One comment stated percentage of the population that healthy dietary practices. that, beyond prevention of rickets, the consumes total vitamin D (food and We note that, under our food additive importance of vitamin D and the supplement) above the UL is low (0.1 to and GRAS regulations (§ 172.380 and optimum serum levels or dietary intake 0.4 percent). As for fortification, we § 184.1950 respectively), vitamin D can for chronic disease risk are hotly reiterate that our food additive and be added in specific amounts to various debated subjects, and it is premature to GRAS regulations create a regulatory foods such as breakfast cereals, grain focus on this nutrient as being of structure that does not allow for products and pastas, fluid milks and particular concern. The comment said unilateral fortification of food; the milk products, and calcium-fortified the U.S. Preventive Services Task Force addition of vitamin D to food beyond juices. In addition vitamin D can be concluded that the evidence is those limitations set out in § 184.1950 obtained through dietary sources, such insufficient to determine how vitamin D requires either a food additive as fish (e.g., salmon, rockfish, and ) supplementation (and, therefore, regulation or an amendment of and shellfish, which are the primary fortification) affects fracture incidence. § 184.1950. The manufacturer has to natural food sources of vitamin D. The comment also noted that data from formally petition FDA to amend the (Comment 371) One comment said the the Women’s Health Initiative are regulation. lack of compelling research has consistent with largely inconclusive (Comment 373) One comment said permitted vitamin D to become findings about hormone vitamin D that there is inconsistency in vitamin D ‘‘trendy,’’ such that vitamin D is supplements and bone health. The assays, and individuals may be told that advertised on boxes of fortified cereals, comment said that the IOM does not they are deficient when they are not. has its own pro-supplement advocacy consider deficiency of vitamin D to be (Response) We recognize that there group, and generates millions of dollars a serious problem in the United States, may be inconsistencies in serum in dietary supplement sales annually. except among certain population vitamin D assays from various The comment suggested that, in the groups. Instead, according to the laboratories and that this inconsistency absence of stronger evidence for benefit comment, because of widespread may cause variations in an individual’s from fortification and some evidence fortification and supplementation, the serum vitamin D analysis. However, for from possible adverse consequences, we IOM is concerned about the possibility purposes of determining the nutrients of should not contribute to further of adverse consequences from over- public health significance, our data commercialization of ‘‘this misnamed consumption through supplementation indicating poor vitamin D status hormone’’ by declaring vitamin D on or fortification. (through serum vitamin D analysis) food labels. (Response) We disagree with the were based on NHANES data. The (Response) The mandatory comment that the association of vitamin serum data were analyzed by the same declaration of vitamin D on the D to bone health is inconclusive. The valid vitamin D method for the survey Nutrition Facts label is not intended to consensus report by IOM set the dietary period (Ref. 190). promote or encourage excess reference intake for vitamin D based on (Comment 374) One comment fortification of foods with vitamin D. its role in bone health and calcium opposed the mandatory declaration of Given the benefits of adequate vitamin absorption and uptake by bones (Ref. vitamin D because, according to the

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comment, testing for vitamin D is very expectation that the nutrient occurs in (Response) While mandatory labeling challenging and expensive. Other the food. of potassium may help patients with comments supported mandatory We also agree that USDA nutrient chronic kidney disease, this was not a declaration of vitamin D, but said that databases may be missing vitamin D factor we considered when we proposed limited data is available on the vitamin values for nearly one-third of the the mandatory declaration of potassium D content in many foods and products in those databases. Vitamin D on the Nutrition Facts label. As we ingredients, so manufacturers will need occurs naturally in a limited number of stated in the preamble to the proposed time and resources to obtain data for foods, such as exposed to rule (79 FR 11879 at 11890) and purposes of revising their Nutrition UV light, egg yolks (often the feed is maintain in this final rule, we consider Facts labels. Some comments said that supplemented with D3 or 25(OH)D3), mandatory declaration appropriate for an analysis of the 7,189 foods in the and meats or other animal products. these types of nutrients when there is USDA National Nutrient Database There is usually a minimal amount of public health significance and a reveals that approximately one-third of vitamin D in milk and unless the quantitative intake recommendation those foods are missing values for food is fortified. Many foods that would that can be used for setting a DV (DRV vitamin D and that this does not take be reporting vitamin D on labels greater or RDI), although we also have into account the thousands of other than zero are fortified (with the considered mandatory declaration ingredients that are also missing vitamin exception of foods listed previously or based, in part, on evidence highlighting D values. foods that contain them) and already the role of a nutrient in a specific (Response) We acknowledge that would have declarations. The USDA relationship to chronic disease risk. For performing an accurate vitamin D national nutrient database (standard potassium, we concluded that analysis requires some expertise, but reference (SR)) provides a complete set potassium is a nutrient of public health there are commercial laboratories with of all nutrients (including vitamin D) to significance for the general U.S. expertise in the analysis. Having quality use with NHANES database (Ref. 4). population and its declaration is control food matrix material certified for However, vitamin D may not be always necessary to assist consumers in vitamin D is important, and the National required to be filled in the SR. USDA is maintaining healthy dietary practices. Institute of Standards and Technology working with various industries to Therefore, the final rule, at (NIST) has worked and continues to determine the vitamin D values on § 101.9(c)(8)(ii), requires the mandatory work to come up with better standard meats and eggs, and it plans to have declaration of potassium. (Comment 376) One comment stated reference material for quality control of these data available in future SR that food manufacturers may start to vitamin D analysis. Under our releases. We intend to work with USDA fortify their foods with potassium in an preexisting regulations, declaration of to determine ways to have more values attempt to offset the sodium content of vitamin D was mandatory when vitamin for vitamin D on the SR databases. a food product. The comment said we D was added as a nutrient supplement b. Potassium. Under our preexisting should monitor how food manufacturers or claims are made about it on the label regulations, at § 101.9(c)(5), the respond to this new requirement. The or labeling. Therefore, manufacturers declaration of potassium content is comment also said that, as part of an who have added vitamin D to their voluntary, except when a claim is made overall consumer education campaign, products have already been using about it. In the preamble to the we should encourage consumers to methods for testing and determining proposed rule (79 FR 11879 at 11922), obtain potassium through a diet high in vitamin D content of foods, so, with we discussed how the scientific fruits and vegetables and recommend respect to those manufacturers, evidence regarding potassium had amounts of low-fat/fat-free dairy additional time and resources to changed, such that we recognized products rather than obtain potassium conduct analyses for vitamin D may not potassium’s importance in the risk from dietary supplements or potassium be necessary. reduction of certain chronic diseases. fortified foods. As for other products whose We also noted that the 2010 DGA (Response) The comment did not manufacturers have not added vitamin concluded that potassium is a nutrient provide any evidence to suggest that D to the food, there is adequate of concern for the general U.S. mandatory declaration of potassium on methodology for determining vitamin D population. Given the benefits of the Nutrition Facts label will increase in the foods. However, an analysis may adequate potassium intake in lowering fortification of foods; consequently, we not be needed for vitamin D where blood pressure, reflected in IOM’s DRIs, are unable to determine whether such reliable databases or scientific and data indicating low likelihood of fortification is likely or the extent to knowledge establish that a nutrient is potassium adequacy and high which it might occur. The final rule not present in the food. For example, prevalence of hypertension among the requires mandatory labeling of there might not be a need to analyze for general population, we tentatively potassium and other essential vitamins vitamin D in foods that are not natural concluded that potassium is a nutrient and minerals on the Nutrition Facts sources of vitamin D, and to which our of public health significance for the label to assist consumers in maintaining regulations, at § 172.380 and § 184.1950, general U.S. population and proposed to health dietary practices. do not allow vitamin D to be added. amend § 101.9(c)(8)(ii) to require the With respect to fortification, we note Therefore, regarding the analytical mandatory declaration of potassium. that we published a policy statement on burden, if a manufacturer has adequate (Comment 375) Almost all comments the rational addition of nutrients to and reliable reasons to believe that supported the mandatory declaration of foods (§ 104.20). We urge vitamin D is not present, there is no potassium on the Nutrition Facts label. manufacturers, if they elect to add need to analyze for it: It can be declared Some comments, however, supported nutrients to a food, to follow the as zero or the manufacturer can state at mandatory declaration of potassium for guidelines stated in the fortification the bottom of the nutrition label ‘‘not a different reasons. Many comments policy for rational addition of nutrient significance source of vitamin D.’’ Costs would require mandatory declaration of to foods to preserve a balance of associated with nutrition labeling will potassium because potassium is nutrients in the diet of the U.S. be contained by not analyzing for a important for dialysis and renal population. We intend to continue nutrient where there is no reasonable patients. assessing the nutritional status

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(inadequacy and excess) of potassium these two nutrients and their respective limited space may be challenging for consumption, among other nutrients, in amounts in a food are related. manufacturers; thus, our preexisting the general healthy U.S. population after Consequently, we cannot evaluate the regulation, at § 101.9(j)(13), provides for the final rule’s compliance dates. We comment’s claim regarding placement special labeling provisions for packages also intend to monitor the market to and consumer understanding. with limited space. assess fortification practices in response (Comment 378) One comment said the (Comment 379) Several comments to the revised Nutrition Facts label. mandatory declaration of potassium on said that manufacturers would need With respect to educational activities, the Nutrition Facts label will pose more than 2 years to gather nutrition we intend to work with other Federal challenges for very small packages data for potassium and to comply with Agencies and organizations to (because another line in the label would the mandatory declaration of potassium emphasize the changes to the Nutrition be needed). Additionally, some on the Nutrition Facts label. Some Facts label (see part II.B.1). However, comments noted that beverages, such as comments said that the data are often consistent with our mission, our plain unsweetened coffee and tea, are lacking in many company and public educational activities will focus on the exempt from nutrition labeling (under databases, so time will be needed to Nutrition Facts label rather than fresh § 101.9(j)(4)) because they contain collect the data. produce (i.e., fresh fruits and insignificant amounts of all nutrients (Response) We disagree, in part, with vegetables). The reason for the required to be declared on the Nutrition the comments. There are public mandatory declaration of potassium and Facts label. According to the comments, databases, such as USDA Nutrient Data other essential vitamins and minerals on plain coffee and tea may have low, but Database, that can provide information the Nutrition Facts label is to assist declarable, levels of potassium, so the regarding the potassium content of consumers in maintaining health dietary mandatory declaration of potassium foods. For example, in the USDA practices rather than to recommend would cause plain coffee and tea to lose Nutrient Data Database for current consumption of specific foods or their current exemption from nutrition Standard Reference (SR 27), nearly products. labeling. The comments said we should 8,200 of the approximately 8,600 foods (Comment 377) Several comments examine § 101.9(j)(4) and make any in the database, or approximately 95 suggested that potassium should appear necessary adjustments. The comment percent of the foods, have potassium on the Nutrition Facts label after suggested that, when levels of values. sodium. The comments said that there potassium are less than 5 percent of the Additionally, the operations involved is an association between potassium DV and on small packs with limited and equipment required for the methods intake and reduced blood pressure in space, declaration of potassium would for potassium determination are certain individuals, so potassium be voluntary. standard in analytical laboratories. should appear below sodium. The (Response) We recognize the Nevertheless, we have revised the comments said this placement will help discrepancy between the exemption compliance dates for the final rule (see consumers understand that these two under § 101.9(j)(4) and the labeling that part III). nutrients and their respective amounts would be required for products that (Comment 380) One comment asked in a food are related. have significant levels of nutrients. In us to clarify the use of potassium in (Response) We decline to revise the the proposed rule, we did not ask for dietary supplement products. The rule as suggested by the comment. We comments specifically about the comment said that many dietary stated in the preamble to the 1993 final continued applicability of this supplement companies have been rule (58 FR 2079 at 2106) that, for exemption from nutrition labeling limiting potassium in their formulas to essential vitamins and minerals, the provisions in light of what would be a 99 mg per serving and that 99 mg of decisions about mandatory or voluntary changing level of nutrients that will be potassium is not an appreciable fraction declarations were based on public considered ‘‘insignificant’’ as a result of of the current (3,500 mg) or proposed health concerns relative to inadequate this rule and the final rule entitled (4,700 mg) reference daily intake for dietary intakes as well as the possible ‘‘Food Labeling: Serving Sizes of Foods potassium. The comment said that this association between several of these That Can Reasonably Be Consumed at limitation is based on a position we took nutrients and the risk of chronic One-Eating Occasion; Dual-Column in 1975 that any capsule or coated tablet disease. The main difference between Labeling; Updating, Modifying, and of a potassium salt intended for oral the DRV and RDI nutrients was/is that Establishing Certain Reference Amounts ingestion (without prior dilution with DRV nutrients are: (1) Nutrients to limit Customarily Consumed; Serving Size for an adequate volume of liquid to (e.g., sat fat, cholesterol, and trans fat); Breath Mints; and Technical preclude gastrointestinal injury) should or (2) based on a specific caloric intake Amendments’’ (Serving Size final rule) carry a warning statement regarding (e.g., fat, carbohydrate, protein, and published elsewhere in this issue of the small-bowel lesions related to the use of dietary fiber). However, RDIs have been Federal Register. Therefore, we intend oral drug products containing 100 mg or and are being proposed based on age to consider the future applicability of more potassium. The comment said we specific RDAs (and now AIs). In 1993, the exemption with respect to have not established an upper limit for there were not age specific RDAs for mandatory nutrition labeling on potassium in dietary supplement potassium. Currently, there are age products that would have been exempt formulations, so the comment asked us specific AIs for potassium that are based under § 101.9(j)(4) prior to the effective to clarify how potassium might be used on chronic disease risk. Thus, because date of this rule and the Serving Size in solid oral dietary supplements. potassium is now being assigned an final rule. After the effective date of this (Response) We have not established RDI, rather than a DRV, we are moving final rule, we intend to consider the any limits on potency or recommended it down in the label with the other exercise of enforcement discretion with uses for dietary supplements that essential vitamins and minerals that respect to the use of mandatory contain potassium salts. Under the have RDIs. Furthermore, the comment nutrition labeling on such products that FD&C Act, a manufacturer or distributor did not provide any evidence to support would have been exempt under is responsible for ensuring that the the claim that having sodium and § 101.9(j)(4). dietary supplements are safe and meet potassium near each other on the label We understand that providing other applicable requirements of the would help consumers understand that Nutrition Facts labels on packages with FD&C Act and its implementing

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regulations. The safety of or need for a In the preamble to the proposed rule (79 rule to require the mandatory warning statement on dietary FR 11879 at 11922 through 11923), we declaration of phosphorus on the supplements with certain potencies of explained how we had considered Nutrition Facts label. potassium are outside the scope of this comments to the 2007 ANPRM (Response) While a mandatory rulemaking. recommending mandatory declaration phosphorous declaration may aid (Comment 381) Several comments did of vitamin E, folate, vitamin B12, patients with chronic kidney disease not support mandatory declaration of magnesium, and phosphorus and how, and dialysis patients, the Nutrition potassium on the Nutrition Facts label. based on our analysis of available data Facts label is not targeted to individuals Some comments said that consumers do and using the factors we consider for with a particular acute or chronic not know what potassium is, so the mandatory and voluntary declaration of disease (see part II.B.2). The information declaration of potassium on the label non-statutory nutrients, we did not on the label is meant for the general would not be helpful. The comments propose any changes to the provisions healthy U.S. population. For said it would be better to omit for voluntary declaration of vitamin E, determining the nutrients of public potassium from the label so that the vitamin K, vitamin B6, vitamin B12, health significance, we considered the Nutrition Facts label is less cluttered, thiamin, riboflavin, niacin, folate, factors that were discussed in the can be better organized, and be less biotin, pantothenic acid, phosphorus, proposed rule and determined that likely to overwhelm the consumer with iodine, magnesium, zinc, selenium, phosphorous intakes are generally information. copper, manganese, chromium, adequate and not of public health (Response) We decline to revise the molybdenum, and chloride. significance in the general, healthy U.S. rule as suggested by the comments. We Several comments addressed the population (Ref. 204). Furthermore, total consider whether a vitamin or mineral voluntary declaration of specific intakes (food and supplement) among is of public health significance to be the vitamins or nutrients, and we discuss the general U.S. population were not key factor in deciding when to require those comments in this section. found to be above the UL (Ref. 199). mandatory declaration on the Nutrition a. Phosphorus. Based on these factors, we determined Facts label. Available quantitative (Comment 383) Most comments asked that phosphorous is considered a evidence suggests that the declaration of that we amend our regulations so that voluntary nutrient for the general nutrients of public health significance declaration of phosphorus is mandatory healthy U.S. population, and are not including vitamins and minerals can rather than voluntary. making changes to the voluntary help consumers maintain healthy Most comments said that many declaration of phosphorus in response dietary practices. We consider people have kidney problems, and to this comment. Therefore, potassium to be a nutrient of public patients under dialysis have to watch manufacturers can declare phosphorus health significance, and the final rule their intake of phosphorous in addition on the Nutrition Facts label voluntarily. includes potassium in the list of to potassium and calcium. The However, if phosphorous is added as a nutrients in § 101.9(c)(8)(ii) for which a comments said that it can be very nutrient supplement or claims are made quantitative amount by weight and difficult for individuals who are on a about it on the label or in labeling of percent of the RDI are required in low potassium and phosphorous diet to foods, then it must be declared on the nutrition labeling to assist the calculate their daily intake. The label. All ingredients, including consumers in maintaining healthy comments said that dialysis patients are phosphate compounds, must be dietary practices. educated about foods high in declared in the ingredient list on the As for the comment’s mention of phosphorus, but it is difficult to manage label. clutter, we consider clutter as a matter one’s phosphorus intake when b. Magnesium. of graphic design, but possible clutter is phosphorus is ‘‘in almost everything.’’ (Comment 384) Several comments not our basis for omitting or removing The comments said that many dialysis would revise the rule so that declaration a nutrient of public health significance patients have neither the motivation nor of magnesium on the Nutrition Facts from the Nutrition Facts label. the resources to be diligent about label would be mandatory instead of (Comment 382) One comment monitoring phosphorus in their diet. voluntary. Several comments stated that suggested that potassium should be a One comment stated that phosphorus magnesium is needed for dialysis qualifying nutrient for ‘‘Healthy’’ claim can occur naturally in various forms of patients. One comment said that, criteria. food, or as a component in commonly instead of paying too much emphasis on (Response) Issues regarding labeling used food additives, and that the calcium for adults, we should pay more outside the Nutrition Facts and processing of meat and fish products attention to magnesium because, Supplement Facts labels, such as increases the phosphorus content above according to the comment, nearly 90 nutrient content claims, are outside the the naturally occurring levels in the percent of dialysis patients are deficient scope of this rulemaking (see part protein itself. The comment said that in magnesium. II.B.4). the addition of phosphorous to the (Response) We decline to revise the Nutrition Facts label will help kidney rule as suggested by the comments. As 4. Other Essential Vitamins and patients to be aware of the high amount we stated in part II.B.2, the Nutrition Minerals of phosphorus in foods. The comment Facts label is not targeted to individuals Under our preexisting regulations, at noted that, in determining mandatory or who have a specific acute or chronic § 101.9, several other essential vitamins voluntary labeling, FDA considers disease. and minerals, in addition to vitamin D whether there is evidence of a (Comment 385) Some comments said and potassium, may be declared relationship between the nutrient and a that magnesium is an essential mineral voluntarily on the Nutrition Facts label, chronic disease, health-related and necessary for maintaining more i.e., vitamin E, vitamin K, vitamin B6, condition, or health-related than 300 essential metabolic reactions vitamin B12, thiamin, riboflavin, niacin, physiological endpoint and whether in the human body. One comment said folate, biotin, pantothenic acid, there is evidence of a problem related to that magnesium interacts with calcium phosphorus, iodine, magnesium, zinc, health in the general U.S population. and potassium and foods and that selenium, copper, manganese, Thus, the comment said, using these dietary supplements are frequently chromium, molybdenum, and chloride. considerations, we should revise the enriched with calcium. The comment

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said that magnesium deficiency in the among adolescent girls, adult women, include magnesium content on the face of a normal calcium intake can lead and the elderly. One comment stated Nutrition Facts label for their products. to soft tissue calcification in animals that the impact of adding another item The comment said that, for example, (Refs. 205–206). The comment said that to the label is minimal compared to Kelloggs includes magnesium content the most prominent feature of overall costs. The comment said that, on Bran cereal (but not on its magnesium deficiency is the given that the costs are inevitable, it is Corn Flakes), Nestle includes calcification predominantly of arteries better to add all mandatory declarations magnesium content on its Instant (Refs. 207–209) and that magnesium to the label at one time. In other words, Breakfast products, and General Mills inhibits the release of calcium ion from if a manufacturer is already changing includes magnesium content on the sarcoplasmic reticulum, blocks the the label for potassium for example, Cheerios cereal. The comment suggested influx of calcium ion into the cell by there is a minimal incremental cost to that these steps are to be encouraged inactivating the calcium channels in the add magnesium at the same time. and broadened. cell membrane, and competes with One comment noted that, from a food (Response) We are not making calcium ions at binding sites on processing perspective, given the label changes to the voluntary declaration of troponin C and myosin, thereby desirability of increasing potassium and magnesium in the final rule, and inhibiting the ability of calcium ions to reducing sodium levels, manufacturers therefore, manufacturers may declare stimulate myocardial tension (Refs. might replace a portion of currently magnesium voluntarily on the Nutrition 210–212). The comment noted that used sodium salts, such as sodium Facts label. However, if magnesium is magnesium, a calcium antagonist, citrate and sodium phosphate, with the added as a nutrient supplement or substitutes itself for the calcium ions on potassium salts with equivalent claims are made about it on the label or hydroxyapatite, producing more soluble functional characteristics. Thus, the in labeling of foods, then it must be phosphate salts and thus inhibiting comment said, labeling of magnesium declared on the label. bone formation and perhaps aortic valve content becomes more important to c. Vitamin K. stenosis (Ref. 213). avoid creating an imbalance of (Comment 387) Several comments One comment stated that the potassium and magnesium. stated that declaration of vitamin K on absorption of calcium and magnesium (Response) We agree that magnesium the Nutrition Facts label is necessary for may be altered depending upon the is an essential nutrient and that it is individuals who are on blood thinners. levels and ratio between them. The important in many different pathways (Response) We decline to revise the comment said that emerging evidence and functions of the body (Ref. 218). rule as suggested by the comment, and indicates that it may be better to However, consistent with our vitamin K remains a voluntarily optimize one’s intake of calcium and consideration of the factors for declared nutrient in the final rule. magnesium rather than supplementing mandatory and voluntary declaration of While information regarding vitamin K with either mineral alone. The comment vitamins and minerals (see part II.D), may help patients on blood thinners, as said that the mandatory declaration of while magnesium dietary intake is we stated in part II.B.2, the Nutrition magnesium on the Nutrition Facts label currently low, the IOM recommended Facts label is for the general, healthy will help consumers avoid an imbalance intake is not set based on a public U.S. population rather than for of calcium and magnesium by health endpoint (e.g., a chronic disease), individuals with acute or chronic highlighting to the consumer how and the overt symptoms of magnesium disease. inadequate his or her magnesium intake deficiency are rarely seen among general d. Choline. is in relation to the calcium content of healthy U.S population. Consequently, (Comment 388) In general, comments packaged foods (which the comment we do not consider magnesium to be a regarding the declaration of choline on said are frequently supplemented with nutrient of public health significance for the Nutrition Facts label supported calcium). The comment also stated that the general U.S. population (Ref. 204). voluntary declaration. the IOM has said that ‘‘magnesium is We consider whether a vitamin or (Response) Because declaration of necessary for sodium, potassium- mineral is of public health significance choline on the Nutrition Facts label is ATPase activity, which is responsible to be the key factor in deciding when to already voluntary, no changes to the for active transport of potassium’’ (Ref. require mandatory declaration on the rule are necessary. 214) and that magnesium regulates the Nutrition Facts label, cost consideration e. Vitamin B12. outward movement of potassium in was not a factor in determining (Comment 389) One comment stated myocardial cells (Ref. 215). The nutrients of public health significant. that fortified foods and dietary comment further stated that magnesium In the case of magnesium, similar to supplements are the only reliable way inadequacy has a variety of other our recommendation, the 2010 DGA and for individuals who avoid all animal adverse health effects and that dietary 2015 DGAC did not include magnesium products to obtain vitamin B12. The magnesium intake was found to be as a nutrient of public health concern comment said that including the inversely associated with mortality risk for the general U.S. population. (The amount of vitamin B12 added to fortified in individuals at high risk of 2015–2020 DGA also does not include foods and dietary supplements would cardiovascular disease (Ref. 216). In magnesium as a nutrient of public enable these individuals to monitor addition, the comment said, a higher health concern.) Magnesium was their intake of this essential vitamin. dietary magnesium intake is associated considered as a shortfall nutrient. The comment said that labeling also with lower fasting glucose and insulin Although some comments cited would help individuals aged 50 years (Ref. 217), and dietary magnesium published articles, most articles cited by and older who are advised to meet their intake is inversely associated with the comments are either animal studies, RDA mainly by consuming foods plasma concentrations of the not using valid surrogate endpoints fortified with crystalline vitamin B12 or inflammation indicator C-reactive (such as C-reactive protein), or are based vitamin B12-containing dietary protein (CRP). on single studies and emerging evidence supplements. One comment stated that national and the conclusions are not based on (Response) Declaration of vitamin B12 survey data indicate that dietary the totality of scientific data. on the Nutrition Facts or Supplement magnesium intake is inadequate in the (Comment 386) One comment noted Facts label is mandatory when vitamin general U.S. population, particularly that some manufacturers already B12 is added as a nutrient supplement or

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when claims are made about it on the Daily Reference Values (DRVs) for should not dismiss the label or in labeling of foods. Thus, certain nutrients, are used to declare recommendations of the IOM Labeling because the information is already nutrient contents as percent DVs (id. at report (Ref. 219) to use the EAR as the available to consumers under the 11883, 11926), and the RDIs for basis for setting DVs, in favor of the circumstances described in the vitamins and minerals have been based 2003 IOM Planning report (Ref. 220) comment, no changes to the rule are primarily on RDAs (or on other recommendation to use RDAs to plan necessary. available quantitative intake diets of individuals. The comment recommendations if an RDA has not stated that there is no better reference M. Reference Daily Intakes for Vitamins been established for a particular vitamin value against which to appraise the and Minerals or mineral). nutritional contribution of a product 1. Need To Update RDIs The preamble to the proposed rule than a DV based on a population also stated that the RDA was developed Our preexisting regulations, at weighted EAR and that any other basis as a target intake level for individuals for the DV will either understate or § 101.9(c)(8)(iv), set forth RDIs used to and is designed to meet the nutrient calculate the percent DVs for vitamins overstate the nutritional contribution of needs of practically all (97 to 98 a food product when considered in and minerals that are required or percent) individuals within a life stage permitted to be declared on the comparison to the population weighted and gender group (id. at 11926). RDAs EAR. The comment said that we Nutrition Facts label. RDIs are intended are available for calcium, copper, folate, as general food labeling reference values misinterpreted the purpose of the 2003 iodine, iron, magnesium, molybdenum, IOM Planning report recommendation and are not intended to represent niacin, phosphorus, riboflavin, dietary allowances for individuals. They to use the RDA to plan diets and that selenium, thiamin, vitamins A, B6, B12, function as an overall population there is no reason to assume that the C, D, and E, and zinc (id.). very specific notion of dietary planning reference to help consumers judge a In contrast, the EAR is the median food’s usefulness in meeting overall for individuals (as described in the 2003 requirement that is most likely to be IOM Planning report) is what consumers daily nutrient requirements or close to an individual’s actual needs recommended consumption levels and mean when they say they use the label within a particular life stage and gender for planning purposes. The comment to compare nutrient contributions of group (id.). The EAR is a quantitative different foods. further stated that the DVs are not intake recommendation that is used to appropriate to use for planning an The preamble to the proposed rule derive target nutrient intake goals for discussed how new information caused individual’s entire diet because they do the planning of diets for groups (such as not represent the individual’s age and us to reconsider the RDIs and our planning diets in an assisted living approach to setting RDIs (79 FR 11879 sex, and that this nutrition information facility for senior citizens or planning is only provided on packaged foods (not at 11925 through 11928). In brief, the menus for a school nutrition program), fresh fruits and vegetables, meat, proposed rule would revise the existing but is not used as a target intake goal for poultry, fish). The comment also said RDIs for vitamins and minerals based on individuals. The EAR is not intended to that this information is only available the DRIs set by the IOM (1997 to 2010) be a target intake level for individuals for nutrients that are mandatory on the and would consider the RDAs, when because an individual does not know Nutrition Facts label. available, as the basis for establishing how his or her needs relate to the EAR. RDIs, instead of the EAR. Using Therefore, if the RDI were to be based (Response) We continue to believe corresponding RDAs, proposed on the EAR, the RDI would not meet the that the RDA is the most appropriate § 101.9(c)(8)(iv) would update the RDIs daily nutrient requirements for some reference value to use to establish RDIs, for calcium, copper, folate, iodine, iron, consumers and would understate target considering the purpose of the DV. As magnesium, molybdenum, niacin, intake levels. In contrast, an RDI that is we noted in the preamble to the phosphorus, riboflavin, selenium, based on a RDA would meet the daily proposed rule (79 FR 11879 at 11926), thiamin, vitamins A, B6, B12, C, D, and nutrient requirements for most the percent DV advises the consumer E and zinc (see 79 FR 11879 at 11926 individuals 4 years of age and older. An how much of the recommended intake through 11927). RDI based on the RDA would mean that of that nutrient is provided by the food. While the DV for a nutrient is not to be 2. Approach To Setting RDIs: EAR a product with 100 percent of the DV would have a higher probability of interpreted as a precise recommended Versus RDA meeting an individual’s nutrient needs intake level for an individual, it is a In the preamble to the proposed rule than if the RDI was based on the EAR. general guide or a reference value that (79 FR 11879 at 11926 through 11927), As a result, in the preamble to the the consumer can use to help judge a we explained our approach to setting proposed rule (id. at 11927), we stated food’s usefulness in meeting overall RDIs. In brief, the percent DV advises that RDAs, when available, provide the daily nutrient requirements or the consumer how much of the most appropriate basis for establishing recommended consumption levels and recommended intake of a particular RDIs and, using corresponding RDAs, to compare nutrient contributions of nutrient is provided by the food. The we proposed, at § 101.9(c)(8)(iv), to different foods (id.). The EAR is not DV for a nutrient is not to be interpreted update the RDIs for calcium, copper, intended to be a target intake level for as a precise recommended intake level folate, iodine, iron, magnesium, individuals because an individual does for an individual; instead, it is a general molybdenum, niacin, phosphorus, not know how his or her needs relate to guide or a reference value that the riboflavin, selenium, thiamin, vitamins the EAR. While the RDA may not be the consumer can use to help judge a food’s A, B6, B12, C, D, and E, and zinc. best estimate of any given individual’s usefulness in meeting overall daily (Comment 390) Several comments nutrient requirements, which are nutrient requirements or recommended supported using the RDA, rather than usually unknown, the RDA was consumption levels and to compare the EAR, as the basis for establishing developed as a target intake level for nutrient contributions of different foods RDIs. individuals. The RDA is designed to (id. at 11926). Two types of reference In contrast, one comment opposed meet the needs of practically all (97 to values, the Reference Daily Intakes using the RDA and supported using the 98 percent) individuals within a life (RDIs) for vitamins and minerals and EAR. The comment asserted that we stage and gender group. If the RDI was

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based on the EAR, the RDI would not they provide an appropriate basis for part II.L.3.b, the final rule requires the meet the daily nutrient requirements for selecting RDIs for those vitamins and declaration of potassium on the label. some consumers and would understate minerals where available data are Thus, if consumers are interested in the target intake levels. insufficient to determine RDAs. sodium and potassium ratio, they will We also disagree with the comment’s Consequently, we proposed to use the have both the absolute amounts as well characterization of the 2003 IOM AI to set RDIs for biotin, chloride, as the percent DV for both nutrients. In Planning report recommendations. The choline, chromium, manganese, addition, the Aburto et al., 2013 2003 IOM Planning report noted that pantothenic acid, potassium, and systematic review and meta-analysis intake goals (i.e., RDAs) should be vitamin K. cited by the comment concluded that translated into dietary plans to help (Comment 391) Several comments daily potassium intakes in the range of individuals choose foods that will make supported using the AI as the basis for 90 to 120 mmol (3,519 mg to 4,700 mg) up a healthy diet. The 2003 IOM establishing RDIs for those vitamins and were associated with lower risk of Planning report gave several examples minerals where data were insufficient to stroke (Ref. 223). This range is of dietary plans such as the Nutrition determine a RDA. However, other consistent with the AI of 120 mmol Facts label, the U.S. Food Guide comments opposed using the AI for (4,700 mg/day) that was based on Pyramid, and the Dietary Guidelines for potassium to establish an RDI of 4,700 potassium’s ability to blunt the effects of Americans that are intended to help mg and recommended that we retain the sodium intake on blood pressure and to consumers choose foods that are part of current DRV of 3,500 mg. The comments reduce the risk of kidney stones. a healthful diet (Ref. 220). The 2003 stated that the AI is established at a Furthermore, Aburto et al. 2013 noted IOM Planning report noted that, when level assumed to ensure nutritional their analysis of randomized trials that food guides are used, reference adequacy in all members of a healthy examined how sodium intakes influence standards for nutrients such as the population when there is insufficient potassium’s effect on blood pressure RDAs are implicitly used in planning scientific evidence to develop an RDA. shows there was no statistically individual diets (see 79 FR 11879 at The comments said that using a different effect among subgroups based 11926). Therefore, we disagree with the reference value based on inadequate on sodium intake. A majority of the comment’s suggestion that the 2003 quantity or quality science would be individual studies cited in the Aburto et IOM Planning report is somehow at providing inconclusive information to al., 2013 meta-analysis were reviewed in odds with the use of the RDA as a consumers. A few comments noted that the 2005 Electrolytes report which reference value for establishing RDIs. there is now additional evidence (Refs. concluded that data on the sodium and Furthermore, we disagree with the 223–224) that is more reflective of the potassium ratio was insufficient to be comments’ assertion that the DVs are current state of the science and used to set requirements (Ref. 223). The not appropriate to use for planning an recognizes the sodium to potassium other article cited in the comment (Ref. individual’s entire diet because ratio. Some comments also suggested 224) is a review article that does not nutrition information is only provided that the IOM should re-assess the DRI include the totality of the scientific on packaged foods (and not on fresh for potassium in light of the new data evidence and does not provide fruits and vegetables, meat, poultry, or to determine if the current AI is truly sufficient information for FDA to fish). Retail stores that sell raw fruits, reflective of the actual requirements. review. While we recognize that the vegetables, and fish participate in the One comment suggested that increasing intakes of sodium and potassium are voluntary point-of-purchase nutrition the RDI could result in increased interrelated, we do not consider the information program (§§ 101.42 through reliance on fortification or use of dietary evidence to be sufficient to set an RDI 101.45). Additionally, we have supplements. based on the sodium and potassium developed posters that provide nutrition (Response) We agree with the ratio, and we continue to consider that information for the 20 most commonly comments that support the use of the AI the AI set by the IOM is appropriate to consumed fruits, vegetables and seafood to set the RDIs for nutrients that do not use for setting the RDI. Additionally, that are available to consumers and have a RDA. We disagree that we should given the extensive reviews already industry (Ref. 221). Similarly, USDA not use the AI to set an RDI for conducted by the IOM, we do not agree requires that retail stores that sell meat potassium and that the existing DV of that it is necessary to ask the IOM to and poultry to label products with 3,500 mg should be retained. The reevaluate the existing evidence for nutrition information or to post point- existing DV for potassium was set in potassium. of-purchase nutrition information. 1993 based on the 1989 Diet and Health USDA also has developed posters for report and no longer represents the most As for the comment regarding nutrition information for meat and current recommendations for potassium fortification, the comment did not poultry that are available for use by intake. As discussed in the preamble to provide any evidence, and we are not consumers and industry (75 FR 82148) the proposed rule (79 FR 11879 at aware of any evidence, that suggests (Ref. 222). For these reasons, we are 11927), while there is more uncertainty using the AI would lead to excessive making no changes to the rule based on with an AI than an EAR or RDA, in the fortification and increased use of dietary the comment. case of nutrients without established supplements. Currently, the adequacy of We address comments on specific RDAs, the AI reflects the most current intakes for potassium is very low (see 79 vitamins and minerals at parts II.M.6 scientific recommendations for intake FR 11879 at 11922). Only 1.9 percent of and II.M.7. (id.). When establishing RDIs, we the general population has usual consider the quantitative intake potassium intake above the AI from 3. Approach To Setting RDIs: Adequate recommendations from U.S. consensus conventional foods only, and 2.4 Intake reports (e.g., the IOM DRI reports) (see percent have intakes above the AI from In the preamble to the proposed rule 79 FR 11879 at 11890). conventional foods plus dietary (79 FR 11879 at 11927), we explained We disagree that the sodium and supplements. RDIs which are expressed that, in the absence of RDAs, AIs potassium ratio should be used to set a on the label as a percent DV, give a represent the best estimate of an DV for potassium. First, sodium is not consumer a general idea how much of adequate daily nutrient intake level presented on the label as a ratio of a nutrient they should consume. While based on available science and, as such, sodium and potassium. As discussed in RDIs may influence the vitamin or

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mineral content of foods, FDA’s weighted approach), using the highest the population because such a value is principles of rational fortification are RDA and, where an RDA has not been not derived from averaging the expressed in our fortification policy established, the highest AI (79 FR 11879 requirements for populations with lower (§ 104.20). The addition of nutrients to at 11928). We explained that using a needs (children and elderly) and those foods is also governed by the population-coverage approach would with greater needs (adolescents or requirements established in food avoid a higher risk of nutrient adults). While incidences of deficiency standards of identity (21 CFR parts 130 inadequacy among certain segments of diseases, such as pellagra, are now rare, to 169), nutrition quality guidelines (21 the population because the RDA/AI intakes and status biomarkers of certain CFR part 104), substitute food value is not derived from averaging the nutrients continue to be inadequate and regulations (§ 101.3(e)), and relevant requirements for populations with lower of public health significance. specifications in food additive and food needs (children and elderly) and those Furthermore, in addition to iron, the substance regulations (e.g., folic acid with greater needs (adolescents or proposed RDIs for calcium and vitamin (§ 172.345) and vitamin D (§§ 184.1950 adults). We acknowledged that, for some D were based on vulnerable groups. The and 172.380)). Consistent with our nutrients, the population-coverage RDA RDI for calcium was based on the previous position (58 FR 2206 at 2210), approach would result in RDIs that are highest RDA of 1,300 mg/day for 9 to 18 we acknowledge that some higher than the nutrient requirements year olds, and the proposed RDI of 20 manufacturers may fortify products to a for some consumers, but said that the mcg for vitamin D was based on the specific percentage of the DV (e.g., 25 RDA, by definition, is the target intake RDA for adults 70 years and older. All percent) and, to the extent this practice goal for nutrient intakes for individuals three nutrients have been identified as continues, nutrient levels in these foods (id.). nutrients of public health concern (see would be affected by updated RDI We proposed to amend 79 FR 11879 at 11918 through 11922). values. Manufacturers must comply § 101.9(c)(8)(iv) to update RDIs and to We continue to use the population- with relevant regulations, and we urge present the updated RDIs in a table. coverage approach to set RDIs and them to follow the principles stated in (Comment 392) Several comments decline to make a change based on this our fortification policy. We conclude supported the use of the population- comment. that the AIs set by the IOM provide an coverage approach, using the highest As for the comment suggesting that appropriate basis for selecting RDIs for RDA or AI to set the RDIs. Other using a population-coverage approach those vitamins and minerals where comments, however, said we should use would set nutrient targets unnecessarily available data are insufficient to the population-weighted approach. too high and would make it harder for determine RDAs and will not be making Comments supporting the use of a consumers to meet their nutrient a change as a result of this comment. population-weighted approach asserted requirements while staying within that a DV derived from the population- energy needs, we acknowledge that, for 4. Approach To Setting RDIs: Tolerable coverage RDA will result in setting some nutrients, the population-coverage Upper Intake Level target intakes for nutrients above the RDA approach will result in RDIs that The preamble to the proposed rule (79 needs for the majority of the population, are higher than the nutrient FR 11879 at 11928) explained that the that the use of a population-weighted requirements for some consumers. UL is the highest average daily intake RDA would still result in an increase in However, the RDA, by definition, is the level likely to pose no risk of adverse the RDIs for calcium, vitamin D, and target intake goal for nutrient intakes for health effects for nearly all people in a potassium, and that the RDI for iron individuals. In addition, unlike the particular group. As intake increases would decrease from 18 mg to 11 mg, population-weighted approach, the above the UL, potential risk of adverse but that this level would still exceed or population-coverage approach would effects may increase. The UL can be meet the RDA for 80 percent of the not be susceptible to changes in age used to estimate the percentage of the population. demographics of the population. population at potential risk of adverse One comment supporting use of a Therefore, any future revisions to RDIs effects from excess nutrient intake, but population-weighted EAR disagreed would be based primarily on new it is not intended to be a recommended with our rationale that using a scientific data related to nutrition or level of intake for vitamins and minerals population-coverage approach ensures new dietary recommendations, and we where excess intake is not a concern, as that vulnerable groups are covered; the would not need to revise RDIs solely there is generally no established benefit comment stated that, with the exception based on the availability of new census for consuming amounts of nutrients of iron, the highest RDAs are those for data (see 79 FR 11879 at 11928). above the RDA or AI. Thus, we do not young men who are not vulnerable to Furthermore, because many of the new consider the UL to be an appropriate nutrient inadequacies. RDAs and AIs established by the IOM basis for setting RDIs for vitamins and A few comments suggested that using are now lower than the older RDAs or minerals. a population-coverage approach would ESADDIs that were used in the past to We did not receive comments on this set nutrient targets unnecessarily too develop RDIs, the new RDIs established topic. high and would make it harder for in the final rule based on a population- consumers to meet their nutrient coverage RDA for many nutrients will 5. Approach To Setting RDIs: requirements while staying within be lower. We are not aware of, nor did Population-Weighted Versus energy needs. Another comment the comment provide, any evidence to Population-Coverage suggested that using a population- suggest that retaining the population- In the preamble to the proposed rule coverage approach might lead to coverage approach would make it (id.), we discussed how we considered consumer confusion and frustration. harder for consumers to meet their recommendations of current consensus (Response) As we discussed in the nutrient requirements while staying reports, scientific review articles, and preamble to the proposed rule (79 FR within energy needs. comments to the 2007 ANPRM. We 11879 at 11928), using the highest age As for the assertion that consumers tentatively concluded that RDIs for and gender group RDA/AI value (i.e., a confusion may result, the comments did vitamins and minerals should continue population-coverage approach) would not provide any data or information that to be based on a population-coverage avoid a higher risk of nutrient such difficulties or consumer confusion approach (rather than a population- inadequacy among certain segments of exists or the extent to which such

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difficulties or confusion exists, so we American children’s intakes currently considered whether there is public are unable to determine the nature or exceed the UL. The comment stated that health significance to exceeding the UL. severity, if any, of such consumer the proposed RDI (11 mg) is more than As noted in the 2014 memo to the file, difficulties or confusion. We do note two times the RDA for children 4 to 8 no reports on adverse effects of zinc on that the current DVs on the label are years (5 mg/day) and almost four times copper absorption have been reported in based on a population-coverage the RDA for children 1 through 3 years children and adolescents (Ref. 199). A approach, and we are not aware of any (3 mg/day). The comment said that a dose response intervention study data and information that the product with 20 percent of the DV for published in 2013 found that population-coverage approach, which zinc (e.g. 11 mg × 0.20 = 2.2 mg) supplementation with 5 to 15 mg/day of we have used for decades, has caused declared on the label would provide zinc for 4 months did not alter copper consumer confusion. almost 100 percent of the zinc RDA for status in healthy Canadian boys aged 6 We conclude that setting RDIs based a young child (3 mg/day). to 8 years (Ref. 227). Furthermore, the on a population-coverage approach is (Response) We disagree with the proposed RDI for zinc of 11 mg, which more appropriate than a population- comment that stated that the use of a is based on the highest new RDA, weighted approach, and we are not population-coverage RDA would lead to decreases by 27 percent from the current making changes to the rule based on excessive fortification and intakes of RDI of 15 mg. In addition, the proposed these comments. Thus, the final rule, at nutrients. Instead, we agree with the RDI for zinc of 11 mg does not exceed § 101.9(c)(8)(iv), updates the RDIs for comments that stated that a population- the UL for children 4 to 8 years of age. various nutrients and presents them in coverage RDA would not lead to The RDIs are currently intended for table form, although we have, on our excessive intakes of nutrients from adults and children 4 or more years of own initiative, elected to use non- fortified foods. As noted in the preamble age and not younger children because italicized numbers for RDI values that to the proposed rule (79 FR 11879 at children over the age of 4 years were italicized in the proposed rule and 11928) and the accompanying consume the same foods that the rest of deleted the footnote regarding the memorandum to the file (Ref. 199), the population consumes. However, as declaration of a percent daily value for intakes of vitamins and minerals discussed in part II.O.6.k, we also are ‘‘bolded’’ (italicized) nutrients. establishing a RDI of 3 mg for zinc for generally do not exceed the ULs under (Comment 393) Some comments younger children 1 through 3 years of current RDIs that are based on a agreed that using the population- age. coverage RDA does not lead to excessive population-coverage RDA approach, (Comment 394) Several comments intakes of nutrients due to over except for zinc, vitamin A (preformed), opposed any revision to the RDIs that fortification of foods. The comments iodine, and folic acid among children 4 would lower the RDIs. The comments noted several recent analyses that to 8 years. In these few instances where stated that Americans need more support our analysis and conclusions total usual intakes of vitamins and vitamins and minerals because toxin that a population coverage RDA would minerals by children 4 to 8 years exceed intake is increasing and nutrient intake not lead to excessive intakes of nutrients corresponding ULs, we have determined is decreasing. The comments suggested from fortified foods (Refs. 194–195, that such intakes are not of public that our goal was to harmonize our food 225). One comment pointed out that health significance, and for some laws to Codex standards and guidelines RDIs would likely reset levels of nutrients, are not as a result of and stated that this has been specifically vitamins and minerals in discretionary fortification (Ref. 199). Analyses done prohibited by Congress. The comments enriched/fortified foods as by other groups also have determined requested that we obey the law and manufacturers adjust absolute levels to that fortified foods contribute to the withdraw the proposal rule for revision maintain current label claims. The nutrient intakes and adequacy of many and bring it in line with modern science comment said that, based on diet nutrients without leading to excessive which, according to the comments, modeling done by Murphy et al. that intakes for most vitamins and minerals shows that we need higher daily intake assumes that discretionary enrichment/ (Refs. 194–195, 225). Furthermore, of vitamin B and other vitamins as well fortification levels reset, a population- because many of the new RDAs and AIs as more minerals such as magnesium coverage RDA would be likely to result established by the IOM are now lower and selenium. in a greater percentage of Americas than the older RDAs or ESADDIs that (Response) We disagree that the RDIs meeting their nutrient requirements were used in the past to develop RDIs, should not be revised. As we discussed compared to a population-weighted the final rule’s RDIs, based on in the preamble to the proposed rule, we EAR (Ref. 225). Furthermore, the population-coverage RDAs for many are revising the RDIs based on our comment said, the results of diet nutrients, will be lower. We consider consideration of the RDA or AI set in modeling conducted by Murphy that that, from a public health perspective, it the most recent IOM DRI reports that are assumed that discretionary enrichment/ is more important for the DV of vitamins U.S. consensus reports (see 79 FR 11879 fortification levels would reset indicated and minerals to cover the intake needs at 11926). The comments did not that using a population-coverage of most consumers than it is for certain provide any data, information, or approach would result in less than 1 age and gender groups to be covered by explanation to support the various percent of the total populations 4 years the DV based on their proportion of the assertions made, including that of age and older having intakes above overall population. As discussed in the Americans need more vitamins and the ULs (Ref. 225). 2014 memo to the file, we acknowledge minerals due to increased toxins, that Some comments suggested that the that total usual zinc intakes from the IOM DRI reports are incorrect, that use of a population-coverage RDA could conventional foods and dietary our proposed actions are not consistent result in over-fortification of products. supplements exceed the UL for with the law and the proposed rule One comment noted that intakes of zinc approximately 33 percent of children 4 should be withdrawn, or that our goal exceed the UL for young children. The to 8 years of age. The UL for zinc of 12 is to harmonize food labeling with comment stated that we should not mg/day was extrapolated upward from Codex standards and guidelines. We are dismiss this finding by challenging the the UL set for infants based on unaware of new consensus research that basis for the UL, because doing so fails decreased copper absorption (Ref. 226). would lead us to change our proposed to recognize the extent to which many In addition to intake data, we approach to revise the RDIs. Therefore,

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we are not making changes or taking any not provide consumers with information did the comment provide, any data or action in response to these comments. on optimal amounts of nutrients for information that increasing the RDI for (Comment 395) Several comments good health. The comment cited a vitamin C will lead to consumer objected to lowering the RDIs for review by McCann and Ames that confusion. specific nutrients such as biotin, niacin, suggest modest deficiency of selenium 6. Declaration of Absolute Amounts of pantothenic acid, riboflavin, thiamin, my increase the risk of age-associated Vitamins and Minerals vitamin B6, chromium, copper, diseases (Ref. 228). molybdenum, selenium, and zinc. One (Response) We agree that the current Our preexisting regulations, at comment suggested that we did not RDIs are out of date and should be § 101.9(d)(7)(i), require the declaration outline our specific reasoning for revised. The RDAs set by the IOM of mandatory nutrients and, when lowering the RDIs for these particular which are the basis for the new RDIs, declared, voluntary nutrients by their nutrients. Another comment stated that did consider intakes over the lifespan absolute amounts in weight on the we should reevaluate more recent and to the extent possible based on Nutrition Facts label, except for science that evaluates the effects of high available data consider the relationship vitamins and minerals (other than doses of nutrients from foods and between optimal health and intakes of sodium and potassium). Thus, except supplements and look at clear nutrients. The article cited by the when the linear label format is used differences between synthetic and comment was a review article and does (§ 101.9(j)(13)(ii)(A)(2)), listings for naturally occurring vitamins. Another not include the totality of the scientific sodium and potassium (when declared) comment stated that the proposed evidence for FDA to review. The RDIs appear above the third bar and include changes will lead to consumer are based on our consideration of the both weight amounts and percent DVs, confusion and a drop in intake as RDA or AIs set in the IOM DRI reports while vitamins A and C, calcium, and consumers will now perceive foods and that are U.S. consensus reports and we iron appear below the third bar and supplements to contain a much larger are not aware of any new consensus include percent DVs only. In the case of percentage of these nutrients when, in from a body of research that would lead dietary supplements, both the reality, the nutrient level is the same. us to change our proposed approach to quantitative amount by weight and (Response) We disagree that RDIs for revise the RDI for selenium. Therefore, percent DV (if available) are required to biotin, niacin, pantothenic acid, we are not making changes or taking any be declared on the Supplement Facts riboflavin, thiamin, vitamin B6, action in response to this comment. label (§ 101.36(b)(2)(ii) and (iii)). The chromium, copper, molybdenum, (Comment 397) Some comments proposed rule would require that, selenium, and zinc should not be questioned why we are increasing the similar to the requirement for dietary revised. As discussed in the preamble to DV for vitamin C from 60 mg to 90 mg supplements (§ 101.36(b)(2)(i)(A)), all the proposed rule (see 79 FR 11879 at when we determined that the vitamins and minerals declared on the 11890), we are revising the RDIs based declaration of vitamin C on the Nutrition Facts label include their on our consideration of the RDA or AIs Nutrition Facts or Supplement Facts quantitative amounts (in addition to the set in the IOM DRI reports that are U.S. label should no longer be mandatory. A requirement for corresponding percent consensus reports. We consider the few comments suggested that increasing DV declaration) (proposed § 101.9(c)(8)). quantitative intake recommendations the DV for vitamin C may negatively We address the comments to this from these reports when establishing impact the consumer perception of this proposed requirement in part II.Q.9. RDIs. vitamin and result in consumer The proposed rule also would remove As for the comment suggesting that confusion. The comments suggested the the specific requirements for the we consider new more recent science, percent DV declaration will be lower declaration of potassium in § 101.9(c)(5) the comment did not identify any new because the DV is higher for vitamin C, and provide, instead, for the declaration references for us to consider, and we are and so consumers may perceive that the of fluoride. The proposed rule also unaware of any new consensus from a product has changed when it has not. A would require that, when a product body of research that would lead us to few comments also suggested that, if the contains less than 2 percent of the RDI change the rule. However, with respect higher DV for vitamin C is adopted, we for a vitamin or mineral, the to synthetic and naturally occurring should engage in consumer education. manufacturer must declare the nutrients, in establishing RDAs or AIs, (Response) The preexisting RDI of 60 quantitative amount of the vitamin or the IOM does consider the various mg was based on the 1968 RDA which mineral and the percent DV in the same sources of nutrients (synthetic and is outdated and does not reflect current manner. For example, if a serving of the naturally occurring) when establishing recommendations for intake of vitamin product contains less than 2 percent of the nutrient requirements. C. We disagree that the RDI for vitamin the RDI for calcium, both the As for possible consumer confusion or C should not be increased because we quantitative amount and the percent DV lower intakes by consumers, we are not are no longer requiring mandatory for calcium may be listed as zero or an aware of any data or information about declaration. As we stated in the asterisk (or symbol) directing the that outcome, nor did the comment preamble to the proposed rule (79 FR consumer to a statement at the bottom provide any to support its assertions. 11879 at 11928), we are basing the RDIs of the label may be used in place of both Although the final rule lowers many for vitamins and minerals, including the quantitative amount and the percent RDIs, using the population-coverage vitamin C, on the highest RDA set by the DV declaration for calcium. We stated RDA to set the RDIs would cover the IOM. Thus, for vitamin C, we set the that we saw no reason to provide needs of most individuals in the RDI at 90 mg. The RDIs, which are different declaration increments for the population. For these reasons, we are expressed on the label through the Nutrition Facts label than those that making no further changes to the rule percent DV, give a consumer a general have already been established for the based on these comments. idea how much of a nutrient they declaration of quantitative amounts of (Comment 396) One comment stated should consume. vitamins and minerals on the that the current RDIs which are largely We recognize that consumer Supplement Facts label in based on preventing deficiency diseases education on the various changes to the § 101.36(b)(2)(ii). are out of date and do not consider label will be important (see part II.B.1). We also invited comment on whether nutrient intakes over the lifespan and do Furthermore, we are not aware of, nor quantitative amounts for nutrients with

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RDI values that contain three or four (Comment 399) We proposed to use between the value obtained before and digits should be rounded, what the the same declaration increments for the after applying the rounding rules for the rounding increments should be, and Nutrition Facts label as those that have percent DV declaration. data to support rounding increments (79 already been established for the In addition, requiring a declaration of FR 11879 at 11930, 11961). declaration of quantitative amounts of the amount of the nutrient that (Comment 398) For conventional vitamins and minerals on the corresponds to the nearest whole foods, we specify in § 101.9(c)(8)(iii) Supplement Facts label in number of the percent DV calculated that the percent DV declaration for § 101.36(b)(2)(ii). The proposed rule, at before rounding could result in declared vitamins and minerals present at less § 101.9(c)(8)(iii), would require that the quantitative amounts that are different than 2 percent of the RDI is not required quantitative amounts of vitamins and than what has been determined by for nutrition labeling, but may be minerals on the Nutrition Facts label, analytical methods, but still not declared as zero or by the use of an excluding sodium, be the amount of the correspond with the rounded percent asterisk (or other symbol) that refers to vitamin or mineral included in one DV declaration. For example, if testing another asterisk (or symbol) that is serving of the product, using the units is done to determine that a product placed at the bottom of the table and of measure and the levels of significance contains 300 mg of potassium per that is followed by the statement given in § 101.9(c)(8)(iv), except that serving, the calculated percentage of the ‘‘Contains less than 2 percent of the zeros following decimal points may be RDI for potassium of 4,700 is 6.4 Daily Value of this (these) nutrient dropped, and additional levels of percent. If that percentage is then (nutrients).’’ Alternatively, the significance may be used when the rounded to the nearest whole number of statement ‘‘Not a significant source of number of decimal places indicated is 6 percent and then multiplied by the (listing the vitamins or minerals not sufficient to express lower amounts RDI for potassium, it would result in a omitted)’’ may be placed at the bottom (e.g., the RDI for zinc is given in whole declared value of 282 mg, which is of the table of nutrient values. milligrams, but the quantitative amount different than the value which is One comment said that quantitative may be declared in tenths of a determined by analytical methods. amounts less than 2 percent of the DV milligram). The approaches suggested by should be exempt from declaration as Several comments would change the comments to make the quantitative such amounts are nutritionally rule’s declaration increments. Two amount of a vitamin or mineral declared insignificant. Other comments suggested comments asked us to ensure that there on the label as close as possible to the that we should not allow for the amount is consistency between the rounded quantitative amount calculated from the of a nutrient to be declared as zero. absolute amount and the declared percent DV declaration would either These comments suggested that, if there percent DV. One comment stated that result in a declared value that is either is even the smallest amount of the any declaration of quantitative amounts less accurate or no better that the nutrient in a serving of the product, the of vitamins and minerals should proposed approach. Therefore, we amount should be declared. provide for declaration of a quantitative decline to make changes to our label (Response) We decline to revise the amount that corresponds to the nearest declaration increments. rule to require the declaration of small, whole number of the percent DV (Comment 400) One comment said quantitative amounts of vitamins and beginning with 2 percent. Another that nutrients with ‘‘equivalents,’’ such minerals on the Nutrition Facts label. comment said that most consumers will as Vitamin A, folate, and niacin, make While it may be desirable to have a not do the math to convert the absolute it impossible to simply convert a precise nutrient value on the label, such amount of the percent DV, but providing numerical value to a percentage and precision is impractical. There is both absolute amount and percentages could create consumer confusion. variability inherent in the food supply. could result in different values for (Response) We disagree with the Nutrients found in foods can vary similar products in the marketplace. comment. For those nutrients with slightly due to many factors such as the (Response) We agree that the rounded ‘‘equivalents,’’ the equivalent amount season of the year, soil type, variety absolute amount and the declared should already be determined for the (), and weather conditions. The percent DV may be slightly inconsistent. purposes of the amount declared on the processing that a food undergoes also For example, if the quantitative amount label. For calculation of the percent DV, can alter its nutrient content. The of the vitamin or mineral is rounded the declared amount should be divided rounding rules were established to after the rounding rules for the percent by the RDI for that nutrient and avoid the impression of unwarranted DV declaration are applied, it could multiplied by 100. The equivalent accuracy as well as to make a label result in a rounded value that is amount should already be determined easier for the consumer to review and significantly different than the actual for the label declaration and would not understand. amount of the nutrient in a serving of prevent a manufacturer from Furthermore, very small quantities of a food. For example, if a product is determining the percent DV declaration nutrients in a food product do not determined by analytical methods to for vitamin A, niacin, folate, or folic contribute significantly to nutrient have 1,550 mg of potassium per serving, acid. requirements for the total daily diet. A the percent DV declaration would be (Comment 401) Some comments consumer would most likely exceed determined by dividing 1,550 mg by the suggested that less precision is needed their calorie needs trying to obtain the RDI of 4,700 mg for a value of 33 for declaration of quantitative amounts recommended amount of a certain percent. After application of the of nutrients declared on the label. One nutrient if their diet is made up of only rounding requirements for the percent comment suggested that the declared foods that contribute less than 2 percent DV declaration, the declared percent DV amounts should be rounded to whole of the DV for that nutrient. To obtain the value would be rounded to 35 percent. numbers because they are easier for recommend amount of that nutrient for If the declared quantitative amount of consumers to understand. the day, the consumer would need to potassium in a serving of the product is Another comment suggested that any consume other foods containing larger then multiplied by 35 percent by the nutrient in an amount greater than 10 quantities (at least more than 2 percent RDI of 4,700, the declared quantitative units (e.g., 10 mg or 10 mcg) should be of the DV for that nutrient) of the amount of would be 1,645 mg of rounded to the nearest 1 (unless a larger nutrient. potassium. This is a difference of 95 mg increment is specified in the proposed

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rule, such as ‘‘Calories from saturated places indicated is not sufficient to (Response) We established the fat ’’ for which 5 calorie increments are express lower amounts for those rounding rules to provide an accurate specified for amounts up to and nutrients with small RDI values, we are representation of the amount of a including 50 calories), those in an giving manufacturers some flexibility to nutrient in the product so that amount greater than 100 units should be determine if the value should be consumers can determine how the rounded to the nearest 10 units (unless rounded to the nearest whole number or nutrients in a serving of a food a larger increment is specified in the to a fraction of a whole number based contribute to their total daily diet. The rule), and those in amounts greater than on the nutrient and the quantity present rounding rules also allow for natural 1,000 units should be rounded to the in a serving of the food. variability in the nutrient content of nearest 100 (unless a larger increment is We recognize that determining the foods, analytical variability in test specified in the rule). The comment appropriate value to declare for methods, and statistical probability, and suggested that rounding should be based quantitative amounts of vitamins and we have set practical limits of variation on the declared quantity of a nutrient minerals could be confusing to in nutrient levels since 1973 (see 38 FR rather than on the RDI or DRV for the manufacturers when the rule provides 2125 at 2128 (January 19, 1973) (final nutrient. some flexibility based on the RDI and rule titled ‘‘Regulations for the One comment recommended that the quantity of the nutrient present in a Enforcement of the Federal Food, Drug, numbers ending in ‘‘5’’ should be serving of food, especially for nutrients and Cosmetic Act and the Fair rounded up. The comment suggested with relatively small RDIs. For example, Act Nutrition that we could consider alternatively the rounding requirements allow a Labeling’’)). We appreciate the need for allowing for numbers ending in 5 to be manufacturer to declare an amount of consumers to be able to understand the rounded to the nearest even number, but zinc as 2 mg or 2.4 mg per serving. information on a product label, yet the said this could be confusing and Additionally, consumers use the comment did not provide information to counterintuitive for most members of information found on the label in show how our rounding rules have industry. different ways. Some may use it to get confused consumers nor did it suggest Other comments suggested that more enough of certain nutrients whereas how such tests would be done. We do precision is needed for declaration of others may be more concerned with not not consider the changes we are making quantitative amounts of nutrients exceeding a certain calorie level. There to the rounding rules to require declared on the label. One comment has always been built in variability in consumer testing. recommended that quantitative amounts the label declarations due to variation in (Comment 404) Our preexisting be rounded to the nearest tenth instead the food supply and variance in the regulations, at § 101.9(c), provide for the of to the nearest integer. The comment analytical methods used to determine rounding of quantitative amounts of indicated that rounding errors can occur the amount of nutrients in a serving of calories and macronutrients declared on when quantitative amounts are rounded a food. The amount of vitamins and the Nutrition Facts label. The to the nearest integer. minerals declared on a label is not requirements vary based on the nutrient. Another comment also recommended always the exact amount of the nutrient For example, our regulations state that that nutrients be rounded to the nearest in a serving of the food. Therefore, we quantitative amounts in milligrams may tenth of a gram for quantities under 10 decline to revise the increments used for be listed on the Nutrition Facts label for grams per serving. declaration of quantitative amounts of only two minerals: Sodium (Response) We disagree that the same vitamins and minerals as suggested by (§ 101.9(c)(4)) and potassium rounding increments should be used for the comments. (§ 101.9(c)(5)). Our regulations state quantitative amounts of all vitamins and (Comment 402) One comment said that, when a serving contains less than minerals. Some nutrients, such as that, if the final rule requires the 5 mg of sodium or potassium, the value potassium, have a relatively large RDI declaration of quantitative amounts of must be declared as zero; when a value (4,700 mg) while others, such as vitamins and minerals, we should serving contains 5 to 140 mg of sodium thiamin, have a relatively small RDI provide sufficient guidance regarding or potassium, the declared value must value (1.2 mg). The declaration of those rounding rules and how to quantify be rounded to the nearest 5 milligram nutrients with relatively smaller RDI amounts of naturally occurring increment; and when a serving contains values requires greater specificity than substances that inherently are subject to greater than 140 mg of sodium or those with relatively larger RDI values. variability (e.g., vitamins and minerals potassium, the declared value must be Furthermore, for some nutrients with from plants that are subject to variable rounded to the nearest 10 mg increment. relatively larger RDI values, it may not growing conditions that affect nutrient We did not propose any changes to be possible, given current analytical content). these requirements. methods, to determine the amount of (Response) There may be different One comment suggested that the the nutrient with precision when very ways in which manufacturers may want amount of calories in a serving of a small quantities are present (e.g., at a to consider the variability in the foods product should not be rounded because level of less than 1 mg). they produce. Manufacturers should people who are counting calories need The comments recommending know how much variability to expect in to know exactly how many calories are specific rounding increments of all the foods they produce based on in the product. nutrients based on the number of units adequate sampling. Manufacturers (Response) We disagree with the in the RDI or DRV value did not explain should consider the range of nutrients comment. As with quantitative amounts why those increments are appropriate so which may be in a finished food of nutrients, determining the exact that we might determine if the product and determine the label value amount of calories in a serving of a approaches suggested are merited. By which they think will best meet the specific package of food is not possible using the levels of significance provided requirements for class II nutrients in or practical. The determination of in the RDI table in § 101.9(c)(8)(iv), § 101.9(g). calories is a somewhat imprecise allowing for zeros following decimal (Comment 403) One comment measure. The exact amount of calories points to be dropped, and allowing for suggested we should test any rounding per serving in a given food may vary additional levels of significance to be rules which are adopted to ensure that from package to package. Therefore, used when the number of decimal consumers are not confused. providing an exact amount of calories

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on a food label would give the consumer label compliance and making 7. Issues Concerning Specific Vitamins the incorrect impression that the determinations regarding misbranding and Minerals declared amount is a precise value. charges. We also recognize that Furthermore, providing an exact amount § 101.9(c)(1) provides several methods The preamble to the proposed rule of calories rather than a rounded value for determining calories, which also discussed issues related to RDIs for is unlikely to provide consumers who allows manufacturers flexibility in vitamin K, chloride, potassium, choline, count their calories for weight determining the declared calorie value. and vitamin B12 (79 FR 11879 at 11930). management purposes more helpful Thus, the regulations provide for a. Vitamin K. The preamble to the information because consumption of an variability that is acceptable under our proposed rule noted that there are three extra 5 or 10 calories in a given food is regulations. general forms of vitamin K: unlikely to have a significant impact on (Comment 406) One comment Phylloquinone (vitamin K1), body weight when most adults need to recommended that fractions of menaquinone (vitamin K2), and consume well over 1,000 calories per quantities should be shown per serving menadione (vitamin K3) (id.). For day, even when trying to lose weight. for nutrients such as trans fat because labeling purposes, there is no specific (Comment 405) Our preexisting some people consume multiple servings definition for vitamin K and the AI for regulations, at § 101.9(g)(5), state, in of a product at the same time and may vitamin K is based on the intake of part, that a food with a label declaration not realize that they add up to greater phylloquinone, the major form of of calories, sugars, total fat, saturated than 1 gram per serving. vitamin K in the diet. The proposed fat, trans fat, cholesterol, or sodium (Response) We decline to revise the rule, at § 101.9(c)(8)(iv), would establish shall be deemed to be misbranded under rule as suggested by the comment. We 120 mcg as the RDI for vitamin K. section 403(a) of the FD&C Act if the note that the requirements of § 101.9(c) (Comment 408) One comment nutrient content of the composite is do require the declaration of total fat, supported using the AI for vitamin K greater than 20 percent in excess of the saturated fat, trans fat, and which pertains only to phylloquinone. value for that nutrient declared on the monounsaturated fat be expressed using Other comments objected to limiting label. The regulation goes on to say fractions, which are the nearest 0.5 gram the RDI for vitamin K to phylloquinone ‘‘Provided, That no regulatory action increment below 5 grams. For many (Vitamin K ). The comments stated that will be based’’ on a determination of a macronutrients, it is not possible for 1 menaquinone contributes to the nutrient value that falls above this level manufacturers to declare fractions of a nutritional requirements for vitamin K by a factor less than the variability gram or mg amount on the label due to generally recognized for the analytical the level of variability inherent in the and should be included in the method used in that food at the level analytical methods used to determine definition. One comment stated that involved. the amount of the nutrient. inclusion of menaquinone would be in The proposed rule would amend Similar comments recommended that line with other regulatory bodies such § 101.9(g)(5) to insert ‘‘added sugars’’ we require manufacturers to declare as EFSA and Health Canada. One after the word ‘‘sugars’’ and delete the amounts of trans fat when present at comment also noted that dairy and meat words ‘‘Provided, That.’’ less than 0.5 grams per serving of a food. products are important sources of One comment would revise We address those comments in part menaquinone and contribute to the § 101.9(g)(5) to stipulate that products II.F.3.d. daily intake of vitamin K. The comment labeled in accordance with the rounding (Comment 407) One comment stated that the bioavailability of or increment requirements are not suggested that we allow for grams of menaquinone has been demonstrated misbranded if the use of such rounding dietary fiber to be rounded to the using both in vitro and in vivo studies. or increments causes the content of nearest 0.5 grams. The comment noted The comment also stated that calories, sugars, total fat, saturated fat, that the proposed DV for children 1 menaquinone is rapidly absorbed intact trans fat, cholesterol, or sodium to be through 3 years of age is 14 grams. from the gastrointestinal tract (Ref. 229) understated by more than 20 percent. Therefore, the comment said, 10 percent and is more bioavailable than The comment explained that of the DV for that age group would be phylloquinone, which is strongly bound § 101.9(g)(5) companies equivalent to 1.5 grams of dietary fiber, to vegetable fiber (Refs. 229–230). The vulnerable to lawsuits under state and 20 percent of the DV for that age comment also noted that it has been consumer protection laws because a group would be 2.5 grams. The well-established that dietary intake of company could be sued for selling a comment also noted that 10 percent of phylloquinone meets the nutritional ‘‘misbranded’’ product labeled as the current DV for the general requirements necessary for coagulation containing 5 calories per serving when population of 25 g would be 2.5 grams. through the activation of biochemical the actual caloric content is just over 6 The comment suggested that allowing pathways in the liver. The comment calories per serving, despite the fact that for fiber to be declared in 0.5 gram also noted that menaquinone has similar the product’s labeling meets our increments up to 5 grams could help activity as phylloquinone in the blood requirement to express the number of facilitate consumer communication and coagulation system (Ref. 229), and data calories to the nearest 5 calories. help reduce any confusion with respect also suggest an important role for (Response) We decline to revise the to claims. menaquinone in extra-hepatic rule as suggested by the comment. (Response) We decline to revise the processes. The comment stated that Section 101.9(g)(6) states that reasonable rule as suggested by the comment. The menaquinone intake has been shown to deficiencies of calories under labeled declaration of dietary fiber is expressed have a protective effect against CHD amounts are acceptable within current in increments of 1 gram due to the level (Ref. 231), helps regulate bone good manufacturing practice. We of precision of analytical methods for metabolism, and plays a role in continue to consider the variability dietary fiber. The level of precision of reducing the risk of osteoporotic generally recognized for the analytical the methods for determining dietary fractures (Refs. 229, 232). The comment method used and reasonable fiber do not allow for the accurate pointed out that the USDA database deficiencies of declared amounts determination of the amount of dietary (2014) now includes vitamin K2. The acceptable within current good fiber in increments of less than 1 gram comment also requested that we include manufacturing practice when evaluating per serving. phytonadione, which is an additional

