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Home , Human nutrition, Nutrition facts label, Raisin, Reference Daily Intake

Vol. 79 Monday, No. 41 March 3, 2014

Part II

Department of and Services

Food and Drug Administration 21 CFR Part 101 Labeling: Revision of the and Supplement Facts ; Proposed Rule

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DEPARTMENT OF HEALTH AND Reduction Act of 1995’’ section of this 7. Impact on Other Regulations document). C. Factors for Mandatory or Voluntary Declaration of Non-Statutory Food and Drug Administration Electronic Submissions 1. Factors Considered Submit electronic comments in the 2. Approach for Mandatory Declaration 21 CFR Part 101 following way: 3. Approach for Voluntary Declaration • Federal eRulemaking Portal: http:// II. The Proposed Rule [Docket No. FDA–2012–N–1210] www.regulations.gov. Follow the A. 1. Calories From RIN 0910–AF22 instructions for submitting comments. 2. Calories From Written Submissions 3. Two Thousand Calories as the Reference Food Labeling: Revision of the Caloric Intake Level Nutrition and Supplement Facts Labels Submit written submissions in the 4. Percent DV Declaration for Calories following ways: B. Fat AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for HHS. 1. Total Fat submissions): Division of Dockets 2. Saturated Fat ACTION: Proposed rule. Management (HFA–305), Food and Drug 3. Trans Fat Administration, 5360 Fishers Lane, Rm. 4. Polyunsaturated Fat SUMMARY: The Food and Drug 1061, Rockville, MD 20852. 5. Monounsaturated Fat Administration (FDA, the Agency, or Instructions: All submissions received C. we) is proposing to amend its labeling must include the Agency name and 1. Mandatory Declaration regulations for conventional and Docket No. FDA–2012–N–1210 and RIN 2. DRV dietary supplements to provide updated 0910–AF22 for this rulemaking. All D. nutrition information on the to 1. Total Carbohydrate comments received may be posted 2. assist consumers in maintaining healthy without change to http:// dietary practices. The updated 3. Added Sugars www.regulations.gov, including any 4. Alcohols information is consistent with current personal information provided. For data on the associations between 5. additional information on submitting 6. Other Carbohydrate nutrients and chronic diseases or comments, see the ‘‘Comments’’ heading E. health-related conditions, reflects of the SUPPLEMENTARY INFORMATION 1. Mandatory and Voluntary Declaration current conditions in the section of this document. 2. Analytical Methods , and corresponds to new Docket: For access to the docket to 3. DRV information on consumer behavior and read background documents or F. consumption patterns. We are proposing comments received, go to http:// 1. Mandatory Declaration 2. DRV to update the list of nutrients that are www.regulations.gov and insert the required or permitted to be declared; G. Fluoride docket number, found in brackets in the 1. Voluntary Declaration provide updated Daily Reference Values heading of this document, into the and values that 2. DRV ‘‘Search’’ box and follow the prompts H. Essential and of are based on current dietary and/or go to the Division of Dockets Public Health Significance recommendations from consensus Management, 5630 Fishers Lane, rm. 1. Essential Vitamins and Minerals That reports; amend requirements for foods 1061, Rockville, MD 20852. Are Mandatory represented or purported to be FOR FURTHER INFORMATION CONTACT: 2. Essential Vitamins and Minerals That specifically for children under the age of Are Voluntary Blakeley Fitzpatrick, Center for Food 4 years and pregnant and lactating 3. Other Essential Vitamins and Minerals Safety and Applied Nutrition (HFS– women and establish reference 4. Summary 830), Food and Drug Administration, values specifically for these population I. Reference Daily Intakes for Vitamins and 5100 Paint Branch Pkwy., College Park, subgroups; and revise the format and Minerals MD 20740, 240–402–5429, email: appearance of the . 1. Need To Update RDIs [email protected]. 2. Approach To Setting RDIs: EAR Versus DATES: Submit either electronic or With regard to the information RDA written comments on the proposed rule collection: Domini Bean, Office of 3. Approach To Setting RDIs: Adequate by June 2, 2014. Submit comments on Information Management, Food and Intake information collection issues under the Drug Administration, 1350 Piccard Dr., 4. Approach To Setting RDIs: Tolerable Paperwork Reduction Act of 1995 by PI50–400T, Rockville, MD 20850, Upper Intake Level April 2, 2014 (see the ‘‘Paperwork [email protected]. 5. Approach To Setting RDIs: Population- Weighted Versus Population-Coverage Reduction Act of 1995’’ section of this SUPPLEMENTARY INFORMATION: document). See section III of this 6. Declaration of the Absolute Amounts of document for the proposed effective Table of Contents Vitamins and Minerals 7. Issues Concerning Specific Vitamins and date of a final rule based on this Executive Summary Minerals proposed rule. I. Background J. Units of Measure, Analytical Methods, ADDRESSES: You may submit comments, A. Legal Authority and Terms for Vitamins and Minerals identified by Docket No. FDA–2012–N– B. Need To Update the Nutrition Facts and 1. Sodium, , , and 1210, and/or Regulatory Information Supplement Facts Labels Number (RIN) 0910–AF22, by any of the 1. Rates of Chronic Disease 2. and Folic Acid following methods, except that 2. Dietary Recommendations, Consensus 3. Vitamins A, D, and E comments on information collection Reports, and National Survey Data K. Labeling of Foods for Infants, Young Children, and Pregnant or Lactating issues under the Paperwork Reduction 3. Consumer Use and Understanding of the Nutrition Facts Label Women Act of 1995 must be submitted to the 4. Other Relevant Considerations 1. Age Range for Infants and Young Office of Information and Regulatory 5. Citizen Petitions Children Affairs, Office of Management and 6. Advance Notices of Proposed 2. Mandatory Declaration of Calories and Budget (OMB) (see the ‘‘Paperwork Rulemaking (ANPRMs) Statutorily Required Nutrients

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3. Declaration of Non-Statutory Nutrients Following the passage of the Nutrition foods, whereas corresponding changes Other Than Essential Vitamins and Labeling and Act (NLEA) of to the Supplement Facts label of dietary Minerals 1990 (the 1990 amendments) (Pub. L. supplements are presented in section 4. Declaration of Essential Vitamins and 101–535), which added section 403(q) of II.L. We present our considerations Minerals 5. DRVs and RDIs for Infants 7 Through 12 the Federal Food, Drug, and Cosmetic related to the format of the Nutrition Months of Age Act (the FD&C Act) (21 U.S.C. 343(q)), Facts and Supplement Facts labels in 6. DRVs and RDIs for Children 1 Through we issued various regulations related to section II.M., and discuss issues related 3 Years of Age nutrition information on food labels, to compliance with the proposed 7. DRVs and RDIs for Pregnant and including the declaration of nutrients, requirements in section II.N. Some of Lactating Women the format for nutrition labeling, the key proposed actions and L. Dietary Supplements reference values for use in declaring the considerations of the proposed rule are 1. Mandatory Dietary Ingredients nutrient content, and allowances for highlighted in this document. 2. Folate and Folic Acid 3. Units of Measure certain specified products to be exempt Among other amendments related to 4. Order of Nutrients Declared on the Label from nutrition labeling (§ 101.9 (21 CFR declaration of nutrients, we are 5. Subpopulations 101.9)). In addition, following the proposing to remove the declaration of 6. Footnote passage of the ‘‘Calories from fat’’ because current M. Format Health and Education Act (DSHEA) of supports a view that the type of 1. Increasing the Prominence of Calories 1994 (Pub. L. 103–417 and 21 U.S.C. fat is more relevant than overall total fat and Serving Size 321(ff)), we amended our food labeling intake in increased risk of chronic 2. Changing the Order of the ‘‘Serving regulations to establish requirements for diseases. In addition, removal of the Size’’ and ‘‘Servings Per Container’’ Declarations and Increasing the nutrition labeling of dietary ‘‘calories from fat’’ disclosure had no Prominence of ‘‘Servings Per Container’’ supplements (§§ 101.9(j)(6) and 101.36). effect on consumers’ judgments of 3. Right-Justifying the Quantitative Section 403(q) of the FD&C Act specifies product healthfulness, accuracy in Amounts Declared in the ‘‘Serving Size’’ certain nutrients to be declared in identifying nutrient contents of Statement nutrition labeling, and authorizes the products, or perceptions in FDA’s 4. Changing the ‘‘Amount Per Serving’’ Secretary of Health and Human Services consumer research. Statement to require other nutrients to be declared Considering current science and 5. Declaration of ‘‘Calories From Fat’’ if the Secretary determines that a recommendations related to added 6. Presentation of Percent DVs sugars, we are also proposing to require 7. Placement of ‘‘Added Sugars’’ nutrient will provide information 8. Declaration of Absolute Amounts of regarding the nutritional value of such the declaration of ‘‘added sugars,’’ that Vitamins and Minerals food that will assist consumers in will provide consumers with 9. Single and Dual Column Labeling maintaining healthy dietary practices. information they need to implement the 10. The Footnote The Secretary also has discretion under dietary recommendations of the Dietary 11. Use of Highlighting With a Type section 403(q) of the FD&C Act to Guidelines for Americans, 2010 (2010 Intermediate Between Bold or Extra Bold remove, by regulation and under certain DGA). and Regular Type circumstances, nutrient information that We are also proposing to update the 12. Addition of Horizontal Line Beneath is otherwise explicitly required in food list of vitamins and minerals of public the Nutrition Facts Heading health significance. We currently 13. Replacing ‘‘Total Carbohydrate’’ With labeling under this section. ‘‘Total Carbs’’ We are proposing to revise our require the mandatory declaration of 14. Alternative Visual Formats/Fonts regulations to provide updated nutrition percent Daily Values (DVs) of vitamins N. Compliance information on the label and improve A and C, and . We analyzed 1. Level of Variance Allowed for the Label how the nutrition information is the nutrient inadequacy for vitamins Declaration of Specific Nutrients presented to consumers, in light of and minerals based on biomarker data 2. Methods Used To Determine current scientific evidence, dietary and total dietary intake (conventional Compliance recommendations of most recent foods and dietary supplements) using 3. Records Requirements National Health and Nutrition 4. Inclusion of Potassium as a consensus reports, and public 5. Requirements for Other Carbohydrate, comments received in response to Examination Survey (NHANES) data Soluble and Insoluble Fiber, Added advance notices of proposed and other factors for mandatory and Sugars, and Sugar Alcohols rulemaking. FDA invites comment on its voluntary declaration discussed in O. Technical Amendments use of the most recent consensus reports section I.C. to determine which essential 1. Changing the Name of the Program and whether the information and data vitamins and minerals should be Office on which FDA relies from such reports included as nutrients of public health 2. Changing the Publication Date of Report significance. Based on this analysis, we Incorporated by Reference for proposed changes is consistent with 3. Plain Language Edits current scientific information. are not proposing any changes to the III. Proposed Effective and Compliance Dates current requirement for mandatory Summary of the Major Provisions of the declaration of calcium and iron. In IV. Analysis of Impacts Regulatory Action in Question V. Paperwork Reduction Act of 1995 addition, we are proposing to require VI. Analysis of Environmental Impact We discuss the need to update the the declaration of D and VII. Federalism Nutrition Facts and Supplement Facts potassium, and to permit, rather than VIII. Comments labels in section I.B., and our scientific require, the declaration of vitamins A IX. References considerations for mandatory and and C. Executive Summary voluntary declaration of nutrients are With respect to reference values used presented in section I.C. In sections II.A. to declare percent DVs of nutrients, Purpose of the Regulatory Action through II.K., we discuss provisions since 1993, new reports from the FDA is proposing to amend the related to the declaration, reference Institute of Medicine (IOM) and other regulations for the nutrition labeling of values, analytical methods, and consensus and policy reports (for conventional foods and dietary definitions of nutrients that are required example, the 2010 DGA and the Report supplements to assist consumers in or permitted to be declared on the of the Dietary Guidelines Advisory maintaining healthy dietary practices. Nutrition Facts label of conventional Committee on the Dietary Guidelines for

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Americans) have been published that IOM’s report that set Dietary Reference number of calories in a product. We are update the quantitative intake Intakes (DRIs) for sodium, including a also proposing to move the ‘‘% DV’’ to recommendations of nutrients as well as Tolerable Upper Intake Level of 2,300 the left side of the label in order to their association with chronic disease mg/day (d) as a reference intake level highlight the information for consumers. and health-related conditions. We are not to exceed. We are also proposing to remove the using these new data to update, as A primary change that we are requirement for the footnote table listing appropriate, the reference values used proposing to the format of the Nutrition the reference values for certain nutrients in the declaration of percent DVs of Facts and Supplement Facts labels is to for 2,000 and 2,500 diets. We increase the prominence of the nutrients on the Nutrition Facts and intend to continue to perform consumer Supplement Facts labels. ‘‘Calories,’’ numeric value of calories, research during this rulemaking process Among other amendments to ‘‘Servings per container,’’ and numeric reference values, we are proposing an value of servings per container to evaluate how variations in label updated reference value for the declarations. Research suggests that format may affect consumer declaration of percent DV for sodium these proposed changes may increase understanding and use of the Nutrition from the current value of 2,400 mg consumers’ attention to the information, Facts label. We intend to publish the (milligrams) to 2,300 mg based on a and in certain situations, help results of our research for public review consideration of current science and consumers to accurately identify the and comment.

We are also proposing to require the and folic acid and there are no undergo fermentation, various forms of maintenance of records to support the analytical methods that can determine , or folate and folic acid, we declarations of certain nutrients under the amount of added sugar in specific are proposing that manufacturers must specified circumstances. Currently, foods containing added sugars alone or make and keep certain written records there are no analytical methods that can in combination with naturally occurring to verify their declarations of each of distinguish between dietary fiber sugars, where the added sugars are these nutrients in the labeling of the (soluble and insoluble fiber) and non- subject to fermentation. Therefore, for food associated with such records. We digestible that do not products that contain non-digestible are also proposing that records must be meet the definition of dietary fiber; carbohydrates that do not meet the kept for a period of at least 2 years after added and naturally occurring sugars; definition of dietary fiber, more than introduction or delivery for introduction the various forms of vitamin E; or folate one source of sugar, added sugars that of the food into interstate commerce and

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may be kept as original records, as true Finally, we are proposing an effective impact analysis that presents the copies, or electronically, and date of 60 days after the date of the final benefits and costs of this proposed rule manufacturers must provide those rule’s publication in the Federal as well as the proposed rules entitled records to us for inspection and copying Register with a compliance date 2 years Food Labeling: Serving Sizes of Foods upon request during an inspection. after the effective date. We invite That Can Reasonably Be Consumed at We anticipate that consumer comment on the proposed compliance One Occasion; Dual Column education efforts would be needed to date. In addition to the proposed Labeling; Updating, Modifying, and help with consumer understanding and compliance date, we invite comment on Establishing Certain Reference Amounts use of information presented under the various other issues, as summarized in Customarily Consumed; Serving Size for changes to the Nutrition Facts and section XI. Breath Mints; and Technical Supplement Facts labels proposed in Amendments taken together. The Costs and Benefits this rule. We plan to use the results of cumulative impact of these two our consumer research to help inform We have developed one nutrition labeling proposals, taken as a our future actions on this issue. comprehensive preliminary regulatory whole, is shown in the following table.

SUMMARY OF COSTS AND BENEFITS [In billions of 2011 $]

Benefits Costs Net benefits

Present Value (PV): 3% ...... $31.4 $2.3 $29.1 7% ...... 21.1 2.3 18.8 Annualized (3% PV Amount) 3% ...... 2.0 0.2 1.8 Annualized (7% PV Amount) 7% ...... 1.9 0.2 1.7 Notes: Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total costs.

I. Background form of nutrition labeling and the if, with certain exceptions, it fails to circumstances in which such simplified bear nutrition labeling and identifies The 1990 amendments added section nutrition labeling can be used. (See specific nutrient and calorie information 403(q) to the FD&C Act, which specifies, § 101.9.) Elsewhere in this issue of the required in labeling. Section in part and with certain exceptions, that Federal Register, we are publishing a 403(q)(2)(A) of the FD&C Act provides food is deemed misbranded unless its proposed rule that will amend the the Secretary, and by delegation, FDA, label or labeling bears nutrition definition of a single-serving container, with discretion to require by regulation information for certain nutrients. To require dual column labeling for certain implement the 1990 amendments, on nutrition information about nutrients containers, update the reference other than those specified in section January 6, 1993, FDA issued several amounts customarily consumed and rules, including ‘‘Food Labeling: 403(q)(1) of the FD&C Act to assist serving sizes for several food product consumers in maintaining healthy Mandatory Status of Nutrition Labeling categories and amend the serving size and Nutrient Content Revision, Format dietary practices. Section 403(q)(2)(B) of for breath mints. the FD&C Act permits the Secretary, and for Nutrition Label (the 1993 nutrient In 1994, DSHEA became law. Among content final rule)’’; ‘‘Food Labeling; by delegation, FDA, to remove other things, DSHEA amended section information relating to a nutrient Reference Daily Intakes and Daily 403(q)(5)(F) of the FD&C Act by adding required by section 403(q)(1) or Reference Values (1993 RDI/DRV final specific requirements that relate to the 403(q)(2)(A) of the FD&C Act if the rule)’’; and ‘‘Food Labeling: Serving labeling of dietary supplement products. Secretary determines that it is not Sizes’’, to modify how nutrition Accordingly, we amended our food necessary to assist consumers in information is presented on food labels labeling regulations to establish maintaining healthy dietary practices. (58 FR 2079; 58 FR 2206; 58 FR 2229, requirements for nutrition labeling of respectively). FDA published dietary supplements (§§ 101.9(j)(6) and Consistent with these authorities, we are regulations related to: (1) Declaration of 101.36). proposing to revise certain nutrient nutrients on food labeling, including The regulatory history, our rationale declarations in the Nutrition Facts label nutrients that are required or permitted for existing requirements, and FDA and Supplement Facts label. In to be declared and the format for such activities related to nutrition labeling of addition, FDA’s authority includes declaration; (2) label reference values foods and dietary supplements are section 2(b)(1) of the 1990 amendments for use in declaring the nutrient content described in Reference 1. (21 U.S.C. 343 note). Specifically, of a food on its label or labeling; (3) two section 2(b)(1)(A) of the 1990 types of reference values, Reference A. Legal Authority amendments requires nutrition label Daily Intakes (RDIs) for vitamins and We are proposing to update the information be conveyed in a manner minerals and Daily Reference Values Nutrition Facts label and Supplement that enables the public to readily (DRVs) for certain nutrients, which are Facts label, as set forth in this proposed observe and comprehend the used to declare nutrient contents as rule, consistent with our authority in information and to understand its percent DVs on the Nutrition Facts section 403(q) of the FD&C Act. Section relative significance in the context of a label; (4) exemptions for certain 403(q)(1) of the FD&C Act states that a total daily . Such section states that specified products; and (5) a simplified food shall be deemed to be misbranded such information should be consistent