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name for vitamin K1, in the definition of limited. Furthermore, we generally some comments opposed using the AI vitamin K. consider U.S. dietary recommendations, for potassium to establish an RDI of (Response) We agree that the AI consensus reports, and U.S. national 4,700 mg. We address those comments should be used as the basis for the RDI survey data to develop our regulations. in part II.M.3 (see comment 391). The for vitamin K. However, we disagree While we decline to include final rule, at § 101.9(c)(8)(iv), establishes that the definition of vitamin K should menaquinone in a definition of vitamin an RDI of 4,700 mg for potassium. include menaquinones. While the K, we note that information about d. Choline. Our existing regulations comment referred to actions by Health menaquinones that might be added to a do not establish a reference value for Canada, we note that Health Canada food may be listed in the ingredient list choline. The preamble to the proposed also is proposing using the AI for the to alert consumers that other forms of rule noted that the IOM established age- RDI for vitamin K (Ref. 233). vitamin K are present in the product. and gender-specific AIs for choline Furthermore, the EFSA review cited by We also discuss the labeling of based on intakes necessary to maintain the comment was a safety assessment menaquinone as a dietary ingredient in liver function and that, in 2001, we for vitamin K as a source of vitamin K part II.P (Dietary Supplements). received a FDAMA notification under 2 We also disagree that the term added to foods and was not an section 403(r)(2)(G) of the FD&C Act for phytonadione should be included in the assessment of the possible nutritional the use of certain nutrient content definition for vitamin K. benefits of vitamin K (Ref. 229). One claims for choline (79 FR 11879 at 2 ‘‘Phytonadione’’ is U.S. Pharmacopeia 11930). The FDAMA notification study (Ref. 232) submitted by a Convention’s (USP) nomenclature for identified the DV for choline as 550 mg, comment was a review article on ‘‘phylloquinone,’’ and both have the which was based on the population- menaquinone-4 and osteoporosis and same structure (Ref. 237). In the coverage AI for choline. Thus, the did not provide data for us to evaluate. Nutrition Facts label, phylloquinone is proposed rule, at § 101.9(c)(8)(iv), It does not represent the totality of the declared as vitamin K (§ 101.9(c)(8)). would set an RDI of 550 mg for choline scientific evidence on menaquinones Furthermore, for dietary supplements, based on the population-coverage AI. and does not provide sufficient labeling representations that the source (Comment 409) Several comments information for FDA to review. The ingredient conforms to an official agreed with the proposed RDI for other two studies, Gast et al., 2009 and compendium may be included either in choline. Geleijnse et al., 2004, were prospective the nutrition label or the ingredient list (Response) The final rule, at cohort studies that showed an (e.g., calcium (as calcium carbonate § 101.9(c)(8)(iv), establishes an RDI of association of menaquinone intake and USP) (§ 101.36(d)(3)). 550 mg for choline. reduced risk of CHD. Intakes for Thus, the final rule establishes, in e. Vitamin B12. The proposed rule menaquinone in these two studies were § 101.9(c)(8)(iv), an RDI for vitamin K of would lower the RDI for Vitamin B12 estimated from food frequency 120 mcg based on the AI that pertains from 6 mcg/day to 2.4 mcg/day to reflect questionnaires and, because food only to phylloquinone. We are making the population-coverage RDA for composition data for menaquinones is no changes to the rule based on these Vitamin B12 established by the IOM in limited, the results of these studies comments. 2000 (Ref. 238). We acknowledged that should be interpreted with caution b. Chloride. The preamble to the lowering the RDI from 6 to 2.4 mcg (Refs. 230–231). As we stated in the proposed rule (79 FR 11879 at 11930) could result in a reduction of the preamble to the proposed rule (79 FR stated that, under our preexisting fortification level in foods, such as 11879 at 11930), the AI for vitamin K regulations, the RDI for chloride is 3,400 ready-to-eat breakfast cereals, thereby does not account for the intake of mg (§ 101.9(c)(8)(iv)) and is based on the decreasing the overall amount of menaquinone or menadione because: (1) midpoint of the range (1,700 to 5,100 crystalline vitamin B12 in the food The NHANES data that was used as the mg/day) of the ESADDI. The proposed supply (see 79 FR 11879 at 11930). (The basis for the AI only included the rule would have chloride remain a RDI, preamble to the proposed rule (id.) also phylloquinone content of foods; (2) the but based on a population-coverage AI noted that individuals older than 50 contribution of menaquinones, which of 2,300 mg/day. years of age meet their RDA mainly by can be produced by bacteria in the gut, We did not receive comments on the consuming foods fortified with to the maintenance of vitamin K status RDI for chloride and have finalized it crystalline vitamin B12 or vitamin B12- has not been established; and (3) without change. containing supplements.) menadione is a synthetic form of c. Potassium. The preamble to the (Comment 410) Some comments vitamin K that can be converted to a proposed rule (id.) explained that the supported our use of the RDA set by the form of menaquinone in animal tissues. DRV of 3,500 mg for potassium was IOM to revise the RDI for vitamin B12. In addition, menaquinones are poorly established based on its beneficial One comment noted that, if the understood in terms of vitamin K health effects (e.g., reduction in blood proposed RDI was adopted, absorption and utilization (Refs. 234– pressure) and that we established a DRV manufacturers of fortified ready-to-eat 236). Unlike phylloquinone, there have rather than an RDI because an RDA for cereals and other products may adjust been no stable isotope studies specific age and gender groups was not fortification levels of vitamin B12 to conducted with menaquinones that are established in 1990 (when we issued maintain their current DV claim levels, needed to improve the understanding of various regulations related to nutrition thereby reducing the amount of menaquinone bioavailability and information on food labels). However, crystalline vitamin B12 in the food metabolism (Ref. 235). While the USDA because potassium is an essential supply. However, the comment stated National Nutrient Database for Standard mineral and because age- and gender- that, based on an analysis by Murphy et Reference Release 27 includes data on specific AIs became available in 2005, al., this change would not lead to a one form of menaquinones we proposed to establish an RDI for significant increase in the proportion of (menaquinone-4), there are limited food potassium, instead of the DRV, and thus the population with inadequate dietary composition data available (490 foods revise § 101.9(c)(8)(iv) to set the RDI for intakes of vitamin B12. The comment out of 8,618 or <6 percent in USDA potassium at 4,700 mg. said that the Murphy study indicated NND SR27) (Ref. 4), and estimates of We did not receive comments directly that the difference in the proportion of intakes of menaquinones are very on the RDI for potassium, although the total population with usual intakes

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of vitamin B12 less than the EAR would N. Units of Measure, Analytical 3. Folate and Folic Acid be about 3 percent regardless of whether Methods, and Terms for Vitamins and a. Units of measure. Our preexisting the revised RDI was based on a Minerals regulations, at § 101.9(c)(8)(iv), have the population-weighted EAR or a The preamble to the proposed rule (79 RDI for ‘‘folate’’ in micrograms. In the population-coverage RDA, and this FR 11879 at 11931) discussed how the preamble to the proposed rule (79 FR would be within 2 percentage points of IOM set DRIs using new units of 11879 at 11931 through 11932), we the percentage calculated by using the measure for vitamin A, vitamin E, and explained how, in 1998, the IOM set the current DV. The comment noted that the folate and provided recommendations RDA for folate expressed as microgram results for older adults and teenage girls on the use of International Units (IUs) (mcg) Dietary Folate Equivalents (DFE) were a little higher, but similar and the expression of weight amounts and how the IOM Labeling Committee regardless of the approach. The for sodium, potassium, copper, and recommended that the use of similar comment recommended that we chloride. The new units of measure for units of measure in nutrition labeling. vitamin A, vitamin E, and folate affect continue to promote vitamin B12 intake The preamble to the proposed rule in at-risk subpopulation groups and to how total amount of each nutrient is explained how the IOM developed the continue monitoring population intake. measured. new term, DFE, to account for the Other comments opposed lowering 1. General Comments greater bioavailability of synthetic folic acid that is added to fortified foods or the RDI for vitamin B12 and said we (Comment 411) While we did not should retain the RDI of 6 mcg for request comment on using teaspoons or dietary supplements than folate that occurs naturally in foods (food folate) vitamin B12. The comments expressed tablespoons as units of measure, several concern that a substantial decrease in comments supported using teaspoons and that mcg DFE is equivalent to mcg food folate + (1.7 × mcg synthetic folic the RDI would result in lower amounts (tsp) and tablespoons (tbsp) in addition acid) (id. at 11932). The proposed rule of crystalline vitamin B12 in food and to or instead of grams (g) for nutrients. The comments said that consumers use would amend § 101.9(c)(8)(iv) to use dietary supplements. The comments mcg DFE to declare the amount of total stated that this decrease would make it these common household measures in recipes and can visualize them. folate (food folate and synthetic folic more difficult for those at-risk for acid) on the Nutrition Facts label. The deficiency, including older adults, In contrast, other comments recommended using only metric units, proposed rule would make a similar vegetarians, and vegans, to achieve such as grams, only because they are change, at § 101.36(b)(2)(ii)(B), with adequacy for this nutrient. The more precise and used by other respect to the declaration of folic acid comments noted that the IOM and DGA countries. on the Supplement Facts label. recommended these at-risk groups (Response) We address this issue in The preamble to the proposed rule (79 should consume the crystalline forms. part II.B.3. FR 11879 at 11932) also stated that we (Response) The final rule adopts an 2. Sodium, Potassium, Copper, and are aware that education efforts should RDI for vitamin B12 of 2.4 mcg based on Chloride be provided to help consumers the RDA. The RDA was established by understand the new ‘‘equivalent’’ units the IOM in 2000 for all adults and can Our preexisting regulations at of measurement for folic acid. We said § 101.9(c)(9) and (c)(8)(iv) express the be met by consuming natural and that one option to help ensure consumer units of measurement for sodium, crystalline forms. While the IOM noted understanding would be to allow the potassium, copper, and chloride in that it is advisable that individuals older declaration of the mcg amount of folic milligrams. Although the preamble to acid in parentheses in addition to than 50 years of age meet their RDA the proposed rule (79 FR 11879 at mainly by consuming foods fortified declaring the amount of folate in mcg 11931) discussed IOM DFE and percent DV based on mcg DFE. with crystalline vitamin B12 or vitamin recommendations to use grams rather (Comment 413) Although one B12-containing supplements, less than 1 than milligrams (mg) and how percent of men and 6.4 to 7.5 percent of comments to the 2007 ANPRM comment supported using DFEs as the women older than 50 years of age supported retaining mg instead of using unit of measure, many comments said we should retain the preexisting DV of consume below the EAR for vitamin B12, grams, we declined to propose any while only 3 to 5 percent of men and changes to the units of measure for these 400 mcg folate or folic acid and not women in this age group have serum nutrients. adopt DFEs as the unit of measure. vitamin B12 levels that are considered to (Comment 412) Several comments Several comments stated that using be inadequate (2003–2006 NHANES) supported retaining the declaration of mcg DFE as the unit of measure will (see 79 FR 11879 at 11930). Based on ‘‘mg’’ for sodium and potassium. Other confuse the public, limit the ability to the data provided by the comment in comments recommended the use of monitor folate/folic acid intake and support of lowering the RDI, it is ‘‘mg’’ for calcium and phosphorus, but safety, and could negatively impact unlikely that lowering the RDI will did not explain their reasoning. birth outcomes. The comments said that entities such as the IOM, the Centers for result in a significant increase in the (Response) For reasons stated in the Disease Control and Prevention, the U.S. proportion of the population with preamble to the proposed rule (79 FR 11879 at 11931), we agree with retaining Public Health Service (USPHS), and the inadequate dietary intakes of vitamin ‘‘mg’’ for the units of measure for March of Dimes have educated the B . If we became aware that foods are 12 sodium, potassium, copper, and public on the importance of women of formulated as a result of this final rule, chloride, so the units of measure in child-bearing age consuming at least 400 leading to lower amounts of crystalline § 101.9(c)(8)(iv) and (c)(9) remain mcg of synthetic folic acid daily to help B12 are in the food supply, we would unchanged. prevent neural tube defects. The consider the need for consumer As for calcium and phosphorus, we comments said that changing the unit of education, particularly for at-risk did not propose changing the units of measure may promote suboptimal individuals who may need to increase measure, and so the final rule continues intake of the nutrient, especially if intake of certain foods to meet nutrient to use ‘‘mg’’ as the unit of measure for women do not understand the needs. calcium and phosphorus. difference in the bioavailability of

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naturally occurring folate versus DV based on mcg DFE folate in the understand the new labels (see part synthetic folic acid. Supplement Facts label. If a dietary II.B.1). We intend to coordinate Other comments stated that an supplement has added folic acid (alone education and outreach efforts with educational campaign would be or in combination with natural or Federal Agencies and other necessary, especially for obstetricians synthetic folate), or a claim is made organizations with an interest in and women of child-bearing age, to about folic acid, the nutrient declaration nutrition and health to emphasize, teach them how to achieve adequate must include folate as a quantitative among other things, the newly adopted dietary folate levels if we were to use amount by weight of folate (mcg DFE units of measure for folate in mcg DFE, mcg DFE as the unit of measure. The folate), and the percent DV based on percent DV based on mcg DFE, and mcg comments said we should continue to mcg DFE folate, in addition to the of folic acid for the first time on the declare the amount of folic acid in quantitative amount by weight of folic Nutrition Facts and Supplement Facts micrograms along with the percent of acid (mcg folic acid) in parentheses. If labels. DV (based on the PHS recommendation) a dietary supplement has naturally (Comment 414) Several comments in both the Nutrition and Supplement occurring folate (with no folic acid were concerned about the removal of Facts. added) and a claim is not made about mcg folic acid from the food label. Some (Response) As we stated in the folate, the manufacturer may voluntarily comments stated that, by only reporting preamble to proposed rule (79 FR 11879 declare folate as a quantitative amount mcg DFE folate on the label, it would no at 11932), the IOM developed the DFEs by weight in mcg DFE and percent DV longer be possible to measure the to reflect the most current based on mcg DFE folate. percentage of a subpopulation that recommendation for folate/folic acid for With respect to conventional food consumes in excess of the UL for folic the general healthy U.S. population. The labeling, if a conventional food has acid. The comments said that intake DFE accounts for the differences in naturally occurring folate (with no folic data is obtained through the NHANES, bioavailability between food folate acid added) and there is no claim made which uses food labels to collect (natural folate) and folic acid which is about folate, the manufacturer can information on the type and amount of more bioavailable (about 1.7 times more voluntarily declare folate in the micronutrients (including folic acid) bioavailable). Use of mcg DFE on the Nutrition Facts label. If the contained in food products. label is important to make sure that the manufacturer voluntarily declares Other comments stated that limiting consumer is aware of the total amount folate, the manufacturer may declare the units of measure to mcg DFE would of folate in a serving of food. For folate followed by the percent DV based make it difficult for consumers to make example, assume that the level of total on mcg DFE folate, or alternatively, can an informed decision regarding their folate in a packaged cereal is declare the quantitative amount by actual folic acid intake. The comments approximately 200 mcg folate per weight in mcg DFE folate followed by said that this is a particular concern for serving. If all of the folate in the cereal the percent DV based on mcg DFE older adults who are at greater risk for is added folic acid, then the amount of folate. If a claim is made about folate, developing macrocytic anemia due to a folate would be 340 mcg DFE (200 mcg the manufacturer must declare folate deficiency of vitamin B12 and that this × 1.7) because folic acid is more either by declaring folate as the percent condition could be masked by excessive bioavailable than folate. This value is DV folate based on mcg DFE folate, or intake of folic acid from fortified foods higher than the RDA set by IOM for as the quantitative amount by weight in and/or supplements. Other comments children 4 to 8 years of age (200 mcg mcg DFE folate followed by the percent stated that the introduction of mcg DFE DFE). Thus, if we retained mcg as the DV based on mcg DFE folate. If folic as the unit of measure for folic acid may only unit of measure for folate, we acid is added to the conventional food, prompt some manufacturers (who would not differentiate between folic the manufacturer must declare folate currently provide 100 percent of the DV acid and food folate in food, and we either by declaring folate as the percent for folic acid) to reduce the amount of would underestimate the contribution of DV folate based on mcg DFE, or as the folic acid in their products. For fortified foods to the folate requirement; quantitative amount by weight in mcg example, the manufacturer of a dietary consequently, consumers may think DFE folate followed by the percent DV supplement that currently contains 100 they need more folate/folic acid than based on mcg DFE folate, in addition to percent of DV for folic acid (400 mcg they receive from a food that contains the quantitative amount of folic acid in folic acid) may reduce the amount to both folate and folic acid. mcg in parentheses. This will provide 235 mcg folic acid or 400 mcg DFE to As for the comment suggesting that the needed information about the retain 100 percent DV. we allow the use of both mcg and mcg amount of folic acid in a conventional (Response) As stated in our response DFE as units of measure, we agree that food or dietary supplement for women to comment 413, we are not limiting the declaring the amount of folic acid in who are capable of becoming pregnant. units of measure for folic acid to mcg mcg will provide information that Declaring folate, either as a quantitative DFE folate on the Nutrition Facts label. women of childbearing age need in amount in mcg DFE followed by the If folic acid is added or claims are made order to understand the unique percent DV or only as a percent DV about folic acid, the Nutrition Facts contribution of synthetic folic acid from based on mcg DFE, and, mcg folic acid, label must include the declaration of a food, given the differences in in circumstances when folic acid is folic acid as a quantitative amount by bioavailability compared to folate and added or claims are made about folic weight in mcg folic acid. nutrition recommendations for risk acid, the declaration of folate/folic acid With respect to measuring the reduction of neural tube defects (Ref. should provide adequate and correct percentage of a subpopulation that 238). information for the general U.S. consumes in excess of the UL for folic With respect to dietary supplement population, including the women of acid, we note that the rule was not labeling, if a dietary supplement has childbearing age. intended nor designed to facilitate such added synthetic folate or a claim is As for the comments regarding the research. The Nutrition Facts label made about folate, the manufacturer need for an educational campaign, we provides information to assist must include the declaration of folate as agree that it is important for changes to consumers in maintaining healthy a quantitative amount by weight of the labeling to be accompanied by dietary practices. By having only mcg folate (mcg DFE folate), and the percent education efforts to help consumers DFE or mcg of folic acid on the label,

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it would not be possible to determine determine the extent to which glucosamine salts of L–5–MTHF have the percentage of a subpopulation that reformulation might occur or whether bioavailabilities similar to folic acid. exceeds the UL for folic acid. To reformulation would present any The comments said we should support determine the percentage of a potential issues with respect to a conversion factor equivalent to that for subpopulation with folic acid intake in consumption of folate. We note, folic acid (× 1.7) for the labeling of these excess of the UL, one would have to however, that if manufacturers decrease synthetic in dietary supplements perform an analysis using the the amount of folic acid from 400 mcg and conventional foods. consumption data from NHANES and folic acid to 400 mcg DFE to retain the (Response) The use of synthetic the UL set by IOM for various age and 100 percent DV, the needs of the folates (i.e., calcium and glucosamine gender groups. majority of the U.S. population will be salts of L–MTHF) in dietary As for the comment’s statements met. For the majority of U.S. population, supplements, and the appropriate regarding NHANES, What We Eat in the RDA and its unit of measure is mcg conversion factor for these substances, America (WWEIA)/NHANES does not DFE folate and not mcg of folic acid. warrants further review. We are not use only food labels to collect Therefore, reporting total folate as mcg aware of the use of any synthetic folates, information on the type and amount of DFE folate and percent DV based on including calcium and glucosamine micronutrients contained in food mcg DFE is more accurate. salts of L–5–MTHF, in conventional products. The preexisting Nutrition (Comment 415) Several comments food. We note that folic acid is regulated Facts label declares folate in mcg which stated that, for a dietary supplement that as a food additive under § 172.345; the represents both natural folate and is ingested on an empty stomach, 1 mcg additive is identified as (N-[4-[[(2- synthetic folic acid, without taking into DFE is equivalent to 0.5 mg folic acid amino-1,4-dihydro-4-oxo-6-pteridinyl) account differences in bioavailability and is therefore subject to the methyl]amino]benzoyl]-L-glutamic acid; factors. The WWEIA/NHANES currently conversion factor of 2.0 not 1.7. The CAS Reg. 59–30–3) for use as a nutrient reports the amount of folate consumed comment said we should clarify this in in foods and may be added to as mcg DFE, as well as folic acid (mcg), the final rule if we adopt DFEs as the conventional foods subject to a standard food folate (mcg), and total folate (mcg). unit of measure. of identity when the standard provides Thus, the Nutrition Facts label is not the (Response) We are not limiting the for the addition of folic acid; to sole source of information for folate and units of measure to DFEs in the final breakfast cereal and corn grits at folic acid for this database. rule. The IOM defined DFE as follows: specified levels; and to infant formula As for older adults and the risk of 1 mcg DFE = 1 mcg food folate; 1 mcg according to applicable regulations developing macrocytic anemia due to a DFE = 0.6 mcg folic acid from fortified (§ 172.345). Conditions of use of folic deficiency of vitamin B12, we disagree foods or dietary supplements consumed acid in medical foods, foods for special that using mcg DFE on the label will put with foods; 1 mcg DFE = 0.5 mcg folic dietary use, and for meal-replacement older adults at greater risk. The current acid from dietary supplements taken on products also are included in § 172.345. Nutrition Facts label does not an empty stomach. We do not know Additional uses of folic acid as differentiate between synthetic folic how many people take a supplement described in § 172.345 would require acid and naturally occurring folate in containing folic acid on an empty submission of a food additive petition the food label. The folate RDA for stomach or with a meal. To ensure asking us to amend the regulations to individuals 19 years of age and older is consistency in the labeling of allow for the additional use. Information 400 mcg DFE, and not 400 mcg folic conventional foods fortified with folic on submitting a food additive petition is acid. The DFE accounts for the acid, dietary supplements containing described in § 171.1. Manufacturers of differences in bioavailability between folic acid, and dietary supplements food products that contain other forms food folate (natural folate) and folic acid containing folic acid that may also of folic acid or synthetic folate, such as (which is approximately 1.7 times more contribute calories and other nutrients, calcium and/or glucosamine salts of L– bioavailable than food folate). Therefore, we conclude that using the conversion 5–MTHF should consult the Office of by declaring folate as mcg DFE and factor of 0.6 mcg (multiply by 1.7) for Food Additive Safety to determine the percent DV based on mcg DFE folate, as folic acid is appropriate. The final rule appropriate regulatory pathway for the applicable, on the Nutrition Facts label, requires dietary supplements to include lawful use of their products. the total folate will be reported and will the declaration of the quantitative Although we asked for comment in provide the majority of the general, amount of folic acid, when added or the 2007 ANPRM about whether the healthy U.S. population (including when a claim is made about folic acid, current DV units for folate (mcg folate) older individuals) a more accurate in addition to folate in mcg DFE and should be consistent with the IOM DRI amount of their intake. Furthermore, by percent DV based on mcg DFE. The final reports for folate (mcg DFE) (72 FR requiring the mandatory declaration of rule also states that 1 mcg DFE is equal 62149 at 62170), we did not ask about the amount of folic acid as mcg folic to 1 mcg naturally occurring folate and the use of synthetic folate, such as acid in parentheses, when folic acid is equal to 0.6 mcg folic acid. calcium and/or glucosamine salts of L– added or a claim is made about it, (Comment 416) Some comments said 5–MTHF in food, including dietary women of childbearing age will have the that mcg DFE fails to take into supplements, or invite comment about information they need to understand the consideration the higher bioavailability the conversion factor for synthetic folate unique contribution of synthetic folic of synthetic folates compared with compared to that for folic acid. acid from a food to adhere to nutrition naturally occurring dietary folate and Therefore, we intend to consider the recommendations to reduce the risk of should not be used on labels. The comparability of synthetic folates in neural tube defects. In addition, other comments said that added L–5- dietary supplements and the need for a consumers, such as older adults, can methyltetrahydrofolate (also known as conversion factor for each in a separate determine how much folic acid is in a L–5–MTHF or L–MTHF) would be rulemaking. Until such rulemaking is serving of food. assigned the same bioavailability as completed, we do not intend to object With respect to reformulation, the naturally occurring folate and would to a manufacturer using its own comment did not provide any evidence underestimate the true bioavailability of established conversation factors, to suggest that reformulation would the folate in the food. The comments provided that the declaration is truthful occur, and so we have no basis to noted that both the calcium and and not misleading. We would not

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expect a conversion factor to exceed 1.7 and Supplement Facts labels. One records of the amount of folic acid (comparable to folic acid) when comment suggested that an educational added to the food and folate in the reporting mcg DFE on the Supplement campaign would be necessary, finished food when a mixture of folate Facts label. Any declaration of mcg DFE especially for obstetricians and women and folic acid is present in that food. for a dietary supplement that represents of child-bearing age, to teach them how One comment would revise in whole or in part the amount of to achieve adequate dietary folate levels § 101.9(g)(10)(vii) to state that, when synthetic folate present, for which a if we adopt the mcg DFE unit of folic acid and/or purified folate salts conversion factor was applied, must be measure. (e.g., L-methylfolate) is added to a food, truthful and not misleading under (Response) We agree that consumer manufacturers must make and keep section 403(a) and 201(n) of the FD&C education regarding the new unit of written records of the amount of folic Act. We will be able to determine the measure will be helpful (see part II.B.1 acid, and/or purified folate salt, added conversion factor used through for a discussion of educational to the food, as well as the amount of information obtained from records activities). We disagree that we should naturally occurring folate if present. The required by this final rule for natural retain the DV and the percent DV based comment noted that these records will folate, folic acid, and synthetic folate on the amount of mcg of folic acid. The be necessary any time folic acid or folate present in the product and the declared DV and the percent DV should be based salt is added to food to justify the mcg DFE on the label. on mcg DFE, which reflects the most calculation of the declared mcg DFE, (Comment 417) The preamble to the current recommendation for folate/folic even if no naturally occurring folate is proposed rule also stated that we are acid for the general U.S. population and present. aware that education efforts should be takes into account the differences in (Response) We agree that when folic provided to help consumers understand bioavailability between food folate and acid is added to a conventional food or the new ‘‘equivalent’’ units of measure folic acid which is more bioavailable. dietary supplement and synthetic folate for folic acid (79 FR 11879 at 11932). b. Analytical methods. The preamble (e.g., L–5–MTHF) is added to a dietary We also said that one option to help to the proposed rule (79 FR 11879 at supplement, manufacturers must keep ensure consumer understanding would 11932) noted that available analytical written records of the amount of be to allow the declaration of the methods cannot distinguish between synthetic folate added to a dietary amount of folic acid in parentheses in naturally occurring folate in supplement and the amount of folic acid addition to declaring the amount in mcg conventional food and folic acid that is added to the conventional food or DFE, and we invited comment on this added to conventional food products. dietary supplement as well as the option (id.). To calculate DFEs, the preamble to the amount of naturally occurring folate in Several comments stated that, if DFEs proposed rule (id.) explained that it is the finished conventional food or are to be included on food labels, the necessary to know both the amount of dietary supplement. We have revised mcg of folic acid must be included in folate and folic acid in the food product, § 101.9(g)(10)(vii) accordingly. parentheses. The comments said that and so proposed § 101.9(g)(10) would c. Terms to declare folate. Our the IOM recommended that women who require manufacturers to make and keep preexisting regulations identify ‘‘folic may become pregnant consume 400 mcg records to verify the amount of folic acid’’ and ‘‘folacin’’ as synonyms of of folic acid in addition to the RDA. The acid added to the food and folate in the folate and allow these terms to be added comments also said that using mcg DFE finished food, when a mixture of both in parentheses after folate or listed alone as the unit of measure will make naturally occurring folate and added without parentheses in lieu of ‘‘folate’’ it difficult for women to discern how folic acid are present in the food. on the Nutrition Facts label much of their daily intake is from folic (Comment 419) We did not receive (§ 101.9(c)(8)(v)) or on the Supplement acid and which foods would be best any comments with respect to Facts label (§ 101.36(b)(2)(B)(2)). choices for ensuring a daily intake of scientifically valid methods for Consistent with the proposed 400 mcg folic acid a day. The comments determining folate and folic acid amendments related to the units of added that this approach could put separately. However, one comment measure for folate that take into account women at higher risk for having a neural objected to the proposed recordkeeping the differences between folate and folic tube defect affecting a pregnancy. Some requirement. acid, the proposed rule would: (1) comments also noted that there may (Response) We decline to revise the Eliminate the synonym ‘‘folacin’’ also be conventional foods containing rule to remove the recordkeeping specified in §§ 101.9(c)(8)(v) and only added folic acid, such as meal requirement. In the absence of an 101.36(b)(2)(i)(B)(2); (2) require, in replacement foods based on protein analytical method that distinguishes proposed § 101.9(c)(8)(vii), that the term concentrates that do not contain between folate and folic acid, records ‘‘folate’’ be used in the labeling of significant levels of naturally occurring are necessary to demonstrate conventional foods that contain either folate. compliance with the label declaration folate only or a mixture of folate and (Response) We agree that including and include written records of the folic acid; and (3) require that the term the mcg folic acid when added to a food amount of folic acid added to the food ‘‘folic acid’’ be used in the labeling of or when a claim is made about folic acid (conventional food or dietary dietary supplements only. Thus, under is necessary to help women of supplement), the amount of synthetic the proposed rule, conventional foods childbearing age determine the amount folate, if added to the dietary would not be permitted to use the term of folic acid in each food. Thus, we have supplement, and naturally occurring ‘‘folic acid.’’ revised § 101.9(c)(8)(iv) and (c)(8)(vii) to folate in the finished product. Without (Comment 421) One comment require the declaration of folic acid in such records, we would be unable to supported eliminating the term mcg under such circumstances. determine or verify the amounts and ‘‘folacin’’ from the Nutrition Facts and (Comment 418) Some comments also would not be able to determine Supplement Facts labels. However, stated that we should retain the current whether the mcg DFE value listed on the other comments asked that we continue DV of 400 mcg as folate or folic acid label is correct. to allow the use of the term ‘‘folate’’ on without adopting a DFE approach, along (Comment 420) Proposed Supplement Facts labels. Several with the percent DV (based on the PHS § 101.9(g)(10)(vii) would require comments stated that the use of the term recommendation) in both the Nutrition manufacturers to make and keep written folate on dietary supplement labels

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refers to dietary folates which are immediately following ‘‘folate’’ on the needed for the final stage of conversion members of the folate group that can be Nutrition Facts label in § 101.9(c)(8)(v) of folic acid into the active form needed found in food, including folinic acid (5- or in place of the term ‘‘folate’’ on the by the human body and that these fomryltetrahyrofolate). For some dietary Supplement Facts label in defects relate to an enzyme called supplements, calcium L-methylfolate § 101.36(b)(2)(i)(B)(2) because we are MTHFR and are very common, although (L–5 MTHF), and various other now requiring that both the terms the defects vary enormously between tetrahydrofolates, as synthetic folate, ‘‘folate’’ and ‘‘folic acid’’ be included, ethnic groups and regions. The may be added. In comparison, the when declared, on both the Nutrition comments said that the defects can be comments said that folic acid is and Supplement Facts label. found in as many as 44 percent of North synthetically produced and refers to (Comment 422) Several comments American Caucasians and over 50 only one member of the folate group suggested that not allowing the use of percent of Italians and are more (pteroylmonoglutamic acid). The the term ‘‘folate’’ on Supplement Facts common among those predisposed to comments said it would be scientifically labels and not considering L–5 MTHF diseases such as cancer, heart disease, and chemically incorrect and calcium (Metafolin) to be equivalent to and autism. The comments said that misleading to consumers to refer to the folic acid would have devastating, these estimates do not account for reduced folate forms in dietary negative effects on industry. The mutations in other genes involved in supplements as folic acid, given that comments said that eliminating the term folate metabolism, such as DHFR, where folic acid represents only the ‘‘folate’’ would prevent dietary data have only been emerging recently. monoglutamic form. supplement manufacturers from being For individuals who have mutations Other comments noted there are a able to use L-methylfolate in their impacting MTHFR or other genes large number of dietary supplements products. Other comments said we relating to folate metabolism, the that are ‘‘whole food’’ supplements should clarify how L–5 MTHF should comments said there is a distinct containing naturally occurring folate be labeled. possibility of building up too much un- rather than added folic acid (e.g., (Response) The final rule requires the metabolized folic acid thereby multivitamin capsules manufactured use of the term ‘‘folate’’ on Supplement potentially increasing the risk of cancer, using powdered cultured yeast). Facts labels and achieves consistency heart disease or stroke. Consequently, a (Response) We agree that there are between the Supplement Facts and substantial segment of the population dietary supplements that may contain Nutrition Facts labels. needs to consume folate rather than natural folate from food or synthetic We also intend to consider the folic acid and would not be able to folate (e.g., L–5–MTHF). If synthetic comparability of synthetic folates (e.g., process dietary supplements containing folate is added to a dietary supplement, L–5–MTHF calcium (metafolin)) in folic acid. folate must be declared as mcg DFE dietary supplements and the need for a Several comments stated that folate and percent DV based on DFE. conversion factor for each in a separate requiring dietary supplement labels to This will result in consistency in the rulemaking. In the interim, use the term ‘‘folic acid,’’ when the nutrient terms used and units of manufacturers of synthetic folates, such product only contains folates found in measure for the declaration of folate on as calcium and/or glucosamine salts of food, would mislabel the product. both conventional foods and dietary L–5- MTHF may use their established (Response) When folic acid is added supplements, which will avoid conversation factors (not to exceed 1.7 to conventional food, the final rule confusion among consumers. We are not (comparable to folic acid)) when requires the declaration of mcg folic aware of a manufacturer choosing to reporting mcg DFE, and we can acid in addition to the declaration of voluntary declare naturally occurring determine what conversion factor is folate as a percent DV based on mcg folate in a dietary supplement being used through information DFE or as a quantitative amount by ingredient, but if not added for the obtained from records required by this weight in mcg DFE and the percent DV purpose of supplementation, the final rule for natural folate, folic acid, based on mcg DFE. When folic acid is manufacturer is not required to declare and synthetic folate present in the added to dietary supplements, the final the quantitative amount or the percent product and the declared folate mcg rule requires the the quantitative DV for naturally occurring folate. If a DFE on the label. amount by weight for folate (mcg DFE manufacturer chooses to voluntary (Comment 423) Some comments folate) and the percent DV based on mcg declare naturally occurring folate, the stated that limiting the use of the term DFE for folate, in addition to the mcg manufacturer must declare both the ‘‘folate’’ to conventional food only folic acid in parentheses. This should quantitative amount in mcg DFE and the would effectively make drug companies address the comments’ concerns. percent DV. In addition, if folic acid is the only source for people who have a (Comment 424) One comment would added to the dietary supplement that genetic polymorphism in the MTHFR revise the rule to state that the term has naturally occurring folate present, gene. Some comments stated that it is ‘‘folic acid’’ should be used in the the quantitative amount of folate, the important and essential that the labeling labeling of dietary supplements, but that quantitative amount of folic acid, and of dietary supplements explicitly state the term ‘‘folate’’ should be used if the the % DV must be declared. The the form or forms of folate they contain dietary supplement contains folates in terminology for the units of measure in because many people are not able to food as opposed to folic acid. The the Supplement Facts label will be convert folic acid to folate. The comment said that conventional foods consistent with the terminology in the comments added that, although there is would not be permitted to use the term Nutrition Facts label. Therefore, the no agreement regarding the number of ‘‘folic acid’’ unless they are fortified final rule removes ‘‘folacin’’ from the people whose bodies have difficulty with folic acid. The comment said this list of synonyms that may be used for converting folic acid to folate, there is result would be consistent with our folate in the Nutrition Facts label in agreement that it is a serious concern for intent to distinguish between items § 101.9(c)(8)(v) and the Supplement many individuals. The comments said containing folate and those that Facts label in § 101.36(b)(2)(i)(B)(2)). In there is much knowledge available primarily contain synthetic folic acid. addition, the final rule removes the term regarding defects in two Another comment would revise ‘‘folic acid’’ from the list of synonyms deoxyribonucleic acid (DNA) sequences footnote 3 in proposed § 101.9(c)(8)(iv). that may be added in parentheses responsible for producing enzymes The proposed footnote would state that

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folic acid ‘‘must be used for purpose of label, we do not require it to be listed uncertain. The comment suggested declaration in the labeling of dietary again in the ingredient statement. With using the term FAE (folic acid supplements’’ and ‘‘must also be respect to conventional food, the only equivalent) instead of DFE because FAE declared in mcg DFE.’’ The comment form that currently can be added to is based on a well-defined compound, would revise the footnote to say that conventional food is folic acid under unlike folate naturally present in folic acid ‘‘must be used for foods that § 172.345 and not any other forms. If unspecified food. Furthermore, the contain this nutrient solely in the form folic acid is added to a conventional comment said, when the folic acid dose of added folic acid. Foods which supply food, folic acid must be listed in the is sufficiently small, the biological both folate and folic acid must list the ingredient list (§ 101.4(a)). availability is much better defined than predominant form. Folate and folic acid (Comment 425) Some comments folate from unspecified food. The must both be declared in mcg DFE. stated that not allowing the term calculation of FAE would include Additional information regarding the ‘‘folate’’ on dietary supplement labels contribution from all folates, which types(s) or sources(s) of the nutrients violates the First Amendment. The would include folic acid and L–5– (e.g., folate, folic acid, or L5–MTHF) and comments said we cannot require that MTHF salts. The comment also stated or/relative amounts where more than labeling to refer to folate as folic acid that, as understanding of folate naturally one form is present, may be included in because, according to the comments, occurring in food improved, the parentheses.’’ The comment also would such labeling would then be false. calculation of its contribution to FAE revise § 101.9(c)(8)(vii) to require (Response) The final rule requires the can be improved. ‘‘folate’’ ‘‘for products containing only use of the terms ‘‘folate’’ and ‘‘folic (Response) We address the or predominantly folate’’ and ‘‘folic acid,’’ when declared, on Supplement requirements for labeling folate in our acid’’ for ‘‘products containing only or Facts labels and achieves consistency response to comment 413. predominantly folic acid.’’ (The between the terms used and units of We disagree that the term FAE should proposed rule would require, when the measure in the Supplement Facts and be used on the label instead of DFE. amount of folate is declared in the Nutrition Facts labels. Therefore, the Based on the IOM report (IOM 1998), labeling of a conventional food, the use comments’ First Amendment concerns the correct terminology that is accepted of the name ‘‘folate’’ for products are no longer applicable. by the scientific community is mcg DFE containing either folate alone or a (Comment 426) One comment said and not FAE. We will, however, monitor mixture of folate and folic acid and the that there is sufficient theoretical and the science in this area and, if there are use of the term ‘‘folic acid’’ when the circumstantial evidence that could any major changes based on the future nutrient is declared in the labeling of a compel the informed consumer to seek consensus report, we will consider dietary supplement.) The comment also dietary supplements containing methyl whether further changes are needed. would revise the rule to say that folate rather than folic acid. Other (Comment 428) One comment stated additional information regarding the comments suggested putting the term that, while there is consensus that pure types(s) or sources(s) of the nutrients ‘‘folate’’ on conventional foods and folic acid is more bioavailable than (e.g., folate, folic acid, or L-methylfolate) dietary supplement labels, and using naturally occurring folate in food, there and or/relative amounts where more ‘‘folic acid’’ on dietary supplement is currently no scientific consensus as to than one form is present, may be labels with the source in parentheses the magnitude of this effect. The included in parentheses. (e.g., Folic acid as calcium l-5 comment said that one recent review (Response) The final rule requires the methyltetrahyrofolate). states that the bioavailability of food use of the term ‘‘folate’’ on Supplement (Response) Under the Supplement folate is commonly estimated at 50 Facts labels when folic acid or synthetic Facts label requirements at § 101.36(d), percent of folic acid bioavailability, but folate is added and must be declared the source ingredient may be identified said this should be considered a rough and when naturally occurring folate is in parentheses immediately following or estimate because the data on the present and may be declared. The final indented beneath the name of a dietary bioavailability of food folate vary rule also requires the use of the term ingredient and preceded by the word between 30 and 98 percent. The ‘‘folic acid’’ in mcg folic acid when folic ‘‘as’’ or ‘‘from’’ (e.g., ‘‘folate (as L–5– comment noted that, even if a dietary acid is present. This achieves MTHF-calcium)).’’ When a source supplement’s direction for use specifies consistency in terminology between the ingredient is not identified within the taking the products with food or alone, Supplement Facts and Nutrition Facts Nutrition Facts label, it must be listed many consumers may not comply. The labels. If folic acid is declared, in an ingredient statement in comment also stated that the more manufacturers of dietary supplements accordance with § 101.4(g). However, precise estimates (i.e., based on must also declare the quantitative when a source ingredient is identified in consumption of the nutrient in fortified amount of folate. The mcg DFE reflects the Nutrition Facts label, it will not be food or a supplement taken with food the higher bioavailability of folic acid listed again in the ingredient statement. vs. supplement taken alone) are not and certain synthetic folate (e.g., L–5– For conventional food, under § 172.345, justified by the available data. The MTHF) than that of food folate and is the only form that currently can be comment said that our proposed the basis of DV. added to conventional food is folic acid definition, based on IOM Under the Supplement Facts label and not any other forms. If folic acid is recommendations dating to 1998, no requirements at § 101.36(d), the source added to a conventional food, folic acid longer represents current knowledge ingredient may be identified in must be listed in the ingredient list and developments in the formulation of parentheses immediately following or (§ 101.4(a)). foods and supplements accurately. The indented beneath the name of a dietary (Comment 427) One comment stated comment would revise the definition to ingredient and preceded by the word that it is reasonable not to permit the assign a value to naturally occurring ‘‘as’’ or ‘‘from.’’ When a source term folate to be used alone on dietary folate at 50 percent of the value of folic ingredient is not identified within the supplement labels because it is not acid (as well as at 50 percent of the nutrition label, it must be listed in an sufficiently specific. The comment value of L–MTHF salts on the equimolar ingredient statement in accordance with added that if DFE is used for foods, it basis to folic acid. § 101.4(g). However, when a source should be used for dietary supplements The comment also would revise ingredient is identified in the nutrition as well, but that correct calculation is footnote 4 in § 101.9(c)(8)(iv). As

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proposed, the footnote would explain (IUs) for the labeling of vitamins A, D, such as the IOM report on calcium and that DFE stands for ‘‘Dietary folate and E on the Nutrition and Supplements vitamin D (Ref. 200) present both IUs equivalents’’ and that 1 DFE equals 1 Facts labels. The preamble to the and mcg as the unit of measure. Thus, microgram food folate and equals 0.6 proposed rule (79 FR 11879 at 11932) we agree, in part, with the comment micrograms folic acid from fortified described how changes in our noting that the IOM uses IUs as the unit food or as a supplement consumed with understanding of vitamin activity, along of measure. Second, we found that the food equals 0.5 micrograms of a with the IOM Labeling Committee’s majority of the U.S. population has supplement. The comment would revise recommendation to change the units of usual intakes of vitamin D below the the footnote to capitalize the first letters measure for these nutrients to be EAR from conventional foods alone, and in ‘‘folate equivalents’’ and to state that consistent with the units in the new DRI even when combined with dietary ‘‘1 DFE = 1 mcg naturally occurring reports, led us to propose amending supplements (79 FR 11879 at 11922). folate = 0.5 mcg folic acid (anhydrous § 101.9(c)(8)(iv) to replace IUs for the Moreover, certain segments of the U.S. basis)* = 0.56 mcg of L-methylfolate RDIs for vitamin A, vitamin D, and population are at risk for inadequacy calcium salt (anhydrous basis, vitamin E with mcg RAE for vitamin A, and may be at increased risk of molecular weight of 497.5))* = 0.93 mcg mcg for vitamin D, and mg a-tocopherol deficiency. Inadequate intakes of L-methylfolate glucosamine salt for vitamin E. vitamin D are associated with (anhydrous basis, molecular weight of a. General comments. osteoporosis and osteopenia (id.). Third, 817.8))*. With respect to the asterisks, (Comment 429) Several comments there are not a wide variety of food the comment said that, because these supported changing the units of sources of vitamin D (79 FR 11879 at numbers will often be calculated rather measure for vitamin A, vitamin D, and than determined through testing, it is vitamin E. One comment supported 11921), and many individuals rely on important to specify how water present using mg because, the comment vitamin D supplements labeled in IUs to in the ingredient is to be accounted for asserted, that is how most registered achieve an optimal intake, often on the in the calculation. dietitians give recommendations. advice and prescription of a clinician. (Response) We disagree that we Another comment cited a study that For these reasons, we have determined should assign the value of naturally reported that physicians typically it is appropriate to permit the voluntary occurring folate at 50 percent of the prescribe vitamin and mineral intakes in labeling of vitamin D in IUs, in value of folic acid (folic acid multiply mg (Ref. 239). Other comments asked us parentheses, alongside the mandatory by 2 instead of 1.7). We agree that the to retain IUs rather than change to mcg declaration in mcg units. In this way, bioavailability of food folate at 50 RAE, mcg vitamin D, and mg vitamin E. the manufacturer can determine percent of the bioavailability of folic The comments said that consumers are whether to include IUs on the label for acid is considered a rough estimate, as familiar with IUs and would be its products, based on the use of the data on the bioavailability of food folate confused by use of new units for these product and consumers who may be may vary between 30 percent and 98 nutrients. Other comments seeking to relying on the advice of a clinician who percent. While we recognize that the retain IUs as the unit of measure for recommends or prescribes vitamin D in IOM recommendation dates to 1998, it vitamin D noted that IUs are used on IUs alone, or combined with, mcg units. remains the best scientific consensus dietary supplements and by clinicians. The reasons we provide for the need for report that is available now. We will Another comment requested that the voluntary labeling of IUs for vitamin D monitor the science in this area and, if unit of measure for vitamin D be are not present with respect to vitamin there are any changes based on the consistent for foods and supplements. A or E as the IOM is consistent in future consensus report, we will One comment supporting the continued presenting units of measure for these consider whether to make use of IUs as a unit of measure noted nutrients and we have determined them modifications. that the IOM uses IUs for vitamin D. not to be nutrients of public health In regard to taking into account the Other comments recommended that significance. Therefore, we are replacing weights of the salts in the formula we develop an educational campaign to IUs with mcg which will be consistent weights of the available 5–MTHF help consumers understand that with the IOM Labeling Committee’s derivatives, label values and changes in the units of measure. Some recommendation that the units of requirements are presented on labels on comments suggested that we make a measure be consistent with the DRIs. a weight basis (e.g., mg of calcium, gradual transition to the new units of We agree that the unit of measure for rather than molar equivalents of measure, including a period during vitamin D should be consistent for foods calcium). Manufacturers are responsible which the labels could use IUs in and supplements. We note that the for calculating amounts of the salt forms addition to the new units of measure to Supplement Facts label reflects the unit that, when added, will provide accurate help consumer understanding. of measure for vitamin D required by (Response) We acknowledge that amounts of folate for the label §§ 101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B) consumers may need some time to declaration. This is routinely done with thus will reflect mcg as the unit of other compounds such as minerals (e.g., adjust to the new units and consider educational activities important to assist measure for both conventional foods for calcium, the label states the amount and dietary supplements. of calcium, not the amount of calcium consumers to understand the changes carbonate that is added). made. However, unlike for vitamins A Furthermore, we provide for As for the footnote pertaining to DFE and E, we have further considered the voluntary labeling of vitamin D in IUs in § 101.9(c)(8)(iv), we have revised it to use of IUs for vitamin D and have on both conventional food and dietary read as follows: ‘‘DFE = Dietary Folate determined there are good reasons, supplements. Because we have Equivalents; 1 DFE = 1 mcg naturally specific to vitamin D, to permit the determined that vitamin D is a nutrient occurring folate = 0.6 mcg folic acid.’’ voluntary labeling in IUs for vitamin D of public health significance, we in addition to requiring the new mcg consider that voluntary labeling in IUs 4. Vitamins A, D, and E units. First, although the IOM Labeling for vitamin D will assist consumers in Our preexisting regulations, at Report (Ref. 25) recommended the use maintaining healthy dietary practices. §§ 101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B), of mcg as the unit of measure for The voluntary listing of the amount of require the use of International Units vitamin D, some other IOM materials vitamin D in IUs should be listed in

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parentheses next to the mcg amount for § 101.9(c)(8)(iv) of the final rule in rats (Ref. 241). Mahabir et al. 2008 vitamin D. includes the conversions for mcg RAE to studied the associations between 4 As for a transition period to the new mcg supplemental b-carotene: (a-, b-, c-, and d-tocopherol) units of measure, we note that the final 1 retinol activity equivalent (mcg RAE) in human diets and lung cancer risk rule has a compliance date of July 26, = 1 mcg retinol (Ref. 243). The review article by Wolf 2018, although the compliance date for 2 mcg supplemental b-carotene discussed the biochemical mechanism manufacturers with less than $10 12 mcg of dietary b-carotene by which a-tocopherol influences million in annual food sales is July 26, 24 mcg of other dietary provitamin A gamma-tocopherol (Ref. 245). Christen 2019. This should give manufacturers carotenoids et al. 1997 studied the effects of gamma- and consumers some time to convert to (a-carotene or b-cryptoxanthin) tocopherol on lipid peroxidation in the new units of measure and also give (Comment 432) The proposed rule, at vitro (Ref. 240). Jiang et al. 2008 studied us some time to educate consumers § 101.9(c)(8)(iv), would change the units the effect of different forms of vitamin about the change. of measure for vitamin E by replacing E and their metabolites on enzyme (Comment 430) Some comments ‘‘IU’’ with ‘‘mg,’’ representing mg a- reactions involved in the inflammation urged that we use the symbol ‘mg’ tocopherol. The preamble to the pathway (cyclooxygenase-catalyzed instead of ‘mcg’. reactions) in vitro (Ref. 242). The review (Response) We decline to amend the proposed rule (79 FR 11879 at 11932) explained that the new measure of article by Sen et al. 2007 discussed rule as suggested by the comment. tocotrienols and their biological While the abbreviation ‘‘mg’’ may also be vitamin E activity would account for the difference in activity between naturally functions. While these animal studies used for micrograms, the use of ‘‘mcg’ and review articles may suggest instead of ‘‘mg’’ may prevent consumers occurring and synthetic vitamin E. Several comments supported the biological activity of other forms of from misinterpreting the prefix m as m vitamin E, outcomes in humans are (milli). definition of vitamin E as mg a- tocopherol. However, other comments lacking, thus a totality of evidence for a b. Specific comments on the units of role of other forms of vitamin E in disagreed with mg a-tocopherol and measure for individual vitamins. human health is lacking (Ref. 246). We recommended that we include other Several comments focused on the units consider the totality of evidence, such forms, in addition to a-tocopherol, in of measure for individual vitamins. as what is presented in consensus the definition of vitamin E. The (Comment 431) We proposed to reports like those issued by the IOM, comments said that other forms of change the units of measure for vitamin rather than individual studies, to vitamin E have biological activity and A in § 101.9(c)(8)(iv) by replacing ‘‘IU’’ establish the RDIs. Therefore, based on that some forms are linked to cancer, with ‘‘mcg,’’ representing mcg Retinol the information provided in the stroke, and neurodegeneration. One Activity Equivalents (RAE). The comment, we do not have a basis to comment cited several studies to preamble to the proposed rule explained include other forms of vitamin E in our that the IU for vitamin A does not reflect support the assertion that other forms of definition. the carotene:retinol equivalency ratio, vitamin E have bioactivities that are We note, however, that other forms of that the vitamin A activity of provitamin important to disease prevention and/or vitamin E can be listed in the ingredient A carotenoids (such as b-carotene) is therapy (Refs. 240–245). One comment statement for foods. less than pre-formed vitamin A (retinol), disagreed with the use of mg a- (Comment 433) The proposed rule, at and that RAEs consider 6 mcg of dietary tocopherol for vitamin E and suggested § 101.9(g)(10), would require b-carotene to be equivalent to 1 mcg of we include different forms of vitamin E manufacturers to verify the declared purified b-carotene in supplements (79 and relative amounts so that the vitamin amount of both all rac-a-tocopherol FR 11879 at 11932). We proposed a E declaration is not misleading. acetate and RRR-a-tocopherol in the similar change dietary supplements in (Response) We decline to include finished food product. The preamble to proposed § 101.36(b)(2)(i)(B)(3). other forms in the definition of vitamin the proposed rule (79 FR 11879 at Several comments agreed with the E. As we noted in the preamble to the 11933) explained that the RDA for change to mcg RAE. However, other proposed rule (79 FR 11879 at 11926), vitamin E is 15 mg/day of a-tocopherol comments opposed changing IUs to mcg RDIs for vitamins and minerals are and that a-tocopherol is the only form RAE; the comments said that the change based on the DRIs set by the IOM that of vitamin E that is maintained in blood fails to distinguish between synthetic reflect the most current science and has biological activity. The b-carotene and naturally derived regarding nutrient requirements. The preamble to the proposed rule also b-carotene in foods and supplements RDA for vitamin E was established for explained that there are eight and results in less vitamin A declared mg of a-tocopherol because a- stereoisomers of a-tocopherol (RRR, on supplements. tocopherol is the only form of vitamin RSR, RRS, RSS, SRR, SSR, SRS, SSS) One comment noted that we provided E that is maintained in blood and has and that only RRR a-tocopherol occurs only RAE conversions for retinol, beta- biological activity (79 FR 11879 at naturally in foods. Commercially carotene, alpha-carotene and beta- 11933). We acknowledge the studies available vitamin E that is used to fortify cryptoxanthin and said it would be submitted to support the assertion that foods and used in dietary supplements incorrect to apply the same conversion other forms of vitamin E, such as contains esters of either the natural factor to naturally occurring, as gamma-tocopherol, have biological RRR- or, more commonly, mixtures of compared to synthetically derived, b- activity that may be pertinent to disease the 8 stereoisomers (e.g., all rac-a- carotene. prevention and/or therapy. However, tocopherol acetate). Four stereoisomers (Response) We agree there is a these individual studies measured (SRR, SSR, SRS, and SSS) are not difference in biological activity between outcomes other than induced human maintained in human plasma or tissues, synthetic and naturally derived b- vitamin E deficiency assessed by the so we proposed to limit the new RDA carotene. Information presented in correlation between red blood cell lysis for vitamin E to the four 2R Table 2 of the proposed rule (79 FR and plasma a-tocopherol on which the stereoisomeric forms (RRR, RSR, RRS 11879 at 11931) inadvertently omitted a RDA was based (Ref. 246). Jiang et al. and RSS) of a-tocopherol. We stated that conversion for RAE from b-carotene 2003 studied gamma tocopherol and its these four forms of a-tocopherol are from supplements. The table in metabolite on markers of inflammation found in nonfortified and fortified

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conventional foods and dietary is the correct term to refer to the As for the comment objecting to supplements and that the all rac-a- synthetic form of vitamin E. narrowing the definition of vitamin E to tocopherol acetate in fortified foods or With respect to analytical testing, we four stereoisomers because it is dietary supplements has one-half the decline to speculate on the methods that burdensome to confirm which activity of RRR-a-tocopherol naturally manufacturers may deem practical to stereoisomer is present in synthetic found in foods or the 2R stereoisomeric verify the declared amount of both RRR- vitamin E additives, we point out that forms of a-tocopherol (id.). However, a-tocopherol and all rac-a-tocopherol in providing information that a vitamin E because AOAC methods cannot finished food products. We additive is only present in a product individually measure the naturally acknowledge that it is a new (rather than confirming the occurring and synthetic forms of requirement to verify the amount of stereoisomers present in the synthetic vitamin E, it is necessary to know the both RRR-a-tocopherol in the finished vitamin E additive) would provide an amount of both RRR-a-tocopherol and food and all rac-a-tocopherol added to inaccurate estimation of the vitamin E all rac-a-tocopherol in a food product to the food in finished food products when activity in the body. We reiterate that calculate vitamin E activity for a mixture of both are present in a food. the RDI for vitamin E is based on the declaration as mg a-tocopherol. However, without AOAC methods to RDA for vitamin E which is limited to One comment suggested that it is individually measure these two forms of the four 2R stereoisomeric forms (RRR, more practical for manufacturers of vitamin E and the inability to determine RSR, RRS, and RSS) of a-tocopherol (79 vitamin E esters to ascertain the RRR, the amount of RRR-a-tocopherol in a FR 11879 at 11926). Because synthetic RSR, RRS and RSS content in their food by subtracting the amount of all vitamin E, also referred to as all rac-a- ingredients and to disclose this rac-a-tocopherol from the total amount tocopherol, contains both 2R- and 2S- information to finished food declared, we need to rely on stereoisomers of a-tocopherol and has manufacturers for use in calculating the recordkeeping to verify the amount of one-half the activity of the RRR-a- declared amount of vitamin E, instead of vitamin E in a product. tocopherol naturally found in foods or requiring finished food manufacturer to As for the comment’s statement that the other 2R stereoisomers of a- test the finished product to verify the analytical methods may be prohibitively tocopherol, it is necessary to determine amounts of various forms of vitamin E, expensive, the practicality or feasibility the stereoisomers present in a food to especially since valid methods for many of using new analytical methods can determine vitamin E activity. depend on a variety of factors. For food matrices may not be available. The (Comment 434) One comment noted example, a method that uses equipment comment was concerned that, even if that the proposed rule did not mention or technology that is readily available they can be identified, analytical other esters of both natural (d-a- may be less costly compared to a methods may not be valid for a wide tocopheryl acetate) and synthetic forms method that uses proprietary equipment variety of food matrices and may be of vitamin E (a-tocopheryl succinate) or technology. The number of facilities prohibitively expensive. and said we should revise the rule to that can use a new analytical method include these forms. Another comment asked that we may influence cost. For example, if a (Response) We agree that the ester affirmatively state that, if appropriate large number of facilities are able to use forms of natural and synthetic vitamin new methods become available to a new analytical method, then testing E are considered as a-tocopherol forms distinguish natural and synthetic costs between facilities may become of vitamin E. The RDA for a-tocopherol vitamin E, manufacturers must declare competitive; in contrast, if there are few is limited to RRR-a-tocopherol the amount of vitamin E by appropriate facilities that can use the analytical (historically and incorrectly labeled d-a- and reliable analytical testing. method, then testing costs may be less tocopherol) the only form of a- Another comment disagreed with sensitive to competition. Consequently, tocopherol that occurs naturally in narrowing the definition of vitamin E to because we do not know what new foods, and the other 2R-stereoisomeric four stereoisomers and said it is analytical methods may exist in the forms of a-tocopherol (RSR-, RRS-, and burdensome to confirm which future or the market for those new RSS-a-tocopherol) that are synthesized stereoisomer is present in synthetic methods, we cannot say whether those chemically and found in fortified foods vitamin E additives compared to simply methods will be prohibitively and supplements. Vitamin E confirming that the additive is, indeed, expensive. compounds include RRR-a-tocopherol vitamin E. We also decline to revise the rule to (also referred to as d-a-tocopherol or (Response) We decline to revise the affirmatively state that manufacturers natural) and its esters (i.e. RRR-a rule as suggested by the comments. declare the amounts of vitamin E by -tocopheryl acetate, RRR-a -tocopheryl However, on our own initiative, we appropriate and reliable analytical succinate) and all rac-a-tocopherol (also are correcting an inadvertent error that testing, if appropriate new methods referred to as dl-a-tocopherol) and its we made in the proposed rule. The become available. The comment did not esters (i.e., all rac-a-tocopheryl acetate, proposed rule used the term ‘‘all rac-a- explain how manufacturers would be all rac-a-tocopheryol succinate) (Ref. tocopherol acetate’’ when referring to able to determine whether a new 247). We note that all of these vitamin the synthetic form of vitamin E in method was ‘‘appropriate’’ or E compounds may be present in fortified foods or dietary supplements ‘‘available’’ or how differences in fortified foods and multivitamins. We because esters of synthetic vitamin E are opinion as to whether a particular have revised the rule to include the commonly used in fortified foods and method is ‘‘appropriate’’ or ‘‘available’’ ester forms of natural and synthetic dietary supplements. However, the might be resolved. Current AOAC vitamin E. correct term for synthetic vitamin E is methods cannot individually measure (Comment 435) Another comment all rac-a-tocopherol, just as the term for naturally occurring vitamin E (RRR-a- requested we provide a conversion in naturally occurring vitamin is RRR-a- tocopherol) and synthetic vitamin E (all the final rule stating 1 mg a-tocopherol tocopherol. Esters of synthetic vitamin E rac-a-tocopherol and its esters) in food (label claim) = 1 mg RRR-a-tocopherol; are not limited only to ‘‘all rac-a- products. Nevertheless, we will 1 mg a-tocopherol (label claim) = 2 mg tocopherol acetate’’ and also include continue to monitor developments all rac-a-tocopherol. ‘‘all rac-a-tocopheryl succinate.’’ We regarding methods to distinguish (Response) We agree with the note that the term ‘all rac-a-tocopherol’ natural and synthetic vitamin E. comment. The final rule provides this

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conversion as a footnote in the table in preamble to the proposed rule discussed information on tryptophan required, § 101.9(c)(8)(iv): 1 mg a-tocopherol updating the RDIs for various nutrients manufacturers would be required to (label claim) = 1 mg a-tocopherol = 1 mg (including niacin) and compared the determine niacin and tryptophan RRR- a-tocopherol = 2 mg all rac- a- current RDI of 20 mg against the content, either through analytic testing tocopherol. proposed RDI of 16 mg NE (79 FR 11879 or existing databases. (Comment 436) Some comments at 11927, 11931). (Response) The declaration of niacin objected to changing the units of Several comments supported is voluntary unless it is added as a measure for vitamin E. Several changing ‘‘mg’’ niacin to mg niacin nutrient supplement to the food or if the comments stated that there are no equivalents (NE). The comments said label makes a nutrition claim about it. AOAC international official methods to the change would be consistent with the Compliance may be determined by distinguish between different forms of IOM’s use of RDAs as the basis for measuring niacin and tryptophan vitamin E in foods and supplements. establishing reference values for separately. The unit of measure (mg NE) One comment objected the change to mg purposes of food labeling. Another includes both preformed niacin (from a-tocopherol and said there is a lack of comment referred to the footnote in nicotinic acid and nicotinamide in the scientifically validated methods capable proposed § 101.9(c)(8)(iv) and noted that diet or niacin) and niacin resulting from of individually measuring all rac-a- ‘‘milligrams NE’’ is different from the the conversion of tryptophan (Ref. 249), tocopherol acetate and RRR-a- existing regulation’s use of and AOAC methods exist for both tocopherol. ‘‘milligrams.’’ The comment said that it niacin and tryptophan. Thus, a Another comment said that it is not assumed that compliance would be declaration of niacin content requires possible to measure total vitamin E by determined by testing the product using products to include contributions from subtracting all rac-a-tocopherol acetate AOAC methods for both niacin and preformed niacin as well as tryptophan, from total vitamin E to determine RRR- tryptophan and that this, if correct, including those that may not contain a-tocopherol. would increase the burden on preformed niacin. (Response) We agree that current manufacturers because it will As for the comment’s statement that AOAC methods cannot individually necessitate additional testing. manufacturers may not notice the measure naturally occurring vitamin E In contrast, other comments would revised requirements for niacin (RRR-a-tocopherol) and all rac-a- have us continue to use milligrams as declaration, we decline to revise the tocopherol in foods. We also agree that the unit of measure for niacin. rule as suggested by the comment. We it is not possible to measure total (Response) The RDA for niacin is note that § 101.3(e)(4)(ii) (regarding vitamin E by subtracting all rac-a- expressed as niacin equivalents (NE) identity labeling of food in packaged tocopherol from total vitamin E to because the body’s niacin requirement form) states, in relevant part, that a determine RRR-a-tocopherol. For this is met not only by preformed niacin measurable amount of an essential reason, the final rule, at (nicotinamide, nicotinic acid, and its nutrient in a food shall be considered to § 101.9(g)(10)(vi), requires derivatives) in the diet, but also from be 2 percent or more of the Reference manufacturers to make and keep written conversion from dietary protein Daily Intake (RDI) of any vitamin or records of the amount of all rac- a- containing tryptophan (Ref. 248). mineral listed under § 101.9(c)(8)(iv) per tocopherol added to the food and RRR- We agree with the comment that reference amount customarily a-tocopherol in the finished food. compliance with a voluntary declaration consumed. We recognize that We disagree with the comment of niacin would be determined by manufacturers may be unaware of the objecting to changing the unit of analysis, using AOAC methods, for both requirement for niacin declaration in mg measure to mg a-tocopherol because niacin and tryptophan, or by reference and plan to engage in education and there is a lack of scientifically validated to existing databases for both nutrients. outreach explaining the revised changes methods capable of individually Niacin equivalents would be calculated to units of measurement for vitamins measuring all rac-a-tocopherol and using the following conversion: NE and minerals. RRR-a-tocopherol. We consider the DRIs (niacin equivalents): 1 mg NE = 1 mg As for the comment that that reflect the most current science preformed niacin = 60 milligrams of manufacturers would be required to regarding nutrient requirements as the tryptophan. While the unit of determine niacin and tryptophan basis for establishing RDIs and, measurement for the RDI for niacin is content, either through analytic testing therefore, the declaration of vitamin E as listed as mg NE in § 101.9(c)(8)(iv), only or existing databases, we note we have mg a-tocopherol. The choice of unit of the amount ‘‘mg’’ will continue to be not stated how a company should measure for vitamin E is not based on declared on nutrition and supplement determine the nutrient content of their the availability of scientifically facts labeling. product for labeling purposes (Ref. 122). validated methods capable of (Comment 438) One comment asked Regardless of its source, a company is individually measuring all rac-a- how compliance will be determined and responsible for the accuracy and the tocopherol and RRR-a-tocopherol. asked us to clarify whether a declaration compliance of the information of niacin content will be required for presented on the label. Use of a database 5. Niacin products that contain no actual niacin. that we have accepted may give (Comment 437) Our preexisting The comment would revise the rule to manufacturers some assurance in that regulations, at § 101.9(c)(8)(iv), state that include a provision specifying that we have stated that we will work with the RDI for niacin is 20 mg. The products containing more than 19 mg of industry to resolve any compliance proposed rule would amend tryptophan (corresponding to 0.32 mg of problems that might arise for food § 101.9(c)(8)(iv), in relevant part, by niacin or 2 percent of the RDI) must labeled on the basis of a database that changing the unit of measure from ‘‘mg’’ declare niacin even if there is no actual we have accepted. A manual entitled to ‘‘milligrams NE’’ where ‘‘NE’’ would niacin present or else the manufacturers ‘‘FDA Nutrition Labeling Manual: A stand for ‘‘niacin equivalents,’’ and a of such products might not notice the Guide for Developing and Using footnote to proposed § 101.9(c)(8)(iv) revised requirements for niacin Databases’’ is available online. would explain that 1 milligram NE is declaration. Another comment noted (Comment 439) One comment pointed equal to 1 milligram niacin or also equal that, for many protein-containing out that the use of mg NE may not to 60 milligrams of tryptophan. The products for which there is presently no accurately reflect niacin contribution in

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foods because the conversion of permitted to declare calories from fat, Therefore, we proposed to revise the tryptophan to niacin is highly variable calories from saturated fat, saturated fat, exceptions for requirements for among individuals and because the polyunsaturated fat, monounsaturated nutrition labeling provided in body uses tryptophan primarily for its fat and cholesterol on the Nutrition § 101.9(j)(5)(i) and the exception to the role in protein synthesis instead of Facts label (§ 101.9(j)(5)(i)). requirement for the format used for niacin production. The comment said The preamble to the proposed rule (79 nutrient information on food labeling in that using mg NE as the unit of measure FR 11879 at 11933) also mentioned that § 101.9(d)(1) for foods represented or could represent an over-estimate of our regulations do not include DRVs or purported to be specifically for infants niacin intake in the diet. Another RDIs for nutrients, generally, for infants, and children less than 4 years of age. comment was concerned there could be children under 4 years of age, or Specifically, we proposed to replace the an extra step in food labeling and pregnant and lactating women, but there current category of infants and children another potential source of error. are requirements for a DRV for protein less than 4 years with infants 7 through (Response) We disagree that using mg for children 4 or more years of age and 12 months and children 1 through 3 NE may lead to overestimates of niacin RDIs for protein for each of the years of age. intake from foods. We acknowledge that following subpopulations: (1) Children (Comment 441) Several comments the conversion of tryptophan to niacin less than 4 years of age; (2) infants; (3) supported providing nutrition may vary among individuals and that pregnant women; and (4) lactating information for children less than 4 tryptophan has a role in protein women (§ 101.9(c)(7)(iii)). years because, according to the synthesis. The conversion factor of 1 mg comments, these subgroups have 1. Age Range for Infants and Young NE = 60 mg tryptophan is the mean of different nutritional needs. Another Children a wide range of individual values from comment recommended mandatory human studies that measured the Our preexisting regulations, at nutrition labeling for children less than conversion of tryptophan to urinary § 101.9(j)(5), use the age ranges ‘‘less 12 months and children 1 through 3 niacin metabolites (Ref. 248). than 2 years of age’’ and ‘‘less than 4 years. One comment said that we should We acknowledge the concern that years of age’’ to establish labeling continue to allow labeling information using mg NE involves an added step of requirements for foods represented or on foods for infants less than 7 months, measuring tryptophan, but note that purported to be specifically for infants such as infant cereals, or, at a minimum, tryptophan is converted to niacin by the and young children. The preamble to allow such labeling to remain voluntary. body and using mg NE provides a more the proposed rule (79 FR 11879 at 11933 (Response) We agree, in part, with the accurate estimation of available niacin through 11934) stated that comments to comments that recommended in the body compared to mg of niacin. our 2007 ANPRM recommended mandatory nutrition labeling for infants (Comment 440) The proposed rule, at changing the age categories to infants 7 less than 12 months. We decline to § 101.9(c)(8)(iv), would include a to 12 months and young children 1 revise the age range for infants to infants footnote stating that ‘‘NE’’ means niacin through 3 years (13 through 48 months), less than 12 months because using that equivalents and that ‘‘1 milligram niacin consistent with the age ranges used in age range would leave a 1 month gap as = 60 milligrams of tryptophan.’’ One the IOM’s age-specific DRI the age for children 1 through 3 years comment suggested that, for additional recommendations. In the preamble to represents 13 through 48 months. We clarity and consistency, we should the proposed rule (79 FR 11879 at 11933 also agree that nutrition labeling on revise footnote 2 to say ‘‘NE = Niacin through 11934), we discussed why we foods represented or purported to be for equivalents, 1 NE = 1 milligram niacin considered it appropriate to adopt the infants less than 7 months old such as = 60 milligrams of tryptophan.’’ same age categories as those used in the infant cereals should continue to be (Response) We agree with the IOM DRIs for infants and children. In mandatory. We proposed the age comment and have revised the footnote brief, we said: category for labeling of infants 7 through for NE as follows: NE = Niacin • Our proposed DVs are based on 12 months to be consistent with the age equivalents, 1 mg NE = 1 mg niacin = these age-specific DRIs; ranges used in the IOM’s age-specific 60 milligrams tryptophan.’’ • Infants are transitioning to eating DRI recommendations as well as current breastfeeding recommendations for the O. Labeling of Foods for Infants, Young solid foods by 7 through 12 months, and first 6 months of life (79 FR 11933). Children, and Pregnant or Lactating there are a number of foods in the Optimally, infants should begin eating Women marketplace identified for this age group; complementary foods at around 6 In the preamble to the proposed rule • With respect to children 1 through months of age (AAP Section on (79 FR 11879 at 11933), we explained 3 years of age, using the DRI age range Breastfeeding 2012, WHO that our general labeling requirements would result in infants no longer being Complementary feeding 2010); however, for foods in § 101.9(c) apply to foods for the lower end of the age range in the some infants are being introduced to infants, young children, and pregnant category of infants and children less foods and beverages before then (siega- and lactating women, with certain than 2 years and less than 4 years of age Riz JADA 2010). To ensure that exceptions. For example, foods, other as specified in § 101.9(j)(5); nutrition labeling includes products for than infant formula, represented or • Assigning DVs for children 1 infants and allow for flexibility in purported to be specifically for infants through 3 years of age would ensure timing of complementary food, we have and children less than 4 years of age are consistency with the 1 through 3 year amended § 101.9(j)(5)(i) and (ii) to refer not permitted to include declarations of toddler age category established for only to ‘‘infants’’ as infants through 12 percent DV for the following nutrients: RACCs specified in § 101.12(a)(2); and months of age rather than infants less Total fat, saturated fat, cholesterol, • Because the growth velocity in than 12 months (as suggested by the sodium, potassium, total carbohydrate height is most similar for children 1 comment) or ‘‘infants 7 through 12 and dietary fiber (§ 101.9(j)(5)(ii)(A)). As through 3 years of age, we consider it months’’ of age as we had proposed. another example, foods, other than appropriate to revise the age range to (We have made similar edits in infant formula, represented or purported include children of these ages into a § 101.9(c), (c)(7), (c)(8), (d)(1), (e), and (f) to be specifically for infants and single category for food labeling to refer to ‘‘infants through 12 months children less than 2 years of age are not purposes. of age.’’)