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with current scientific knowledge about contains. Moreover, the nutrient requirements, but also includes access nutrients and health. We are proposing declaration must be truthful and not to such records. Without such authority, changes to DVs (RDIs and DRVs, as misleading under sections 403(a)(1) and the nutrient declarations for these applicable) for some nutrients, which 201(n) of the FD&C Act. Thus, when a specific nutrients that FDA has values are used to calculate the percent food product contains dietary fiber determined are necessary to assist DV for use on food labels. The use of (whether soluble, insoluble, or a consumers in maintaining healthy reference values based on current combination of both) and added non- dietary practices under section science and the use of such values to digestible carbohydrate(s) that does not 403(q)(2)(A) of the FD&C Act are, calculate the percent DV assists meet the definition of dietary fiber, we practically speaking, not enforceable. consumers in comprehending the are proposing to require manufacturers Without access to such records, FDA nutrition information and its relative to make and keep certain written would not know whether the amount significance in a total daily diet. We are records to verify the amount of added declared on the label or in the labeling also proposing changes to the format non-digestible carbohydrate that does of each these nutrients, under the pertaining to information on the percent not meet the definition of dietary. When circumstances described, is truthful and DV value. Further, section 2(b)(1)(C) of vitamin E is present in a food as a not misleading under sections 403(a)(1) the 1990 amendments stipulates that mixture of all rac-a- acetate and 201(n) of the FD&C Act. The regulations ‘‘shall permit the label or and RRR-a-tocopherol, we are proposing introduction or delivery for introduction labeling of food to include nutrition to require manufacturers to make and into interstate commerce of a information which is in addition to the keep written records to verify the misbranded food is a prohibited act information required by such section amount of all rac-a-tocopherol acetate under section 301(a) of the FD&C Act 403(q) [of the FD&C Act] and which is added to the food and RRR-a-tocopherol (21 U.S.C. 331(a)). Thus, to determine of the type described in subparagraph in the finished food. When a mixture of whether the food is misbranded and the (1)(or (2) of such section . . . .’’ We are folate and folic acid is present in a food, manufacturer has committed a proposing changes to the voluntary we are proposing to require prohibited act, we must have access to declaration of certain nutrients in the manufacturers to make and keep records the manufacturer’s records that we are Nutrition Facts label consistent with to verify the amount of folic acid added requiring be made and kept under such authority. to the food and folate in the finished sections 403(q), 403(a)(1), 201(n) and Other relevant authorities include food. When added sugars as well as 701(a) of the FD&C Act. Failure to make sections 701(a), 403(a)(1) and 201(n) of naturally occurring sugars are present in and keep records and provide the the FD&C Act (21 U.S.C. 371(a), 21 a food, we are proposing to require records to FDA, as described in U.S.C. 343(a)(1), and 21 U.S.C. 321(n), manufacturers to make and keep records proposed § 101.9(g)(10) and (g)(11), respectively). Under section 701(a) of to verify the declared amount of added would result in the food being the FD&C Act, the Agency may issue sugars in the food. Finally, we are misbranded under sections 403(q) and regulations for the efficient enforcement proposing to require manufacturers to 403(a)(1) of the FD&C Act. of the FD&C Act in order to ‘‘effectuate make and keep records to verify the B. Need To Update the Nutrition Facts a congressional objective expressed declared amount of added sugars in and Supplement Facts Labels elsewhere in the Act’’ (Association of specific foods, alone or in combination American Physicians and Surgeons, Inc. with naturally occurring sugars, where FDA first issued regulations related to v FDA, 226 F. Supp. 2d 204 (D.D.C. the added sugars are subject to the Nutrition Facts label in 1993. We 2002) (citing Pharm. Mfrs. Ass’n. v FDA, fermentation. have not updated the Nutrition Facts 484 F. Sup. 1179, 1183 (D. Del. 1980).) The proposed record requirements for label since the 2003 trans fat rulemaking We are relying on our authority under these nutrients, under the circumstances (68 FR 41434; July 11, 2003) or sections 403(q), 403(a), 201(n) and described, are designed to ensure that established new or updated DVs for 701(a) of the FD&C Act, to propose the nutrient declarations are accurate, nutrients since 1995 (60 FR 67164; record requirements to support nutrient truthful and not misleading, based on December 28, 1995). Since that time, the declarations in labeling for added information known only to the public health profile of the U.S. sugars, dietary fiber, soluble fiber, manufacturer, and to facilitate efficient population has changed (e.g., increase insoluble fiber, vitamin E, and folate/ and effective action to enforce the in ), new information has become folic acid, under certain circumstances, requirements when necessary. Our available about nutrient definitions (e.g., so that we can determine compliance authority to establish records vitamin E), reference intake values, and with labeling requirements and take requirements has been upheld under analytical methods, and new dietary enforcement action, as needed. For other provisions of the FD&C Act where recommendations (see section I.B.2.) these nutrients, as explained in section FDA has found such records to be have been published. As a result, we are II.N., there is no AOAC official method necessary (National Confectioners reconsidering what nutrients we should of analysis of AOAC International or Assoc. v Califano, 569 F.2d 690, 693–94 require or permit to be listed on the other reliable or appropriate analytical (D.C. Cir. 1978). The records we propose Nutrition Facts label and what nutrient procedure, otherwise required by to require are only for foods for which reference intake values we should use as § 101.9(g), available for FDA to quantify an adequate analytical method is not a basis for calculating the percent DVs the declared amount of the nutrient, available. The records would allow us to in food labeling. We also considered under certain circumstances. Section verify the declared amount of each of corresponding changes to the 101.9(g) sets forth the standards for these nutrients and that such amount is Supplement Facts labels. We discuss accuracy of the amount statements of truthful and not misleading. Thus, the specific nutrient declarations in greater nutrients on food labels. Failing to proposed records requirements would detail in section II. Section I.B. includes accurately state the amounts of nutrients help in the efficient enforcement of the an overview of information we on the label under § 101.9(g) would FD&C Act. considered when forming our tentative result in a product being misbranded. The authority granted to FDA under conclusions, including scientific and Under section 403(q) of the FD&C Act, sections 701(a), 403(q), 403(a)(1) and technical data and recommendations, a food must bear, in its label or labeling, 201(n) of the FD&C Act not only citizen petitions submitted to us, and the amount of the nutrient the food includes authority to establish records public comments to previous requests

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for comment in advance notices of population (Ref. 2). High intakes of individuals in a particular stage and proposed rulemaking on topics related sodium are directly associated with gender group. EARs are used for to this proposed rule. We also elevated blood pressure (Ref. 10). assessing the statistical probability of considered the role of nutrition labeling Average sodium intake for the U.S. adequacy of nutrient intakes of groups to assist consumers in maintaining population 4 years of age and older is of people. The RDA is an estimate of the healthy dietary practices and approximately 3,650 mg/d (Ref. 11). average intake level that meets the consumers’ use and understanding of Almost all Americans consume more nutrient requirements of nearly all (97 the Nutrition Facts label. sodium than the levels recommended by to 98 percent) healthy individuals in a the 2010 DGA (Ref. 12) particular life stage and gender group. 1. Rates of Chronic Disease Furthermore, while concerns in recent The RDA is set using the EAR. In Chronic diseases, such as heart years have largely shifted away from general, the RDA is the EAR plus two disease, and are the nutritional deficiencies, some times the standard deviation of the EAR. leading causes of death and in population subgroups may consume The RDA is used to plan nutrient the United States, and account for 70 excess calories but still consume intakes for individuals to ensure a low percent of all deaths in the United inadequate amounts of certain probability of inadequacy. Nutrients States (Ref. 2). In 2005, 133 million such as iron, , with EARs and RDAs include Americans, almost one out of every two calcium and potassium (see section carbohydrate, protein, , adults, had at least one chronic illness II.H.). , vitamin E, thiamin, (Ref. 2). An estimated 37 percent of The mandatory declaration of , , , folate, Americans suffer from cardiovascular nutrients that have public health , copper, , iron, disease (CVD) (Ref. 3), 11.3 percent of significance, the use of updated DVs , , , the population 20 years and older has based on current scientific evidence, , calcium and vitamin D. , 35 percent of adults has pre- and the use of a format for the Nutrition An AI is the level determined for an diabetes (Ref. 4), and 41 percent of the Facts label to assist with consumer use essential nutrient or a nutrient that is population is predicted to be diagnosed and understanding can help consumers beneficial for human health when there with cancer during their lifetime (Ref. make informed food choices to consume is insufficient evidence to calculate an 5). While the causes of these chronic a nutritionally adequate diet while EAR for that nutrient, and therefore diseases are multifactorial, poor diet is monitoring calorie intake and lowering insufficient evidence on which to a contributing factor associated with their risk of some chronic diseases. establish an RDA. AIs can be based on morbidity and mortality (Ref. 6). Many 2. Dietary Recommendations, Consensus a variety of data, including scientific nutrients are associated with chronic Reports, and National Survey Data evidence about the essentiality of a disease risk. For example, diets low in nutrient (i.e., , , fluoride), saturated fat and cholesterol, and/or a. IOM Dietary Reference Intakes experimental data on risk reduction of sodium are associated with a decreased Reports (IOM DRI Reports)—In 1994, chronic disease (i.e., dietary fiber, risk of CVD (58 FR 2739; January 6, the Food and Nutrition Board (FNB) of potassium), and median intakes of a 1993, and 58 FR 2820; January 6, 1993). the Institute of Medicine (IOM) nutrient using national survey data (i.e., Adequate or increased intake of calcium identified principles for the , , , and vitamin D may decrease the risk of development of a new set of reference , , and [alpha]- (73 FR 56477; September values that could expand and replace linolenic acid). Although there is less 29, 2008). the IOM’s Recommended Dietary certainty about an AI value than about Obesity rates have increased Allowances (RDAs) of 1989 (Refs. 13 an RDA value, the AI is similarly dramatically over the last three decades. and 14). A comprehensive review and designed to cover the needs of nearly all Between 1976 and 1980 and 2007 and application of a growing body of individuals. The IOM Dietary Planning 2008, obesity rates increased more than research resulted in Report and Dietary Assessment Report twofold (from 15 to 34 percent) in adults the development of a set of reference noted that ‘‘the AI should be used with and more than threefold (from 5 to 17 values, collectively known as DRIs, less confidence if it has not been percent) among children and published from 1997 to 2010 (Ref. 15). established as the mean intake of a adolescents (Refs. 6 to 8). Data The DRIs represent a shift in the way healthy group.’’ published by the U.S. Centers for that reference values are established or The UL is the highest average daily Disease Control and Prevention (CDC) intended for use. In contrast to previous intake level likely to pose no risk of indicate that 68 percent of adults and editions of RDAs (e.g., the 1968 and adverse health effects for nearly all about 32 percent of children aged 2 to 1989 RDAs), which involved people in a particular group. The UL is 19 years in the U.S. population are establishing single values for each not intended to be a recommended level or obese (Refs. 7 and 8). nutrient with appropriate adjustments of intake. The UL is used to assess the Excessive body weight is a risk factor for for age, sex and physiological status, the risk of adverse health effects from chronic diseases such as heart disease, new DRI framework consisted of four excessive nutrient intake. As intake some forms of cancer, and type II categories of reference values. These above the UL increases, so does the diabetes (Ref. 9). The 2010 DGA categories include the Estimated potential for risk of adverse health affirmed the role of over consumption of Average Requirement (EAR), RDA, effects. Nutrients with ULs include calories and physical inactivity as the Adequate Intake (AI) and Tolerable vitamin A, vitamin C, vitamin D, primary risk factors contributing to an Upper Intake Level (UL). For vitamin E, niacin, vitamin B6, folate, of overweight and obesity in macronutrients—carbohydrates, , choline, calcium, copper, fluoride, this country, and urged for a focus on and protein—the IOM developed a new iodine, iron, magnesium, manganese, improved nutrition and physical set of reference values called the , phosphorus, selenium, activity choices among Americans (Ref. Acceptable Macronutrient Distribution zinc, sodium, and chloride. 6). Ranges (AMDRs). Moreover, while the previous RDAs Elevated blood pressure, an important The EAR is the average daily nutrient primarily focused on reducing the risk factor for CVD (Ref. 10), affects intake level that is estimated to meet the incidence of diseases of nutrient about one-third of the U.S. adult requirements of half of the healthy deficiency in the population, the DRIs

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now take into consideration data on Principles for Nutrition Labeling and evidence for associations between chronic disease risk, such as heart Fortification (the IOM Labeling Report) sodium intake and the risk of CVD- disease, and developmental (Ref. 25), with the goal of having an related events and mortality. abnormalities, such as teratogenicity, updated nutrition label that consumers i. Dietary Guidelines for Americans rather than only the signs of deficiency. can use to make informed dietary (DGA), 2010—The 2010 DGA, Finally, where sufficient data exist, the choices. developed jointly by the U.S. DRIs take into account the potential e. IOM Dietary Planning Report—In Department of (USDA) and benefit or risk to health of substances 2003, the IOM Subcommittee on the U.S. Department of Health and that are not essential (such as dietary interpretation and uses of DRIs (IOM Human Services (HHS), provide several fiber and fluoride) that are in addition Uses Committee) published a report, key recommendations including to the macronutrients of total DRIs Application in Dietary Planning recommendations about dietary carbohydrate, protein, and fat, and the (IOM Dietary Planning Report) (Ref. 26) patterns, as well as quantitative intake vitamins and minerals on how to use the DRIs for planning recommendations with respect to permitted or required on the Nutrition intakes of individuals and groups. This micronutrients and macronutrients, Facts label (Ref. 15). Beginning in 1997, report discusses the use of the DRIs for most of which are based on the IOM DRI the IOM began publishing its DRIs for food and supplement labels. reports (Ref. 6). In a few cases, the 2010 those vitamins, minerals, and f. IOM Sodium Strategies Report—In DGA provided quantitative intake macronutrients that are essential in 2008, the IOM convened a Committee recommendations for certain nutrients or provide a beneficial role in on Strategies to Reduce Sodium Intake (i.e., cholesterol and saturated fat) that human health (Refs. 16 to 22). In in the United States to address a were not provided by the IOM DRI addition, the IOM also set AMDRs for Congressional request for reports (Ref. 6). The 2010 DGA carbohydrates, fat, and protein (Ref. 23). recommendations about various means emphasized the importance of meeting The AMDR for a macronutrient is based that could be employed to reduce food and nutrient recommendations on the amount of the macronutrient that dietary sodium intake to levels while balancing calorie needs (Ref. 6). is associated with a reduced risk of recommended by the 2005 DGA (less More information regarding the chronic disease while providing than 2,300 mg/d and no more than 1,500 scientific basis that informed the adequate intakes of essential nutrients. mg/d for African-Americans, people development of the 2010 DGA can be The AMDR is expressed as a range of with , and middle-aged found in the Report of the Dietary percent energy intake (e.g., 20 to 35 and older adults). The Committee’s Guidelines Advisory Committee on the percent of calories from total fat for report, Strategies to Reduce Sodium Dietary Guidelines for Americans, 2010 adults over 18 years of age). The DRIs Intake in the United States (IOM (2010 DGAC) (Ref. 30). An important and AMDRs were set for the following Sodium Strategies Report), published in note related to the 2010 DGA is the life stage groups: Infants (0 to 6 and 7 2010, among other strategies, discusses specified intended audience for its to 12 months); toddlers (1 to 3 years); how the labeling of sodium on foods can recommendations (Ref. 6). From the boys and girls (4 to 8 years); adolescent serve as a supporting strategy for 1980s until 1995, the DGAs were boys and girls (9 to 13 and 14 to 18 reducing sodium intake (Ref. 27). targeted toward healthy Americans and years); adult men and women (19 to 30, g. IOM Front-Of-Package Nutrition designed to provide advice to healthy 31 to 50, 51 to 70, and greater than 70 Rating Systems and Symbols Phase I individuals about food choices that years); and pregnant and lactating and Phase II Reports—In 2010, the IOM promote health and prevent disease women. Committee on Front-of-Package (FOP) (Refs. 31 to 34). In 2000, the b. IOM Dietary Fiber Report—In 2001, Nutrition Rating Systems and Symbols recommendations specified an audience the IOM Panel on the Definition of reviewed the existing FOP systems and of ‘‘healthy children ages 2 years and Dietary Fiber (the IOM Dietary Fiber their underlying nutrition criteria. In the older and adults of any age,’’ and the Panel) responded to our request to Phase I report, the IOM identified the 2005 DGA provided recommendations provide definitions for dietary fiber nutrients for which there was sufficient for the ‘‘general public age 2 years and based on its role in human evidence of their role in chronic disease older.’’ (Refs. 35 and 36). While the and health. The IOM Dietary Fiber Panel risk and which should be included in a DGAs have always taken into account developed two categories of definitions FOP label (Ref. 28). In 2012, the IOM the needs of subpopulations, the most of fiber: ‘‘Dietary Fiber’’ and ‘‘Added published its phase II report that recent 2010 DGA goes beyond the Fiber’’ in its report Dietary Reference recommended developing a single traditional target of a ‘‘healthy’’ Intakes: Proposed Definition of Dietary standardized FOP rating system and audience to provide chronic disease,’’ Fiber (the IOM Dietary Fiber Report) updated their recommendations for noting ‘‘the reality that a large (Ref. 24). nutrients to be included on the FOP percentage of Americans are overweight c. IOM Dietary Assessment Report—In label (Ref. 29). or obese and/or at risk of various 2000, the IOM Subcommittee on h. IOM Sodium Intake in Populations chronic diseases’’ (Ref. 6). Interpretation and Uses of Dietary Report—In 2012 the IOM convened a j. National Health and Nutrition Reference Intakes (IOM uses Committee) Committee to review and assess the Examination Survey (NHANES)—The published the report, DRIs Application benefits and adverse outcomes (if any) NHANES provides the primary source in Dietary Assessment (IOM Dietary of reducing the sodium intake in the of information on the health and Assessment report) on how to use the population, particularly in the range of nutritional status of adults and children DRIs for dietary assessment of 1,500 to 2,300 mg/d. The Committee in the United States. The survey individuals and groups. was also asked to specifically emphasize examines a nationally representative d. IOM Labeling Report—In 2003, the relevant subgroups in the analysis sample of about 5,000 persons each IOM Committee on nutrition labeling including those 50 years of age and year. These persons are located in (IOM Labeling Committee) considered older, African Americans, and those counties across the country. The survey how the DRIs can be used to develop with diabetes, chronic kidney disease, combines interviews, which include appropriate reference values for and congestive heart failure. The Report demographic, socioeconomic, dietary, nutrition labeling and published its was published in May of 2013 and and health-related questions, and report, co-funded by FDA, DRI Guiding focused its findings and conclusions on physical examinations, which consist of

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medical, dental, and physiological total daily diet. In particular, the label format may affect consumer measurements, as well as laboratory percent DV of a nutrient present in food understanding and use of the Nutrition tests administered by highly trained is declared on food labels to help Facts label. Issues to be addressed medical personnel (Ref. 37). consumers understand the relative include how a declaration of ‘‘Added significance of nutrition information in Sugars’’ and alternative footnote 3. Consumer Use and Understanding of the context of a total daily diet, compare statement may influence consumer use the Nutrition Facts Label the nutritional values of food products, of the label. The Nutrition Facts label is intended and to plan general diets (58 FR 2206 at The overall goal of these studies is to to help consumers make informed food 2213; January 6, 1993). We also noted assess a consumer’s ability to use the choices and maintain healthy dietary that the percent DV information advises Nutrition Facts label and assess a practices. Consumers became the consumer how much of a consumer’s preferences related to increasingly aware of the new label in recommended intake of that nutrient is proposed modifications of the Nutrition the years following implementation of provided by the food (58 FR 2079 at Facts label format. In addition, the the 1990 amendments, and reported 2123; January 6, 1993). We developed studies will help us focus our efforts on using food labels more often in their the term ‘‘Daily Value’’ to refer to all consumer education as well as enhance purchasing decisions compared to their reference values on the nutrition label our understanding of whether use before the introduction of the (DRVs and RDIs). We noted that some of modifications to the Nutrition Facts Nutrition Facts label (Ref. 38). the reference values were intended to label format could help consumers make Data from a nationally representative guide consumers relative to maximum more informed choices based on their sample of U.S. adults collected through intakes (DRVs) (e.g., saturated fat), while perceptions of the nutritional attributes FDA’s Health and Diet Surveys suggest others were intended to serve as the and overall healthfulness of a food that the frequency of food label use basis for planning general diets to meet product. (See also discussion in section among consumers progressively nutrient requirements (RDIs) (e.g., II.M.) increased between 2002 and 2008 (Refs. vitamin C) (58 FR 2079 at 2124). Our 4. Other Relevant Considerations 39 to 41). For example, the percentage research at the time showed that the of consumers reporting that they ‘‘often’’ term ‘‘Daily Value’’ was generally In developing this proposed rule, we read a food label the first time they understood by consumers as a point of considered changes that would assist purchase a food product rose from 44 reference (58 FR 2079 at 2125). consumers in maintaining healthy percent in 2002 to 54 percent in 2008. In order to determine a nutrition dietary practices and recognize that it is Among those indicating they read food labeling format that could be used most important for the updated Nutrition labels when purchasing a product for effectively by consumers, we conducted Facts label to be useful and relevant to the first time, two-thirds of them in consumer research and evaluated the American population. While the 2008 reported using the label to see how research conducted by others in Nutrition Facts label information has high or low the food was in calories, considering requirements for the never been nor is it now targeted to , vitamins or fat, while more than nutrition label format (58 FR 2079 at individuals with acute or chronic half said they used labels to get a 2115–2121). When available, we used disease, we are considering the large general idea of the nutritional content of empirical data on how consumers use portion of the U.S. population that is at the product. A similar increase in and understand the label in proposing risk for chronic disease in proposing reported use of food labels has also been what information should be declared on changes to the label’s content and shown using data from the National the label and how. We used focus group format. The population at risk for Health and Nutrition Examination data to inform what we would test in chronic disease includes those who are Surveys 2007–2008 and 2009–1010. The experimental studies, but did not rely overweight, and therefore at increased percent of working age adults that on such data to make policy decisions. risk of certain chronic diseases, or those reported using the Nutrition Facts Panel Several comments to the ANPRMs who are obese, leading to a variety of (NFP) always or most of the time when submitted focus group data. However, complications including diabetes and shopping for food increased to 42% in we are not relying on focus group data CVD. This approach is consistent with 2009–2010 from 34% in 2007–2008. for the proposed changes to the the new IOM DRIs, which are for Among older adults the percentage Nutrition Facts label because focus healthy individuals, including those at- increased to 57% in 2009–2010 from groups do not yield meaningful risk of disease, but not for individuals 51% in 2007–2008. (Ref. 42). quantitative findings and are not able to with acute or chronic disease or nutrient Consumer research data suggest that, support conclusions about the deficiencies (Ref. 15). Similarly, the despite the widespread use of food relationships between the presentation DGAs are for Americans ages 2 years labels, certain elements of the Nutrition of label information and consumer and older, including those at risk of Facts label may need improvement. For responses. As such, they cannot be used chronic disease. While consumers with example, some consumers have to drive the development of policies, acute or chronic disease, such as difficulty understanding the concept of programs, and services. Policy makers obesity, CVD, or diabetes, may be able percent DV (Refs. 43 and 44) or are and educators can use focus groups to use quantitative information on the confused by the label footnote that lists findings to test and refine their ideas, label to follow advice they have DVs for certain nutrients based on a but should then conduct further received from a health care professional 2,000 and 2,500 calorie diet (Ref. 45). research before making important concerning their conditions, the Section 2(b)(1)(A) of the 1990 decisions such as adopting new policies nutrient declarations and percent DVs amendments mandated that FDA and allocating or redirecting significant on the label are to help consumers make regulations implementing section 403(q) resources to support these policies. more informed choices to consume a of the FD&C Act require that nutrition We have completed one study that and not intended for the labeling must be conveyed to the public examined dual-column labels and ways clinical management of an existing in a manner which enables the public to to increase prominence of certain label disease. In addition, we recognize the readily observe and comprehend such information, and intend to continue to importance of federal regulations information and to understand its perform research during this rulemaking reflecting the most current science. In relative significance in the context of a process to evaluate how variations in developing this proposed rule, we

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considered new scientific evidence and of fat in a food product (http:// but less than 0.5 grams (g) of trans fat dietary recommendations about the www.regulations.gov/ per tablespoon’’ (http:// relationship between nutrients and #!docketDetail;D=FDA-1997-P-0476); (4) www.regulations.gov/ health. the Calorie Control Council submitted a #!docketDetail;D=FDA-2007-P-0404); Finally, we recognize that the goal of citizen petition on February 13, 1998 and (12) CSPI submitted a citizen assisting consumers in maintaining (Docket No. FDA–1997–P–0232) petition on February 13, 2013 (Docket healthy dietary practices requires that requesting that the caloric value of No. FDA–2013–P–0217) requesting, in we consider certain practicalities. For soluble fiber be no more than 2 part, that FDA revise the ‘‘Sugars’’ line example, as we noted in the 1993 kcal/g (http://www.regulations.gov/ on the Nutrition Facts label to address nutrient content final rule (58 FR 2079 #!docketDetail;D=FDA-1997-P-0232); (5) ‘‘added sugars’’ (http:// at 2107), while the 1990 amendments the Center for Science in the Public www.regulations.gov/ permit the Secretary of Health and Interest (CSPI) submitted a citizen #!docketDetail;D=FDA-2013-P-0217). Human Services to include in the petition on August 4, 1999 (Docket No. We address the specific requests Nutrition Facts label any information FDA–1999–P–0158) requesting that FDA identified previously for each citizen about a nutrient that will assist establish a DV for added sugars and petition related to the labeling of consumers in maintaining healthy require the amount of added sugar, and conventional foods and dietary dietary practices, there is not room on the percent DV that represents, to be supplements in the appropriate sections the label for all information that may be declared on food labels (http:// in this document. Requests in these related to maintaining healthy dietary www.regulations.gov/ citizen petitions that are unrelated to the content of the Nutrition Facts label practices. Space constraints on the label #!docketDetail;D=FDA-1999-P-0158); (6) of most foods make declaring all are outside of the scope of this Protein International, Inc. essential nutrients impractical. In rulemaking and we will address those submitted a citizen petition on addition, having a large amount of requests separately from this December 21, 2000 (FDA–2000–P–0569) information on the label could interfere rulemaking. requesting that FDA modify the with consumers’ abilities to use the reference to the method used to 6. Advance Notices of Proposed information that has the greatest public calculate protein content (http:// Rulemaking (ANPRMs) health significance. Therefore, not only www.regulations.gov/ are we aware of the amount and format We also published three ANPRMs #!docketDetail;D=FDA-2000-P-0569); (7) of mandatory information on the label, seeking public comment on issues but we recognize that limits to the the National and Chemical relevant to updating the Nutrition Facts voluntary information are necessary, so Company (‘‘National Starch’’) submitted label. that voluntary information does not a citizen petition on July 8, 2004 a. ANPRM on Trans Fat—In the clutter the label, does not mislead, (Docket No. FDA–2004–P–0094) Federal Register of July 11, 2003 (68 FR confuse, or overwhelm the consumer, requesting that dietary fiber content be 41507), we published an ANPRM (the and does not take away prominence of excluded from the ‘‘total carbohydrate’’ 2003 ANPRM) to solicit information and and emphasis on the required declaration on the Nutrition Facts label data that potentially could be used to information. (http://www.regulations.gov/ establish new nutrient content claims #!docketDetail;D=FDA-2004-P-0094); (8) about trans fatty acids; to establish 5. Citizen Petitions the Sugar Association submitted a qualifying criteria for trans fat in Since 1993, we received a number of citizen petition on August 15, 2005 nutrient content claims for saturated citizen petitions requesting that FDA (Docket No. FDA–2005–P–0373) fatty acids and cholesterol, lean and make various changes to the Nutrition requesting, in part, that FDA amend extra lean claims, and health claims that and Supplement Facts labels. We are regulations related to the labeling of contain a message about cholesterol- addressing a number of issues raised in sugar and alternative sweeteners (http:// raising ; and, in addition, to the following petitions within this www.regulations.gov/ establish disclosure and disqualifying proposed rule: (1) The Calorie Control #!docketDetail;D=FDA-2005-P-0373); (9) criteria to help consumers make heart- Council submitted a citizen petition on CSPI submitted a citizen petition on healthy food choices. We also requested April 13, 1995 (Docket No. FDA–1995– November 8, 2005 (Docket No. FDA– comments on whether we should P–0142) requesting that FDA permit the 2005–P–0196) requesting, in part, that consider statements about trans fat, use of the term ‘‘polyols’’ in lieu of FDA lower the DV for sodium from either alone or in combination with sugar alcohols on the Nutrition Facts 2,400 to 1,500 mg/day (http:// saturated fat and cholesterol, as a label (http://www.regulations.gov/ www.regulations.gov/ footnote in the Nutrition Facts label or #!docketDetail;D=FDA-1995-P-0142); (2) #!docketDetail;D=FDA-2005-P-0196); as a disclosure statement in conjunction the American Cocoa Research Institute (10) an individual submitted a citizen with claims to enhance consumer submitted a citizen petition on April 4, petition on May 25, 2005 (Docket No. understanding about cholesterol-raising 1996 (Docket No. FDA–1996–P–0035) FDA–2005–P–0126) requesting that FDA lipids and how to use the information recommending the accurate preclude the declaration of b-carotene in to make healthy food choices. On March communication of the scientific fact that supplements as vitamin A (http:// 1, 2004 (69 FR 9559), we reopened the stearic acid does not affect blood www.regulations.gov/ comment period for the 2003 ANPRM to cholesterol (http://www.regulations.gov/ #!docketDetail;D=FDA-2005-P-0126); receive comments that considered the #!docketDetail;D=FDA-1996-P-0035); (3) (11) an individual submitted a citizen information in the IOM Labeling Report Nabisco, Inc. submitted a citizen petition on January 17, 2007 (Docket No. (Ref. 25) published in the interim that petition on May 8, 1997 (Docket No. FDA–2007–P–0404) requesting that FDA addressed the labeling of trans fat. On FDA–1997–P–0476) requesting that FDA amend the definition of trans fat in its April 19, 2004 (69 FR 20838), we amend the definition of ‘‘total fat’’ and food labeling regulations to express the extended the comment period for the ‘‘saturated fat’’ in its food labeling value of ‘‘zero’’ for trans fat when there 2003 ANPRM to receive comments that regulations to clarify that acetic, are ‘‘absolutely no trans fats at all’’ and considered the information in the 2004 propionic, and butyric acids may be require the use of a symbol (e.g., ‘‘∼’’) to meeting of the Nutrition Subcommittee excluded when calculating the amount indicate when there is ‘‘more than zero of the Food Advisory Committee (Ref.

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46), which addressed whether the added or removed from the Nutrition sodium, total carbohydrates, sugars, available scientific evidence supported Facts and Supplement Facts labels. dietary fiber, and total protein (See Ref. listing the percent DV for saturated fat In response to the 2007 ANPRM, we 1 for information on regulatory history). and trans fat together or separately on received about 820 comments, from As part of the effort to update the the Nutrition Facts label and what the industry, trade associations, consumer Nutrition Facts label, we reconsidered maximal daily intake of trans fat may groups, individual consumers, the declaration of these statutorily be. government, and academia. We consider required nutrients. Our considerations In response to the 2003 ANPRM, we these comments in each of the relevant and tentative conclusions on these received about 120 comments. We individual nutrient sections in this nutrients are presented within the consider the comments related to document (see also accompanying Ref. discussion of individual nutrients in determining a DV for trans fat in section 47). section II. Section 403(q)(2)(A) of the FD&C Act II.B.3. (see also accompanying Ref. 47). 7. Impact on Other Regulations Other issues raised by comments that provides that the Secretary (and by are unrelated to the DV for trans fat will We recognize that changes to the list delegation FDA) may, by regulation, be addressed in a separate rulemaking at of nutrients declared on the Nutrition require other nutrients to be declared if a future time. Facts label or the RDIs or DRVs of the Secretary determines that a nutrient nutrients will likely affect other FDA b. ANPRM on Prominence of will provide information regarding the regulations, including certain labeling Calories—In the Federal Register of nutritional value of such food that will requirements for foods in 21 CFR part April 4, 2005 (70 FR 17008), we assist consumers in maintaining healthy 101. For example, the DVs are used to published an ANPRM on the dietary practices. For purposes of this determine, in part, whether a food or proposed rule, we consider such prominence of calories on the food label dietary supplement is eligible to bear (the 2005 ANPRM). The 2005 ANPRM nutrients that are not statutorily nutrient content claims or health claims required but subject to our discretion was issued in response to (see for example §§ 101.14, 101.54, recommendations from the Obesity under section 403(q)(2)(A) of the FD&C 101.76, 101.78, and 101.79). In addition, Act, as ‘‘non-statutory nutrients’’ to Working Group created by the our fortification policy refers to RDIs Commissioner of Food and Drugs to distinguish such nutrients from those and certain DRVs that are specified in expressly required by the statute. In the develop an action plan to address the § 101.9 in describing principles for the growing incidence of obesity in the 1993 nutrient content final rule (58 FR rational addition of nutrients to foods 2079), we considered the existence of a United States. The 2005 ANPRM, in (§ 104.20 (21 CFR 104.20)). We plan to quantitative intake recommendation part, requested comments on whether evaluate the impact of the proposed highlighted in U.S. consensus reports giving more prominence to the changes to the Nutrition Facts and and the public health significance of the declaration of calories per serving Supplement Facts labels, if finalized, on nutrient in exercising our discretion to would increase consumer awareness of other FDA regulations. We intend to determine which non-statutory the caloric content of the packaged food. address, as appropriate, the impact on nutrients to require or permit on the We also sought comment on whether other FDA regulations in future separate Nutrition Facts label. Based on these providing a percent DV for total calories rulemakings. Thus, issues related to considerations, with respect to non- would help consumers understand the nutrient content claims and health statutory nutrients, we (1) required the caloric content of the packaged food in claims are outside the scope of this declaration of certain essential vitamins the context of a 2,000 calorie diet. In rulemaking. and minerals for which an RDI was addition, we also requested comments established and that were determined to on questions concerning the declaration C. Factors for Mandatory or Voluntary Declaration of Non-Statutory Nutrients have public health significance (i.e., of ‘‘Calories from fat’’ (70 FR 17008 at vitamins A and C, iron, and calcium); 17010). Under section 403(q)(1)(C) and (D) of and (2) permitted the declaration of the We received about 400 comments to the FD&C Act, nutrition information in remaining essential vitamins and the 2005 ANPRM, each containing one food labeling must include the total minerals for which there was an or more issues, from industry, trade number of calories, derived from any established RDI or DRV (i.e., vitamin E) associations, consumer groups, source and derived from the total fat, or that had public health significance, as individual consumers, government, and and the amounts of total fat, saturated well as permitted the declaration of academia. We consider the comments in fat, cholesterol, sodium, total certain subcategories of macronutrients sections II.A. and II.M. (see also carbohydrates, complex carbohydrates, for which a DRV was not established accompanying Ref. 47). sugars, dietary fiber, and total protein. (including monounsaturated fat, c. ANPRM on Food Labeling: Revision For purposes of this proposed rule, we polyunsaturated fat, soluble fiber, of Reference Values and Mandatory consider the nutrients that are explicitly insoluble fiber, sugar alcohol, and other Nutrients—In the Federal Register of required by the FD&C Act to be declared carbohydrate) (58 FR 2079). November 2, 2007 (72 FR 62149), we on the Nutrition Facts label as In this section, we describe our published an ANPRM regarding the ‘‘statutorily required nutrients.’’ Section current thinking related to revision of reference values and 403(q)(2)(B) of the FD&C Act permits the considerations used to determine mandatory nutrients (the 2007 ANPRM). Secretary, and by delegation, FDA, to whether a non-statutory nutrient should The 2007 ANPRM requested comment remove a statutorily required nutrients be required or permitted to be declared on various aspects of nutrition labeling, from the label or labeling of food, by on the Nutrition Facts label. Applying including what new reference values we regulation, if the Secretary determines this current thinking, in section II, we should use to calculate the percent DV the information related to that nutrient are proposing the mandatory declaration in the Nutrition Facts and Supplement is not necessary to assist consumers in of certain non-statutory nutrients, Facts labels and what factors we should maintaining healthy dietary practices. voluntary declaration of others, and consider in establishing such new FDA regulations require the declaration proposing to remove the mandatory reference values. In addition, we of the following statutorily required declaration of another nutrient. For requested comments on whether we nutrients: Total calories, calories from purposes of this proposed rule, we use should require that certain nutrients be fat, total fat, saturated fat, cholesterol, the term ‘‘nutrient’’ to refer to