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We note that, while nutrition labeling for the composition of processed cereal- health during a critical stage of human is mandatory for food for children less based complementary foods, we note development and physiology and, than 4 years, we are not establishing that the Codex Guidelines on Nutrition therefore, their mandatory declaration DVs for infants less than 7 months of Labelling (CAC/GL 2–1985) (Ref. 121) can assist in maintaining healthy dietary age. Therefore, nutrition information on do not provide Nutrient Reference practices. We proposed to remove foods purported for infants less than 7 Value—Requirements that are § 101.9(j)(5)(i) and revise and months would not reflect DVs for that comparable to our proposed DRVs and redesignate current § 101.9(j)(5)(ii) as age group. RDIs for children 1 through 3 years. § 101.9(j)(5)(i). (Comment 442) One comment said (Comment 443) Some comments asked Similarly, foods consumed by that labeling of foods for infants 7 that we require the declaration of pregnant and lactating women must through 12 months and children 1 cannabinoid content, nutritional values, declare statutorily required nutrients, through 3 years is overdue and and/or health risks pertaining to the including calories, calories from fat, important. The comment said, however, consumption of tetrahydrocannabinol total fat, saturated fat, cholesterol, that separate labeling for these two ages (THC) and/or marijuana edibles for all sodium, total carbohydrate, sugars, is not necessary and could be confusing, consumers, in particular, children under dietary fiber, and protein. Women of so the comment recommended that we the age of 4 years as well as pregnant reproductive age consume the same use a population approach to set single and lactating women. foods as the general population and, in values for 7 months through 3 years. (Response) We decline to revise the general, continue consuming similar Another comment noted that the rule as suggested by the comment. We foods during pregnancy and lactation. In proposed new age range to set labeling note that section 403(q)(2)(A) of the the preamble to the proposed rule (79 requirements for these foods (infants 7 FD&C Act authorizes the inclusion of FR 11879 at 11934), we tentatively through 12 months and children 1 nutrients on the label or labeling of food concluded that, except for the through 3 years of age) did not take into for purposes of providing ‘‘information declaration of calories from fat, the account the definition of ‘‘young regarding the nutritional value of such declaration of statutorily required children’’ given in different Codex food that will assist consumers in nutrients should be mandatory because standards (e.g., 074–1981 Rev. 1–2006) maintaining healthy dietary practices.’’ the declaration of calories and these whereby ‘‘young children’’ are ‘‘persons General labeling requirements of nutrients is mandated by section 403(q) from the age of more than 12 months up products containing THC and/or of the FD&C Act and we have no basis to the age of 3 years (36 months).’’ marijuana edibles is outside the scope of on which to not require or permit their (Response) We disagree with the this rule. Therefore, we are making no declaration as discussed previously. comment suggesting an age range of 7 changes in response to this comment. Thus, we proposed to require the months through 3 years of age. mandatory declaration of calories, and 2. Mandatory Declaration of Calories Providing one label for infants and the amount of total fat, saturated fat, and Statutorily Required Nutrients children 7 months through 3 years of trans fat, cholesterol, sodium, total age is inappropriate because growth and Currently, foods, other than infant carbohydrate, dietary fiber, sugars, and nutrient needs differ for infants through formula, represented or purported to be protein for foods represented or 12 months of age and children 1 through specifically for infants and children less purported to be specifically for infants 3 years of age (beginning at the start of than 4 years must declare statutorily 7 through 12 months of age, children 1 the 13th month through the end of 48th required nutrients, including calories, through 3 years of age, and pregnant and month of age). These differences in calories from fat, total fat, saturated fat, lactating women, and permit the growth and development between cholesterol, sodium, total carbohydrate, declaration of calories from saturated fat infants and young children are reflected sugars, dietary fiber, and protein. For such that the declaration of these in the age categories established by the foods, other than infant formula, nutrients on foods for these populations IOM (79 FR 11879 at 11933). represented or purported to be for would be subject to the same As for the comment noting that we infants and children less than 2 years, requirements applicable to foods for the did not take into account the definition the declaration of certain statutorily general population. of ‘‘young children’’ used in certain required nutrients, which include (Comment 444) Several comments Codex texts, we note that our age range calories from fat, saturated fat, and supported the declaration of saturated of children 1 through 3 years of age cholesterol, is not required or permitted fat and cholesterol on labeling for includes ‘‘persons from the age of more (§ 101.9(j)(5)(i)). infants and children 1 through 3 years than 12 months up to the age of 36 a. Declaration of saturated fat and old and agreed such labeling will help months.’’ We also note that our age cholesterol. In the preamble to the maintain healthful dietary practices. In range aligns with the age specific proposed rule (79 FR 11879 at 11934), response to our request for information category used in the IOM’s DRI we tentatively concluded that, except on whether consumers may be confused recommendations for the purposes of for the declaration of calories from fat, by these changes, one comment said establishing DRVs and RDIs for this the declaration of statutorily required that its products have been labeled for subpopulation. Our purpose of nutrients that include saturated fat and children under 2 years as well as for establishing a DRV or RDI for use in cholesterol on the label of foods children less than 4 years of age on the nutrition labeling is distinct from a represented or purported to be market for many years. The comment purpose related to defining the age specifically for infants 7 through 12 noted that these dual label formats range when infants and young children months and children 1 through 3 years include the declaration of both saturated are fed processed cereal-based of age should be mandatory because: (1) fat and cholesterol and the company has complementary foods (CODEX STAN The declaration of calories and these received no comments or concerns 074–1981, REV.1–2006). Furthermore, nutrients is mandated by section 403(q) about the inclusion of this information while certain Codex standards such as of the FD&C Act, and we have no basis on its labels from either consumers or the Standard for Processed Cereal-based on which to not require or permit their health care professionals. The comment Foods for infants and young children declaration as discussed previously; and said that declaring saturated fat and (CODEX STAN 074–1981, REV.1–2006) (2) these nutrients are essential in cholesterol in addition to trans fat on provide minimum and maximum levels fostering growth and maintaining good infant foods will be more helpful in

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food selection than having trans fat assist consumers in maintaining healthy foods for children aged 1 through 3 alone. The comment said declaring dietary practices (79 FR 11879 at years. The comment cited dietary intake saturated fat, cholesterol, and trans fat 11934). We considered the Integrated data suggesting that protein intakes are will provide more information on the fat Guidelines for Cardiovascular Health above 40 grams per day and from high composition of foods and their and Risk Reduction in Children and quality sources. Another comment relationship to chronic disease risk. The Adolescents which suggest a diet with recommended allowing for the use of comment also noted that some children saturated fat less than 10 percent of the PDCAAS for determining the as young as 12 months, with a family calories and cholesterol intake less than percent DV for protein for all population history of obesity, dyslipidemia, or 300 mg/day can safely and effectively groups, including infants. The comment CVD, may benefit from a diet lower in reduce the levels of total and LDL asked us to clarify the acceptability of saturated fat and that having saturated cholesterol in healthy children (Ref. PDCAAS for determining protein fat on food labels can assist families in 250). This type of diet may have similar quality for foods for infants and specify choosing foods that are lower in effects when started in infancy and the specific amino acid pattern that saturated fat while maintaining total fat sustained throughout childhood into should be used (i.e., IOM pattern) and intakes. adolescence (Ref. 250). to reference the pattern by Table Another comment said we should not We acknowledge, in general, that total number. finalize the rule until we had conducted fat should not be limited in the diets of (Response) The final rule requires the appropriate research, including young children less than 2 years of age mandatory declaration of percent DV for consumer testing, to better understand unless directed by a health professional. protein on foods for infants though 12 the impacts of declaring saturated fat In response to the comment noting that months of age and children 1 through 3 and cholesterol on the labels of products research is unavailable on whether years of age. While the evidence represented or purported to be declaration of saturated fat and suggests that protein intake is adequate specifically for infants and children 1 cholesterol will result in restricted and of high quality, the level and through 3 years of age and to determine intakes for infants and children, we quality of protein present in a food if an explanatory footnote would assist intend to monitor fat and cholesterol remain an important consideration in in improving consumer understanding intakes in these age groups and will food selection for infants because infant when accompanying any relative consider whether to revisit our diets are derived from a limited number declaration. The comment also noted requirements for this labeling, as of foods. Calculating the percent DV for that relevant empirical research is not appropriate. protein incorporates a measure of available to determine whether the We also decline to include a protein quality. Thus, the percent DV declaration of saturated fat and voluntary footnote. We intend to declaration is a useful tool to indicate cholesterol will result in restricted monitor fat intakes and educate protein quality to the consumer. intakes for infants and children ages 1 consumers on changes to the labeling of Because of the importance of adequate through 3 years old. One comment foods for infants through 12 months of high quality protein in the diets of would revise the rule to include a age and children 1 through 3 years of infants and young children, we voluntary footnote stating that ‘‘total fat age. conclude that the percent DV should not be limited in the diets of b. Percent DV declaration. In the declaration for protein for infants children less than 2 years unless preamble to the proposed rule (79 FR though 12 months of age and children directed by a physician’’ or similar 11879 at 11935), we explained that, 1 through 3 years of age should remain wording to provide dietary guidance to under our preexisting regulations, the mandatory. parents and other caregivers to help percent DV declaration is not permitted We disagree with the comment asking assure total fat is not restricted in the on the food label for foods, other than that we allow for the use of the PDCAAS diet of young children. infant formula, represented or purported to determine protein quality for infants. (Response) We acknowledge that to be specifically for infants and The PDCAAS allows evaluation of food products dual labeled for children children less than 4 years (which protein quality based on the needs of under 2 and children less than 4 years includes infants and children less than humans as it measures the quality of a of age include the declaration of both 2 years) for total fat, saturated fat, protein based on the amino acid saturated fat and cholesterol. We agree cholesterol, sodium, potassium, total requirements (adjusted for digestibility) that declaration of saturated fat and carbohydrate, and dietary fiber of a 2- to 5-year-old child (considered cholesterol provides more nutrition (§ 101.9(j)(5)(ii)). Percent DV is required the most nutritionally demanding age information and can help consumers for protein and vitamin A, vitamin C, group), not infants (Ref. 251). Protein make informed choices and maintain a iron, and calcium. We tentatively quality is important during infancy for healthy diet, and the final rule requires concluded that it is appropriate to growth and development. We the declaration of saturated fat and require declarations of percent DV for established the protein efficiency ratio cholesterol on Nutrition Facts labeling those nutrients for which we are (PER) as the method of determining for infants and children 1 through 3 establishing a DRV or RDI for infants 7 protein quality (see 79 FR 7934 at 8022) years of age. through 12 months, for children 1 for infants based on recommendations As for the comment regarding through 3 years of age, and for pregnant from the 1991 WHO Protein Quality consumer testing, we disagree that and lactating women (except for a % DV report. A protein source may contain the consumer testing is necessary before we for protein for pregnant and lactating necessary amino acids, but they may be can require the declaration of saturated women), and this change would be in a form that an infant cannot digest fat and cholesterol on Nutrition Facts reflected in redesignated § 101.9(j)(5)(i). and absorb. The PER method, unlike labels for infants and children 1 through (Comment 445) One comment would chemical measures of protein 3 years of age. Section 403(q) of the retain a requirement for the mandatory composition, provides an estimate of the FD&C Act lists total fat, saturated fat, declaration of percent DV for protein on bioavailability or amount absorbed, of and cholesterol as nutrients required on infant foods. the protein. nutrition labeling. These nutrients are In contrast, another comment would (Comment 446) One comment said essential for growth and development, not require the mandatory declaration of that, if the percent DV for protein thus their mandatory declaration can the percent DV for protein on labels of remains mandatory, we should provide

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an exemption from the mandatory PDCAAS or another comparable method evidence to suggest that reduction of declaration of percent DV for protein for that scores the amino acid profile of the total and LDL cholesterol levels can foods intended for infants and children specific food protein after it has been occur with reducing saturated fat intake aged 1 through 3 years that declare less digested is not appropriate. to less than 10 percent of calories, than 1 gram of protein per serving, such beginning in infancy and sustained 3. Declaration of Non-Statutory as fruits, because these foods contain an throughout childhood into adolescence, Nutrients Other Than Essential insignificant amount of protein and are that there is no evidence to suggest that Vitamins and Minerals not expected to contribute meaningfully infants 7 through 12 months of age to protein intake. The comment also In the preamble to the proposed rule would be different than children 1 would revise the rule to allow the (79 FR 11879 at 11935), we stated that through 3 years of age, and that there is optional declaration of ‘‘0% DV’’ foods, other than infant formula, no basis to continue to provide an instead of the phrase ‘‘not a significant represented or purported to be exception that does not permit the source of protein’’ on infant foods with specifically for infants and children less declaration of calories from saturated a protein quality of less than 40 percent than 2 years of age are not permitted to fat, or polyunsaturated and of casein as measured by PER or less declare calories from saturated fat and monounsaturated fats on foods than 40 percent by PDCAAS or other the amount of polyunsaturated fat and represented or purported to be comparable method. The comment monounsaturated fat (§ 101.9(j)(5)(i)), specifically for infants and children less explained that these options will help whereas soluble fiber, insoluble fiber, than 2 years of age. save label space, especially on small and sugar alcohols can be declared (Comment 447) One comment argued packages, while still providing voluntarily. Polyunsaturated fat, the declaration of alpha linoleic acid meaningful information on protein monounsaturated fat, soluble fiber, (ALA) on foods for infants and children quantity relative to the DV. insoluble fiber, and sugar alcohols can 7 months to 3 years of age should be (Response) We decline to revise the be declared voluntarily on the label of considered for voluntary labeling using rule as suggested by the comment. foods represented or purported to be the AI as the basis for a DRV. The While we recognize that the protein specifically for children 2 through 4 comment noted that much of the quantity of some foods, such as fruits, years of age, and pregnant and lactating evidence for a health benefit of n-3 fatty may be small, we consider the women. acids derives from studies on infants, mandatory declaration of percent DV to For foods represented or purported to and labeling of ALA is consistent with provide important information on be specifically for children 1 through 3 FDA’s criteria of encouraging health protein quality to the consumer. In years of age and pregnant and lactating dietary practices. Another comment establishing mandatory declaration of women, we considered whether to recommended that we examine percent DV for protein on foods propose the mandatory or voluntary NHANES data for ALA consumption to intended for infants through 12 months declaration of non-statutory nutrients. determine whether there is a public of age and children aged 1 through 3 In the preamble to the proposed rule (79 health risk from inadequate dietary years and associated statements of ‘‘less FR 11879 at 11935), we said that most intake. than 1 g of protein per serving’’ or ‘‘not advisory consensus and policy reports (Response) We decline to amend the a significant source of protein,’’ we on which we rely for the general rule to permit the voluntary labeling of considered that: (1) Protein is of critical population apply to children 2 years of ALA on labels or labeling for foods importance in maintaining good health age and older and pregnant and intended for infants though 12 months because it supplies essential amino lactating women, unless noted of age and children 1 through 3 years of acids and is a principal source of otherwise (e.g., 2010 DGAC and health age and to use the AI for ALA to calories along with fat and claims (§ 101.14(e)(5)). establish a DRV. carbohydrate; and (2) calculating the a. Voluntary declaration of calories We agree with promoting healthy percent DV for protein incorporates a from saturated fat, and the amount of dietary practices in this subpopulation; measure of protein quality. Thus, the polyunsaturated and monounsaturated however, well-established evidence for percent DV declaration is a useful tool fat. Our preexisting regulations, at ALA and disease risk reduction in to indicate protein quality to the § 101.9(j)(5)(i), state that foods, other adulthood and infancy is lacking (Ref. consumer. than infant formula, represented or 29). As discussed in part II.F.4, we While label space on small packages purported to be specifically for infants decided that, because of the lack of may be a concern, we decline to make and children less than 2 years of age well-established evidence for a role of n- the change requested by the comment must bear nutrition labeling with 3 or n-6 polyunsaturated fatty acids in that would allow the optional certain, specific exceptions. Among the chronic disease risk and the lack of a declaration of ‘‘0% DV’’ instead of the exceptions, the label is not to include quantitative intake recommendation, the phrase ‘‘not a significant source of polyunsaturated fat or monounsaturated declarations of a-linolenic acid as well protein’’ on infant foods with a protein fat. as other n-3 and n-6 polyunsaturated quality of less than 40 percent of casein The proposed rule would remove the fatty acids are not necessary to assist as measured by PER or less than 40 restriction regarding the declaration of consumers to maintain healthy dietary percent by PDCAAS or other polyunsaturated fat and practices. Because the declaration of comparable method. As explained in monounsaturated fat on foods ALA is not permitted on labeling, a DRV part II.I and in our response to comment represented or purposed to be for this nutrient is unnecessary. 445, we concluded that the PDCAAS specifically for children less than 2 We disagree with the analysis of was the most suitable pattern for use in years of age. In the preamble to the NHANES data for ALA intake to the evaluation of dietary protein quality proposed rule (79 FR 11879 at 11935 determine public health risk from for all age groups, except infants through 11936), we explained that, for inadequate dietary intake. An analysis through 12 months of age. We infants 7 to 12 months, there are no of dietary intake data alone does not established the PER as the method of specific recommendations provided meet our criteria of public health determining protein quality for infants about calories from saturated or significance. Moreover, an analysis of because infants cannot digest and polyunsaturated or monounsaturated ALA intakes from NHANES data cannot absorb all forms of protein; thus, fat. We also stated there is some determine inadequacy of dietary intake

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because an EAR has not been (Response) The comments did not 7 to 12 months, children 1 through 3 established for ALA. EARs, not AIs, are provide, and we are not aware of, data years of age, or pregnant and lactating used for assessing the statistical or information to support the claim that women. probability of adequacy or nutrient consumers seeking to consume DHA We did not receive comments on this intakes of groups of people (79 FR would be misled by the voluntary topic, so no changes to the rule are 11879 at 11885). declaration of polyunsaturated fats or an necessary. (Comment 448) One comment noted ALA nutrient content claim on labeling c. Mandatory declaration of trans fat. that we proposed mandatory labeling of for children less than 2 years of age. In the preamble to the proposed rule (79 the quantitative amount of some Therefore, we are not making changes in FR 11879 at 11936), we stated that trans nutrients (trans fatty acids for which response to this comment. fat must be declared on the Nutrition there is no DRI) on foods for infants We acknowledge the 2011 IFIC survey Facts label and that our regulations do aged 7 through 12 months and children conclusions suggesting that consumers not provide exceptions for foods aged 1 through 3 years. The comment eating foods containing n-3 fatty acids represented or purported to be said we should provide for the are somewhat likely to begin eating specifically for infants, young children, voluntary declaration of these foods to benefit cognitive or pregnant and lactating women. We docosahexaenoic acid (DHA) on these development. We also recognize that noted that cardiovascular disease is foods to encourage healthy dietary total polyunsaturated fats in foods known to begin in childhood (id.). Thus, practices. include both n-6 and n-3 we tentatively concluded that declaration of trans fat continues to be (Response) We decline to revise the polyunsaturated fatty acids and the n-3 necessary to assist consumers in rule as suggested by the comment. Our polyunsaturated fatty acids content may maintaining health dietary practices, regulations, at § 101.9(c)(2)(ii), require include ALA and DHA. However, we are unable to determine, including among infants, young the declaration of trans fat on nutrition based on the information provided in children, and pregnant and lactating labeling for people of all ages because the comment, if some consumers women, and we did not propose any the consumption of trans fats may affect seeking to consume DHA may be changes to the mandatory declaration of their risk of CHD; therefore, the confused or misled by the declaration of trans fat on the label of foods presence or absence of trans fat in a total polyunsaturated fats or the ALA represented or purported to be food product is a material fact that nutrient content claim. Furthermore, we specifically for infants, children 1 consumers need to know to make are unable to determine if consumers through 3 years of age, or pregnant and healthy choices and allow them to understand that ALA may be converted lactating women. reduce risk of CHD. Trans fat continues to DHA. Without knowledge of the Trans fat declaration is voluntary to be a nutrient with public health conversion from ALA to DHA, when the total fat content of a food is significance because of its well- consumers would not be able to less than 0.5 grams (§ 101.9(c)(2)(ii)). In established role in chronic disease distinguish between the level and type addition, if a manufacturer does not through its effect on blood cholesterol of n-3 fatty acids in the food. declare the trans fat content because levels (79 FR 11879 at 11896). However, Thus, the final rule removes the total fat amount is less than 0.5 grams, DHA lacks well-established evidence for restriction regarding the declaration of then the statement ‘‘Not a significant its role in chronic disease as well as calories from saturated fat, source of trans fat’’ must be placed at growth or neural development (IOM polyunsaturated fat, and the bottom of the table of nutrient Macro report). As discussed in part II.F, monounsaturated fat on foods values. voluntary labeling of DHA is not represented or purposed to be We did not receive comments on this permitted because of the lack of well- specifically for infants through 12 topic and have finalized this provision established evidence for DHA’s role in months of age and children 1 through 3 without change. chronic disease risk and lack of a years of age. d. Mandatory declaration of added quantitative intake recommendation (79 b. Voluntary declaration of soluble sugars. Our preexisting regulations do FR 11879 at 11898). fiber, insoluble fiber, and sugar not provide for the declaration of added (Comment 449) One comment cited a alcohols. In the preamble to the sugars on the Nutrition Facts label, but 2011 IFIC survey suggesting that 45 proposed rule (79 FR 11879 at 11936), the proposed rule would require the percent of consumers were already we stated that, while quantitative intake mandatory declaration of added sugars eating foods containing n-3 fatty acids to recommendations are lacking for soluble on the Nutrition Facts label. benefit cognitive development, fiber, insoluble fiber, and sugar Additionally, in the Federal Register of especially in children and 39 percent alcohols, there is well-established July 27, 2015 (80 FR 44303), we were somewhat likely to begin eating n- evidence for the role of these nutrients published a supplemental proposed rule 3 fatty acids for this health benefit in the in chronic disease risk, risk of a health- that would, among other things, next 12 months. The comment said that related or a beneficial physiological establish a Daily Reference Value (DRV) continued allowance of ALA nutrient endpoint (i.e., CHD, improved laxation, of 10 percent of total energy intake from content claims, absent a voluntary or dental caries). We also said that there added sugars and require the declaration of DHA, increases the is no evidence to suggest that the role declaration of the percent DV for added likelihood that consumers may purchase of these nutrients would be different sugars on the label. foods for a benefit that the food will not among infants 7 through 12 months, (Comment 450) Several comments supply. The comment also said that children 1 through 3 years of age, or supported mandatory declaration of allowing polyunsaturated fat labeling of pregnant and lactating women added sugars. One comment stated that foods for children younger than 2 years compared to the general population. As sugar is used as a means to attract without allowance for labeling of a result, we did not propose any children, and this practice should be individual polyunsaturated fatty acids changes to the provisions for the discouraged. creates a scenario where voluntary declaration of soluble fiber, Another comment opposed the polyunsaturated fat values, inflated by insoluble fiber, and sugar alcohols on mandatory labeling of added sugars for ALA, may mislead consumers actually the label of foods represented or infants and children aged 1 through 3 seeking DHA. purported to be specifically for infants years and pregnant and lactating

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women. The comment argued that DRV for added sugars for infants declaration of fluoride on foods scientific consensus is lacking for the through 12 months. Dietary represented or purported to be health effects of added sugars alone recommendations for infants through 12 specifically for infants 7 through 12 versus sugars as a whole and months suggest introducing months of age, children 1 through 3 recommended careful consideration of complementary foods such as infant years of age, and pregnant and lactating the totality of the scientific evidence, as cereal, vegetables, fruits, meat, and women. well as consideration of compliance and other protein-rich foods modified to a We did not receive comments on this other technical issues. The comment texture appropriate (e.g., strained, topic and have finalized the provision to also noted that consumer testing is also pureed, chopped, etc.) for the infant’s permit the voluntary declaration of highly important prior to any developmental readiness one at a time. fluoride on foods represented or determination relative to added sugars A DRV for added sugars for infants purported to be specifically for infants being made. through 12 months is not necessary as through 12 months, children 1 through (Response) We disagree that added the infant diet is comprised primarily of 3 years of age, pregnant women, and sugars should not be required on the breast milk and/or infant formula as lactating women. label for infants and children aged 1 well as complementary foods. As the 4. Declaration of Essential Vitamins and through 3 years and pregnant and food introduced does not comprise the Minerals lactating women. We discuss in part majority of the infant diet, a DRV is not II.H.3 our rationale for requiring the necessary to compare added sugars in Our preexisting regulations require declaration of added sugars on the label the context of a daily diet. Mandatory the declaration of vitamin A, vitamin C, for the general population. We are also declaration of added sugars for infants calcium, and iron on the Nutrition Facts basing an added sugars declaration on through 12 months of age can help label, and there are no specific labeling for infants, children 1 through consumers limit the added sugars in the exceptions to this requirement for foods 3 years of age, pregnant women, and limited complementary foods that are represented or purported to be lactating women on the need to provide being introduced individually. specifically for infants and children less consumers with information to (Comment 451) One comment would than 2 years and children less than 4 construct a healthy dietary pattern that modify the definition of added sugars to years of age, and pregnant and lactating meets the dietary recommendations for exclude ingredients that are inherent in women. In the preamble to the proposed added sugars. the food or are present for purposes rule (79 FR 11879 at 11937), we In response to the comment about the other than sweetening the food and that explained that the AIs for essential totality of evidence for the health effects this modified definition should apply vitamins and minerals (and RDAs for of added sugars, we discuss in part for adults and children between 7 iron and zinc) for infants 7 through 12 II.H.3 that rather than basing a months to 3 years of age, and pregnant months of age are based on the average declaration of added sugars on an and lactating women. intake of nutrients that infants association with risk of chronic disease, (Response) We received many consumed from breast milk, a health-related condition, or a comments on the definition of added complementary foods, and/or physiological endpoint, we are sugars and, in part II.H.3.n, discuss supplements with the understanding considering a declaration of added ingredients that are inherent in the food, that these sources provided sufficient sugars in the context of how it can assist such as naturally occurring sugars, and amounts of the nutrients to meet the consumers in maintaining healthy the intended purpose of sweetening. infant’s daily needs. The AIs (as well as dietary practices by providing The comment did not explain why a the RDAs for iron and zinc) for infants information to help them limit regulatory definition for added sugars were not based on endpoints related to consumption of added sugars, and to should be different for infants, children chronic disease risk, or a health-related consume a healthy dietary pattern. We 1 through 3 years of age, and pregnant conditions or health-related physiology. have established that there is public women, and lactating women, so we Furthermore, because the AI represents health significance of added sugars decline to revise the rule as suggested intakes that are considered adequate through other evidence related to a by the comment. and are based on average nutrient healthy dietary pattern low in sugar- e. Voluntary declaration of fluoride. intakes from breast milk, foods, and/or sweetened foods and beverages that is Our preexisting regulations do not supplements, the presence of an AI associated with reduced risk of CVD, provide for the declaration of fluoride indicates that there is not a public through consumption data showing that on the Nutrition Facts label of any health concern about adequate intake of Americans are consuming too many foods. The proposed rule would allow that nutrient. So, rather than determine calories from added sugars, through voluntary declaration of fluoride on the public health significance for a nutrient evidence showing that it is difficult to labeling of foods for the general during infancy based on an AI for meet nutrient needs within calorie population, and we also tentatively infants, we considered the importance limits if one consumes too many added concluded that the declaration of of the nutrient in establishing healthy sugars, and through evidence showing fluoride on foods represented or dietary practices during infancy for later that increased intake of sugar-sweetened purported to be specifically for children in life, as well as the relevant available beverages is associated with greater 1 through 3 years of age and pregnant information for children 1 through 3 adiposity in children. and lactating women can assist in months of age that may also be The comment did not explain what maintaining healthy dietary practices. applicable to infants. For nutrients with compliance and other technical issues We stated, in the preamble to the an RDA for infants 7 through 12 months merit further consideration. In response proposed rule (79 FR 11879 at 11937 of age (i.e., iron and zinc), we to the comment noting the importance through 11938), that evidence on dental considered the factors for mandatory for consumer testing of a declaration of caries is lacking for infants 7 through 12 and voluntary labeling described in added sugars, we have received several months of age, but we did not expect the section I.C to determine whether to comments on this topic and discuss role of fluoride in the protection against propose mandatory or voluntary responses in part II.H.3.g. dental caries to be different from other labeling for the nutrient. While the declaration of added sugars age groups. Therefore, proposed For the declaration of essential is mandatory, we are not establishing a § 101.9(c)(5) would permit the voluntary vitamins and minerals for children 1

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through 3 years of age and pregnant and later in life is important given that based on intakes from conventional lactating women, we said, in the calcium intakes are inadequate for the foods and supplements (see 79 FR preamble to the proposed rule (79 FR majority of the population. Intakes of 11879 at 11937). Among pregnant 11879 at 11937) that we would use the calcium, which is necessary for growth women aged 12 to 49 years, 25 percent same considerations, based on the same and bone development, are inadequate were iron deficient and 13 percent had rationale as we set forth and proposed among children. Similar to the general iron deficiency anemia. While intakes for the general population, because population, approximately 20 percent of appear adequate for most individuals, scientific and policy considerations are pregnant women consumed less than the prevalence of iron deficiency and generally the same and the DGA the EAR for calcium from conventional iron deficiency anemia indicates that recommendations apply to Americans 2 foods as well as from conventional iron deficiency is of public health years of age and older. We also foods and supplements. Consequently, significance for pregnant women. explained that, while NHANES data we tentatively concluded that calcium is Therefore, we tentatively concluded that were collected in lactating women, we a nutrient of public health significance iron is a nutrient of public health did not include these data in our for children 1 through 3 years of age and significance for lactating women as analysis because the sample size of for pregnant and lactating women and well. lactating women was small, and we that, because calcium is important for Thus, we proposed to amend could not reliably estimate mean intake growth and development, calcium is of § 101.9(c)(8)(ii) to require the mandatory and status of this population (id.). public health significance for infants 7 declaration of calcium and iron on foods However, we stated that the conclusions through 12 months of age. represented or purported to be specifically for infants 7 to 12 months, made about nutrient inadequacy during With respect to iron, we stated, in the children 1 through 3 years of age, or pregnancy are applied to lactating preamble to the proposed rule (id.) that, pregnant and lactating women. women since the needs of essential while the EAR and RDA are based on vitamin and minerals are increased for We did not receive any comments daily iron requirements and not directly with respect to mandatory declaration of both pregnant and lactating women, and on chronic disease risk, iron deficiency we proposed to remove the provision in calcium and iron for these populations, is associated with delayed normal infant and so, other than replacing ‘‘infants 7 § 101.9(c)(8)(i) that requires separate motor function (i.e., normal activity and declaration of percent DVs based on to 12 months’’ with ‘‘infants through 12 movement) and mental function (i.e., both RDI values for pregnant women months,’’ we have finalized the normal thinking and processing skills) and for lactating women in the labeling provisions without change. and that our analysis of NHANES 2003– of foods represented or purported to be b. Mandatory declaration of vitamin D 2006 data estimated that about 18 for use by both pregnant and lactating and potassium. We proposed to require percent of infants ages 7 through 12 women. the declaration of vitamin D on foods for We did not receive comment on this months have usual iron intakes below the general population. With respect to topic and are removing the provision in the EAR, based on intakes from infants, we stated, in the preamble to § 101.9(c)(8)(i) regarding separate conventional foods only and 4 percent the proposed rule (79 FR 11879 at declaration of percent DVs based on of infants ages 7 through 12 months 11938), that the AI for vitamin D for both RDI values for pregnant women have usual iron intakes below the EAR infants was based on maintenance of and for lactating women in the labeling based on intakes from conventional serum 25(OH)D concentrations at a level of foods represented or purported to be foods and supplements. For children 1 to achieve and maintain serum 25(OH)D for use by both pregnant and lactating through 3 years of age, about 1 percent concentrations above a defined level (30 women. of children have usual iron intakes to 50 nmol/L) in order to meet the needs a. Mandatory declaration of calcium below the EAR, based on intakes from of the majority of the infants and and iron. We did not propose any conventional foods only and 0.4 percent support bone accretion and that DRIs changes to the mandatory declaration of of children have usual iron intakes (EAR and RDA) for vitamin D were calcium on foods for the general below the EAR based on intakes from established at a level to achieve and population. In the preamble to the conventional foods and supplements. maintain serum 25(OH)D concentrations proposed rule (79 FR 11879 at 11937), While total iron intakes appear above a defined level (40 to 50 nmol/L) we stated that the AI for calcium for adequate, the prevalence of iron to maintain bone health for children 1 infants 7 through 12 months of age is deficiency in children ages 1 to 2 years through 3 years of age and pregnant based on average calcium consumption has been reported to be 14.4 percent and women. Although serum 25(OH)D data of these nutrients, rather than chronic the prevalence of iron deficiency were not available in NHANES 2003– disease risk, health related-condition, or anemia in children younger than 5 years 2006 for infants ages 7 to 12 months, we physiological endpoints and that, for has been reported to be 14.9 percent (see noted that our analysis of NHANES children 1 through 3 years of age and 79 FR 11879 at 11937). We also stated 2003–2006 dietary data showed that pregnant and lactating women, the that inadequate iron intakes during 28.7 and 33.6 percent of infants ages 7 RDAs for calcium are based, in part, on pregnancy are of public health to 12 months have usual vitamin D bone health. significance because of the adverse intakes above the AI from conventional Our analysis of NHANES 2003–2006 effects for both the mother and the fetus foods and conventional foods plus data estimated that infants ages 7 to 12 (such as maternal anemia, premature supplements, respectively (see 79 FR months have usual calcium intakes delivery, low birth weight, and 11879 at 11938). above the AI and that about 12 percent increased perinatal infant mortality) and Our analysis of NHANES 2003–2006 of children 1 through 3 years of age had that our analysis of data collected by data showed that about 3 percent of usual intakes of calcium below the EAR, NHANES 2003–2006 estimated that 5 children 1 through 3 years of age had based on intakes from conventional percent of pregnant women 14 to 50 serum 25(OH)D levels below 40 nmol/ foods only (see 79 FR 11879 at 11937). years of age had usual iron intakes L, while an analysis of NHANES 2005– We said, in the preamble to the below the EAR based on intakes from 2008 dietary data showed that, proposed rule (id.), that promoting the conventional foods and 4 percent of assuming minimal sun exposure, about development of eating patterns that are pregnant women 14 to 50 years of age 82 percent of these children had usual associated with adequate calcium intake had usual iron intakes below the EAR vitamin D intakes below the EAR from

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conventional foods only and 66 percent women, and lactating women and that, comment cited data that assessed usual had usual intakes below the EAR from because of the benefits of adequate intakes using the AI for vitamin D conventional foods and supplements potassium intake in lowering blood established in 1997 (Ref. 253). The IOM (see 79 FR 11879 at 11938). For pressure, data indicating low likelihood has since established an EAR for pregnant women, 15 percent had serum of potassium adequacy, and importance vitamin D (Ref. 38). Our analysis of 25(OH)D levels below 40 nmol/L, while of establishing healthy dietary practices NHANES data compared to the EAR about 88 percent of pregnant women for later life, potassium is a nutrient of showed 66 percent of children 1 had usual vitamin D intakes below the public health significance for infants 7 through 3 years of age had inadequate EAR from conventional foods only and through 12 months of age, children 1 intake of vitamin D from foods and 48 percent had usual intakes below the through 3 years of age, pregnant women, supplements (79 FR 11879 at 11938). EAR from conventional foods and and lactating women. Thus, we We also disagree that mandatory supplements (id.). We tentatively proposed to require the labeling of declaration of vitamin D, including the concluded that vitamin D has public vitamin D and potassium on foods declaration of zero percent DV, is not of health significance in children 1 represented or purported to be value because few foods have naturally through 3 years of age and pregnant specifically for infants 7 through 12 occurring vitamin D. As we discussed in women based on the high prevalence of months of age, children 1 through 3 the preamble to the proposed rule (79 inadequate intakes of vitamin D and its years of age, or pregnant and lactating FR 11879 at 11938) and part II.L, we important role in bone development and women based on the quantitative intake identified vitamin D as a nutrient of health and that vitamin D is of public recommendations for vitamin D and public health significance for children 1 health significance for infants 7 through potassium and the public health through 3 years of age based on the high 12 months of age based on its significance of these nutrients and did prevalence of inadequate intakes of importance for growth and development not provide for any exceptions for these vitamin D and its important role in bone during infancy. subpopulations from the general development and health (Ref. 198). Our analysis also shows that vitamin D We also proposed, at proposed requirement for declaration of vitamin D intakes and status remain inadequate in § 101.9(c)(8)(ii), to require the and potassium in proposed § 101.9(c)(8)(ii). the general population (79 FR 11879 at declaration of potassium on foods for We did not receive comments 11922). While limited label space may the general population. The AI for the regarding potassium and these present challenges, the consideration for general population is set at a level to subpopulations, so, other than replacing the mandatory declaration of vitamin D maintain blood pressure, reduce the ‘‘infants 7 to 12 months’’ with ‘‘infants on the label is whether it will help adverse effects of sodium chloride through 12 months,’’ we have finalized consumers maintain healthy dietary intake on blood pressure, and reduce those provisions without change. practices. the risk of recurrent kidney stones, but (Comment 452) One comment While we acknowledge that some, but for infants, the AI is based on average questioned the need for mandatory not all, vitamin D needs can be met by potassium intake from breast milk and/ disclosure of vitamin D on the Nutrition the body’s exposure to sunlight, we or complementary foods (id.). Our Facts panel. The comment cited dietary determined the mandatory declaration analysis of NHANES 2003–2006 showed intake data from food, beverages and of vitamin D based on the high that 99 percent of infants ages 7 to 12 supplements that suggests at least 75 prevalence of inadequate intakes of months have usual potassium intakes percent of children ages 1 through 3 vitamin D and its important role in bone above the AI and that only 7 percent of years have adequate intakes of vitamin development and health (see part II.L). children 1 through 3 years of age and 4 D, not including sun exposure (Ref. The mandatory declaration of vitamin D percent of pregnant women had usual 252). The comment said that mandatory is intended to help consumers maintain potassium intakes above the AI from declaration of vitamin D is not of value healthy dietary practices and make conventional foods or conventional because relatively few foods have healthy choices in context of a daily foods plus dietary supplements, naturally occurring vitamin D, diet. The mandatory declaration of indicating that the adequacy of intakes limitations on vitamin D addition to vitamin D also provides information to is very low. We acknowledged, in the foods already exist, and vitamin D consumers about what foods are good preamble to the proposed rule (79 FR added to foods is already required on sources of vitamin D and what foods do 11879 at 11938) that, as a result of a labeling. In addition, according to the not contain vitamin D. Therefore, we FDAMA notification for a health claim comment, labeling can not necessarily have finalized this provision without about potassium, blood pressure, and help consumers achieve adequate change. stroke, foods may bear the following intakes of vitamin D because it is not c. Voluntary declaration of vitamin A claim ‘‘Diets containing foods that are expected that all the required vitamin D and vitamin C. We proposed to no good sources of potassium and low in will be provided by foods or longer require the declaration of vitamin sodium may reduce the risk of high supplements. Another comment noted A and vitamin C on foods for the general blood pressure and stroke,’’ on the label that its products have many labels with population. With respect to or labeling of any food product that very little label space and that using this subpopulations, we noted, in the meets the eligibility criteria described in label space for a declaration of 0 percent preamble to the proposed rule (79 FR the notification and meets the general DV for vitamin D will limit its ability to 11879 at 11939) that our analysis of data requirements for a health claim provide other label information from NHANES 2003–2006 showed that (§ 101.14(e)(6)). This health claim including information on other less than 2 percent of children 1 through pertains to the general population 2 nutrients present in the products at 3 years of age had usual vitamin A years of age and older. Thus, because significant levels. intakes below the EAR from potassium is important in the risk (Response) We disagree with conventional foods or conventional reduction of these chronic diseases for comments arguing against the foods plus dietary supplements and children 2 years of age and older, we mandatory declaration of vitamin D. We that, while 36 percent of pregnant tentatively concluded that potassium is have determined that vitamin D is a women had usual intakes below the of public health significance to children nutrient of public health significance EAR from conventional foods and 22 1 through 3 years of age, pregnant (79 FR 11879 at 11921 and 11938). The percent had usual intakes below the

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EAR for conventional foods plus dietary vitamin E, vitamin K, vitamin B6, foods with higher levels of vegetable fat, supplements, only 1 percent of these vitamin B12, thiamin, riboflavin, niacin, and we are not aware of any evidence women had serum vitamin A levels that folate, biotin, pantothenic acid, to support that proposition. Therefore, were considered to be indicative of a phosphorus, iodine, magnesium, zinc, we are not making changes in response vitamin A deficiency. Furthermore, our selenium, copper, manganese, to this comment. analysis of data from NHANES 2003– chromium, molybdenum, chloride, and (Comment 454) One comment 2006 showed that neither vitamin A nor choline on foods represented or supported the voluntary declaration of vitamin C is considered to have public purported to be specifically for infants choline for pregnant and lactating health significance for children 1 7 to 12 months, children 1 through 3 women. The comment noted that through 3 years of age and pregnant years of age, pregnant women, or choline has a role in preventing neural women. Therefore, we tentatively lactating women, under the tube defects in infants and high intakes concluded that vitamin A and vitamin requirements of this section, unless they improve placental function and ease C are not of public health significance are added to foods as a nutrient babies’ response to stress during among infants 7 through 12 months of supplement or if the label or labeling pregnancy. Another comment suggested age, children 1 through 3 years of age, makes a claim about them, in which that some nutrients should be and pregnant and lactating women, but case the nutrients would have to be considered for mandatory labeling, e.g., we proposed to permit, but not require, declared. choline and selenium as public health the declaration of vitamin A and We did not receive comments concerns. The comment also vitamin C on foods represented and regarding the voluntary declaration of recommended that choline be purported to be specifically for infants vitamin K, vitamin B6, vitamin B12, considered for mandatory labeling on 7 through 12 months, children 1 thiamin, riboflavin, niacin, folate, foods for pregnant and lactating women. through 3 years of age, or pregnant and biotin, pantothenic acid, phosphorus, The comment explained that mandatory lactating women. As for other voluntary iodine, magnesium, zinc, copper, labeling on foods in general, should be nutrients, the declaration of these manganese, chromium, molybdenum, driven by the interest to reduce the risk nutrients would be required when these and chloride on foods represented or of chronic diseases in adulthood, and nutrients are added as nutrient purported to be specifically for infants should be revisited for foods for 7 supplements or claims are made about through 12 months of age, children 1 months through 3 years to emphasize them (proposed § 101.9(c)(8)(ii)). through 3 years of age, pregnant women, the role of nutrients in development. We did not receive comments or lactating women. Therefore, other (Response) We disagree that the regarding the voluntary declaration of than replacing ‘‘infants 7 to 12 months’’ declaration of choline and selenium vitamins A and C for subpopulations, with ‘‘infants through 12 months,’’ we should be mandatory. As the comment so, other than replacing ‘‘infants 7 to 12 have finalized these provisions without suggested, we have considered the months’’ with ‘‘infants through 12 change. relationship of nutrients and chronic months,’’ we have finalized that (Comment 453) One comment disease risk, health-related conditions, provision without change. requested we reconsider mandatory or a health-related physiological d. Voluntary declaration of other declaration of vitamin E on nutrition endpoints (i.e. growth and vitamins and minerals. For the general labeling for children 1 through 3 years development) in infants, children, and population, we proposed to permit the of age. The comment said that about 63 pregnant and lactating women to voluntary declaration of vitamin E, percent of children 12 to 24 months and determine its mandatory or voluntary vitamin K, vitamin B6, vitamin B12, 37 percent of children 24 to 48 months declaration on labeling. Based on our thiamin, riboflavin, niacin, folate, have vitamin E intakes below the EAR analysis of dietary intakes, we found no biotin, pantothenic acid, phosphorus, (Ref. 252). The comment also noted that evidence of inadequate intakes of iodine, magnesium, zinc, selenium, encouraging an adequate intake of choline and selenium in these copper, manganese, chromium, vitamin E in the diets of young children subpopulations. We also found no molybdenum, chloride, and choline may encourage adequate consumption evidence for a substantial prevalence of (proposed § 101.9(c)(8)(ii)). In the of foods with higher levels of vegetable chronic disease, health-related preamble to the proposed rule (79 FR fat. condition, or nutrient deficiency with 11879 at 11939), we said that vitamins (Response) We agree that vitamin E clinical significance linked to choline and minerals other than iron, calcium, intakes are below the EAR and disagree and selenium in these subpopulations. vitamin D and potassium for infants that mandatory declaration of vitamin E Therefore, consistent with the factors for either have DRIs that are not based on is needed. Our analysis of NHANES mandatory or voluntary declaration of chronic disease risk, heath-related data also has shown that intakes of these types of non-statutory nutrients conditions, or health-related children 1 through 3 years of age are (see part II.D), we have determined that physiological endpoints or are not below the EAR (79 FR 11879 at 11944). choline and selenium are not nutrients shown to have public health However, low intakes of vitamin E have of public health significance for infants significance due to the prevalence of a not been associated with clinically through 12 months of age, children 1 clinically relevant nutrient deficiency. relevant nutrient deficiency (Ref. 246). through 3 years of age and pregnant and For infants 7 to 12 months, children 1 Therefore, consistent with the factors for lactating women and have finalized the through 3 years of age, and pregnant and mandatory or voluntary declaration of provision regarding voluntary lactating women, we tentatively non-statutory nutrients (79 FR 11879 at declaration. concluded that the essential vitamins 11889 and 11918, and part II.D), we and minerals, other than iron, calcium, have determined that vitamin E is not a 5. DRVs and RDIs for Infants Through vitamin D and potassium, do not have nutrient public health significance for 12 Months of Age public health significance and there is children 1 through 3 years of age and Our preexisting regulations do not no basis for the declaration of these the general population. include DRVs or RDIs for nutrients for nutrients to be different from that The comment did not provide infants, except for an RDI of protein of proposed for the general population. evidence to suggest that mandatory 14 grams. However, the proposed rule Thus, proposed § 101.9(c)(8)(ii) would declaration of vitamin E may encourage would establish a DRV or RDI for certain allow the voluntary declaration of adequate intake and consumption of nutrients, and we explained, in the case

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of polyunsaturated fat, stated that we have not established a alcohols. For polyunsaturated fat, monounsaturated fat, insoluble fiber, reference calorie intake for infants. We monounsaturated fat, insoluble fiber, soluble fiber, added sugars, sugar noted that there is no quantitative intake soluble fiber, added sugars, and sugar alcohols, sodium, and fluoride, why we recommendation for calories for infants alcohols, there are no quantitative were not proposing to establish a DRV. and that we were not aware of scientific intake recommendations from U.S. a. General comments. data and information on which we consensus reports available with respect (Comment 455) One comment could rely to establish such a level (id.). to infants. Thus, we did not propose to recommended considering dietary Thus, we did not propose to establish a establish DRVs for these nutrients for intake data and public health need in reference calorie intake level for infants infants 7 through 12 months of age. addition to quantitative intake 7 to 12 months. We did not receive comments on our recommendations to determine We did not receive comments on this decision not to establish DRVs for appropriate RDIs for vitamins and issue. Consequently, the final rule does polyunsaturated fat, monounsaturated minerals to be established for infants 7 not establish a reference calorie intake fat, insoluble fiber, soluble fiber, added months through 12 months of age and for infants though 12 months of age. sugars, and sugar alcohols. Thus, the children 1 through 3 years of age. c. Total fat. Regarding total fat, the final rule does not establish DRVs for Another comment recommended that IOM set an AI of 30 grams/day for fat infants though 12 months of age for menu modeling and intake survey data for infants 7 through 12 months of age these nutrients. should be a consideration in the based on the average intake of human f. Total carbohydrates. For total establishment of certain DRVs as they milk and complementary foods. The AI carbohydrates, the IOM set an AI of 95 provide insight on whether a DV is provides a basis on which we can grams/day for carbohydrates for infants achievable, without compromising determine an appropriate DRV for total 7 through 12 months of age based on the intake of another food group or nutrient fat for infants 7 through 12 months, so average intake of human milk and and whether they align with dietary we proposed to amend § 101.9(c)(9) to complementary foods; the AI provides a recommendations. include a DRV of 30 grams for fat for basis on which we can determine an (Response) We agree dietary intake infants 7 through 12 months of age. appropriate DRV for total carbohydrate data and public health significance are We did not receive comments for this subpopulation that can assist important considerations in determining regarding the proposed DRV for infants, consumers in maintaining healthy appropriate RDIs for vitamins and so the final rule establishes a DRV of 30 dietary practices among this minerals. We consider public health grams for fat for infants though 12 subpopulation. Therefore, we proposed significance in the context of developing months of age. RDIs for vitamins and minerals to refer d. Saturated fat, trans fat, cholesterol, to amend § 101.9(c)(9) to establish a to the existence of ‘‘well-established’’ dietary fiber, and sugars. Regarding DRV of 95 grams for total carbohydrate scientific evidence from U.S. consensus saturated fat, trans fat, cholesterol, for infants 7 through 12 months of age. reports that there is a relationship dietary fiber, and sugars, there are no We did not receive comments between a nutrient and chronic disease quantitative intake recommendations regarding the proposed DRV of 95 grams risk, a health-related condition, or a from U.S. consensus reports available for total carbohydrates for infants. health-related physiological endpoint with respect to infants. Thus, we did not Consequently, the final rule adopts the and where the intake of such nutrient is propose to establish DRVs for these DRV of 95 grams for total carbohydrates of general importance in the general nutrients for infants 7 through 12 for infants though 12 months of age. U.S. population, e.g., where intakes are months of age. g. Protein. For protein, the DV for generally too low or too high among the We did not receive comments on our protein for infants is an RDI, rather than U.S. population. Thus, we established decision not to establish DRVs for a DRV. The preexisting RDI for infants RDIs for vitamins and minerals based on saturated fat, trans fat, cholesterol, and is 14 grams/day for infants, but, in the the DRIs set by the IOM that reflect the dietary fiber for infants. Thus, the final preamble to the proposed rule (79 FR most current science regarding nutrient rule does not establish DRVs for infants 11879 at 11940), we said we would requirements and associated disease though 12 months of age for these revise the RDI to rely on current risk, health-related condition, or health- nutrients. quantitative intake recommendations related physiological endpoints (79 FR (Comment 456) One comment and that, in 2002, the IOM established 11879 at 11926). While the DRI reports recommended establishing a DRV for an RDA for infants 7 through 12 months also consider dietary intake data, we sugars for infants and children and of 1.2 grams/kilogram/day based on also have analyzed more recent dietary suggested that we work with the IOM to nitrogen balance studies and using a intake data for these age groups (79 FR establish a DRV for sugar for this reference body weight of 9 kilograms. 11879 at 11944). population. The value 1.2 grams/kilogram/day × 9 We acknowledge the comment (Response) We decline to establish a kg equals 10.8 grams/day or a rounded suggesting that menu modeling and DRV for sugars for infants though 12 value of 11 grams/day, yet we also noted intake survey data could be a months of age and children 1 through 3 that protein intakes are well above the consideration in the establishment of years of age. As discussed in part II.H.2, current and proposed RDI. Mean protein certain DRVs. Dietary recommendations we are not aware of data or information intake for infants 6 to 11 months of age based on menu modeling may aim to related to a quantitative intake was 22 grams/day, well above the RDA achieve nutrient requirements, but are recommendation for sugars that we of 11 grams/day. Thus, we proposed to not the sole determining factor for could use as the basis for a DRV for total revise § 101.9(c)(8)(iv) to establish an establishing all DRVs. We agree that sugars. The IOM reviewed the evidence RDI of 11 grams for protein for infants menu modeling can be considered in on this topic in the Macronutrient report 7 through 12 months of age. choosing a reference point for daily (IOM, 2002) and did not provide We did not receive comments on our intake that is realistically achievable quantitative intake recommendations for proposed RDI of 11 grams for infants, so and practical in light of the current food infants and children. the final rule, at § 101.9(c)(7)(iii) and supply and consumption patterns. e. Polyunsaturated fat, (c)(8)(iv), establishes a RDI for protein of b. Calories. The preamble to the monounsaturated fat, insoluble fiber, 11 grams for infants though 12 months proposed rule (79 FR 11879 at 11939) soluble fiber, added sugars, and sugar of age.

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h. Sodium. For sodium, we noted, in riboflavin, niacin, vitamin B6, calcium, IOM that reflect the most current the preamble to the proposed rule (79 iron, thiamin, biotin, pantothenic acid, science regarding nutrient requirements, FR 11879 at 11940), that the IOM did phosphorous, iodine, magnesium, zinc, not on potential changes in fortification not set a UL for sodium for infants 7 selenium, copper, manganese, of products. We recognize the through 12 months of age due to chromium, molybdenum, chloride, and importance of adequate iron intake in insufficient data on adverse effects of potassium for infants 7 through 12 the diets of infants and intend to chronic overconsumption in this age months of age. monitor the nutrient adequacy for this group. Thus, we did not propose a DRV We did not receive comments population and consider the need for for sodium for infants 7 through 12 regarding our proposed RDIs for vitamin consumer education. months of age. A, vitamin C, vitamin D, vitamin E, (Comment 459) One comment asked We did not receive comments vitamin K, vitamin B12, folate, choline, that we use the current DV of 5 mg for regarding a DRV for sodium for infants. riboflavin, niacin, vitamin B6, calcium, zinc for infants as the DV for infants Thus, the final rule does not establish a thiamin, biotin, pantothenic acid, because previous RDA panels have DRV for sodium for infants though 12 phosphorous, iodine, magnesium, recommended intakes of up to 10 mg for months of age. selenium, copper, manganese, children 1 through 3 years of age and i. Fluoride. For fluoride, although the chromium, molybdenum, chloride, and now recommend a RDA of 3 mg for IOM set an AI for fluoride, the AI for potassium for infants. Thus, the final infants and children 1 through 3 years infants 7 through 12 months is close to rule adopts these RDIs for infants of age. The comment also cited a study the EPA benchmarks for total fluoride though 12 months of age without by Walravens et al. 1989 (Ref. 254) intake. Additionally, we did not change. referenced by the IOM confirming the propose a DRV for fluoride for use in the (Comment 457) One comment would factorial approach and questioned the labeling of foods for the general have us retain a DV for iron of 15 mg IOM’s use of the Walraven baseline data population because of a concern about for infants given the importance of minus 2 standard deviations to support excess intakes associated with dental adequate iron in the diets of infants and for the EAR and suggested that reported fluorosis, and so, in the proposed rule, young children and the prevalence of dietary intake data, instead of standard we tentatively concluded that a DRV for iron deficiency in children. The deviations, maybe a more appropriate fluoride is not warranted for infants 7 comment noted that published data basis for EAR. The comment stated that through 12 months. Thus, we did not reported 12 percent of infants aged 6 to lowering the DV to 3 mg/day may affect propose to establish a DRV for fluoride 11 months have iron intakes from food, the availability and level of zinc for infants 7 through 12 months of age. beverages, and supplements below the fortification in foods and reduce intake We did not receive comments EAR (Butte 2010) and our analysis of levels without a full understanding of regarding establishment of DRVs for NHANES data showed that 17.8 percent the potential impact in this sensitive fluoride for infants. Thus, the final rule of infants aged 7 to 12 months have iron population. does not establish DRVs for fluoride for intakes from conventional foods only (Response) We decline to revise the infants though 12 months of age. below the EAR. rule as suggested by the comment. We j. Other vitamins and minerals. For (Response) We decline to revise the are changing the DVs to reflect the most vitamins and minerals, we reviewed rule as suggested by the comment. We recent comprehensive reviews and current quantitative intake recognize the importance of adequate applications of nutrition science recommendations for vitamins and iron in the diets of infants. We research provided by current DRI minerals for infants to determine acknowledge the dietary intake data and reports and its set of nutrient reference appropriate RDIs for vitamins and prevalence of iron deficiency for infants values (see 79 FR 11879 at 11885). minerals to be established in regulations cited by the comment and point out that Modifying the reference value for zinc for infants 7 through 12 months of age. our analysis of NHANES data showed provided by these consensus reports is In the preamble to the proposed rule (79 that 3 percent of infants aged 7 to 12 not warranted based on the scientific FR 11879 at 11940), we explained that months have iron intakes below the evidence to support the DRI. we considered it important to establish EAR from food, beverages, and We also disagree that using reported RDIs for infants 7 through 12 months of supplements. While we evaluated dietary intake data may be a more age because infants in this age range intakes, we consider that the DRI is the appropriate basis for the EAR infants. transition from a diet of mostly breast appropriate basis for establishing the DV We note that the IOM established the milk and infant formula to infant cereal for iron for infants because the DRI EAR for zinc using a factorial approach and baby foods, and labeling foods for reports and its set of nutrient reference and did not base the EAR on the growth this subpopulation with percent DV values are comprehensive reviews and data from the Walravens study (Ref. declarations can help parents make applications of nutrition science 226). We decline to comment on the nutritious food choices. The DRIs (AIs research (79 FR 11879 at 11885). IOM’s rationale for the calculation used and RDAs) provide a basis on which to (Comment 458) One comment in confirming the factorial approach determine RDIs for vitamins and questioned how a decrease in the DV for using the growth data cited by the minerals for this subpopulation. We iron would affect iron fortification of Walraven study. We decline to considered it appropriate to use RDAs foods for infants. The comment said that speculate on how consumers may and, in the absence of RDAs, AIs to such a decrease in the DV could cause interpret % DV for zinc resulting from determine appropriate micronutrient manufacturers to reduce iron a recommended dietary pattern and RDIs for infants. We also stated that the fortification of products for this whether they may inappropriately limit IOM established DRIs based on population group. zinc intake. The comment did not scientific knowledge that update and (Response) We disagree with the provide, and we are not aware of, any supersede previous RDA comment. The comment did not evidence to suggest how consumers will recommendations. Consequently, we provide, and we are not aware of, any react to the changes in percent DV as a proposed to amend § 101.9(c)(8)(iv) to evidence to suggest that decreasing the result of changes to the DVs and include a listing of RDIs for vitamin A, DV for iron would impact iron whether they would inappropriately vitamin C, vitamin D, vitamin E, fortification of foods for infants. DVs are limit zinc intake. We recognize the vitamin K, vitamin B12, folate, choline, established based on DRIs set by the importance of adequate zinc intake in

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the diets of infants and intend to declarations of percent DV should be sex groups, they function as an overall monitor the nutrient adequacy for this required for products targeted to population reference to help consumers population and consider the need for children 4 through 13 years of age that judge a food’s usefulness in meeting consumer education. contain nutrients for which this age- overall daily nutrient requirements or We also have no evidence to suggest specific DRV or RDI is established. recommended consumption levels and how that decreasing the DV for zinc (Response) We decline to revise the to compare nutrient contributions of would impact zinc fortification of foods rule as suggested by the comments. different foods. for infants and decline to speculate on While we recognize that nutritional b. Calories. With respect to calories, how availability and level of zinc needs of children aged 4 to 8 or 4 to 13 we stated, in the preamble to the fortification may change. DVs are years are different from adults, we proposed rule (79 FR 11879 at 11940 established based on DRIs set by the disagree with establishing RDIs for through 11941), that several comments IOM that reflect the most current children aged 4 to 8 or 4 to 13 years due to the 2007 ANPRM supported science regarding nutrient requirements to concerns about excessive intake of establishing a DV for calories and not on potential changes in the nutrients above the UL or recommended specifically for young children 1 fortification of products. intakes for these age groups. As noted in through 3 years of age and that we the preamble to the proposed rule (79 considered it appropriate to establish a 6. DRVs and RDIs for Children 1 FR 11879 at 11928) and the reference calorie intake level for Through 3 Years of Age accompanying memorandum to the file children 1 through 3 years of age With respect to children 1 through 3 rule (Ref. 199), intakes of vitamins and because we proposed to set DRVs using years of age, our preexisting regulations minerals generally do not exceed the quantitative intake recommendations do not include DRVs or RDIs, except an ULs under current RDIs that are based that are based on calories (e.g., total fat, RDI for protein of 16 grams for children on a population coverage approach, saturated fat, and dietary fiber). Because less than 4 years of age. In the preamble except for zinc, vitamin A (preformed), recommendations from the IOM, AHA, to the proposed rule (79 FR 11879 at iodine and folic acid among children 4 AAP, and the 2010 DGA for caloric 11940 through 11941), we explained to 8 years old. In these few instances intake range from 800 to 900 calories/ that we reviewed scientific evidence where total usual intakes of vitamins day for children 1 year old, and current recommendations, as well and minerals by children aged 4 to 8 approximately 1,000 calories/day for as comments in response to the 2007 years exceed corresponding ULs, we children 2 years of age, and from 1,000 ANPRM to consider establishing DRVs have determined that such intakes are to 1,200 calories/day for children 3 and RDIs for nutrients for this not of public health significance. years of age, we used an average of the subpopulation and to consider revisions With respect to the comment range of these caloric intake to the current RDI for protein. regarding niacin, the UL for niacin recommendations (800 to 1,200 calories/ a. General comments. applies to niacin obtained from fortified day), i.e., 1,000 calories/day, as a (Comment 460) Several comments foods and/or supplements and is based reasonable reference calorie intake level supported establishing DVs for children on flushing (burning, tingling sensation and proposed to amend § 101.9(c)(9) to 1 through 3 years (13 through 48 and reddening flush primarily on skin, provide a reference calorie intake level months) that are consistent with the arms and face) which is not considered of 1,000 calories/day for children 1 IOM’s DRI recommendations for a serious adverse effect. The UL for through 3 years of age. children 1 through 3 years age ranges. children was set by extrapolating (Comment 461) One comment In contrast, one comment suggested downward from the UL for adults. supported the reference calorie intake of setting DVs specific for 4- to 8-year-old While niacin intakes from fortified 1,000 calories/day for children 1 children because, according to the foods and dietary supplements may through 3 years of age. comment, setting a single DV that exceed the UL for children aged 4 to 8 (Response) We agree with the groups 4- to 8-year-old children with years old (Refs. 194–195), no data were reference calorie intake of 1,000 adults could lead to excessive intakes of found to suggest that children have calories/day for labeling represented or some fortified vitamins and minerals increased susceptibility to flushing purported to be for children 1 through and potentially increase the risk of effects from excess intake (Ref. 249). 3 years of age. Thus, the final rule, at adverse health effects from ingesting too We also disagree with establishing § 101.9(c)(9), establishes a reference much. The comment pointed out that RDIs and DRVs for children 4 to 13 calorie intake of 1,000 calories/day for the updated DVs for two nutrients, years of age and mandatory declaration children aged 1 through 3 years. vitamin A and niacin, are the same as of percent DV for products targeted to c. Total fat. In the preamble to the or higher than the IOM Tolerable Upper children 4 through 13 years of age to proposed rule (79 FR 11879 at 11941), Intake Levels (ULs) for 4-to-8-year-olds. provide an opportunity for companies to we noted that there is no DRV for total Other comments suggested formulate children’s products to age- fat for children ages 1 through 3 years, establishing RDIs and DRVs for children specific RDAs rather than adult values but a comment to the 2007 ANPRM 4 to 13 years of age because product which may not be appropriate for recommended that 35 percent of the labeling based on RDIs for adults, in children’s nutritional needs. We recommended 1,050 calories or 41 most cases, exceed the nutritional needs recognize that RDAs for adults may be grams/day of fat be used to as the DRV for children 4 to 13 years of age. The higher than the RDAs of children 4 for fat because it is the midpoint of the comments also noted that setting RDIs through 8 years of age and 9 through 13 AAP/AHA recommendation and the for children would provide an years of age. RDIs are intended to help IOM Acceptable Macronutrient opportunity for more companies to persons to understand the relative Distribution Range (AMDR) for 1 formulate children’s products to age- significance of nutrients in the context through 3 year olds. We agreed that 35 specific RDAs (rather than adult values of a total daily diet, to compare foods, percent of calories from fat for children which may not be appropriate for and to plan general diets. They are not 1 through 3 years of age serves as an children’s nutritional needs) and intended to be used to decide whether appropriate basis on which to set the communicate the information to a particular individual’s consumption of DRV for total fat and would be consumers via product labeling. One nutrients is appropriate. While RDIs are consistent with AHA and AAP comment recommended that not precise values for certain age and recommendations that 30 to 40 percent

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of calories consumed by children 12 to d. Saturated fat, trans fat, and We did not receive comments 24 months of age and 30 to 35 percent cholesterol. For saturated fat, trans fat, regarding our tentative decision not to of calories consumed by children 24 and cholesterol, we stated, in the establish a DRV for trans fat or the through 48 months of age should come preamble to the proposed rule (79 FR proposed DRV of 300 mg for cholesterol from fat. Therefore, we tentatively 11879 at 11941), that there are no DRVs for children aged 1 through 3 years. concluded that 35 percent of total for children 1 through 3 years of age. Thus, the final rule establishes a DRV of calories from fat (i.e., 39 grams using the Based on the scientific evidence in the 300 mg for cholesterol for children aged proposed reference calorie intake level 2010 DGA to support that Americans 2 1 through 3 years and does not establish of 1,000 calories/day) is an appropriate years of age and older consume less a DRV for trans fat. DRV for total fat for children 1 through than 10 percent of calories from e. Polyunsaturated fat, 3 years of age, and we proposed to saturated fat and less than 300 mg/day monounsaturated fat, sugars, insoluble amend § 101.9(c)(9) to establish a DRV of cholesterol, we tentatively concluded fiber, soluble fiber, added sugars, and of 39 grams for fat for children 1 that it would be appropriate to set a sugar alcohols. For polyunsaturated fat, through 3 years of age. DRV of 10 grams for saturated fat, based monounsaturated fat, sugars, added (Comment 462) One comment would on 10 percent of total calories from sugars, insoluble fiber, soluble fiber, and increase the DRV for total fat for saturated fat and using the proposed sugar alcohols, we stated, in the children 1 through 3 years of age to 41 reference calorie intake level of 1,000 preamble to the proposed rule (79 FR grams, given the importance of an calories/day, which equals 11 grams, 11879 at 11941), that there are no DRVs adequate intake of total fat in this rounded down to 10 grams, and a DRV for children 1 through 3 years of age. We population for healthy development and of 300 mg for cholesterol for children 1 recognized the essential nature of a- growth. The comment noted that this through 3 years of age. We proposed to linolenic acid in the diet, but we said level of total fat would be 37 percent of amend § 101.9(c)(9) to establish a DRV that, for children 1 through 3 years of total calories from fat (based on 1,000 of 10 grams for saturated fat and a DRV age, DRIs or other data and information calories/day reference calorie intake of 300 mg for cholesterol for children 1 were not available on which we could level) which is within the AMDR of 30 through 3 years of age. We declined to rely to establish DRVs for to 40 percent total calories from fat. The propose a DRV for trans fat because the polyunsaturated fat, monounsaturated comment cited dietary intake data scientific evidence from the IOM and fat, sugars, added sugars, insoluble fiber, suggesting that 23 percent (12 to 23 the 2010 DGA did not provide any soluble fiber, and sugar alcohols (id.). months) and 47 percent (24 to 48 specific appropriate levels of intake. Therefore, we tentatively concluded that months) of children are below the (Comment 463) One comment there was no basis for setting DRVs for AMDR. The comment noted that it is recommended using the DRV of 12 these nutrients and did not propose important for the total fat DV to help grams for saturated fat for children 1 DRVs for polyunsaturated fat, including encourage adequate fat intake. through 3 years of age. The comment n-3 or n-6 polyunsaturated fatty acids, noted that this value represents 10.7 monounsaturated fat, sugars, added (Response) We decline to increase the percent of calories from saturated fat sugars, soluble fiber, insoluble fiber, or DRV for total fat. In the preamble to the based on a 1,000 calorie diet and is sugar alcohols for children 1 through 3 proposed rule (79 FR 11879 at 11941), consistent with the diets of about 25 years of age. we determined that 35 percent of percent of children between 12 and 47 We did not receive comments on our calories from fat, based on a 1,000 months, an indication that this level of tentative decision not to establish DRVs calorie/day reference calorie intake intake is achievable. for polyunsaturated fat, level, is an appropriate basis for the (Response) We decline to change the monounsaturated fat, sugars, insoluble DRV for total fat because it aligns with DRV for saturated fat as suggested by the fiber, soluble fiber, and sugar alcohols. the AHA and AAP recommendations comment. In establishing the DRV for Thus, the final rule does not establish that 30 to 40 percent of calories saturated fat, we considered that DRVs for children 1 through 3 years of consumed by children 12 through 24 cardiovascular disease can begin in age for these nutrients. months of age and 30 to 35 percent of childhood and the scientific evidence in (Comment 464) Some comments calories consumed by children 24 the 2010 DGA that support Americans 2 agreed with not defining DVs for added through 48 months of age should come years of age and older consuming less sugars. One comment recommended from fat and is consistent with our than 10 percent of calories from establishing a DRV for added sugar for proposed approach to setting the DRV saturated fat (79 FR 11879 at 11941). We children. for total fat for the general population disagree that the DRV for saturated fat (Response) We received many (Ref. 255). We acknowledge the dietary should be based on dietary intake data comments on defining a DRV for added intake data suggesting the total fat that suggest that a level of 12 grams is sugars and explain, in part II.H.3.o, that intake of children is below the AMDR. achievable. DVs are established based we are establishing a DRV for added This calculation yields a DRV of 39 on DRIs set by the IOM that reflect the sugars for children and adults 4 years of grams. most current science regarding nutrient age and older of no more than 10 We disagree that the purpose of the requirements, not on levels of intakes percent of total calories, or 50 grams total fat DV is to encourage fat intake. that are achievable. Thus, the final rule, using a 2,000 calorie intake reference The DVs are intended to help persons to at § 101.9(c)(9), establishes a DRV of 10 amount based on food pattern modeling. understand the relative significance of grams for saturated fat for children aged For the reasons discussed in part nutrients in the context of a total daily 1 through 3 years. Additionally, on our II.H.3.o, we are also establishing a DRV diet, to compare foods, and to plan own initiative, we have replaced of 25 grams of added sugars for children general diets. They are not intended to ‘‘saturated fatty acids’’ in the table with 1 through 3 years of age based on food be used to decide whether a particular ‘‘saturated fat’’ for consistency in how pattern modeling. Using the 1,000 individual’s consumption of nutrients is we refer to saturated fat. We also have calorie intake reference amount for appropriate. replaced ‘‘Unit of measurement’’ with children 1 through 3 years of age and Thus, the final rule, at § 101.9(c)(9), ‘‘Unit of measure’’ in the table for the DRV of no more than 10 percent of establishes a DRV of 39 grams for total consistency with the introductory total calories, the DRV for children 1 fat for children aged 1 through 3 years. sentence to § 101.9(c)(9). through 3 years of age is 25 grams (1,000

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calories × 0.1 = 100 calories and 100 h. Protein. Under our preexisting 20 percent of calories and the RDA is calories ÷ 4 calories per gram for regulations, at § 101.9(c)(7)(iii), the RDI approximately 5 percent of calories. carbohydrates = 25 grams). Thus, the for protein for children younger than 4 Thus, a DRV for protein should be based final rule, at § 101.9(c)(9), establishes a years of age was based on the 1989 RDA on 5 percent of 1,000 calories or 50 DRV of 25 grams for added sugars for for protein of 16 grams/day. Taking into calories which equals 12.5 grams or, children ages 1 through 3 years of age. account current recommendations and when rounded up, 13 grams, and the f. Total carbohydrates. In the protein intakes, we noted, in the final rule, at § 101.9(c)(7)(iii) and (c)(9), preamble to the proposed rule (79 FR preamble to the proposed rule (79 FR establishes a DRV for protein of 13 11879 at 11941), we said that, for total 11879 at 11942), that protein intakes are grams for children 1 through 3 years of carbohydrates, there is not a DRV for well above the current RDI, with the age. children 1 through 3 years of age. We mean protein intake for children 12 to i. Sodium. In the preamble to the noted, however, that we were proposing 23 months of age being 44 grams/day, proposed rule (79 FR 11879 at 11942), a DRV for total carbohydrate for the well above the RDA of 13 grams/day, we noted that, for the general general population based on the and the midpoint of the AMDR of 5 to population, we proposed to establish a percentage of calories in a 2,000 calorie 20 percent calories from protein (i.e., DRV based on the UL for sodium and diet remaining after the sum of the DRV 12.5 percent of calories from protein or that there is no DRV for sodium for for fat (30 percent) plus the DRV for 31 grams/day). The protein AMDR for children 1 through 3 years of age. We protein (10 percent) have been children 1 through 3 years of age is 5 to also noted that the IOM derived the UL subtracted and that we considered this 20 percent of calories, and the RDA is for children 1 through 3 years of age by method to be appropriate for setting a approximately 5 percent of calories. extrapolation from the adult UL of 2,300 DRV for total carbohydrate for children Given the proposed reference calorie mg/day based on observational studies 1 through 3 years of age (id.). We also intake level and the approaches used for showing that blood pressure increases stated that total calories (100 percent) the proposed DRVs for fat and with age into adulthood and the minus the proposed DRV for total fat (35 carbohydrate that are based on percent recognition that risk factors for CVD, percent of calories) and the proposed of calories, we tentatively concluded such as high blood pressure and DRV for protein (5 percent of calories) that, as with the general population, the atherosclerosis, occur in childhood (id.). equals 60 percent of calories from total DV for protein for children 1 through 3 We proposed to amend § 101.9(c)(9) to carbohydrate. A value of 60 percent of years of age should be a DRV, rather establish a DRV of 1,500 mg for sodium total calories from total carbohydrates than an RDI (using the RDA) and that a for children 1 through 3 years of age. also falls within the IOM AMDR DRV for protein should be based on 5 We did not receive comments recommendation of 45 to 65 percent of percent of 1,000 calories or 50 calories regarding the DRV of 1500 g for sodium calories from carbohydrates for children which equals 12.5 grams or, when for children 1 through 3 years of age. 1 through 3 years of age. Therefore, we rounded up, 13 grams. We proposed to Thus, the final rule, at § 101.9(c)(9), tentatively concluded that an amend § 101.9(c)(7)(iii) and (c)(9) to establishes a DRV of 1,500 mg for appropriate DRV for total carbohydrate establish a DRV for protein of 13 grams sodium for children 1 through 3 years is 60 percent of calories (i.e., 150 grams for children 1 through 3 years of age. of age. using the proposed reference calorie (Comment 465) One comment j. Fluoride. There is not a DV for intake level of 1,000 calories/day), and recommended retaining the current DV fluoride for children 1 through 3 years we proposed to amend § 101.9(c)(9) to of 16 grams for protein or using 10 of age. In the preamble to the proposed set a DRV of 150 grams for total percent of calories from protein. The rule (79 FR 11879 at 11942), we said carbohydrate for children 1 through 3 comment noted that children 24 to 47 that, although the IOM recognized years of age. months have 13 to 19 percent of energy fluoride as a trace mineral that is We did not receive comments intakes from protein, respectively. The important for public health by setting an regarding the proposed DRV of 150 comment said that the proposed DV of AI based on evidence of its role in grams for children 1 through 3 years of 13 grams appears to be low relative to reducing the risk of dental caries, we age, so the final rule adopts this DRV the protein that would be expected to be tentatively concluded that a DRV should without change. contributed from a diet that supplies the not be established for fluoride. The g. Dietary fiber. In the preamble to the appropriate servings of foods from the proposed rule did not contain a DRV for proposed rule (79 FR 11879 at 11941), recommended food groups, including fluoride for children 1 through 3 years we stated that there is not a DRV for milk, meat/poultry and beans and other of age. dietary fiber for children 1 through 3 legumes. We did not receive comments years of age, but we agreed with a (Response) We decline to retain a DV regarding the establishment of DRVs for comment to an ANPRM that an AI of 14 of 16 grams for protein. In the preamble fluoride for children 1 through 3 years grams/1,000 calories for dietary fiber for to the proposed rule (79 FR 11879 at of age. Thus, the final rule does not children 1 through 3 years of age should 11942), we discussed a comment to the establish a DRV for fluoride for children be used to set a DRV for dietary fiber to 2007 ANPRM recommending the DV for 1 through 3 years of age. be consistent with how other proposed protein be maintained at 16 grams. We k. Other vitamins and minerals. In the DRVs are being set. Additionally, declined to keep the DV for protein at preamble to the proposed rule (79 FR because we proposed a reference calorie 16 grams, in part, because protein 11879 at 11942 through 11943), we intake level of 1,000 calories/d for this intakes are well above the current RDI. stated that the IOM’s quantitative intake subpopulation, we proposed to amend Mean protein intake for children 12 to recommendations (AIs and RDAs) § 101.9(c)(9) to establish a DRV of 14 23 months of age was 44 grams/day, provide a basis on which to determine grams for dietary fiber for children 1 well above the RDA of 13 grams/day RDIs for vitamins and minerals for through 3 years of age. and the midpoint of the AMDR of 5 to children 1 through 3 years of age. We We did not receive comments 20 percent calories from protein (i.e., explained that the RDA, when available, regarding the proposed DRV of 14 grams 12.5 percent of calories from protein or is the best estimate of an intake level for fiber for children 1 through 3 years 31 grams/day, which we rounded up to that will meet the nutrient goals of of age. Thus, the final rule adopts this 13 grams). The protein AMDR for practically all consumers who would DRV without change. children 1 through 3 years of age is 5 to use the Nutrition Facts label and that,

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while AIs have less certainty than research. We acknowledge that current applications of nutrition science RDAs, AIs represent goals for nutrient potassium intakes are below the research (79 FR 11879 at 11885). intake for individuals and provide the proposed DV of 3,000 mg. However, we (Comment 468) One comment best estimate based on current science disagree that the DV for potassium may questioned how a decrease in the DV for for use in setting RDIs for such nutrients promote an unbalanced diet. Dietary iron would affect iron fortification of (see id.). Therefore, using the RDAs and sources of potassium are found in all foods for toddlers. The comment said AIs, we proposed to amend food groups, notably in vegetables and that such a decrease in the DV could § 101.9(c)(8)(iv) to establish RDIs for fruits, and milk and milk products (Ref. cause manufacturers to reduce iron vitamin A, vitamin C, vitamin D, 30). Promoting the development of fortification of products for this vitamin E, vitamin K, vitamin B12, healthy eating patterns that will be population group. folate, choline, riboflavin, niacin, associated with adequate potassium (Response) We disagree with the vitamin B6, calcium, iron, thiamin, intake later in life is important because comment. The comment did not biotin, pantothenic acid, phosphorous, chronic conditions such as elevated provide, and we are not aware of, any iodine, magnesium, zinc, selenium, blood pressure, bone demineralization, evidence to suggest that decreasing the copper, manganese, chromium, and kidney stones likely result from DV for iron would impact iron molybdenum, chloride, and potassium inadequate potassium intakes over an fortification of foods for toddlers. DVs for children 1 through 3 years of age. extended period of time, including are established based on DRIs set by the We did not receive comments childhood (Ref. 256). IOM that reflect the most current regarding our proposed RDIs for vitamin We disagree that DVs should be set science regarding nutrient requirements, A, vitamin C, vitamin D, vitamin E, based on realistic intakes or eligibility to not on potential changes in fortification vitamin K, vitamin B12, folate, choline, make a nutrient content claim. The DVs of products. We recognize the riboflavin, niacin, vitamin B6, calcium, are established based on DRIs set by the importance of adequate iron intake in thiamin, biotin, pantothenic acid, IOM that reflect the most current the diets of young children and intend phosphorous, iodine, magnesium, science regarding nutrient requirements, to monitor the nutrient adequacy for selenium, copper, manganese, not on levels of intakes that are this population and consider the need chromium, molybdenum, and chloride achievable or eligibility to make for consumer education. for children 1 through 3 years of age. nutrient content claims. (Comment 469) One comment asked Thus the final rule adopts these RDIs for (Comment 467) One comment would that we use the current DV of 5 mg for children 1 through 3 years of age have us retain a DV for iron of 10 mg zinc for infants as the DV for children without change. of children 1 through 3 years given the (Comment 466) One comment said importance of adequate iron in the diets 1 through 3 years of age because that a DV for potassium of 3,000 mg for of infants and young children and the previous RDA panels have children aged 1 through 3 years is prevalence of iron deficiency in recommended intakes of up to 10 mg for unrealistic and may promote an children. The comment noted that children 1 through 3 years of age and unbalanced diet. The comment said that dietary intake data in children aged 12 now recommend a RDA of 3 mg for the DV for potassium should be to 24 months suggests that children may infants and children 1 through 3 years calculated using a 1,000 calorie diet be consuming less heme iron than of age. The comment also cited a study instead of the 1,372 calorie factor used assumed in the determination of the by Walravens et al. 1989 (Ref. 254) by the IOM for 1 through 3 year olds. IOM EAR so the EAR may be too low referenced by the IOM confirming the The comment requested a DV of 2,300 to achieve the requirement of absorbed factorial approach and questioned the mg given the reference caloric intake of iron. However, the comment did not IOM’s use of the Walravens baseline 1,000 for children ages 1 through 3 provide an amount or percentage of data minus 2 standard deviations to years. heme iron being consumed from current support for the EAR and suggested that Another comment expressed concern intakes and also cited data from reported dietary intake data, instead of that, with a DV of 3,000 mg, several published and unpublished sources. standard deviations, maybe a more foods products would no longer be (Response) We decline to revise the appropriate basis for EAR. The comment considered a ‘‘good source’’ of rule as suggested by the comment. We said that the zinc consumption from a potassium. recognize the importance of adequate recommended dietary pattern for (Response) We decline to establish a iron in the diets of infants and young children 1 through 3 years of age would DV of 2,300 mg for potassium, and we children. As for the statement that be at least 6 mg, or 200 percent of the disagree with the comment regarding children may be consuming less heme proposed DV and that consumers would foods that would no longer be iron than assumed in the IOM’s likely be confused by these high considered as a ‘‘good source’’ of determination of the EAR, as the amounts per serving and could take potassium. In the preamble to the comment provided data from one steps to inappropriately limit zinc proposed rule (79 FR 11879 at 11942), published study reflecting dietary intake intake. The comment stated that we discussed how we had considered data from 2002 and did not provide lowering the DV to 3 mg/day may affect comments to the 2007 ANPRM estimates of the heme iron consumed or the availability and level of zinc suggesting that we use 1,800 or 2,000 total iron absorbed, we cannot fortification in foods and reduce intake mg/day potassium as the basis for the determine from the information levels without a full understanding of RDI for potassium; we said that it would provided by the comment that the EAR the potential impact in this sensitive be inconsistent with the approach for may be too low to achieve the population. the general population. Selecting a requirement of absorbed iron. (Response) We decline to revise the number other than a RDA or AI, when Furthermore, selecting a number other rule as suggested by the comment. We there is one, is inconsistent with our than a RDA or AI is inconsistent with are changing the DVs to reflect the most approach for establishing DVs. We rely our approach for establishing DVs. We recent comprehensive reviews and on the DRI reports and its set of nutrient rely on the DRI reports and its set of applications of nutrition science reference values for establishing the DVs nutrient reference values for research provided by current DRI because they are comprehensive reviews establishing the DVs because they are reports and its set of nutrient reference and applications of nutrition science comprehensive reviews and values (see 79 FR 11879 at 11885).