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substances that are currently included that can be used to set a DRV or RDI. disease or health-related conditions for or that we are considering for inclusion We expect these consensus reports to be which we have authorized a health on the Nutrition Facts label, including published for the purpose of setting claim would be considered ‘‘well- carbohydrate, fat, and protein and their quantitative intake recommendations established’’ evidence for the purposes subcomponents (e.g., added sugars, (e.g., the IOM DRI reports). If DRIs are of what public health significance refers sugar alcohols, saturated fat), not available for nutrients, other than to in this proposed rule; or (2) nutrients micronutrients (vitamins and minerals), essential vitamins and minerals, then for which there are DRIs set by the IOM and to calories, including calories from we consider science-based (i.e., RDA or AI) that are based on fat. recommendations from other U.S. chronic disease risk (e.g., osteoporosis), 1. Factors Considered consensus reports or the DGA policy a health-related condition (e.g., blood reports. Such recommendations may be pressure) or a nutrient deficiency with We updated the information that we identified as a conclusion, key clinical significance (e.g., low iron consider for determining whether the recommendation, or reported in the storage leading to declaration of a non-statutory nutrient executive summary of the consensus ) for which inadequate intakes of should be mandatory or voluntary. This report. these nutrients are likely to have update responds to several b. Public Health Significance—For the important clinical consequences. The developments. Since the 1993 nutrient purposes of nutrition labeling of foods nutrients for which this may occur are content final rule was published, (1) and dietary supplements, we consider essential vitamins and minerals; and (3) new scientific data have provided for all nutrients, there is evidence of additional evidence of the role of certain public health significance to refer to two elements. First we consider whether inadequate or excess intake of the nutrients in chronic disease risk, health- nutrient based on national nutritional related conditions, or health-related there is evidence of a relationship between the nutrient and a chronic survey data or U.S. consensus reports, physiological endpoints and, in some and that a substantial prevalence exists cases, based on the review of this disease, health-related condition, or health-related physiological endpoint. in the general U.S. population of the evidence, DRIs are now available from chronic disease, health-related the IOM that can be used as quantitative This can be demonstrated either by well-established evidence or, for condition, or health-related intake recommendations (i.e., RDA and physiological endpoint that was linked AI), as well as for assessing the essential vitamins and minerals, recommendations regarding the health to the particular nutrient (e.g., soluble inadequacy and adequacy of essential fiber and coronary heart disease (CHD) vitamins and minerals in the U.S. consequences of inadequacy of the risk, calcium and risk of osteoporosis). population (i.e., EAR and AI); (2) the nutrient. Second we consider whether Because we remain concerned about the rates of certain diseases or health- there is evidence of a problem related to large number of nutrients that could be related conditions have either changed health in the general U.S. population. listed as mandatory or voluntary, for or remained high; and (3) the process for This needs to be demonstrated by both essential vitamins and minerals, we are evaluating the relationship between a evidence of a problem with the intake proposing for mandatory declaration, nutrient and chronic disease risk, a of the nutrient in the general U.S. those for which inadequacy has the health-related condition, or a health- population and evidence of the greatest impact on public health because related physiological endpoint has been prevalence of the chronic disease, of their association with a risk of refined based on the use of systematic health-related condition, or health- evidence-based reviews for a number of related physiological endpoint that is chronic disease, a health-related nutrients (e.g., 2010 DGA, FDA health linked to that nutrient in the general condition, or a nutrient deficiency with claims). U.S. population. We consider public clinical significance (e.g., iron We continue to be mindful of past health significance to refer to the deficiency anemia). factors we considered as part of our following: (1) Existence of ‘‘well- The methods used in the evaluation of deliberations related to the Nutrition established’’ scientific evidence from public health significance of essential Facts label, such as the number of U.S. consensus reports that there is a vitamins and minerals are discussed in nutrients that could be listed in relationship between a nutrient and greater detail in section II.H. and the nutrition labeling, that some individuals chronic disease risk, a health-related accompanying reference document (Ref. could interpret a long list of nutrients as condition, or a health-related 48). implying that a food has greater physiological endpoint and where the 2. Approach for Mandatory Declaration nutritional significance than is the case, intake of such nutrient is of general and that there is limited space for importance in the general U.S. In general, we continue to consider nutrition information on the label (55 population, e.g., where intakes are mandatory declaration appropriate FR 29487 at 29493; July 19 1990). generally too low or too high among the when there is public health significance To help us determine whether a non- U.S. population. U.S. consensus reports and a quantitative intake statutory nutrient should be a required are those reports that provide consensus recommendation that can be used for or permitted declaration, we are conclusions or recommendations by a setting a DV (DRV or RDI). However, we considering the same general types of group of experts as requested by U.S. have also considered mandatory information used in 1993 when the Government Agencies (e.g., IOM reports, declaration based, in part, on evidence nutrient content final rule was the DGAs, National Institutes of Health highlighting the role of a nutrient in published: (1) Existence of quantitative (NIH) consensus reports). We generally chronic disease risk. For example, in intake recommendations; and (2) public consider scientific evidence to be ‘‘well- 2003, we published a final rule health significance. We discuss each of established’’ when such consensus requiring trans fat declaration on the these factors in greater detail in this reports have determined the evidence to Nutrition Facts label (68 FR 41434). We document. be ‘‘conclusive,’’ ‘‘documented,’’ or considered data and information related a. Quantitative Intake ‘‘strong.’’ Evidence that meets the to the risk of coronary heart disease Recommendations—Quantitative intake significant scientific agreement standard from consumption of trans fat. In recommendations are reference intake in section 403(r)(3)(B)(i) of the FD&C addition, we considered the public levels provided in consensus reports Act in support of those nutrients and health significance of trans fat intake

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based on consensus reports and federal macronutrients (including fat, fatty to the 2005 and 2007 ANPRMs, in policy statements. acids, cholesterol, carbohydrates, which we requested comment on Information related to nutrient intake sugars, fiber, and protein), whereas various questions related to ‘‘Calories and its effect on health is not static. sections II.F. through II.J. discuss issues from fat’’ declared on the Nutrition Recommendations from various related to vitamins and minerals, and Facts label. Unlike dietary scientific bodies of the U.S. Government sections II.K. and II.L. discuss nutrition recommendations that we relied on that are responsible for public health labeling requirements applicable to during the 1993 rulemaking, current protection or research directly relating certain population subgroups and dietary recommendations no longer to human nutrition may change or dietary supplements, respectively. emphasize total fat. Certain fatty acids evolve over time. We include, as part of Section II.M. covers issues related to the are understood to be beneficial, while our review of nutrient information in format of the Nutrition Facts label, others are understood to have negative this proposed rule, the current followed by section II.N., which focuses health effects, particularly related to recommendations from such scientific on provisions related to compliance and (Refs. 6, 36, and bodies. In section D.3, we specifically verification. Finally, section II.O. 49). Accordingly, the 2005 DGA shifted consider recommendations from the describes technical amendments to 2010 DGA related to the intake of added existing provisions in § 101.9. its focus from total fat reduction to sugars in the diet and the role of such As discussed in this document, our reduction in certain types of fatty acids information in assisting consumers to evaluation of these issues was informed and their influence on the risk of maintain healthy dietary practices. Our by current scientific evidence, dietary cardiovascular disease (Ref. 36). The review is not based on the factors we recommendations, and conclusions of 2002 IOM Macronutrient Report (Ref. have traditionally considered for current consensus reports. We took into 49) set an AMDR for total fat at 20 to mandatory declaration that are related account any related requests from 35 percent of calories, recognizing that to chronic disease, health-related petitioners and public comments. there were some benefits to consuming condition, or health-related moderate amounts of fat (Ref. 49). The A. Calories physiological endpoint linked to the 2002 IOM Macronutrient Report and the particular nutrient. Instead, our review Section 403(q)(1)(C) of the FD&C Act 2010 DGA (Refs. 6 and 49) concluded is based on the need for nutrient requires the declaration of the total that the type of fat consumed was more information for consumers to implement number of calories derived from any relevant in reducing the risk of CHD key dietary recommendations to assist source. Correspondingly, FDA than overall total fat intake. regulations require the total caloric consumers to maintain healthy dietary Based on the these dietary practices and the need for consumers to content of a food to be declared on the recommendations and consensus be able to readily observe and Nutrition Facts label (§ 101.9(c)(1)). We reports that emphasize intake of total comprehend the information and to are not proposing to modify the calories and the type of fat consumed, understand its relative significance in requirement to declare total calories. the context of a total daily diet. However, we are reconsidering a as well as comments to the 2005 and number of other requirements related to 2007 ANPRMs that supported 3. Approach for Voluntary Declaration the declaration of information about eliminating the declaration of ‘‘Calories For nutrients that are not essential calories. The requirements related to from fat’’ in order to place greater vitamins and minerals (e.g., fluoride, ‘‘Calories from fat,’’ ‘‘Calories from emphasis on total calories (Ref. 47), we soluble and insoluble fiber, saturated fat,’’ the 2,000 reference tentatively conclude that declaration of monounsaturated fatty acids and calorie intake level, and a percent DV ‘‘Calories from fat’’ is not necessary to polyunsaturated fatty acids), we for calories are discussed in section assist consumers in maintaining healthy consider voluntary declaration to be II.A., whereas requirements related to dietary practices. Therefore, we are appropriate when the nutrient either has prominence of the calorie declaration proposing to no longer require, and to a quantitative intake recommendation and the footnote statement and table of not allow voluntarily, the declaration of but does not have public health DVs for 2,000 and 2,500 calorie diets are ‘‘Calories from fat’’ on the Nutrition significance, or does not have a discussed in section II.M. Facts label. While eliminating the quantitative intake recommendation 1. Calories From Fat declaration of ‘‘Calories from fat’’ may available for setting a DRV but has appear to be a loss of information on the The declaration of ‘‘Calories from fat’’ public health significance. In addition, amount of fat being consumed, as some is mandatory (§ 101.9(c)(1)(ii)). Section we consider that voluntary declaration comments suggested, the amount of fat 403(q)(1)(C)(ii) of the FD&C Act requires should be permitted for essential being consumed can still be obtained vitamins or minerals that we determine total calories from fat to be declared on the label or labeling of food. Section from the total fat declaration elsewhere do not fit within our considerations for on the Nutrition Facts label, and mandatory declaration, but that have an 403(q)(2)(B) of the FD&C Act provides the Secretary of Health and Human consumers can still use the percent DV RDI. for total fat to put fat content in the We invite comment on the factors for Services (and by delegation, FDA) with context of a total daily diet, compare considering mandatory and voluntary discretion to remove the requirement by products, and plan diets. Therefore, we declaration of non-statutory nutrients. regulation if the Secretary determines that it is not necessary to assist are proposing to remove current II. The Proposed Rule consumers in maintaining healthy § 101.9(c)(1)(ii) to remove the In this proposed rule, we address dietary practices. We reviewed current requirement for declaration of calories issues related to the information scientific evidence and from fat (and redesignate declared on the Nutrition Facts label, recommendations in current consensus § 101.9(c)(1)(iii) as proposed i.e., declaration of nutrients, definitions, reports in determining whether § 101.9(c)(1)(ii)). We invite comment on analytical methods, RDIs and DRVs, information on calories from fat is the tentative conclusion to no longer format, and compliance with declared necessary to assist consumers in require, and to not allow voluntarily the values. Sections II.A. through II.E. maintaining healthy dietary practices. declaration of ‘‘Calories from fat’’ on the discuss issues related to calories and We also considered comments (Ref. 47) Nutrition Facts label.

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2. Calories From Saturated Fat we require a footnote on the Nutrition reference calorie intake level applicable The declaration of ‘‘Calories from Facts label that states, ‘‘Percent Daily to the general population. Further, all of saturated fat’’ is voluntary Values are based on a 2,000 calorie diet. the comments supported the use of the (§ 101.9(c)(1)(iii)). The 2010 DGA Your daily values may be higher or 2,000 calorie reference intake level. Therefore, we are not proposing any continues to recommend that Americans lower depending on your calorie changes to the current use of 2,000 should consume less than 10 percent of needs,’’ followed by a table with certain reference calorie intake level as the calories from saturated fat (Ref. 6). DVs based on 2,000 and 2,500 calorie basis for setting DRVs for total fat, Saturated fat is known to increase the diets (§ 101.9(c)(9)). In reconsidering the saturated fat, total carbohydrate, dietary risk of cardiovascular disease and, 2,000 calories reference intake level, we considered relevant recommendations fiber, and protein, as specified in unlike ‘‘Calories from fat,’’ which could from the IOM macronutrient report that § 101.9(c)(9). include calories attributable to fatty provided estimated energy requirements acids that decrease or increase the risk 4. Percent DV Declaration for Calories (EERs) and the IOM Labeling Report of certain diseases, ‘‘Calories from (Refs. 25 and 50). We also considered Current regulations do not provide for saturated fat’’ would provide comments (Ref. 47) received in response a DRV for calories. Setting a DRV for information about calories from a source to the 2007 ANPRM, in which we asked calories would necessitate the known to increase disease risk (Ref. 49). whether 2,000 calories should continue determination of a quantitative intake We considered the recommendations in to be used as the reference calorie intake recommendation for calories. To current consensus reports as well as the level and asked questions related to the determine an appropriate DRV for comments (Ref. 47) received in response use of the EERs. calories, we reviewed recommendations to the 2007 ANPRM requesting An EER is a DRI set by the IOM for in current consensus reports. We also comment on whether the declaration of energy intake and is defined as the considered comments (Ref. 47) received ‘‘Calories from saturated fat’’ should dietary energy intake that is predicted to in response to the 2005 and 2007 continue to be voluntary or whether it maintain energy balance in a healthy ANPRMs, in which we asked whether should be mandatory. adult of defined age, gender, weight, providing a percent DV disclosure for Based on the recommendations in height, and level of physical activity total calories would assist consumers in current consensus reports and consistent with good health. The IOM understanding the caloric content of the supported by many comments, we set EERs for all life-stage and gender packaged food in the context of a 2,000 tentatively conclude that mandatory groups and based these EERs on normal calorie diet. The IOM macronutrient declaration of ‘‘Calories from saturated weight individuals (i.e., BMI < 25) (Ref. report is the most recent consensus fat’’ is not necessary because the amount 50). The IOM Labeling Committee report that provides quantitative intake of saturated fat being consumed can still considered whether there was a basis to recommendations for calories (Ref. 50), be obtained from the total saturated fat use the EERs for developing a new and those quantitative intake declaration elsewhere on the Nutrition reference calorie intake level for recommendations are the EERs. For the Facts label. Additionally, as with total macronutrients in nutrition labeling. same reasons that EERs are not fat, consumers can still use the percent The IOM Labeling Committee noted that appropriate for setting the reference DV for saturated fat to put saturated fat using the EER to derive a reference calorie intake level as described content in the context of a total daily calorie intake level would require previously, these EERs are not diet, compare products, and plan diets. making assumptions about height, appropriate for setting a DV for calories. However, because there is strong weight, and physical activity level. First, the EERs do not apply to evidence associating higher intakes of Furthermore, the equations used to overweight individuals, and are saturated fat with higher low-density calculate the EERs were based on therefore not applicable to a substantial lipoprotein (LDL) cholesterol levels, normal weight individuals; however, portion of the general population. information on ‘‘Calories from saturated the American population has a high Second, combining the EERs into a fat’’ can assist consumers in maintaining prevalence of overweight and obesity. single, meaningful reference value is healthy dietary practices. Therefore, we Thus, the IOM Labeling Committee challenging because they vary by age, are not proposing to change the current found that the data necessary to use the gender, height, weight, and PAL. In voluntary labeling of ‘‘Calories from EER concept as the basis for a reference addition, DRVs were established for saturated fat’’ in the Nutrition Facts calorie intake level for nutrition labeling those nutrients that are important in label as specified in § 101.9(c)(1)(iii). were incomplete and it could not diet and health interrelationships and/ However, considering our proposal to recommend the approach (Ref. 25). The or based on caloric intake (55 FR 29476 eliminate the declaration of ‘‘Calories IOM Labeling Committee concluded at 29479; July 19, 1990). Accordingly, from fat’’ on the Nutrition Facts label that retaining the current 2,000 most of the DRVs have been based on (see section II.A.1.), we are proposing to reference calorie intake level would be quantitative intake recommendations revise § 101.9(c)(1)(iii) and (d)(5) to the best approach as it would provide associated with chronic disease risk or specify that the statement ‘‘Calories continuity and would not encourage a health-related condition (e.g., total fat, from saturated fat,’’ when declared, higher calorie intake and saturated fat, cholesterol, and dietary must be indented under the statement of overconsumption of energy (Ref. 25). fiber). In contrast, the EERs are neither calories. In addition, we are proposing We agree with the IOM Labeling associated with chronic disease risk or to redesignate § 101.9(c)(1)(iii) as Report and comments in response to the a health-related condition, nor are they proposed § 101.9(c)(1)(ii). 2007 ANPRM (Ref. 47) that the EERs do intended to be treated as a single not provide an appropriate basis for the recommended value that can be applied 3. Two Thousand Calories as the derivation of a reference calorie intake to the general U.S. population. Thus, we Reference Caloric Intake Level level for the purpose of nutrition tentatively conclude that there is no Per FDA regulations, a reference labeling. The EERs are influenced by appropriate quantitative intake calorie intake level of 2,000 calories is various parameters such as age, gender, recommendation and we are not aware used to set DRVs for total fat, saturated height, weight, and physical activity of any other data or information on fat, total carbohydrate, protein, and level (PAL), which makes it challenging which a DRV for calories can be dietary fiber (§ 101.9(c)(9)). In addition, to combine the EERs into a single determined. Although a majority of

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comments to the ANPRMs supported differently than fatty acids and are similar definitions found in nutrition the addition of a percent DV for total biochemically and physiologically more and references (Refs. 51 to calories, we are not persuaded to closely related to carbohydrates than to 54). We request comment on the propose to require or permit such fat; and (4) the acids do not cause the proposed definition of fatty acids. declaration due to the lack of an adverse health effects associated with b. Mandatory Declaration—Section appropriate quantitative intake fat and may even have benefits that 403(q)(1)(D) of the FD&C Act requires recommendation or other data or make them distinct from fat. The the declaration of the amount of total fat information on which FDA could rely to petitioner noted that excluding the acids on food labels. Consequently, the establish a DRV for calories. We invite from the definition of fat would not Nutrition Facts label includes the comment on the tentative conclusion affect current labeling practices because mandatory declaration of the gram not to establish a DRV for calories and they are found in such small amounts in amount for total fat in § 101.9(c)(2). include a percent DV for the declaration the food supply. In addition, the The 2010 DGA recognizes that the of calories. petitioner asserted that analytical types of fatty acids consumed are more Therefore, we are not proposing to set methods would not be affected because important in influencing the risk of CVD a DRV for calories and, as a result, a approved AOAC methods for total fat than the total amount of fat in the diet percent DV declaration for calories measurement do not detect the acids. (Ref. 6). Current dietary would be neither required nor We disagree with the petitioner that recommendations and clinical permitted. the acids are chemically different from guidelines encourage replacing fatty acids because they are saturated and trans fatty acids with B. Fat soluble and that insolubility in water is beneficial fats, such as polyunsaturated In section II.B., we discuss the essential chemical property of a fat. and monounsaturated fatty acids (Refs. considerations related to definitions, Fatty acids are monocarbonic acids with 6 and 55). A high intake of most types declaration, and DRVs for total fat, chain lengths between 1 and nearly 30 of saturated fatty acids, trans fatty acids, saturated fat, trans fat, monounsaturated atoms (Ref. 51). The chain length and cholesterol can increase LDL fat, and polyunsaturated fat. of a determines its physical cholesterol levels, which in turn may 1. Total Fat properties (Ref. 51). Short-chain fatty increase the risk of CHD (Ref. 49). While acids are compounds that are soluble in there is a significant amount of evidence a. Definition—FDA defines ‘‘fat, total’’ water. As the chain length increases, showing that a diet high in saturated or or ‘‘total fat’’ in § 101.9(c)(2) as a water-solubility decreases (Ref. 51). trans fatty acids may be detrimental to statement of the number of g of total fat Short chain acids such as acetic, health, there is also evidence that in a serving defined as total fatty propionic, and butyric acids are still consumption of less than 20 percent of acids and expressed as . considered fatty acids although they are calories from fat can lead to an In 1997, we received a citizen petition water soluble. Furthermore, the increased risk of insufficient intake of from Nabisco, Inc. (Docket No. FDA– characteristic feature of a fatty acid is a vitamin E and essential fatty acids (Ref. 1997–P–0476) requesting that FDA terminal carboxyl group attached to a 49). In addition, consumption of a low amend the definitions of ‘‘total fat’’ and chain of alkyl groups containing carbon fat diet that is high in carbohydrate can ‘‘saturated fat’’ in its food labeling atoms of which these short chain acids lead to a reduction in high density regulations to clarify that acetic, are composed (Ref. 52). lipoprotein cholesterol concentration propionic, and butyric acids may be We determine the amount of the and an increase in blood triglycerides, excluded when calculating the amount major macronutrients (carbohydrate, fat, which can result in an increased risk of of fat in a food product (http:// and protein) in a food product by their CHD (Ref. 49). www.regulations.gov/ chemical composition. We tentatively We concur with the 2010 DGA that # !docketDetail;D=FDA-1997-P-0476). conclude that the petitioner did not consuming a diet low in saturated fatty The petitioner’s requests related to the provide a scientific basis on which we acids and cholesterol is more important definition and labeling of total fat are could rely to propose to exclude acetic, for reducing CVD risk than consuming presented here and the petitioner’s propionic, and butyric acids from the a diet low in total fat. This finding is requests related to the definition of definition of total fat based on consistent with the conclusions in the saturated fat are discussed in section differences in chemical composition. IOM Macronutrient Report (Ref. 49), as II.B.2. Moreover, the petitioner did not explain well as with current practice guidelines With respect to total fat, the petitioner why we should define total fat based on such as the National Heart, Lung, and requested that we amend § 101.9(c)(2) to physiological differences identified for Blood Institute (NHLBI) Third Report of read as follows: ‘‘Fat, total’’ or ‘‘Total such fatty acids compared to other fatty the Expert Panel on Detection, fat’’: A statement of the number of g of acids, even if true, and not retain our Evaluation, and Treatment of High total fat in a serving defined as total current approach to define total fat Blood Cholesterol in Adults (Ref. 55). lipid fatty acids, excluding acetic (C:2), based on chemical composition. Total fat is a calorie-yielding propionic (C:3), and butyric (C:4) acids Therefore, we are not proposing any macronutrient and an important piece of and expressed as triglycerides . . .’’ The changes to the current definition of the macronutrient profile of a food. petitioner stated that acetic, propionic, ‘‘total fat.’’ We request comment on our However, consumption of inadequate and butyric acids (‘‘the acids’’), which tentative conclusion that acetic, amounts of total fat is also associated have very short two, three, and four propionic, and butyric acids should not with an increased risk of impaired carbon chains, respectively, are organic be excluded from the definition of ‘‘total growth and consumption of excessive acids that should not be considered fatty fat.’’ amounts of total fat is associated with acids for food labeling purposes for the To clarify what we consider to be a an increased risk of chronic diseases, following reasons: (1) The acids are fatty acid, we are proposing to define such as CHD and diabetes (Ref. 49). In chemically different from fatty acids ‘‘fatty acids’’ in § 101.9(c)(2) as addition, the IOM noted that high fat because they are water soluble; (2) the ‘‘aliphatic carboxylic acids consisting of diets are usually accompanied by and absorption of the acids are a chain of akyl groups and characterized increased intakes of saturated fatty acids distinctly different from those of fatty by a terminal carboxyl group.’’ This which can increase the risk of CHD (Ref. acids; (3) the acids are metabolized definition is consistent with other 49). Thus, we tentatively conclude that

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mandatory declaration of total fat on the reduction in risk of chronic diseases, comments on the definition of saturated Nutrition Facts label continues to be such as CHD and diabetes (Ref. 49). fat, but received a few comments that necessary to assist consumers in We also conclude that the upper level requested excluding stearic acid from maintaining healthy dietary practices. of the AMDR of 35 percent of 2,000 the definition of saturated fat or Therefore, we are not proposing any calories as the basis for a DRV would permitting a separate listing for stearic changes to the current requirement for provide no meaningful health benefit acid below the line for saturated fat (Ref. mandatory declaration of total fat on the and that a population-weighted mid- 47). Nutrition Facts label. point of 28 percent of the AMDR (28 We considered the comments to the c. DRV—The DRV for total fat is 30 percent of calories) as the basis for the 2007 ANPRM and the request by the percent of calories (65 g/d) (§ 101.9 DRV is not significantly different from American Cocoa Research Institute (c)(9)). In developing the DRIs for a public health outcome standpoint than petition, and do not agree that stearic various nutrients, the IOM cited a lack the current value of 30 percent of acid should be excluded from the of data sufficient to determine a defined calories. Using the population-weighted definition of saturated fat. While there level of fat intake at which no risk of AMDR midpoint approach would result is evidence that there are potential inadequacy or prevention of chronic in an insignificant reduction from the differences in the physiological effects disease occurs, and therefore, decided to DRV of 65 g (rounded from 30 percent of different saturated fatty acids, establish neither an AI nor an RDA for of a 2,000 calorie diet) to 60 g (rounded including on LDL cholesterol levels, the total fat (Ref. 49). Instead, the IOM from 28 percent of calories), which may definitions of nutrients for food labeling established an AMDR for total fat intake imply a greater level of precision in a purposes have traditionally been based of 20 to 35 percent of energy for adults DRV than is actually true. on chemical definitions, rather than on and an AMDR of 25 to 35 percent of Furthermore, the DRV for total fat is individual physiological effects. The energy for children age 4 to 18 years. linked to the DRVs for total definition for saturated fat in The AMDRs are associated with reduced carbohydrate and protein. For reasons § 101.9(c)(2)(i) includes all fatty acids risk of chronic diseases, such as CHD, discussed in sections II.D. and II.E., we without double bonds and the accepted are not proposing to change the DRVs while providing for adequate intake of analytical methods capture all of the for carbohydrate or protein at this time. essential nutrients. The 2010 DGA saturated fatty acids, including stearic Because the DRV for carbohydrate is acknowledged the IOM’s AMDR and acid. In adopting this definition, we determined by difference, an increase in noted that total fat intake should fall addressed the issue of inclusion/ the DRV for fat would result in a within the AMDRs set by the IOM (Ref. exclusion of individual saturated fatty decrease in the DRV for carbohydrate. acids and determined that a chemical 6). The IOM Labeling Committee The DRV of 30 percent of calories fits recommended that AMDRs should be definition (which includes all fatty within the AMDR and represents a acids containing no double bonds) was the basis for DVs for protein, total moderate value that is not close to the the appropriate approach to define carbohydrate, and total fat (72 FR 62149 upper or lower levels of the AMDR. A saturated fat (58 FR 2079 at 2088). We at 62164). Accordingly, for total fat, the majority of comments supported further note that the 2010 DGA IOM Labeling Committee recommended maintaining the current DRV of 30 recommendation related to saturated fat a population-weighted midpoint of the percent of calories. As noted previously, intake is based on scientific evidence AMDR since AMDRs vary with age. A the DRV for total fat was calculated related to the intake of all saturated fatty population-weighted mid-point of the based on a 2,000 reference calorie intake acids combined, which includes stearic AMDR for adults, i.e., 20 to 35 percent, and the dietary recommendation for fat acid. The DGA recommendation to yields a DRV of 28 percent or 62 g of intake at the time of 30 percent or less consume less than 10 percent of calories total fat. The use of the upper level (35 of total caloric intake, amounting to 66.7 from saturated fatty acids makes no percent of energy) of the AMDR would g of fat, which was rounded down to 65 specific exclusion of stearic acid and, increase the DRV from 65 g to 78 g for g. Current dietary recommendations for instead, relates to the intake of total a 2,000 calorie diet. fat intake provide a range of acceptable saturated fatty acids (Ref. 6). There are Considering the recommendations of intakes (i.e., between 20 and 35 percent no quantitative intake recommendations the IOM Labeling Committee, we of caloric intake) and encompass the 30 for stearic acid. requested comment, in the 2007 percent value that formed the basis for The inclusion of stearic acid in the ANPRM, on: (1) Whether a population- the existing DRV. Therefore, we are not definition of saturated fat is consistent weighted midpoint of the AMDR (e.g., proposing any changes to the current with our overall approach to rely on 28 percent for adults) should be used, as DRV for total fat of 30 percent of chemical definitions of nutrients as the suggested in the IOM Labeling Report calories. basis for regulatory definitions for food and (2) whether the upper level of labeling purposes. The American Cocoa AMDR of 35 percent (78 g) should be 2. Saturated Fat Research Institute petition did not used. a. Definition—FDA regulations define provide a basis for why we should We reviewed the IOM Labeling ‘‘Saturated fat’’ in § 101.9(c)(2)(i) as the deviate from this overall approach to Committee’s recommendations, IOM sum of all fatty acids containing no rely on the chemical definition of DRIs, and comments in response to the double bonds. We received a citizen nutrient as a basis for a regulatory 2007 ANPRM (Ref. 47). We tentatively petition from the American Cocoa definition. Thus, we are not proposing conclude that changing the DRV for Research Institute on April 3, 1996 to exclude stearic acid from the total fat to the lower end of 20 percent (Docket No. FDA–1996–P–0035) definition of saturated fat. of 2,000 calories would not be requesting that the Agency exclude Finally, we also considered voluntary appropriate because: (1) It would not be stearic acid from the definition of declaration of stearic acid on the appropriate for children 4 to 18 years of saturated fat because the petitioner Nutrition Facts label, as recommended age because it falls below the lower end claimed that stearic acid does not raise by a few comments. The effects of of the AMDR (i.e., 25 to 35 percent of LDL-cholesterol levels or the risk of stearic acid on LDL cholesterol levels energy) and (2) scientific evidence CHD (http://www.regulations.gov/ appear to vary depending on the supports consumption of greater than 20 # !docketDetail;D=FDA-1996-P-0035). In macronutrient component that is percent of total calories from total fat for the 2007 ANPRM, we did not seek replaced by stearic acid (Ref. 30).

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Moderate evidence indicates that when Therefore, we are not proposing to existing DRV of 20 g continues to stearic acid substitutes for other change the requirement for mandatory conform to current dietary saturated fatty acids or trans fat, plasma declaration of saturated fat on the recommendations as a maximum intake LDL cholesterol levels decrease whereas Nutrition Facts label in § 101.9(c)(2)(i). level that covers the general U.S. when it replaces monounsaturated or c. DRV—The DRV for saturated fat is population. polyunsaturated fatty acids, LDL 20 g, which is 10 percent of calories We do not consider the use of food cholesterol levels increase (Ref. 30). based on a 2,000 reference calorie intake composition data, menu modeling, or Considering such scientific data, the level (§ 101.9(c)(9)). The IOM Labeling dietary survey data as a suitable 2010 DGAC concluded that the potential Committee recommended that the DV approach to determine DRVs. We note effects of changes in dietary intake of for saturated fatty acids (along with that the majority of comments opposed stearic acid on the risk of CVD remain trans fatty acids and cholesterol) should the use of such alternative methods to unclear. Thus, the evidence for a role of be set at a level that is as low as possible determine the DRV for saturated fat. stearic acid in human health (e.g., in keeping with an achievable health- We established the current DRVs changes in plasma LDL cholesterol promoting diet and consistent with IOM based on quantitative intake levels) is not well-established. DRIs (Ref. 25). The IOM Labeling recommendations and underlying Furthermore, there is no quantitative Committee suggested that FDA use on the association between intake recommendation available for composition data, menu modeling, and increased intakes and either reduced stearic acid. Therefore, we tentatively data from dietary surveys to estimate risk of chronic disease (e.g., dietary fiber conclude that the individual declaration minimum intakes that are consistent and CHD) or increased risk of chronic of stearic acid is not necessary to assist with nutritionally adequate and health- disease (e.g., saturated fat and CHD). consumers in maintaining health dietary promoting diets for diverse populations. The approach to determine DRVs using practices, consistent with the factors we In the 2007 ANPRM, we asked for , menu modeling, consider, discussed in section I.C., and public comment on (1) whether the or dietary surveys has a number of therefore the declaration would not be current DRV for saturated fat of 20 g deficiencies. Menu modeling is an permitted on the Nutrition Facts label. should be retained and (2) whether food approach, based on available foods in As discussed in section II.B.1., we composition data, menu modeling, and the marketplace, to design a set of food received a citizen petition from Nabisco, data from dietary surveys should be items for , which will meet certain Inc. on May 7, 1997 (Docket No. FDA– used to establish a DRV for saturated fat nutrient or food intake pattern 1997–P–0476) requesting that FDA that is as low as possible while recommendations (Ref. 56). Menu amend the definitions of ‘‘total fat’’ and consuming a nutritionally adequate diet. modeling, by its very nature, would not ‘‘saturated fat’’ in its food labeling We received several comments in permit the selection of DRVs that are regulations to exclude acetic, propionic, response to these questions (Ref. 47). based on scientific evidence related to and butyric acids (http:// Current consensus reports that actual public health outcomes. www.regulations.gov/ reviewed scientific evidence related to Furthermore, menu modeling permits # !docketDetail;D=FDA-19970-P-0476). saturated fatty acid intake continue to the creation of model menus that may With respect to saturated fat, the recommend saturated fat intakes of no be able to meet certain nutrient petition requested that FDA amend more than 10 percent of calories, based thresholds through the inclusion of § 101.9(c)(2) to read as follows: (i) on risk of CVD. Specifically, the IOM foods that are not representative of the ‘‘Saturated fat,’’ or ‘‘Saturated’’: A DRIs recommended that intakes of these type or quantity of foods eaten in the statement of the number of g of fats should be as low as possible while U.S. population or any specific saturated fat in a serving defined as the consuming a nutritionally adequate diet population and, thus, may result in sum of all fatty acids, excluding acetic (Ref. 49). In addition, confirming the nutrient intake levels that do not reflect (C:2), propionic (C:3), and butyric (C:4) relationship between high intakes of typical diets and, as such, may be acids, containing no double bonds.’’ For saturated fatty acids and increased risk unachievable or unreasonable. The use the same reasons discussed in section of unhealthy blood lipid levels and of menu modeling can be appropriate in II.B.1. regarding total fat, we are not CHD, the 2010 DGA reaffirmed the other circumstances, such as the use of proposing to exclude acetic, propionic, recommendation to reduce saturated modeling to determine scenarios of and butyric acids from the definition of fatty acid intake to less than 10 percent highest possible nutrient intake levels or saturated fat. of calories and noted that lowering the potential nutrient profiles of diets. b. Mandatory Declaration—Section intake even more, to 7 percent of Thus, food composition data and related 403(q)(1)(D) of the FD&C Act requires calories, can further reduce the risk of models can help provide useful the declaration of the amount of CVD (Ref. 6). The 2002 report from the information about consumption trends saturated fat on food labels. National Cholesterol Education Program and the general nutrient content of the Accordingly, FDA regulations require of the NIH National Heart, Lung, and food supply and can serve as an mandatory declaration of the gram Blood Institute established saturated fat additional consideration in choosing a amount for saturated fat (§ 101.9(c)(2)). intakes of no more than 10 percent of reference point for daily intake that is Dietary recommendations continue to calories as an optimal intake level for realistically achievable and practical in recognize the well-established reduction of CHD risk while also light of the current food supply and relationship between consumption of establishing intakes of no more than 7 consumption patterns. However, these saturated fat and its effect on blood percent of calories as a therapeutic data cannot form the primary scientific cholesterol levels (Refs. 6 and 49). In intake level for treating CHD (Ref. 55). bases for selecting DRVs. Another addition, the 2010 DGA provided a Although some comments suggested challenge with the use of the menu quantitative intake recommendation for reducing the DRV to 15 g and to lower modeling approach is that numerous saturated fat. We are unaware of the DRV to 7 percent of calories, we are and rapid changes to food formulations evidence to support a determination not persuaded to do so because the can make it difficult for food that information relating to saturated fat current saturated fatty acid composition databases to provide on the Nutrition Facts label is no longer recommendation of less than 10 percent current and accurate estimates of necessary to assist consumers in of calories is still appropriate for the nutrient intakes. Based on these maintaining healthy dietary practices. general U.S. population and that the inherent limitations of menu modeling