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We also disagree that using reported b. Total fat, saturated fat, cholesterol, defining a DRV for added sugars for dietary intake data may be a more total carbohydrate, sodium, and dietary children and adults 4 years of age and appropriate basis for the EAR children fiber. For total fat, saturated fat, older and explain, in part II.H.3.o, that 1 through 3 years of age. We note that cholesterol, total carbohydrate, sodium, we are establishing a DRV for added the IOM established the EAR for zinc and dietary fiber, we explained, in the sugars for children and adults 4 years of using a factorial approach and did not preamble to the proposed rule (79 FR age and older of no more than 10 base the EAR on the growth data from 11879 at 11943), that the quantitative percent of total calories, or 50 grams the Walravens study (Ref. 226). intake recommendations for total fat, using a 2,000 calorie intake reference The comment did not provide, and we saturated fat, cholesterol, total amount based on food pattern modeling. are not aware of, any evidence to carbohydrate, sodium, and dietary fiber For the reasons discussed in part suggest how consumers will react to the for pregnant and lactating women are II.H.3.o, we also are establishing a DRV changes in percent DV as a result of generally similar to the general for added sugars for pregnant women changes to the DVs and whether they population. Thus, we tentatively and lactating women of no more than 10 would inappropriately limit zinc intake. concluded that the DRVs for total fat, percent of total calories, or 50 grams We recognize the importance of saturated fat, cholesterol, total using a 2,000 calorie intake reference adequate zinc intake in the diets of carbohydrate, sodium, and dietary fiber amount based on food pattern modeling. young children and intend to monitor for pregnant and lactating women Thus, the final rule at § 101.9(c)(9), the nutrient adequacy for this should remain the same as for the establishes a DRV of 50 grams for added population and consider the need for general population, and so we proposed sugars for pregnant women and lactating consumer education. to amend § 101.9(c)(9) to establish DRVs women. We also have no evidence to suggest for pregnant and lactating women using d. Protein. Our preexisting how that decreasing the DV for zinc the proposed DRVs for the general regulations, at § 101.9(c)(7)(iii), establish would impact zinc fortification of foods population for total fat, saturated fat, RDIs of 60 grams of protein for pregnant for toddlers and decline to speculate on cholesterol, total carbohydrate, sodium, women and 65 grams of protein for how availability and level of zinc and dietary fiber. lactating women based on the highest fortification may change. DVs are We did not receive comments on our 1989 RDAs for pregnant and lactating established based on DRIs set by the proposal to establish DRVs for total fat, women. In the preamble to the proposed IOM that reflect the most current saturated fat, cholesterol, total rule (79 FR 11879 at 11943), we noted science regarding nutrient requirements carbohydrate, sodium, and dietary fiber that the IOM established 71 grams/day and not on potential changes in the for pregnant and lactating women based protein as the RDA for pregnant and fortification of products. on the DRVs for the general population lactating women based on the needs for 7. DRVs and RDIs for Pregnant Women for total fat, saturated fat, cholesterol, maternal and fetal development and and Lactating Women total carbohydrate, sodium, and dietary human milk production. Because the fiber. Thus, we have finalized these RDA for protein during both pregnancy The proposed rule would establish provisions without change. and lactation is the same, and given that certain DRVs and RDIs for pregnant c. Trans fat, polyunsaturated fat, most foods represented or purported to women and lactating women. monounsaturated fat, insoluble fiber, be specifically for pregnant women are a. Calories. The proposed rule would soluble fiber, sugars, added sugars, and also represented or purported to be use the 2,000 reference calorie intake sugar alcohols. For trans fat, specifically for lactating women, we level for setting DRVs for pregnant polyunsaturated fat, monounsaturated tentatively concluded that it would be women and lactating women fat, soluble fiber, insoluble fiber, sugars, appropriate to establish a single RDI of (§ 101.9(c)(9)). In the preamble to the added sugars, and sugar alcohols, in the 71 grams applicable to both pregnant proposed rule (79 FR 11879 at 11943), preamble to the proposed rule (79 FR and lactating women and that the DV for we explained that the calorie needs for 11879 at 11943), we said that we did not protein for pregnant and lactating pregnant women and lactating women propose DRVs for these nutrients for the women should remain an RDI (using the are similar to the general population, general population because of a lack of RDA) instead of a DRV because the DRV and few products are purported for quantitative intake recommendations. approach used to calculate protein for pregnant and lactating women. Thus, Because quantitative intake the general population based on 10 because the reference calorie intake for recommendations are lacking for these percent of 2,000 calories, which equals the general population is 2,000, we nutrients for pregnant and lactating 50 grams of protein/day, falls short of proposed to use the 2,000 reference women, we did not propose to establish the recommended protein needs of calorie intake level for setting DRVs for DRVs for trans fat, polyunsaturated and pregnant and lactating women of 71 pregnant women and lactating women monounsaturated fat, soluble fiber, grams/day. Thus, we proposed to amend (§ 101.9(c)(9)). insoluble fiber, sugars, added sugars, or § 101.9(c)(7)(iii) to establish an RDI of We did not receive comments on our sugar alcohols for pregnant and lactating 71 grams for protein for pregnant and proposed 2,000 reference calorie intake women. lactating women. level for setting DRVs for pregnant We did not receive comments on our We did not receive comments on the women and lactating women. Thus, we proposal not to establish DRVs for trans proposed RDI of 71 grams for protein for have finalized the provision without fat, polyunsaturated and pregnant and lactating women. Thus, change on this point. However, on our monounsaturated fat, insoluble fiber, we have finalized this provision without own initiative, we have made a soluble fiber, sugars, or sugar alcohols change. grammatical change to the rule’s for pregnant and lactating women. Thus, e. Fluoride. For fluoride, we did not mention of ‘‘pregnant and lactating the final rule does not establish DRVs propose to establish a DRV for pregnant women’’ to refer, instead, to ‘‘pregnant for trans fat, polyunsaturated and or lactating women because we were not women and lactating women.’’ We have monounsaturated fat, insoluble fiber, proposing a DRV for fluoride in the made this change to clarify that the rule soluble fiber, sugars, or sugar alcohols general population. is referring to two groups (pregnant for pregnant and lactating women. We did not receive comments women and lactating women) instead of However, with respect to added regarding the establishment of a DRV for one group. sugars, we received many comments on fluoride for pregnant and lactating

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women. Thus, the final rule does not the RDI for vitamins and minerals). The • remove ‘‘folate’’ and ‘‘folacin’’ from establish a DRV for fluoride for pregnant regulation also requires, in the list of synonyms that may be used and lactating women. § 101.36(b)(2), that calories from to declare folic acid on the Supplement f. Vitamins and minerals. For saturated fat and polyunsaturated fat, Facts label. vitamins and minerals, in the preamble monounsaturated fat, soluble fiber, (Comment 470) Many comments to the proposed rule (79 FR 11879 at insoluble fiber, sugar alcohol, other opposed allowing only the use of the 11943), we considered it appropriate to carbohydrate, and § 101.9(c)(8)(iv) or term ‘‘folic acid’’ on dietary establish RDIs for pregnant and lactating (c)(9) vitamins and minerals other than supplements. The comments said that women for vitamins and minerals that vitamin A, vitamin C, calcium, and iron dietary supplements can contain folate. have DRIs, using population-coverage may be declared, but they must be (Response) As discussed in part RDAs and AIs, instead of population- declared when they are added to the II.N.3.b, the final rule requires that the weighted EARs. We proposed to product for purposes of Supplement Facts label declare folate in establish a single set of RDIs intended supplementation, or when a claim is mcg DFE, a percent DV based on mcg for both pregnant women and lactating made about them. DFE, and that the mcg of folic acid be women because nutrient needs during We proposed to update the list of stated in parenthesis when folic acid is pregnancy and lactation are similar. (b)(2)-dietary ingredients to maintain added as a nutrient supplement to a Thus, we proposed to amend consistency with the proposed dietary supplement. In doing so, there § 101.9(c)(8)(iv) to establish RDIs as set requirements for nutrition labeling of will be consistency with the use of the forth previously for vitamin A, vitamin foods in § 101.9. Therefore, proposed term folate in labeling of both C, vitamin D, vitamin E, vitamin K, § 101.36(b)(2)(i) would: (1) No longer conventional foods and dietary vitamin B12, folate, choline, riboflavin, require declaration of vitamin A, supplements. In addition, the mcg DFE niacin, vitamin B6, calcium, iron, vitamin C, or Calories from fat; (2) reflects the fact that folic acid is more thiamin, biotin, pantothenic acid, require vitamin D and potassium; (3) bioavailable than folate and is the basis phosphorous, iodine, magnesium, zinc, require the declaration of added sugars; of the DV. By requiring the declaration selenium, copper, manganese, and (4) retain the other (b)(2)-dietary of the mcg DFE folate, a percent DV chromium, molybdenum, chloride, and ingredients as mandatory declarations. based on mcg DFE, and the mcg of folic acid in parentheses on dietary potassium for pregnant and lactating We also proposed to amend supplements when folic acid is added as women. § 101.36(b)(2)(i), (b)(2)(i)(B)(1), and a nutrient supplement, consumers will We did not receive comments with (b)(2)(iii)(G) to remove the requirement be aware of the type and amount of respect to these DRVs and RDIs for for declaration of ‘‘Calories from fat.’’ pregnant and lactating women, and so folate or folic acid in the dietary We did not receive comments on supplement. we have finalized these provisions these proposed changes to the without change. The final rule also removes ‘‘folacin’’ Supplement Facts label, and so, with from the list of synonyms that may be P. Dietary Supplements the exception of replacing ‘‘sugars’’ with used for folate in the Nutrition Facts Our preexisting regulations specific to ‘‘total sugars’’ in § 101.36(b)(2)(i), we label in § 101.9(c)(8)(v) and the dietary supplement nutrition labeling have finalized the provisions without Supplement Facts label in appear in § 101.36. Many requirements change. § 101.36(b)(2)(i)(B)(2)). In addition, the in § 101.36 are consistent with the We note that we did receive final rule removes the term ‘‘folic acid’’ requirements for the nutrition labeling comments, in general, on removing the from the list of synonyms that may be of conventional foods in § 101.9, and declaration of vitamins A and C and on added in parentheses immediately there are references throughout § 101.36 requiring the declaration of vitamin D following ‘‘folate’’ on the Nutrition to requirements established in § 101.9. and potassium; we discuss those Facts label in § 101.9(c)(8)(v) or in place The proposed rule would amend both comments in part II.L.2 and II.L.3. We of the term ‘‘folate’’ on the Supplement the content and format of the also received comments on removing Facts label in § 101.36(b)(2)(B)(2) Supplement Facts label to correspond to the requirement for declaration of because we are now requiring that the the Nutrition Facts label. ‘‘Calories from fat;’’ we discuss those terms ‘‘folate’’ and ‘‘folic acid’’ be comments in part II.E.1. included, when declared, on both the 1. Mandatory Dietary Ingredients 2. Folate and Folic Acid Nutrition and Supplement Facts label. Our preexisting regulations, at § 101.36(b)(2), provide information on The preamble to the proposed rule (79 3. Units of Measure dietary ingredients that have an RDI or FR 11879 at 11947) explained that folate The proposed rule would amend a DRV as established in § 101.9(c)(8)(ii) is a nutrient found in conventional § 101.9(c)(8)(iv) to replace ‘‘IU’’ for the and (c)(9). These dietary ingredients are foods, whereas folic acid is the synthetic RDIs for vitamin A, vitamin D, and known as the ‘‘(b)(2)-dietary form of folate that is added to fortified vitamin E with mcg RAE for vitamin A, ingredients.’’ Of these 15 nutrients, conventional foods and dietary mcg for vitamin D, and mg a-tocopherol vitamin A, vitamin C, calcium, and iron supplements. Because of the difference for vitamin E. The proposed rule would must be listed in the Supplement Facts in bioavailability between naturally quantify and declare folate and folic label for a dietary supplement when the occurring folate and synthetic folic acid, acid in ‘‘mcg DFE’’ instead of ‘‘mcg.’’ quantitative amount by weight exceeds we proposed to: For consistency in nutrition labeling of the amount that can be declared as zero • Amend § 101.9(c)(8)(v) such that foods and dietary supplements, the in the nutrition labeling of foods in the term ‘‘folate’’ would be used in the proposed rule also would amend accordance with § 101.9(c). Section labeling of conventional foods that § 101.36(b)(2)(i)(B)(3) to require that, 101.36(b)(2) states that any (b)(2)-dietary contain either folate alone or a mixture when b-carotene is included in ingredients that are not present, or that of folate and folic acid; parentheses following the percent are present in amounts that can be • amend § 101.36(b)(2)(i)(B) and statement for vitamin A, it should be declared as zero in § 101.9(c), must not (b)(2)(i)(B)(2) to specify that ‘‘folic acid’’ declared using ‘‘mcg’’ (representing mcg be declared (e.g., amounts is the term used to declare folic acid RAE) as the unit of measure. In corresponding to less than 2 percent of content of dietary supplements; and addition, under § 101.36(b)(2)(ii)(B), the

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proposed units of measure for vitamin measure for , enzymes, and infants 7 through 12 months, children 1 D, vitamin E, and folate in other dietary ingredients. We need to through 3 years, and pregnant and § 101.9(c)(8)(iv) would be used in the fully evaluate each unit of measure for lactating women. The proposed rule declaration of vitamin D, vitamin E, and dietary ingredients to determine if it is would amend § 101.36(b)(2)(iii) to state folic acid in the Supplement Facts label. appropriate for use on the Supplement that the percent of the DV of all dietary (Comment 471) Some comments Facts label, and if there are any ingredients declared under disagreed with our proposal to replace implications to allowing for the use of § 101.36(b)(2)(i) must be listed, except ‘‘IU’’ for the RDIs for vitamin A, vitamin such units of measure on the label. that the percent DV for protein may be D, vitamin E with mcg RAE for vitamin Because of the complexity of these omitted as provided in § 101.9(c)(7) and A, mcg for vitamin D, and mg a- labeling concerns, we plan to issue that no percent DV is to be given for tocopherol for vitamin E. information related to this subject at a subcomponents for which DRVs have (Response) We address these later date. We have, therefore, finalized not been established. comments in part II.N.4. The final rule, § 101.36(b)(2)(ii)(A) without change. When the percent DV is declared for at § 101.9(c)(8)(iv), revises the units of total fat, saturated fat, total measure to be mcg RAE for vitamin A, 4. Order of Nutrients Declared on the carbohydrate, dietary fiber, or protein, mcg for vitamin D (with the allowance Label our existing regulations require that a of voluntary declaration of IUs), and mg For dietary supplements, symbol be placed next to the percent DV a-tocopherol for vitamin E, and § 101.36(b)(2)(i)(B) specifies that declaration for these nutrients that § 101.36(b)(2)(ii)(B), therefore, adopts vitamins and minerals must be declared refers the consumer to a statement at the the same units of measure for vitamin D, in a specific order on the Supplement bottom of the label that says ‘‘Percent vitamin E, and folate. Facts label. The proposed rule would Daily Values are based on a 2,000 Additionally, we did not receive add choline to the list of ordered calorie diet.’’ This statement is only comments on the proposed changes to nutrients in § 101.36(b)(2)(i)(B) and that, accurate for products meant for children the declaration of b-carotene at when declared, choline must follow and adults that are 4 years of age and § 101.36(b)(2)(i)(B)(3), so we have potassium on the label. older. In the preamble to the proposed finalized that provision without change. We proposed to amend § 101.9(c)(5) to rule (79 FR 11879 at 11947), we (Comment 472) One comment said we provide for the voluntary declaration of explained that the proposed DRVs for should adopt a unit of measure for fluoride, unless a claim about fluoride, total fat, total carbohydrate, dietary fluoride of mg per liter (mg/L) rather in which case fluoride would be fiber, and protein for children 1 through than mg/servings. mandatory on the label. We 3 years of age are based on a 1,000 (Response) We address this comment inadvertently did not propose to add calorie diet, so, when a product that is in part II.K.3. The final rule does not fluoride to the list of ordered nutrients represented or purported to be for adopt mg/L as the unit of measure for for declaration on the Supplement Facts children 1 through 3 years of age fluoride. label in § 101.36(b)(2)(i)(B). contains a percent DV declaration for (Comment 473) The proposed rule, at We did not receive any comments on total fat, total carbohydrate, dietary § 101.36(b)(2)(ii)(A), would state that the proposed addition of choline to the fiber, or protein, the proposed rule amounts must be expressed in the list of nutrients on the Supplement would require, in § 101.36(b)(2)(iii)(D), increments specified in § 101.9(c)(1) Facts label. Therefore, the final rule that a symbol be placed next to the through (c)(7), which includes adds choline to the list of nutrients in percent DV declaration that refers the increments for sodium. One comment § 101.36(b)(2)(i)(B) and requires it to consumer to a statement at the bottom said we should permit the use of appear after pantothenic acid on the of the label that says ‘‘Percent Daily additional units of measure for dietary label because choline is a vitamin and Values are based on a 1,000 calorie ingredients to allow for use of more pantothenic acid is the last vitamin in diet.’’ appropriate units of measure when the list of nutrients provided in The proposed rule also would amend metric weight is not the most accurate § 101.36(b)(2)(i)(B). In addition, the final § 101.36(b)(2)(iii)(E) to change the way to express the quantity of the rule specifies that calcium and iron categories of infants and children less dietary ingredient. The comment gave shall be declared after choline on the than 4 years of age to infants 7 through examples of ‘‘colony forming unit’’ label because choline will now be 12 months of age and children 1 through (CFU) for probiotics and enzyme assay declared after pantothenic acid on the 3 years of age, and, because we are units (e.g. HUT, PC, SU, ALU) for label. proposing DRVs for various nutrients for enzymes. Another comment would As for fluoride, to enable infants 7 through 12 months, children 1 amend § 101.36(b)(2)(ii)(A) to state manufacturers to know where to declare through 3 years, and pregnant and ‘‘these amounts shall be expressed in fluoride on the Supplement Facts label, lactating women, amend metric or other appropriate units of we are adding fluoride to the end of the § 101.36(b)(2)(iii)(F) such that the measure.’’ list of nutrients in § 101.36(b)(2)(i)(B) requirement for an asterisk noting that (Response) We decline to permit the such that, when it is declared, it should a DV has not been established would be use of additional units of measure for be placed below potassium on the applicable to foods for these dietary ingredients. The comment Supplement Facts label. subpopulations only when a DRV has provided the examples of CFUs for not been established for a nutrient (i.e., probiotics and enzyme assay units for 5. Subpopulations for saturated fat, cholesterol, or dietary enzymes; however, the broader change The preamble to the proposed rule (79 fiber for dietary supplements that are suggested in the comment, by including FR 11879 at 11947) indicated that, to represented or purported to be for use ‘‘other appropriate units of measure,’’ maintain consistency with the proposed by infants 7 through 12 months). would allow for the use of units of requirements for nutrition labeling of We did not receive comments specific measure for dietary ingredients other foods in § 101.9, we would revise to subpopulations and the proposed than just probiotics and enzyme assay portions of § 101.36 pertaining to changes to § 101.36, and so, except as units. labeling requirements for foods, other described in our response to comment We recognize that manufacturers are than infant formula, that are represented 474, we have finalized those provisions using a number of different units of or purported to be specifically for without change. As discussed in our

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response to comment 441, we are using final requirement to include a the public in evaluating health the terminology ‘‘infants through 12 declaration for added sugars in the implications of supplements. For months of age’’ throughout § 101.36. As nutrition label. As with the declaration example, the comment stated that discussed in part II.O.7.a, we also have of the footnote statement on the calling tocotrienols vitamin E is not decided to use the terminology Nutrition Facts label, the footnote accurate because these forms of vitamin ‘‘pregnant women and lactating statement on the Supplement Facts label E differ from other forms of vitamin E. women’’ rather than ‘‘pregnant and provides context for the consumer and The comment also noted that the lactating women’’ to clarify that the rule enables the consumer to better judge proposed rule does not distinguish is referring to two groups (pregnant how the nutrients in the supplement between different forms of vitamin K, women and lactating women) instead of contributes towards the total daily diet. selenium, vitamin B12, vitamin B6, and one group. Therefore, we decline to remove the vitamin B3 for purposes of identifying footnote statement from the Supplement on the label the actual ingredient that is 6. Footnote Facts label. contained in a dietary supplement The Supplement Facts label can bear When the food is purported to be for product. The comment suggested that a footnote stating that the percent Daily children 1 through 3 years of age, the the identification of the actual form of Values are based on a 2,000 calorie diet. final rule requires footnote to state that vitamin B3 that is included in the In the preamble to the proposed rule (79 ‘‘Percent Daily Values are based on a product is essential because of the FR 11879 at 11947 through 11948), we 1,000 calorie diet’’ because a 1,000 physiological differences between these noted that we intended to modify the calorie reference caloric value is used forms. For example, vitamin B3 could be footnote on the Nutrition Facts label and when calculating percent DVs for identified as niacin or niacinamide; and to conduct consumer studies related to children 1 through 3 years of age. similarly, vitamin B12 could be the footnote on the Nutrition Facts label. Therefore, the final rule amends methylcobalamin or cyanocobalamin; We also noted that the footnote for the § 101.36(b)(2)(iii)(D) to require the vitamin B6 could be pyridoxal 5- Supplement Facts label differs from the footnote statement ‘‘Percent Daily phosphate or ; vitamin K footnote for Nutrition Facts label, yet we Values are based on a 2, 000 calorie could be phylloquinone or menaquione; expected that consumers who buy diet’’ on the Supplement Facts label selenium could be selenomethionine or dietary supplements would be more when the percent DV for total fat, sodium selenite or selenocysteine. The interested in information about the saturated fat, total carbohydrate, dietary comment also cited references to suggest amount of specific micronutrients fiber, protein, or added sugars is selenium in different forms has been contained in dietary supplements and declared on the label, and to require the reported to have different effects. would be less focused on the caloric footnote statement ‘‘Percent Daily Furthermore, the comment noted that reference value used in determining the Values are based on a 1,000 calorie diet’’ the name of a nutrient ingredient in a percent DV for macronutrients (id.). We if the product is represented or dietary supplement may be a structure/ said that, based on the results of the purported to be for use by children 1 function claim because the form of the consumer study, we would consider through 3 years of age and, if the molecule determines its function. For whether it is necessary to make percent DV is declared for total fat, total example, the comment stated that corresponding changes to the footnote carbohydrate, dietary fiber, protein, or gamma-tocopherol denotes a particular used on the Supplement Facts label added sugars. structure of vitamin E that has a when certain macronutrients are 7. Miscellaneous Comments particular function because of its declared, and we invited comment on structure. whether we should change the footnote Several comments raised other issues (Response) With respect to the on the Supplement Facts label to be regarding dietary supplements and comment related to added versus consistent with the footnote on the labeling. naturally occurring micronutrients in Nutrition Facts label. (Comment 475) One comment said dietary supplement products, we (Comment 474) One comment said that the current method of labeling decline to revise the rule as suggested there should be no footnote on the dietary supplements causes confusion by the comment. In dietary supplement Supplement Facts label. The comment regarding which micronutrients, products, when terms such as ‘‘naturally said that consumers do not receive their especially vitamins and minerals, are occurring’’ are used to refer to nutrition solely from a supplement, so, added to a product as opposed to those micronutrients in dietary supplements, according to the comment, there is no that are naturally occurring within the they may imply that there is an inherent need to refer to total calories. In product. The comment suggested that difference in nutritional quality of the addition, because all nutrition the terminology ‘‘naturally occurring’’ vitamin depending on its source. We are calculations are being made from the be used when nutrients are naturally not aware of any evidence that this is 2,000 calorie total, the comment said present in ingredients or products, and the case. Typically, ‘‘added’’ nutrients that the information provided by the that other terms, such as ‘‘added,’’ be are synthetic forms of the nutrient. As footnote is already standardized across used when ingredients containing stated in § 101.9(k)(4), a food is industry, so the footnote is unnecessary. micronutrients have been added to a misbranded if its labeling suggests or (Response) We decline to remove the product. implies that a natural vitamin is footnote from the Supplement Facts Another comment objected to the superior to an added or synthetic label. Our preexisting regulations, at nomenclature we proposed for the vitamin. § 101.36(b)(2)(iii)(D), require declaration of certain vitamins and With respect to the comment manufacturers to declare the footnote minerals, suggesting the limitations in objecting to the nomenclature we ‘‘Percent Daily Values are based on a nomenclature are unconstitutional proposed for the declaration of certain 2,000 calorie diet’’ only when total fat, under the First Amendment (citing vitamins and minerals, the comment saturated fat, total carbohydrate, dietary Pearson v. Shalala, 164 F.3d 650 (D.C. seems to misunderstand our fiber, or protein are declared. The final Cir. 1999); reh’g, en banc, denied, 172 requirements for the declaration of rule amends § 101.36(b)(2)(iii)(D)) to F.3d 72 (D.C. Cir. 1999)) and stating that vitamins and minerals and for structure include added sugars in the list of the nomenclature prevents the or function claims. We provide for the macronutrients to be consistent with the dissemination of information helpful to truthful, nonmisleading labeling of

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nutrients in their varying forms on these forms of vitamin E together. As we Supplement Facts and/or Nutrition dietary supplements in § 101.36(b) and discuss in part II.M, we established the Facts label, the information reflects (d) and § 101.9(c). Our regulation (21 RDI for vitamin E based on a-tocopherol those micronutrients that are typically CFR 101.36(b)(2)) provides for the § 101.9(c)(8)(iv). In § 101.36, we provide present at the end of the shelf-life labeling on the nutrition label of dietary for dietary ingredients, such as period in the finished product, taking ingredients with RDIs such as vitamins tocotrienols for which we have not into account industry-accepted or minerals listed in § 101.9(c)(8)(iv), established RDI’s or DRV’s and that are overages/tolerances. with the exception of vitamin B3. We not subject to regulation under (Response) The Supplement Facts discussed, in the preamble to the paragraph (b)(2) of this section, as label provides the nutrition information proposed rule (79 FR 11879 at 11925) ‘‘other dietary ingredients’’ in for nutrients that have a RDI or a DRV and also in part II.M (Reference Daily § 101.36(b)(3). If other statements are as established in § 101.9(c). A (b)(2)- Intakes for Vitamins and Minerals), the made about ‘‘other dietary ingredients,’’ dietary ingredient may only be listed if reference intakes for vitamins and the statements must be consistent with it is a quantitative amount by weight minerals listed in the Nutrition Facts the all applicable statutory and that exceeds the amount that can be and Supplement Facts panels that are regulatory requirements. declared as zero in § 101.9(c). We are identified in § 101.9(c)(8)(iv). The RDIs To the extent the comment suggests aware that micronutrients are for vitamins and minerals are based on that our regulations limit the sometimes added to naturally occurring the IOM RDAs or AIs. In some cases, the information about the form of a nutrient micronutrients. The value declared on RDA is based on the form of a vitamin on the label, we disagree. Although we the label should be the value that is or mineral recognized to meet human have specific requirements related to supported by data that factors in requirements (i.e., the a-tocopherol form nomenclature for the nutrient variability generally recognized for the of vitamin E) and the AI is based on declarations, there are ways to convey analytical method used for the finished intakes of a specific form of the vitamin the source of the nutrient in labeling, dietary supplement product for the level or mineral (i.e., phylloquinone form of and thus, we do not restrict information involved. We disagree that the label vitamin K). With the exception of about the source of the nutrient, declaration should be based on a shelf- provided the information presented is life period because the Dietary vitamin B3, we note that § 101.9(c)(8)(iv) lists the common and usual names of consistent with our statutory and Supplement Good Manufacturing vitamins and minerals. The dietary regulatory requirements. Practices regulations do not require an supplement label requirements at With respect to the comment that the expiration date, shelf-life date, or ‘‘best § 101.36(d) provide for labeling of the name of a nutrient may be a structure if used by’’ date (see 72 FR 34752 at source ingredient that supplies a dietary or function claim, a structure or 34912 and 34856). Therefore, not all function claim is described in section ingredient (i.e. niacin, vitamin B products would have a shelf-life date 12, 403(r)(6)of the FD&C Act. Such a claim vitamin B , vitamin K, and selenium) that could be used when determining 6 is a statement that describes the role of within the nutrition label in parentheses what the final value should be. a nutrient or dietary ingredient intended immediately following or indented (Comment 477) Several comments to affect the structure or function in beneath the name of a dietary ingredient opposed decreasing the RDIs for humans or that characterizes the and preceded by the words ‘‘as’’ or vitamins and minerals because of the documented mechanism by which a ‘‘from,’’ e.g., ‘‘Calcium (as calcium impact on the dietary supplement nutrient or dietary ingredient acts to carbonate).’’ When a source ingredient industry. The comments also stated that maintain such structure or function is not identified within the nutrition decreasing the RDIs for vitamins and (section 403(r)(6)(A) of the FD&C Act). minerals makes it difficult for label, it must be listed in an ingredient Gamma-tocopherol is a name for a statement in accordance with § 101.4(g). consumers to get therapeutic dosages of particular form of tocopherol. While the vitamins and minerals in one In addition, dietary ingredients, such as molecular form of a vitamin may result menaquinone, that are ‘‘other dietary supplement. in a particular function, the name of the (Response) We address these ingredients’’ within the meaning of form does not describe the role of the comments in part II.M. § 101.36(b)(3) must be declared by their dietary ingredient in affecting the common or usual name when they are structure or function in humans nor 8. Compliance Requirements for Dietary present in a dietary supplement in does it describe a documented Supplements accordance with that section. Thus, the mechanism by which the dietary Compliance for dietary supplements forms of vitamins and minerals ingredient acts to maintain such is currently determined in accordance contained in dietary supplements such structure or function. Thus, structure or with § 101.9(g)(1) through (g)(8), except as niacinamide; methylcobalamin or function claims are permitted for dietary that the sample for analysis must consist cyanocobalamin; pyridoxal 5-phosphate ingredients provided they meet the of a composite of 12 subsamples or pyridoxine; phylloquinone or applicable statutory and regulatory (consumer packages) or 10 percent of menaquione; and selenomethionine, requirements for such claims. the number of packages in the same sodium selenite, or selenocysteine may (Comment 476) One comment said inspection lot, whichever is smaller, be identified, as appropriate, in the there is confusion whether nutrient randomly selected to be representative Nutrition Facts label or the ingredient declarations on the Supplement Facts of the lot. The regulation also says that statement. label represent only the added nutrients the criteria on class I and class II Although we do not recognize the or the total amount of a nutrient based nutrients given in § 101.9(g)(3) and term vitamin B3 and instead list niacin on analysis of the finished product in (g)(4) are applicable to other dietary in § 101.9(c)(8)(iv), the term ‘‘vitamin products where either micronutrients ingredients. B3’’ if identified in labeling, other than have been added or botanical The proposed rule would require in the Nutrition Facts label, must be ingredients are present that are natural manufacturers to declare added sugars truthful and not misleading. sources of particular micronutrients. on the Supplement Facts label under Furthermore, we disagree that we are The comment suggested we could § 101.36(b)(2)(i). It would also require requiring misinformation by calling resolve the issue by ensuring that, manufacturers to make and keep records tocotrienols vitamin E and lumping where micronutrients are listed on the to verify the amount of dietary fiber,

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soluble fiber, insoluble fiber, added no image or text exists. The format may declaring the quantitative (or absolute) sugars, vitamin E, and folate, under differ from package to package amounts (in addition to percent DVs) of certain circumstances for foods (79 FR according to the amount of space on the mandatory vitamins and minerals and, 11879 at 11956). The proposed rule, at package that is available for labeling, as when declared, voluntary vitamins and § 101.9(g)(10) and (g)(11), also would described and detailed in the relevant minerals; (9) requiring dual column establish recordkeeping requirements sections in this document. labeling under certain conditions; (10) for foods that contain a mixture of The original format of the Nutrition modifying the footnote; (11) requiring dietary fiber and added non-digestible Facts label was informed by a number that all nutrients not currently carbohydrate(s) that does not meet the of factors, including consumer research highlighted in bold or extra bold type be definition of dietary fiber, foods that that we conducted; consideration of the highlighted in a type that is contain a mixture of soluble fiber and environment in which consumers intermediate between bold or extra bold added non-digestible carbohydrate(s) typically use the label (i.e., grocery and regular (i.e., semi-bold) type; (12) that does not meet the definition of stores); the diversity of consumers (i.e., adding a horizontal line directly dietary fiber, foods that contain a with respect to education, age, beneath the ‘‘Nutrition Facts’’ heading; mixture of insoluble fiber and added socioeconomic status, etc.) for whom and (13) replacing the listing of ‘‘Total non-digestible carbohydrate(s) that does the label is intended; and comments and Carbohydrate’’ with ‘‘Total Carbs.’’ We not meet the definition of dietary fiber, data received on this issue in response also invited comments on other issues foods that contain a mixture of naturally to rulemaking activities conducted in related to the Nutrition Facts label occurring and added sugars, foods that the 1990s. Research studies consistently format, including the use of an contain added sugars that are reduced confirmed that simple formats are easier alternative format design or requiring to comprehend and require less through non-enzymatic browning and/ the use of a specific font. or fermentation, foods that contain a consumer effort than complex mixture of all rac-a-tocopherol and information formats. A simple format is The preamble to the proposed rule RRR-a-tocopherol, and foods that one that minimizes clutter and best also discussed certain modifications to contain a mixture of folate and folic meets the NLEA requirements that be applied to other label formats to acid. nutrition information should enable the maintain consistency with the proposed The same records requirements in public to readily observe and Nutrition Facts label. These other § 101.9(g)(10) and (g)(11) also should comprehend such information. In modifications would pertain to formats apply to dietary supplements. addition, a simple format allows for packages of products that contain Therefore, the final rule revises consumers to search for accurate two or more separately packaged foods § 101.36(f)(1) to include the nutrition information with minimum that are intended to be eaten recordkeeping requirements for specific effort, and provides information in a individually (e.g., variety packs of nutrients under § 101.9(g)(10) and succinct manner that maximizes cereals and snacks) or that are used (g)(11). understanding (79 FR 11879 at 11948). interchangeably for the same type of Manufacturers of dietary supplements In the preamble to the proposed rule foods (e.g., round ice cream containers may request an alternative means of (79 FR 11879 at 11948), we explained (§ 101.9(d)(13)); formats that apply to compliance or additional exemptions that we were not proposing an extensive subpopulations (§ 101.9(e) and (j)(5)); under § 101.36(f)(2) when it is reformatting of the Nutrition Facts label. the simplified format (§ 101.9(f)); the technologically feasible, or some other We further explained that we were tabular display on packages that do not circumstance makes it impracticable, for proposing to make changes based on have sufficient continuous vertical firms to comply with the requirements graphic design principles (such as space (§ 101.9(d)(11)(iii)); and the of the regulation. This allowance is the alignment, consistency, repetition, and tabular display (§ 101.9(j)(13)(ii)(A)(1)) similar to what is made for conventional contrast), highlight key nutrients and and linear display foods under § 101.9(g)(9). Therefore, the key information, and remove or modify (§ 101.9(j)(13)(ii)(A)(2)) for small final rule, at § 101.36(f)(2), does not parts of the label to assist consumers in packages. refer to § 101.9(g)(9). maintaining healthy dietary practices. In brief, we proposed the following Additionally, in the Federal Register Q. Format changes to the format of the Nutrition of July 27, 2015 (80 FR 44303), we Under our preexisting regulations Facts label: (1) Increasing the proposed text for the footnotes to be (see, e.g., § 101.9(d) through (f) and (j)), prominence of calories and serving size; used on the Nutrition Facts label and nutrition information must be presented (2) reversing the order of the ‘‘Serving proposed to require the declaration of on food labels in a specific format. The Size’’ declaration and the ‘‘Servings Per the percent DV for added sugars on the elements of format related to the Container’’ declaration and increasing Nutrition Facts label. In a separate Nutrition Facts label include such the prominence of ‘‘Servings Per notice published in the Federal Register features and graphic design principles Container;’’ (3) right-justifying the of July 27, 2015 (80 FR 44302), we as the type style (i.e., font) and size of quantitative amounts of the serving size reopened the comment period for the the type (i.e., point); use of boldface, information; (4) changing the phrase proposed rule for inviting public lines, and bars; arrangement of ‘‘Amount Per Serving’’ to ‘‘Amount Per comments on two consumer studies: information in one or more columns; ll’’ with the blank filled in with the One using an experimental design column headings; presence of a footnote serving size; (5) removing the methodology (the format study) and one and use of a symbol (such as an asterisk) declaration of ‘‘Calories from fat;’’ (6) using eye-tracking methodology (the to designate a footnote; and whether modifying the presentation of the ‘‘% eye-tracking study). The purpose of nutrition information is listed as a DV’’ information by changing its these studies was to examine the percentage or in absolute (i.e., position to the left of the name of the combined effects of most of the changes quantitative) amounts. The elements of nutrient on certain labels and separating outlined in the proposed rule in their format also include the alignment of it from the list of nutrients with a totality; however, both studies also information; whether indentations are vertical line; (7) declaring ‘‘Added examined certain individual changes, used in listing nutrient data; and the use Sugars’’ as an indented listing directly selected on the basis of priorities and of white space (or negative space) where beneath the listing for ‘‘Sugars’’; (8) resources available at that time.

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1. General Comments significance of the food in the context of amount of dietary fiber shown on the 1 To make a determination about the the daily diet (58 FR 2079 at 2115). In label indicated there were only 2 ⁄2 final format for the Nutrition Facts label, the consumer studies we conducted to servings per container. Therefore, we we considered many factors including: determine the format for the original are not able to rely on the results of this Comments we received about the Nutrition Facts label, no single format study to inform our decisions regarding proposed label format in response to our emerged as being superior in every Nutrition Facts label formats. (Comment 480) Several comments proposed rule (79 FR 11879), the aspect that was investigated. We said that we should not move forward supplemental proposed rule (80 FR subsequently worked with graphic with the proposed nutrition label format 44303) and the reopening of the design experts to develop the new label, changes without conducting further comment period (80 FR 44302); graphic drawing on research that considered not only comprehension, but also legibility consumer research. design principles; and results from (Response) We disagree with consumer research conducted by and literacy (Ref. 257). (Comment 479) One comment comments suggesting that we should not ourselves and others. This is similar to described a study designed to finalize this rulemaking until we the approach we took when determining investigate the extent that consumers conduct further consumer research (see, the original Nutrition Facts label are able to quickly notice and also, our response to comment 6). We formats. At that time, our decisions understand label information, as they considered consumer research studies about format elements drew on would during grocery shopping (Ref. and public comments, and we also information collected from a variety of 258). The study compared consumer relied on graphic design principles sources including focus groups and a reactions to FDA’s current and proposed (such as contrast, proximity, alignment, professional package design firm, in versions of four different Nutrition Facts consistency, etc.) in deciding how the addition to label research conducted by label formats, each portraying a different various Nutrition Facts label formats FDA and other organizations (57 FR food product, so that a total of eight should appear in finalizing the 32060). different labels were examined. The requirements for the label format. (Comment 478) Several comments current and proposed label formats, and stated that neither the results of our 2. Increasing the Prominence of Calories the foods depicted, were: Standard and Serving Size consumer studies nor those submitted format for single-serve yogurt; tabular by outside parties support the proposed format for frozen vegetables; dual- The ability to determine the caloric label changes and that our proposed column label for breakfast cereal (per content of packaged foods is important changes do not improve consumer serving and with 1⁄2 cup skim milk); and for all consumers, especially those who understanding of nutrition information a dual-column label for a multi-serving are trying to control their total caloric on the label over the current label snack mix package (per serving and per intake and manage their weight. Our format. One comment said that the container). The comment recommended preexisting regulations require proposed format changes do not offer that we not implement the proposed ‘‘Calories’’ to be declared in a type size ‘‘enhanced value’’ to the consumer that changes in format for the Nutrition Facts no smaller than 8 point would justify a change from the label because, according to the (§ 101.9(d)(1)(iii)) and highlighted in preexisting label format. comment, the study indicated that bold or extra bold type or other (Response) The consumer studies that participants perceived few differences highlighting (§ 101.9(d)(1)(iv)). While we conducted focused mainly on between the current and proposed label calorie information is mandatory on the comparing the Current, Proposed, and formats. Nutrition Facts label, modifying the Alternative formats in their totality. We (Response) The results of this study Nutrition Facts label to give more found that overall consumer are difficult to interpret because a prominence to calories may benefit preferences, understanding, or number of details were not provided. consumers in weight control and perceptions of product healthfulness (as Among other things, the comment did maintenance, as noted by the OWG in indicated by the label) were comparable not adequately describe or explain the its final report entitled ‘‘Calories Count’’ among the Current, Proposed, and demographic characteristics of the (Ref. 127). Alternative label formats. In this final participants, the statistical methods that In the preamble to the proposed rule rule, we are making minor changes, were used, how the survey instrument (79 FR 11879 at 11849 and 11948 such as highlighting certain specific was validated, how the participants through 11949), we explained that the features and characteristics of the label, were selected and the study was OWG recommended, in part, that we to enhance the information or for other administered, and why 90 percent issue an ANPRM to solicit comments on reasons. Our consumer research confidence levels were chosen to how to give more prominence to provided important information and indicate significant differences rather calories on the food label. The OWG insights about consumer perceptions, than the conventional 95 percent suggested possible changes to the judgments, and understanding that will confidence interval. In addition, the Nutrition Facts label, such as increasing be useful in informing our future manner in which some questions were the prominence of ‘‘Calories’’ and consumer education efforts. We worded could have affected the ‘‘Serving Size,’’ providing a percent DV acknowledged in our 1993 nutrition responses, and the full range of response for calories, and eliminating the labeling final rule that various options was not presented. Furthermore, ‘‘Calories from fat’’ declaration, which considerations (i.e., in addition to the proposed snack mix label appeared may detract from the emphasis on total consumer research) would bear on the to be inconsistent in how the ‘‘per calories. The OWG recommended that selection of a final nutrition label serving’’ and ‘‘per container’’ values we obtain information on the format. We previously said that an were listed for various nutrients. effectiveness of these options on essential criterion would be how well a Although the label indicated ‘‘31⁄2 consumer understanding and behavior format conveyed information that servings per container’’ for some related to calorie intake (Ref. 127). In Congress expected a nutrition label to nutrients (e.g., calories, carbohydrates, response to the 2005 ANPRM, several provide, such as information that would sodium, protein) the amounts that were comments supported increasing the allow people to decide whether to buy listed on the label suggested that there prominence of calories on the Nutrition a product or to understand the relative were 4 servings per container, and the Facts label. These comments suggested

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various approaches for doing so and encourage them to pay more attention to of the calorie information, we must pointed out the need for additional labels in general. Several comments provide another justification to increase research to fully understand the effects pointed out that increasing the type size the font size. of potential label changes on consumer and visibility of calories would be Many comments also expressed understanding and behavior (Ref. 26). especially helpful to people with concerns that overemphasizing calories We considered available data from impaired vision, including many older could have the unintended consequence consumer research and comments adults and diabetics, and even people of suggesting that information about received in response to the ANPRMs with normal vision would benefit if calories is much more important than and conducted our own research on shopping in a dimly lit grocery store. information about other nutrients food labels. We tentatively concluded The comments said that, although appearing on the label. For example, that the proposed changes to the information about other nutrients is some comments said that the proposed number of calories per serving and the important, information on calories is Nutrition Facts label could give the number of servings per container would particularly important because of the impression that calorie counting is the result in these declarations serving as an prevalence of obesity and the most important consideration in anchor to the Nutrition Facts label by association between obesity and chronic managing health, when, in fact, focusing the reader’s attention to this diseases and disabilities. The comments reducing the risk of chronic diseases information and therefore would assist agreed that enlarging the calories and other health-related conditions goes consumers to effectively use this information and making it bolder would well beyond caloric intake. Other information in the Nutrition Facts label be an important step, not only in comments said that consumers might (Ref. 259). The proposed rule would fighting obesity, but also in controlling evaluate and compare food or beverage revise § 101.9(d) to increase the type diabetes. products based solely on their caloric size for ‘‘Calories’’ and the numeric Although most comments content and choose the option having value for ‘‘Calories’’ and also would acknowledged the importance of the fewest calories, without considering require the numeric value for calories be calories and supported increasing the the product’s total nutrient profile. highlighted in bold or extra bold type to prominence to some extent, many Consequently, this could inadvertently draw attention to this information, comments opposed declaring the calorie result in consumers avoiding nutrient emphasize the importance of calories on information in a type size substantially dense foods as recommended by the the label, and maintain consistency with larger than that of other information on Dietary Guidelines for Americans. the bolded declaration for ‘‘Calories.’’ the label. Many comments expressed Several comments expressed concerns We also expressed a tentative view concerns that the proposed format that making the calorie declaration so that the Supplement Facts label should overemphasized calories at the expense prominent could affect consumer use have a format similar to the format being of other nutrients declared on the label, and understanding of other information proposed for the Nutrition Facts label and several comments suggested that on the Nutrition Facts label. For with respect to increasing the the calorie information was example, comments suggested that, prominence of information for calories. ‘‘disproportionately large’’ or consumed because the ‘‘Amount per ll We invited comment on whether any too much label space. Other comments (serving)’’ declaration is relatively small changes we proposed to the Nutrition included suggestions for improving the compared to the proposed ‘‘Calories’’ Facts label also should be required for overall design and balance of the label and ‘‘llservings per container’’ certain products with Supplement Facts by adjusting the relative type sizes for declarations, consumers may mistakenly labels, and if so, under what conditions ‘‘Calories,’’ the numeric value for associate the numeric value for and for which dietary supplement calories, and other nutrition information ‘‘Calories’’ with the contents of the products should such labeling be on the label, including the ‘‘Nutrition entire container, rather than with only required. Facts’’ heading. A few comments stated one serving. Several comments (Comment 481) Most comments that there was no need to increase the emphasized that consumer research is supported our proposal to increase the prominence of calories because the needed to further investigate formats prominence of the calories declaration, Nutrition Facts label already provides that would facilitate consumer indicating that giving more emphasis to calorie information and that increasing understanding of this label information calories on the Nutrition Facts label the prominence may not provide any and ensure that the format does not would likely benefit consumers in additional benefits. result in consumers misinterpreting the helping them to monitor their caloric Several comments said that there is calories information. One comment intake and make healthier food choices. no convincing data that enlarging the suggested that as part of a consumer Several comments suggested that calorie information would help test, the ‘‘Amount per ll’’ (i.e., increasing the prominence of calories consumers choose healthier products serving size) listing and the numeric would help focus consumer attention on and that additional consumer research value for ‘‘Calories’’ could be shown in their total caloric intake because the would be essential for determining a equal type sizes. information on the label would be more format that improves consumer (Response) We agree that giving more visible, readily accessible, and hard to understanding of calorie information in prominence to calories by increasing the ignore. Many comments noted that the the Nutrition Facts label. One comment type size and bolding of the ‘‘Calories’’ larger, bolder font would draw attention pointed out that, although the FDA declaration and the numeric value for to the calorie content of the product, consumer study cited in the proposed ‘‘Calories’’ would emphasize the encourage consumers to consider this rule failed to demonstrate that importance of calories on the Nutrition information when selecting a product or increasing the font size for calories lead Facts label. deciding how much to eat, and help to healthier choices, we nevertheless We disagree with the comments them to grasp the relative significance of decided to proceed with our proposal to suggesting it is not necessary to increase a particular food in the context of their increase the prominence of calories on the prominence of the calorie daily diet. Other comments said that the label. The comment further stated declaration or that the numeric value for increasing the prominence of calories that, because FDA’s own consumer calories should not be larger than the also would help consumers compare research suggested that a larger font size word ‘‘Calories,’’ because, as we explain products when shopping and perhaps does not improve consumer awareness later in this response, emphasizing this

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information has potential benefits to explained in the preamble to the that eating disorders could be triggered consumers who read the label. However, proposed rule (79 FR 11879 at 11949) or exacerbated by enlarging the we agree that the 24 point type size that that existing data from studies on ‘‘Calories’’ declaration on the Nutrition was proposed for the numeric value for warning label and drug label formats Facts label. We are unaware of the ‘‘Calories’’ on most label formats have demonstrated that increasing the existence of such an association and (excluding small packages and dual prominence of label information such as remain convinced that the potential column labels using the tabular format) warning statements increases consumer public health benefits of increasing the could be considered too large and that attention to such information. prominence of ‘‘Calories’’ would adequate prominence could still be Furthermore, the OWG report suggested outweigh the risk of a possible negative achieved by slightly reducing the type that we consider increasing the font size impact on individuals struggling with size. Therefore, the final rule, at for calories on the Nutrition Facts label eating disorders. § 101.9(d)(i)(iii), requires a type size of because of the critical importance of (Comment 483) One comment stated 22 point for the numerical value for caloric balance in relation to overweight that, because dietary supplement labels ‘‘Calories,’’ (excluding labels for smaller and obesity (Ref. 127). Similar to often contain a large amount of packages that have a total surface area graphic design principles underlying information on a small label, increasing available to bear labeling of 40 square the appearance of warning labels, the prominence of calories information inches or less) and a type size of 16 increasing the prominence of calories would likely be difficult because of a point for the word ‘‘Calories’’ on all would be expected to draw consumer lack of space. The comment stated that label formats (excluding labels on attention to this information. The OWG an increased prominence for ‘‘Calories’’ smaller packages, with a total surface report recommend mainitaining a on Supplement Facts labels should be area available to bear labeling of 40 healthy body weight and calorie balance required only if consumption of the square inches or less and all tabular is key factor for managing body weight. dietary supplement would make a major displays) and highlighting both pieces The OWG report concluded that obesity contribution to daily caloric intake (e.g., of information in bold or extra bold is positively associated with adult 50 or more calories per serving). type. The requirements for smaller morbidity and mortality and has become However, the comment noted that, in packages require a type size of no a pervasive and urgent public health most cases, dietary supplement smaller than 14 point for the numerical problem in the United States. The OWG products contribute insignificant value for ‘‘Calories’’ for the tabular report also emphasized the medical and amounts of calories to the overall diet. display for small packages as shown in health related costs that result from high (Response) In the preamble to the § 101.9(j)(13)(ii)(A)(1) and the linear rates of overweight and obesity. proposed rule, we invited comments on display as shown in Moreover the 2015–2020 DGA does not whether any of the changes being proposed for the Nutrition Facts label § 101.9(j)(13)(ii)(A)(2), a type size of no alter these conclusions and corroborates should also apply to products with smaller than 10 point for the word these findings. We agree with the OWG Supplement Facts labels that list ‘‘Calories’’ for the tabular displays as report’s recommendations and calories and/or other macronutrients (79 shown in § 101.9(d)(11)(iii) and (e)(6)(ii) conclusions particularly emphasizing FR 11879 at 11949). We did not propose and for the tabular display for small calories, but we are sensitive to increasing the prominence of calories on packages as shown in concerns about over-emphasizing the labels of dietary supplement products § 101.9(j)(13)(ii)(A)(1) and the linear calories declaration on the label. An and did not display the calories display as shown in important goal in addressing concerns information in a larger and bolder type § 101.9(j)(13)(ii)(A)(2). These type sizes regarding nutrient density is education. size in any of the labels illustrated in will be sufficiently large to emphasize Nutrition education, especially around the Nutrition Facts label should be the proposed rule in § 101.36(e)(11) and the importance of calories on the label § 101.36(e)(12). We agree with the and draw attention to this information multifactorial and highlight the importance of calories, but also the comment that many dietary supplement while decreasing the size to address products may contribute a negligible issues raised in the comments as well as other nutrients that can affect health and chronic disease. Therefore, the final amount of calories. Therefore, the final accommodating size constraints for rule requires a smaller type size for the rule does not require that information packages with a total surface available number of calories on all labels than about calories be displayed in a larger to bear labeling of 40 square inches or what we had originally proposed (i.e., type size or be highlighted in bold or less (see our response to comment 517). 22 point rather than 24 point for all extra bold type or other highlighting on We disagree with the comments displays except those for smaller any Supplement Facts labels. suggesting that emphasizing calories packages), and even further decreased (Comment 484) Several comments would detract from information about type size (14) requirements are pointed out that increasing the font size other nutrients on the label, or would permitted for small packages with a for ‘‘calories’’ and ‘‘serving size’’ on the result in consumers avoiding nutrient total surface area available to bear Nutrition Facts label would affect the dense foods. No evidence was submitted labeling of 40 square inches of surface size of the percentage juice declaration in support of these comments, and we area or less as described in that manufacturers are required to make are unaware of any data that § 101.9(j)(13)(ii)(A)(1) and (2). on juice products. Under § 101.30(e)(2), emphasizing the calories declaration (Comment 482) A few comments the percent of juice declaration must be would encourage consumers to always expressed concerns that excessively in a height not less than the largest type choose the lower calorie option, result focusing on calories and drawing too found on the information panel except in poor nutritional practices, or lead to much attention to the caloric content of that used for the brand name, product adverse health consequences. Although a food product would likely have a name, logo, universal product code, or we also are unaware of any consumer negative impact on individuals who are the title for Nutrition Facts. Because studies demonstrating that increasing at risk for an eating disorder, or who are information about ‘‘Calories’’ is not the prominence of calories information already struggling with an eating included among these exceptions, the on the Nutrition Facts label would disorder. type size of the juice declaration would either help or hinder consumer use and (Response) The comments did not have to be at least as large as the type understanding of this information, we submit data or other evidence to show size of the numeric value for ‘‘Calories.’’

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Therefore, according to the comments, in response to their hunger and fullness that, with respect to the Nutrition Facts increasing the size of the ‘‘Calories’’ cues, rather than providing foods for label, an important consumer need is to information would mean increasing the children based on the number of identify the number of servings per size of the percent juice declaration calories in a serving of the product. container of a packaged food. Therefore, significantly. The comments further However, the IOM report also we proposed placing ‘‘Servings Per suggested that we revise § 101.30(e)(2) emphasized the importance of parents Container’’ above ‘‘Serving Size’’ to help to clarify that the percent juice establishing healthful eating habits for consumers find the number of servings declaration does not have to be larger their children early in life. The IOM per container with less effort than is than the information about ‘‘Calories’’ or report stated that children who consume now needed. We also proposed that ‘‘Serving size.’’ a diet that restricts energy-dense foods listing ‘‘ll servings per container’’ (Response) We inadvertently omitted high in sugar, fat, and salt, but that is with the blank filled in with the actual the corresponding correction to rich in nutrient-dense foods, are less number of servings directly beneath the § 101.30(e)(2) to include ‘‘Serving size,’’ likely to become overweight or obese. ‘‘Nutrition Facts’’ heading, and ‘‘Calories,’’ and the numerical value for Thus, although the IOM report did not highlighting it in bold or extra bold ‘‘Calories’’ in the list of exceptions for explicitly recommend restricting type, would help increase awareness declarations in larger type to avoid children’s foods based on calorie that the information presented in the requiring a type that would be too large content, it suggested that parents and Nutrition Facts label does not refer to for the declaration of the amount of caregivers should at least be aware of the contents of the entire package when juice. Therefore, we have made a the amount of calories (and other the label indicates that there is more technical correction in the final rule and nutrients) in the foods they give their than one serving per container. We revised § 101.30(e)(2) to state that the children, especially those over 2 years explained that listing ‘‘Serving size’’ in title phrase ‘‘Nutrition Facts, the of age, in order to begin establishing the same proximity to where the actual declaration of ‘‘Serving size,’’ good eating habits. nutrient information is located on the ‘‘Calories,’’ and the numerical value for The comment did not provide label (rather than directly beneath the ‘‘Calories’’ appearing in the nutrition evidence that parents would restrict Nutrition Facts heading as in our information must be in easily legible foods or make inappropriate food preexisting regulations, § 101.9(d)(3)) boldface print or type in distinct choices for their young children and would help consumers understand that contrast to other printed or graphic infants based solely on the food’s caloric this nutrient information pertains to the matter, in a height not less than the content. We acknowledge that parents particular serving size that is declared. largest type found on the information and caregivers would likely consider a (According to the graphic design panel except that used for the brand variety of factors when making principle of proximity, items that are name, product name, logo, or universal decisions about what to feed their young positioned closer together are perceived product code. children and that increasing the to be more closely related (Ref. 262)). (Comment 485) One comment said we prominence of calories information on Thus, we tentatively concluded that should not require the calories the labels of foods intended for young reversing the order of the declarations of information listed on labels of food children does not necessarily mean that ‘‘Servings Per Container’’ and ‘‘Serving products intended for infants and young parents would restrict these foods. Size’’ would help consumers more children to have the same prominence Therefore, we do not consider it readily observe and comprehend the as the calories information on product necessary for the calories information nutrition information appearing in the labels intended for people 4 or more on products for infants through 12 Nutrition Facts label, allow consumers years of age. The comment stated that months of age and children 1 through 3 to search for information with a decisions about food choices that are years of age to differ from that required minimum of effort, and assist made for infants and young children on Nutrition Facts label formats for consumers in their food purchasing should not be based on the number of foods intended for individuals 4 years of decisions and in maintaining healthy calories per portion, but rather on the age and older. To maintain consistency dietary practices. We proposed to overall nutrient profile of the food. The in label formats, the final rule requires redesignate § 101.9(d)(3)(i) as comment explained that, by relying too that the calories information on labels of § 101.9(d)(3)(ii), redesignate much on a food’s caloric content, foods intended for infants through 12 § 101.9(d)(3)(ii) as § 101.9(d)(3)(i), and parents may inadvertently restrict months of age and children 1 through 3 to make changes in how the serving size healthful foods or make inappropriate years of age be displayed prominently, information is capitalized on the label food choices for their young children as indicated in the label mockups so that no capital letters are used, except and infants. The comment also said that, shown in § 101.9(j)(5)(i) and (ii). according to nutrition experts, children for the first letter in ‘‘Serving size.’’ We in this age range should be encouraged 3. Changing the Order of the ‘‘Serving also proposed to require that the to self-regulate caloric intake and that Size’’ and ‘‘Servings Per Container’’ declaration of ‘‘llservings per parents and caregivers should feed Declarations and Increasing the container’’ (with the blank filled in with children in response to the child’s Prominence of ‘‘Servings Per Container’’ the actual number of servings) be hunger and fullness cues rather than on Our preexisting regulations specify highlighted in bold or extra bold type the basis of a preconceived number of that information on serving size, and be in a type size no smaller than 11 calories they believe the child should consisting of a statement of the serving point (except for the tabular and linear consume. size (§ 101.9(d)(3)(i)) and the number of displays for small packages) (proposed (Response) We agree with the servings per container (§ 101.9(d)(3)(ii)), § 101.9(d)(3)(i)), and that the comment that food choices for infants must immediately follow the identifying information for ‘‘Serving size’’ be in a through 12 months of age and children heading of ‘‘Nutrition Facts.’’ In type size no smaller than 8 point (except 1 through 3 years of age should focus addition, ‘‘Serving Size’’ and ‘‘Servings for the linear display for small packages) primarily on a food’s overall nutrient Per Container’’ must be in a type size no (proposed § 101.9(d)(3)(ii)). profile rather than on the number of smaller than 8 point (§ 101.9(d)(1)(iii)). We did not propose similar changes calories per serving (Refs. 260–261). The In the preamble to the proposed rule for serving size information for dietary IOM report advocated feeding children (79 FR 11879 at 11949), we explained supplements. In the preamble to the

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proposed rule (79 FR 11879 at 11950), (Response) As we explained in the per container’’ statement because this we said that, when taking dietary preamble to the proposed rule (79 FR could help consumers identify more supplements, consumers need to know 11879 at 11949), reversing the order in readily the number of servings in a how much of the product to take (e.g., which ‘‘Serving Size’’ and ‘‘Servings Per package and help consumers decide 1 capsule, 2 tablets, 1 packet) and that Container’’ are listed would place the how many people a particular food item this information, which is currently serving size information in closer could serve or feed. The comments said provided in the ‘‘Serving Size’’ line of proximity to where the actual nutrient that consumers would have a better idea the Supplement Facts label, is more information is located on the Nutrition of the total number of calories in the important for the consumer to know Facts label. According to graphic design package as well as the number of than the number of servings (e.g., 100 principles (i.e., the principle of calories they would actually consume if tablets) contained in the package. ‘‘proximity’’), this would increase the they eat the entire contents of a multi- (Comment 486) Many comments perception that the serving size is serving package. supported changing the order of the closely related to the nutrition (Response) We agree with the ‘‘Serving Size’’ and ‘‘Servings Per information that follows directly below comments, and so the final rule, at Container’’ declarations because the it, and thus provide necessary context § 101.9(d)(3)(i), requires the actual comments felt that this change would for helping consumers understand that number of servings at the beginning of make the label easier to read and this nutrition information pertains to the ‘‘servings per container’’ statement. understand. The comments said the particular serving size that is (Comment 488) Many comments consumers would be better able to declared. If the order of the ‘‘Serving agreed that increasing the prominence compare products when shopping and Size’’ and ‘‘Servings Per Container’’ and visibility of ‘‘servings per make better buying decisions, which declarations was preserved as in our container’’ would enable consumers to could ultimately lead to improved preexisting regulations and as preferred notice and use this information. The health for themselves and their families. by some comments, the relationship comments further stated that Other comments suggested that the between the nutrition information and individuals who did not previously or proposed changes could help consumers the serving size might be less clear. regularly use the label might begin to do understand that nutrition information Although some comments suggested so and that increasing the prominence on the label is based on the serving size, that we put the serving size declaration of the ‘‘servings per container’’ which could increase awareness of the in bold print rather than shift its declaration would not only be ‘‘eye amount of food actually being position, it is unlikely that bold print, catching’’ and ‘‘hard to ignore,’’ but also consumed. In addition, comments said alone, would provide the necessary would be helpful to people with poor that the proposed change could help context for helping consumers to vision or those who shop in dimly lit consumers monitor their caloric and understand the association between grocery stores. nutrient intakes, compare products serving size and the nutrient Some comments suggested increasing more easily, eat more moderate information because these pieces of the size and prominence of the ‘‘Serving portions, and more easily grasp the information in the preexisting Size’’ declaration, as well as that of relative significance of a food product in regulation would be lacking in ‘‘servings per container.’’ One comment the context of their daily diet. proximity, and the contrast between the acknowledged that one intention of the Other comments said that reversing ‘‘Serving size’’ declaration and the proposed rule is to help consumers the order of serving size and the number ‘‘Nutrition Facts’’ heading directly more easily recognize multi-serving of servings per container, especially in above it would be reduced if both were packages, but said there was no valid combination with increasing the in a bold or extra bold font. We address justification for making the ‘‘ll prominence of information about the comments concerns regarding servings per container’’ information calories, would make the relationship increased emphasis of ‘‘serving size’’ more prominent than the ‘‘Serving size’’ between the ‘‘Calories’’ and ‘‘Serving instead of ‘‘servings per container’’ in declaration. Another comment size’’ declarations clearer, lead to a our response to comment 488. suggested that increasing the better understanding of the calories Therefore, the final rule, at prominence of both calories and serving information, and improve the flow of § 101.9(d)(3)(ii), requires that ‘‘serving size could be especially important on the label. size’’ be placed below ‘‘lServings per labels of some sugar-sweetened In contrast, several comments container.’’ The final rule also requires beverages, particularly on products that opposed changing the order and said we the information to be highlighted in may contain more than one serving, but should continue to list ‘‘Serving size’’ bold or extra bold and be in a type size are often consumed during one eating above ‘‘ll servings per container.’’ no smaller than 10 point, except the occasion. The comments suggested that type size must not be smaller than 8 Several other comments opposed information about a product’s serving point for the information for small increasing the prominence of ‘‘servings size was more important than the packages as shown in per container’’ because, according to the number of servings per container § 101.9(j)(13)(ii)(A)(1) and (2). comments, ‘‘serving size’’ is the more because the label’s information is based Displaying both pieces of information important piece of information. The on the serving size declaration. Many related to serving size adjacent to each comments would emphasize ‘‘Serving comments that opposed reversing the other should help consumers size’’ in a larger and bolder font. Many order of serving size and servings per understand how the serving size relates comments said that making the serving container expressed a preference for us to the nutrition information on the label size information easier for consumers to to increase the prominence of serving and use the label to plan and maintain see and understand was important for size instead. The comments said that healthy dietary practices. It is important properly interpreting the calorie putting the ‘‘Serving size’’ declaration in for consumers to understand the serving information (in addition to increasing bold print and increasing its type size size and realize how it relates to the rest the prominence of ‘‘Calories’’) and is would emphasize its importance and of the label’s nutrition information. also ‘‘what consumers are used to’’ increase awareness that the nutrition (Comment 487) Many comments seeing. Several comments said that the information on the label is based on the supported inserting the actual number proposed font size of the ‘‘ll servings serving size. of servings at the beginning of ‘‘servings per container’’ statement was so large