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and the data sources used, we (Ref. 6). Furthermore, under section at levels below 0.5 g per serving are tentatively conclude that the menu 403(r)(3)(C) of the FD&C Act, we did not currently not available. For most modeling approach, as recommended in object to a 2006 Food and Drug nutrients declared on the nutrition the IOM Labeling Report, is an Administration Modernization Act of label, the maximum amount permitted unsuitable method for determining 1997 (FDAMA) notification for the for a declaration of a zero value is DRVs (or RDIs). Instead, we intend to ‘‘Diets low in saturated fat governed by the limitations associated continue using science-based and cholesterol, and as low as possible with analytical methods available to recommendations to set DRVs and RDIs. in trans fat, may reduce the risk of heart determine the content of a nutrient in a In the case of saturated fat, as explained disease,’’ based on statements made in food. The analytical methods used to previously, the existing scientific the 2005 DGA (Ref. 57). As such, determine nutrient content for purposes evidence does not support a change to because of its role in chronic disease, of compliance are discussed in more the current 20 g DRV. Therefore, we are trans fat continues to be a nutrient with depth in section II.N. The petition did not proposing any changes to the public health significance. We are not provide any information on current DRV of 20 g for saturated fat as unaware of evidence to support a alternative analytical methodologies specified in § 101.9(c)(9). determination that information relating that are more sensitive and reliable nor to trans fat on the Nutrition Facts label did the petition provide any evidence to 3. Trans Fat is not necessary to assist consumers in support the claim that consumers are a. Definition—FDA defines ‘‘Trans maintaining healthy dietary practices. misled by the provisions for the fat’’ or ‘‘Trans’’ in § 101.9(c)(2)(ii) as the We tentatively conclude that declaration of zero trans fat. Thus, we sum of all unsaturated fatty acids that information on the amount of trans fat are not proposing any changes to the contain one or more isolated (i.e., non- in food products allows consumers to requirement for the declaration of zero conjugated) double bonds in a trans reduce their intake of trans fat, and when trans fat content is less than 0.5 configuration. In the 2007 ANPRM, we thus, reduce the risk of CHD. Therefore, g per serving. did not seek public comment on the we are not proposing any changes to the c. DRV—FDA regulations do not definition of trans fat. However, we requirement for mandatory declaration provide a DRV for trans fat. At the time received a comment recommending the of trans fat on the Nutrition Facts label of the issuance of the trans fat final rule, exclusion of a specific trans fat isomer, in § 101.9(c)(2)(ii). However the Agency we concurrently issued the 2003 vaccenic acid (18:1 t11) from the recently published a tentative ANPRM in the same issue of the Federal definition of trans fat because, determination that partially Register (68 FR 41507) to solicit according to the comment, unlike other hydrogenated oils, the source of information and data on several trans fat trans fat isomers, vaccenic acid may not industrially produced trans fat, may not labeling issues. In the 2007 ANPRM, we have adverse health effects. As be generally recognized as safe (78 FR again requested comments on various discussed in the preamble to the final 67169; November 8, 2013). We request issues related to the DV for trans fat, rule regarding trans fat labeling (68 FR comment on whether mandatory including the use of food composition 41434 at 41461), we defined trans fatty labeling of trans fat would still be data, menu modeling and data from acids by their chemical structure, not necessary if this determination is dietary surveys, and a potential joint their physiological effects or functional finalized. percent DV for trans fat and saturated attributes. While the comment provided Per § 101.9(c)(2)(ii), if a food contains fat. We received several comments in us with some preliminary observational less than 0.5 g of trans fat per serving, response to the 2007 ANPRM. We data suggesting that trans fat from the content, when declared, is to be considered the recommendations in the ruminant sources, such as vaccenic expressed as zero. We received a citizen IOM Labeling Report, available acid, may not have the same effects on petition from an individual on January scientific evidence, and comments (Ref. CHD risk as trans fat from industrial 17, 2007 (Docket No. FDA–2007–P– 47) received in response to both the sources, such as partially hydrogenated 0404) which requested that FDA amend 2003 and 2007 ANPRMs. oils, we do not agree that potential the definition of trans fat in its food i. Use of food composition data, menu differences in physiological effects labeling regulations to express the value modeling, and dietary surveys. FDA should be the basis for determining the of ‘‘zero’’ for trans fat only when there considered the approach recommended specific isomers to be included in a are ‘‘absolutely no trans fats at all’’ and in the IOM Labeling Report to use food regulatory definition of trans fat. The require the use of a symbol (e.g., ‘‘∼’’) to composition data, menu modeling, and definition for trans fat is its chemical indicate when there is ‘‘more than zero dietary survey data to estimate a definition which captures all trans fat but less than 0.5g of trans fat per minimum trans fat intake within a isomers that have isolated bonds and, tablespoon’’ (http:// nutritionally adequate diet. thus, vaccenic acid would be measured www.regulations.gov/ As explained previously (see section by the analytical method used to # !docketDetail;D=FDA-2007-P-0404). II.B.2.c.), we do not consider food determine trans fat content of foods. The petition claimed that the composition data, menu modeling, or This chemical definition is consistent declaration of zero trans fats on the dietary survey data suitable for with how polyunsaturated fat is defined label is misleading to consumers determining DRVs. Furthermore, such as cis, cis-methylene-interrupted because it does not denote the absence an approach is not linked to a health (§ 101.9(c)(2)(ii)). Accordingly, we are of trans fat (as ‘‘zero’’ is defined in outcome, which we have traditionally not proposing to change the definition Webster’s Dictionary) and that people used as a basis for determining DRVs. of trans fat in § 101.9(c)(2)(ii). will consume a food incorrectly As described in the IOM macronutrient b. Mandatory Declaration—FDA thinking that it has zero amount of trans DRI report (Ref. 49), the IOM reviewed regulations require the declaration of fat. The petition stated that, because the evidence for trans fat and was not trans fat on the Nutrition Facts label trans fat is associated with negative able to set a UL for trans fat, which (§ 101.9(c)(2)(ii). Dietary effects on heart health, this situation indicates that there is insufficient recommendations continue to recognize could be detrimental to people’s health. scientific evidence from which to the well-established relationship Validated analytical methodologies determine a specific level of trans fat between consumption of trans fat and that provide sensitive and reliable intake that would likely pose no risk of its effect on blood cholesterol levels estimates of trans fatty acids in all foods adverse health effects. We continue to

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adhere to the approach of determining 4. Polyunsaturated Fat that replacing saturated fatty acids with DRVs for a nutrient based on the Polyunsaturated fats represent two polyunsaturated and monounsaturated nutrient’s association with specific general categories: n-6 and n-3 fatty acids reduces blood LDL health outcomes (e.g., LDL cholesterol polyunsaturated fatty acids. The most cholesterol levels and, therefore, the risk levels). common n-6 and n-3 polyunsaturated of CVD (Ref. 30). The prevalence of CVD As an additional consideration, even fatty acid in food is linoleic acid and a- in the U.S. population is substantial if we were to use the menu modeling linolenic acid, respectively. Other n-3 (Ref. 30). We are not proposing any approach, it would be difficult to apply fatty acids found in foods, particularly changes to the requirement for such an approach for trans fat. Current in fish, are the long chain fatty acids, mandatory declaration of saturated fat estimates of trans fat content in food (see section II.B.2.). Because eicosapentaeneoic acid (EPA) and composition databases are not polyunsaturated fat has public health docosahexaenoic acid (DHA). comprehensive and do not include trans a. Voluntary Declaration—FDA significance when it replaces saturated fat content for all foods. The levels of regulations permit, but do not require, fat, consistent with the factors for trans fat in foods have changed since voluntary declaration discussed in the declaration of polyunsaturated fat the publication of the 2003 trans fat section I.C., we are proposing to (defined as cis, cis-methylene- final rule, in part due to reformulation continue to permit voluntary interrupted polyunsaturated fatty acids) of foods (Ref. 58). The numerous and declaration of polyunsaturated fat, as on the Nutrition Facts label rapid changes to food formulations can provided in § 101.9(c)(2)(iii). We request (§ 101.9(c)(2)(iii)). make it difficult for food composition comment about whether there is an To determine whether any changes databases to provide current and appropriate alternative analysis to the are needed to the current provision for accurate estimates of the usual intake of application of the factors in section I.C. voluntary declaration, we considered trans fat. regarding the voluntary declaration of recommendations of current U.S. Therefore, we tentatively conclude polyunsaturated fat. that the menu modeling approach, as consensus reports as well as comments b. DRV—FDA regulations do not recommended in the IOM Labeling received (Ref. 47) in response to the provide a DRV for polyunsaturated fat. Report, is an unsuitable method for 2007 ANPRM, in which we requested The IOM did not set a DRI or AMDR for determining an appropriate DRV for comment on whether declaration of polyunsaturated fat, but provided AIs trans fat. polyunsaturated fat should continue to and AMDRs for two specific essential ii. Determining a DRV. The IOM did be voluntary or made mandatory. fatty acids, linoleic acid (an n-6 not set a UL for trans fat in the DRI Current dietary recommendations polyunsaturated fatty acid) and a- macronutrient report. The IOM noted advise consumers to increase intakes of linolenic acid (an n-3 polyunsaturated that any increase in trans fat intake polyunsaturated fatty acids to replace fatty acid) based on median intakes of increases CHD risk but because trans saturated fatty acids in their diets (Ref. each fatty acid using NHANES data (Ref. fats are unavoidable in ordinary diets, 6). The 2010 DGA recommends limiting 49). The AIs for linoleic acid and a- consuming zero percent of calories the consumption of saturated fatty acids linolenic acid are 17 and 1.6 would require significant changes in accompanied with replacing them with micrograms (mcg)/d, respectively. The dietary intake patterns that may polyunsaturated and monounsaturated AMDRs for linoleic acid and a-linoleic introduce undesirable effects and fatty acids (Ref. 6). However, as acid are 5 to 10 percent of calories and unknown and unquantifiable health discussed in this document, the IOM 0.6 to 1.2 percent of calories, risks (Ref. 49). The 2005 and 2010 DGA did not set DRIs for total respectively. In the 2007 ANPRM, we and the FDA Food Advisory Committee polyunsaturated fatty acids, but rather asked: (1) Whether a DRV for total (Refs. 6 and 36) likewise could not set provided AIs and AMDRs each for two polyunsaturated fat should be derived a definitive quantitative intake specific fatty acids, linoleic acid (an n- based upon AIs for linoleic acid plus a- recommendation for trans fat. 6 polyunsaturated fatty acid) and a- linolenic acid; and (2) whether a DRV Comments generally supported a single linolenic acid (an n-3 polyunsaturated for total polyunsaturated fat should be trans fat DRV and a single percent DV, fatty acid) based on median intakes of established using the AMDRs for n-6 but noted that such levels are not each fatty acid using NHANES data (Ref. and n-3 polyunsaturated fatty acids and, possible based on existing science. 49). if so, should a midpoint be used. We Although some comments supported a We acknowledge that certain received comments in response to these joint percent DV declaration for polyunsaturated fatty acids are essential questions (Ref. 47). saturated and trans fat combined, the and understand the interest expressed We are not able to set an appropriate majority of comments opposed it due in by some comments that there is a need DRV for polyunsaturated fat at this time large part to the chemical and to provide information on beneficial given the lack of established DRIs for physiological differences between these fats. However, the essentiality of a total polyunsaturated fatty acids. We do fats. We will consider determining a nutrient is not a factor considered for not consider that the AMDRs or AIs for DRV for trans fat, if and when scientific the mandatory or voluntary labeling of linoleic acid and a-linolenic acid evidence and relevant dietary non-statutory nutrients, other than provide a sufficient basis on which a recommendations become available. At essential vitamins and minerals (see DRV for polyunsaturated fat could be that time, we will also consider whether section I.C). Although certain derived. The AIs for linoleic and a- a single DRV specific to trans fat or a polyunsaturated fatty acids are linolenic acid were set based on U.S. provision for joint DV declaration for essential, an median intake levels because there were trans fat and saturated fat are deficiency is basically nonexistent in insufficient experimental data to set an appropriate. Thus, we tentatively the United States and, therefore, is not RDA (Ref. 49). Similarly, the AMDRs for conclude that there is no basis for of public health significance (Ref. 49). linoleic acid and a-linolenic acid were setting a DRV for trans fat and, A quantitative intake based on the percent of calories needed accordingly, we are not proposing a recommendation is not available from to meet the AI for each fatty acid (lower DRV for trans fat, a joint DRV relevant U.S. consensus reports (see range) and the percent of calories declaration or joint percent DV discussion in this document), but there representing the highest intake level of declaration. is well-established evidence to indicate each fatty acid (upper range). As such,

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neither of these values provides an observed only as a result of a reduction should remain voluntary or be made adequate basis on which to determine a in saturated fatty acid intake (Refs. 6 mandatory. DRV. For these reasons, we disagree and 59). The IOM noted that the In 2002, the IOM noted that there was with comments that supported using the evidence for a role of EPA and DHA in no known independent role of sum of AIs or AMDRs to establish a DRV CHD risk is growing (Ref. 49), but set monounsaturated fatty acids in for total polyunsaturated fat. AIs and AMDRs for a-linolenic acid, not preventing chronic disease (Ref. 49). Therefore, we tentatively conclude for EPA or DHA. The lack of an independent effect of that there is no appropriate quantitative While a ‘‘healthy’’ n-6:n-3 ratio may monounsaturated fatty acids on heart intake recommendation to form a basis be important in human health, such a disease risk was also substantiated in a for setting a DRV for polyunsaturated ratio has not been defined and much of 2004 FDA review of a qualified health fat. Accordingly, we are not proposing the available evidence is based on claim regarding monounsaturated fatty a DRV for polyunsaturated fat. studies conducted in animals, infants, acids from oil and CHD (Ref. 61). c. Declaration of Individual and patients on total parenteral Upon review of data related to this Polyunsaturated Fatty Acids—The nutrition and much of the evidence in qualified health claim, we concluded declaration of individual adults has come from observational that there was no evidence to indicate polyunsaturated fatty acids on the studies (Ref. 49). that monounsaturated fatty acids from Nutrition Facts label is not permitted. Because of the lack of well- , independent of saturated fatty The IOM did not set DRIs for total n-6 established evidence for a role of n-3 or acid displacement, lower serum total and n-3 polyunsaturated fatty acids, but and LDL cholesterol levels. Most n-6 polyunsaturated fatty acids in established AIs and AMDRs for two recently, the 2010 DGAC (Ref. 30) noted chronic disease risk and the lack of a specific fatty acids, linoleic acid (an n- that there was strong evidence quantitative intake recommendation, 6 polyunsaturated fatty acid) and a- indicating that monounsaturated fatty and consistent with the factors linolenic acid (an n-3 polyunsaturated acids are associated with improved discussed in section I.C., we tentatively fatty acid) (Ref. 49). The 2007 ANPRM blood lipids related to CVD when they conclude that the declarations of n-3 asked for public comment on whether replace saturated fatty acids. and n-6 polyunsaturated fatty acids are separate DRVs for linoleic acid and a- Consequently, the 2010 DGA not necessary to assist consumers to linolenic acid should be established recommends that most fats should be maintain healthy dietary practices. and, if so, whether the declaration of consumed as polyunsaturated and these nutrients should be voluntary or Accordingly, we are not proposing to monounsaturated fatty acids (Ref. 6). made mandatory. We received provide for the individual declaration of Current dietary recommendations comments in response to these either n-3 or n-6 polyunsaturated fatty advise consumers to increase intakes of questions (Ref. 47). acids on the Nutrition Facts label. monounsaturated fatty acids to replace Linoleic and a-linolenic acids are Similarly, because of the lack of well- saturated fatty acids in their diets. essential fatty acids that differ established evidence for a role of EPA We acknowledge that physiologically and compete and DHA in chronic disease risk and the monounsaturated fatty acids are not metabolically. Based on a review of lack of a quantitative intake essential in the diet (Ref. 49). However, relevant scientific research, in 2004, recommendation, consistent with the a lack of essentiality is not a basis for FDA concluded in its qualified health factors discussed in section I.C., we determining whether a nutrient should claim review that there is supportive, tentatively conclude that the be required to be declared (see section but not conclusive, research to suggest declarations of EPA and DHA are not I.C.). Indeed, nonessential nutrients that n-3 polyunsaturated fatty acids necessary to assist consumers to trans fat, saturated fat, and cholesterol (EPA and DHA) reduce the risk of CHD maintain healthy dietary practices. are required to be declared on the label (Ref. 59). Results of one on Accordingly, we are not proposing to because of their public health the effects of EPA published since 2004 provide for the mandatory or voluntary significance. Scientific evidence points fail to demonstrate a significant declaration of EPA or DHA on the to the positive effects of increased reduction in the hazard ratio for the Nutrition Facts label. We request monounsaturated fatty acid intake as a primary prevention of major coronary comment about whether there is an result of reduced intake of saturated events (Ref. 60). appropriate alternative analysis to the fatty acids. More recently, the 2010 DGAC application of the factors in section I.C. While a quantitative intake concluded that moderate evidence regarding the individual declaration of recommendation is not available from shows that the consumption of two n-3 or n-6 polyunsaturated fatty acids, relevant U.S. consensus reports, there is servings of seafood per week, which as well as EPA or DHA. well-established evidence to indicate provides an average of 250 mg/d of long- 5. Monounsaturated Fat that replacing saturated fatty acids with chain n-3 polyunsaturated fatty acids polyunsaturated and monounsaturated (i.e., EPA and DHA), is associated with a. Voluntary Declaration—FDA fatty acids reduces blood LDL reduced cardiac mortality from CHD or regulations currently permit, but do not cholesterol levels and, therefore, the risk sudden deaths, both in persons with require, the declaration of of CVD, and that the prevalence of CVD and without CVD (Ref. 30). The DGAC monounsaturated fat (defined as cis- is substantial in the United States (Ref. also concluded that the evidence for monounsaturated fatty acids (e.g., oleic 30). We are not proposing any changes plant-derived n-3 polyunsaturated fatty acid)) on the Nutrition Facts label to the current requirement for acids (i.e., a-linolenic acid) in reducing (§ 101.9(c)(2)(iii)). To determine mandatory declaration of saturated fat mortality among persons with existing whether any changes are needed to the (see section II.B.2.). Because CVD is limited (Ref. 30). Similarly, there provision for voluntary declaration, we monounsaturated fat has public health is no conclusive evidence for an considered recommendations in current significance when it replaces saturated independent role of n-6 polyunsaturated consensus reports as well as comments fat, consistent with the factors we fatty acids in reducing blood cholesterol received in response to the 2007 consider for voluntary declaration levels and, consequently, the risk of ANPRM (Ref. 47), in which we discussed in section I.C., we are CHD. Evidence suggests that the benefit requested comment on whether proposing to continue to allow for of n-6 polyunsaturated fatty acids is declaration of monounsaturated fat voluntary declaration of

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monounsaturated fat, as provided in use food composition data, menu levels as an appropriate basis for setting § 101.9(c)(2)(iii). We request comment modeling, and data from dietary surveys a DRV because it represents the about whether there is an appropriate to estimate minimum intakes that are maximum intake level that covers the alternative analysis to the application of consistent with nutritionally adequate general U.S. population 4 years of age the factors in section I.C. regarding the and health-promoting diets for diverse and older. Therefore, we are not voluntary declaration of populations (Ref. 25). Acknowledging proposing any changes to the DRV for monounsaturated fat. these IOM recommendations, in the cholesterol of 300 mg specified in b. DRV—FDA regulations do not 2007 ANPRM, we asked for public § 101.9(c)(9). comment on (1) whether the current provide a DRV for monounsaturated fat. D. Carbohydrate Current consensus reports do not DRV for cholesterol of 300 mg should be provide specific quantitative intake retained; and (2) whether food In this section, we discuss our recommendations for monounsaturated composition data, menu modeling, and consideration of provisions related to fatty acids. The IOM did not set a DRI data from dietary surveys should be definitions, declarations, DRVs, and for monounsaturated fatty acids because used to establish a DRV for cholesterol analytical methods for total these fatty acids are not essential in the that is as low as possible while carbohydrate, total sugars, added sugars, diet and have no known independent consuming a nutritionally adequate diet. dietary fiber, soluble and insoluble role in preventing chronic diseases (Ref. We considered recommendations in fiber, sugar alcohols, and other 49). Therefore, we tentatively conclude current consensus reports as well as carbohydrates. that there is no scientific basis on which comments received (Ref. 47). 1. Total Carbohydrate we can rely to set a DRV for The 2010 DGA recommends a. Calculation of Total Carbohydrate— monounsaturated fat and, therefore, we consuming less than 300 mg/d of For the purposes of the Nutrition Facts are not proposing to set a DRV for cholesterol to help maintain normal label, total carbohydrate content is monounsaturated fat. blood cholesterol levels and reducing intake to less than 200 mg/d for calculated by subtracting the sum of C. Cholesterol individuals at high risk of CVD (Ref. 6). protein, total fat, moisture, and ash from the total weight of the food 1. Mandatory Declaration The IOM also reported a relationship between increased cholesterol intake (§ 101.9(c)(6)). This calculation method Section 403(q)(1)(D) of the FD&C Act and increase in serum cholesterol, a is called ‘‘carbohydrate by difference’’ requires the declaration of the amount surrogate endpoint for CHD risk (Ref. and is described in A.L. Merrill and B.K. of cholesterol on food labels, and 62). The IOM macronutrient report Watt, ‘‘Energy Value of Foods—Basis cholesterol content must be declared on recommended that cholesterol intakes and Derivation,’’ in the USDA the Nutrition Facts label in accordance should be as low as possible while Handbook No. 74 (Ref. 63). Total with § 101.9(c)(3). Current dietary consuming a nutritionally adequate diet, carbohydrate includes starch, sugars, recommendations continue to recognize but did not set ULs for cholesterol (Ref. sugar alcohols, and dietary fiber. the well-established relationship 62). Based on the reasons set forth On July 8, 2004, the National Starch between consumption of cholesterol and previously, we disagree with the and Chemical Company (National its effect on blood cholesterol levels, comments suggesting that a DRV of 300 Starch) submitted a citizen petition which are a surrogate endpoint for CHD mg is too low or that there is no strong requesting that dietary fiber content be risk (Ref. 6). In addition, the 2010 DGA association between cholesterol intake excluded from the calculation of total provided a quantitative intake and CHD risk, or that current science carbohydrate that is declared on the recommendation for cholesterol (Ref. 6) justifies eliminating the percent DV Nutrition Facts label (Docket No. FDA– (see discussion in this document). declaration. 2004–P–0094) (http:// Furthermore, FDA authorized a health We do not agree with the IOM www.regulations.gov/ claim for dietary saturated fat and recommendation that food composition # !docketDetail;D=FDA-2004-P-0094). cholesterol and risk of CHD, for which data, menu modeling, and data from The petition noted that consumers we evaluated the scientific evidence on dietary surveys offer a suitable approach wishing to reduce their intake of the association between dietary for determining DRVs. Limitations carbohydrate may also be inadvertently cholesterol and serum cholesterol levels inherent to menu modeling and food decreasing their consumption of high (§ 101.75). composition and dietary survey data fiber foods, such as whole , We are unaware of evidence that sources are discussed in sections because dietary fiber is included in the would support a change to the II.B.2.c. and II.B.3.c. We established the definition of ‘‘Total Carbohydrate.’’ requirement for mandatory declaration current DRV for cholesterol based on National Starch, therefore, requested an of cholesterol on the Nutrition Facts quantitative intake recommendations amendment to the second sentence in label in § 101.9(c)(3) and, therefore, we that considered specific effects on § 101.9(c)(6) to read as follows: ‘‘Total are not proposing any changes to the health outcomes (e.g., CHD) (58 FR 2206 carbohydrate content shall be calculated current requirement for mandatory at 2217). Use of menu modeling to by subtraction of the sum of the crude declaration. determine a quantitative intake protein, total fat, moisture, ash, and recommendation for cholesterol is dietary fiber from the total weight of the 2. DRV inconsistent with this approach and food.’’ The petition noted that excluding FDA regulations provide a DRV for may result in a reference intake level dietary fiber from the definition would cholesterol of 300 mg (§ 101.9(c)(9)). that is not based on scientific evidence be consistent with the way the IOM DRI The IOM Labeling Committee related to actual public health report and Codex guidelines refer to recommended, based on the IOM DRIs, outcomes. carbohydrates and would be a more that the DV for cholesterol (along with Although the 2010 DGA recommends accurate representation of the amount of saturated fat and trans fat) should be set that cholesterol intake levels should be calories contributed by carbohydrates. at a level that is as low as possible in less than 200 mg/d for individuals at To support this request, the petition keeping with an achievable health- high risk of CVD, we consider the DGA presented study findings reported in the promoting diet (Ref. 25). The IOM recommendation of 300 mg/d for New York Times in 2004 and from Labeling Committee suggested that FDA maintaining normal blood cholesterol research conducted on the Internet. In