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that consumers might mistakenly think 262). Contrast is a graphic design container’’ information on the Nutrition that the number of calories listed in the principle that uses opposing elements Facts label. ‘‘Calories’’ declaration on the label (such as bolding) to differentiate objects (Response) We disagree with the pertained to the entire package; i.e., to in the same field of view, or to intensify comment suggesting that many all of the servings that appear in the the effect between objects that would consumers do not look at serving size ‘‘ll’’ space. Another comment otherwise look similar (Ref. 263). Thus, information, but otherwise do refer to suggested reducing the type size for we are providing contrast in the first the Nutrition Facts label and ingredients ‘‘ll servings per container’’ to a size three lines of the Nutrition Facts label list. The comment apparently smaller than the ‘‘Amount per ll’’ in the final rule (i.e., the Nutrition Facts misinterpreted a published abstract (Ref. statement. One comment suggested that heading, the ‘‘ll servings per 264) of a study that investigated the relative differences in type sizes in container’’ declaration, and the ‘‘Serving consumer perceptions and use of the the listings for the number of servings size’’ declaration) by alternating the use serving size information, ingredient list, per container, the amount per serving, of bold font with non-bold font for this health claim information, and the and the numeric value for ‘‘Calories’’ information. We also realize that Nutrition Facts label in general, could result in consumers mistakenly enlarging the ‘‘ll servings per particularly with regards to the extent associating the number of calories with container’’ declaration through bolding that each of these impact purchasing the total package because the ‘‘Amount may pose space challenges if the word decisions. The study, which drew on per ll’’ is relatively small compared ‘‘about’’ is used in this statement, which data from the 2005–2006 and 2007–2008 to the other declarations. One comment is allowed under § 101.9(b)(8)(i). NHANES, was recently published in its said that giving increased prominence to Therefore, the final rule requires that entirety (Ref. 265). In contrast to what ‘‘Serving size’’ would be a reasonable the ‘‘Serving size’’ declaration, and the the comment said, the abstract stated way to implement the recommendations quantitative information associated with that the study participants were more of the OWG’s Calories Count report and this declaration, be listed in a type size likely to use the Nutrition Facts label (in would be consistent with existing no smaller than 10 point (except on general) and the ingredient list in research data suggesting a lack of labels of smaller packages with a total particular than information about attention to this listing. surface area available to bear labeling of serving size and health claims. In addition, according to data from the (Response) The comments reflect the 40 square inches or less and all tabular formats where a type size of 9 point type NHANES 2009–2010 cycle, need to consider how much emphasis to approximately 64 percent of is permissible due to space constraints) provide for the ‘‘Serving size’’ respondents (16+ years of age) reported ll and be highlighted in bold or extra bold declaration compared to the ‘‘ at least ‘‘sometimes’’ using the serving type. Additionally, if a product has a servings per container’’ declaration. We size information on the food label when ‘‘Serving size’’ declaration with too agree with the comments that the deciding to buy a food product, and 31 many characters to fit in the provided serving size information was not percent of the respondents reported that space allocated for the ‘‘Serving prominent enough in our proposal and they used the serving size information size’’declaration, then a type size of 8 that consumers could potentially either ‘‘always’’ or ‘‘most of the time’’ point is permissible for any size package associate the calorie and nutrition (Ref. 266). information on the label with the (§ 101.9(d)(3)(ii)). To reduce the As for the comments suggesting that ‘‘servings per container’’ declaration prominence of the ‘‘ll servings per we need to evaluate consumer research since it was more prominent compared container’’ declaration, we are requiring and conduct further research in regards to the serving size declaration. We also that ‘‘ll servings per container’’ be to switching the order and increasing agree that the ‘‘servings per container’’ listed in a regular type in a type size no the prominence of ‘‘Serving size’’ and declaration should be more prominent smaller than 10 point (except on labels ‘‘servings per container,’’ we address and visible than on the preexisting label of smaller packages with a total surface these issues in our responses to so consumers will be able to use this area available to bear labeling of 40 comments 478 and 480. We also note information if they consume all or a square inches or less that we are finalizing the requirement to larger portion of a multi-serving (§ 101.9(j)(13)(ii)(A)(1) and (2)) where a include, directly below ‘‘Nutrition container. Increasing the prominence of type size of 9 point is permissible due Facts,’’ the ‘‘servings per container’’ the ‘‘Serving size’’ information by to space constraints) directly beneath declaration followed by the ‘‘Serving bolding and slightly increasing the font the Nutrition Facts heading, followed size’’ declaration. As we explain in our size will emphasize the importance of directly below by the ‘‘Serving size’’ response to comment 488, the location the information and, along with its declaration in bolder font. of ‘‘Serving size’’ to where ‘‘servings per placement, would assist consumers in (Comment 489) One comment referred container’’ was formerly located places better understanding how to use the to a study suggesting that many it in closer proximity to the nutrient Nutrition Facts label to interpret consumers do not look at serving size information that pertains to the serving accurately the calories and nutrient information, but otherwise do refer to size of the product. information on the label that is directly the Nutrition Facts label and ingredients (Comment 490) One comment said below the ‘‘Serving size’’ declaration. To list, as evidence that the serving size that ‘‘ll servings per container’’ is provide prominence to ‘‘Serving size,’’ declaration needs to be made more irrelevant information because the however, we need to reduce the prominent. Other comments suggested nutrition information on the label refers prominence of ‘‘servings per container.’’ that we should more closely review to the amount of nutrients and calories According to graphic design principles previous consumer research studies or in a single serving. The comment would (e.g., contrast), alternating a larger and conduct additional studies to determine have the Nutrition Facts label bolder type style with a smaller, regular the effects of displaying ‘‘Serving size’’ emphasize the size of a serving (i.e., the type style on successive lines of the and ‘‘servings per container’’ serving size) rather than the number of Nutrition Facts label will provide information more prominently, and servings that are in the container. maximum visibility and optimal determine the potential implications of (Response) The declaration of ‘‘ll highlighting to the information that we increasing the prominence and changing servings per container’’ provides wish to emphasize on the label (Ref. the location of the ‘‘ll servings per important information to the consumer

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about how the information on calories serving size information, which would § 101.9(b)(5)) and gram amounts must be and nutrients for one serving of food help clarify the number of servings to right-justified on the same line that relate to the entire package of food. which the label refers. Although the ‘‘Serving size’’ is listed. Under our Consumers may consume more than one survey findings reported in the preexisting regulations at § 101.9(d)(12), serving and need to know how the comment indicated that respondents did this numerical information is stated portions consumed relate to their total not need to see ‘‘per container’’ on the immediately adjacent to the ‘‘Serving daily dietary intake. Therefore, we label to correctly interpret information Size’’ declaration. By keeping the decline to revise the rule as suggested about serving size and the number of proposed ‘‘Serving size’’ declaration by the comment. However, we have servings per container, it is difficult to left-justified while right-justifying the revised § 101.9(d)(3) to clarify that both evaluate the results without any data. corresponding numerical values, the the ‘‘ll servings per container’’ and Therefore, we decline to change our proposed change would create white ‘‘Serving size’’ declarations are longstanding practice of including ‘‘per space on the Nutrition Facts label that components of the serving size container’’ as part of the ‘‘servings’’ would result in a less cluttered information required on the label. declaration, as this information is appearance, heightened focus and (Comment 491) Other comments intended to help consumers accurately emphasis, and improved readability opposed increasing the prominence of identify the number of servings in a (Ref. 268). This design feature would ‘‘__ servings per container’’ because, in package. provide enhanced emphasis to the combination with other proposed (Comment 492) Many comments information about serving size, allowing changes, it would increase the space suggested that we explain that nutrition this information to be more noticeable requirements for the Nutrition Facts information is based on the serving size and thereby facilitating its access and label. One comment said that, because listed in the Nutrition Facts label or use by consumers. of space limitations on the label, we conduct an education program to help (Comment 493) Some comments should not require the words ‘‘per consumers understand that the label addressed the issue of right-justifying container’’ to be included in the ‘‘ll serving size is not a recommendation the quantitative amounts declared in the servings per container’’ statement. The but is based on actual food intake data. ‘‘Serving size’’ statement. One comment comment further said that ‘‘per Some comments also asked us to suggested that moving the serving size container’’ is not needed for consumers explain the difference between serving information to the right-hand side of the to identify the number of servings in the size and portion size. One comment Nutrition Facts label would help package. The comment cited data from stated that, because some consumers use emphasize the information, create white an online consumer research study (Ref. the terms ‘‘serving size’’ and ‘‘portion space leading to a less cluttered 267) to assert that 98 percent of the size’’ interchangeably, we should clarify appearance, and would allow the eye to study participants correctly identified the label by either: (1) Denoting the ‘‘flow across the information.’’ Another the number of servings per package and serving size provided as a ‘‘typical’’ comment said that the proposed change the serving size when the label did not serving size; or (2) including a footnote would make it easier for readers to find include the words ‘‘per container,’’ to clarify that ‘‘the serving size is based the values for calories, serving size, while 92 percent of respondents who upon the amount typically consumed, number of servings per container, and viewed the proposed Nutrition Facts and is not a recommended portion percent Daily Values if all of these label (i.e., ‘‘ll servings per container’’) size.’’ Other comments said it was values were consistently placed in the were able to correctly identify this important to educate consumers that, if same right-hand side of the label. information. one eats more than one serving of a food One comment opposed to right- (Response) We note in our response to product, the amount of calories justifying the serving size quantitative comment 488 that we are requiring that consumed will increase proportionally. information on the Supplement Facts ‘‘ll servings per container’’ be listed (Response) We recognize the label. The comment said that because in a type size no smaller than 10 point importance of providing consumers the ‘‘Serving size’’ declaration must be (except on labels of smaller packages with more in-depth information about left-justified, the quantitative with a total surface available for labeling the meaning of the serving size and information for serving size should of 40 square inches or less, where the intend to make this a key component of appear near this declaration, rather than type size will be no smaller than 9 our future nutrition education efforts for on the other side of the panel where it point) and in regular font in order to consumers. However, we decline to would be separated by a large white provide adequate contrast to the revise the rule to add a footnote to the space. The comment added that this prominent information displayed Nutrition Facts label to indicate that the may be a particular concern for dietary directly above and below it (i.e., the serving size is based on what is supplement products that use dual ‘‘Nutrition Facts’’ heading and ‘‘Serving typically consumed, rather than what is column labeling (e.g., with columns for size’’ information, respectively). We recommended. Manufacturers can ‘‘Per Serving’’ and ‘‘Per Day’’). disagree that the words ‘‘per container’’ include a truthful and not misleading (Response) Keeping the ‘‘Serving should not be required to be included in statement explaining the meaning of size’’ declaration left-justified, while the ‘‘ll servings per container’’ serving size elsewhere on the product requiring the corresponding numerical statement because ‘‘per container’’ label. value be right-justified, provided that would provide context and a frame of adequate space is available, will make reference for the number of servings. 4. Right-Justifying the Quantitative this information more noticeable and Furthermore, the comment did not Amounts Declared in the ‘‘Serving Size’’ facilitate its access and use by provide adequate details about its study Statement consumers. Although we did not design, methodology, and statistical In the preamble to the proposed rule propose to right-justify quantitative analyses, and did not include data that (79 FR 11879 at 11950), we said that we amounts in the ‘‘Serving size’’ would enable us to appropriately tentatively concluded, based on design declaration in the Supplement Facts evaluate the survey results. Including considerations, that the label statement label, we agree that it would not be the words ‘‘per container’’ would for ‘‘Serving size’’ in both household appropriate to do this. The remove any potential ambiguity units (e.g., cups, tablespoons, teaspoons, ‘‘Supplement Facts’’ title in the between servings per container and the pieces or slices, as explained in Supplement Facts label requires more

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space than the ‘‘Nutrition Facts’’ title in unit is. Because studies suggest that should have the option of using the the Nutrition Facts label and (unless consumers often find serving size abbreviation ‘‘Amt Per llll’’ on impractical) must span the full width of information difficult to interpret (Ref. 9) Supplement Facts labels when extra the label (§ 101.36(e)(1)). Also, the we stated that specifying the actual space is required for the quantity Supplement Facts label is less likely serving size in the ‘‘Amount per statement (e.g., ‘‘2 capsules’’). than the Nutrition Facts label to be llll’’ declaration would likely help (Response) We recognize there are situated on the narrow side panel of a consumers to more readily observe and multiple viewpoints and potential package. Therefore, because comprehend the nutrition information advantages and disadvantages with Supplement Facts labels are often wider that is displayed in the label. respect to listing the actual serving size than Nutrition Facts labels, right- (Comment 494) Some comments in the blank space of the ‘‘Amount per justifying the serving size amount might supported the proposed change and said llll’’ declaration. We acknowledge leave too much white space between the that replacing ‘‘Amount Per Serving’’ that inserting the serving size in the words ‘‘Serving size’’ and the with ‘‘Amount per llll’’ would blank space would essentially repeat the quantitative amount. It may not be reinforce the concept of serving size and value for serving size that is listed apparent on some Supplement Facts help people realize how many calories directly above this statement. We labels that the quantitative amount per are actually in a serving of the product. further agree that this information serving listed on the far right side of the One comment said it was reasonable for would be duplicative and add to the label would refer to the serving size the label to include duplicate amount of numerical information declaration, which would be left- information (i.e., in both the ‘‘Serving already present on the label. Therefore, justified. With dietary supplements in size’’ and ‘‘Amount per llll’’ we will retain the preexisting particular, it is important that declarations) about what constitutes a requirement to declare ‘‘Amount per consumers understand the serving size serving because it is important for serving’’ directly above the ‘‘Calories’’ unit (e.g., 1 tablet, 1 capsule) to consumers to understand that the declaration rather than finalize a change minimize the possibility of taking an nutrition information on the label is to declare ‘‘Amount per llll’’ with excessive amount of the product. The based on the serving size. Another the blank filled in with the actual serving size amount also is important so comment suggested that both the serving size expressed in household that consumers can understand and ‘‘Serving size’’ and ‘‘Amount per units. We also will retain the preexisting follow instructions on dietary llll’’ declarations should be bolded requirement to list ‘‘Amount per supplement labels for the suggested use to increase their visibility. serving’’ in bold or extra bold type or of the product, which explain how, Many comments disagreed with the other highlighting and in a type size no when, or how much of the product to proposed change and said it would smaller than 6 point rather than finalize take daily and (if applicable) the amount make the serving size information a change in type size and contrast. not to exceed. Therefore, the final rule repetitive, create unnecessary clutter, With respect to the comment that said only requires that quantitative amounts and impose additional space constraints changing ‘‘Amount Per Serving’’ to declared in the ‘‘Serving size’’ statement on the label. One comment said that ‘‘Amount per llll’’ should be be right-justified on Nutrition Facts including duplicative information about voluntary for dietary supplement labels, labels, provided that adequate space is serving size would be distracting and we did not propose this change for the available, and not on Supplement Facts ‘‘slow down’’ the comprehension Supplement Facts label. Consequently, labels. process, especially if the serving size is there is no need to provide the option listed as a fraction (e.g., 2⁄3 cup). 5. Changing the ‘‘Amount Per Serving’’ of using the abbreviation ‘‘Amt Per Another comment suggested that listing llll Statement ’’ on Supplement Facts labels the serving size in the ‘‘Amount per as the comment requested. Our preexisting regulations require llll’’ statement is unnecessary the Nutrition Facts label to include a because our proposal to reverse the 6. Declaration of ‘‘Calories From Fat’’ subheading designated as ‘‘Amount Per order of ‘‘Serving size’’ and ‘‘Servings The proposed rule would eliminate Serving’’ and to separate this Per Container’’ and make the ‘‘ll the requirement for declaring ‘‘Calories subheading from the serving size servings per container’’ information from fat’’ on the label. information by a bar (§ 101.9(d)(4)) and more prominent already allows the Most comments supported removing highlight the subheading in bold or serving size to be more easily identified. the requirement for declaring ‘‘Calories extra bold type or other highlighting The comment said that only the from fat,’’ and we discuss those (§ 109(d)(1)(iv)). The proposed rule ‘‘Serving size’’ declaration should be comments in part II.E.1. would change the ‘‘Amount Per used to indicate the amount of food 7. Presentation of Percent DVs Serving’’ declaration to ‘‘Amount per contained in a serving, and that doing llll’’, with the blank filled in with so would maintain consistency with the Our preexisting regulations at the actual serving size expressed in current Nutrition Facts label. § 101.9(d)(7) establish the format for household units. We also proposed Another comment suggested listing nutrients with DRVs on the increasing the type size of this improving the clarity of the label by Nutrition Facts label, including the information and, to heighten contrast moving the ‘‘Amount per llll’’ quantitative amount by weight and with the calories information, using declaration directly above the list of percent DV. The preamble to the semi-bold rather than bold or extra bold percent Daily Values, listing the serving proposed rule (79 FR 11879 at 11950 highlighting. We explained, in the size after ‘‘Calories ’’ (i.e., ‘‘Calories per through 11951) explained that, when we preamble to the proposed rule (79 FR llll’’), and using the same type size established the requirements for percent 11879 at 11950), that these changes for the ‘‘Serving size’’ and ‘‘Amount per DV declaration, we considered that the would make it easier for label users to llll’’ declarations. Another information would help consumers understand what the nutrition comment said that changing ‘‘Amount evaluate the nutrient characteristics of a information in the Nutrition Facts label Per Serving’’ to ‘‘Amount per llll’’ single product (e.g., how high or low a refers to, because it would eliminate the should be voluntary for dietary particular product is in certain nutrients need to first locate the ‘‘Serving size’’ supplement labels, but if the change is or the extent to which it contributes declaration to see what the serving size made mandatory, then manufacturers toward daily nutritional goals) and help

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consumers make choices between choices. Other comments said that percent DVs are not relevant to people products. We also explained that shifting the percent DV column to the who do not eat 2,000 calories per day; consumer research back in 1992 left would be ‘‘eye catching,’’ create a moving the percent DVs to the left indicated that the percent DV cleaner design, and make the label more would make the label look ‘‘foreign’’ information improved consumers’ logical, better organized, and easier to and would be an unnecessary change abilities to make correct dietary read and comprehend. It also would having no benefits; and shifting the judgments about a food in the context of improve the simplicity and visual location of the percent DVs would not a total daily diet and helped consumers clarity of the label, as recommended by help consumers understand the to verify the accuracy of front panel the IOM. information any better than they claims (id.). Many comments that opposed placing currently do. Many comments said that, The proposed rule would use ‘‘% DV’’ the percent DV column on the left side because people are generally confused rather than ‘‘% Daily Value’’ as the of the label said that, because we read by the meaning of percent DV and do column heading above the nutrient from left to right, consumers would see not know how to properly use this listings to provide consistency among the percent DV before knowing to which information, percent DVs should not be the different label formats and to nutrient the value referred. The given a more prominent placement on maintain the alignment of this heading comments said it is more logical to list the left side of the Nutrition Facts label. over the DV column. For most labels, an item first and then its value. Some Several comments said it was premature the proposed rule also would list comments said that moving the percent to shift the percent DVs to the left based percent DVs in a column to the left of DV information to the left of the solely on theoretical design principles, the names of the nutrients and their nutrient name would be counter- and that we should not do this unless quantitative amounts, with a thin intuitive and confusing to consumers. research data become available vertical line separating the % DV One comment included data from a demonstrating that this change would column from the list of nutrients. On study it had commissioned; the study assist consumers in maintaining healthy dual column labels and on labels using indicated that, when the percent DV dietary practices. the aggregate display, we proposed to was on the left side of the label, there (Response) We acknowledge that the list the names of nutrients to the left of was no advantage in consumer conventional way to display data would the % DV columns and the quantitative comprehension of this information. The be to list the percent DV after the name (weight) amounts of each nutrient to the study found that a higher percentage of of the nutrient, as shown in the right of the % DV column, to use thin respondents answered a question about preexisting Nutrition Facts label format, vertical lines to separate the information Daily Values correctly when the percent and that shifting the percent DVs to the in the ‘‘% DV’’ column from the DV information was on the right versus left might present layout challenges information in the column containing the left side of the label (Ref. 269). with certain formats. We also note that the quantitative weights, and to use the Another comment noted that the the results of our consumer research same style of thin vertical lines to proposed label would be awkward to study were equivocal, as we found that separate each of the dual columns and read because consumers would need to no significant benefit was achieved by aggregate display columns from each first find the name of the nutrient in the shifting the percent DV column to the other. middle of the label. left side of the Nutrition Facts label (Ref. We also invited comment on Several comments agreed with the 270). alternative terms that may be more concern we expressed in the preamble We have no evidence that the readily understandable than Daily to the proposed rule, that giving more placement of the percent DV Value, such as Daily Guide or Daily prominence to the percent DV by listing information on the left would result in Need; whether the word ‘‘percent’’ (or it first could potentially make the less comprehension by consumers who the % symbol) needs to precede Nutrition Facts label appear less user- do not understand the meaning of whatever term is used in the column friendly particularly to frequent users percent DV, as suggested by some heading where the percent DVs are who are accustomed to its current comments. Nevertheless, we have listed or if this would be redundant format and could draw attention away reconsidered how percent DV should be because the ‘‘%’’ symbol is already from nutrients that do not have a DV (79 presented and have decided to retain included next to the numerical values FR 11879 at 11951). Another comment the preexisting requirement to list the listed in this column; and the said that shifting the percent DV to the percent DV information on the right side appropriate placement of percent DVs in left could hinder, rather than assist, of the label. the labeling of foods for infants 7 individuals with lower levels of health We anticipate that an increased focus through 12 months, children 1 through literacy and numeracy in understanding on percent DV through the introduction 3 years of age, and pregnant and the label. of a new footnote and enhanced lactating women (id. at 11961). Several comments said that moving consumer education efforts could help (Comment 495) Some comments the percent DV information to the left consumers who currently have some supporting our proposal said that might cause layout problems for certain difficulty understanding percent DV moving the percent DVs to the left formats, such as dual-column labels, become more comfortable using the would draw attention to this because of the difficulty in aligning the percent DV information. Furthermore, information and help people realize its column headings with the information we may study this issue, and other importance. Some comments said that, in the columns, and in differentiating issues involving the DV, in the future. because we read from left to right, the columns. Other comments expressed (Comment 496) Several comments people would be less likely to skip over concerns that placing percent DVs on suggested that the term ‘‘Daily Need’’ the percent DVs. Furthermore, because the left would be distracting because would be more helpful to consumers the information would be more consumers are mainly interested in the than ‘‘Daily Value.’’ Another comment noticeable, consumers might find it quantitative values of nutrients and tend suggested using the term ‘‘Daily more quickly and use it more often to to look for that information rather than Requirement’’ because it would be judge the percent DV of a specific the percent DVs. Other comments said ‘‘more in keeping with a DRV nutrient and to compare products when that increasing the focus on percent DVs calculation.’’ The comment cautioned shopping, leading to healthier food would be misguided because the that the term ‘‘Need’’ may have a

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negative perception because it conveys (Response) We acknowledge that the amounts, and that an example of this a ‘‘personal tone’’ and therefore may be term % DV is spelled out on most labels label would be helpful. seen as prescriptive or patronizing. An (with the exception of some small (Response) The description of the additional comment suggested using ‘‘% packages) and therefore the term ‘‘% vertical array of vitamins and minerals Ref’’ instead of ‘‘% DV.’’ Daily Value’’ should be familiar to in § 101.9(d)(8), which the comment (Response) In the preamble to the consumers. We also acknowledge that it said was inconsistent with the proposed rule, we said that we had would be desirable for the Nutrition associated mockup because the percent previously provided our rationale for Facts label to be able to ‘‘stand alone’’ Daily Values were listed in parentheses choosing the term Daily Value in the as a source of information to assist in the regulation, was not meant to be format final rule (58 FR 2079 at 2124, consumers in maintaining healthy a literal description of what was shown January 6, 1993) and had explained why dietary practices, and that the label in the label mockup in proposed we considered ‘‘need’’ and should be self-explanatory insofar as § 101.9(d)(12). However, we agree with ‘‘requirement’’ to be misleading terms possible. By spelling out the words the comment that the phrase ‘‘or may be that might complicate nutrition Daily Value instead of abbreviating listed in two columns’’ needs to be education efforts. Although one them, the meaning of the nutrition clarified, particularly with regards to comment suggested the use of the term information presented on the Nutrition where the percent Daily Values and the ‘‘% Ref.’’ (which we interpret as Facts label would be less ambiguous to absolute amounts are displayed relative meaning % Reference) instead of % DV, consumers, alleviate the need to explain to the names of the respective vitamins the comments, in general, did not the abbreviation, and improve the and minerals. Therefore, we have now suggest alternative terms or provide data ability of the label to stand alone. stated in § 101.9(d)(8) that the name of or information to support why an Therefore, the % Daily Value, rather the nutrient will be listed first, followed alternative term would be more than % DV, should be used as the by the absolute amount and then by the appropriate or preferable. Thus, we column heading for most formats if percent Daily Value (which will be continue to believe that the term Daily space is available. In order to provide listed to the right of the absolute amount Value is generally understood by flexibility to manufacturers when there and without parentheses). Furthermore, consumers to be a point of reference (see are space constraints on packages and to as the comment suggested, we have 58 FR 2079 at 2125) and will continue facilitate alignment of the % Daily provided a mockup showing the to use Daily Value as an appropriate Value column heading with the nutrient horizontal (i.e., side-by-side) display of single term to refer to all reference information listed beneath it, the vitamins and minerals in values in the Nutrition Facts label. particularly on formats in which there § 101.9(d)(8). However, we also note (Comment 497) Many comments are multiple columns of information, we that mockups are provided as examples opposed the use of the abbreviated term are retaining the provision in our of labels, and are meant to serve as % DV, and suggested that spelling out preexisting regulations (§ 101.9(d)(6)) illustrations rather than as indications the term Daily Value would be clearer that allows for the substitution of of specific requirements. We have not and easier to comprehend, eliminate ‘‘Percent Daily Value,’’ ‘‘Percent DV,’’ or provided mockups of all possible types possible confusion about the meaning of ‘‘% DV’’ for ‘‘% Daily Value.’’ of labels and we did not intend to state DV, and not require an explanatory With respect to whether consumers literally in the regulation what was footnote. Some comments stated that, may have difficulty understanding the shown in the various label mockups. while abbreviating Daily Value would concept of percent, our public education save space, the abbreviation would not program will help consumers 8. Placement of ‘‘Added Sugars’’ be helpful if consumers did not understand how to use the percent DV The proposed rule would require the understand the abbreviation, especially information and become more declaration of added sugars as an when consumer research has shown that comfortable with the concept of percent. indented line item underneath the the term Daily Value is not well We will continue to use percentages on declaration of total sugars on the understood. One comment noted that if the Nutrition Facts label for presenting Nutrition Facts label. In the Federal ‘‘% Daily Value’’ was abbreviated to ‘‘% nutrition information because it is Register of July 27, 2015 (80 FR 44303), DV,’’ we might replace a concept that is useful for assisting consumers in we issued a supplemental proposed rule already obscure with a shorthand maintaining healthy dietary practices. that would, among other things, designation that would be even more (Comment 498) One comment establish a DRV of 10 percent of total obscure to consumers. requested clarification with regards to energy intake from added sugars and Another comment suggested that how the percent DV information should require the declaration of the percent consumer research is needed to evaluate be displayed for the nutrients of public DV for added sugars. the impact that changing % Daily Value health significance when these nutrients We did not receive any comments to % DV would have on consumer use are listed either vertically or regarding the indentation of the added and understanding of this information. horizontally in two columns (i.e., the sugars declaration. We discuss the Some comments supported using ‘‘%’’ side-by-side arrangement), as permitted requirements for the added sugars rather than spelling out ‘‘percent’’ in § 101.9(d)(8). The comment said there declaration in part II.H.3. because, according to the comments, it was a discrepancy in how we described would decrease the amount of clutter on the vertical arrangement of nutrient 9. Declaration of Absolute Amounts of the label, and the term ‘‘percent’’ information for vitamins and minerals Vitamins and Minerals requires more label space without in § 101.9(d)(8) and how this The proposed rule would require the providing additional information or information was displayed in the label declaration of quantitative amounts for benefits to consumers. Another format shown in proposed all vitamins and minerals listed on the comment questioned whether either § 101.9(d)(12). The comment further Nutrition Facts label (except on labels of ‘‘percent’’ or the ‘‘%’’ symbol should be suggested that the phrase ‘‘or may be smaller packages with a total surface used on the label because the comment listed in two columns’’ should be area available for labeling of 40 square said that many consumers have clarified, particularly with regards to the inches or less as described in difficulty understanding the concept of placement of the nutrient name, the % § 101.9(j)(13)(ii)(A)(1) and (2)), in percent. Daily Value, and the quantitative addition to maintaining the current

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requirement of declaring percent DVs. In contrast, many comments 11928 through 11929). We recognize Because of space limitations, we expressed concerns that declaring that some consumers, particularly those proposed to require only the percent DV absolute amounts of all vitamins and with low numeracy skills, may be better for vitamins and minerals (other than minerals, in addition to the percent DV, able to understand and use the listed sodium) on labels of foods in small or would make the label more confusing, quantitative amounts of nutrients (e.g., intermediate-size packages having a cluttered, and difficult to read. The milligrams of calcium) on the label total surface area available to bear comments said that listing quantitative when making dietary choices, rather labeling of 40 or less square inches. As amounts of all vitamins and minerals than relying solely on the percent DV, we explained in the preamble to the would take up valuable label space and because they would need to know the proposed rule (79 FR 11879 at 11928 add complexity to the label without calculation for converting percent DV to through 11929), comments received in providing any tangible benefits to milligrams. Thus, although some response to the 2007 ANPRM, as well as consumers. Several comments said that comments would not list absolute the 2003 IOM report (Ref. 219) the percent DV listing already provides amounts because (according to the supported declaring both the absolute consumers with the information they comments) the percent DV already gives amounts of mandatory and voluntary need for choosing foods for a healthy consumers the information they need micronutrients on the Nutrition Facts diet, so it is not necessary to also list the for choosing foods for a healthy diet, the label in addition to the percent DVs absolute amounts for all nutrients on the percent DVs and absolute amounts, (when they exist). Among other reasons, Nutrition Facts label. The comments particularly for nutrients of public the IOM report said that listing absolute questioned whether consumers would health significance, are useful because amounts of all vitamins and minerals understand how to use absolute consumers receive information on the would make the Nutrition Facts label amounts in conjunction with the recommended intake of these vitamins internally consistent and more aligned percent DV and said there was little and minerals in quantitative amounts with the current requirements of the evidence that declaring absolute (i.e., the advice is given in milligrams, Supplement Facts labels amounts on the Nutrition Facts label micrograms, or International Units) (§ 101.36(b)(3)(ii) and (iii)). would help consumers maintain through public sources and from health We also considered previous research healthful dietary practices. Some professionals (Refs. 219, 271–272). which indicated that both consumers comments expressed concerns that, Furthermore, folic acid intake is related and health professionals have difficulty because consumers in general are not to the risk reduction of neural tube understanding how percent DVs relate familiar with metric system units such defects, and is generally provided in to the absolute amounts of nutrients as grams, milligrams, and micrograms or terms of mcg of folic acid. By requiring listed on the Nutrition Facts label (Ref. the relative magnitude of differences the mandatory declaration of folic acid 239). The previous research indicated between these units, they may not as a quantitative amount by weight in that physicians, dietitians, and other realize that a quantitative weight listed mcg, when folic acid is added or when health professionals found it easier to as a large number, but expressed in a claim is made about the vitamin in refer to absolute amounts of nutrients micrograms, can actually represent a labeling, women of childbearing age can rather than to the percent DVs when small amount of the nutrient. Another gain a better understanding of the advising patients. The results suggested comment said that, because some high unique contribution that synthetic folic that declaring both the absolute amount DVs are based on small quantitative acid from food provides in reducing the amounts and some small DVs are based and the percent DV would improve risk of neural tube defects and will have on high quantitative amounts, the understanding of the label. the information they need to improve quantitative information could be (Comment 499) Many comments their ability to adhere to nutrition confusing to consumers. recommendations with respect to folic agreed that we should require the (Response) In the past, we have stated acid. declaration of absolute amounts of all that we must be selective with regard to vitamins and minerals on the Nutrition the information we require to be listed Thus, requiring both the quantitative Facts label. Some comments said that on the label and that not all vitamins amount and the percent DV will help to people, especially those with low and minerals are of equal public health ensure that consumers are fully numeracy skills, have difficulty significance (58 FR 2206 at 2107). We informed about the content of these understanding the concept of have limited the mandatory declaration products, similar to how these nutrients ‘‘percentage’’ (such as percent DV) and of vitamins and minerals to those of are declared in dietary supplement would prefer using nutrition particular public health significance. product labeling (56 FR 60366; information expressed in absolute These vitamins and minerals include November 27, 1991). Nevertheless, we amounts rather than in percentages to vitamin D, calcium, iron, and have decided not to include in the final plan diets. The comments also potassium, which are ‘‘shortfall’’ rule the proposed requirement to suggested that people who want to nutrients in the general U.S. population include the declaration of absolute follow a health professional’s nutrition that are often consumed in inadequate amounts for all vitamins and minerals. guidance, such as advice to consume a amounts. In addition, we are requiring We clarify, in § 101.9(c)(8)(ii), that the specific amount of a nutrient (e.g., 500 the absolute amount for folic acid in declaration of voluntarily declared mg calcium/day), would find mcg to be declared when folic acid is vitamins and minerals listed in quantitative amounts on labels to be added as a nutrient supplement or paragraph (c)(8)(iv) may include the more useful than the percent DVs. claims are made about the vitamin on quantitative amount by weight and Other comments from registered the label or in labeling of foods percent of the RDI. We also revised the dietitians said they perceived percent (§ 101.9(c)(8)(ii) in the final rule). preexisting requirement in § 101.9(c)(8) DVs to be confusing and cumbersome As we stated in the preamble to the to remove the requirement that the and preferred to use absolute amounts proposed rule, research suggests that declaration for vitamins and minerals of nutrients when counseling clients on consumers and health professionals include a statement of the amount per how to use the Nutrition Facts label to have difficulty understanding how serving as a percent DV. A requirement build a healthy diet, compare food percent DVs relate to the absolute to compel absolute amounts for all products, and establish dietary goals. amounts of nutrients (79 FR 11879 at vitamins and minerals could make it

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difficult for consumers to use and read units such as grams and milligrams. To informed about the content of the label, particularly on fortified foods the extent consumers are less likely to conventional foods and will achieve such as cereals where many vitamins be familiar with ‘‘micrograms’’ (mcg), parity in labeling for nutrients of public and minerals may be listed. In addition, we anticipate that consumers will health significance in conventional the public health need among the become increasingly familiar and foods and dietary supplements. We do general U.S. population is not as great comfortable with this metric unit and not consider issues related to potential for listing quantitative amounts for others on the Nutrition Facts label. We greater toxicity from consumption of voluntary vitamins and minerals, such plan to address the different nutrients of nutrients in dietary supplements to as thiamin, riboflavin, or niacin, public health concern and their units of negate the benefits of also providing for because deficiencies of these vitamins measure as part of our education efforts conventional foods the information on are rare and because enriched bread, aimed at enhancing consumer absolute amounts for these particular rolls, and buns must be fortified with understanding of the label. nutrients of public health significance these nutrients. Requiring the (Comment 500) Some comments said that are considered shortfall nutrients. declaration of absolute amounts of that for people who have special dietary Requiring absolute amounts of nutrients of public health significance, requirements because of a medical vitamins and minerals of public health and folic acid when added as a nutrient condition, such as chronic kidney significance and folic acid under the supplement or claims are made about disease, the percent DV by itself may be circumstances previously described to the vitamin, while providing voluntary inadequate for making decisions about be listed on the Nutrition Facts label declaration of absolute amounts for food selections (e.g., kidney patients will make it easier for both consumers other vitamins and minerals, will who monitor their phosphorus intake and health professionals to understand provide manufacturers with flexibility would find the phosphorus content and use the Nutrition Facts label and in assessing how much voluntary expressed in milligrams to be more help consumers in maintaining healthy information to provide on the Nutrition useful than the % DV of phosphorus). dietary practices. Furthermore, (Response) While the Nutrition Facts Facts label without creating unnecessary consumers can use the information to label information has never been, nor is clutter. However, if one of these other obtain these shortfall nutrients it now, targeted to individuals with vitamins or minerals is added as a primarily through healthy eating acute or chronic disease, consumers nutrient supplement or there is a claim patterns containing nutrient-dense may be able to use quantitative made about it, the manufacturer must conventional foods, as recommended by information on the label to follow include a declaration of the nutrient as the DGA (Ref. 28). advice they have received from a health a percent DV, or alternatively, as a (Comment 502) Several comments quantitative amount by weight and care professional concerning their conditions (see part II.B.2). expressed concerns that requiring the percent DV (§ 101.9(c)(8)(ii) in the final (Comment 501) Several comments absolute amounts of all vitamins and rule). questioning the need for declaring minerals to be listed on the Nutrition With respect to the comment absolute amounts of vitamins and Facts label would be problematic expressing concern that quantitative minerals on the Nutrition Facts label because FDA’s established rounding information could be confusing to said that people who meet their rules only apply to percent DV consumers, the comment discussed a nutritional needs through conventional declarations, and the proposed rounding situation where a product that contains foods are less likely to be interested in rules for declaring quantitative amounts 100 percent DV for vitamin D and lists quantitative amounts of vitamins and of vitamins and minerals are not clear. only 20 mcg (a ‘‘low’’ amount) on the minerals compared to those who use The comments said that different label also contains 5 percent DV for dietary supplements to supplement products having the same absolute potassium, which would correspond to their diets with specific amounts of amounts of a nutrient listed on the label an absolute amount of 235 mg (a ‘‘high’’ such nutrients. The comments said that may have different percent DVs amount). However, only two of the four labels designed for conventional food associated with that nutrient due to nutrients (vitamin D and potassium) are products and for dietary supplements rounding. Some comments also said that new nutrient declarations under the are not necessarily analogous because two different products having the same final rule, and we expect consumers to the two types of products have different percent DV for a nutrient may declare become familiar with these nutrients as purposes as reflected in their nutrient different absolute amounts for that part of the new label. Vitamin D is a composition; e.g., nutrient levels in nutrient, which would lead to consumer shortfall nutrient that many health dietary supplements are often much confusion. In addition to such professionals discuss with their clients higher than those in foods and discrepancies, several comments said it or patients as part of a healthy dietary beverages. The comments also noted is not feasible to require absolute intake. As noted elsewhere in part that, because there is a greater potential amounts of vitamins and minerals to be II.N.4, vitamin D must be listed in for toxicity resulting from the use of listed because analytical assays for micrograms and may be listed dietary supplement products due to obtaining this information lack the voluntarily in International Units. In overconsumption compared to necessary precision, resulting in addition, although only the percent conventional food products, it is considerable variability in results from Daily Values for calcium and iron are important that nutrient levels on assay to assay. Other comments said currently listed on the Nutrition Facts Supplement Facts labels be expressed in that levels of nutrients in foods and food label, consumers who take these absolute amounts so that this products are naturally variable and due nutrients as dietary supplements may be information is plainly visible to to this variability, declaring absolute familiar with the corresponding consumers. amounts would imply greater precision quantitative amounts because these (Response) Requiring the absolute than is currently required for the must be declared on Supplement Facts amounts of vitamins and minerals for declaration of the percent DV. The labels. Furthermore, the Nutrition Facts the nutrients of public health comments also said it would be label has included metric units since its significance and folic acid under the particularly difficult and costly to inception in 1993, so consumers have circumstances previously described will obtain information on vitamin D levels had considerable exposure to metric help ensure that consumers are fully because this information was not

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previously required for most dual column labeling is mandatory for than the preexisting footnote, and conventional food products. products that are promoted on the label, include a statement that 2,000 calories (Response) The quantitative amount or in advertising, for a use that differs a day is used for general nutrition of sodium has always been required to in quantity by twofold or greater from advice (id.). be declared on the Nutrition Facts label, the use upon which the reference We also stated in the preamble of the and dietary supplement products have amount was based (e.g., liquid cream proposed rule (id. at 11953 through required weight amounts to be declared substitutes promoted for use with 11954) that we would continue to since 1993. Rounding rules for the breakfast cereals) (§ 101.9(b)(11)). The conduct research during the rulemaking Nutrition Facts label have been proposed rule would require (under process to evaluate how variations in established for potassium (§ 101.9(c)(5)) certain conditions) dual column label format, including percent DV and for other vitamins and minerals labeling where nutrition information information in the footnote area, may (§ 101.9(c)(8)(iii)) in the Nutrition Facts would be presented based both on the affect consumer understanding and use label and for vitamins and minerals serving size and on the entire package of the Nutrition Facts label and that we declared on labels of dietary or unit of food. would make the results of our study supplements (§ 101.36(b)(2)(ii)(B) and We respond to comments on single available for public review and § 101.36(b)(2)(iii)(B)). We discuss this and dual-column labeling in the final comment. topic further in part II.M.6. To declare serving size rule. In the preamble to the supplemental the percent DV for vitamins and (Comment 504 and Response) We proposed rule (80 FR 44303 at 44306 minerals on the Nutrition Facts label, address comments regarding dual and 44309), we described an manufacturers should already have column labeling in the final rule on experimental study on consumer information about the levels of nutrients ‘‘Food Labeling: Serving Sizes of Foods responses to Nutrition Facts labels with in their products. Such information also That Can Reasonably Be Consumed At various footnote formats. (We can be obtained through laboratory One Eating Occasion; Dual-Column summarize the footnote study at part analysis or by consulting standard Labeling; Updating, Modifying, and II.B.5.) The supplemental proposed rule nutrient databases, such as the USDA Establishing Certain Reference Amounts would add language to the space Nutrient Data Lab Standard Reference Customarily Consumed; Serving Size for reserved in proposed § 101.9(d)(9) to (http://www.ars.usda.gov/Services/ Breath Mints; and Technical explain that the % Daily Value tells how docs.htm?docid=8964). Substituting Amendments’’ which is published much a nutrient in a serving of food vitamin D and potassium for vitamin A elsewhere in this issue of the Federal contributes to a daily diet and that 2,000 and vitamin C for the nutrient analysis Register. calories a day is used for general nutrition advice. The supplemental should not result in a significant 11. The Footnote difference in cost to the manufacturer. proposed rule also would create an Furthermore, we are not aware of Our preexisting regulations, at exemption to the proposed footnote problems in obtaining quantitative data § 101.9(d)(9)(i), require the Nutrition requirement in § 101.9(d)(9) for the related to variability and precision. Facts label to bear an asterisk after the foods that can use the terms ‘‘calorie Manufacturers already must address ‘‘% Daily Value’’ declaration; the free,’’ ‘‘free of calories,’’ ‘‘no calories,’’ these issues to comply with the asterisk refers to a footnote that reads: ‘‘zero calories,’’ ‘‘without calories,’’ preexisting nutrition labeling ‘‘*Percent Daily Values are based on a ‘‘trivial source of calories,’’ ‘‘negligible regulations. 2,000 calorie diet. Your Daily Values source of calories,’’ or ‘‘dietary (Comment 503) One comment may be higher or lower depending on insignificant source of calories’’ on the included the results of a consumer your calorie needs.’’ Our preexisting Nutrition Facts label or in the labeling study to suggest that it is more regulations also require, below the of foods as defined in § 101.60(b) important for FDA to gain a better footnote, a table that lists DRVs for total because such products would have little understanding of how consumers use fat, saturated fat, cholesterol, sodium, to no impact on the average daily 2,000 percent DV information rather than total carbohydrate, and dietary fiber calorie intake, which the footnote understand how consumers would use based on 2,000 and 2,500 calorie diets addresses. The supplemental proposed information on absolute amounts. The (§ 101.9(d)(9)(i)). However, the preamble rule also would amend comment said that, according to its to the proposed rule (79 FR 11879 at § 101.9(j)(13)(ii)(C) to allow the footnote research, declaring absolute amounts on 11953) explained that the percent DV is to be omitted on small or intermediate- the label would decrease consumer not described in the footnote or size packages (§ 101.9(j)(13)(ii)(A)(1) attention to the percent DV information anywhere else on the Nutrition Facts and § 101.9(j)(13)(ii)(A)(2)) provided and would present ‘‘significant label, and so we wondered if such a that an abbreviated footnote statement implementation challenges.’’ description would help improve (that % DV = % Daily Value) is used. (Response) The comment refers to the consumer understanding of the percent Although the preamble to the study which we addressed in our DV information. We also noted that supplemental proposed rule discussed response to comment 184. We are not consumers did not understand what was allowing the footnote proposed in aware of any evidence that including being conveyed in the footnote or the § 101.9(d)(9) to be omitted from absolute amounts for the public health DRV table (id.). Consequently, we products that qualify for a simplified nutrients would detract from the proposed to remove the requirement for format (§ 101.9(f)) (80 FR 44303 at percent DV information, and we intend the footnote table and to reserve a 44309) provided that the abbreviated to conduct consumer education on subparagraph (proposed § 101.9(d)(9)) footnote statement is used, this increasing the understanding of the for a future footnote. The preamble to provision was inadvertently omitted percent DVs. the proposed rule (79 FR 11879 at from the codified section of the 11953) also stated our tentative view supplemental proposed rule. 10. Single and Dual Column Labeling that a new, simple footnote was needed With respect to the Supplement Facts The preamble to the proposed rule (79 to help consumers understand the label, our preexisting regulations, at FR 11879 at 11952 through 11953) noted meaning of the percent Daily Value. We § 101.36(b)(2)(iii)(D), require that, if the that we have preexisting regulations for said that the new footnote should have percent DV is declared for total fat, voluntary dual column labeling and that a larger type size, be more noticeable saturated fat, total carbohydrate, dietary

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fiber, or protein on the Supplement should require language in the footnote (Ref. 273). We also recognize that label Facts label, a footnote state that explaining that growing children and space is limited and agree that ‘‘Percent Daily Values are based on a adolescents may need more or less than eliminating the footnote table would 2,000 calorie diet.’’ The proposed rule 2,000 calories per day, depending on free up space on the label that could be would require, for a product that is their age, gender, size, and activity used for other purposes. Therefore, the represented or purported to be for level. final rule does not require the footnote children 1 through 3 years of age and Other comments suggested that, table which lists the DRVs for total fat, contains a percent DV declaration for because some consumers may view the saturated fat, cholesterol, sodium, total total fat, total carbohydrate, dietary label serving size as a recommended carbohydrate, and dietary fiber for 2,000 fiber, or protein, that a symbol be placed portion size, or use these terms and 2,500 calorie diets. next to the percent DV declaration that interchangeably, we should include a We disagree with comments refers the consumer to a statement at the footnote clarifying that ‘‘serving size’’ is suggesting that a footnote be used to bottom of the label that says ‘‘Percent based on the amount typically explain that calorie needs vary among Daily Values are based on a 1,000 consumed and is not a recommended population groups (including children calorie diet’’ (79 FR 11879 at 11947). We amount. and adolescents) or to clarify the illustrated this footnote in a mockup of Another comment said that the meaning of ‘‘serving size.’’ The footnote a Supplement Facts label depicting a Nutrition Facts label should go beyond area of the label is not an appropriate multiple vitamin product for children just providing factual information and place for providing this information and adults (§ 101.36(e)(11)(ii)). In the be a ‘‘tool’’ to help consumers make because of limited space on the label. preamble to the proposed rule, we healthier food and beverage choices. For Furthermore, we do not agree that it invited comments on whether changes example, the comment said we should would be appropriate to use a footnote to the footnote statement on the use a footnote to provide consumers to indicate ‘‘beneficial’’ or ‘‘harmful’’ Supplement Facts label should be with information about nutrients on the nutrients that are declared on the label, consistent with any changes that are label that are ‘‘beneficial’’ (such as as the comment suggested. We made to the footnote statement in the dietary fiber) or ‘‘harmful’’ (such as considered a similar concept in the Nutrition Facts label (79 FR 11879 at saturated fat) to their health. Several alternative visual format that was 11948). In the preamble to the comments also said that we should discussed in the preamble to the supplemental proposed rule, we invited consider including a link to a Web page proposed rule (79 FR 11879 at 11995), comments on whether we should where consumers can find more but, after reviewing the comments on replace the preexisting footnote in the information about nutrition, health and the proposed rule, indicated that we did Supplement Facts label with a footnote calorie needs. not intend to consider the alternative comparable to what we would require Several comments suggested that we format for the Nutrition Facts label for the Nutrition Facts label; i.e., ‘‘2,000 seek a broader understanding of how further (see 80 FR 44302). calories a day is used for general consumers use the footnote. The With respect to comments suggesting nutrition advice’’ (80 FR 44303 at comments emphasized that any that we base revisions of the footnote 44307). revisions to the footnote should be (including the option of not having any (Comment 505) Many comments based on research, and that the results footnote at all) on research and that our supported removing the footnote table of our consumer research should be research results should be made listing DRVs for certain nutrients based made available to the public for review available to the public for review and on 2,000 and 2,500 calorie diets. The and comment. However, other comment, we did conduct research on comments said that the footnote table is comments would remove the footnote various footnote options and made those confusing and difficult to read; entirely, and some comments suggested results publicly available (see 80 FR consumers generally do not understand that, as part of our consumer studies, we 44302; 80 FR 44303). how to use it and probably derive little should evaluate whether a footnote is Finally, we do not agree with the value from it; and the footnote occupies even needed. Several comments noted comments stating that we should valuable label space that could be used that the footnote itself is not an effective consider including a link to a Web page for other information. However, other means for educating consumers and where consumers can find more comments favored retaining the footnote should not be used as an educational information about nutrition, health and table, indicating that it is useful for tool. calorie needs. Information on the nutrition education purposes, may help Several comments said that, Nutrition Facts label should be available consumers gain a perspective on their regardless of which footnote was to the consumer at the time of product daily nutrient intake, and is a ultimately decided upon, the footnote purchase or consumption. convenient reference for consumers who should be succinct, occupy little space, (Comment 506) Many comments to want this information. and fit on small packages. Many the supplemental proposed rule Other comments suggested that the comments emphasized that, because the supported FDA’s proposed footnote, footnote should contain additional proposed rule did not specify the exact ‘‘*The percent DV tells you how much information beyond what is currently footnote text and the amount of space a nutrient in a serving of food included or proposed. For example, the new footnote would require, it contributes to a daily diet. 2,000 calories some comments said the footnote would be difficult to submit meaningful a day is used for general nutrition should continue to explain that percent comments until further details were advice,’’ and generally agreed that the DVs are based on a 2,000 calorie diet provided. footnote should include both a and that an individual’s Daily Values (Response) We agree with removing definition of percent DV as well as a may be higher or lower depending on the footnote table listing DRVs for reference calorie level. The comments one’s particular calorie needs. Some certain nutrients based on 2,000 and said that the proposed footnote conveys comments expressed concern that, 2,500 calorie diets. As stated in the the information that consumers need to without context, the public will not proposed rule (79 FR 11879 at 11953), understand the significance of the know whether 2,000 calories represents we are aware of research suggesting that percent DV declaration in the context of too many or too few calories. In consumers do not understand what is a daily diet and highlights factors (i.e., addition, some comments said we being conveyed in the footnote table nutrient values and total calorie intake)

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that are important in making dietary a nutrient may be helpful to consumers caloric intake. Therefore, it would not decisions. Several comments also in judging the nutrient content of a be accurate to link the percent DV in a pointed out that, because the footnote particular product. One comment also serving ‘‘to a 2,000 calorie daily diet,’’ has been condensed (i.e., by removing expressed support for the footnote as stated in the modified footnote, rather the footnote table), it would help stating, ‘‘These are nutrients to reduce than ‘‘to a daily diet’’ as stated in our counterbalance the increased space in your diet,’’ with the footnote symbol footnote. requirements of the Nutrition Facts inserted to the left of the listings for Although we agree that including label. saturated fat, trans fat, cholesterol, ‘‘5% or less is a little, 20% or more is Other comments objected to the sodium, and sugars in the Nutrition a lot’’ after the % Daily Value proposed footnote and suggested Facts label (experimental footnote 5). description (experimental footnote 2) alternative footnote text. For example, The comment said that this footnote can be helpful in judging the nutrient one comment said that the first sentence scored well in our consumer study and content of a particular product, we note in the footnote is confusing offers ‘‘real value’’ for consumers that our consumer research study did grammatically; the second sentence seeking information on nutrients in the not demonstrate that this footnote does not flow naturally from the first diet that should be reduced. performed any better than the other sentence; it is unclear how the two (Response) We appreciate the footnotes that we investigated. As we concepts expressed in the footnote are suggestions for modifying or refining the explained in the preamble to the related; and the proposed footnote text footnote. However, the alternative supplemental proposed rule (80 FR is longer than that of the current footnote statements do not offer a 44303 at 44306), our results indicated footnote and will take up too much significant improvement over the that none of the modified footnotes we valuable label space. The comment footnote text that we have proposed. tested significantly affected consumer suggested an alternative footnote, Furthermore, the comments did not perceptions of the products or ‘‘*The % Daily Value (DV) tells you provide any evidence or data indicating judgments of nutrient levels; all five how much a nutrient in a serving of that any alternative footnote represented footnote options elicited similar food contributes to a 2,000 calorie daily an improvement over the proposed perceptions and judgments relative to diet.’’ The comment said its suggested footnote. the current footnote and a no-footnote footnote is more concise and easier to The second statement of our proposed control. We also are concerned that follow. footnote, ‘‘2,000 calories a day is used including this qualifying phrase would Another comment said that the for general nutrition advice,’’ is the increase the amount of space required footnote should specify that a 2,000 same as the succinct statement that will for the footnote. However, as we stated calorie daily diet pertains to adults and be required on menus and menu boards in the preamble to the proposed rule (79 suggested the following footnote text: under FDA’s menu labeling final rule FR 11879 at 11954), the ‘‘5/20 rule’’ can ‘‘The % Daily Value (DV) tells you how (79 FR 71156 (December 1, 2014)). be used as a general frame of reference much a nutrient in a serving of food Moreover, by including this statement for evaluating the nutrient content of contributes to a daily diet. 2,000 calories as a separate, stand-alone sentence in foods. We anticipate that explaining this a day is used for general nutrition the footnote text, we provide approach for using the percent DV advice for adults.’’ Another comment consistency between labels on packaged information will be a part of our future that criticized the proposed footnote for foods and those on foods sold in consumer education efforts, so it would being ‘‘too verbose’’ and provided six restaurants. Adding the words ‘‘for not be necessary to include an different, but similar, versions of a adults’’ at the end of this sentence, as explanation of the ‘‘5/20 rule’’ in the ‘‘more succinct’’ alternative footnote, one comment suggested, would footnote. with one option reading as: undermine this consistency, take up As for the comments that favored ‘‘* %DV = %Daily Value, how much a additional space, and is not needed consideration of the footnote which nutrient in a serving contributes to a because the Nutrition Facts label is indicated ‘‘nutrients to reduce in your daily 2,000 calorie diet.’’ intended to apply to individuals 4 years diet’’ (footnote 5), we previously Several other comments either of age and older (with the exception of considered this concept in our suggested modifications to the proposed labels on products other than infant ‘‘alternative format’’ (79 FR 11879 at footnote (e.g., expanding the term formula represented or purported to be 11995), but found it offered no clear ‘‘food’’ to ‘‘food or beverage’’ to specifically for infants through 12 advantages over the current and emphasize that beverages also months of age and children 1 through 3 proposed formats in helping consumers contribute to one’s daily nutrient intake) years of age). Furthermore, as we to identify specific information on the or opposed the footnote because, explain in part II.E.3, a 2,000 calorie label or to make healthier food choices. according to the comments, the footnote reference intake level is applicable to We do not agree with the comment was not tested and was not supported the general population and is used as that said our proposed footnote is by research. Furthermore, several the basis for setting DRVs for total fat, ‘‘confusing grammatically.’’ We comments said that, because no saturated fat, total carbohydrate, dietary deliberately used language that was significant differences were found fiber, and protein, so there is no need to informal rather than grammatically rigid among the footnotes in our consumer add the words ‘‘for adults’’ in the or technical. Our intent was to make the study, we should give further footnote text. footnote consumer friendly. We also consideration to some footnotes that Regarding the comment suggesting the consider our footnote to be simple and were tested, but ultimately rejected. In modified footnote text, ‘‘The % Daily brief in providing a description of the particular, the comments said we Value (DV) tells you how much a percent Daily Value, which is lacking in should reconsider the footnote which nutrient in a serving of food contributes the preexisting footnote. included the statement, ‘‘5% or less is to a 2,000 calorie daily diet,’’ the Finally, we decline to include the a little, 20% or more is a lot’’ after the statement is brief and grammatically word ‘‘beverage’’ in the footnote. The % Daily Value description correct, but may not be technically term ‘‘food’’ is defined in section (experimental footnote 2). The correct because the daily values of some 201(f)(1) of the FD&C Act as including comments said that this guideline for declared nutrients, such as sodium and articles used for both ‘‘food or drink.’’ what constitutes a ‘‘lot’’ or a ‘‘little’’ of cholesterol, do not depend on the Moreover, the Nutrition Facts label has

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appeared on beverages for more than 20 used on small and intermediate-size Furthermore, the final rule does not years, so consumers should understand packages because, according to the require the footnote in § 101.9(d)(9) to that the entire label, including the comment, such products are often high be used on products that qualify for footnote, applies to foods that are in added sugars and are routinely using the simplified format, as beverages. marketed to children and adolescents. explained in § 101.9(f)(5), provided that We expect that our footnote, which The comment suggested that consumers the abbreviated footnote ‘‘% DV = % explains the term ‘‘% Daily Value’’ and would benefit by having the complete Daily Value’’ in a type size no smaller provides a reference calorie level, will footnote appear on these food packages. than 6 point is used on these package assist consumers in better (Response) As we explained in the labels when Daily Value is not spelled understanding the information on the preamble to the supplemental proposed out in the column heading. Nutrition Facts label and in maintaining rule (80 FR 44303 at 44309), we are Finally, in the preamble to the healthy dietary practices. Therefore, the applying the same rationale in this final proposed rule (79 FR 11879 at 11953), final rule, at § 101.9(d)(9), requires a rule that we used in the 1993 final rule we recognized that the footnote, by footnote stating that, ‘‘* The % Daily with regards to exempting small and appearing in a small type size at the Value tells you how much a nutrient in intermediate-size packages from some of bottom of the label, may be less a serving of food contributes to a daily the footnote language we required for noticeable to consumers and of less use diet. 2,000 calories a day is used for larger products. The 1993 final rule gave than if it had been larger and otherwise general nutrition advice,’’ in all manufacturers flexibility in using the more noticeable. Consequently, our Nutrition Facts label formats except for complete footnote on all product labels. tentative view was that increasing the the exemptions previously noted. The We recognized that the benefits of type size of the footnote would assist final rule also requires, on labels of requiring this footnote were not relative consumers in using the information, and products represented or purported to be to the specific product that carries the we requested comments on this issue. for children 1 through 3 years of age, information and that the information We did not receive any comments that that the second sentence of the footnote would be available to consumers if it supported increasing the type size of the substitute ‘‘1,000 calories’’ for ‘‘2,000 appeared on a significant percentage of footnote (although comments supported calories,’’ so the footnote statement will food labels (58 FR 2079 at 2129). increasing the font size for certain other read: ‘‘* The % Daily Value tells you Therefore, although the final rule does declarations, e.g., ‘‘Calories’’ and how much a nutrient in a serving of not require any footnote on these ‘‘Serving size’’), but some comments food contributes to a daily diet. 1,000 products, we will allow the voluntary supported using as little space as calories a day is used for general use of the first part of the footnote possible for the footnote information. nutrition advice.’’ statement, ‘‘* The % Daily Value tells Therefore, the final rule does not affect (Comment 507) Many comments you how much a nutrient in a serving the pre-existing requirement in supported the exemption for a footnote of food contributes to a daily diet’’ on § 101.9(d)(1)(iii) that specifies that the on products containing a negligible products that can use the terms ‘‘calorie information required in § 101.9(d)(9) be amount of calories and that can use the free,’’ ‘‘free of calories,’’ ‘‘without in a type size no smaller than 6 point. term ‘‘calorie free’’ or one of its calories,’’ ‘‘trivial source of calories,’’ (Comment 508) Many comments synonyms. The comments agreed that a ‘‘negligible source of calories,’’ or discussed whether there should be a footnote which addresses a 2,000 calorie ‘‘dietary insignificant source of calories’’ footnote on the labels of foods intake is not relevant for these products, on the label or in the labeling of foods, represented for infants 7 to 12 months and the exemption would be a practical as defined in § 101.60(b). of age or children 1 through 3 years of way of conserving label space for the We acknowledge that small and age. Most comments supported having a nutrient declarations that are required. intermediate-size packages may be high footnote on the label of foods intended However, other comments opposed in added sugars and marketed to for these subpopulation groups. For the exemptions because, according to children and adolescents. However, example, one comment said that a comments, products that have little or both the absolute amount and % DV of voluntary footnote should be permitted no impact on calorie intake still may added sugars will be declared on labels for foods specifically marketed to contain substantial amounts of nutrients of small packages, so this information children 1 through 3 years of age and such as vitamins and minerals. As an will be available to consumers. We also that the footnote should state, ‘‘Percent example, one comment said that recognize the need to conserve space on Daily Values are based on a 1,000 fortified beverages may contain smaller packages, which is why we calorie diet.’’ Other comments said that significant amounts of electrolytes as allow other adjustments, such as not both conventional foods and dietary well as 100 percent of the DV of certain requiring the declaration of absolute supplement products marketed for these vitamins. The comment suggested that amounts of the public health nutrients age groups should have a footnote ‘‘calorie free’’ products include the first and the use of the tabular (denoted by an asterisk) indicating the sentence of the footnote, ‘‘The % Daily (§ 101.9(j)(13)(ii)(A)(1)) and linear number of calories that the percent DVs Value tells you how much a nutrient in (§ 101.9(j)(13)(ii)(A)(2)) display on small listed on the labels is based on. One a serving of food contributes to a daily packages and intermediate-size comment noted that this had already diet’’ because it would help consumers packages having a total surface area been proposed for dietary supplements understand the vitamin and mineral available to bear labeling of 40 or less (79 FR 11879 at 11947). The comment content of these calorie-free foods. square inches. Therefore, the final rule further suggested that information about Other comments supported the use of does not require the footnote in percent DVs of nutrients for different an abbreviated footnote, such as ‘‘% DV § 101.9(d)(9) to be used on products in age groups be made available online = % Daily Value’’ on the simplified small packages as specified in (arranged by age group) so that parents format label and on labels of small and § 101.9(j)(13)(ii)(A)(1) and and others interested in nutrition would intermediate-size packages. Some § 101.9(j)(13)(ii)(A)(2), but have ready access to this information. comments explained that an abbreviated manufacturers may voluntarily include Another comment suggested that we footnote would save label space. the abbreviated footnote ‘‘% DV = % allow a voluntary footnote stating ‘‘Total However, one comment opposed Daily Value’’ on these packages and in fat and cholesterol should not be limited allowing the abbreviated footnote to be a type size no smaller than 6 point. in the diets of children less than 2 years

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unless directed by a physician’’ to continuing to consider how a voluntary conventional foods that references 2,000 provide dietary guidance to parents and footnote explaining that total fat should calories as a basis for ‘‘general nutrition other caregivers to help assure total fat not be restricted in the diets of children advice,’’ or explains percent DV in the is not restricted in the diet of young less than 2 years of age may help context of what a serving contributes to children. The comment said that the caregivers maintain healthy dietary a daily diet, is for a different use from American Academy of Pediatrics practices for these subgroups, and how that of dietary supplements. recommends not restricting fat or the information can be conveyed Although the intent of the comment cholesterol for infants and children effectively. Although, for this final rule, regarding the need for consistency younger than 2 years of age, as rapid we decline to allow this voluntary between the Nutrition Facts label and growth and development occur during statement to be located within the Supplement Facts label is not clear, we this time, necessitating a high energy Nutrition Facts label, manufacturers recognize the necessity of having intake. Another comment said we may place this or a similar statement in different footnotes on labels of should not finalize the rule until we had another area of the package, provided conventional foods and dietary conducted appropriate research, the statement is truthful and not supplements, consistent with how these including consumer testing, to better misleading. We intend to engage in products are used. Therefore, the final understand the impacts of declaring education efforts to explain changes to rule retains the preexisting footnote on saturated fat and cholesterol on the the Nutrition Facts label and will Supplement Facts labels and amends labels of products represented or include labeling of foods for infants and the list of macronutrients, for when the purported to be specifically for infants children 1 through 3 years of age in footnote is required, to include added and children 1 through 3 years of age these efforts. sugars. Therefore, the final rule requires and if an explanatory footnote would (Comment 509) One comment said a footnote if the percent of Daily Value assist in improving consumer that the Supplement Facts label should is declared for total fat, saturated fat, understanding when accompanying any be similar to the Nutrition Facts label total carbohydrate, dietary fiber, protein, relative declaration. used for conventional foods because or added sugars), stating that ‘‘Percent (Response) We recognize that the different versions of the labels may Daily Values are based on a 2,000 percent DVs of certain nutrients (e.g., decrease consumer use, understanding calorie diet’’ (§ 101.36(b)(2)(iii)(D)) fats, carbohydrates, protein) for foods and trust. However, it was not clear if because that information is related to specifically intended for children 1 the comment was referring specifically the calorie contribution of the calorie- through 3 years of age are based on a to the footnotes of these labels. Another containing ingredients. The footnote reference calorie intake of 1,000 comment said there should not be a statement for Supplement Facts labels calories/day. However, as explained in footnote on the Supplement Facts labels does not contain the statement required part II.O (Subpopulations), the IOM’s because consumers do not receive for conventional foods that states ‘‘The quantitative intake recommendations nutrition solely from these products, so % Daily Value tells you how much a (AIs and RDAs), rather than a calorie a footnote referring to total calories nutrient in a serving of food contributes level, provide a basis on which to would be unnecessary. The comment to a daily diet.’’ In addition, if a product determine RDIs (and percent DVs) for added that, because nutrition declares a percent DV for total fat, vitamins and minerals for this calculations are based on 2,000 calories, saturated fat, total carbohydrate, dietary subpopulation. Although the comments this information is already standardized fiber, protein, or added sugars, and is suggested including the footnote across the industry, making the notation represented or purported to be for use ‘‘Percent Daily Values are based on a unnecessary. by children 1 through 3 years of age, the 1,000 calorie diet’’ on labels of foods Another comment expressed concern final rule, at § 101.36(b)(2)(iii)(D), specifically intended for children 1 that the statement ‘‘2,000 calories a day requires a footnote statement, ‘‘Percent through 3 years of age, this statement is used for general nutrition advice’’ on Daily Values are based on a 1,000 would not be accurate for all nutrients. Supplement Facts labels would not be calorie diet.’’ Therefore, as illustrated in the label useful to consumers in the absence of (Comment 510) One comment asked mockup in § 101.9(j)(5)(ii), the final rule additional information. However, the us to clarify the footnote’s width requires the labels of these food comment said it would be difficult to because the width requirements were products to have a footnote that include additional, explanatory text not specified. The comment said that includes the statement ‘‘1,000 calories a because of limited space, especially on this issue would be particularly day is used for general nutrition small packages. Therefore, the comment important when either the tabular advice;’’ this information would parallel would retain the preexisting footnote, format (§ 101.9(d)(11)(iii)) or the dual the footnote statement used on food ‘‘Percent Daily Values are based on a column tabular format (§ 101.9(e)(6)(ii)) labels for the general population (i.e., 4 2,000 calorie diet,’’ on Supplement was used because, without a specific years of age and older). Facts labels. width requirement, the footnote text With respect to the comment (Response) We agree that information could be wrapped in various ways, suggesting we allow a voluntary about calories is not relevant for many resulting in the footnote occupying footnote stating that total fat should not dietary supplement products because space varying from being mostly be limited in the diets of children less the products contain only vitamins and horizontal (i.e., wide and short) to than 2 years unless directed by a minerals and do not contain nutrients mostly vertical (i.e., narrow and tall). physician (or similar wording), we that provide calories, such as total fat, The comment suggested the possibility acknowledge, in general, that total fat saturated fat, total carbohydrate, and of specifying a minimum width that should not be limited in the diets of protein. Therefore, the footnote in would require at least the words ‘‘The young children less than 2 years of age previously required § 101.9(d)(9) would % Daily Value’’ to fit on a single line. unless directed by a health professional not be appropriate on Supplement Facts (Response) Manufacturers have the (as previously explained in part II.O, labels for products that do not contain flexibility, within certain parameters, in Subpopulations). Because the final rule these calorie sources. Furthermore, how they display the footnote to satisfy requires the mandatory declaration of dietary supplements are intended to the configuration and design constraints saturated fat and cholesterol on labeling supplement the diet, and the of their packages. Therefore, we decline for infants and children, we are information in the footnote for to specify a minimum number of words

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per line for the footnote, as the comment reverse highlighting (i.e., white text rest of the label with a horizontal suggested. However, we intend to printed in a black box, also known as hairline rule, which is a thin line. monitor how firms comply with the reverse ) as a method of Horizontal lines are used throughout the format requirements, including the increasing prominence. The comment Nutrition Facts label as a key graphic footnote display. If we determine that stated that since the Nutrition Facts element to divide space, direct the eye, manufacturers are having difficulty label was introduced in 1993, vast and give the label a unique and fitting the footnote text and other improvements have been made in identifiable look. The proposed rule required information within the printing technologies and capabilities, would require that a thin horizontal line Nutrition Facts label, we will consider which should help alleviate previous (i.e., a 0.25 point hairline rule) be whether further action, including concerns with regards to whether inserted directly beneath the Nutrition rulemaking, is needed with regard to reverse printing could meet minimum Facts heading with the exception of the positioning the footnote. printing tolerances. linear display for smaller packages in (Response) We agree that too much § 101.9(j)(13)(ii)(A)(2). 12. Use of Highlighting With a Type bolding may reduce the contrast (Comment 512) One comment said Intermediate Between Bold or Extra between information that is intended to that the hairline rule beneath the Bold and Regular Type be relatively more or less prominent on Nutrition Facts title improves the Under our preexisting regulations, the Nutrition Facts label and that overall appearance of the Nutrition only nutrients that are not indented (i.e., maintaining adequate resolution of Facts label and its ‘‘ease of use.’’ ‘‘Calories,’’ ‘‘Total Fat,’’ ‘‘Cholesterol,’’ printed information on labels of small Another comment said that the use of ‘‘Sodium,’’ ‘‘Total Carbohydrate,’’ and packages might be particularly difficult. horizontal lines and other design ‘‘Protein’’) on the Nutrition Facts label We also agree that it is more likely that elements (e.g., white space, bold fonts, are required to be highlighted in bold or letters or numbers may run together etc.) are visual cues that draw attention extra bold type or other highlighting when information is highlighted, to important information on the (§ 101.9(d)(1)(iv)). In the preamble to the especially on labels of small packages, Nutrition Facts label, helping to proposed rule (79 FR 11879 at 11954), and we note that our preexisting improve readability and make the we stated that, based on design regulations (§ 101.9(d)(1)(ii)(D)) specify information easier to process and considerations of using bold type to that letters on the Nutrition Facts label remember. Another comment said that a help differentiate the name of the should never touch. Therefore, based on horizontal line beneath the Nutrition nutrient from its absolute amount (Ref. the graphic design principle of using Facts heading would help separate the 262), all of the other nutrients listed on contrast to distinguish differences heading from the ‘‘ll servings per the Nutrition Facts label, including between adjacent items that would container’’ declaration, because all of those that are indented and the vitamins otherwise appear similar, and the the information in the first two lines of and minerals, should also be importance of preserving adequate the label was presented in bold type. highlighted to help set the names of the resolution to ensure the sharpness and (Response) We agree that a thin nutrients apart from other information clarity of the label information, the final horizontal line directly beneath the that appears on the label. The key rule does not amend the portion of Nutrition Facts heading would make the nutrients that are not indented would proposed § 101.9(d)(1)(iv) that would heading more visually appealing. Our still be highlighted in a font that is require the indented nutrients and the requirement in § 101.9(d)(1)(v) to insert bolder than the indented nutrients, so vitamins and minerals (except sodium) the horizontal line beneath the Nutrition the overall style of the Nutrition Facts to be highlighted in a type intermediate Facts heading for all formats (except the label would not change. Thus, we between bold or extra bold type and linear display for smaller packages proposed to amend § 101.9(d)(1)(iv) to regular type. described in § 101.9(j)(13)(ii)(A)(2)) is remove the restriction that prohibits any As for the comment suggesting that based on graphic design principles and other information on the label to be we reconsider the use of reverse other design considerations previously highlighted and to require that all printing, we had concluded in the 1993 discussed in the preamble to the voluntary nutrients specified in final rule (58 FR 2079 at 2137), based on proposed rule. § 101.9(c), including the vitamins and comments and the professional minerals listed in § 101.9(c)(8)(iv), literature at that time, that the use of 14. Replacing ‘‘Total Carbohydrate’’ appear in a type intermediate between reverse printing on the Nutrition Facts With ‘‘Total Carbs’’ bold and regular type (if bold type is label would give rise to technical and Nutrition information declared on the used) or between extra bold and regular legibility problems, especially on small Nutrition Facts label must be presented type (if extra bold type is used) on the containers, and therefore we declined to using the nutrient names specified in Nutrition Facts label. permit reverse printing as a form of § 101.9(c) or § 101.9(j)(13)(ii)(B). (Comment 511) One comment highlighting (§ 101.9(d)(1)(iv)). While According to § 101.9(c)(6), the nutrient suggested that if too much information advances in technology may have name used for listing information about on the Nutrition Facts label was bolded, removed some previous barriers that the carbohydrate content of a product is nothing would stand out. The comment existed with this printing technique, we ‘‘Total Carbohydrate.’’ Certain also said that too much bolding would need to learn more about the technology abbreviations, as specified in be especially problematic for small before we consider revising the rule to § 101.9(j)(13)(ii)(B), may be used on the packages because it would be difficult to address reverse printing. Nutrition Facts label on packages that maintain legibility of the printed have a total surface area available to information. The comment said that 13. Addition of a Horizontal Line bear labeling of 40 or less square inches. small print that is bolded would be even Beneath the Nutrition Facts Heading In the preamble to the proposed rule more difficult to read, because the Our preexisting regulations, at (79 FR 11879 at 11954), we explained letters would appear to run together § 101.9(d)(2), require that the Nutrition that replacing ‘‘Total Carbohydrate,’’ the even more. Facts heading be set in a type size larger nutrient name currently required on Another comment suggested that, as than all other print size in the nutrition most formats, with the shorter term an alternative to bolding, we might want label (§ 101.9(d)(2)) but does not require ‘‘Total Carbs’’ would maximize white to reconsider the restriction of using that this heading be set apart from the space, maintain simplicity, and because

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it is a commonly used term, help the healthy dietary practices. One comment informal term and may have a negative public to readily observe and noted that the term ‘‘carbs,’’ if perceived connotation for some individuals and comprehend the nutrition information negatively, could inadvertently because a ‘‘Total Carbs’’ declaration may presented in the Nutrition Facts label. challenge advice to consume 65 percent be problematic on some bilingual labels (Comment 513) Most comments of calories from carbohydrates, as when this term is used instead of ‘‘Total objected to replacing ‘‘Total recommended in the 2010 DGA. Carbohydrate’’ generally, we will Carbohydrate’’ with ‘‘Total Carbs’’ on Another comment questioned why continue to require that ‘‘Total the Nutrition Facts label. Several carbohydrates should be treated Carbohydrate’’ be used as the nutrient comments referred to the term ‘‘Total differently than other nutrients on the name for carbohydrates, as specified in Carbs’’ as being ‘‘jargon,’’ ‘‘slang,’’ Nutrition Facts label because it would § 101.9(c)(6), and that ‘‘Total carb.’’ ‘‘sloppy,’’ or ‘‘denigrating.’’ Other be the only abbreviated nutrient on most continue to be the abbreviation for this comments stated that ‘‘Total label formats. term (e.g., as applicable on small Carbohydrate’’ is a term that is familiar One comment said that, because packages) as specified in to consumers, is frequently used in the previous research suggests that § 101.9(j)(13)(ii)(B). media, and has appeared on the consumers have difficulty Nutrition Facts label for more than 20 understanding acronyms and 15. Alternative Visual Formats/Fonts years. The comments also noted that abbreviations, the term ‘‘carbs’’ may not We did not propose any changes to ‘‘carbohydrate’’ is the correct, be appropriate on the label, and may the basic format of the Nutrition Facts scientifically accurate term specified in present an additional challenge on label, as specified in § 101.9(d)(12), the FD&C Act and NLEA and is used in bilingual labels. Another comment because we were unaware of any the DGA, IOM reports, and other indicated that if the final rule uses evidence that would support an government or scientific documents. ‘‘Total Carbs,’’ the ‘‘Added Sugars’’ alternative format. However, the One comment questioned whether declaration would become more preamble to the proposed rule did any data exist suggesting that consumers prominent, leading to consumer contain a mockup of an alternative are either confused by the word confusion and distracting from an concept for the Nutrition Facts label ‘‘carbohydrate’’ or would understand overall focus of reducing calorie format (79 FR 11879 at 11955) that the term ‘‘carbs’’ any better. Another consumption from all macronutrient categorized nutrient declarations as comment suggested that research is sources. ‘‘quick facts’’ about certain nutrients, needed to evaluate whether the Some comments supported replacing nutrients to ‘‘avoid too much’’ of, and proposed change would affect consumer the term ‘‘Total Carbohydrate’’ with nutrients to ‘‘get enough of,’’ and we use and understanding of the ‘‘Total Carbs’’ and said that ‘‘carbs’’ is invited comment on whether we should carbohydrate information presented on a term that is part of the daily require a specific type style for the the label. vocabulary of many people and the term Nutrition Facts label. Many comments said that listing the would ‘‘draw their attention’’ which After reviewing the comments on the total carbohydrate content in a serving could be beneficial. proposed rule, we tentatively concluded of food as ‘‘Total Carbs’’ rather than (Response) We acknowledge that that we did not intend to further ‘‘Total Carbohydrate’’ could have a ‘‘carbohydrate’’ is the correct, consider the alternative format for the negative impact on the ability of people scientifically accurate term used in Nutrition Facts label (80 FR 44302). with diabetes to accurately assess their government or scientific documents and Most comments agreed with our carbohydrate intake and thus their that ‘‘carbs’’ may be perceived as jargon. tentative conclusion, and other ability to manage their disease. The We further recognize the possibility that comments raised questions that we may comments explained that diabetics, who some diabetics may have difficulty consider if we decide to conduct further monitor their blood glucose levels and distinguishing between the terms ‘‘Total research on this issue in the future. A adjust their insulin requirements Carbs,’’ ‘‘carb choice,’’ and ‘‘carb review of the results of FDA’s consumer accordingly, must be able to accurately serving,’’ but note that the Nutrition research, which we made available in determine the carbohydrate content of Facts label, and any associated changes reopening of the comment period as to their foods, such as through in format resulting from this specific documents (80 FR 44302), did ‘‘carbohydrate counting.’’ Several rulemaking, applies to the general not provide information to change our comments pointed out that many healthy population rather than to those tentative conclusion, so we are not diabetics, especially those who are with a specific disease. We are unaware giving further consideration to the newly diagnosed, recognize the term of any data suggesting that consumers alternative format as part of this ‘‘carb choice’’ or ‘‘carb serving’’ as would be confused by the abbreviation rulemaking. referring to a serving of food that ‘‘Carbs’’ or that this term would contains 15 grams of total carbohydrate. adversely affect the ability of consumers 16. Miscellaneous Comments The comments noted that, in this to interpret other parts of the Nutrition a. Size and space issues. The context, the word ‘‘carb’’ has a specific Facts label, or adversely impact dietary preamble to the proposed rule did not meaning, and that declaring ‘‘Total advice, as suggested by some comments. invite comments on whether our Carbs’’ on the Nutrition Facts label Furthermore, we already permit the proposed format changes would affect could cause confusion and result in abbreviation ‘‘carb.’’ (singular) for the ability of small packages to diabetics taking the wrong dose of ‘‘carbohydrate’’ on small packages accommodate the Nutrition Facts label. insulin. having space constraints, as specified in Our intention was to use graphic design Other comments suggested that § 101.9(j)(13)(ii)(B), and we note that the principles to improve the overall visual ‘‘carb’’ or ‘‘carbs’’ frequently carries a term ‘‘carbohydrate’’ is spelled out on appearance of the Nutrition Facts label negative connotation when it is linked the Nutrition Facts label of most food formats without altering the labels’ to a ‘‘low carb’’ diet, the ‘‘net carbs’’ of products and therefore is readily dimensions. However, several a product, or to ‘‘carb loading’’ before an observable for consumers who might be comments addressed this issue, athletic competition. The comments confused by the abbreviated term on particularly with regards to the use of expressed concerns that the term may be small packages. However, because the proposed linear format on small and used in a context that does not support ‘‘carbs’’ (plural) may be perceived as an very small food packages.