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addition, the petition discussed the use Nutrient Database for Standard methods. It is, therefore, included in the of the term ‘‘net carbs’’ in labeling and Reference, Release 23, when the calculation of total carbohydrate. discussed inconsistencies in the way analyses of starch, sugars, sugar alcohol, Further, dietary fiber is a mandatory different manufacturers define the term and dietary fiber are performed separate listing on the Nutrition Facts ‘‘net carbs.’’ According to the petition, separately, the result reflects the label. Therefore, for consumers who some manufacturers define ‘‘net carbs’’ analytical variability inherent to each of wish to know the carbohydrate content as the amount of total carbohydrate those measurement processes (Ref. 65). of a food that excludes dietary fiber, this excluding the amount of dietary fiber Thus, such an approach does not information can be deduced by and sugar alcohols while others exclude provide any distinct advantage over subtracting the declared amount of sugar alcohols and ‘‘other measuring carbohydrate by difference. dietary fiber from the declared amount carbohydrates,’’ as specified in With respect to removal of dietary of total carbohydrate on the Nutrition § 101.9(c)(6)(iv), or sugar alcohols and fiber from the calculation of total Facts label. ‘‘certain other carbohydrates.’’ The carbohydrate, we agree that the IOM In addition, a calculation based on petition suggested that the varied provided separate DRIs for carbohydrate eliminating dietary fiber content from approaches to describing carbohydrates (i.e., starch and sugars) and dietary the declared value of total carbohydrate have led to consumer . fiber. However, the IOM DRI Report would necessitate calculating total In the 2007 ANPRM, we asked for does not provide recommendations for carbohydrate by difference using the comment on whether the approach for nutrition labeling. Furthermore, the current method and then subtracting calculating total carbohydrate by report defines dietary fiber as ‘‘non- from that number the amount of dietary difference should be retained and, if digestible carbohydrates and lignin that fiber obtained from separate analysis. not, which specific components should are intrinsic and intact in plants’’ (Ref. This option presents a challenge with be included or excluded from the 66). Thus, the report acknowledges that respect to the use of existing databases calculation of total carbohydrate. In dietary fibers, with the exception of in the United States, which include addition, acknowledging the 2005 DGA lignin, are carbohydrates. As discussed dietary fiber in the calculation of total recommendation to consume fiber-rich in section II.D.5., the definition of carbohydrate. foods, we asked for comment on dietary fiber adopted by Codex in 2010 Moreover, the petition provided no whether separating dietary fiber from specifies that dietary fibers are references to (and we could not locate) the amount of total carbohydrate would carbohydrate polymers (Ref. 67). The the studies identified in the petition. We affect consumer understanding and use Codex Guidelines on Nutrition Labeling, have no data or information at this time of the information, particularly with however, indicate that the nutrient to indicate that removal of dietary fiber respect to fiber consumption. We declaration for carbohydrate should be from the declaration of total received several comments (Ref. 47). ‘‘available carbohydrate,’’ which is the carbohydrate would promote We reviewed scientific evidence and amount of dietary carbohydrate, consumption of dietary fiber due to considered the petition’s requests and excluding dietary fiber (Ref. 67). lower amounts of carbohydrate contents comments received. As explained in The petition states that the inclusion declared in nutrition labeling. Finally, this document, we decline to change to of dietary fibers in the calculation of to the extent that the petition seeks to the current method for calculating total total carbohydrate is not fully aligned define the term ‘‘net carbs,’’ such a carbohydrate by difference. with the Codex Guidelines on Nutrition request is outside the scope of this Under FDA regulations, compliance Labeling. Our rationale for including rulemaking. In this proposed rule, we with certain nutrition labeling dietary fiber in the calculation of total are considering whether to propose a requirements may be achieved by the carbohydrate is based on what is change in how ‘‘total carbohydrate’’ is use of an FDA-approved database considered to be a carbohydrate. To the calculated. Therefore, to the extent the (§ 101.9(g)(8)). Nutrient databases extent the petition is requesting the petitioner is requesting to remove include carbohydrate values that are removal of dietary fiber from the total ‘‘dietary fiber’’ from the total determined by difference. Changing the carbohydrate calculation due to its carbohydrate calculation to prevent way carbohydrate is calculated would physiological effects, we consider in consumer confusion from the term ‘‘net either necessitate an analogous change greater detail in this document the carb,’’ we decline to change the to the way carbohydrate is calculated in classification and declaration of calculation of total carbohydrate by major nutrient databases, such as the carbohydrates based on their chemical difference on that basis. We consider the USDA National Nutrient Database for definition or their physiological effects. calculation and declaration of ‘‘net Standard Reference, or would As discussed in greater detail in this carbs’’ and the total carbohydrate substantially decrease the usefulness of document, we find that inclusion of calculation and declaration on the label these databases in assisting dietary fiber in the determination of the as separate and distinct. The declaration manufacturers in making nutrient label declaration of total carbohydrate is of total carbohydrate is required under content declarations. scientifically sound based on our section 403(q)(1)(D) of the FD&C Act. We also considered an alternative chemical definition of total For these reasons, we decline to approach of calculating total carbohydrate and the analytical change the method for calculating total carbohydrates by summing individual methods used to determine carbohydrate by difference and, carbohydrate measurements rather than carbohydrate content, as well as being therefore, we are not proposing any calculating by difference, as suggested consistent with the way subcategories of changes to the method for calculating by a comment. There is variability and other macronutrients, such as fat, are total carbohydrate by difference error that are introduced with each listed on the Nutrition Facts label. specified in § 101.9(c)(6). analytical test that is performed (Ref. Dietary fiber is a subset of b. Classification of Carbohydrates 64). When summing the values from the carbohydrates. All dietary fibers, with Based on a Chemical Definition or various tests, the amount of variability the exception of lignin, are carbohydrate Physiological Effect—In the 2007 and error would multiply and such an polymers. Although lignin is not a ANPRM, we asked for comment on approach is likely to result in greater carbohydrate, it is tightly bound to other whether carbohydrates should be variability and error. As discussed in dietary fibers and cannot be easily classified and declared in nutrition the documentation for USDA’s National isolated using AOAC or equivalent labeling based on their chemical

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definition (current method) or on their taken together, did not support population-weighted mid-point of the physiological effect (e.g., attenuation of declaration of additional types of AMDR for adults and children, i.e., 45 blood sugar or laxation if dietary fiber carbohydrates. Some comments stated to 65 percent, the DV for total were to be included in the total that such additional information could carbohydrate would amount to 55 carbohydrate declaration), and whether distract consumers from information percent or, based on a 2,000 calorie additional types of carbohydrates (e.g., that is important, such as dietary fiber. reference calorie intake, 275 g of starch) should be listed separately on A few comments that supported the carbohydrate. the Nutrition Facts label. We received declaration of starch provided no However, as we noted in the 2007 several comments (Ref. 47) in response evidence to support their assertions ANPRM, the IOM’s AMDR, EAR, and to these questions. regarding the benefit of this declaration RDA values for carbohydrate do not We considered this issue in light of for diabetics. Moreover, there is no include sugar alcohols or dietary fiber. the comments received. We agree with strong scientific evidence for us to In contrast, our calculation of total the comments that stated that consider related to the role of starch in carbohydrates for the purposes of classification of carbohydrates based on human health. Therefore, we are not nutrition labeling accounts for all types validated analytical techniques, which proposing to require the separate of carbohydrates, including sugar isolate and measure the individual declaration of additional types of alcohols and dietary fiber. Therefore, carbohydrates based on their chemical individual carbohydrates such as starch applying the IOM Labeling Committee’s structure rather than based on their on the Nutrition Facts label. approach, in which a DV is derived physiological effects, is necessary for d. Mandatory Declaration—Section from the AMDR, would result in a determining the accuracy of values 403(q)(1)(D) of the FD&C Act requires reference value based on declared on the label. Carbohydrates the declaration of total carbohydrate. recommendations specifically for sugars include starch, sugars, sugar alcohols, Correspondingly, regulations require the and , whereas the absolute gram and dietary fibers. Different types of declaration of the amount of total amount of carbohydrates declared on carbohydrates have different carbohydrate on the Nutrition Facts the label includes all carbohydrates. physiological effects. The effects of label (§ 101.9(c)(6)). Carbohydrates are Consequently, if the midpoint of the some carbohydrates are not fully an essential part of the diet because they AMDR range is used as the basis for the understood and are the subject of debate provide energy to the cells in the body, DRV, there would be a discrepancy in in the scientific community. Within the especially the brain, which is dependent what carbohydrates are encompassed in different types of carbohydrate (i.e., on carbohydrate for proper functioning the information provided on the label starch, sugars, sugar alcohols, and (Ref. 68). We have no basis on which to for the absolute gram amount versus the dietary fibers), too, specific reconsider the requirement for percent DV. We did not ask any carbohydrates may have different mandatory declaration of the amount of questions about the DRV for total physiological effects (e.g., different total carbohydrate on the Nutrition carbohydrate in the 2007 ANPRM nor types of dietary fibers) making it Facts label and comments in response to did we receive any comments on this difficult to apply a definition that is the 2007 ANPRM also supported this issue. Consistent with calculating total based on physiological effects across a mandatory declaration. We tentatively carbohydrate ‘‘by difference’’ (discussed category of carbohydrates. Furthermore, conclude that the declaration of previously), we are proposing no analytical methods for measuring carbohydrates on the Nutrition Facts changes to the approach to calculate the different types of carbohydrates are label continues to be necessary to assist percent DV for carbohydrate ‘‘by based on chemical structure rather than consumers in maintaining healthy difference’’ as well. In addition, we are physiological effect. Given the various dietary practices. Therefore, we are not not proposing to change the DRVs for fat components of total carbohydrate and proposing any changes to the current or protein (see sections II.B. and II.E.), different types of physiological effects of requirement for mandatory declaration which are used to derive the DRV for each, we disagree that a definition based of total carbohydrate, as specified in total carbohydrate. Therefore, we are not on ‘‘physiological effects’’ would be a § 101.9(c)(6). proposing any changes to the DRV for better approach than a chemical e. DRV—The DRV for total total carbohydrate of 300 g/d. We note definition for total carbohydrate carbohydrate is 300 g (§ 101.9(c)(9)). The that the RDA for carbohydrate for men declaration. The use of a chemical IOM established an AMDR for and women 19 years of age and older is definition is also consistent with the carbohydrate intake of 45 to 65 percent 130 g/d. Therefore, the DRV should not classification and declaration of fat on of energy for adults and an EAR of 100 be viewed as an intake requirement, but the Nutrition Facts label. Different types g/d for adults and children (Ref. 69). In as a reference amount. of fats identified in nutrition labeling the IOM report, ‘‘carbohydrate’’ only f. Calculation of Calories From are not classified based on their included starch and sugars, not sugar Carbohydrate—FDA regulations require physiological effect but rather on their alcohols or dietary fiber. The IOM also that the calories from total carbohydrate chemical definition. set the RDA for ‘‘carbohydrate’’ (i.e., be calculated by using the general factor Therefore, we are not proposing to use starch and sugars) at 130 g/d for adults of 4 calories/g of carbohydrate less the physiological effects of carbohydrates as and children based on the average amount of insoluble dietary fiber a basis for classifying or declaring total minimum amount of utilized by (§ 101.9(c)(1)(i)(C)). We are proposing a carbohydrate. Accordingly, we are not the brain in adults, which was new definition of dietary fiber (see proposing to change our provisions for extrapolated to children ages 1 through section II.D.5.a.i.) that only allows for the classification or declaration of 18 years. Subsequently, the IOM the declaration of dietary fibers that we carbohydrates specified in § 101.9(c)(6). Labeling Committee recommended that, have determined to have a physiological c. Separate Declaration of Additional as in the case of protein and total fat, the effect that is beneficial to human health, Individual Types of Carbohydrates—In AMDRs should be the basis for DVs for as ‘‘dietary fiber’’ on the Nutrition Facts the 2007 ANPRM, we asked whether total carbohydrate (Ref. 25). Considering label. Therefore, the new definition of additional types of carbohydrates (e.g., that AMDRs vary with age, the IOM dietary fiber would exclude both soluble starch) should be listed separately on Labeling Committee recommended a and insoluble non-digestible the Nutrition Facts label. We considered population-weighted midpoint of the carbohydrates that do not meet the comments received (Ref. 47), which, AMDR. Under this approach, using a proposed definition. For the purposes of

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calculating calories from carbohydrate, expressed concern about the potential We also decline the petition’s request all soluble and insoluble non-digestible caloric and health effects of alternative to require manufacturers to declare the carbohydrates should be excluded from sweeteners and asserted that the current specific type of artificial sweetener used the calculation, not just those known to labeling of sugar and lack of labeling for on the Nutrition Facts label so that meet the definition of dietary fiber. To artificially produced sweeteners on the consumers can be made aware of the ensure that all soluble and insoluble Nutrition Facts label did not provide degree of substitution, when artificial non-digestible carbohydrates are consumers with relevant information sweeteners are substituted for sugars, excluded from the calculation of about alternative sweeteners. However, and the overall level of the artificial calories from carbohydrate, we are the petitioner did not include any data sweeteners in the food. Under FDA proposing to amend § 101.9(c)(1)(i)(C) to to specifically support these assertions regulations, artificial sweeteners that are require that calories from carbohydrate and concerns. added to a food are required to be be calculated using a general factor of 4 In the 2007 ANPRM, we requested declared in the ingredient statement of calories/g of total carbohydrate less the comment on whether ‘‘sugars’’ should the label. The petition did not provide amount of non-digestible carbohydrates. continue to be included on the Nutrition any justification that additional As discussed in section II.D.5.b.v., a Facts label. We received several information about artificial sweeteners value of 2 calories/g of soluble non- comments which were in favor of in nutrition labeling is warranted and digestible carbohydrates is then added continuing to require mandatory we have no data to suggest that a to the calculation. labeling of sugars on the Nutrition Facts declaration of artificial sweeteners is label (Ref. 47). 2. Sugars necessary to assist consumers in We considered the petition and maintaining healthy dietary practices. a. Definition—Sugars are defined in comments received in light of scientific Therefore, we are not proposing any § 101.9(c)(6)(ii) as a statement of the evidence. There is strong and consistent change to the current requirement for number of g of sugars in a serving. They evidence based on valid endpoints that mandatory declaration of sugars on the are the sum of all free mono and consumption of sugars is associated Nutrition Facts label, as specified in (e.g., glucose, , with an increased risk of dental caries § 101.9(c)(6)(ii). We are also not , and ). We received a (Refs. 6 and 68). We authorized a health proposing to rename the ‘‘sugars’’ citizen petition on the term ‘‘sugars’’ claim for dietary non-cariogenic category as ‘‘sugars/syrups’’ or require and, as explained in this document, we carbohydrate sweeteners and dental the mandatory declaration of specific are not proposing any changes to the caries (§ 101.80). The IOM sugar alcohols or other artificial term or its definition for the purpose of macronutrient report noted that dental sweeteners. nutrition labeling. caries is a condition of public health b. Mandatory Declaration—Section concern that is associated with c. DRV—FDA regulations do not 403(q)(1)(D) of the FD&C Act requires consumption of sugars (Ref. 68). specify a DRV for sugars. Current the declaration of sugars. FDA Therefore, we tentatively conclude that consensus reports have not set dietary regulations require the declaration of the declaration of sugars continues to be reference values based on which we sugars on the Nutrition Facts label necessary to assist consumers in could derive an appropriate DRV for (§ 101.9(c)(6)(ii)). maintaining healthy dietary practices, total sugars. While the IOM found an The Sugar Association submitted a and we are not proposing to change the association between sugar consumption citizen petition on August 16, 2005 current requirement for mandatory and risk of dental caries, due to the (Docket No. FDA–2005–P–0373) declaration of sugars. various factors that contribute to dental requesting among other things that we Moreover, we decline the petition’s caries, IOM could not determine an eliminate ‘‘sugars’’ as a mandatory request to rename ‘‘sugars’’ as ‘‘sugars/ intake level of sugars that is associated nutrient that is declared on the syrups’’ on the Nutrition Facts label. with increased risk of dental caries and, Nutrition Facts label or, alternatively, The petition requested that we rename therefore, did not have sufficient rename ‘‘sugars’’ as ‘‘sugars/syrup’’ and the ‘‘sugars’’ category to prevent evidence to set a UL for sugars (Ref. 68). require the mandatory declaration of consumers from being misled with We did not ask any questions related to polyol and artificial sweeteners on the regard to the ingredients that are the DRV for sugars in the 2007 ANPRM Nutrition Facts label, as well as the permitted to be considered sugars under nor did we receive any comments mandatory labeling of each specific the current regulation ( recommending the establishment of a polyol and artificial sweetener plus disaccharides such as high fructose DRV for total sugars. For these reasons, ingredient and its amount on the food corn syrup). The petition, however, did we are not proposing to establish a DRV label (http://www.regulations.gov/ not provide data or information to for total sugars. #!docketDetail;D=FDA-2005-P-0373). support the assertion that consumers are 3. Added Sugars The petition asserted that consumers misled by the term ‘‘sugars’’ on products understand ‘‘sugars’’ to mean sucrose. containing sweeteners that are a a. Declaration—FDA regulations The petition stated that an increasing combination of mono and disaccharides, neither define the term ‘‘added sugars’’ number of manufacturers are using as defined in § 101.9(c)(6)(ii). We are nor require or permit its declaration on artificially produced (alternative) considering using the term ‘‘total the Nutrition Facts label. We are sweeteners, such as high fructose corn sugars’’ in lieu of ‘‘sugars’’ on the reconsidering the declaration of added syrup, instead of sucrose products such Nutrition Facts label if ‘‘added sugars’ sugars taking into account new data and as table sugar. The petition also asserted declaration is finalized, as proposed. information, including U.S. consensus that, under current regulations, FDA plans to conduct consumer testing reports and recommendations related to information on sugar content is of the terms ‘‘total sugars’’ and ‘‘sugars’’ the consumption of added sugars, a presented in a manner that is on the Nutrition Facts label (FR 2013– citizen petition submitted by the CSPI, misleading to consumers because it does 12824) to determine if use of the term and public comments. For the purposes not reflect the caloric content of ‘‘total sugars’’ aids consumers in of the discussion in this document, artificially produced sweeteners and understanding that added sugars are added sugars refer to sugars and syrups does not identify the specific sweeteners part of the total amount of sugars in that are added to foods during used in food products. The petition also product. processing or preparation (Ref. 6).