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(Comment 514) Many comments said Sugars’’ information, we are also in § 101.2(a)) is not considered to be a the proposed Nutrition Facts label removing the requirement for the factor in determining the sufficiency of formats appeared to be larger than the ‘‘Calories from Fat’’ declaration and available space for the placement of the preexisting label formats and, therefore, reducing the amount of space that will Nutrition Facts label. Therefore, all would take up too much space on food be necessary for the footnote. In certain manufacturers, regardless of size, who packages. The comments said that cases (e.g., on labels of foods are required to display the Nutrition implementing many proposed changes, represented or purported to be Facts label on its products must follow such as increasing the prominence of specifically for infants through 12 the regulations with regards to general ‘‘servings per container and the months of age or on labels of foods that food labeling requirements and ‘‘calorie’’ information as well as adding can use the terms ‘‘calorie free,’’ ‘‘free of provisions as discussed in § 101.1 a line for ‘‘Added Sugars,’’ would calories,’’ ‘‘no calories,’’ ‘‘zero calories,’’ through 101.5. necessarily increase label size. One ‘‘without calories,’’ ‘‘trivial source of (Comment 515) Several comments comment suggested that we did not calories,’’ ‘‘negligible source of noted that label space, which is already adequately consider how the proposed calories,’’ or ‘‘dietary insignificant limited, would be further constrained Nutrition Facts labels would fit on source of calories’’ on the Nutrition on bilingual labels. The comments actual food products and asked us to Facts label or in the labeling of foods as suggested that bilingual labels will ‘‘verify’’ that the proposed formats defined in § 101.60(b)), we are removing become increasingly common and that would not result in larger labels. Several the footnote requirement altogether. We we should provide examples of comments said that companies would also note that we are reducing the type bilingual labels for further public need to redesign their packages to size of the numerical value for calories, comment. accommodate the increased amount of from 24 point to 22 point, and 14 point (Response) The use of bilingual space that would be necessary for labels for the tabular display and linear Nutrition Facts labels is voluntary. We to comply with the proposed format display for smaller packages with a total do not agree that our format changes changes and to fit on packages, resulting surface area available to bear labeling of will prevent manufacturers from using a in significant costs to the industry. 40 square inches or less in bilingual label, as many options are Other comments indicated that, for all § 101.9(j)(13)(ii)(A)(1) and (2). Taken available regarding where the label is of the required information to fit within together, these format modifications will located on a package (e.g., the back the boundaries of certain proposed not result in a significant change in the panel). We have provided an example of formats, some labels would be cluttered, size of the labels. Therefore, we decline a bilingual Nutrition Facts label in ‘‘A difficult to read, and challenging for to ‘‘verify’’ that the revised formats will Food Labeling Guide: Guidance for consumers to use. One comment said not be larger than the current ones and Industry’’ (Ref. 122). Manufacturers who use a bilingual label can review this that the label’s overall visual disagree that manufacturers will need to guidance document. We anticipate that appearance would be dense, complex, redesign packages extensively to future updates will be made to ‘‘A Food cluttered, and contradict FDA’s intent to accommodate the revised Nutrition Labeling Guide: Guidance for Industry’’ maintain the NLEA requirements. The Facts labels. Also, because we are not to correspond to format changes in the comment said that the Nutrition Facts requiring that absolute amounts be final rule. label should have a simple format, listed for voluntary nutrients, we do not minimize clutter, and enable consumers (Comment 516) One comment said anticipate that excessive crowding will that, because the standard format to observe and comprehend the be problematic on labels with multiple information readily. requires both percent DV and absolute columns, such as those on breakfast Several comments emphasized that a amounts of mandatory vitamins and cereal packages which list nutrition larger nutrition label would occupy minerals to be declared, there would not ‘‘valuable’’ package space that could be information for the product as packaged, be enough space on some packages to used for other purposes. One comment as served (e.g., with milk), and for a allow the nutrients of public health said that a larger Nutrition Facts label subpopulation (e.g., children less than 4 concern to be listed side by side in two might reduce the available package years of age). Although providing columns (as specified in § 101.9(d)(8)), space that could be used for marketing nutrition information for these which the comment called a ‘‘space and promotional messages, and this categories is voluntary, if a saving feature.’’ The comment provided would be of particular concern to small manufacturer chooses to use such an example of a label demonstrating that firms unable to afford advertising costs. multiple columns and adequate space is it is not possible to list micronutrients Another comment said that the not available on the side panel, the in two columns because of layout proposed format changes might limit the Nutrition Facts label may be placed on constraints caused by the package’s amount of space on packages that could the back panel of the package (as configuration. The comment said that be used for product recipes and cooking provided for in § 101.2(a)(1)) where although the proposed Nutrition Facts instructions (e.g., information about more space is likely to be available. label changes were intended to have a proper cooking times and temperature With respect to the comment minimum impact on product packages, settings) which may be necessary for regarding the need for small businesses layout constraints in some cases would ensuring food safety. to have adequate space on packages for necessitate significant package redesign (Response) We disagree with the promotional and marketing messages, to comply with the revised format. The comments suggesting that the proposed we acknowledge the importance of comment suggested that we had not formats would be significantly larger communicating information about the adequately considered certain package than the current formats. Each label was product. Similarly, we recognize the shapes where changes in format would specifically designed to occupy the importance of providing consumers have ‘‘consequential’’ effects on package same amount of package space as the with information about food design. preexisting label. While some nutrient preparation, recipes, and safety issues (Response) We acknowledge there are information will be declared in a larger relative to the product. However, as layout constraints with certain font size and style compared to the specified in § 101.9(j)(17), non- packages, but we have given preexisting format, and the final rule mandatory label information on the manufacturers flexibility in how they requires the declaration of ‘‘Added package information panel (as described apply the Nutrition Facts label on

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products having significant size and that could not otherwise accommodate that could accommodate the tabular space challenges. The comment’s the tabular display for small packages, display for small packages or on larger- example used certain text sizes and as provided in § 101.9(j)(13)(ii)(A)(1) (79 size packages that could accommodate bolding that were initially proposed, but FR 11879 at 11979)). Other comments the standard format. Manufacturers are not included in the final rule, so the said that the proposed linear format should understand that the linear format comment’s example, under the final would be especially problematic for is only to be used for certain size rule’s requirements, would take up less products having small labels (e.g., packages (as described in space. In response to concerns of packages with 13 square inches of § 101.9(j)(13)(ii)(A)), and only if the products that have significant size and available labeling space) but that are not label will not accommodate a tabular space constraints we are removing the small enough to qualify for the complete display. The linear format is more requirement for the footnote statements exemption under § 101.9(j)(13)(i), which difficult to read than other formats and in § 101.9(j)(13)(ii)(C) for the tabular exempts nutrition labeling when the is not permitted for larger packages. We format for small packages as shown in total surface area available to bear consider the use of a linear display as § 101.9(j)(13)(ii)(A)(1) and the linear labeling is less than 12 square inches a last resort when the tabular display for format as shown in and no claims are made in labeling or small packages cannot be § 101.9(j)(13)(ii)(A)(2), however, the advertising. The comments asked us to accommodated in the available label abbreviated footnote ‘‘% DV = % Daily propose a revised linear format that space (e.g., when small packages with a Value’’ may be used on these packages. would fit on small packages (i.e., <12 total surface area available to bear Because we are removing the square inches) or retain the preexisting labeling of less than 12 square inches, requirement in § 101.9(j)(13)(ii)(C), we linear format as an option when neither or 40 square inches or less and the are redesignating § 101.9(j)(13)(ii)(D) as of the proposed small label formats package shape or size cannot § 101.9(j)(13)(ii)(C). We also are would fit on a package. Other comments accommodate a standard vertical allowing ‘‘vitamin’’ to be abbreviated as suggested that we broaden the criteria column or tabular display would ‘‘vit.’’ and potassium to be abbreviated that would allow more labels to qualify otherwise have to take advantage of the as ‘‘Potas.’’ in § 101.9(j)(13)(ii)(B) which for the linear and tabular formats (as exemption allowing use of an address or will further conserve space. Although provided in § 101.9(j)(13)(ii)(A)); for telephone number in lieu of nutrition we cannot predict all the different sizes example, by increasing the intermediate information). Consumers would be ≤ and shapes of packages that may enter package size from 40 square inches to expected to be more likely to take a few ≤ the marketplace, we permit various 50 square inches. extra moments to read a linear nutrition formats of the Nutrition Facts label and (Response) We agree that the label than to write a letter or call the allow flexibility in order to proposed linear format for small manufacturer. We do not want the linear accommodate packages having various packages may not be able to fit on many format to be misused, so we intend to design features. small packages, such as those of monitor the marketplace to ensure that confectionery products. We also the proper Nutrition Facts label format (Comment 517) Many comments said acknowledge the advantage of the text is used on the correct size package. that the proposed linear display for wrapping feature of the preexisting We have addressed the size and space small packages (illustrated in linear format in providing flexibility for concerns expressed in the comments for § 101.9(j)(13)(ii)(A)(2) (79 FR 11879 at labels on small packages having various smaller packages by decreasing the 11979)) would not fit on many small shapes and sizes. Consequently, we are prominence of the calorie declaration packages, such as those for candy, not finalizing the requirements for the from our original proposal, by removing chewing gum, and other confectionery proposed linear format. Instead, we are the requirement for a footnote, and products, because it occupies retaining the text wrapping feature of permitting the abbreviated footnote ‘‘% substantially more space than the the preexisting linear format, but DV = % Daily Value’’ to be optional, current linear display format. Some adapting it to maintain consistency with providing acceptable abbreviations for comments included detailed mockups the other format changes we are terms, and also permitting the text of complete small product packages finalizing, i.e., increasing the wrapping feature. Based on these demonstrating that, due to their shape prominence of ‘‘Calories’’ information, spacing accommodations, we decline to or size, some packages would not be removing the ‘‘Calories from Fat’’ increase the intermediate package size able to accommodate the proposed declaration, changing ‘‘Sugars’’ to from ≤40 square inches to ≤50 square Nutrition Facts labels without obscuring ‘‘Total Sugars,’’ including an ‘‘Added inches, as the comment suggested, some information on the package or Sugars’’ declaration, modifying the because retaining the preexisting linear label, even if a minimum legible font mandatory vitamins and minerals, and format and other space saving size of 6 point was used on the label. making the abbreviated footnote ‘‘% DV requirements would preclude the Other comments pointed out that the = % Daily Value’’ optional for small necessity of doing so. preexisting linear format was packages. We also are providing that the (Comment 518) One comment stated specifically designed to be flexible actual number of servings may be listed that because foods in small packages because it allows nutrition information after the ‘‘ll servings per container’’ (i.e., less than 12 square inches) must to be presented as a wrapped string of declaration and note that ‘‘Servings’’ is bear the Nutrition Facts label if the text that can be adapted to fit the an acceptable abbreviation for ‘‘ll food’s label makes nutrition claims (e.g., specific dimensions of a small package. Servings per container’’ (as provided in ‘‘sugar-free’’ gums), manufacturers need The comments suggested that the § 101.9(j)(13)(ii)(B)). Additionally, on a Nutrition Facts label format that proposed ‘‘linear’’ display is not our own initiative, we have revised the would fit on such packages. Otherwise, accurate because it has a ‘‘table’’ format rule so that ‘‘Incl. Xg added sugars’’ is manufacturers would be prohibited rather than an arrangement that is an acceptable abbreviation for ‘‘includes from making a claim, which the linear, and it cannot be displayed as a X g of added sugars.’’ comment suggested might be an string of wrapped text. According to the However, we are concerned that some unintended consequence of the final comments, the proposed linear display companies may be using the linear rule and adversely affect consumers would not fit on many small packages format inappropriately because we have (because the claim would not be for which it was intended (i.e., packages seen the linear format used on packages available to them). Alternatively, the

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comment suggested that we exempt confectionery packages. Furthermore, comment said that allowing the optional foods in very small packages from we will retain the preexisting use of this information on the label may bearing a Nutrition Facts label, even if requirement in § 101.9(j)(13)(ii)(A) that lead to consumer confusion because we a nutrient content claim is made or if stipulates that the linear format may have proposed new caloric conversion the nutritional contribution of the food only be used if the label will not factors for certain carbohydrate sub- is minimal. The comment urged us to accommodate a tabular display. types. carefully consider the impact that the (Comment 519) Several comments Another comment suggested that, if increase in certain type sizes and the pointed out that the proposed leading we retain the optional caloric additional ‘‘Added Sugars’’ information requirements (i.e., the vertical space conversion information, there should would have on the ability of the between lines) differ from the also be a ‘‘disclaimer’’ or ‘‘education Nutrition Facts label to fit on very small preexisting leading requirements so that statement’’ indicating that the calorie packages. the proposed labels will take up more values listed for fat, carbohydrate, and Several comments also asked us to space. One comment said we could protein are not exact. The comment said consider additional label formats that increase the amount of white space by that a disclaimer or education statement would be appropriate for products in enlarging the leading requirements. would help consumers understand that, small and very small packages making Another comment said that there was a if the grams of fat, carbohydrate, and nutrient content claims or health claims. lack of detail about the leading protein that are listed on the Nutrition Some comments offered suggestions that requirements for the information Facts label are multiplied by their would enable the Nutrition Facts label displayed in the Nutrition Facts label respective caloric values (i.e., 9, 4 and to fit on small and intermediate-size format shown in § 101.9(d)(12). 4), the total may not necessarily be the packages, remain legible when printed (Response) We agree with the same as the number of calories listed with a 6 point font size, and still comment and acknowledge an error in near the top of the label in the ‘‘embrace the spirit’’ of our proposed § 101.9(d)(1)(ii)(C) in which the leading ‘‘Calories’’ declaration. The comment rule. Specifically, the comments requirements were increased. This has further suggested that such a suggested allowing a proportional now been corrected in the final rule so discrepancy might cause consumer reduction of the tabular and linear that the original leading requirements confusion. Another comment suggested formats to accommodate certain package are retained, i.e., all information within the caloric information for fat, shapes or sizes; an abbreviated format the nutrition label shall utilize at least carbohydrate, and protein should be that lists fewer nutrients but would still one point leading except that at least provided on a ‘‘per ounce’’ basis rather allow a claim to be made (such as four points leading shall be utilized for than on a ‘‘per gram’’ basis. Finally, one ‘‘sugar free’’ or ‘‘calorie free’’); the the information required by paragraphs comment said that retaining the caloric declaration of certain information to be (d)(7) and (d)(8) of this section as shown conversion information could help voluntary; and either a telephone in paragraph (d)(12). We allow consumers adjust their caloric intake if number, Web site, or mailing address manufacturers some degree of discretion their individual calorie needs were that consumers could use to obtain more and flexibility with respect to the above or below 2,000 calories per day. complete nutrition information (similar leading requirements, and the label (Response) We previously recognized to the provision in § 101.9(j)(13)(i)(A)) mockups that we have provided in this that 9, 4, and 4 calories per gram for fat, for very small packages (i.e., having less final regulation are for the purpose of carbohydrates, and protein, than 6 square inches of available space illustration rather than to provide exact respectively, are general factors that are to bear labeling). specifications. An underlying purpose applicable to the majority of foods, and (Response) While we appreciate the of the Nutrition Facts label is to help displaying them on the label can help extensive amount of time and effort that consumers make healthful food choices, consumers better understand and use manufacturers devoted to designing and we expect manufacturers to provide the nutrition information on the label alternative labels for small product legible labels to help consumers do this. and to apply the DGA recommendations packages, we disagree that such b. Calorie conversion factors. In the (58 FR 2079 at 2131). For example, the products, in general, should not be preamble to the proposed rule (79 FR calorie conversion information might be required to display a Nutrition Facts 11879 at 11954), we requested useful to consumers who want to keep label if claims are made for the product. comments and supporting data on the track of the number (or percentage) of Depending on the particular claim and extent that consumers use the caloric calories they consume derived from fat product, a variety of information may be conversion information (i.e., ‘‘Calories and carbohydrate, or who are following required on the label (e.g., a disclosure per gram: Fat 9, Carbohydrate 4, Protein certain dietary recommendations, such statement, as described in 4’’) that may voluntarily be declared at as for weight loss or other health § 101.13(h)(1)) to prevent the claim from the bottom of the footnote area of the reasons. Furthermore, because we are no being misleading. The packages Nutrition Facts label under longer requiring the number of calories described in the comment appear to be § 101.9(d)(10). We stated that we may from fat to be declared on the label, hypothetical, as we are not aware that consider deleting this optional consumers who want this information such packages currently exist in the requirement in the final rule if we can do their own calculations using the marketplace. determine the information is not useful caloric conversion factors. We are We also decline to exempt foods in (id.). unaware whether the caloric conversion small packages that have a total surface (Comment 520) Some comments information is underused by consumers, area available to bear labeling of less would prohibit the voluntary listing of as suggested by one comment, and than 12 square inches from bearing a caloric conversion information. These disagree that it comprises too much Nutrition Facts label if a nutrition claim comments stated that it is too much information, as it is displayed is made or if the nutritional contribution information for consumers; its purpose succinctly and is listed voluntarily. of the food is minimal. We also are in relation to the rest of the Nutrition However, given the comments’ concerns continuing to allow the preexisting Facts label is not readily apparent; it related to the need to conserve space on linear format for small packages, as would require ‘‘hands-on consumer the Nutrition Facts label, we will described in § 101.9(j)(13)(ii)(A), which education’’ to be useful or understood; continue to allow the caloric conversion we anticipate will fit on most small and the information is underused. One factors to be listed voluntarily.

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We disagree with the comment stating proposed removing and reserving information going to consumers. The that the proposed caloric conversion § 101.9(d)(9). Our proposed amendment comment said that modern factors for carbohydrate sub-types might to § 101.9(d)(10) would have removed a manufacturing and testing methods lead to consumer confusion if the cross-reference to § 101.9(d)(9) and should allow food manufacturers to current caloric conversion information referred, instead, to a part of the provide a more accurate representation is retained. The comment did not Nutrition Facts label. In the of the nutrient content of foods. explain this assertion. Although we supplemental proposed rule, however, (Response) As we stated in the proposed new caloric conversion factors we suggested text that would become a preamble to the proposed rule (79 FR for certain carbohydrate sub-types, new § 101.9(d)(9) (thereby eliminating 11879 at 11955), we received a similar including soluble fiber (2 calories per the need to reserve that paragraph). comment to the 2007 ANPRM asking us gram) and specific sugar alcohols Thus, the proposed amendment to to reevaluate the level of variance (ranging from 1.6–3.0 calories per gram), § 101.9(d)(10) is no longer necessary, permitted for nutrient content consumers would not be expected to be and the final rule does not amend declarations. When initially aware of this information and would § 101.9(d)(10). (We have made a similar determining the allowances for have no reason to use it because it is revision to § 101.9(d)(11) to restore a variability, we considered the variability intended for manufacturers to use in cross-reference to § 101.9(d)(9).) in the nutrient content of foods, developing product labels. Therefore, With respect to the comment that said analytical variability inherent to test we disagree that retaining the caloric retaining the caloric conversion methods used to determine compliance, conversion information on the Nutrition information could help consumers and statistical probability (38 FR 2125 at Facts label would lead to consumer adjust their caloric intake if their 2128, January 19, 1973). We also confusion. Furthermore, although the individual calorie needs were above or evaluated compliance procedures and general conversion factors may not below 2,000 calories per day, we found them to be statistically sound and apply to all foods (but relatively few acknowledge this is a reasonable adequate. products would be expected to include assumption because understanding the The comment provided no caloric values for soluble fiber and sugar relative amount of calories contributed information for us to consider, such as alcohols as part of the total calorie by fat, carbohydrate, and protein may information to show that the variability calculations), we do not consider that to help consumers better comprehend and in the nutrient content of foods or be a reason to prohibit their use. use the Nutrition Facts label, which may analytical variability inherent in test We also decline to provide a assist them in maintaining healthy methods used to determine compliance ‘‘disclaimer’’ or ‘‘education statement’’ dietary practices. have decreased. Therefore, because we on the label to indicate that the caloric do not have a basis to change the level conversion factors are approximations. R. Compliance of variance permitted for the label The reason that multiplying the grams Section 101.9(g) provides information declaration of nutrients, we decline to of fat, carbohydrate, and protein listed about how we determine compliance revise the rule as suggested by the on the label by 9, 4, and 4 calories per with our nutrition labeling comment. gram, respectively, does not exactly add requirements, including the methods of 2. Methods Used To Determine up to the number of calories listed on analysis used to determine compliance, Compliance the label is due mainly to rounding reasonable excesses and deficiencies of rules that apply to the Nutrition Facts nutrients, and acceptable levels of Under our preexisting regulations, at label. Rather than explain this in a variance from declared values. § 101.9(g)(2), a composite of 12 footnote, however, we intend to include subsamples, each taken from 12 1. Level of Variance Allowed for the information about rounding as part of different randomly chosen shipping Label Declaration of Specific Nutrients our planned nutrition education efforts cases are analyzed by appropriate and clarify why the caloric values of Under our preexisting regulations, at methods as given in the ‘‘Official individual macronutrients may not add § 101.9(g)(5), a food with a label Methods of Analysis of the AOAC up to the total number of calories listed declaration of calories, sugars, total fat, International,’’ 15th Ed. (1990) to on the label. saturated fat, trans fat, cholesterol, or determine compliance with the We also do not agree that the caloric sodium shall be deemed to be requirements in § 101.9, unless a conversion factors on the label should misbranded under section 403(a) of the particular method of analysis is be listed on a ‘‘per ounce’’ basis, rather FD&C Act if the nutrient content of the specified in § 101.9(c). If no AOAC than on a ‘‘per gram’’ basis, as one composite is greater than 20 percent in method is available or appropriate, we comment suggested. The information, if excess of the value for that nutrient use other reliable and appropriate present, must be provided on a per gram declared on the label. The provision analytical procedures (see § 101.9(g)(2)). basis (§ 101.9(d)(10)), which is provides that no regulatory action will The proposed rule would amend consistent with the units that are used be based on a determination of a § 101.9(g)(2) to update the reference to for declaring amounts of fat, nutrient value that falls above this level the 19th Edition of the ‘‘Official carbohydrate, and protein on the by a factor less than the variability Methods of Analysis of the AOAC Nutrition Facts label and therefore most generally recognized for the analytical International.’’ The preamble to the likely to be useful for consumers. method used in that food at the level proposed rule (79 FR 11879 at 11913) Furthermore, the comment did not involved. explained that the 19th edition provide data to show that ounces would The proposed rule would not change published in 2012 and that if a newer be better understood or would be more the level of variance allowed in edition were published before we issued useful to consumers than grams, and we § 101.9(g)(5). a final rule, we intended to finalize the have no evidence to support listing the (Comment 521) One comment rule to refer to the newer edition conversion factors on a ‘‘per ounce’’ suggested that we tighten the allowable provided there are no substantive basis. We also note that the final rule no variance to no more than 10 percent. changes in the newer edition requiring longer amends § 101.9(d)(10); we had The comment was concerned that the 20 additional comment. The Official proposed revising § 101.9(d)(10) as part percent allowable variance could result Methods of Analysis of AOAC of the proposed rule when we also in inaccurate and misleading International, 20th Edition was

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published in 2016. The 20th Edition dietary fibers. Many comments composite sampling and analysis to includes a number of new methods of recommended that we allow for the use determine compliance with labeling analysis as well as changes to current of all validated AOAC methods for the declarations. Specifically, unless a methods. We need additional time to determination of dietary fiber. (We specific analytical method is identified consider the additions and changes, and discuss issues related to AOAC methods by regulation, composites are analyzed to determine if additional public in greater detail in our response to by the appropriate AOAC method or, if comment is necessary on the 20th comment 299.) no AOAC method is available or Edition of the AOAC Methods of (Response) In proposed appropriate, by other reliable and Analysis. Therefore, the final rule, at § 101.9(c)(6)(i), we stated that dietary appropriate analytical procedures. § 101.9(g)(2), incorporates by reference fiber content may be determined by In the preamble to the proposed rule the 19th Edition of the Official Methods subtracting the amount of non-digestible (79 FR 11879 at 11956), we noted that, of Analysis of the AOAC International. carbohydrates added during processing for certain nutrients subject to the (Comment 522) Some comments that do not meet the definition of proposed rule, there is no AOAC official supported incorporating the 19th dietary fiber from the value obtained method of analysis or other reliable or Edition of the AOAC Methods by using AOAC 2009.01, AOAC 2011.25, or appropriate analytical procedure that is reference in the final rule. Other an equivalent method of analysis given available for us to verify the amount of comments suggested other alternatives. in the 19th edition of the AOAC the declared nutrient on the Nutrition Some comments suggested that a methods. We stated, in proposed Facts label and ensure that the declared specific edition of the AOAC Methods § 101.9(c)(6)(i)(A), that soluble fiber may nutrient amount is truthful, accurate should not be incorporated by reference be determined using AOAC 2011.25 or and complies with all applicable to allow companies to use future an equivalent method of analysis as labeling requirements. The preamble to editions of the reference to meet given in the 19th edition of the AOAC the proposed rule (79 FR 11879 at compliance requirements. One comment Methods and stated, in proposed 11956) stated that there is no suitable stated that, given the potential § 101.9(c)(6)(i)(B), that insoluble fiber analytical procedure available to limitations of the two AOAC methods may be determined using AOAC measure the quantity of: (1) Added for fiber identified in the proposed rule 2011.25 or an equivalent method of sugars (when a food product contains (AOAC 2009.01 and AOAC 2011.25) analysis given in the 19th edition of the both naturally occurring sugars and and the inevitable delays between AOAC Methods. Although we intended added sugars and for specific foods adoption by AOAC of the most relevant, that the terms ‘‘other equivalent containing added sugars, alone or in updated, and appropriate methods, we methods’’ refer to other AOAC methods combination with naturally occurring should incorporate all appropriate, and their AACCI counterparts, to sugars, where the added sugars are equivalent, and validated methods into provide clarification, the final rule subject to non-enzymatic browning and/ the final rule. omits the incorporation by reference of or fermentation); (2) dietary fiber (when (Response) We decline to revise the the specific AOAC methods in a food product contains both non- rule to adopt the alternative approaches § 101.9(c)(6)(i), (c)(6)(i)(A), and digestible carbohydrate(s) that meets the suggested by the comments. We note (c)(6)(i)(B). Any dietary fiber declared proposed definition of dietary fiber and that, under the incorporation by on the label would have to meet the new non-digestible carbohydrate(s) that does reference regulations issued by the definition of dietary fiber and not meet the definition of dietary fiber); Office of the Federal Register, manufacturers can measure the amount (3) soluble fiber (when a mixture of incorporation by reference of of dietary fibers in their product soluble fiber and added nondigestible publication is limited to a specific accurately by using a method that can carbohydrate(s) that does not meet the edition and ‘‘future amendments or measure lower molecular weight definition of dietary fiber are present in revisions of the publication are not nondigestible oligosaccharides with DP a food); (4) insoluble fiber (when a included’’ (1 CFR 51.1(f)). Thus, under 3–9. We would determine compliance mixture of insoluble fiber and non- Federal regulations, we cannot by using appropriate methods, as given digestible carbohydrate(s) that does not incorporate by reference a specific in the ‘‘Official Methods of Analysis of meet the definition of dietary fiber are AOAC method and all future editions of the AOAC International,’’ 19th Ed. present in a food); (5) vitamin E (when that method. (2012). We consider AOAC 2009.01 and a food product contains both RRR- a- (Comment 523) Some comments AOAC 2011.25 to be reliable and tocopherol and all rac-a-tocopherol questioned what we mean by appropriate methods to measure the acetate); and (6) folate (when a food ‘‘equivalent AOAC method,’’ and amount of dietary fiber in a serving of product contains both folate and folic whether the terms mean that any other a product. We consider AOAC 2011.25, acid). AOAC method is acceptable for as given in the ‘‘Official Methods of Under our preexisting regulations, at determining fiber content. Analysis of the AOAC International,’’ § 101.9(g)(9), we may permit the use of (Response) We used the terminology 19th Ed. (2012), to be a reliable and an alternative means of compliance or ‘‘equivalent AOAC method’’ to mean a appropriate method to measure the additional exemptions when it is not reliable and appropriate method which amount of soluble and insoluble fiber in technologically feasible, or some other can be used for measuring dietary fiber, a serving of a product, if separately circumstance makes it impracticable, for soluble fiber, and insoluble fiber. For declared. There may be other methods firms to comply with the requirements example, the definition of dietary fiber which manufacturers may use to of § 101.9. Under § 101.9(g)(9), firms requires that the fiber must contain 3 or measure certain fibers which can must submit a written request to us for more monomeric units. We would provide an accurate and consistent the use of an alternative means of consider a reliable and appropriate result. We will consider the method to compliance or for a labeling exemption. method for dietary fiber to be one that use for purposes of determining The proposed rule would establish an can measure fibers with 3 or more compliance consistent with § 101.9(g). alternative approach for assessing monomeric units. compliance of the declared amount of (Comment 524) Several comments 3. Records Requirements certain nutrients when there is no suggested that AOAC 2009.01 and Our preexisting regulations, at suitable analytical method available to AOAC 2011.25 do not capture all § 101.9(g)(2), set forth requirements for measure the nutrient’s quantity as

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declared on the label or in labeling. commerce and that such records be manufacturers and that they would need Specifically, the proposed rule, at provided to us upon request during an to create systems and dedicate proposed § 101.9(g)(10) and (g)(11), inspection for official review and additional resources to create and would require the manufacturer to make copying or other means of reproduction. maintain appropriate records on a large and keep records that are necessary to The proposed rule also stated that scale. Other comments said that verify the declaration of: (1) The amount records could be kept either as original manufacturers typically get ingredients of added sugars when both naturally records, true copies (such as from suppliers in an extensive supply occurring and added sugars are present photocopies, pictures, scanned copies, chain and that many ingredients also in a food (in § 101.9(c)(6)(iii)); (2) the microfilm, microfiche, or other accurate contain multiple ingredients amount of added non-digestible reproductions of the original records), or themselves. Suppliers may not have the carbohydrate(s) that does not meet the electronic records in accordance with 21 information themselves, or the proposed definition of dietary fiber CFR part 11. information for the formulations could when the dietary fiber present in a food (Comment 525) Many comments be proprietary. Additionally, nutrient is a mixture of non-digestible agreed with the proposed recordkeeping information could be provided in carbohydrates that do and that do not requirements. However, other comments ranges, and manufacturers would be meet the definition of dietary fiber (in objected to the proposed recordkeeping unable to determine or verify the § 101.9(c)(6)(i)); (3) the amount of added requirements. Some comments said that specific amounts of certain nutrients soluble non-digestible carbohydrate(s) our compliance program for nutrition analytically. that does not meet the proposed labeling should be based on the (Response) Although some definition of dietary fiber when the validation of nutrient declarations manufacturers could have a large soluble dietary fiber present in a food is through analytical methods and not number of foods that contain nutrients a mixture of soluble non-digestible through recordkeeping. Other comments that would necessitate recordkeeping to carbohydrates that do and that do not said that compliance should be based on verify amounts, we do not agree that meet the definition of dietary fiber (in objective, analytical measures to yield determining the nutrient composition of § 101.9(c)(6)(i)(A)); (4) the amount of consistent labeling practices across the a food and recording that information added insoluble non-digestible food industry. Others comments said would present undue difficulty for carbohydrate(s) that does not meet the that the proposed recordkeeping manufacturers. On the contrary, proposed definition of dietary fiber requirements could invite unethical knowledge of what ingredients and when the insoluble dietary fiber present manufacturers to provide inaccurate nutrients are in a food and providing in a food is a mixture of insoluble non- information about the quantity of that information truthfully to consumers digestible carbohydrates that do and nutrients in a serving of their product. is a basic requirement for food (Response) As discussed in the that do not meet the definition of producers. Manufacturers, even those preamble to the proposed rule (79 FR dietary fiber (in § 101.9(c)(6)(i)(B)); (5) who produce large amounts of food 11879 at 11956), for certain nutrients, the amount of all rac-a-tocopherol products, have experience with there are no official methods of analysis acetate added to the food and RRR-a- determining nutrient content of the food or other reliable or appropriate tocopherol in the finished food when a they produce, and the maintenance of analytical procedures that are available mixture of both forms of vitamin E are records of nutrient content, either to verify the amount of the declared present in a food (in § 101.9(g)(10)(i)); written or electronic. Regarding nutrient on the Nutrition Facts label. In obtaining information from ingredient and (6) and the amount of folic acid the absence of such methods, there suppliers, manufacturers are well suited added to the food and the amount of needs to be some means for determining to work with suppliers to ensure that folate in the finished food when a compliance, and so we proposed proper information is communicated mixture of both forms are present in a recordkeeping as an alternative throughout the supply chain. Ingredient food (in § 101.9(g)(10)(ii)). In the approach for assessing compliance of suppliers are obliged to have knowledge preamble to the proposed rule (79 FR the declared amount of certain of the contents of ingredients they 11879 at 11956), we explained that the nutrients. While the amount of most provide to food manufacturers and this manufacturer is in the best position to other nutrients in Nutrition Facts can be information will need to be properly know which of its records provide the verified analytically, for those nutrients communicated. Manufacturers may be documentation required under the whose amounts cannot be determined able to choose suppliers that provide circumstances described for us to analytically, recordkeeping enables FDA appropriate information as to the determine compliance. These records to determine compliance with contents of their ingredients or be able could include one or more of the § 101.9(g). Regarding the potential for to ask their ingredient suppliers for following: Analyses of databases, encouraging manufacturers to provide nutrient information. recipes or formulations, or batch inaccurate information to FDA, we note (Comment 527) Some comments records. We stated that most that all nutrient declarations must be suggested that the required approach manufacturers should already have the truthful and not misleading under should be flexible and not mandate a type of records needed to validate the sections 403(a)(1) and 201(n) of the specific type of record. The comments declared amount of these nutrients and FD&C Act. Thus, whether determined indicated that manufacturers should be that the proposed records requirements analytically or through calculations able to substantiate using the records provide flexibility in what records the documented in appropriate records, they believe best accomplish the manufacturer makes available to us to manufacturers are obligated to provide validity of nutrient information. The verify the declared amount of these nutrient information that is not false or comments stated that we did not need nutrients for a particular marketed misleading. access to manufacturing records and product (id.). (Comment 526) Several comments that other methods, such as database The proposed rule, at proposed said that it would be very difficult to information or an explanation from a § 101.9(g)(11), also would require that obtain and retain the information manufacturer, would suffice. records be kept for a period of 2 years required by FDA. Some comments noted (Response) Manufacturers will be after introduction or delivery for that the number of product formulations responsible for the type of records they introduction of the food into interstate can be greater than 20,000 for certain maintain and are not required to

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produce any specific form or document provide data on the weight of certain fraudulent statement or representation; for verification purposes. Records used nutrient contributions to the total batch. or (3) makes or uses any false writing or to verify nutrient content could include With these types of data, calculations document knowing the same to contain various types of batch records providing can be made to determine nutrient any materially false, fictitious, or data on the weight of certain nutrient content for individual foods or servings fraudulent statement or entry may be contributions to the total batch, records of a food. Documentation of this type subject to a fine or imprisonment. of test results conducted by the would not reveal any proprietary (Comment 531) Some comments manufacturer or an ingredient supplier, recipes or formulations and would be disagreed with the proposed certificates of analysis from suppliers limited to specific nutrient information. requirement to keep records for at least subject to initial and periodic Information about the nutrient content 2 years after a food’s introduction into qualification of the supplier by the of the ingredients of a food product interstate commerce. The comments manufacturer, or other appropriate could be acquired from ingredient said manufacturers would have to keep verification documentation that provide suppliers subject to initial qualification track of an additional data point (the the needed assurance that a and periodic requalification by the date on which the food is actually manufacturer has adequately ensured manufacturer, and this type of shipped) as opposed to the date on the food or ingredients comply with information on quantitative source which it is manufactured. The labeling requirements. The records amounts can be included in the batch comments said that shipping dates can submitted for inspection by FDA would records. vary, even for foods from the same only need to provide information on the Furthermore, even if a manufacturer’s batches, and could occur months after nutrient(s) in question. Information records contained confidential manufacture, and this could result in about other nutrients can be redacted if commercial information or trade secret extremely divergent record maintenance necessary to ensure confidentiality of a information or a manufacturer believes timeframes for foods. food product formulation. that certain information should be Furthermore, some comments said (Comment 528) Several comments protected from public disclosure, we that is unclear whether the term ‘‘food’’ addressed our legal authority to require note that there are safeguards to protect is intended to refer to a particular batch recordkeeping as described in the against public disclosure of that of food or to an individual food. proposed rule. information and mechanisms that a Other comments suggested that 2 (Response) We address these manufacturer can use to assert that years is a long time for foods with very comments in part II.C.4. certain information should be protected short shelf lives. Some comments noted (Comment 529) Some comments from disclosure. As we stated in the that the Seafood Hazard Analysis and expressed concern that proprietary preamble to the proposed rule (79 FR Critical Control Points (HACCP) information in recipes and formulations 11879 at 11957), we would protect regulations allow for a 1-year record could be divulged and said that the confidential information from retention period for refrigerated ability to retain and claim the disclosure, consistent with applicable proprietary nature of product statutes and regulations, including 5 products and a 2 year period for frozen, formulations is essential to staying U.S.C. 552(b)(4), 18 U.S.C. 1905, and preserved, or shelf-stable products. The competitive in the marketplace. Other part 20 (21 CFR part 20). For example, comments suggested that, similarly, the comments suggested that we clarify that our regulations pertaining to disclosure 2 year requirement for recordkeeping the recordkeeping requirements will not of public information, at part 20, related to nutrition labeling should be require access to proprietary include provisions that protect trade limited to frozen, preserved, or shelf- information, such as recipes and secrets and commercial or financial stable products and that a shorter period formulations. In addition, the comments information which is privileged or of 1 year should be allowed for recommended that we specify what confidential. If a manufacturer keeps maintenance of records for refrigerated level of information and types of proprietary recipe information in its and perishable foods. documents are required to meet the records, it should mark the information (Response) We recognize that there recordkeeping requirements. Several as such before providing the records to can be a wide variation of comments requested that manufacturers us upon request. manufacturing practices, shipping be permitted to develop a stand-alone (Comment 530) One comment practices, and shelf lives among document that articulates the basis for expressed concerns that allowing for packaged foods. We believe, however, the declaration of added sugars in a recordkeeping as a way to verify the that it is more practical to establish a product. Other comments recommended amount of nutrients such as added sugar single recordkeeping period rather than that, if we finalize the recordkeeping in some products would encourage establish different recordkeeping requirements and require the copying of those manufacturers to provide false periods for different products or for records, we address the security of the reporting of the added sugar content of different manufacturing or shipping information coming from inspections their products. practices. It would be more difficult for and the protection of confidential (Response) We note that having a false FDA to establish a compliance program information. declaration on the label is a violation of for one segment of the regulated (Response) The final rule does not section 403(a)(1) of the FD&C Act. industry that starts the recordkeeping require a specific document to be Providing false information in records to process when the food is made and a retained nor does it require information the Agency may also be a potential different compliance program for on proprietary recipes or overall criminal violation under 18 U.S.C. 1001. another segment of the industry that formulations. Instead, the recordkeeping Under 18 U.S.C. 1001, whoever, in any starts the recordkeeping process when requirements seek specific content matter within the jurisdiction of the the food is shipped. Likewise, for information for certain nutrients, and executive, legislative, or judicial branch manufacturers who make several food this information can be provided in of the Government of the United States, products, it may be easier for them to various forms. For example, information knowingly and willfully: (1) Falsifies, use the same recordkeeping period for in some batch records could include conceals, or covers up by any trick, all products rather than use different data on the total batch weight of the scheme, or device a material fact; (2) recordkeeping periods for different production of a particular food and also makes any materially false, fictitious, or products. Therefore, we have designed a

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compliance program or strategy that or directly related to a risk of chronic § 101.9(g)(10)(v) to all foods is involves a single recordkeeping period. disease, a health-related condition, or a unnecessary. As for the comment asking whether physiological endpoint. Some (Comment 536) One comment noted ‘‘food’’ referred to a particular batch or comments noted that previous FDA that we have described the new to an individual food, the term food recordkeeping requirements involved recordkeeping requirement for certain refers to an individual food item, but pharmaceutical safety or potentially nutrients as analogous. The comment there are not specific requirements on adulterated foods that pose safety said that the recordkeeping for added what type of documentation is required. hazards. Some comments stated that we sugars is different than those for other If the same documentation addresses the have never required recordkeeping to nutrients, such as fiber, folate, or declarations on an entire batch of food support a mandatory disclosure on the vitamin E in that the recordkeeping or an even greater quantity of food, Nutrition Facts label that does not requirement for added sugars is those records may be sufficient. involve risk of disease. A few comments unavoidable due to the mandatory (Comment 532) Some comments explained that obtaining added sugar nature of the added sugars declaration. suggested that manufacturers should be information, in particular, from (Response) The new recordkeeping allowed to keep records at locations ingredient suppliers is difficult because requirements are analogous based on the separate from factories (e.g., corporate ingredients do not distinguish between fact that inspection of records is the headquarters) and that we allow a naturally occurring and added sugars only method to evaluate compliance reasonable timeframe (e.g., 72 hours or and manufacturers are unable to with the nutrition labeling regulations 15 days) to obtain the records and make distinguish them analytically. for a certain number of nutrients. For them available. (Response) We recognize that it may certain nutrients there are no AOAC (Response) Records must be made be difficult to determine the quantity of official methods of analysis or other available to us for examination or added sugars and intrinsically occurring reliable or appropriate analytical copying during an inspection upon sugars in a particular ingredient or food, procedures that are available for us to request; this is consistent with our other and we stated this several times in the verify the amount of the declared recordkeeping regulations (see, e.g., 21 nutrient on the Nutrition Facts label and preamble to the proposed rule (see 79 CFR 111.605 and 111.610). The records ensure that the declared nutrient FR 11879 at 11905, 11906, and 11956). would need to be reasonably accessible amounts are truthful, accurate and The recordkeeping requirement, in the (access to records within 24 hours can complies with all applicable labeling absence of an analytical method that be considered reasonable) to FDA requirements. However, we agree that would distinguish between added and during an inspection at each there are difference as to which intrinsically occurring sugars in a food, manufacturing facility (even if not manufacturers will need to keep records is an alternative means of verifying stored onsite) to determine whether the for nutrient content and which products compliance; contrary to the comments’ food has been manufactured and labeled will necessitate recordkeeping. Some statements regarding added sugars and in compliance with labeling manufacturers who voluntarily declare requirements. Records that can be safety hazards or chronic disease, the vitamin E content, for example, will immediately retrieved from another recordkeeping requirement was not have to keep records for vitamin E location by electronic means are based on or otherwise dependent on an content but manufacturers who do not considered reasonably accessible. independent relationship between declare vitamin E will not need to (Comment 533) Some comments said added sugars and chronic disease. maintain any records for vitamin E that the recordkeeping requirements Instead, as we stated in the preamble to content. Conversely, most could present a barrier to trade. They the proposed rule (79 FR 11879 at manufacturers will need to maintain stated that access to records of 11956), the information contained in records on added sugar content. As manufacturers of imported foods may manufacturers’ records is an accurate discussed in part II.H.3, however, we not be possible unless reciprocal and practical method for assuring that have concluded that the declaration of agreements are in place and that such the nutrient declarations comply with added sugars is necessary to assist agreements could pose a challenge to section 403(q) of the FD&C Act. consumers in maintaining healthy trade with certain countries. (Comment 535) Some comments dietary practices. Thus, the added (Response) We disagree with the suggested that we extend the sugars declaration is required and, as is comments. As in the case of domestic requirement in proposed the case for any nutrient that does not manufacturers, foreign manufacturers of § 101.9(g)(10)(v) to all foods declaring have any analytical method available to food produced for sale in the United added sugar to allow food assess compliance, the records States must follow all applicable laws manufacturers to keep records to described here will have to be and regulations related to nutrition demonstrate the amount of added sugars maintained and made available for labeling. The final rule establishes the remaining in the finished food when inspection. same recordkeeping requirements for that amount is less than the initial (Comment 537) One comment stated foreign and domestic firms. To the amount of added sugars. that we have said that requiring extent records are not available during (Response) We decline to revise the recordkeeping could spur reformulation, a foreign facility inspection for imported rule as suggested by the comment. but also stated that we have not products, that would certainly inform a Section 101.9(g)(10)(v) states that when provided any evidence of this. determination about the admissibility of the amount of added sugars is reduced (Response) We do not cite potential the food. through non-enzymatic browning and/ reformulation of food products as a (Comment 534) Several comments or fermentation, the manufacturer must reason for or a benefit resulting from addressed recordkeeping as it pertained make and keep certain data, recordkeeping requirements. The to added sugars. The comments said the information, and records to document recordkeeping requirements are only proposed recordkeeping requirements the differences in added sugar content being created to establish an alternative were overreaching, especially when, between the unfinished and finished approach for assessing compliance of according to the comments, we products. Not all foods undergo non- the declared amount of certain nutrients acknowledged that added sugars do not enzymatic browning and/or when there is no suitable analytical pose a safety issue and are not uniquely fermentation, so extending method available to measure the

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nutrient’s quantity as declared on the or on the addition of soluble and standards exist and products are label or in labeling. insoluble fiber to § 101.(g)(4) and (6), represented as complying with those and so we have finalized those standards (21 U.S.C. 343(s)(2)(D)). 4. Inclusion of Potassium as a Mineral provisions without change. We address One comment also would revise Potassium is specified as a Class I and comments on the compliance § 101.36(f)(1) to state that the food is Class II nutrient in our preexisting requirements for added sugars in part also in compliance if it conforms to the regulations at § 101.9(g)(4)(i) and II.H.3; however, we are finalizing the specifications of an official (g)(4)(ii), respectively and is the only addition of added sugars to the compendium. The comment suggested vitamin or mineral that is specifically compliance requirements of that reasonable excesses of dietary listed under the description of both § 101.9(g)(5) and (g)(6) as proposed. ingredients over labeled amounts would Class I and Class II nutrients. Because still be acceptable within current good the proposed rule (at § 101.9(c)(8)(iv)) 6. Miscellaneous Comments manufacturing practices. would establish an RDI for potassium Although we did not receive any Another comment noted that and require declaration of the absolute comments on our proposed revisions to jurisdictions outside of the United amount along with a percent DV on the the compliance requirements in States, such as Denmark, Korea, and the Nutrition Facts label, we also proposed § 101.9(g)(4), (g)(5), and (g)(6), we did United Kingdom, recognize a minimum to not list potassium separately under receive a number of comments related to value of 80 to 90 percent of the declared the description of Class I and Class II Class I and Class II nutrients. amount for added vitamins and nutrients and to remove the term (Comment 538) We proposed to minerals at the end of shelf life. The ‘‘potassium’’ from § 101.9(g)(4), (g)(4)(i), amend § 101.9(g)(4)(i) to say that, when comment suggested that allowing for a (g)(4)(ii), and (g)(6). Instead, potassium a vitamin, mineral, protein, or non- minimum of 90 percent of the declared would be covered under the term digestible carbohydrate(s) (when the amount of an added vitamin or mineral ‘‘mineral’’ that appears in each section, food contains only non-digestible in the Class I requirements would and any listing of potassium on the carbohydrates (soluble or insoluble) that promote harmonization with other Nutrition Facts label would have to meet the definition of dietary fiber) jurisdictions. meet the specific compliance meets the definition of a Class I One comment suggested that allowing requirements for minerals under nutrient, the nutrient content of the for a minor loss of strength during the § 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and composite must be formulated to be at product shelf life for Class I nutrients (g)(6). least equal to the value for that nutrient and other dietary ingredients would be We did not receive any comments declared on the label. Currently, our similar to what is allowed in drug regarding potassium and § 101.9(g)(4) or preexisting regulations, at § 101.36(f)(1), monographs. (g)(6). Therefore, we have finalized state that compliance for dietary (Response) We acknowledge the those provisions without change. supplements will be determined in comments’ arguments for revising our accordance with § 101.9(g)(1) through compliance requirements for Class I 5. Requirements for Other Carbohydrate, (g)(8) and that the criteria on Class I and nutrients, but decline to revise the rule Soluble and Insoluble Fiber, Added Class II nutrients given in § 101.9(g)(3) to allow for less than 100 percent of the Sugars, and Sugar Alcohols and (g)(4) also are applicable to other amount declared on the label. We note Our preexisting labeling requirements dietary ingredients. that the USP compendial standards for for Class I and Class II nutrients are at Two comments would revise the label claims deviations vary from § 101.9(g)(4). Because the proposed rule requirements for Class I nutrients in nutrient to nutrient and even vary with would revise § 101.9(c)(6)(iv) to remove § 101.9(g)(4)(i) and § 101.36(f)(1) such different dietary supplement the provision for voluntary declaration that added nutrients in fortified or formulations (e.g., high potency of ‘‘Other carbohydrate,’’ we proposed fabricated foods must contain at least 90 products). This is a complex issue that to remove the compliance requirements percent of the declared amount rather warrants further consideration. We need related to ‘‘Other carbohydrate’’ in than the current requirement of 100 to further consider and review the § 101.9(g)(4) and (g)(6). percent of the declared amount. The available information and to make a We also proposed, when all of dietary comments recommended that we allow determination whether to propose fiber in a food product meets the for fortified and fabricated foods to changes with respect the requirements proposed definition of dietary fiber, to contain less than the declared amount of for Class I nutrients and/or other include soluble and insoluble fiber as a Class I nutrients because degradation requirements that may be affected. both Class I and Class II nutrients under of dietary ingredients is anticipated and (Comment 539) One comment referred § 101.9(g)(4); include added sugars can occur during the shelf life of the to a statement made in the preamble to within § 101.9(g)(5) such that the label product. The comments said that the proposed rule (79 FR 11879 at declaration of added sugars will be degradation can occur faster in some 11958) that we expect that, when a food deemed misbranded under section nutrients than others with certain product contains added sugars, added 403(a) of the FD&C Act if the nutrient matrices. The comments expressed dietary fiber, vitamin E as all rac-a- composite is greater than 20 percent in concern that firms may include large tocopherol acetate, and added folic acid, excess of the added sugars value excesses (greater than 120 percent of the the declared amount must be at least declared on the label, and within declared amount) to remain in equal to the amount of the nutrient § 101.9(g)(6) such that reasonable compliance with requirements for Class added to the food. The comment noted deficiencies of added sugars would be I nutrients and other dietary ingredients that there are instances when the permitted; and include soluble and over the shelf life of the product. One declared amount of vitamin E, fiber, or insoluble fiber and sugar alcohols comment stated that a lower limit of 90 folic acid could be less than the amount within § 101.9(g)(6) such that reasonable percent potency as in the U.S. added to the recipe as a result of process excesses of these nutrients would be Pharmacopeia (USP) should be losses or losses over shelf life. The permitted. permitted because DSHEA made it clear comment said it is incorrect to assume We did not receive comments with that Congress’ intent was that the that the declared amount would be respect to the removal of other compendial standards should be the equal to at least the amount added to the carbohydrate from § 101.9(g)(4) and (6) guiding influence where compendial recipe.

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(Response) We agree that there could products. In the example provided in We received no comments regarding be process losses or losses over shelf life the comment, the manufacturer could this change and have revised for some nutrients added to a product. use milk that is not fortified with § 101.9(c)(7)(ii) by replacing ‘‘1990’’ Product loss over the shelf-life of a vitamin A in formulating the product. In with ‘‘1991.’’ However, with respect to product is a complex issue that warrants such case, the vitamin A in the finished this and other references that we further review. We need additional time food would be from a naturally incorporated by reference in the final to review the available information and occurring source, and the food would rule, we have revised the incorporation- to make a determination whether to have to meet the requirements for Class by-reference language in the final rule to propose changes with respect the II nutrients rather than Class I nutrients. meet the current requirements at 5 CFR requirements for Class I nutrients and/ part 51. Consequently, much of the or other requirements that may be S. Technical Amendments incorporation by reference language can affected. The proposed rule also would make be found at a new § 101.9(l). (Comment 540) The proposed rule, at certain technical amendments, such as 3. Plain Language Edits § 101.9(g)(3)(ii), would state that when a changing the name of the program office nutrient or nutrients are not naturally to reflect its current name and making On October 13, 2010, the President occurring in an ingredient added to a non-substantive edits for purposes of signed the Plain Writing Act of 2010 food, the total amount of such nutrient plain language. requiring that Federal Agencies use in the final food product is subject to ‘‘clear Government communication that Class I requirements. One comment 1. Changing the Name of the Program the public can understand and use.’’ On supported the rule, but two comments Office January 18, 2011, the President issued asked us to clarify that this provision is The proposed rule would update the Executive Order (E.O.) 13563, referring to ingredients, such as vitamin name of the program office that is ‘‘Improving Regulation and Regulatory Review’’ (75 FR 3821 (January 21, premixes, that contribute to, but do not responsible for developing regulations 2011)); section 1 of E.O. 13563 sets forth account for, the total declared amount of and answering questions related to ‘‘General principles of regulation,’’ and the nutrient. The comments expressed nutrition labeling as well as for these principles include ensuring that concern that the rule could be construed maintaining some references discussed regulations are ‘‘accessible, consistent, to apply to the use of ingredients such throughout § 101.9. The program office’s written in plain language, and easy to as enriched flour or vitamin A fortified former name was the Office of understand.’’ To make the requirements milk which may not contribute Nutritional Products, Labeling and of § 101.9 easier to understand, we substantially to the nutrient Dietary Supplements; at the time we proposed editorial changes that would composition of foods. An example issued the proposed rule, the program not change the meaning or intent of the might be a mixed dish containing office’s name was the Office of language in § 101.9(g)(3)(ii); (g)(4)(i); and a small amount of milk with Nutrition, Labeling and Dietary added vitamin A. Because the naturally (g)(4)(ii); (g)(5); and (g)(8). Specifically, Supplements. We proposed to update occurring vitamin A in the carrots the proposed rule would: the name throughout § 101.9. would be the primary source of vitamin • Revise § 101.9(g)(3)(ii) to clarify that A in the product rather than the added We did not receive any comments when a nutrient or nutrients are not vitamin A in the milk, the comment regarding the change in the program naturally occurring (exogenous) in an would have us consider vitamin A to be office’s name. However, since we issued ingredient that is added to a food, the a Class II nutrient. the proposed rule, the program office’s total amount of such nutrient(s) in the (Response) We decline to revise the name changed again, to be the Office of final food product is subject to Class I rule to refer to ingredients that Nutrition and Food Labeling, and so we requirements rather than Class II contribute to, but do not account for, the have revised § 101.9 accordingly. requirements. We proposed this change total declared amount of the nutrient. 2. Changing the Publication Date of because the existing rule did not There are cases when fortified Report Incorporated by Reference explicitly state that such a nutrient ingredients contribute significantly to would be subject to Class I the amount of a nutrient when the same Our preexisting regulations, at requirements. nutrient also occurs naturally in the § 101.9(c)(7)(ii), provide that the protein • Remove ‘‘Class I’’ and ‘‘Class II’’ food. For example, enriched flour digestibility-corrected amino acid score from § 101.9(g)(4)(i) and (g)(4)(ii), and to containing thiamin could be added to must be determined by methods given state instead that when the list of bread containing oats where oats are in sections 5.4.1, 7.2.1, and 8.00 in nutrients provided in those sections also a source of thiamin. Our intent in ‘‘Protein Quality Evaluation, Report of meets the definition of a Class I or Class proposing to amend § 101.9(g)(3)(ii) was the Joint FAO/WHO Expert II nutrient provided for in to clarify, rather than alter, the Consultation on Protein Quality § 101.9(g)(3)(i) and (g)(3)(ii), the requirement for manufacturers so that, Evaluation,’’ Rome, 1990, except that declaration of those nutrients must meet even if a small amount of a nutrient is when official AOAC procedures certain requirements. We explained that added to a food, where the final food described in § 101.9(c)(7) require a this change was intended to prevent product also contains an ingredient with specific food factor other than 6.25 to be confusion by having two different the same nutrient in a naturally used. We incorporated the ‘‘Report of definitions of a ‘‘Class I’’ and ‘‘Class II’’ occurring form, the final food product is the Joint FAO/WHO Expert nutrient for compliance with nutrition subject to the Class I requirements. Consultation on Protein Quality labeling requirements. Thus, contrary to the comments’ Evaluation’’ by reference in • Remove the words ‘‘Provided, interpretation, we would not consider § 101.9(c)(7)(ii), but § 101.9(c)(7)(ii) That’’ from §§ 101.9(g)(4)(ii) and (g)(5) the vitamin A to be a Class II nutrient incorrectly uses 1990 as the publication because the words do not provide in the example provided by the date when the report actually was further clarification and are comment. published in 1991. Thus, the proposed unnecessary. We note that manufacturers can rule would change the publication date • Add the word ‘‘Alternatively’’ at the choose to use ingredients that are not of the report that is incorporated by beginning of § 101.9(g)(8) to indicate fortified when formulating their reference from 1990 to 1991. that use of an FDA approved database

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is an alternative to the type of nutrient § 101.9(c)(8)(iii) did not provide clear § 101.9(c)(1)(i)(D) and (E) by deleting the analysis described in § 101.9(g)(1) and instructions for how to declare the word ‘‘or’’ from the former and adding (g)(2). percent DVs for vitamins and minerals the word ‘‘or’’ to the latter. This change (Comment 541) One comment stated when the percent daily is between 2 to reflected the addition of a new that the proposed rule does not meet the 10 percent, between 10 to 50 percent, or subparagraph (F), such that we needed requirements of the Plain Writing Act of above 50-percent. to move the conjunction to its correct 2010 (Pub. L. 111–274) and said it (Response) The text in first sentence place between the last two should be rewritten at a much lower in proposed § 101.9(c)(8)(iii) was subparagraphs in § 101.9(c)(1)(i). The literacy level. inadvertently changed, and we did not final rule adopts these changes. (Response) Although we strive to use mean to propose to amend this plain language and to draft our requirement. The text in the first T. Miscellaneous Comments regulations in a manner such that they sentence of § 101.9(c)(8)(iii) should read We also received comments on a are easy to understand, we disagree with ‘‘The percentages for vitamins and variety of topics that were unrelated to the comment. The comment did not minerals shall be expressed to the the proposed rule. In brief, we received provide any specific examples or nearest 2-percent increment up to and comments asking about: suggestions on how we should rewrite including the 10-percent level, the • Declaring the presence of the rule, so we do not have an adequate nearest 5-percent increment above 10 genetically modified organisms (GMOs) basis to determine which parts of the percent and up to and including the 50- or GMO-related issues; rule, in the comment’s view, should be percent level, and the nearest 10-percent • Ingredient listing, particularly with rewritten or how they should be revised. increment above the 50-percent level.’’ respect to specific ingredients such as high-fructose corn syrup; We also note that, while we have 5. Miscellaneous Changes made every effort to write the rule in • Front-of-package labeling; • plain language and in easily understood The final rule also makes several non- Labeling of alcoholic beverages by terms, the rule imposes requirements on substantive changes. another Federal Agency; • firms who have Nutrition Facts or The proposed rule would amend Declaring whether a product § 101.9(c) to state that the requirements Supplement Facts labels on their contains , gluten, allergens, of § 101.9(c) apply to the labeling of products rather than on laymen. The ‘‘toxins’’ (particularly from food ‘‘for adults and children over the intended ‘‘audience’’ for the rule is an and food containers); age of 4 years, and on foods (other than • important consideration when it comes Listing the glycemic index of foods infant formula) purported to be to plain language. As the Federal Plain and listing whole grains in a food; specifically for infants through 12 • Language Guidelines state: Health claim or nutrient content months, children 1 through 3 years of claim regulations; One of the most popular plain language age, and pregnant women and lactating • Expiration dates on food labels; myths is that you have to ‘‘dumb down’’ your women.’’ After further consideration, • Whether we should define the term content so that everyone everywhere can read we have decided not to amend ‘‘natural’’ on food labels; it. That’s not true. The first rule of plain § 101.9(c) as we had proposed because • Issues related to our final rules on language is: Write for your audience. Use language your audience knows and feels the additional language is not necessary. menu labeling and vending machine comfortable with. Take your audience’s As discussed part II.O, we have the labeling; and current level of knowledge into account. same requirements for mandatory and • Listing artificial sweeteners in the Don’t write for an 8th grade class if your voluntary labeling for products Nutrition Facts label. audience is composed of Ph.D. candidates, represented or purported to be for Generally speaking, these topics are small business owners, working parents, or pregnant women and lactating women distinct from the Nutrition Facts and immigrants. Only write for 8th graders if your because women of reproductive age Supplement Facts label requirements, audience is, in fact, an 8th grade class. consume the same foods as the general and so they are beyond the scope of this Federal Plain Language Guidelines, population and, in general, continue rulemaking. We note, however, that we ‘‘Think About Your Audience,’’ p. 1 consuming similar foods during have issued regulations regarding (March 2011). pregnancy. Therefore, the requirements ‘‘gluten-free’’ labeling (see 78 FR 47154 Consequently, the final rule makes the for mandatory and voluntary labeling (August 5, 2013) (now codified at 21 plain language edits to § 101.9(g)(4)(i), for children and adults 4 years of age CFR 101.91), labeling of standard menu (g)(4)(ii), and (g)(8). However, we have and older also apply to products items in restaurants and similar retail made additional revisions to represented or purported to be for food establishments (known informally § 101.9(g)(3)(ii) for clarification. In pregnant women and lactating women, as ‘‘menu labeling’’) (see 78 FR 71155 addition, upon further consideration, and there is no reason to mention (December 1, 2014)) (now codified at 21 we decided to retain the words requirements for pregnant women and CFR 101.9), calorie labeling of articles of ‘‘Provided, That’’ in §§ 101.9(g)(4)(ii) lactating women in § 101.9(c). In food in vending machines (78 FR 71259 and (g)(5). Removing the clause would addition, the requirements for (December 1, 2014) (also codified at 21 no longer signal to the reader that no mandatory and voluntary labeling for CFR 101.9), and Small Entity regulatory action will be taken based on products purported to be for infants Compliance Guides for the gluten-free a determination of a nutrient value that through 12 months of age and children labeling rule and the menu labeling falls above a certain level by a factor less 1 through 3 years of age are provided in rules (see 79 FR 36322 (June 26, 2014) than the variability generally recognized § 101.9(j)(5). Therefore, there is no and 80 FR 13225 (March 13, 2015) for the analytical method used in that reason to mention requirements for respectively). food at the level involved. mandatory and voluntary labeling of We also have a longstanding policy nutrients on products represented or for the use of the term ‘‘natural’’ on 4. Correcting § 101.9(c)(8)(iii) To purported to be for infants through 12 labels of human food (see 56 FR 60421 Provide Instructions for Rounding months or children 1 through 3 years in at 60466 (November 27, 1991) (proposed Percent DVs § 101.9(c). rule on food labeling, nutrient content (Comment 542) One comment noted The proposed rule also would make claims, and general principles)), and, in that the first sentence in proposed minor conforming changes to the Federal Register of November 12,

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2015 (80 FR 69905), issued a notice to 17, 2015)), a Vermont state law manufacturer with less than $10 million receive information and comments on requiring labeling of genetically in annual sales, which we estimate the use of the term ‘‘natural’’ in the engineered foods and similar legislation using Nielsen data that covers labeling of human food products, in other States, and a possible change to approximately 95 percent of all food including foods that are genetically the Nutrition Facts Table and ingredient manufacturers and 48 percent of food engineered or contain ingredients statements in Canada. Some comments UPCs. produced through the use of genetic said that synchronizing compliance We also decline to extend the engineering and on specific questions dates would reduce the economic compliance date for small businesses to we posed in the notice. impact of food manufacturers or that 4 or 5 years. We note that the Nutrition providing a longer compliance date Facts label’s principal purpose is to III. Effective and Compliance Dates would reduce the economic impact on assist consumers in maintaining healthy In the preamble to the proposed rule manufacturers. dietary practices. In establishing the (79 FR 11879 at 11959), we indicated Several comments also said that compliance date for the rule, we have that a final rule, as well as any final rule manufacturers may decide to tried to balance the label’s principal resulting from the proposed rule reformulate products. One comment purpose against the need for industry to entitled ‘‘Food Labeling: Serving Sizes said that a longer compliance date analyze products and to review, update, of Foods That Can Reasonably Be would make it possible for more change, and print labels (see 79 FR Consumed At One-Eating Occasion; manufacturers to reformulate products 11879 at 11959). If we were to extend Dual-Column Labeling; Updating, to reduce added sugars, to qualify for the compliance date for small Modifying, and Establishing Certain nutrient content claims, or ‘‘otherwise businesses to 4 or 5 years, we may Reference Amounts Customarily meet FDA’s public health objectives.’’ inadvertently create consumer Consumed; Serving Size for Breath Another comment said that a longer confusion because different versions of Mints; and Technical Amendments,’’ compliance period would give the Nutrition Facts label would exist in would become effective 60 days after companies time to reformulate ‘‘where the market for a longer period of time. the date of the final rule’s publication in appropriate.’’ The more years that differences exist the Federal Register (79 FR 11879 at Some comments said there would be between label formats on different 11959). We also suggested that a final environmental consequences or impacts products due to extended compliance rule have a compliance date that would if companies had to dispose of labels or periods, the more concern we would be 2 years after the effective date (id.). could not use existing label stock. have about these differences frustrating, We explained that industry might need In general, the comments suggested rather than enhancing, the consumer’s some time to analyze products for different compliance dates, ranging from ability to maintain healthy dietary which there may be new mandatory 3 to 5 years, and stressed the impact on practices and potentially undermining nutrient declarations, make any small businesses. public confidence in the Nutrition Facts required changes to the Nutrition Facts (Response) After considering the label. label (which may be coordinated with comments, we have maintained the other planned label changes), review compliance date of 2 years after the IV. Economic Analysis of Impacts and update records of product labels, effective date, except that manufacturers We have examined the impacts of this and print new labels. with less than $10 million in annual final rule under Executive Order 12866, (Comment 543) Several comments food sales have a compliance date of 3 Executive Order 13563, the Regulatory asked that we provide for a longer years after the effective date. Because Flexibility Act (5 U.S.C. 601–612), and compliance date. Some comments the comments emphasized the rule’s the Unfunded Mandates Reform Act of specifically requested more time for potential impact on small businesses, 1995 (Pub. L. 104–4). small businesses. Some comments said we agree that the impacts to smaller Executive Orders 12866 and 13563 that there are a limited number of label businesses may be more substantial than direct us to assess all costs and benefits printing facilities and that they those on larger businesses, and so we of available regulatory alternatives and, anticipated that small firms would have have decided to provide a 3-year when regulation is necessary, to select to wait longer to have new labels compliance date for manufacturers with regulatory approaches that maximize printed. The comments indicated that less than $10 million in annual food net benefits (including potential printing facilities would work with sales. Thus, for manufacturers with less economic, environmental, public health larger companies before working with than $10 million in annual food sales, and safety, and other advantages; small businesses or that the large the compliance date will be July 26, distributive impacts; and equity). We companies would be able to negotiate 2019. are publishing two final rules on more quickly with printing facilities to We take no position with respect to nutrition labeling in the Federal fill their labeling orders first. Other the comment’s statements on label Register. We have developed one final comments stated that small businesses printing facilities and their interaction Regulatory Impact Analysis (RIA) (Ref. often order a 2-year supply of labels or with large companies, but agree, 274) that assesses the impacts of the two packaging, so a 2-year compliance date generally, that small businesses may final rules taken together; the RIA is would force small businesses to discard have fewer resources (both in terms of available at http://www.regulations.gov inventory. One comment said that some personnel and financial resources) to (Docket No. FDA–2012–N–1210) and at manufacturers would need to work with deal with regulatory changes and that an http://www.fda.gov/AboutFDA/ design firms to revise or develop label extended compliance date may mitigate ReportsManualsForms/Reports/ designs. the rule’s impact on small businesses EconomicAnalyses/. We believe that the Another comment requested a longer and reduce the need to dispose of final rules, taken as a whole, are an compliance date because of other label potentially non-compliant labeling economically significant regulatory changes that we or other nations are stock. Although the comments did not action as defined by Executive Order requiring or anticipated new labeling suggest any criteria to decide what 12866. requirements. The comment mentioned constitutes a ‘‘small business,’’ for The Regulatory Flexibility Act our declaratory order regarding partially purposes of this rulemaking, we requires Agencies to analyze regulatory hydrogenated oils (80 FR 34650 (June consider a small business to be a options that would minimize any

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significant impact of a rule on small States, whose products contain: (1) A considered to meet the definition of entities. Additional costs per entity from mixture of naturally occurring and dietary fiber and the definition would the final rules are small, but not added sugars; or (2) a mixture of non- be amended to include the dietary fiber negligible, and as a result we find that digestible carbohydrates that do and do in the listing of dietary fibers that must the final rules, taken as a whole, will not meet the definition of dietary fiber. be included in the total amount of have a significant economic impact on The likely respondents to this dietary fiber declared on the Nutrition a substantial number of small entities. information collection also include or Supplement Facts label by food The Unfunded Mandates Reform Act manufacturers of retail food products manufacturers who manufacture food of 1995 (Section 202(a)) requires us to marketed in the United States, whose products that contain the isolated or prepare a written statement, which products contain: (1) Mixtures of synthetic non-digestible carbohydrate. includes an assessment of anticipated different forms of vitamin E; or (2) both The record requirements are necessary costs and benefits, before issuing ‘‘any folate and folic acid. because analytical methods are not rule that includes any Federal mandate Description: The Nutrition Facts label available that would allow us to that may result in the expenditure by rule requires that, under certain differentiate between naturally State, local, and tribal governments, in circumstances, manufacturers make and occurring and added sugars, non- the aggregate, or by the private sector, of keep certain records to verify the digestible carbohydrates (soluble or $100,000,000 or more (adjusted amount of added sugars when a food insoluble) that do and do not meet the annually for inflation) in any one year.’’ product contains both naturally definition of dietary fiber, the various The current threshold after adjustment occurring sugars and added sugars, forms of vitamin E, and folate or folic for inflation is $144 million, using the isolated or synthetic non-digestible acid in order to quantify the amount of most current (2014) Implicit Price carbohydrates that do not meet the added sugars, dietary fiber, soluble Deflator for the Gross Domestic Product. definition of dietary fiber, different fiber, insoluble fiber, vitamin E, or These final rules, taken as a whole, forms of vitamin E, and folate/folic acid folate/folic acid in the final food would result in an expenditure that declared on the Nutrition Facts or product. For the nutrients described in meets or exceeds this amount. The Supplement Facts label, which is the the preceding sentence for which there analysis that we have performed to amount in the finished food product. are no analytical methods available to examine the impacts of the final rules Manufacturers are required to provide under Executive Order 12866, Executive verify the label declaration, we must such records to an appropriate rely on information known only to the Order 13563, the Regulatory Flexibility regulatory official upon request during Act, and the Unfunded Mandates manufacturer, e.g., analyses of nutrient inspection. Manufacturers also are databases, the food’s formulation or Reform Act of 1995 are included in the required to maintain the records to RIA (Ref. 274) and is available at http:// recipe, batch records, or other records, verify the label declaration of the to determine whether their product www.regulations.gov (Docket No. FDA– aforementioned nutrients for a period of 2012–N–1210). contains the declared amount of the 2 years after introduction or delivery for nutrient and is in compliance with the V. Paperwork Reduction Act of 1995 introduction of the food into interstate requirements of §§ 101.9(g) and commerce. Manufacturers of food This final rule contains information 101.36(f). products that contain an isolated or collection provisions that are subject to synthetic non-digestible carbohydrate We require that firms make and keep review by the OMB under the PRA. The certain records necessary to verify the title, description, and respondent that are not listed in the definition of dietary fiber will have the option of amount of the nutrients in the finished description of the information collection food product. The Nutrition Facts label provisions are shown in the following submitting a citizen petition to FDA asking us to amend the definition of rule does not specify what records must paragraphs with an estimate of the be used to verify the amounts of these annual reporting and recordkeeping ‘‘dietary fiber’’ to include the carbohydrate as a listed dietary fiber, by nutrients, but does specify the burden. Included in the estimate is the information that the records must time for reviewing instructions, demonstrating the physiological benefits of the isolated or synthetic non- contain. The Nutrition Facts label rule searching existing data sources, would require manufacturers to, upon gathering and maintaining the data digestible carbohydrate to human health. In addition, if the isolated or request during an inspection, provide needed, and completing and reviewing FDA with the records that contain the each collection of information. synthetic non-digestible carbohydrate is the subject of an authorized health required information for each of these Title: Record Retention, Reporting, nutrients to verify the amount of the and Third-Party Disclosure claim, FDA would consider the carbohydrate to be a dietary fiber with nutrient declared on the label. These Requirements for the Declaration of records may include analyses of Added Sugars, Dietary Fiber, Soluble a beneficial physiological effect to human health and would amend the nutrient databases, recipes or Fiber, Insoluble Fiber, Vitamin E and formulations, information from recipes Folate/Folic Acid. definition of ‘‘dietary fiber’’ to include the carbohydrate as a listed dietary or formulations, batch records, or any A. Recordkeeping Requirements fiber. If the citizen petition is granted, other records that contain the required Description of Respondents: The or if the isolated or synthetic non- information to verify the nutrient likely respondents to this information digestible carbohydrate is the subject of content in the final product. collection are manufacturers of retail an authorized health claim, then the We estimate the burden of this food products marketed in the United non-digestible carbohydrate is collection of information as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Average Type of declaration/CFR section Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping

Added Sugars/§ 101.9(c)(6)(iii) 2 ...... 31,283 1 31,283 1 31,283

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TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued

Number of Average Type of declaration/CFR section Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping

Dietary Fiber/§ 101.9(c)(6)(i) 2 ...... 31,283 1 31,283 1 31,283 Soluble Fiber/§ 101.9(c)(6)(i)(A) 2 ...... 31,283 1 31,283 1 31,283 Insoluble Fiber/§ 101.9(c)(6)(i)(B) 2 ...... 31,283 1 31,283 1 31,283 Dietary Fiber/§ 101.9(c)(6)(i) ...... 28 1 28 1 28 Vitamin E/§ 101.9(c)(8) 3 ...... 31,283 1 31,283 1 31,283 Folate/Folic Acid/§ 101.9(c)(8) 3 ...... 31,283 1 31,283 1 31,283 Total ...... 187,726 Total Initial Hours ...... 187,726 New Products ...... 216 1 216 1 216 Total Recurring Hours ...... 216 Total Burden Hours ...... 187,942 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars, dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and naturally occurring sugars and prod- ucts with non-digestible carbohydrates (soluble or insoluble) that do and do not meet the definition of dietary fiber. 3 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is being made or these nutrients are directly added to the food for enrichment purposes.

Based on our experience with food nutrition labeling for such product. B. Reporting Requirements labeling regulations, we believe that the Thus, it is estimated that 28 Description of Respondents: The new records that would be required to manufacturers would incur a likely respondents to this information be retained by the final rules are records recordkeeping burden associated with collection are manufacturers of retail that a prudent and responsible filing a citizen petition to amend the food products marketed in the United manufacturer uses and retains as a listing of dietary fiber related to an States, whose products contain: (1) A normal part of doing business, e.g., isolated and synthetic non-digestible combination of both naturally occurring analyses of nutrient databases, recipes carbohydrate that is not currently listed and added sugars; or (2) a mixture of or formulations, batch records, or other in the definition of dietary fiber and that non-digestible carbohydrates that do records. Thus, the recordkeeping burden the required recordkeeping would be 1 and do not meet the definition of dietary of the final rules consists of the time hour per manufacturer. The declaration fiber, soluble fiber, and insoluble fiber. required to identify and assemble the of vitamin E and folate/folic acid is not The likely respondents to this records for copying and retention. Based mandatory unless a health or nutrient information collection also include on our previous experience with similar content claim is being made or these manufacturers of retail food products recordkeeping requirements, we nutrients are directly added to the food marketed in the United States, whose estimate the recordkeeping burden of for enrichment purposes. However, we products contain: (1) Mixtures of the Nutrition Facts Label rule to be 1 conservatively estimate that all roughly different forms of vitamin E; or (2) both hour per product as estimated in table 31,283 food manufacturers would incur folate and folic acid if a health or 1. this recordkeeping burden and that the nutrient content claim is being made or Under the Nutrition Facts label rule, required recordkeeping would be 1 hour these nutrients are directly added to the the declarations for added sugars, per manufacturer. food for enrichment purposes. dietary fiber, soluble fiber, and It is hard to predict with certainty the Description: Under the Nutrition Facts insoluble fiber are mandatory, and we exact number of newly introduced label rule, we require that firms provide conservatively estimate that all roughly products that would be covered under records upon request during an 31,283 food manufacturers would incur the Nutrition Facts label rule each year, inspection that they use to verify the this recordkeeping burden and that the but based on the industry growth rate declared amounts of added sugars, required recordkeeping would be 1 hour estimated using U.S. Census Bureau dietary fiber, soluble fiber, insoluble per manufacturer. We estimate that Business and Industry data, we estimate fiber, vitamin E, and folate/folic acid on there are approximately 28 isolated or that number to be about 216. Thus, we the Nutrition Facts or Supplement Facts synthetic non-digestible carbohydrates estimate that about 216 new products label. that do not meet the definition of would be affected by the Nutrition Facts The reporting requirement is dietary fiber. Once a citizen petition Label rule, and that the required necessary because, at the present time, filed by a manufacturer related to a recordkeeping would be 1 hour per analytical methods are not available that particular isolated or synthetic non- product, for an annual recurring would allow us to differentiate between digestible carbohydrate is granted or recordkeeping burden of 216 hours (216 naturally occurring and added sugars, denied, or the carbohydrate is the × 1). Adding the burden from new non-digestible carbohydrates that both subject of an authorized health claim, products to the burden for existing do and do not meet the definition of and the dietary fiber is listed in the products results in a total of 187,942 dietary fiber, soluble fiber, and definition of dietary fiber, the use of the recordkeeping burden hours for the insoluble fiber, the various forms of dietary fiber as an ingredient in any covered establishments under the vitamin E, and folate or folic acid in food product must be included in the Nutrition Facts Label rule, as reported order to quantify the amount of added total amount of dietary fiber declared in in table 1. sugars, dietary fiber, vitamin E, or

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folate/folic acid in the final food the qualifying amount of nutrient. The inspection. We would review the product. For these foods, we must rely food manufacturer would assemble and records to verify the label declaration on information known only to the provide the records to FDA regulatory and assess compliance. manufacturer to assess compliance with officials upon request during an

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average Type of declaration/CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response

Added Sugars/§ 101.9(c)(6)(iii) 2 ...... 31,283 1 31,283 1 31,283 Dietary Fiber/§ 101.9(c)(6)(i) 2 ...... 31,283 1 31,283 1 31,283 Soluble Fiber/§ 101.9(c)(6)(i)(A) 2 ...... 31,283 1 31,283 1 31,283 Insoluble Fiber/§ 101.9(c)(6)(i)(B) 2 ...... 31,283 1 31,283 1 31,283 Vitamin E/§ 101.9(c)(8) 3 ...... 31,283 1 31,283 1 31,283 Folate/Folic Acid/§ 101.9(c)(8) 3 ...... 31,283 1 31,283 1 31,283

Total ...... 187,698

Total Initial Hours ...... 187,698

New Products ...... 216 1 216 1 216

Total Recurring Hours ...... 216

Total Burden Hours ...... 187,914 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars, dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and naturally occurring sugars and prod- ucts with non-digestible carbohydrates (soluble or insoluble) that do and do not meet the definition of dietary fiber. 3 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is being made or these nutrients are directly added to the food for enrichment purposes.

Based on our experience with food We do not expect to request records 187,698 hours. Also, in accordance with labeling regulations, we believe that the from all covered manufacturers to assess our previous estimate of the number of records that would be required to be compliance, but for the purpose of this newly introduced products that would provided to FDA, upon request, are analysis the number of respondents is be covered by the requirements to be records that a prudent and responsible conservatively estimated to be all 216, we estimate the recurring reporting manufacturer uses and retains as a covered establishments. We estimate the burden hours to be 216. Adding the normal part of doing business, e.g., number of responses per record keeper burden from new products to the initial analyses of nutrient databases, recipes to be 1 and the hourly burden per hours results in a total of 187,914 or formulations, batch records, or other response to be 1 hour. Built into the reporting burden hours for the covered records. Thus, the reporting burden to estimate of 1 hour is the range from 0 establishments under the Nutrition the food manufacturer consists of the hours, for some covered manufacturers Facts Label rule, as estimated in table 2. time required to assemble and provide that do not need to maintain records, to C. Third-Party Disclosure Requirements the records to appropriate regulatory a larger number of hours for some officials. Based on our previous covered manufacturers, such as those Description of Respondents: experience with similar reporting who produce fermented foods, which Respondents to this collection of requirements, we estimate the reporting may require more time to gather or information include manufacturers of burden of the Nutrition Facts Label rule produce the necessary records. As food products. We estimate the burden to be 1 hour per response, as estimated shown in table 2, the initial reporting of this collection of information as in table 2. burden for covered establishments is follows:

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of Average 21 CFR section Number of disclosures Total annual burden per Total hours Total capital costs respondents per respondent disclosures disclosure (in billions of 2014$)

101.9 and 101.36 ...... 31,283 26 813,358 2 1,626,716 $2.47 1 There are no operating and maintenance costs associated with this collection of information.

We have estimated that the burden would be approximately 2 hours per D. Third-Party Disclosure Burden for associated with the Nutrition Facts disclosure, for a total burden of Manufacturers Label rule would be a burden created by 1,626,716 hours. the need for food manufacturers to The incremental time burden for revise their nutrition labels. We estimate reviewing labels to assess how to bring them into compliance with the that the third party disclosure burden requirements of the Nutrition Facts label

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rule has been estimated to be 1 hour per intended preemption of State law, or Food Products’’. Journal of Nutrition label. These requirements do not where the exercise of State authority Education and Behavior. 2013;45:767– generate any recurring burden per label conflicts with the exercise of Federal 772. because establishments must already authority under the Federal statute.’’ 2. Institute of Medicine (IOM) of the National Section 403A of the FD&C Act (21 Academies. ‘‘Front-of-Package Nutrition print packaging for food products as Rating Systems and Symbols: Promoting part of normal business practices, and U.S.C. 343–1) is an express preemption Healthier Choices’’, Washington, DC: must disclose required nutrition provision. Section 403A(a) of the FD&C National Academies Press; 2012. information under the NLEA. Act provides that no State or political 3. U.S. Food and Drug Administration. Each label redesign would require an subdivision of a State may directly or ‘‘Resources for You’’, 2016. Retrieved estimated 1 additional hour, making the indirectly establish under any authority from: http://www.fda.gov/Food/ total burden hours to be 2 hours in or continue in effect as to any food in ResourcesForYou. burden per UPC. interstate commerce with respect to any 4. U.S. Department of Agriculture. We estimate that about 31,283 requirement for nutrition labeling of Agricultural Research Service—Nutrient manufacturers representing about food that is not identical to the Data Laboratory. ‘‘USDA National Nutrient Database for Standard 813,358 UPCs, with an average requirement of section 403(q) of the Reference, Release 27’’, 2014. Retrieved disclosure of 26 (813,358/31,283), FD&C Act. from: http://www.ars.usda.gov/ba/bhnrc/ would be covered under the Nutrition The express preemption provision of ndl. Facts label rule. The total number of section 403A(a) of the FD&C Act does 5. Institute of Medicine (IOM) of the National responses is equal to the total number not preempt any State or local Academies. ‘‘Dietary Reference Intakes of UPCs being changed. Multiplying the requirement respecting a statement in for Energy, Carbohydrate, Fiber, Fat, total number of responses by the hours the labeling of food that provides for a Fatty Acids, Cholesterol, Protein, and per response gives the total burden warning concerning the safety of the Amino Acids (Macronutrients)’’, hours (Table 3, Column 6). Based on the food or component of the food (section Washington, DC: National Academies 6(c)(2) of the Nutrition Labeling and Press; 2002. RIA, we have estimated the capital cost 6. Graham J.D. ‘‘Memorandum for the to be $2.47 billion (2014$). Education Act of 1990, Public Law 101– President’s Management Council— The information collection provisions 535, 104 Stat. 2353, 2364 (1990)). If this Guidance on Agency Survey and in this final rule have been submitted to proposed rule is made final, the final Statistical Information Collections’’, OMB for review as required by section rule would create requirements that fall 2006. 3507(d) of the Paperwork Reduction Act within the scope of section 403A(a) of 7. American Association for Public Opinion of 1995. Before the effective date of this the FD&C Act. Research. ‘‘Why Sampling Works’’. 2006. final rule, we will publish a notice in (Comment 544) One comment argued 8. U.S. Food and Drug Administration. the Federal Register announcing OMB’s that our federalism analysis in the ‘‘What We Do’’, 2016. Retrieved from: http://www.fda.gov/AboutFDA/ decision to approve, modify, or proposed rule should have included a discussion of the limits which the First WhatWeDo/default.htm. disapprove the information collection 9. Cowburn G., L.S., ‘‘Consumer provisions in this final rule. Amendment places on Federal law. The Understanding and Use of Nutrition An Agency may not conduct or comment also said that section 403A of Labeling: A Systematic Review’’. Public sponsor, and a person is not required to the FD&C Act is limited to food in Health Nutrition. 2005;8:21–28. respond to, a collection of information interstate commerce. 10. Kim S.Y., Nayga R.M., Capps Jr O. ‘‘Food unless it displays a currently valid OMB (Response) It is correct that, as quoted Label Use, Self-Selectivity, and Diet control number. in the proposed rule’s Federalism Quality’’. The Journal of Consumer section, section 403A of the FD&C Act Affairs. 2001;35:346–363. VI. Analysis of Environmental Impact applies to food in interstate commerce. 11. Lin C.T.J., Lee J.Y. ‘‘Who Uses Food Label We have carefully considered the We decline to change our Federalism Information—a Case Study of Dietary potential environmental effects of this section to include a First Amendment Fat’’. Journal of Food Products Marketing. 2004;10:17–37. action. We have concluded that the analysis. The Federalism section 12. U.S. Food and Drug Administration. action will not have a significant impact discusses the limitations on states or ‘‘Memorandum to File: Experimental on the human environment, and that an political subdivisions of a State with Study of Proposed Changes to the environmental impact statement is not regard to requirements for food labeling. Nutrition Facts Label Formats (OMB No. required (Refs. 275–276). Our finding of We address First Amendment 0910–0774)—Table 7’’, 2015. no significant impact and the evidence arguments in part II.C.1. 13. U.S. Food and Drug Administration. ‘‘Memorandum to File: Experimental supporting that finding, contained in an VIII. References environmental assessment, may be seen Study of Proposed Changes to the in the Division of Dockets Management The following references are on Nutrition Facts Label Formats— display in the Division of Dockets Additional Analyses (OMB No. 0910– (HFA–305), Food and Drug 0774)’’, 2016. Administration, 5630 Fishers Lane, Rm. Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 14. U.S. Food and Drug Administration. 1061, Rockville, MD 20852, between 9 ‘‘Memorandum to File: Experimental a.m. and 4 p.m., Monday through 1061, Rockville, MD 20852, and are Study on Consumer Responses to the Friday. available for viewing by interested Nutrition Facts Labels with Declaration persons between 9 a.m. and 4 p.m., of Amount of Added Sugars (OMB VII. Federalism Monday through Friday; they are also Control Number 0910–0764)’’, 2015. We have analyzed this proposed rule available electronically at http:// 15. U.S. Food and Drug Administration. in accordance with the principles set www.regulations.gov. FDA has verified ‘‘Memorandum to the File: Eye-Tracking forth in Executive Order 13132. Section the Web site addresses, as of the date Experimental Study on Consumer 4(a) of the Executive Order requires this document publishes in the Federal Responses to Modifications to the Register, but Web sites are subject to Nutrition Facts Label Outlined in the Agencies to ‘‘construe * * * a Federal Food and Drug Administration’s statute to preempt State law only where change over time. Proposed Rulemaking (Docket FDA– the statute contains an express 1. Sinclair S., Hammon D., Goodman S. 2012–N–1210)’’, 2015. preemption provision or there is some ‘‘Sociodemographic Differences in the 16. U.S. Food and Drug Administration. other clear evidence that the Congress Comprehension of Nutrition Labels on ‘‘Regulatory Impact Analysis for Final

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Rules On: ‘‘Food Labeling: Revision of Intakes for Energy, Carbohydrate, Fiber, Reduced Risk of Heart Disease’’, 2007. the Nutrition and Supplement Facts Fat, Fatty Acids, Cholesterol, Protein, Retrieved from: http://www.fda.gov/ Labels’’ (Docket FDA–2012–N–1210 and and Amino Acids (Macronutrients), food/ingredientspackaginglabeling/ ‘‘Food Labeling: Serving Sizes of Foods Chapter 5: Energy’’, Washington, DC: labelingnutrition/ucm073631.htm. That Can Reasonably Be Consumed at National Academies Press; 2002. 36. Institute of Medicine (IOM) of the One Eating Occasion; Dual-Column 25. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Labeling; Updating, Modifying, and National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Establishing Certain Reference Amounts Intakes: Guiding Principles for Nutrition Fat, Fatty Acids, Cholesterol, Protein, Customarily Consumed; Serving Size for Labeling and Fortification’’, Washington, and Amino Acids (Macronutrients), Breath Mints; and Technical DC: National Academies Press; 2003. Chapter 7: Dietary, Functional, and Total Amendments’’, 2016. 26. U.S. Food and Drug Administration. Fiber’’, Washington, DC: National 17. National Heart Lung and Blood Institute. ‘‘Memorandum to the File: Comments Academies Press; 2002. ‘‘Lifestyle Interventions to Reduce Considered in the Development of the 37. U.S. Food and Drug Administration. Cardiovascular Risk: Systematic Revision of the Nutrition and ‘‘Letter Responding to Health Claim Evidence Review from the Lifestyle Supplements Facts Proposed Rule’’, Petition Dated November 3, 2003 (Martek Work Group’’, Bethesda, MD; 2013. 2014. Petition): Omega-3 Fatty Acids and 18. Eckel R.H., Jakicic J.M., Ard J.D., et al. 27. IUPAC. Compendium of Chemical Reduced Risk of Coronary Heart Disease ‘‘2013 AHA/ACC Guideline on Lifestyle Terminology (the ‘‘Goldbook’’). 2nd ed. (Docket No. 2003q–0401)’’, 2004. Management to Reduce Cardiovascular Oxford: Blackwell Scientific Retrieved from: http://www.fda.gov/ Risk: A Report of the American College Publications, 1997. food/ingredientspackaginglabeling/ of Cardiology/American Heart 28. U.S. Department of Health and Human labelingnutrition/ucm072932.htm. Association Task Force on Practice Services and U.S. Department of 38. Institute of Medicine (IOM) of the Guidelines’’. Journal of the American Agriculture. ‘‘Dietary Guidelines for National Academies. ‘‘Dietary Reference College of Cardiology. 2014;63:2960– Americans 2015–2020’’, 8th ed. Intakes for Calcium and Vitamin D, 2984. Washington, DC: U.S. Government Chapter 5: Dietary Reference Intakes for 19. U.S. Department of Agriculture and U.S. Printing Office, 2015–2020. Retrieved Adequacy: Calcium and Vitamin D’’, Department of Health and Human from: http://health.gov/ Washington, DC: National Academies Services. ‘‘Scientific Report of the 2015 dietaryguidelines/2015/guidelines/. Press; 2011. Dietary Guidelines Advisory 29. Institute of Medicine (IOM) of the 39. Akabas S.R., Deckelbaum R.J. ‘‘Summary Committee’’, Advisory Report to the National Academies. ‘‘Dietary Reference of a Workshop on N–3 Fatty Acids: Secretary of Health and Human Services Intakes for Energy, Carbohydrate, Fiber, Current Status of Recommendations and Future Directions’’. American Journal of and the Secretary of Agriculture. Fat, Fatty Acids, Cholesterol, Protein, Washington, DC, 2015. Retrieved from: . 2006;83:1536S– and Amino Acids (Macronutrients), http://health.gov/dietaryguidelines/ 1538S. Chapter 8: Dietary Fats: Total Fat and 2015-scientific-report/PDFs/Scientific- 40. Papanikolaou Y., Brooks J., Reider C., et Fatty Acids’’, Washington, DC: National Report-of-the-2015-Dietary-Guidelines- al. ‘‘U.S. Adults Are Not Meeting Academies Press; 2002. Advisory-Committee.pdf. Recommended Levels for Fish and 30. U.S. Department of Agriculture and U.S. 20. U.S. Department of Agriculture and U.S. Omega-3 Fatty Acid Intake: Results of an Department of Health and Human Department of Health and Human Analysis Using Observational Data from Services. ‘‘Scientific Report of the 2015 Services. ‘‘Dietary Guidelines for NHANES 2003–2008’’. Nutrition Journal. Dietary Guidelines Advisory Committee, Americans, 2010’’, 7th ed. Washington, 2014;13:31. Figure D1.36 Food Sources of Added DC: U.S. Government Printing Office, 41. Madden S.M., Garrioch C.F., Holub B.J. Sugars’’, Advisory Report to the 2010. Retrieved from: http://www.cnpp. ‘‘Direct Diet Quantification Indicates Secretary of Health and Human Services usda.gov/DGAs2010-Policy Low Intakes of (N–3) Fatty Acids in and the Secretary of Agriculture. Document.htm. Children 4 to 8 Years Old’’. Journal of Washington, DC: U.S. Government 31. Eckel R.H., Jakicic J.M., Ard J.D., et al. Nutrition. 2009;139:528–532. Printing Office, 2015. Retrieved from: ‘‘2013 AHA/ACC Guideline on Lifestyle 42. Casula M., Soranna D., Catapano A.L., et http://health.gov/dietaryguidelines/ Management to Reduce Cardiovascular al. ‘‘Long-Term Effect of High Dose 2015-scientific-report/PDFs/Scientific- Risk: A Report of the American College Omega-3 Fatty Acid Supplementation for Report-of-the-2015-Dietary-Guidelines- of Cardiology/American Heart Secondary Prevention of Cardiovascular Advisory-Committee.pdf. Association Task Force on Practice Outcomes: A Meta-Analysis of 21. Centers for Disease Control and Guidelines’’. Circulation. 2014;129:S76– Randomized, Double Blind, Placebo Prevention (CDC). National Center for 99. Controlled Trials’’. Atherosclerosis Health Statistics (NCHS). ‘‘National 32. Stone N.J., Robinson J.G., Lichtenstein Supplements. 2013;14:243–251. Health and Nutrition Examination A.H., et al. ‘‘2013 ACC/AHA Guideline 43. Danaei G., Ding E.L., Mozaffarian D., et Survey 2009–2010, Consumer Behavior on the Treatment of Blood Cholesterol to al. ‘‘The Preventable Causes of Death in Phone Follow-up Module-Adult, Reduce Atherosclerotic Cardiovascular the United States: Comparative Risk Question DBQ–750’’. Hyattsville, MD, Risk in Adults: A Report of the American Assessment of Dietary, Lifestyle, and 2016. Retrieved from: https://wwwn.cdc. College of Cardiology/American Heart Metabolic Risk Factors’’. PLoS Medicine. gov/Nchs/Nhanes/2009-2010/CBQPFA_ Association Task Force on Practice 2009;6:e1000058. F.htm#DBQ750. Guidelines’’. Circulation. 2014;129:S1– 44. Kotwal S., Jun M., Sullivan D., et al. 22. Centers for Disease Control and 45. ‘‘Omega 3 Fatty Acids and Prevention (CDC). National Center for 33. AOAC. ‘‘AOAC Official Method 996.06, Cardiovascular Outcomes: Systematic Health Statistics (NCHS). ‘‘National Fat (Total, Saturated, and Unsaturated) Review and Meta-Analysis’’. Circulation Health and Nutrition Examination in Foods’’. Official Methods of Analysis Cardiovascular Quality and Outcomes. Survey 2009–2010, Consumer Behavior (AOAC). Gaithersburg, MD: AOAC 2012;5:808–818. Phone Follow-up Module-Adult, International, 2008. 45. Kwak S.M., Myung S.K., Lee Y.J., et al. Question DBQ–685’’. Hyattsville, MD, 34. Tyburczy C., Mossoba M.M., Rader J.I. ‘‘Efficacy of Omega-3 Fatty Acid 2016. Retrieved from: https://wwwn.cdc. ‘‘Determination of Trans Fat in Edible Supplements (Eicosapentaenoic Acid gov/Nchs/Nhanes/2009-2010/ Oils: Current Official Methods and and Docosahexaenoic Acid) in the CBQPFA_F.htm#CBQ685. Overview of Recent Developments’’. Secondary Prevention of Cardiovascular 23. U.S. Food and Drug Administration. Analytical and Bioanalytical Chemistry. Disease: A Meta-Analysis of Center for Food Safety and Applied 2013;405:5759–5772. Randomized, Double-Blind, Placebo- Nutrition. ‘‘2014 FDA Health and Diet 35. U.S. Food and Drug Administration. Controlled Trials’’. Archives of Internal Survey’’. 2016. ‘‘Health Claim Notification for Medicine. 2012;172:686–694. 24. Institute of Medicine (IOM) of the Substitution of Saturated Fat in the Diet 46. Lim S.S., Vos T., Flaxman A.D., et al. ‘‘A National Academies. ‘‘Dietary Reference with Unsaturated Fatty Acids and Comparative Risk Assessment of Burden

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of Disease and Injury Attributable to 67 Not Increase Biomarkers for Chronic 72. Opinion Research Corporation Risk Factors and Risk Factor Clusters in Disease in a Pediatric Population from International. ‘‘Online Caravan Nutrition 21 Regions, 1990–2010: A Systematic Northern ’’. American Journal of Facts Label’’. Princeton, NJ, 2014. Analysis for the Global Burden of Clinical Nutrition. 2004;80:855–861. 73. World Health Organization. ‘‘Guideline: Disease Study 2010’’. The Lancet. 59. Fernandez M.L., Webb D. ‘‘The LDL to Sugars Intake for Adults and Children’’. 2012;380:2224–2260. HDL Cholesterol Ratio as a Valuable Tool Geneva: World Health Organization, 47. Rizos E.C., Ntzani E.E., Bika E., et al. to Evaluate Coronary Heart Disease 2015. Retrieved from: http://who.int/ ‘‘Association between Omega-3 Fatty Risk’’. Journal of the American College of mediacentre/news/notes/2014/ Acid Supplementation and Risk of Major Nutrition. 2008;27:1–5. consultation-sugar-guideline/en/. Cardiovascular Disease Events: A 60. Greene C.M., Zern T.L., Wood R.J., et al. 74. Johnson R.K., Appel L.J., Brands M., et al. Systematic Review and Meta-Analysis’’. ‘‘Maintenance of the LDL ‘‘Dietary Sugars Intake and JAMA: The Journal of the American Cholesterol:HDL Cholesterol Ratio in an Cardiovascular Health: A Scientific Medical Association. 2012;308:1024– Elderly Population Given a Dietary Statement from the American Heart 1033. Cholesterol Challenge’’. Journal of Association’’. Circulation. 48. Engell R.E., Sanman E., Lim S.S., et al. Nutrition. 2005;135:2793–2798. 2009;120:1011–1020. ‘‘Seafood Omega-3 Intake and Risk of 61. Herron K.L., Vega-Lopez S., Conde K., et 75. Institute of Medicine (IOM) of the Coronary Heart Disease Death: An al. ‘‘Pre-Menopausal Women, Classified National Academies. ‘‘Dietary Reference Updated Meta-Analysis with as Hypo- or Hyperresponders, Do Not Intakes for Energy, Carbohydrate, Fiber, Implications for Attributable Burden’’. Alter Their LDL/HDL Ratio Following a Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), The Lancet. 2013;381:S45. High Dietary Cholesterol Challenge’’. Chapter 6: Dietary Carbohydrates: Sugars 49. Mozaffarian D., Lemaitre R.N., King I.B., Journal of the American College of et al. ‘‘Plasma Phospholipid Long-Chain and Starches’’, Washington, DC: National Nutrition. 2002;21:250–258. Omega-3 Fatty Acids and Total and Academies Press; 2002. 62. Li Y., Zhou C., Zhou X., et al. ‘‘Egg Cause-Specific Mortality in Older 76. National Cancer Institute. ‘‘Usual Dietary Consumption and Risk of Cardiovascular Adults: A Cohort Study’’. Annals of Intakes: Food Intakes, US Population, Diseases and Diabetes: A Meta- Internal Medicine. 2013;158:515–525. 2007-10: Applied Research Program.’’, Analysis’’. Atherosclerosis. 50. Nehra D., Pan A.H., Le H.D., et al. 2015. Retrieved from: http:// 2013;229:524–530. ‘‘Docosahexaenoic Acid, G Protein- epi.grants.cancer.gov/diet/usualintakes/ 63. Rong Y., Chen L., Zhu T., et al. ‘‘Egg Coupled Receptors, and Melanoma: Is G pop/2007-10/table_a41.html. Consumption and Risk of Coronary Heart Protein-Coupled Receptor 40 a Potential 77. U.S. Department of Agriculture and U.S. Disease and Stroke: Dose-Response Meta- Therapeutic Target?’’. Journal of Surgical Department of Health and Human Analysis of Prospective Cohort Studies’’. Research. 2014;188:451–458. Services. ‘‘Report of the Dietary British Medical Journal. 2013;346:e8539. 51. Miller P.E., Van Elswyk M., Alexander Guidelines Advisory Committee on the D.D. ‘‘Long-Chain Omega-3 Fatty Acids 64. Scrafford C.G., Tran N.L., Barraj L.M., et Dietary Guidelines for Americans’’. Eicosapentaenoic Acid and al. ‘‘Egg Consumption and Chd and Washington, DC: U.S. Government Docosahexaenoic Acid and Blood Stroke Mortality: A Prospective Study of Printing Office, 2010. Retrieved from: Pressure: A Meta-Analysis of US Adults’’. Public Health Nutrition. http://www.cnpp.usda.gov/DGAs2010– Randomized Controlled Trials’’. 2011;14:261–270. DGACReport.htm. American Journal of Hypertension. 65. Shin J.Y., Xun P., Nakamura Y., et al. 78. U.S. Department of Agriculture and U.S. 2014;27:885–896. ‘‘Egg Consumption in Relation to Risk of Department of Health and Human 52. EFSA. ‘‘Scientific Opinion: Labelling Cardiovascular Disease and Diabetes: A Services. ‘‘Dietary Guidelines for Reference Intake Values for N-3 and Systematic Review and Meta-Analysis’’. Americans’’, Home and Gardening N-6 Polyunsaturated Fatty Acids. Global American Journal of Clinical Nutrition. Bulleting No 232, 2nd ed. Washington Recommendation for EPA and DHA 2013;98:146–159. DC: U.S. Government Printing Office, Intake’’. EFSA Journal. 2009;1176:1–11. 66. Voutilainen S., Nurmi A., Mursu J., et al. 1985. 53. Institute of Medicine (IOM) of the ‘‘Regular Consumption of Eggs Does Not 79. U.S. Department of Agriculture and U.S. National Academies. ‘‘Dietary Reference Affect Carotid Plaque Area or Risk of Department of Health and Human Intakes for Energy, Carbohydrate, Fiber, Acute Myocardial Infarction in Finnish Services. ‘‘Dietary Guidelines for Fat, Fatty Acids, Cholesterol, Protein, Men’’. Atherosclerosis. 2013;227:186– Americans’’, Home and Gardening and Amino Acids (Macronutrients), 188. Bulletin No 232, 1st ed. Washington DC: Chapter 9: Cholesterol’’, Washington, 67. Fernandez M.L. ‘‘Rethinking Dietary U.S. Government Printing Office, 1980. DC: National Academies Press; 2002. Cholesterol’’. Current Opinion in Clinical Retrieved from: http://health.gov/ 54. Weggemans R.M., Zock P.L., Katan M.B. Nutrition and Metabolic Care. dietaryguidelines/1985thin.pdf. ‘‘Dietary Cholesterol from Eggs Increases 2012;15:117–121. 80. U.S. Department of Health and Human the Ratio of Total Cholesterol to High- 68. McNamara D.J. ‘‘Dietary Cholesterol, Services and U.S. Department of Density Lipoprotein Cholesterol in Heart Disease Risk and Cognitive Agriculture. ‘‘Dietary Guidelines for Humans: A Meta-Analysis’’. American Dissonance’’. Proceedings of the Americans, 2005’’, 6th ed. Washington, Journal of Clinical Nutrition. Nutrition Society. 2014;73:161–166. DC: U.S. Government Printing Office, 2001;73:885–891. 69. Merrill A.L., Watt B.K. ‘‘Energy Value of 2005. Retrieved from: http://health.gov/ 55. Grande F., Anderson J.T., Chlouverakis Foods. Basis and Derivation’’. Human dietaryguidelines/dga2005/doc. C., et al. ‘‘Effect of Dietary Cholesterol on Nutrition Research Branch, Agricultural 81. U.S. Department of Agriculture and U.S. Man’s Serum Lipids’’. Journal of Research Service, US Department of Department of Health and Human Nutrition. 1965;87:52–62. Agriculture, Agriculture Handbook No Services. ‘‘Nutrition and Your Health, 56. Hopkins P.N. ‘‘Effects of Dietary 74, 1973. Dietary Guidelines for Americans’’, Cholesterol on Serum Cholesterol: A 70. Iida T., Hayashi N., Yamada T., et al. Home and Gardening Bulletin No 232, Meta-Analysis and Review’’. American ‘‘Failure of D-Psicose Absorbed in the 3rd ed. Washington, DC: U.S. Journal of Clinical Nutrition. Small Intestine to Metabolize into Energy Government Printing Office, 1990. 1992;55:1060–1070. and Its Low Large Intestinal Retrieved from: http://www.health.gov/ 57. Howell W.H., McNamara D.J., Tosca Fermentability in Humans’’. Metabolism: DietaryGuidelines/1990thin.pdf. M.A., et al. ‘‘Plasma Lipid and Clinical and Experimental. 2010;59:206– 82. U.S. Department of Agriculture and U.S. Lipoprotein Responses to Dietary Fat and 214. Department of Health and Human Cholesterol: A Meta-Analysis’’. 71. Matsuo T., Suzuki H., Hashiguchi M., et Services. ‘‘Nutrition and Your Health, American Journal of Clinical Nutrition. al. ‘‘D-Psicose Is a Rare Sugar That Dietary Guidelines for Americans’’, 1997;65:1747–1764. Provides No Energy to Growing Rats’’. Home and Gardening Bulletin No 232, 58. Ballesteros M.N., Cabrera R.M., Saucedo Journal of and 4th ed. Washington, DC: U.S. Mdel S., et al. ‘‘Dietary Cholesterol Does Vitaminology. 2002;48:77–80. Government Printing Office, 1995.

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Retrieved from: http:// 94. Schatzkin A., Kipnis V., Carroll R.J., et al. the Secretary of Health and Human www.cnpp.usda.gov/Publications/ ‘‘A Comparison of a Food Frequency Services and the Secretary of DietaryGuidelines/1995/ Questionnaire with a 24-Hour Recall for Agriculture. Washington, DC 2015. 1995DGConsumerBrochure.pdf. Use in an Epidemiological Cohort Study: Retrieved from: http://health.gov/ 83. U.S. Department of Agriculture and U.S. Results from the Biomarker-Based dietaryguidelines/2015-scientific-report/ Department of Health and Human Observing Protein and Energy Nutrition PDFs/Scientific-Report-of-the-2015- Services. ‘‘Nutrition and Your Health, (Open) Study’’. International Journal of Dietary-Guidelines-Advisory- Dietary Guidelines for Americans’’, Epidemiology. 2003;32:1054–1062. Committee.pdf. Home and Gardening Bulletin No 232, 95. Thompson F.E., Subar A.F. ‘‘Chapter 1: 105. International Food Information Council 5th ed. Washington, DC: U.S. Dietary Assessment Methodology’’. In: (IFIC) Foundation and the U.S. Food and Government Printing Office, 2000. Coulston AM, Boushey, C.J., Ferruzzi, Drug Administration. ‘‘Food Ingredients Retrieved from: http://www.health.gov/ M.G., ed. Nutrition in the Prevention and and Colors’’, 2010. Retrieved from: dietaryguidelines/dga2000/dietgd.pdf. Treatment of Disease; 2013. http://www.fda.gov/downloads/Food/ 84. U.S. Department of Agriculture and U.S. 96. Kit B.K., Fakhouri T.H., Park S., et al. IngredientsPackagingLabeling/ Department of Health and Human ‘‘Trends in Sugar-Sweetened Beverage ucm094249.pdf. Services. ‘‘Scientific Report of the 2015 Consumption among Youth and Adults 106. Weaver D., Finke M. ‘‘The Relationship Dietary Guidelines Advisory Committee, in the United States: 1999–2010’’. between the Use of Sugar Content Chapter 6’’, Advisory Report to the American Journal of Clinical Nutrition. Information on Nutrition Labels and the Secretary of Health and Human Services 2013;98:180–188. Consumption of Added Sugars’’. Food and the Secretary of Agriculture. 97. National Cancer Institute Division of Policy. 2003. Washington DC, 2015. Retrieved from: Cancer Control and Population 107. Laquatra I., Sollid K., Smith Edge M., et http://health.gov/dietaryguidelines/ Sciences—Epidemiology and Genomics al. ‘‘Including ‘‘Added Sugars’’ on the 2015-scientific-report/PDFs/Scientific- Research Program. ‘‘Usual Intake of Nutrition Facts Panel: How Consumers Report-of-the-2015-Dietary-Guidelines- Added Sugars, Table A40.’’, Added Perceive the Proposed Change’’. Journal Advisory-Committee.pdf. Sugars: Means, Percentiles and Standard of the Academy of Nutrition and 85. U.S. Food and Drug Administration. Errors of Usual Intake, 2007-2010. Dietetics. 2015;115:1758–1763. ‘‘Guidance for Industry: Evidence-Based Retrieved from: http:// 108. Graham D.J., Jeffery R.W. ‘‘Predictors of Review System for Scientific Evaluation epi.grants.cancer.gov/diet/usualintakes/ Nutrition Label Viewing During Food of Health Claims- Final’’, 2009. Retrieved pop/2007-10/table_a40.html. Purchase Decision Making: An Eye from: http://www.fda.gov/food/ 98. U.S. Department of Agriculture and U.S. Tracking Investigation’’. Public Health guidanceregulation/guidancedocuments Department of Health and Human Nutrition. 2012;15:189–197. regulatoryinformation/labelingnutrition/ Services. ‘‘Scientific Report of the 2015 109. U.S. Food and Drug Administration. ucm073332.htm. Dietary Guidelines Advisory Committee, ‘‘Comment to Docket FDA–2012–N–1210 86. Liese A.D., Krebs-Smith S.M., Subar A.F., Table D6.1, Chapter 6, P. 19’’, Scientific from American Heart Association & et al. ‘‘The Dietary Patterns Methods Report of the 2015 Dietary Guidelines American Stroke Association’’. 2015. Project: Synthesis of Findings across Advisory Committee. Washington DC: 110. U.S. Food and Drug Administration. Cohorts and Relevance to Dietary U.S. Government Printing Office, 2015. ‘‘Memorandum to the File: Comments on Guidance’’. Journal of Nutrition. Retrieved from: http://health.gov/ Proposed Format Changes to the 2015;145:393–402. Nutrition Facts Label Added Sugars 87. George S.M., Ballard-Barbash R., Manson dietaryguidelines/2015-scientific-report/ J.E., et al. ‘‘Comparing Indices of Diet PDFs/Scientific-Report-of-the-2015- Declaration’’; 2016A. Quality with Chronic Disease Mortality Dietary-Guidelines-Advisory- 111. U.S. Food and Drug Administration. Risk in Postmenopausal Women in the Committee.pdf. ‘‘Memorandum to the File: Comments on Women’s Health Initiative Observational 99. Abaluck J. ‘‘What Would We Eat If We Proposed Format Changes to the Study: Evidence to Inform National Knew More: The Implications of a Large- Nutrition Facts Label Added Sugars Dietary Guidance’’. American Journal of Scale Change in Nutrition Labeling’’; Declaration’’; 2016B. Epidemiology. 2014;180:616–625. 2011. 112. Kools M. Making Reading Materials 88. Harmon B.E., Boushey C.J., Shvetsov 100. Murphy S.P., Johnson R.K. ‘‘The Easier to Understand. Los Angeles: Sage, Y.B., et al. ‘‘Associations of Key Diet- Scientific Basis of Recent US Guidance 2012. Quality Indexes with Mortality in the on Sugars Intake’’. American Journal of 113. Spyridakis J.H. ‘‘Signaling Effects: Multiethnic Cohort: The Dietary Patterns Clinical Nutrition. 2003;78:827S–833S. Increased Content Retention and New Methods Project’’. American Journal of 101. Schroeder N., Park Y.H., Kang M.S., et Answers—Part II’’. Journal of technical Clinical Nutrition. 2015;101:587–597. al. ‘‘A Randomized Trial on the Effects writing and communication. 89. Reedy J., Krebs-Smith S.M., Miller P.E., of 2010 Dietary Guidelines for 1989;19:395–415. et al. ‘‘Higher Diet Quality Is Associated Americans and Korean Diet Patterns on 114. Spyridakis J.H., Standal T.C. ‘‘Signals in with Decreased Risk of All-Cause, Cardiovascular Risk Factors in Expository Prose: Effects on Reading Cardiovascular Disease, and Cancer Overweight and Obese Adults’’. Journal Comprehension’’. Reading Research Mortality among Older Adults’’. Journal of the Academy of Nutrition and Quartely. 1987:285–298. of Nutrition. 2014;144:881–889. Dietetics. 2015;115:1083–1092. 115. Chung J.S. ‘‘Signals and Reading 90. Fung T.T., Chiuve SE., McCullough M.L., 102. Marriott B.P., Olsho L., Hadden L., et al. Comprehension—Theory and Practice’’. et al. ‘‘Adherence to a Dash-Style Diet ‘‘Intake of Added Sugars and Selected System. 2000;28:247–259. and Risk of Coronary Heart Disease and Nutrients in the United States, National 116. Wright P. ‘‘The Comprehension of Stroke in Women’’. Archives of Internal Health and Nutrition Examination Tabulated Information: Some Medicine. 2008;168:713–720. Survey (NHANES) 2003–2006’’. Critical Similarities between Reading Prose and 91. Folsom A.R., Parker E.D., Harnack L.J. Reviews in and Nutrition. Reading Tables’’. NSPI Journal. ‘‘Degree of Concordance with Dash Diet 2010;50:228–258. 1980;19:25–29. Guidelines and Incidence of 103. Institute of Medicine (IOM) of the 117. Rhee S.J., Lee J.E., Lee C.H. ‘‘Importance Hypertension and Fatal Cardiovascular National Academies. ‘‘Dietary Reference of Bacteria in Asian Disease’’. American Journal of Intakes for Energy, Carbohydrate, Fiber, Fermented Foods’’. Microb Cell Fact. Hypertension. 2007;20:225–232. Fat, Fatty Acids, Cholesterol, Protein, 2011;10 Suppl 1:S5. 92. Yang Q., Zhang Z., Gregg E.W., et al. and Amino Acids (Macronutrients), 118. Yun J.W., Kang S.C., Song S.K. ‘‘Added Sugar Intake and Cardiovascular Chapter 11, P. 788’’; 2002. ‘‘Mannitol Accumulation During Diseases Mortality among US Adults’’. 104. U.S. Department of Agriculture and U.S. Fermentation of Kimchi’’. Journal of JAMA Intern Med. 2014;174:516–524. Department of Health and Human Fermentation and Bioengineering. 93. Lee R., Nieman D. Nutritional Services. ‘‘Scientific Report of the 2015 1996;81:279–280. Assessment. Dubuque, IA: Wm. C. Dietary Guidelines Advisory Committee, 119. Golon A., Kuhnert N. ‘‘Unraveling the Brown, 1993; pp. 57–58. Figure D1.31, P.146’’, Advisory Report to Chemical Composition of Caramel’’.

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Journal of Agricultural and Food 133. Wilson E.B. An Introduction to Polydextrose’’. Nutrition Reviews. Chemistry. 2012;60:3266–3274. Scientific Research. Toronto: General 2007;65:544–549. 120. U.S. Food and Drug Administration. Publishing Company, 1990. 147. Mariotti F., Tome D., Mirand P.P. ‘‘Memorandum to the File: Effects of 134. Institute of Medicine (IOM) of the ‘‘Converting Nitrogen into Protein— Maillard Reaction, Caramelization, and National Academies. ‘‘Dietary Beyond 6.25 and Jones’ Factors’’. Critical Fermentation on Added Sugar Content of Supplements: A Framework for Review in Food Science and Nutrition. Foods’’, 2014. Evaluating Safety. Chapter 7, Categories 2008;48:177–184. 121. Codex Alimentarius. ‘‘Guidelines on of Scientific Evidence—in Vitro Data’’, 148. Morr C.V. ‘‘Recalculated Nitrogen Nutrition Labeling CAC/GL 2–1985’’, Washington DC; National Academies Conversion Factors for Several 2010. Retrieved from: Press; 2005, pp. 217–234. Protein Products’’. Journal of Food www.codexalimentarius.net/download/ 135. Institute of Medicine (IOM) of the Science. 1982;47:1751–1752. standards/34/CXG_002e.pdf. National Academies. ‘‘Dietary Reference 149. Mosse J. ‘‘Nitrogen to Protein 122. U.S. Food and Drug Administration. Intakes for Energy, Carbohydrate, Fiber, Conversion Factors for Ten Cereals and Office of Nutrition and Food Labeling. Fat, Fatty Acids, Cholesterol, Protein, Six Legumes or Oilseeds: A Reappraisal ‘‘Guidance for Industry: A Food Labeling and Amino Acids (Macronutrients), Page of Its Definition and Determination’’. Guide’’, 2013. Retrieved from: http:// 346’’. 2002. Journal of Agricultural and Food www.fda.gov/food/guidanceregulation/ 136. Howlett J.F., Betteridge V.A., Champ M., Chemistry. 1990;38:18–24. guidancedocumentsregulatory et al. ‘‘The Definition of Dietary Fiber— 150. Sarwar G., Christensen D.A., Finlayson information/labelingnutrition/ Discussions at the Ninth Vahouny Fiber A.J., et al. ‘‘Inter-and-Intra-Laboratory ucm2006828.htm. Symposium: Building Scientific Variation in Amino Acid Analysis of 123. Hess J., Latulippe M.E., Ayoob K., et al. Agreement’’. Food & Nutrition Research. Food Proteins’’. Journal of Food Science. ‘‘The Confusing World of Dietary Sugars: 2010;54. 1983;526–531. Definitions, Intakes, Food Sources and 137. U.S. Food and Drug Administration. 151. Sosulski F.W., Imafidon G.I. ‘‘Amino International Dietary ‘‘Memorandum to the File: Scientific Acid Composition and Nitrogen-to- Recommendations’’. Food & Function. Review of the Beneficial Physiological Protein Conversion Factors for Animal 2012;3:477–486. Effects of Non-Digestible Carbohydrates and Plant Foods’’. Journal of Agricultural 124. U.S. Department of Agriculture and U.S. for Meeting the FDA Definition of and Food Chemistry. 1990;38:1351– Department of Health and Human Dietary Fiber’’, 2016. 1356. Services. ‘‘Scientific Report of the 2015 138. Institute of Medicine (IOM) of the 152. Tkachuk R. ‘‘Nitrogen-to-Protein Dietary Guidelines Advisory Committee, National Academies. ‘‘Dietary Reference Conversion Factors for Cereals and Appendix E–3.1’’, Advisory Report to the Intakes: Proposed Definition of Dietary Oilseed Meals’’. Cereal Chemistry. Fiber’’, Washington DC: National Secretary of Health and Human Services 1969;46:419–423. Academies Press; 2001. and the Secretary of Agriculture. 153. Tome D. ‘‘Digestibility Issues of 139. National Research Council (NRC). ‘‘Diet Washington DC, 2015. Retrieved from: Vegetable Versus Animal Proteins: and Health: Implications for Reducing http://health.gov/dietaryguidelines/ Protein and Amino Acid Requirements— Chronic Disease Risk’’, Washington, DC; Functional Aspects’’. Food and Nutrition 2015-scientific-report/PDFs/Scientific- National Academies Press; 1989. Bulletin. 2013;34:272–274. Report-of-the-2015-Dietary-Guidelines- 140. EFSA. ‘‘Scientific Opinion on the 154. Food and Agriculture Organization of Advisory-Committee.pdf. Substantiation of Health Claims Related 125. Te Morenga L., Mallard S., Mann J. to Acacia Gum (Gum Arabic) and the United Nations. ‘‘Dietary Protein ‘‘Dietary Sugars and Body Weight: Reduction of Post-Prandial Glycaemic Quality Evaluation in Human Nutrition’’, Systematic Review and Meta-Analyses of Responses (Id 842, 1977) and Rome; 2013. Randomised Controlled Trials and Maintenance of Normal Blood Glucose 155. Hendriks W.H., van Baal J., Bosch G. Cohort Studies’’. British Medical Journal. Concentrations (Id 842, 1977) Pursuant ‘‘Ileal and Faecal Protein Digestibility 2013;346:e7492. to Article 13(1) of Regulation (EC) No Measurement in Humans and Other Non- 126. Moynihan P.J., Kelly S.A. ‘‘Effect on 1924/2006’’. EFSA Journal. 2010. Ruminants—a Comparative Species Caries of Restricting Sugars Intake: 141. Torres D.P.M., Gonsalves M.P.F., View’’. British Journal of Nutrition. Systematic Review to Inform WHO Teixeira J.A. ‘‘Galacto-Oligosaccharides: 2012;108 Suppl 2:S247–257. Guidelines’’. Journal of Dental Research. Production, Properties, Applications, 156. Rutherfurd S.M., Fanning A.C., Miller 2014;93:8–18. and Significance as Prebiotics’’. B.J., et al. ‘‘Protein Digestibility- 127. U.S. Food and Drug Administration. Comprehensive Reviews in Food Science Corrected Amino Acid Scores and ‘‘Calories Count:Report of the Working and Food Safety. 2010;9:438–454. Digestible Indispensable Amino Acid Group on Obesity’’, 2004. Retrieved 142. International Food Information Council. Scores Differentially Describe Protein from: http://www.fda.gov/Food/Food ‘‘Food and Health Survey. Consumer Quality in Growing Male Rats’’. Journal ScienceResearch/ConsumerBehavior Attitudes Towards Food Safety, of Nutrition. 2015;145:372–379. Research/ucm081696.htm. Nutrition and Health’’, 2013. Retrieved 157. Uauy R. ‘‘Report of a Sub-Committee of 128. EU. ‘‘Regulation No. 1169/2011 of the from: http://www.foodinsight.org/ the 2011 FAO Consultation on ‘‘Protein European Parliment and of the Council, articles/2013-food-and-health- Quality Evaluation in Human October 2011’’. 2011. survey#sthash.T9Xfw7Mh.dpbs. Nutrition’’ ’’; 2012. 129. Life Sciences Research Office (LSRO). 143. Maningat C.C., Seib P., Bassi S.D. 158. World Health Organization. Food and ‘‘The Evaluation of the Energy of Certain ‘‘Dietary Fiber Content of Cross-Linked Agriculture Organization. United Sugar Alcohols Used as Food Phosphorylated Resistant Starch (Rs4) Nations University. ‘‘Protein and Amino Ingredients’’, Bethesda, MD: Life Determined by the Prosky and Mccleary Acid Requirements in Human Nutrition: Sciences Research Office; 1994. Methods. Part II. Comparison of Assay Report of a Joint FAO/WHO/UNU Expert 130. Life Sciences Research Office (LSRO). Data’’. Cereal Foods World. 2013;58:252– Consultation’’; 2007. ‘‘Evaluation of the Net Energy Value of 263. 159. World Health Organization. Food and Maltitol’’, Bethesda, MD: Life Sciences 144. World Health Organization & Food and Agriculture Organization. United Research Office; 1999. Agriculture Organization (WHO/FAO). Nations University. ‘‘Energy and Protein 131. Livesey G. ‘‘The Energy Values of ‘‘Diet, Nutrition and Prevention of Requirements: Report of a Joint FAO/ Dietary Fibre and Sugar Alcohols for Chronic Diseases’’, Geneva: World WHO/UNU Expert Consultation’’; 1985. Man’’. Nutrition Research Reviews. Health Organization; 2003. 160. Food and Agriculture Organization & 1992;5:61–84. 145. EFSA. ‘‘Scientific Opinion on Dietary World Health Organization (FAO/WHO). 132. Hiele M., Ghoos Y., Rutgeerts P., et al. Reference Values for Cabohydrates and ‘‘Protein Quality Evaluation: Report of ‘‘Metabolism of Erythritol in Humans: Dietary Fibre’’. EFSA Journal. 2010;8:1– Jopint FAO/WHO Expert Consultation’’; Comparison with Glucose and Lactitol’’. 77. 1991. British Journal of Nutrition. 146. Auerbach M.H., Craig S.A., Howlett J.F., 161. Centers for Disease Control and 1993;69:169–176. et al. ‘‘Caloric Availability of Prevention. ‘‘Nutrition for Everyone:

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Basics: Protein’’, 2012. Retrieved from: 175. U.S. Food and Drug Administration. 187. Institute. ‘‘Shopping for http://www.cdc.gov/nutrition/everyone/ ‘‘Proposed Changes to the Nutrition Health Survey, Tables 22, 24, and 26 and basics/protein.html. Facts Label’’, 2014. Retrieved from: Chart 12’’; 2004, pp. 42, 43, 45, and 48. 162. Fryar C.D., Gu Q., Ogden C.L. http://www.fda.gov/Food/Guidance 188. Food Marketing Institute. ‘‘Shopping for ‘‘Anthropometric Reference Data for Regulation/GuidanceDocuments Health Survey’’; 2011, p. 8. Children and Adults: United States, RegulatoryInformation/Labeling 189. Schleicher R.L., Carroll M.D., Ford E.S., 2007–2010’’. Vital and Health Statistics Nutrition/ucm385663.htm. et al. ‘‘Serum Vitamin C and the Series 11: Data from the National Health 176. Maillot M., Monsivais P., Drewnowski Prevalence of Vitamin C Deficiency in Survey. 2012:1–48. A. ‘‘Food Pattern Modeling Shows That the United States: 2003–2004 National 163. U.S. Department of Agriculture. ‘‘What the 2010 Dietary Guidelines for Sodium Health and Nutrition Examination We Eat in America, NHANES 2011– and Potassium Cannot Be Met Survey (NHANES)’’. American Journal of 2012, Individuals 2 Years and over Simultaneously’’. Nutrition Research. Clinical Nutrition. 2009;90:1252–1263. (Excluding Breast-Fed Children), Day 1’’, 2013;33:188–194. 190. Centers for Disease Control and Prevention. National Center for 2013. Retrieved from: www.ars.usda.gov/ 177. ‘‘Intersalt: An International Study of Environmental Health Division of nea/bhnrc/fsrg. Electrolyte Excretion and Blood 164. International Food Information Council. Laboratory Sciences. ‘‘Second National Pressure. Results for 24 Hour Urinary ‘‘2014 Food & Health Survey: Consumer Report on Biochemical Indicators of Diet Sodium and Potassium Excretion. Attitudes toward Food, Nutrition & and Nutrition in the U.S. Population,’’ Health’’. Washington DC, 2014. Intersalt Cooperative Research Group’’. 2012. Retrieved from: http:// 165. Institute of Medicine (IOM) of the British Medical Journal. 1988;297:319– www.cdc.gov/nutritionreport/pdf/ National Academies. ‘‘Strategies to 328. Nutrition_Book_complete508_ Reduce Sodium Intake in the United 178. Powles J., Fahimi S., Micha R., et al. final.pdf#zoom=100. States’’, Washington, DC: National ‘‘Global, Regional and National Sodium 191. Gibson R.S. Principles of Nutrition Academies Press; 2010. Intakes in 1990 and 2010: A Systematic Assessment, Page 534. New York, 2005. 166. Institute of Medicine (IOM) of the Analysis of 24 H Urinary Sodium 192. U.S. Department of Agriculture and U.S. National Academies. ‘‘Dietary Reference Excretion and Dietary Surveys Department of Health and Human Intakes for Water, Potassium, Sodium, Worldwide’’. British Medical Journal Services. ‘‘Scientific Report of the 2015 Chloride, and Sulfate, Chapter 6: Sodium Open. 2013;3:e003733. Dietary Guidelines Advisory Committee, and Chloride’’, Washington, DC: 179. Graudal N.A., Hubeck-Graudal T., Part D, Chapter 1’’, Advisory Report to National Academies Press; 2005, pp. Jurgens G. ‘‘Effects of Low-Sodium Diet the Secretary of Health and Human 269–423. Vs. High-Sodium Diet on Blood Pressure, Services and the Secretary of 167. Institute of Medicine (IOM) of the Renin, Aldosterone, Catecholamines, Agriculture. Washington DC, 2015. National Academies. ‘‘Sodium Intake in Cholesterol, and Triglyceride (Cochrane Retrieved from: http://health.gov/ Populations: Assessment of Evidence’’, Review)’’. American Journal of dietaryguidelines/2015-scientific-report/ Washington, DC: National Academies Hypertension. 2012;25:1–15. PDFs/Scientific-Report-of-the-2015- Press; 2013, pp. 235–284. 180. Alderman M.H., Madhavan S., Ooi W.L., Dietary-Guidelines-Advisory- 168. Graudal N., Jurgens G., Baslund B., et al. et al. ‘‘Association of the Renin-Sodium Committee.pdf. ‘‘Compared with Usual Sodium Intake, Profile with the Risk of Myocardial 193. Institute of Medicine (IOM) of the Low- and Excessive-Sodium Diets Are Infarction in Patients with National Academies. ‘‘Dietary Reference Associated with Increased Mortality: A Hypertension’’. New England Journal of Intakes for Vitamin A, Vitamin K, Meta-Analysis’’. American Journal of Medicine. 1991;324:1098–1104. Arsenic, Boron, Chromium, Copper, Hypertension. 2014;27:1129–1137. 181. Ekinci E.I., Clarke S., Thomas M.C., et Iodine, Iron, Manganese, Molybdenum, 169. U.S. Food and Drug Administration. al. ‘‘Dietary Salt Intake and Mortality in Nickel, Silicon, Vanadium, and Zinc, ‘‘2002 Health and Diet Survey: Topline Patients with Type 2 Diabetes’’. Diabetes Chapter 4: Vitamin A’’, Washington, DC: Frequency Report’’, 2007. Retrieved Care. 2011;34:703–709. National Academies Press; 2001, pp. 82– from: http://www.fda.gov/food/food 182. Thomas W., Harvey B.J. ‘‘Mechanisms 161. scienceresearch/consumerbehavior Underlying Rapid Aldosterone Effects in 194. Fulgoni V.L., 3rd, Keast D.R., Bailey research/ucm202786.htm. the Kidney’’. Annual Review of R.L., et al. ‘‘Foods, Fortificants, and Supplements: Where Do Americans Get 170. U.S. Food and Drug Administration. Physiology. 2011;73:335–357. Their Nutrients?’’. Journal of Nutrition. ‘‘Health and Diet Survey: Dietary 183. U.S. Department of Health and Human 2011;141:1847–1854. Guidelines Supplement—Report Services. Office of Disease Prevention Findings (2004 & 2005)’’, 2008. Retrieved 195. Berner L.A., Keast D.R., Bailey R.L., et and Health Promotion. ‘‘Nutrition from: http://www.fda.gov/downloads/ al. ‘‘Fortified Foods Are Major Assessment for DRI Review’’, 2014. Food/ScienceResearch/ResearchAreas/ Contributors to Nutrient Intakes in Diets Retrieved from: http://health.gov/dietary ConsumerResearch/UCM080413.pdf. of US Children and Adolescents’’. guidelines/dri/nutrient-assessment.asp. 171. U.S. Food and Drug Administration. Journal of the Academy of Nutrition and ‘‘2008 Health and Diet Survey: Topline 184. U.S. Public Health Service. ‘‘U.S. Public Dietetics. 2014;114:1009–1022 e1008. Frequencies’’, 2010. Retrieved from: Health Service Recommendation for 196. U.S. Food and Drug Administration. http://www.fda.gov/food/foodscience Fluoride Concentration in Drinking ‘‘Memorandum to the File: Evaluation research/consumerbehaviorresearch/ Water for the Prevention of Dental Process of the Public Health Significance ucm193895.htm. Caries’’, 2015. Retrieved from: http:// of Essential Vitamins and Minerals’’, 172. Cook N.R., Cutler J.A., Obarzanek E., et www.publichealthreports.org/fluoride 2014. al. ‘‘Long Term Effects of Dietary Sodium guidelines.cfm. 197. U.S. Department of Agriculture. Reduction on Cardiovascular Disease 185. Institute of Medicine (IOM) of the ‘‘Special Supplemental Nutrition Program Outcomes: Observational Follow-up of National Academies. ‘‘Dietary Reference for Women, Infants and Children (WIC): the Trials of Hypertension Prevention Intakes for Calcium, Phosphorous, Revisions in the WIC Food Packages; Final (Tohp)’’. British Medical Journal. Magnesium, Vitamin D, and Fluoride, Rule. Federal Register, Vol. 79, No. 42. 2007;334:885–888. Chapter 8: Fluoride’’, Washington, DC: March 4 (Part II).’’, 2014. Retrieved from: 173. Whelton P.K. ‘‘Sodium, Blood Pressure, National Academies Press; 1997, pp. http://www.fns.usda.gov/sites/default/ and Cardiovascular Disease: A 288–313. files/03-04-14_WIC-Food-Packages-Final- Compelling Scientific Case for Improving 186. U.S. Environmental Protection Agency Rule.pdf. the Health of the Public’’. Circulation. (EPA) Health and Ecological Criteria 198. Institute of Medicine (IOM) of the 2014;129:1085–1087. Division Office of Water. ‘‘Fluoride: National Academies. ‘‘Dietary Reference 174. Cook N.R., Appel L.J., Whelton P.K. Exposure and Relative Source Intakes for Calcium and Vitamin D, ‘‘Lower Levels of Sodium Intake and Contribution Analysis’’, 2010. Retrieved Chapter 3: Overview of Vitamin D’’, Reduced Cardiovascular Risk’’. from: http://water.epa.gov/action/ Washington DC; National Academies Press; Circulation. 2014;129:981–989. advisories/drinking/fluoride_index.cfm. 2011.

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199. U.S. Food and Drug Administration. Contents in Muscle: Role of Na(+)-K+ Perspective of Triage Theory: Why Modest ‘‘Memorandum to the File: Documentation Pump’’. American Journal of Physiology. Selenium Deficiency May Increase Risk of for the Methodology Used to Determine 1993;264:C457–463. Diseases of Aging’’. FASEB Journal. Total Usual Intakes of Vitamins and 215. Matsuda H. ‘‘Magnesium Gating of the 2011;25:1793–1814. Minerals Compared to Tolerable Upper Inwardly Rectifying K+ Channel’’. Annual 229. EFSA. ‘‘Scientific Opinion of the Panel Levels (UL) and Results of Analysis’’, 2014. Review of Physiology. 1991;53:289–298. on Dietetic Products Nutrition and 200. Institute of Medicine (IOM) of the 216. Guasch-Ferre M., Bullo M., Estruch R., Allergies on a Request from the European National Academies. ‘‘Dietary Reference et al. ‘‘Dietary Magnesium Intake Is Commisiion on the Safety of Vitamin K2’’. Intakes for Calcium and Vitamin D’’, Inversely Associated with Mortality in EFSA Journal. 2008;822:1–32. Washington DC; National Academies Press; Adults at High Cardiovascular Disease 230. Geleijnse J.M., Vermeer C., Grobbee D.E., 2011. Risk’’. Journal of Nutrition. 2014;144:55– et al. ‘‘Dietary Intake of Menaquinone Is 201. Looker A.C., Melton L.J., 3rd, Harris 60. Associated with a Reduced Risk of T.B., et al. ‘‘Prevalence and Trends in Low 217. Hruby A., Ngwa J.S., Renstrom F., et al. Coronary Heart Disease: The Rotterdam Femur Bone Density among Older US ‘‘Higher Magnesium Intake Is Associated Study’’. Journal of Nutrition. Adults: NHANES 2005–2006 Compared with Lower Fasting Glucose and Insulin, 2004;134:3100–3105. with NHANES III’’. Journal of Bone and with No Evidence of Interaction with 231. Gast G.C., de Roos N.M., Sluijs I., et al. Mineral Research. 2010;25:64–71. Select Genetic Loci, in a Meta-Analysis of ‘‘A High Menaquinone Intake Reduces the 202. U.S. Department of Health and Human 15 Charge Consortium Studies’’. Journal of Incidence of Coronary Heart Disease’’. Services. ‘‘Bone Health and Osteoporosis: Nutrition. 2013;143:345–353. Nutrition Metabolism and Cardiovascular A Report of the Surgeon General’’. 218. Institute of Medicine (IOM) of the Disease. 2009;19:504–510. Rockville, MD: Public Health Service National Academies. ‘‘Dietary Reference 232. Iwamoto J. ‘‘Vitamin K(2) Therapy for Office of the Surgeon General, 2004. Intakes for Calcium, Phosphorous, Postmenopausal Osteoporosis’’. Nutrients. Retrieved from: http:// Magnesium, Vitamin D, and Fluoride, 2014;6:1971–1980. www.surgeongeneral.gov/library/reports/ Chapter 6: Magnesium’’, Washington DC; 233. Health Canada. ‘‘Health Canada’s bonehealth/. National Academies Press; 1997. Proposed Changes to the Daily Values 203. Institute of Medicine (IOM) of the 219. Institute of Medicine (IOM) of the (Dvs) for Use in Nutrition Labelling’’, 2014. National Academies. ‘‘Dietary Reference National Academies. ‘‘Dietary Reference Retrieved from: http://www.hc-sc.gc.ca/fn- Intakes for Calcium and Vitamin D, Intakes: Guiding Principles for Nutrition an/consult/2014-daily-value-valeurs- Chapter 4’’, Washington DC; 2011. Labeling and Fortification’’, Washington quotidiennes/document-consultation- 204. U.S. Food and Drug Administration. DC; National Academies Press; 2003, pp. eng.php. ‘‘Memorandum to the File: Declaration of 111–113. 234. Institute of Medicine (IOM) of the Current Voluntarily Declared Essential 220. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference Vitamins and Minerals and Choline’’, 2014. National Academies. ‘‘Dietary Reference Intakes for Vitamin a, Vitamin K, Arsenic, 205. Chiemchaisri Y., Phillips P.H. ‘‘Effect of Intakes: Applications in Dietary Planning’’, Boron, Chromium, Copper, Iodine, Iron, Dietary Fluoride Upon the Magnesium Washington, DC: National Academies Manganese, Molybdenum, Nickel, Silicon, Calcinosis Syndrome’’. Journal of Press; 2003. Vanadium, and Zinc, Chapter 5: Vitamin Nutrition. 1963;81:307–311. 221. U.S. Food and Drug Administration. K’’, Washington, DC: National Academies 206. Chiemchaisri Y., Phillips P.H. ‘‘Certain ‘‘Nutrition Information for Raw Fruits, Press; 2001, pp. 162–196. Factors Including Fluoride Which Affect 235. Shearer M.J., Fu X., Booth S.L. ‘‘Vitamin Magnesium Calcinosis in the Dog and Rat’’. Vegetables, and Fish’’, 2015. Retrieved Journal of Nutrition. 1965;86:23–28. from: http://www.fda.gov/food/ K Nutrition, Metabolism, and 207. Kruse H.D., Orent R.E., McCollum E.V. ingredientspackaginglabeling/ Requirements: Current Concepts and ‘‘Studies on Magnesium Deficiency in labelingnutrition/ucm063367.htm. Future Research’’. Advances in Nutrition. Animals, Part 1: Symptomatology 222. U.S. Department of Agriculture. 2012;3:182–195. Resulting from Magnesium Deprivation’’. ‘‘Nutrition Labeling Information’’, 2015. 236. Shearer M.J., Newman P. ‘‘Recent Journal of Biological Chemistry. Retrieved from: http://www.fsis.usda.gov/ Trends in the Metabolism and Cell Biology 1932;100:603–643. wps/portal/fsis/topics/regulatory- of Vitamin K with Special Reference to 208. Seelig M.S. ‘‘The Requirement of compliance/labeling/labeling-policies/ Vitamin K Cycling and Mk-4 Magnesium by the Normal Adult. nutrition-labeling-policies/nutrition- Biosynthesis’’. Journal of Lipid Research. Summary and Analysis of Published Data’’. labeling. 2014;55:345–362. American Journal of Clinical Nutrition. 223. Aburto N.J., Hanson S., Gutierrez H., et 237. U.S. Pharmacopeial Convention. ‘‘Safety 1964;14:342–390. al. ‘‘Effect of Increased Potassium Intake on Data Sheet. Phytonadione’’, 2013. 209. Tufts E.V., Greenberg D.M. ‘‘The Cardiovascular Risk Factors and Disease: Retrieved from: http://www.usp.org/pdf/ Biochemistry of Magnesium Deficiency I. Systematic Review and Meta-Analyses’’. EN/referenceStandards/msds/1538006.pdf. Chemical Changes Resulting from British Medical Journal. 2013;346:f1378. 238. Institute of Medicine (IOM) of the Magnesium Deprivation’’. Journal of 224. Weaver C.M. ‘‘Potassium and Health’’. National Academies. ‘‘Dietary Reference Biological Chemistry. 1938;122:693–714. Advances in Nutrition. 2013;4:368S–377S. Intakes for Thiamin, Riboflavin, Niacin, 210. Iseri L.T., Chung P., Tobis J. 225. Murphy M.M., Spungen J.H., Barraj Vitamin B6, Folate, Vitamin B12, ‘‘Magnesium Therapy for Intractable L.M., et al. ‘‘Revising the Daily Values May Pantothenic Acid, Biotin, and Choline, Ventricular Tachyarrhythmias in Affect Food Fortification and in Turn Chapter 8: Folate’’, Washington, DC: Normomagnesemic Patients’’. West Journal Nutrient Intake Adequacy’’. Journal of National Academies Press; 1998, pp. 196– of Medicine. 1983;138:823–828. Nutrition. 2013;143:1999–2006. 305. 211. Iseri L.T., Freed J., Bures A.R. 226. Institute of Medicine (IOM) of the 239. Block L.G., Peracchio L.A. ‘‘The Calcium ‘‘Magnesium Deficiency and Cardiac National Academies. ‘‘Dietary Reference Quandary: How Consumers Use Nutrition Disorders’’. American Journal of Medicine. Intakes for Vitamin a, Vitamin K, Arsenic, Labels’’. Journal of Public Policy & 1975;58:837–846. Boron, Chromium, Copper, Iodine, Iron, Marketing. 2006;25:188–196. 212. Iseri L.T., French J.H. ‘‘Magnesium: Manganese, Molybdenum, Nickel, Silicon, 240. Christen S., Woodall A.A., Shigenaga Nature’s Physiologic Calcium Blocker’’. Vanadium, and Zinc, Chapter 12: Zinc’’, M.K., et al. ‘‘Gamma-Tocopherol Traps American Heart Journal. 1984;108:188– Washington, DC: National Academies Mutagenic Electrophiles Such as No(X) and 193. Press; 2001, pp. 442–501. Complements Alpha-Tocopherol: 213. Dritsa V., Pissaridi K., Koutoulakis E., et 227. Bertinato J., Simpson J.R., Sherrard L., Physiological Implications’’. Proceedings al. ‘‘An Infrared Spectroscopic Study of et al. ‘‘Zinc Supplementation Does Not of the National Academy of Sciences of the Aortic Valve. A Possible Mechanism of Alter Sensitive Biomarkers of Copper United States of America. 1997;94:3217– Calcification and the Role of Magnesium Status in Healthy Boys’’. Journal of 3222. Salts’’. In Vivo. 2014;28:91–98. Nutrition. 2013;143:284–289. 241. Jiang Q., Ames B.N. ‘‘Gamma- 214. Dorup I., Clausen T. ‘‘Correlation 228. McCann J.C., Ames B.N. ‘‘Adaptative Tocopherol, but Not Alpha-Tocopherol, between Magnesium and Potassium Dysfunction of Selenoproteins from Decreases Proinflammatory Eicosanoids

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and Inflammation Damage in Rats’’. FASEB 254. Walravens P.A., Hambidge K.M., 269. Center for Science in the Public Interest. Journal. 2003;17:816–822. Koepfer D.M. ‘‘Zinc Supplementation in ‘‘Comment to Docket No. FDA–2012–1210 242. Jiang Q., Yin X., Lill M.A., et al. ‘‘Long- Infants with a Nutritional Pattern of Failure from the Center for Science in the Public Chain Carboxychromanols, Metabolites of to Thrive: A Double-Blind, Controlled Interest (CSPI), Page 38 and Appendix 1.’’, Vitamin E, Are Potent Inhibitors of Study’’. Pediatrics. 1989;83:532–538. 2014. Cyclooxygenases’’. Proceedings of the 255. Gidding S.S., Dennison B.A., Birch L.L., 270. U.S. Food and Drug Administration. National Academy of Sciences of the et al. ‘‘Dietary Recommendations for ‘‘Memorandum to File: Experimental Study United States of America. 2008;105:20464– Children and Adolescents: A Guide for of Proposed Changes to the Nutrition Facts 20469. Practitioners: Consensus Statement from Label Formats (OMB No. 0910–0774)’’, 243. Mahabir S., Schendel K., Dong Y.Q., et the American Heart Association’’. 2015. al. ‘‘Dietary Alpha-, Beta-, Gamma- and Circulation. 2005;112:2061–2075. 271. National Osteoporosis Foundation. Delta-Tocopherols in Lung Cancer Risk’’. 256. Institute of Medicine (IOM) of the 2016. Retrieved from: www.nof.org. International Journal of Cancer. National Academies. ‘‘Dietary Reference 272. U.S. Preventive Services Task Force. 2008;123:1173–1180. Intakes for Water, Potassium, Sodium, 2016. Retrieved from: 244. Sen C.K., Khanna S., Rink C., et al. Chloride, and Sulfate, Chapter 5: www.uspreventiveservicestaskforce.org. ‘‘Tocotrienols: The Emerging Face of Potassium’’, Washington, DC: National 273. International Food Information Council Natural Vitamin E’’. Vitamins and Academies Press; 2005, pp. 186–268. Foundation. ‘‘Food Label Consumer Hormones. 2007;76:203–261. 257. Kessler D.A., Mande J.R., Scarbrough Research Project: Final Qualitative 245. Wolf G. ‘‘How an Increased Intake of F.E., et al. ‘‘Developing the ‘Nutrition Report’’, 2010. Retrieved from: http:// Alpha-Tocopherol Can Suppress the Facts’ Food Label’’. Harvard Health Policy www.foodinsight.org/Content/3145/ Bioavailability of Gamma-Tocopherol’’. Review. 2003;4:13–24. FINAL%20IFIC%20Foundation%20 Nutrition Reviews. 2006;64:295–299. 258. U.S. Food and Drug Administration. Food%20Label%20Consumer%20 246. Institute of Medicine (IOM) of the ‘‘Memorandum to the File: Letter to Research%20-%20Phase%20III%20 National Academies. ‘‘Dietary Reference Division of Dockets Management from Summary%20Report.pdf. Intakes for Vitamin C, Vitamin E, General Mills’’. 2015. 274. U.S. Food and Drug Administration. Selenium, and Carotenoids, Chapter 6: 259. Lupton E. Thinking with Type: A ‘‘Preliminary Regulatory Impact Analysis Vitamin E’’, Washington, DC: National Critical Guide for Designers, Writers, (PRIA) for the Food Labeling: Revision of Academies Press; 2000, pp. 186–283. Editors, & Students. 2nd ed. New York, the Nutrition and Supplement Facts Labels 247. Institute of Medicine (IOM) of the NY: Princeton Archetectural Press, 2010; Notice of Proposed Rulemaking (Docket National Academies. ‘‘Dietary Reference pp. 132–133. No. FDA–2012–N–1210) and Food Intakes for Vitamin C, Vitamin E, 260. American Academy of Pediatrics. Labeling: Serving Sizes of Foods That Can Selenium, and Carotenoids, Chapter 6: ‘‘American Academy of Pediatrics Reasonably Be Consumed at One Eating Vitamin E, Table 6–1.’’, Washington DC; Committee on Nutrition’’. In: Kleinman RE, Occasion; Dual-Column Labeling; 2000. ed. Pediatric Nutrition Handbook. United Updating, Modifying, and Establishing 248. Institute of Medicine (IOM) of the States: American Academy of Pediatrics; Certain Reference Amounts Customarily National Academies. ‘‘Dietary Reference 2014; pp. 249–273. Consumed; Serving Size for Breath Mints; Intakes for Thiamin, Riboflavin, Niacin, 261. Institute of Medicine (IOM) of the and Technical Amendments Notice of Vitamin B6, Folate, Vitamin B12, National Academies. ‘‘Early Childhood Proposed Rulemaking (Docket No. FDA– Pantothenic Acid, Biotin, and Choline’’, Obesity Prevention Policies’’, Washington 2004–N–0258)’’, 2014. Washington, DC: National Academies DC; National Academies Press; 2011, pp. 275. U.S. Food and Drug Administration. Press; 1998. 93–94. ‘‘Supplemental Environmental Assessment 249. Institute of Medicine (IOM) of the 262. Lidwell W., Holden K., Buttler J. for the Revisions of the Nutrition and National Academies. ‘‘Dietary Reference Universal Principles of Design. 1st ed. Supplement Facts Label’’, 2016. Intakes for Thiamin, Riboflavin, Niacin, Beverly, MA: Rockport Publishers, 2003; 276. U.S. Food and Drug Administration. Vitamin B6, Folate, Vitamin B12, pp. 40–41. ‘‘Supplemental Finding of No Significant Pantothenic Acid, Biotin, and Choline, 263. The Free Dictionary. Retrieved from: Impact for the Revisions to the Nutrition Chapter 6: Niacin’’, Washington, DC: www.thefreedictionary.com/contrast. and Supplement Facts Label’’, 2016. National Academies Press; 1998. 264. Juan W.Y., Zhang Y., Kantor M.A., et al. 250. U.S. Department of Health and Human ‘‘Perceptions and Use of Nutrition Labeling List of Subjects in 21 CFR Part 101 Services. National Institutes of Health. Information’’. Abstract Presented at the Food labeling, Incorporation by National Heart Lung and Blood Institute. Experimental Biology Annual Meeting- reference, Nutrition, Reporting and ‘‘Integrated Guidelines for Cardiovascular Boston. 2013. Health and Risk Reduction in Children and 265. Zhang Y., Kantor M.A., Juan W. ‘‘Usage recordkeeping requirements. Adolescents:’’ The Report of the Expert and Understanding of Serving Size Therefore, under the Federal Food, Panel; NIH Publication No 12–7486A, Information on Food Labels in the United Drug, and Cosmetic Act and under 2012. Retrieved from: http:// States’’. American Journal of Health authority delegated to the Commissioner www.nhlbi.nih.gov/guidelines/cvd_ped/ Promotion. 2016;30:181–187. of Food and Drugs, 21 CFR part 101 is index.htm. 266. Centers for Disease Control and amended as follows: 251. Joint Food and Agriculture Organization Prevention (CDC). National Center for of the United States and World Health Health Statistics (NCHS). ‘‘National Health PART 101—FOOD LABELING Organization. ‘‘Protein Quality Evaluation. and Nutrition Examination Survey 2009– Report of Joint FAO/WHO Expert 2010, Consumer Behavior Phone Follow- ■ 1. The authority citation for part 101 Consultation’’, Rome Food and Agriculture up Module-Adult, Question DBQ–770’’, US continues to read as follows: Organization of the United Nations; 1991. Department of Health and Human Services, 252. Butte N.F., Fox M.K., Briefel R.R., et al. Centers for Disease Control and Prevention. Authority: 15 U.S.C. 1453, 1454, 1455; 21 ‘‘Nutrient Intakes of US Infants, Toddlers, Hyattsville, MD, 2016. Retrieved from: U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. and Preschoolers Meet or Exceed Dietary http://wwwn.cdc.gov/Nchs/Nhanes/2009- 243, 264, 271. _ Reference Intakes’’. Journal of the 2010/CBQPFA F.htm#DBQ770. ■ 2. In § 101.9: American Dietetic Association. 267. U.S. Food and Drug Administration. ■ a. Revise paragraphs (c)(1)(i)(A) 2010;110:S27–37. ‘‘Comment to the Docket No. FDA–2012– N–1210 from Kellog Company’’, 2014. through (E). 253. Institute of Medicine (IOM) of the ■ National Academies. ‘‘Dietary Reference 268. Gomez-Palacio B., Vit A. Graphic Design b. Add paragraph (c)(1)(i)(F). ■ Intakes for Calcium, Phosphorous, Referenced: A Visual Guide to the c. Remove paragraph (c)(1)(ii), Magnesium, Vitamin D, and Fluoride, Language, Applications, and History of redesignate paragraph (c)(1)(iii) as Chapter 7: Vitamin D’’, Washington DC; Graphic Design. 1st ed. Beverly, MA: (c)(1)(ii), and revise newly designated National Academies Press; 1997. Rockport Publishers, 2012; pp. 50–54. paragraph (c)(1)(ii).

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■ d. Revise paragraphs (c)(2), (c)(5), digestibility, as described in USDA nearest gram, except that if a serving (c)(6)(i) through (iv), (c)(7), (c)(8) Handbook No. 74 (slightly revised, contains less than 1 gram, declaration of introductory text, (c)(8)(i), (c)(8)(ii) 1973) p. 10; or dietary fiber is not required or, introductory text, and (c)(8)(iii) through (F) Using the following general factors alternatively, the statement ‘‘Contains (v). for caloric value of sugar alcohols: less than 1 gram’’ or ‘‘less than 1 gram’’ ■ e. Add paragraph (c)(8)(vii). Isomalt—2.0 calories per gram, may be used, and if the serving contains ■ f. Revise paragraphs (c)(9), (d)(1) lactitol—2.0 calories per gram, xylitol— less than 0.5 gram, the content may be introductory text, (d)(1)(iii) through (v), 2.4 calories per gram, maltitol—2.1 expressed as zero. Dietary fiber is (d)(2) through (d)(5), (d)(7) introductory calories per gram, sorbitol—2.6 calories defined as non-digestible soluble and text, (d)(7)(i), (d)(8) through (d)(9), per gram, hydrogenated starch insoluble carbohydrates (with 3 or more (d)(11)(ii), (d)(11)(iii), (d)(12), (d)(13)(ii), hydrolysates—3.0 calories per gram, monomeric units), and lignin that are (e), (f) introductory text, (f)(2)(ii), (f)(4) mannitol—1.6 calories per gram, and intrinsic and intact in plants; isolated or and (5), (g) introductory text, (g)(2), erythritol—0 calories per gram. synthetic non-digestible carbohydrates (g)(3)(ii), (g)(4) through (6), and (g)(8). (ii) ‘‘Calories from saturated fat’’ or (with 3 or more monomeric units) ■ g. Add paragraphs (g)(10) and (11). ‘‘Calories from saturated’’ determined by FDA to have ■ h. Revise paragraphs (h)(3)(iv), (h)(4) (VOLUNTARY): A statement of the physiological effects that are beneficial introductory text, (j)(5)(i), (j)(5)(ii) caloric content derived from saturated to human health. Except as provided for introductory text, and (j)(5)(ii)(A) and fat as defined in paragraph (c)(2)(i) of in paragraph (f) of this section, if dietary (B). this section in a serving may be declared fiber content is not required, and as a ■ i. Remove and reserve paragraphs voluntarily, expressed to the nearest 5- result not declared, the statement ‘‘Not (j)(5)(ii)(C) through (j)(5)(ii)(E); and calorie increment, up to and including a significant source of dietary fiber’’ ■ j. Add paragraph (j)(5)(iii). 50 calories, and the nearest 10-calorie shall be placed at the bottom of the table ■ k. Revise paragraphs (j)(13)(i), increment above 50 calories, except that of nutrient values in the same type size. (j)(13)(ii)(A)(1) and (2), and (j)(13)(ii)(B). amounts less than 5 calories may be The following isolated or synthetic non- ■ l. Remove paragraph (j)(13)(ii)(C) and expressed as zero. This statement shall digestible carbohydrate(s) have been redesignate paragraph (j)(13)(ii)(D) as be indented under the statement of determined by FDA to have (j)(13)(ii)(C). calories as provided in paragraph (d)(5) physiological effects that are beneficial ■ m. Revise paragraph (j)(18)(iv) of this section. to human health and, therefore, shall be introductory text. (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A included in the calculation of the ■ n. Add paragraph (l). statement of the number of grams of amount of dietary fiber: [beta]-glucan The revisions and additions read as total fat in a serving defined as total soluble fiber (as described in follows: lipid fatty acids and expressed as § 101.81(c)(2)(ii)(A)), psyllium husk (as § 101.9 Nutrition labeling of food. triglycerides where fatty acids are described in § 101.81(c)(2)(ii)(A)(6)), * * * * * aliphatic carboxylic acids consisting of cellulose, guar gum, pectin, locust bean (c) * * * a chain of alkyl groups and gum, and (1) * * * characterized by a terminal carboxyl hydroxypropylmethylcellulose. The (i) * * * group. Amounts shall be expressed to manufacturer must make and keep 1 (A) Using specific Atwater factors the nearest 0.5 ( ⁄2) gram increment records in accordance with paragraphs (i.e., the Atwater method) given in table below 5 grams and to the nearest gram (g)(10) and (11) of this section to verify 13, USDA Handbook No. 74 (slightly increment above 5 grams. If the serving the declared amount of dietary fiber in revised, 1973), contains less than 0.5 gram, the content the label and labeling of food when a (B) Using the general factors of 4, 4, shall be expressed as zero. mixture of dietary fiber, and added non- and 9 calories per gram for protein, total * * * * * digestible carbohydrate(s) that does not carbohydrate, and total fat, respectively, (5) ‘‘Fluoride’’ (VOLUNTARY): A meet the definition of dietary fiber, is as described in USDA Handbook No. 74 statement of the number of milligrams present in the food. (slightly revised, 1973) pp. 9–11; of fluoride in a specified serving of food (A) ‘‘Soluble fiber’’ (VOLUNTARY): A (C) Using the general factors of 4, 4, may be declared voluntarily, except that statement of the number of grams of and 9 calories per gram for protein, total when a claim is made about fluoride soluble dietary fiber in a serving may be carbohydrate (less the amount of non- content, label declaration shall be declared voluntarily except that when a digestible carbohydrates and sugar required. Fluoride content shall be claim is made on the label or in labeling alcohols), and total fat, respectively, as expressed as zero when the serving about soluble fiber, label declaration described in USDA Handbook No. 74 contains less than 0.1 milligrams of shall be required. Soluble fiber must (slightly revised, 1973) pp. 9–11. A fluoride, to the nearest 0.1-milligram meet the definition of dietary fiber in general factor of 2 calories per gram for increment when the serving contains this paragraph (c)(6)(i). The soluble non-digestible carbohydrates less than or equal to 0.8 milligrams of manufacturer must make and keep shall be used. The general factors for fluoride, and the nearest 0.2 milligram- records in accordance with paragraphs caloric value of sugar alcohols provided increment when a serving contains more (g)(10) and (11) of this section to verify in paragraph (c)(1)(i)(F) of this section than 0.8 milligrams of fluoride. Bottled the declared amount of soluble fiber in shall be used; water that bears a statement about the label and labeling of food when a (D) Using data for specific food factors added fluoride, as permitted by mixture of soluble fiber and added non- for particular foods or ingredients § 101.13(q)(8), must bear nutrition digestible carbohydrate(s) that does not approved by the Food and Drug labeling that complies with meet the definition of dietary fiber is Administration (FDA) and provided in requirements for the simplified format present in the food. Soluble fiber parts 172 or 184 of this chapter, or by in paragraph (f) of this section. content shall be indented under dietary other means, as appropriate; (6) * * * fiber and expressed to the nearest gram, (E) Using bomb calorimetry data (i) ‘‘Dietary fiber’’: A statement of the except that if a serving contains less subtracting 1.25 calories per gram number of grams of total dietary fiber in than 1 gram, the statement ‘‘Contains protein to correct for incomplete a serving, indented and expressed to the less than 1 gram’’ or ‘‘less than 1 gram’’

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may be used as an alternative, and if the of nutrient values in the same type size. food may be used in the nutrition label serving contains less than 0.5 gram, the Added sugars are either added during provided that only one sugar alcohol is content may be expressed as zero.’’ the processing of foods, or are packaged present in the food. Sugar alcohol (B) ‘‘Insoluble fiber’’ (VOLUNTARY): as such, and include sugars (free, mono- content shall be indented and expressed A statement of the number of grams of and disaccharides), sugars from syrups to the nearest gram, except that if a insoluble dietary fiber in a serving may and honey, and sugars from serving contains less than 1 gram, the be declared voluntarily except that concentrated fruit or vegetable juices statement ‘‘Contains less than 1 gram’’ when a claim is made on the label or in that are in excess of what would be or ‘‘less than 1 gram’’ may be used as labeling about insoluble fiber, label expected from the same volume of 100 an alternative, and if the serving declaration shall be required. Insoluble percent fruit or vegetable juice of the contains less than 0.5 gram, the content fiber must meet the definition of dietary same type, except that fruit or vegetable may be expressed as zero. fiber in this paragraph (c)(6)(i). The juice concentrated from 100 percent (7) ‘‘Protein’’: A statement of the manufacturer must make and keep juices sold to consumers, fruit or number of grams of protein in a serving, records in accordance with paragraphs vegetable juice concentrates used expressed to the nearest gram, except (g)(10) and (11) of this section to verify towards the total juice percentage label that if a serving contains less than 1 the declared amount of insoluble fiber declaration under § 101.30 or for Brix gram, the statement ‘‘Contains less than in the label and labeling of food when standardization under § 102.33(g)(2) of 1 gram’’ or ‘‘less than 1 gram’’ may be a mixture of insoluble and added non- this chapter, fruit juice concentrates used as an alternative, and if the serving digestible carbohydrate(s) that does not which are used to formulate the fruit contains less than 0.5 gram, the content meet the definition of dietary fiber is component of jellies, jams, or preserves may be expressed as zero. When the present in the food. Insoluble fiber in accordance with the standard of protein in foods represented or content shall be indented under dietary identities set forth in §§ 150.140 and purported to be for adults and children fiber and expressed to the nearest gram, 150.160 of this chapter, or the fruit 4 or more years of age has a protein except that if a serving contains less component of fruit spreads shall not be quality value that is a protein than 1 gram, the statement ‘‘Contains labeled as added sugars. Added sugars digestibility-corrected amino acid score less than 1 gram’’ or ‘‘less than 1 gram’’ content shall be indented under Total of less than 20 expressed as a percent, may be used as an alternative, and if the Sugars and shall be prefaced with the or when the protein in a food serving contains less than 0.5 gram, the word ‘‘Includes’’ followed by the represented or purported to be for content may be expressed as zero. amount (in grams) ‘‘Added Sugars’’ children greater than 1 but less than 4 (ii) ‘‘Total Sugars’’: A statement of the (‘‘Includes ‘X’ g Added Sugars’’). It shall years of age has a protein quality value number of grams of sugars in a serving, be expressed to the nearest gram, except that is a protein digestibility-corrected except that the label declaration of that if a serving contains less than 1 amino acid score of less than 40 sugars content is not required for gram, the statement ‘‘Contains less than expressed as a percent, either of the products that contain less than 1 gram 1 gram’’ or ‘‘less than 1 gram’’ may be following shall be placed adjacent to the of sugars in a serving if no claims are used as an alternative, and if the serving declaration of protein content by made about sweeteners, sugars, or sugar contains less than 0.5 gram, the content weight: The statement ‘‘not a significant alcohol content. Except as provided for may be expressed as zero. When a source of protein,’’ or a listing aligned in paragraph (f) of this section, if a mixture of naturally occurring and under the column headed ‘‘Percent statement of the total sugars content is Daily Value’’ of the corrected amount of added sugars is present in the food, and not required and, as a result, not protein per serving, as determined in for specific foods containing added declared, the statement ‘‘Not a paragraph (c)(7)(ii) of this section, sugars, alone or in combination with significant source of total sugars’’ shall calculated as a percentage of the Daily naturally occurring sugars, where the be placed at the bottom of the table of Reference Value (DRV) or Reference added sugars are subject to fermentation nutrient values in the same type size. Daily Intake (RDI), as appropriate, for and/or non-enzymatic browning, the Total sugars shall be defined as the sum protein and expressed as a Percent of manufacturer must make and keep of all free mono- and disaccharides Daily Value. When the protein quality records in accordance with paragraphs (such as glucose, fructose, lactose, and in a food as measured by the Protein (g)(10) and (11) of this section to verify sucrose). Total sugars content shall be Efficiency Ratio (PER) is less than 40 indented and expressed to the nearest the declared amount of added sugars in percent of the reference standard gram, except that if a serving contains the label and labeling of food. (casein) for a food represented or less than 1 gram, the statement (iv) ‘‘Sugar alcohol’’ (VOLUNTARY): purported to be specifically for infants ‘‘Contains less than 1 gram’’ or ‘‘less A statement of the number of grams of through 12 months, the statement ‘‘not than 1 gram’’ may be used as an sugar alcohols in a serving may be a significant source of protein’’ shall be alternative, and if the serving contains declared voluntarily on the label, except placed adjacent to the declaration of less than 0.5 gram, the content may be that when a claim is made on the label protein content. Protein content may be expressed as zero. or in labeling about sugar alcohol or calculated on the basis of the factor 6.25 (iii) ‘‘Added Sugars’’: A statement of total sugars, or added sugars when sugar times the nitrogen content of the food as the number of grams of added sugars in alcohols are present in the food, sugar determined by the appropriate method a serving, except that label declaration alcohol content shall be declared. For of analysis as given in the ‘‘Official of added sugars content is not required nutrition labeling purposes, sugar Methods of Analysis of the AOAC for products that contain less than 1 alcohols are defined as the sum of International,’’ except when official gram of added sugars in a serving if no saccharide derivatives in which a AOAC procedures described in this claims are made about sweeteners, hydroxyl group replaces a ketone or paragraph (c)(7) require a specific factor sugars, added sugars, or sugar alcohol aldehyde group and whose use in the other than 6.25, that specific factor shall content. If a statement of the added food is listed by FDA (e.g., mannitol or be used. sugars content is not required and, as a xylitol) or is generally recognized as safe (i) A statement of the corrected result, not declared, the statement ‘‘Not (e.g., sorbitol). In lieu of the term ‘‘sugar amount of protein per serving, as a significant source of added sugars’’ alcohol,’’ the name of the specific sugar determined in paragraph (c)(7)(ii) of this shall be placed at the bottom of the table alcohol (e.g., ‘‘xylitol’’) present in the section, calculated as a percentage of the

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RDI or DRV for protein, as appropriate, (8) ‘‘Vitamins and minerals’’: The stated as quantitative amount by weight and expressed as Percent of Daily Value, requirements related to including a and percent of the Daily Value. Other may be placed on the label, except that statement of the amount per serving of vitamins and minerals need not be such a statement shall be given if a vitamins and minerals are described in declared if neither the nutrient nor the protein claim is made for the product, this paragraph (c)(8). component is otherwise referred to on or if the product is represented or (i) For purposes of declaration of the label or the labeling or advertising purported to be specifically for infants percent of Daily Value as provided for and the vitamins and minerals are: in paragraphs (d), (e), and (f) of this through 12 months or children 1 * * * * * through 3 years of age. When such a section, foods represented or purported declaration is provided, it should be to be specifically for infants through 12 (iii) The percentages for vitamins and placed on the label adjacent to the months, children 1 through 3 years, minerals shall be expressed to the statement of grams of protein and pregnant women, and lactating women nearest 2-percent increment up to and aligned under the column headed shall use the RDIs that are specified for including the 10-percent level, the ‘‘Percent Daily Value,’’ and expressed to the intended group. For foods nearest 5-percent increment above 10 the nearest whole percent. However, the represented or purported to be percent and up to and including the 50- percentage of the RDI for protein shall specifically for both infants through 12 percent level, and the nearest 10-percent not be declared if the food is months of age and children 1 through 3 increment above the 50-percent level. represented or purported to be years of age, the percent of Daily Value Quantitative amounts and percentages specifically for infants through 12 shall be presented by separate of vitamins and minerals present at less months and the protein quality value is declarations according to paragraph (e) than 2 percent of the RDI are not less than 40 percent of the reference of this section based on the RDI values required to be declared in nutrition standard. for infants through 12 months of age and labeling but may be declared by a zero (ii) The ‘‘corrected amount of protein children 1 through 3 years of age. When or by the use of an asterisk (or other (gram) per serving’’ for foods such dual declaration is used on any symbol) that refers to another asterisk represented or purported for adults and label, it shall be included in all labeling, (or symbol) that is placed at the bottom and equal prominence shall be given to children 1 or more years of age is equal of the table and that is followed by the both values in all such labeling. The to the actual amount of protein (gram) statement ‘‘Contains less than 2 percent percent Daily Value based on the RDI per serving multiplied by the amino of the Daily Value of this (these) values for pregnant women and acid score corrected for protein nutrient (nutrients)’’ or ‘‘Contains < 2 lactating women shall be declared on digestibility. If the corrected score is percent of the Daily Value of this (these) food represented or purported to be above 1.00, then it shall be set at 1.00. nutrient (nutrients).’’ Alternatively, specifically for pregnant women and The protein digestibility-corrected except as provided for in paragraph (f) lactating women. All other foods shall amino acid score shall be determined by of this section, if vitamin D, calcium, use the RDI for adults and children 4 or methods given in sections 5.4.1, 7.2.1, iron, or potassium is present in amounts more years of age. and 8.00 in ‘‘Report of the Joint FAO/ less than 2 percent of the RDI, label (ii) The declaration of vitamins and declaration of the nutrient(s) is not WHO Expert Consultation on Protein minerals as a quantitative amount by Quality Evaluation,’’ except that when required if the statement ‘‘Not a weight and percent of the RDI shall significant source of—(listing the official AOAC procedures described in include vitamin D, calcium, iron, and vitamins or minerals omitted)’’ is placed paragraph (c)(7) of this section require a potassium in that order, for infants at the bottom of the table of nutrient specific factor other than 6.25, that through 12 months, children 1 through values. Either statement shall be in the specific factor shall be used. For foods 3 years of age, pregnant women, same type size as nutrients that are represented or purported to be lactating women, and adults and indented. The quantitative amounts of specifically for infants through 12 children 4 or more years of age. The vitamins and minerals, excluding months, the corrected amount of protein declaration of folic acid shall be sodium, shall be the amount of the (grams) per serving is equal to the actual included as a quantitative amount by vitamin or mineral included in one amount of protein (grams) per serving weight when added as a nutrient serving of the product, using the units multiplied by the relative protein supplement or a claim is made about the quality value. The relative protein nutrient. The declaration of vitamins of measurement and the levels of quality value shall be determined by and minerals in a food, as a quantitative significance given in paragraph (c)(8)(iv) dividing the subject food protein PER amount by weight and percent of the of this section, except that zeros value by the PER value for casein. If the RDI, may include any of the other following decimal points may be relative protein value is above 1.00, it vitamins and minerals listed in dropped, and additional levels of shall be set at 1.00. paragraph (c)(8)(iv) of this section. The significance may be used when the (iii) For the purpose of labeling with declaration of vitamins and minerals number of decimal places indicated is a percent of the DRV or RDI, a value of shall include any of the other vitamins not sufficient to express lower amounts 50 grams of protein shall be the DRV for and minerals listed in paragraph (e.g., the RDI for zinc is given in whole adults and children 4 or more years of (c)(8)(iv) of this section as a statement milligrams, but the quantitative amount age, a value of 11 grams of protein shall of the amount per serving of the may be declared in tenths of a be the RDI for infants through 12 vitamins and minerals as described in milligram). months, a value of 13 grams shall be the this paragraph, calculated as a percent (iv) The following RDIs, DRV for children 1 through 3 years of of the RDI and expressed as a percent of nomenclature, and units of measure are age, and a value of 71 grams of protein the Daily Value, when they are added as established for the following vitamins shall be the RDI for pregnant women a nutrient supplement, or when a claim and minerals which are essential in and lactating women. is made about them, unless otherwise human nutrition:

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RDI Pregnant Nutrient Unit of measure Adults and Infants 1 Children 1 ≥ women and children 4 through 12 through 3 lactating years months years women

Vitamin A ...... Micrograms RAE 2 (mcg) ...... 900 500 300 1,300 Vitamin C ...... Milligrams (mg) ...... 90 50 15 120 Calcium ...... Milligrams (mg) ...... 1,300 260 700 1,300 Iron ...... Milligrams (mg) ...... 18 11 7 27 Vitamin D ...... Micrograms (mcg) 3 ...... 20 10 15 15 Vitamin E ...... Milligrams (mg) 4 ...... 15 5 6 19 Vitamin K ...... Micrograms (mcg) ...... 120 2.5 30 90 Thiamin ...... Milligrams (mg) ...... 1.2 0.3 0.5 1.4 Riboflavin ...... Milligrams (mg) ...... 1.3 0.4 0.5 1.6 Niacin ...... Milligrams NE 5 (mg) ...... 16 4 6 18 Vitamin B6 ...... Milligrams (mg) ...... 1.7 0.3 0.5 2.0 Folate 6 ...... Micrograms DFE 7 (mcg) ...... 400 80 150 600 Vitamin B12 ...... Micrograms (mcg) ...... 2.4 0.5 0.9 2.8 Biotin ...... Micrograms (mcg) ...... 30 6 8 35 Pantothenic acid ...... Milligrams (mg) ...... 5 1.8 2 7 Phosphorus ...... Milligrams (mg) ...... 1,250 275 460 1,250 Iodine ...... Micrograms (mcg) ...... 150 130 90 290 Magnesium ...... Milligrams (mg) ...... 420 75 80 400 Zinc ...... Milligrams (mg) ...... 11 3 3 13 Selenium ...... Micrograms (mcg) ...... 55 20 20 70 Copper ...... Milligrams (mg) ...... 0.9 0.2 0.3 1.3 Manganese ...... Milligrams (mg) ...... 2.3 0.6 1.2 2.6 Chromium ...... Micrograms (mcg) ...... 35 5.5 11 45 Molybdenum ...... Micrograms (mcg) ...... 45 3 17 50 Chloride ...... Milligrams (mg) ...... 2,300 570 1,500 2,300 Potassium ...... Milligrams (mg) ...... 4,700 700 3,000 5,100 Choline ...... Milligrams (mg) ...... 550 150 200 550 Protein ...... Grams (g) ...... N/A 11 N/A 8 71 1 RDIs are based on recommendations for infants through 12 months of age. 2 RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental b-carotene, 12 micrograms b-caro- tene, or 24 micrograms a-carotene, or 24 micrograms b-cryptoxanthin. 3 The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the amount of vitamin D in mcg. 4 1 mg a-tocopherol (label claim) = 1 mg a-tocopherol = 1 mg RRR- a-tocopherol = 2 mg all rac-a-tocopherol . 5 NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan. 6 ‘‘Folate’’ and ‘‘Folic Acid’’ must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The dec- laration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid. 7 DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid. 8 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women.

(v) The following synonyms may be folate (natural folate, and/or synthetic percent DV based on folate in mcg DFE, added in parentheses immediately folate as a component of dietary or for conventional food, may be following the name of the nutrient or supplement, such as calcium salt of L– expressed as folate and the percent DV dietary component: 5-MTHF), folic acid, or a mixture of based on folate in mcg DFE. When Calories—Energy folate and folic acid. The name of the declared, folic acid must be in Vitamin C—Ascorbic acid synthetic form of the nutrient ‘‘folic parentheses, mcg of folic acid as shown Thiamin—Vitamin B1 acid’’, when added or a claim is made in paragraph (d)(12) of this section in

Riboflavin—Vitamin B2 about the nutrient, shall be included in the display that illustrates voluntary * * * * * parentheses after this declaration with declaration of nutrition information. (vii) When the amount of folate is the amount of folic acid. The declared in the labeling of a declaration must be folate in mcg DFE (9) The following DRVs, conventional food or a dietary (when expressed as a quantitative nomenclature, and units of measure are supplement, the nutrient name ‘‘folate’’ amount by weight in a conventional established for the following food shall be listed for products containing food or a dietary supplement) and the components:

Adults and Children 1 Pregnant ≥ Infants through women and Food component Unit of measure children 4 12 months through 3 lactating years years women

Fat ...... Grams (g) ...... 1 78 30 2 39 1 78 Saturated fat ...... Grams (g) ...... 1 20 N/A 2 10 1 20 Cholesterol ...... Milligrams (mg) ...... 300 N/A 300 300 Total carbohydrate ...... Grams (g) ...... 1 275 95 2 150 1 275

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Adults and Children 1 Pregnant ≥ Infants through women and Food component Unit of measure children 4 12 months through 3 lactating years years women

Sodium ...... Milligrams (mg)...... 2,300 N/A 1,500 2,300 Dietary Fiber ...... Grams (g) ...... 1 28 N/A 2 14 1 28 Protein ...... Grams (g) ...... 1 50 N/A 2 13 N/A Added Sugars ...... Grams (g) ...... 1 50 N/A 2 25 1 50 1 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating women 2 Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

(d)(1) Nutrient information specified (d)(9) of this section shall be in a type shown in paragraph (d)(12) of this in paragraph (c) of this section shall be size no smaller than 6 point. When section. Such information shall include: presented on foods in the following provided, the information described in (i) ‘‘ll servings per container’’: The format, as shown in paragraph (d)(12) of paragraph (d)(10) of this section shall be number of servings per container, this section, except on foods where the in a type size no smaller than 6 point. except that this statement is not tabular display is permitted as provided (iv) The headings required by required on single serving containers as for in paragraph (d)(11) of this section, paragraphs (d)(2), (d)(3)(ii), (d)(4), and defined in paragraph (b)(6) of this on which dual columns of nutrition (d)(6) of this section (i.e., ‘‘Nutrition section or on other food containers information are declared as provided for Facts,’’ ‘‘Serving size,’’ ‘‘Amount per when this information is stated in the in paragraph (e) of this section, on those serving,’’ and ‘‘% Daily Value*’’), the net quantity of contents declaration. The food products on which the simplified names of all nutrients that are not information required in this paragraph format is required to be used as indented according to requirements of shall be located immediately after the provided for in paragraph (f) of this paragraph (c) of this section (i.e., ‘‘Nutrition Facts’’ heading and shall be section, on foods for infants through 12 ‘‘Calories,’’ ‘‘Total Fat,’’ ‘‘Cholesterol,’’ in a type size no smaller than 10 point, months of age and children 1 through 3 ‘‘Sodium,’’ ‘‘Total Carbohydrate’’ and except the type size for this information years of age as provided for in paragraph ‘‘Protein’’), and the percentage amounts shall be no smaller than 9 point in the (j)(5) of this section, and on foods in required by paragraph (d)(7)(ii) of this tabular display for small packages as small or intermediate-sized packages as section shall be highlighted in bold or shown in paragraph (j)(13)(ii)(A)(1) of provided for in paragraph (j)(13) of this extra bold type or other highlighting this section and the linear display for section. In the interest of uniformity of (reverse printing is not permitted as a small packages as shown in paragraph presentation, FDA strongly recommends form of highlighting) that prominently (j)(13)(ii)(A)(2) of this section. For the that the nutrition information be distinguishes it from other information. linear display for small packages as presented using the graphic No other information shall be shown in paragraph (j)(13)(ii)(A)(2) of specifications set forth in appendix B to highlighted. this section, the actual number of part 101. (v) A hairline rule that is centered servings may be listed after the servings between the lines of text shall separate per container declaration. * * * * * ‘‘Nutrition Facts’’ from the servings per (ii) ‘‘Serving size’’: A statement of the (iii) Information required in container statement required in serving size as specified in paragraph paragraphs (d)(7) and (8) of this section paragraph (d)(3)(i) of this section and (b)(7) of this section which shall shall be in type size no smaller than 8 shall separate each nutrient and its immediately follow the ‘‘llservings point. Information required in corresponding percent Daily Value per container’’ declaration. The paragraph (d)(5) of this section for the required in paragraphs (d)(7)(i) and (ii) information required in this paragraph ‘‘Calories’’ declaration shall be of this section from the nutrient and shall be highlighted in bold or extra highlighted in bold or extra bold and percent Daily Value above and below it, bold and be in a type size no smaller shall be in a type size no smaller than as shown in paragraph (d)(12) of this than 10 point, except the type size shall 16 point except the type size for this section and in Appendix B to Part 101. be no smaller than 9 point for this information required in the tabular (2) The information shall be presented information in the tabular displays as displays as shown in paragraphs (d)(11), under the identifying heading of shown in paragraphs (d)(11) and (e)(6)(ii), and (j)(13)(ii)(A)(1) of this ‘‘Nutrition Facts’’ which shall be set in (e)(6)(ii) of this section, the tabular section and the linear display for small a type size no smaller than all other display for small packages as shown in packages as shown in paragraph print size in the nutrition label except paragraph (j)(13)(ii)(A)(1) of this section, (j)(13)(ii)(A)(2) of this section shall be in for the numerical information for and the linear display for small a type size no smaller than 10 point. ‘‘Calories’’ required in paragraph (d)(5) packages as shown in paragraph The numeric amount for the information of this section, and except for labels (j)(13)(ii)(A)(2) of this section. The required in paragraph (d)(5) of this presented according to the format serving size amount must be right section shall also be highlighted in bold provided for in paragraphs (d)(11), justified if adequate space is available. or extra bold type and shall be in a type (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and If the ‘‘Serving size’’ declaration does size no smaller than 22 point, except the (j)(13)(ii)(A)(2) of this section, unless not fit in the allocated space a type size type size for this information required impractical, shall be set the full width of no smaller than 8 point may be used for the tabular display for small of the information provided under on packages of any size. packages as shown in paragraph paragraph (d)(7) of this section, as (4) A subheading ‘‘Amount per (j)(13)(ii)(A)(1) of this section, and for shown in paragraph (d)(12) of this serving’’ shall be separated from the the linear display for small packages as section. serving size information by a bar as shown in paragraph (j)(13)(ii)(A)(2) of (3) Information on servings per shown in paragraph (d)(12) of this this section no smaller than 14 point. container and serving size shall section, except this information is not The information required in paragraph immediately follow the heading as required for the dual column formats

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shown in paragraphs (e)(5), (e)(6)(i), and of this section (e.g., Vitamin D 2 mcg labeling of foods as defined in (e)(6)(ii) of this section. 10%, Calcium 260 mg 20%, Iron 8 mg § 101.60(b). The footnote shall state: (5) Information on calories shall 45%, Potassium 235 mg 6%) or may be ‘‘*The % Daily Value tells you how immediately follow the subheading listed horizontally. When listed much a nutrient in a serving of food ‘‘Amount per serving’’ and shall be horizontally in two columns, vitamin D contributes to a daily diet. 2,000 calories declared in one line. If ‘‘Calories from and calcium should be listed on the first a day is used for general nutrition saturated fat’’ is declared, it shall be line and iron and potassium should be advice.’’ If the food product is indented under ‘‘Calories’’ and shall be listed on the second line, as shown in represented or purported to be for in a type size no smaller than 8 point. paragraph (d)(12) of this section in the children 1 through 3 years of age, the * * * * * side-by-side display. When more than second sentence of the footnote shall (7) Except as provided for in four vitamins and minerals are declared substitute ‘‘1,000 calories’’ for ‘‘2,000 paragraph (j)(13)(ii)(A)(2) of this section, voluntarily as shown in paragraph calories.’’ nutrient information for both mandatory (d)(12) of this section in the label which * * * * * and any voluntary nutrients listed in illustrates the mandatory plus voluntary (11) * * * paragraph (c) of this section that are to provisions of paragraph (d) of this be declared in the nutrition label, except section, they may be declared vertically (ii) If the space beneath the mandatory for folic acid in conventional food and with percentages listed under the declaration of potassium is not adequate voluntarily declared vitamins and column headed ‘‘% Daily Value.’’ to accommodate any remaining vitamins minerals expressed as a statement of the (9) A footnote, preceded by an and minerals to be declared or the amount per serving calculated as a asterisk, shall be placed beneath the list information required in paragraph (d)(9) percent of the RDI and expressed as a of vitamins and minerals and shall be of this section, the remaining percent Daily Value, shall be declared as separated from the list by a bar, except information may be moved to the right follows: that the footnote may be omitted from and set off by a line that distinguishes (i) The name of each nutrient, as foods that can use the terms ‘‘calorie it and sets it apart from the nutrients specified in paragraph (c) of this free,’’ ‘‘free of calories,’’ ‘‘without and the percent DV information given to section, shall be given in a column and calories,’’ ‘‘trivial source of calories,’’ the left. The caloric conversion followed immediately by the ‘‘negligible source of calories,’’ or information provided for in paragraph quantitative amount by weight for that ‘‘dietary insignificant source of calories’’ (d)(10) of this section may be presented nutrient appended with a ‘‘g’’ for grams, on the label or in the labeling of foods beneath either side or along the full ‘‘mg’’ for milligrams, or ‘‘mcg’’ for as defined in § 101.60(b). The first length of the nutrition label. micrograms as shown in paragraph sentence of the footnote: ‘‘The % Daily (iii) If there is not sufficient (d)(12) of this section. The symbol ‘‘<’’ Value tells you how much a nutrient in continuous vertical space (i.e., may be used in place of ‘‘less than.’’ a serving of food contributes to a daily approximately 3 in) to accommodate the * * * * * diet’’ may be used on foods that can use required components of the nutrition (8) Nutrient information for vitamins the terms ‘‘calorie free,’’ ‘‘free of label up to and including the mandatory and minerals (except sodium) shall be calories,’’ ‘‘without calories,’’ ‘‘trivial declaration of potassium, the nutrition separated from information on other source of calories,’’ ‘‘negligible source of label may be presented in a tabular nutrients by a bar and may be arrayed calories,’’ or ‘‘dietary insignificant display as shown in the following vertically as shown in paragraph (d)(12) source of calories’’ on the label or in the sample label.

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(12) The following sample labels paragraph (d) of this section and the illustrate the mandatory provisions and side-by-side display. mandatory plus voluntary provisions of ·-···' ......

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(13) * * * the identity of each food shall be Daily Value for each nutrient shall be (ii) Aggregate displays shall comply specified immediately to the right of the listed in separate columns under the with the format requirements of ‘‘Nutrition Facts’’ heading, and both the name of each food. The following paragraph (d) of this section to the quantitative amount by weight (i.e., sample label illustrates an aggregate maximum extent possible, except that g/mg/mcg amounts) and the percent display.

* * * * * same food (e.g., both ‘‘as purchased’’ paragraph (h)(4) of this section, for (e) Nutrition information may be and ‘‘as prepared’’) or for common different units (e.g., slices of bread or presented for two or more forms of the combinations of food as provided for in per 100 grams) as provided for in

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paragraph (b) of this section, or for two RDI groups that are being declared as the quantitative information by weight or more groups for which RDIs are shown in paragraph (e)(5) of this and the percent Daily Value shall be established (e.g., both infants through 12 section. presented in two columns and the months of age and children 1 through 3 (2) The quantitative information by columns shall be separated by vertical years of age) as shown in paragraph weight as required in paragraph (d)(7)(i) lines as shown in paragraph (e)(5) of (e)(5) of this section. When such dual and the information required in this section. labeling is provided, equal prominence paragraph (d)(7)(ii) of this section shall (4) Nutrient information for vitamins shall be given to both sets of values. be presented for the form of the product and minerals (except sodium) shall be Information shall be presented in a as packaged and for any other form of separated from information on other format consistent with paragraph (d) of the product (e.g., ‘‘as prepared’’ or nutrients by a bar and shall be arrayed this section, except that: combined with another ingredient as vertically in the following order: (1) Following the serving size shown in paragraph (e)(5) of this information there shall be two or more section). Vitamin D, calcium, iron, potassium as column headings accurately describing (3) When the dual labeling is shown in paragraph (e)(5) of this the amount per serving size of the form presented for two or more forms of the section. of the same food (e.g., ‘‘Per 1⁄4 cup mix’’ same food, for combinations of food, for (5) The following sample label and ‘‘Per prepared portion’’), the different units, or for two or more illustrates the provisions of paragraph combinations of food, the units, or the groups for which RDIs are established, (e) of this section:

(6) When dual labeling is presented weight as required in paragraph (d)(7)(i) (i) Nutrient information for vitamins for a food on a per serving basis and per and the percent Daily Value as required and minerals shall be separated from container basis as required in paragraph in paragraph (d)(7)(ii) shall be presented information on other nutrients by a bar (b)(12)(i) of this section or on a per in two columns, and the columns shall and shall be arrayed vertically in the serving basis and per unit basis as be separated by vertical lines as shown following order: Vitamin D, calcium, required in paragraph (b)(2)(i)(D) of this in the displays in paragraph (e)(6)(i) of iron, and potassium as shown in the section, the quantitative information by this section. following sample labels.

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Nutrition Facts ...... ~ ...... , , ...... Celeries 220.... 440... T.... flot &J ft 1£11 .lillllurelaiFII .. l!'J .. 1iai!IFII .. !!I Cit ...... t!!!J ... Dnl ...... IMOm!! 4llhl -..,. T.... a.rt. 36!1. .... IHIIq fl.tilr - Tdlll!!!i- - !I !3 ...... fld.AIIdld- !I -··~!I tl1l. 'llillmilllD !5· ..... "" 80'!11 -!I!ODMII ,..... 3IJIIIi mr ~·~ INn '!!I .,.. !!I ,... ~ Jlll!lmg 1~ ~ BJIIIIi ~-Uiilll~..r:-~.. -~ ~···lllillllll· ...... --..-

Nutrition Facts

Jlllftl8taftl ...... , ca~or~es 380 780

.,...... 'tl!l llllllrlllcC All Jlaog:Fif •21 ••• ..... IDnJJ ..... ~ ~- !!I l'.illlllatYAHw.... ~ TCIIII911.- ll'ld.Actdllt lllJI .... q t2111111i ...... -• iStl Vn.lllll D &.fllll!f llimllf :IIIIo Ollcillm tllf!IIJ "' ~ 11'1111 llm!l 10. 41lg ~ tljllmg -~ 3I!DI!g -

(ii) The following sample label (b)(2)(i)(D) and (b)(12)(i) of this section illustrates the provisions of paragraphs for labels that use the tabular display.

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(f) The declaration of nutrition in the simplified format when a food (4) If any nutrients are declared as information may be presented in the product contains insignificant amounts provided in paragraphs (f)(2)(iii), simplified format set forth herein when of six or more of the following: Calories, (f)(2)(iv), or (f)(3) of this section as part a food product contains insignificant total fat, sodium, total carbohydrate, of the simplified format or if any amounts of eight or more of the dietary fiber, total sugars, added sugars, nutrition claims are made on the label following: Calories, total fat, saturated protein, vitamin D, calcium, iron, and or in labeling, the statement ‘‘Not a fat, trans fat, cholesterol, sodium, total potassium. significant source of llll’’ (with the carbohydrate, dietary fiber, total sugars, * * * * * blank filled in with the name(s) of any added sugars, protein, vitamin D, (2) * * * nutrient(s) identified in paragraph (f) of calcium, iron, and potassium; except this section that are present in that for foods intended for infants (ii) Any other nutrients identified in insignificant amounts) shall be included through 12 months of age and children paragraph (f) of this section that are 1 through 3 years of age to which present in the food in more than at the bottom of the nutrition label. paragraph (j)(5)(i) of this section applies, insignificant amounts; and nutrition information may be presented * * * * *

(5) Except as provided for in (g) Compliance with this section shall method is available or appropriate, by paragraphs (j)(5) and (j)(13) of this be determined as follows: other reliable and appropriate analytical section, nutrient information declared * * * * * procedures. in the simplified format shall be (2) The sample for nutrient analysis (3) * * * presented in the same manner as shall consist of a composite of 12 (ii) Class II. Naturally occurring specified in paragraphs (d) or (e) of this subsamples (consumer units), taken 1 (indigenous) nutrients. When a nutrient section, except that the footnote from each of 12 different randomly is naturally occurring (indigenous) in a required in paragraph (d)(9) of this chosen shipping cases, to be food or an ingredient that is added to a section is not required, and an asterisk representative of a lot. Unless a food, the total amount of such nutrient shall be placed at the bottom of the label particular method of analysis is in the final food product is subject to followed by the statement ‘‘% DV = % specified in paragraph (c) of this class II requirements, except that when Daily Value’’ when ‘‘Daily Value’’ is not section, composites shall be analyzed by an exogenous source of the nutrient is spelled out in the heading, as shown in appropriate methods as given in the also added to the final food product, the paragraph (f)(4). ‘‘Official Methods of Analysis of the total amount of the nutrient in the final AOAC International,’’ or, if no AOAC food product (indigenous and

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exogenous) is subject to class I handled in accordance with current the processing of the food, and if requirements. good manufacturing practice to prevent packaged as a separate ingredient, as (4) A food with a label declaration of nutrition loss. FDA approval of a packaged (whether as part of a package a vitamin, mineral, protein, total database shall not be considered granted containing one or more ingredients or carbohydrate, dietary fiber, soluble until the Center for Food Safety and packaged as a single ingredient). fiber, insoluble fiber, polyunsaturated or Applied Nutrition has agreed to all (v) When the amount of sugars added monounsaturated fat shall be deemed to aspects of the database in writing. The to food products is reduced through be misbranded under section 403(a) of approval will be granted where a clear non-enzymatic browning and/or the Federal Food, Drug, and Cosmetic need is presented (e.g., raw produce and fermentation, manufacturers must: Act (the act) unless it meets the seafood). Approvals will be in effect for (A) Make and keep records of all following requirements: a limited time, e.g., 10 years, and will relevant scientific data and information (i) When a vitamin, mineral, protein, be eligible for renewal in the absence of relied upon by the manufacturer that or dietary fiber meets the definition of significant changes in agricultural or demonstrates the amount of added a Class I nutrient, the nutrient content industry practices. Approval requests sugars in the food after non-enzymatic of the composite must be formulated to shall be submitted in accordance with browning and/or fermentation and a be at least equal to the value for that the provisions of § 10.30 of this chapter. narrative explaining why the data and nutrient declared on the label. Guidance in the use of databases may be information are sufficient to (ii) When a vitamin, mineral, protein, found in the ‘‘FDA Nutrition Labeling demonstrate the amount of added sugars total carbohydrate, polyunsaturated or Manual—A Guide for Developing and declared in the finished food, provided monounsaturated fat, or dietary fiber Using Data Bases,’’ available from the the data and information used is meets the definition of a Class II Office of Nutrition and Food Labeling specific to the type of food that is nutrient, the nutrient content of the (HFS–800), Center for Food Safety and subject to non-enzymatic browning and/ composite must be at least equal to 80 Applied Nutrition, Food and Drug or fermentation; or percent of the value for that nutrient Administration, 5100 Paint Branch (B) Make and keep records of the declared on the label. Provided, That no Pkwy., College Park, MD 20740 or by amount of added sugars added to the regulatory action will be based on a going to http://www.fda.gov. food before and during the processing of determination of a nutrient value that * * * * * the food, and if packaged as a separate falls below this level by a factor less (10) The manufacturer must make and ingredient, as packaged (whether as part than the variability generally recognized keep written records (e.g., analyses of of a package containing one or more for the analytical method used in that databases, recipes, formulations, ingredients or packaged as a single food at the level involved. information from recipes or ingredient) and in no event shall the (5) A food with a label declaration of formulations, or batch records) to verify amount of added sugars declared exceed calories, total sugars, added sugars the declared amount of that nutrient on the amount of total sugars on the label; (when the only source of sugars in the the Nutrition Facts label as follows: or food is added sugars), total fat, saturated (i) When a mixture of dietary fiber, (C) Submit a petition, under 21 CFR fat, trans fat, cholesterol, or sodium and added non-digestible 10.30, to request an alternative means of shall be deemed to be misbranded under carbohydrate(s) that does not meet the compliance. The petition must provide section 403(a) of the act if the nutrient definition of dietary fiber, is present in scientific data or other information for content of the composite is greater than the food, a manufacturer must make and why the amount of added sugars in a 20 percent in excess of the value for that keep written records of the amount of serving of the product is likely to have nutrient declared on the label. Provided, non-digestible carbohydrate(s) added to a significant reduction in added sugars That no regulatory action will be based the food that does not meet the compared to the amount added prior to on a determination of a nutrient value definition of dietary fiber. non-enzymatic browning and/or that falls above this level by a factor less (ii) When a mixture of soluble fiber fermentation. A significant reduction than the variability generally recognized and added non-digestible would be where reduction in added for the analytical method used in that carbohydrate(s) that does not meet the sugars after non-enzymatic browning food at the level involved. definition of dietary fiber is present in and/or fermentation may be significant (6) Reasonable excesses of vitamins, the food, a manufacturer must make and enough to impact the label declaration minerals, protein, total carbohydrate, keep written records necessary to verify for added sugars by an amount that dietary fiber, soluble fiber, insoluble the amount of the non-digestible exceeds the reasonable deficiency fiber, sugar alcohols, polyunsaturated or carbohydrate(s) added to the food that acceptable within good manufacturing monounsaturated fat over labeled does not meet the definition of dietary practice under paragraph (g)(6) of this amounts are acceptable within current fiber. section. In addition, the scientific data good manufacturing practice. (iii) When a mixture of insoluble fiber or other information must include the Reasonable deficiencies of calories, total and added non-digestible reason that the manufacturer is unable sugars, added sugars, total fat, saturated carbohydrate(s) that does not meet the to determine a reasonable fat, trans fat, cholesterol, or sodium definition of dietary fiber is present in approximation of the amount of added under labeled amounts are acceptable the food, a manufacturer must make and sugars in a serving of their finished within current good manufacturing keep written records necessary to verify product and a description of the process practice. the amount of the non-digestible that they used to come to that * * * * * carbohydrate(s) added to the food that conclusion. (8) Alternatively, compliance with the does not meet the definition of dietary (vi) When a mixture of all rac-a- provisions set forth in paragraphs (g)(1) fiber. tocopherol and RRR-a-tocopherol is through (6) of this section may be (iv) When a mixture of naturally present in a food, manufacturers must provided by use of an FDA approved occurring and added sugars is present in make and keep written records of the database that has been computed the food, a manufacturer must make and amount of all rac-a-tocopherol added to following FDA guideline procedures keep written records of the amount of the food and RRR-a-tocopherol in the and where food samples have been added sugars added to the food during finished food.

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(vii) When a mixture of folate and package having similar dietary uses and mix (per serving) and the percent Daily folic acid is present in a food, similar significant nutritional Value and the quantitative amounts for manufacturers must make and keep characteristics. Reasonable categories of the serving of the final cake when written records of the amount of foods may be used only if accepted by prepared, as shown in paragraph (e)(5) synthetic folate and/or folic acid added FDA. In determining whether a of this section: Provided, that, the type to the food and the amount of naturally- proposed category is reasonable, FDA and quantity of the other ingredients to occurring folate in the finished food. will consider whether the values of the be added to the product by the user and (11) Records necessary to verify characterizing nutrients in the foods the specific method of cooking and certain nutrient declarations that are proposed to be in the category meet the other preparation shall be specified specified in paragraph (g)(10) of this compliance criteria set forth in prominently on the label. section must be kept for a period of at paragraphs (g)(3) through (6) of this * * * * * least 2 years after introduction or section. Proposals for such categories (j) * * * delivery for introduction of the food may be submitted in writing to the (5)(i) Foods, other than infant into interstate commerce. Such records Office of Nutrition and Food Labeling formula, represented or purported to be must be provided to FDA upon request, (HFS–800), Center for Food Safety and specifically for infants through 12 during an inspection, for official review Applied Nutrition, Food and Drug months of age and children 1 through 3 and photocopying or other means of Administration, 5100 Paint Branch years of age shall bear nutrition labeling. reproduction. Records required to verify Pkwy., College Park, MD 20740. The nutrients declared for infants information on the label may be kept * * * * * through 12 months of age and children either as original records, true copies 1 through 3 years of age shall include (such as photocopies, pictures, scanned (4) If a food is commonly combined calories, total fat, saturated fat, trans fat, copies, microfilm, microfiche, or other with other ingredients or is cooked or cholesterol, sodium, total carbohydrates, accurate reproductions of the original otherwise prepared before eating, and dietary fiber, total sugars, added sugars, records), or electronic records which directions for such combination or protein, and the following vitamins and must be kept in accordance with part 11 preparations are provided, another minerals: Vitamin D, calcium, iron, and of this chapter. These records must be column of figures may be used to potassium. accurate, indelible, and legible. declare nutrition information on the Failure to make and keep the records basis of the food as consumed in the (ii) Foods, other than infant formula, or provide the records to appropriate format required in paragraph (e) of this represented or purported to be regulatory authorities, as required by section; e.g., a dry ready-to-eat cereal specifically for infants through 12 this paragraph (g)(11), would result in may be described with the percent Daily months of age shall bear nutrition the food being misbranded under Value and the quantitative amounts for labeling, except that: section 403(a)(1) of the act. the cereal as sold (e.g., per ounce), and (A) Such labeling shall not declare a (h) * * * the percent Daily Value and the percent Daily Value for saturated fat, (3) * * * quantitative amounts for the cereal and trans fat, cholesterol, sodium, dietary (iv) Nutrition information may be milk as suggested in the label (e.g., per fiber, total sugars, or added sugars and provided per serving for individual ounce of cereal and 1⁄2cup of vitamin D shall not include a footnote. foods in the package, or, alternatively, fortified skim milk); and a cake mix may (B) The following sample label as a composite per serving for be labeled with the percent Daily Value illustrates the provisions of paragraph reasonable categories of foods in the and the quantitative amounts for the dry (j)(5)(ii) of this section.

(iii) Foods, other than infant formula, specifically for children 1 through 3 states: ‘‘*The % Daily Value tells you represented or purported to be years of age shall include a footnote that how much a nutrient in a serving of

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food contributes to a daily diet. 1,000 (A) The following sample label calories a day is used for general illustrates the provisions of paragraph nutrition advice.’’ (j)(5)(iii) of this section.

(B) [Reserved] context on the label or in labeling or (f)(5) related to the footnote, however * * * * * advertising. Claims or other nutrition the abbreviated footnote statement ‘‘% (13)(i) Foods in small packages that information subject the food to the DV = % Daily Value’’ may be used. have a total surface area available to provisions of this section. Foods in (ii) * * * bear labeling of less than 12 square packages subject to requirements of (A) * * * inches, Provided, That the labels for paragraphs (j)(13)(ii)(A)(1) and (2) of (1) The following sample label these foods bear no nutrition claims or this section do not require the illustrates the tabular display for small other nutrition information in any information in paragraphs (d)(9) and packages.

(2) The following sample label illustrates the linear display.

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(B) Using any of the following endorse any particular reseller and The revisions read as follows: abbreviations: notes that other resellers also may have the reference for sale. Consult FDA at § 101.36 Nutrition labeling of dietary Serving size—Serv size supplements. Servings per container—Servings 240–402–2404 for more information on * * * * * Calories from saturated fat—Sat fat cal additional resellers. (i) ‘‘Official Methods of Analysis of (b) * * * Saturated fat—Sat fat (2) * * * (i) The (b)(2)-dietary the AOAC INTERNATIONAL,’’ 19th Monounsaturated fat—Monounsat fat ingredients to be declared, that is, total Edition, Volumes 1 and 2, 2012. Polyunsaturated fat—Polyunsat fat calories, total fat, saturated fat, trans fat, (ii) [Reserved] Cholesterol—Cholest cholesterol, sodium, total carbohydrate, (2) Food and Agriculture Organization Total carbohydrate—Total carb. This dietary fiber, total sugars, added sugars, of the United Nations/World Health abbreviation can also be used on dual- protein, vitamin D, calcium, iron, and Organization (FAO/WHO), Publications column displays as shown in potassium, shall be declared when they Division, Viale delle Terme di Caracalla, paragraphs (e)(5), (e)(6)(i), and are present in a dietary supplement in 00100 Rome, Italy (e)(6)(ii). quantitative amounts by weight that (i) FAO Food and Nutrition Paper Dietary fiber—Fiber exceed the amount that can be declared 51,’’Report of the Joint FAO/WHO Soluble fiber—Sol fiber as zero in nutrition labeling of foods in Expert Consultation on Protein Quality Insoluble fiber—Insol fiber accordance with § 101.9(c). Calories Evaluation,’’ Rome, 1991. http://apps. Sugar alcohol—Sugar alc from saturated fat, polyunsaturated fat, Vitamin—Vit who.int/iris/bitstream/10665/38133/1/ _ monounsaturated fat, soluble fiber, Potassium—Potas 9251030979 eng.pdf. insoluble fiber, and sugar alcohol may Includes—Incl. This abbreviation can (ii) [Reserved] be declared, but they shall be declared also be used on dual-column displays (3) United States Department of when a claim is made about them. Any as shown in paragraphs (e)(5), Agriculture (USDA), Agricultural (b)(2)-dietary ingredients that are not (e)(6)(i), and (e)(6)(ii) of this section. Research Service, Washington, DC, present, or that are present in amounts * * * * * Nutrient Data Laboratory, Bldg. 005 that can be declared as zero in (18) * * * Room 105 BARC-West, Beltsville, MD § 101.9(c), shall not be declared (e.g., (iv) A notice shall be filed with the 20705, 301–504–0630. http://www.ars. amounts corresponding to less than 2 Office of Nutrition and Food Labeling usda.gov/News/docs.htm?docid=9447. percent of the RDI for vitamins and (HFS–800), Center for Food Safety and (i) USDA Handbook No. 74, Energy minerals). Protein shall not be declared Applied Nutrition, Food and Drug Value of Foods—basis and derivation, on labels of products that, other than Administration, 5100 Paint Branch by A. L. Merrill and B. K. Watt, (slightly ingredients added solely for Pkwy., College Park, MD 20740 and revised, 1973) http://www.ars.usda.gov/ technological reasons, contain only contain the following information, SP2UserFiles/Place/80400525/Data/ individual amino acids. except that if the person is not an Classics/ah74.pdf. (ii) [Reserved] * * * * * importer and has fewer than 10 full-time (B) The names of dietary ingredients equivalent employees, that person does * * * * * that are declared under paragraph not have to file a notice for any food ■ 3. In § 101.30, revise paragraph (e)(2) (b)(2)(i) of this section shall be product with annual sales of fewer than to read as follows: presented in a column aligned on the 10,000 total units: left side of the nutritional label in the * * * * * § 101.30 Percentage juice declaration for foods purporting to be beverages that order and manner of indentation (l) The standards required in this contain fruit or vegetable juice. specified in § 101.9(c), except that section are incorporated by reference calcium and iron shall follow choline, * * * * * into this section with the approval of and sodium and potassium shall follow (e) * * * the Director of the Federal Register chloride. This results in the following (2) In easily legible boldface print or under 5 U.S.C. 552(a) and 1 CFR part 51. order for vitamins and minerals: type in distinct contrast to other printed All approved material is available for Vitamin A, vitamin C, vitamin D, or graphic matter, in a height not less inspection at the Office of Nutrition and vitamin E, vitamin K, thiamin, than the largest type found on the Food Labeling (HFS–800), Center for riboflavin, niacin, vitamin B , folate and information panel except that used for 6 Food Safety and Applied Nutrition, folic acid, vitamin B , biotin, the brand name, product name, logo, 12 Food and Drug Administration, 5100 pantothenic acid, choline, calcium, iron, universal product code, the title phrase Paint Branch Pkwy., College Park, MD phosphorous, iodine, magnesium, zinc, ‘‘Nutrition Facts,’’ the declaration of 20740, 240–402–2404 and is available selenium, copper, manganese, ‘‘Serving size,’’ ‘‘Calories’’ and the from the sources indicated below. It is chromium, molybdenum, chloride, numerical value for ‘‘Calories appearing also available for inspection at the sodium, potassium, and fluoride. The in the nutrition information as required National Archives and Records (b)(2)-dietary ingredients shall be listed by § 101.9. Administration (NARA). For according to the nomenclature specified information on the availability of this * * * * * in § 101.9 or in paragraph (b)(2)(i)(B)(2) material at NARA, call 202–741–6030, ■ 4. In § 101.36: of this section. or go to: http://www.archives.gov/ ■ a. Revise paragraphs (b)(2)(i) (1) When ‘‘Calories’’ are declared, federal_register/code_of_federal_ introductory text, (b)(2)(i)(B), they shall be listed first in the column regulations/ibr_locations.html. (b)(2)(ii)(A) and (B), (b)(2)(iii) of names, beneath a light bar separating (1) AOAC Reseller. Techstreet, 6300 introductory text, (b)(2)(iii)(D) through the heading ‘‘Amount Per Serving’’ from Interfirst Dr., Ann Arbor, MI 48108, Toll (G), (b)(3)(ii)(A), (c)(4), (e) introductory the list of names. When ‘‘Calories from free in United States: 1–800–699–9277, text, (e)(8), (e)(11)(i) through (viii), saturated fat’’ are declared, they shall be Outside United States: 1–734–780–8000, (e)(12), and (f). indented under ‘‘Calories.’’ Fax: 1–734–780–2046, www.techstreet. ■ b. Remove paragraph (i) introductory (2) The following synonyms may be com,techstreet.service@ text. added in parentheses immediately thomsonreuters.com. FDA does not ■ c. Revise paragraph (i)(1). following the name of these (b)(2)-

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dietary ingredients: Vitamin C (ascorbic established (e.g., total sugars). which a value must be declared in the acid), thiamin (vitamin B1), riboflavin Additionally, the percentage of the RDI ‘‘% DV’’ column, the column may be (vitamin B2), and calories (energy). for protein shall be omitted when a food omitted as shown in paragraph Energy content per serving may be is purported to be for infants through 12 (e)(11)(vii) of this section. When the ‘‘% expressed in kilojoule units, added in months of age. DV’’ column is not required, but the parentheses immediately following the * * * * * dietary ingredients listed are subject to statement of caloric content. (D) If the percent of Daily Value is paragraph (b)(2)(iii)(F) of this section, (3) Beta-carotene may be declared as declared for total fat, saturated fat, total the symbol required in that paragraph the percent of vitamin A that is present carbohydrate, dietary fiber, or protein, shall immediately follow the as beta-carotene, except that the or added sugars, a symbol shall follow quantitative amount by weight for each declaration is required when a claim is the value listed for those nutrients that dietary ingredient listed under ‘‘Amount made about beta-carotene. When refers to the same symbol that is placed Per Serving.’’ declared, the percent shall be declared at the bottom of the nutrition label, (3) * * * to the nearest whole percent, below the bar required under paragraph (ii) * * * immediately adjacent to or beneath the (e)(6) of this section and inside the box, name vitamin A (e.g., ‘‘Vitamin A (90% that is followed by the statement (A) These amounts shall be expressed as beta-carotene)’’). The amount of beta- ‘‘Percent Daily Values are based on a using metric measures in appropriate carotene in terms of micrograms (mcg) 2,000 calorie diet.’’ If the product is units. may be included in the parentheses represented or purported to be for use * * * * * following the percent statement (e.g., by children 1 through 3 years of age, (c) * * * ‘‘Vitamin A (90% (810 mcg) as beta- and if the percent of Daily Value is (4) The sample label shown in carotene)’’). declared for total fat, total carbohydrate, paragraph (e)(11)(v) of this section (ii) * * * dietary fiber, or protein, or added illustrates one method of nutrition (A) The amounts shall be expressed in sugars, a symbol shall follow the value labeling a proprietary blend of dietary the increments specified in § 101.9(c)(1) listed for those nutrients that refers to ingredients. through (7), which includes increments the same symbol that is placed at the * * * * * for sodium. bottom of the nutrition label, below the (B) The amounts of vitamins and bar required under paragraph (e)(6) of (e) Except as provided for small and minerals, excluding sodium and this section and inside the box, that is intermediate sized packages under potassium, shall be the amount of the followed by the statement ‘‘Percent paragraph (i)(2) of this section, vitamin or mineral included in one Daily Values are based on a 1,000 information other than the title, serving of the product, using the units calorie diet.’’ headings, and footnotes shall be in of measurement and the levels of (E) The percent of Daily Value shall uniform type size no smaller than 8 significance given in § 101.9(c)(8)(iv), be based on RDI or DRV values for point. A font size at least two points except that zeros following decimal adults and children 4 or more years of greater shall be used for ‘‘Calories’’ and points may be dropped, and additional age, unless the product is represented or the heading ‘‘Calories’’ and the actual levels of significance may be used when purported to be specifically for infants number of calories per serving shall be the number of decimal places indicated through 12 months of age, children 1 highlighted in bold or extra bold type. is not sufficient to express lower through 3 years of age, pregnant women, Type size no smaller than 6 point may amounts (e.g., the RDI for zinc is given or lactating women, in which case the be used for column headings (e.g., in whole milligrams (mg), but the column heading shall clearly state the ‘‘Amount Per Serving’’ and ‘‘% Daily quantitative amount may be declared in intended group. If the product is for Value’’) and for footnotes (e.g., ‘‘Percent tenths of a mg). The amount of vitamin persons within more than one group, Daily Values are based on a 2,000 D may, but is not required to, be the percent of Daily Value for each calorie diet). expressed in IUs, in addition to the group shall be presented in separate * * * * * mandatory declaration in mcg. Any columns as shown in paragraph (8) If the product contains two or declaration of the amount of vitamin D (e)(11)(ii) of this section. more separately packaged dietary in IUs must appear in parentheses after (F) For declared subcomponents that supplements that differ from each other the declaration of the amount of vitamin have no DRVs or RDIs, a symbol (e.g., (e.g., the product has a packet of D in mcg. an asterisk) shall be placed in the supplements to be taken in the morning * * * * * ‘‘Percent Daily Value’’ column that shall and a different packet to be taken in the (iii) The percent of the Daily Value of refer to the same symbol that is placed afternoon), the quantitative amounts all dietary ingredients declared under at the bottom of the nutrition label, and percent of Daily Value may be paragraph (b)(2)(i) of this section shall below the last heavy bar and inside the presented as specified in this paragraph be listed, except that the percent Daily box, and followed by a statement ‘‘Daily in individual nutrition labels or in one Value for protein, when present, shall Value not established.’’ aggregate nutrition label as illustrated in be calculated using the corrected (G) When calories or calories from paragraph (e)(11)(iii) of this section. amount of protein as specified in saturated fat are declared, the space * * * * * § 101.9(c)(7)(ii); no percent of the Daily under the ‘‘% DV’’ column shall be left Value shall be given for subcomponents blank for these items. When there are no (11) * * * for which DRVs or RDIs have not been other (b)(2)-dietary ingredients listed for BILLING CODE 4164–01–P

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Facts

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(12) If space is not adequate to list the continued to the right as long as the the dietary ingredients and percent of required information as shown in the headings are repeated. The list to the Daily Value information given to the sample labels in paragraph (e)(11) of right must be set off by a line that left. The following sample label this section, the list may be split and distinguishes it and sets it apart from illustrates this display:

(f)(1) Compliance with this section comply with the requirements of this infants through 12 months of age and will be determined in accordance with section, FDA may permit alternative children 1 through 3 years of age. § 101.9(g)(1) through (g)(8), (g)(10), and means of compliance or additional * * * * * (g)(11), except that the sample for exemptions to deal with the situation in analysis shall consist of a composite of accordance with § 101.9(g)(9). Firms in Dated: May 16, 2016. 12 subsamples (consumer packages) or need of such special allowances shall Leslie Kux, 10 percent of the number of packages in make their request in writing to the Associate Commissioner for Policy. the same inspection lot, whichever is Office of Nutrition and Food Labeling [FR Doc. 2016–11867 Filed 5–20–16; 8:45 am] smaller, randomly selected to be (HFS–800), Food and Drug BILLING CODE 4164–01–P representative of the lot. The criteria on Administration, 5100 Paint Branch class I and class II nutrients given in Pkwy., College Park, MD 20740. § 101.9(g)(3) and (g)(4) also are applicable to other dietary ingredients * * * * * described in paragraph (b)(3)(i) of this (i)(1) Dietary supplements are subject section. Reasonable excesses over to the special labeling provisions labeled amounts are acceptable within specified in § 101.9(j)(5)(i) for foods current good manufacturing practice. other than infant formula, represented (2) When it is not technologically or purported to be specifically for feasible, or some other circumstance makes it impracticable, for firms to

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