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i. Consensus Reports. The IOM DRI reduce the intake of calories from solid a 2,000 calorie healthful diet. The Report on Macronutrients stated that fats and added sugars. petition cited USDA Economic Research ‘‘although added sugars are not The report recognized that foods Service’s data that show that the per chemically different from naturally containing solid fats and added sugars capita consumption of added sugars occurring sugars, many foods and are no more likely to contribute to rose by 28 percent from 1983 to 1999 beverages that are major sources of weight gain than any other source of (Ref. 70). The petition also referred to added sugars have lower micronutrient calories in an eating pattern that is evidence that added sugars may densities compared to foods and within calorie limits. However, reducing contribute to obesity and heart disease, beverages that are major sources of the consumption of calories from solid and argued that it is impossible for naturally occurring sugars’’ (Ref. 68). fats and added sugars allows for consumers to determine how much Although an upper level was not set for increased intake of nutrient-dense foods sugar has been added to foods or how total or added sugars, a maximal intake without exceeding overall calorie needs. much added sugars are reasonable to level of 25 percent or less of energy from The report recommended several ways consume because the Nutrition Facts to reduce the consumption of solid fats added sugars was suggested based on label does not currently provide this and added sugars including eating the data that demonstrated decreased information. Although the petition also most nutrient-dense forms of foods from requested that we amend our intakes of some micronutrients among all food groups, limiting the amount of regulations to prescribe nutrient content American subpopulations whose intake solid fats and added sugars when claims and health claims related to of added sugars exceeded this level. or eating, and consuming fewer ‘‘added sugars,’’ those requests are not In addition, the 2010 DGA (Ref. 6) and smaller portions of foods and considered within the scope of this noted that the primary prevention of beverages that contain solid fats and proposed rule. We received another obesity, especially in childhood, is an added sugars. Specifically, the 2010 petition from CSPI on February 13, 2013 important strategy for combating and DGA noted that, for most people, no (hereafter referred to as ‘‘the 2013 CSPI reversing the obesity epidemic. Over the more than about 5 to 15 percent of petition’’), requesting that we revise the last few decades, the prevalence of calories from solid fats and added ‘‘sugars’’ line of the Nutrition Facts label overweight and obese individuals in the sugars can be reasonably accommodated to address ‘‘added sugars.’’ (Docket No. United States dramatically increased in the USDA Food Patterns, which are FDA–2013–P–0217) (http:// among children, adolescents and adults. designed to meet nutrient needs within www.regulations.gov/ Many factors contribute to weight gain calorie limits. The 2010 DGA also #!docketDetail;D=FDA-2013-P-0217). and obesity but maintaining an outlined common elements of healthy CSPI described ‘‘added sugars’’ as appropriate calorie balance and eating patterns and stated that reducing ‘‘various caloric sweeteners,’’ including increasing physical activity and the intake of added sugars is one sucrose, high-fructose corn syrup, corn reducing sedentary behaviors are key component. sugar, invert sugar, corn syrup ‘‘and recommendations to help combat the Although the subject of front-of- others.’’ We address CSPI’s request for problem. The 2010 Dietary Guidelines package labeling (FOP) is outside the an ‘‘added sugar’’ declaration in this Advisory Committee (DGAC) concluded scope of this proposed rule, we proposed rulemaking. The data and that strong evidence shows that children reviewed the IOM Front-of-package information provided by the 2013 CSPI who consume more sugar-sweetened Nutrition Rating Systems and Symbols petition in regards to added sugar beverages have greater adiposity (body Committee’s final report for their declaration does not change our current conclusions on scientific evidence fat) compared to those with a lower considerations or rationale for related to the effect of added sugars on intake. The sole source of calories in mandating added sugars on the label human health. This Committee cited the many sugar-sweetened beverages (e.g., that are addressed in this document. 2010 DGA recommendations related to soda) is added sugars. The 2010 DGA Although CSPI included other requests added sugars and noted that while there specifically suggest that reducing the in its petition, which generally relate to is a lack of scientific agreement on the lowering levels of added sugars in intake of sugar-sweetened beverages effects of added sugars on health may help individuals control their total foods, we do not address those requests outcomes independent of the effects of in the context of this proposed rule calorie intake and manage their body total sugar, there is adequate evidence because they are outside the scope of weight. The report stated that that added sugars (whether a solid or this proposed rule. Americans consume too many calories liquid) contribute extra calories to a iii. Public Comments. On June 26, from solid fats (fats containing a high diet, which could in turn lead to weight 2000, we published a notice of percentage of saturated and trans fatty gain and obesity (Ref. 28). availability of the 1999 CSPI petition in acids and are solid at room temperature) ii. CSPI Petitions. We received a the Federal Register and requested and added sugars and these foods petition from CSPI on August 3, 1999 comment (65 FR 39414). We received replace nutrient-dense foods and (hereafter referred to as ‘‘the 1999 CSPI more than 2,700 comments from beverages and make it difficult for petition’’) requesting that we require the individuals, industry, academic people to achieve the recommended Nutrition Facts label to disclose the institutions, advocacy groups, and nutrient intake while controlling their quantity of added sugars present in health care groups. Several comments calorie intake. Together, solid fats and packaged foods and to set a DRV for stated that added sugar declaration added sugars contribute a substantial refined sugars added to foods (Docket should be voluntary and not mandatory portion of Americans’ calories, 35 No. FDA–1999–P–0158) (http:// (Ref. 47). We did not ask any questions percent on average (16 percent total on www.regulations.gov/ on added sugars in the 2007 ANPRM. average from added sugar) without #!docketDetail;D=FDA-1999-P-0158). However, we received comments that contributing to the overall nutrient The petition stated that the DRV for supported and others that opposed the adequacy of the diet and thus have added sugars should be 40 g based on declaration of added sugars on the implications for weight management. USDA’s ‘‘Food Guide Pyramid’’ Nutrition Facts label (Ref. 47). Thus, to meet nutrient needs within an recommendations that Americans iv. FDA’s Considerations and individual’s calorie limits, a key should limit their daily intake of added Proposal. A key recommendation of the recommendation of the 2010 DGA is to sugars to about ten teaspoons (40 g) for 2010 DGA is to reduce the intake of

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calories from solid fats and added calories from both solid fats and added consistent with the 2010 DGA sugars. A high intake of calories from sugars discussed in the 2010 DGA. recommendations. excess solid fat and added sugars can Although foods containing solid fats Further, we consider it necessary to decrease the intake of nutrient-rich and added sugars do not contribute to require a declaration of added sugars for foods in the diet and can increase the weight gain any more than another all foods for which a Nutrition Facts overall caloric intake which could lead calorie source, they make up a label is required. Using the current to weight management issues. As such, significant percentage of the American label, consumers cannot identify or this key recommendation feeds into two diet and are a source of excess calories. compare the amounts of added sugars to overarching concepts of the intent of the The 2010 DGAC concluded that strong enable them to follow the Dietary Guidelines of maintaining evidence shows that children who recommendation of the 2010 DGA. We calorie balance over time to achieve and consume sugar-sweetened beverages are proposing mandatory declaration of sustain a healthy weight as well as have increased adiposity (increased added sugars on all foods because of (1) supporting consumption of nutrient- body fat). The 2010 DGAC also the variability in ingredients used, (2) the need for consumers to have a dense foods (Ref. 6). As discussed in concluded that there is a moderate body consistent basis on which to compare this document, a declaration of added of evidence suggesting that greater products, (3) the need for consumers to sugars on the Nutrition Facts label consumption of sugar-sweetened would assist consumers in maintaining identify the presence or absence of beverages is associated with increased healthy dietary practices by providing added sugars, and (4) when added body weight in adults and that under them with information necessary to sugars are present, the need for isocaloric controlled conditions, added meet the key recommendations to consumers to identify the amount of construct diets containing nutrient- sugars, including sugar-sweetened added sugars added to the food. The dense foods and reduce calorie intake beverages, are no more likely to cause mandatory declaration of added sugars from added sugars by reducing weight gain in adults than any other may also prompt product reformulation consumption of added sugars. source of energy. While the IOM FOP of foods high in added sugars like what The Nutrition Facts label includes the report did not review scientific data on was seen when trans fat labeling was mandatory declaration of the fatty acids added sugars, based on the 2010 DGA mandated (Ref. 58). that are contained in solid fats from the recommendation to reduce intake of We understand that our rationale to DGA recommendation, in that saturated calories from added sugars, it concluded support an added sugars mandatory fatty acids and trans fatty acids are that added sugars should be included in declaration in labeling is different from required to be declared on the Nutrition an FOP labeling system. In addition the our rationale to support other Facts label. Solid fats are solid at room IOM FOP committee recommended that mandatory nutrients to date which, temperature and contain a mixture of the FOP symbol system should be consistent with the factors we describe saturated and unsaturated fatty acids integrated with the Nutrition Facts label in section I.C., generally relate to the but tend to contain a high percentage of so that the two are mutually reinforcing. intake of a nutrient and risk of chronic saturated or trans fatty acids. The The IOM DRI Macronutrient Report disease, a health-related condition, or a disclosure of saturated fat and trans fat noted the difficulty, among some physiological endpoint. U.S. consensus on the label not only provides populations, of consuming adequate reports have determined that inadequate information to consumers for managing amounts of certain micronutrients when evidence exists to support the direct their effects on CVD (see sections II.B. excessive amounts of added sugars are contribution of added sugars to obesity and II.C.) but also could provide a consumed. or heart disease. Specifically, although it is recognized that sugar-sweetened marker for foods that contain solid fats As the CSPI petition pointed out, beverages increase adiposity (body fat) that are abundant in the diets of other groups such as the American in children (Ref. 30), neither the 2010 Americans and contribute significantly Heart Association (AHA), American to excess calorie intake (Ref. 6). DGA nor the IOM macronutrient report of Pediatrics, and World However, similar information about concluded that added sugars Health Organization (WHO) have added sugars is not currently available consumption from all dietary sources, in recommended limiting added sugars on the Nutrition Facts label. Thus, we itself, increases obesity. In fact, the 2010 consumption. None of these are proposing to require the declaration DGA states that added sugars do not recommendations was based on an of added sugars on the Nutrition Facts contribute to weight gain more than any label to provide consumers with increased risk of obesity or heart other source of calories. The evidence information that is necessary to meet the disease. Both the AHA and American submitted by CSPI supporting the dietary recommendation to reduce Academy of Pediatrics contribution of added sugars to heart caloric intake from solid fats and added recommendations point out that added disease failed to show a direct sugars. sugars intake is associated with a greater association between added sugars Added sugars contribute an average of intake of calories and a lower intake of consumption and heart disease risk. 16 percent of the total calories in essential nutrients, whereas the 1990 Rather, the evidence shows that the American diets (Ref. 6). According to WHO recommendation for decreasing consumption of total carbohydrates (not NHANES, the major sources of added added sugars is based on dental caries added sugars, per se) is associated with sugars in the diet in descending order and that excessive consumption of these an increase in serum levels. are soda, energy and sports drinks, sugars can displace nutrient-containing Moreover, serum triglyceride level is not based desserts, sugar-sweetened fruit foods in the diet (Refs. 71 to 73). While an endpoint that we recognize as a drinks, dairy-based desserts and candy. these groups are not recognized as U.S. validated surrogate marker for CHD risk Most of these foods are not nutrient- consensus groups by FDA, these in our evidence-based review system for dense and may add calories to the diet recommendations support our proposal health claims (Ref. 74). Nevertheless, for without providing dietary fiber or to require the mandatory declaration of the reasons explained previously that essential vitamins and minerals (Ref. 6). added sugars so that consumers can include providing consumers with the The consumption levels of added sugars achieve a dietary pattern that is information necessary to follow the alone exceed the discretionary calorie nutrient-dense and that does not exceed 2010 DGA recommendations to reduce recommendations of 5 to 15 percent of caloric needs from added sugars, the intake of calories from added sugars,

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we tentatively conclude that the reduce or minimize the caloric We also considered the declaration of added sugars is required contribution of added sugars from such appropriateness of voluntary declaration to assist consumers in maintaining sources. The IOM FOP report noted that of added sugars, an approach supported healthy dietary practices. small amounts of added sugars would by several comments. However, we are Additionally, in the absence of be appropriate for foods to earn FOP concerned that voluntary declaration of uniform added sugars declaration on the points in their recommended labeling added sugars may not ensure that Nutrition Facts label, consumers would scheme, which suggests that small consumers have the information that not be able to compare the added sugars amounts would be appropriate in a will allow them to follow the current content of foods, particularly those that balanced diet (Ref. 29). dietary recommendations. Added sugars contain both naturally occurring sugars We acknowledge that, if finalized, a declared voluntarily by manufacturers and added sugars (e.g., and dairy- requirement for declaration of added on some products, but not on others, based desserts). Contrary to what one sugars on the Nutrition Facts label will either within a given product category comment stated, the added sugars need to be accompanied by consumer or across different product categories, declaration in the ingredient statement education on the role of added sugars, could be confusing to consumers, and of a food label may not provide along with solid fats, and the use of the would not provide consumers with the sufficient or quantitative information for new information on the label in overall information they need to plan their consumers to be able to formulate diets dietary planning. We will be conducting dietary pattern to reduce consumption consistent with the dietary consumer studies that include questions of calories from added sugars. recommendations. Sugars may be added regarding including added sugars on the In light of current dietary to foods in the form of various Nutrition Facts label. We plan to use the recommendations that advise ingredients, such as fruit juice results of these studies to help inform Americans to reduce their intake of concentrates, fructose, , sucrose, our future actions on this issue. calories from added sugars, we consider and honey, and consumers may not We understand that there are that an added sugars declaration will realize that these ingredients are, in fact, currently no analytical methods that are help individuals identify foods that are forms of added sugars and would not be able to distinguish between naturally nutrient-dense within calorie limits and able to determine the quantities added. occurring sugars and those sugars added aid in reducing excess discretionary Thus, as pointed out in some comments, to a food. However, we do not agree calorie intake from added sugars. We calorie declaration and ingredient with comments that analytical tentatively conclude that the declaration listing do not provide enough limitations should preclude mandatory of added sugars on the Nutrition Facts information for consumers to determine declaration of added sugars because label is necessary to assist consumers to the amount of calories derived from there is an alternative method to assess formulate diets consistent with current added sugars in the food. We compliance. The amount of added dietary recommendations and, thus, acknowledge that some products may sugars declared on the label could be maintain healthy dietary practices. contain only added sugars and no verified through means other than Therefore, proposed § 101.9(c)(6)(iii) naturally occurring sugars (e.g., soda) chemical analysis, such as through would require the mandatory and that the amount shown in the total maintenance and review of records. The declaration of added sugars as an ‘‘sugars’’ declaration on the Nutrition reliance on records for compliance indented line item underneath the Facts label for such products would be purposes is not unique to added sugars declaration of total sugars on the the amount of added sugars. In this case, as we have previously required that Nutrition Facts label. We invite however, some consumers may still not manufacturers provide records under comment on this issue. We also invite be able to determine the amount of certain circumstances to support comment, including the submission of added sugars because the term would statements made on food labels (for research on whether calories from not appear on the label at all. At this example, with respect to aeration to added sugars should be declared on the point in time, we cannot be certain that reduce fat and caloric content of foods Nutrition Facts label in lieu of a gram most consumers would understand that, (58 FR 2229 at 2271) and caloric content declaration of added sugars to aid in the absence of added sugars of new products with reduced consumers in maintaining healthy declaration, all sugars in these products digestibility (58 FR 2079 at 2111)). In dietary practices. are added sugars. Therefore, without the addition, in sections II.D.5., II.J.2., and FDA regulations require that the added sugars declaration, some II.J.3., we are proposing to use records statement ‘‘Not a significant source of consumers may perceive the amount of to determine compliance with declared ll’’ for calories from fat, saturated fat, added sugars in the product differently values of dietary fiber, folate, and trans fat, cholesterol, dietary fiber, and some perceived amounts may differ vitamin E, under certain specified sugars, and protein must be placed at from the actual amount in the product. circumstances. the bottom of the table of nutrient Food formulations may vary and We continue to recognize the lack of values in the same type size, under the consistency in the mandatory a physiological distinction between specific circumstances described for declaration of added sugars is important added and naturally occurring sugars. each nutrient in § 101.9(c). For sugars, so that consumers are not confused. While comments expressed concerns the phrase ‘‘Not a significant source of We recognize that small amounts of that declaration of added sugars could sugars’’ must be placed at the bottom of added sugars can increase the significantly under-represent the sugars the table of nutrient values if a palatability of nutrient-dense foods, as content of many foods with a large statement of the sugars content is not suggested by a comment. The disclosure quantity of naturally occurring sugars, required and, as a result, not declared. of added sugars on the label may allow we are not proposing to remove the total A statement of sugars content is not consumers to plan and construct their sugars declaration (see section II.D.2.) required for products that contain less diets to include small amounts of added because there continues to be strong than 1 gram of sugars in a serving if no sugars and still consume adequate scientific evidence linking total sugars claims are made about sweeteners, amounts of necessary nutrients. intake with dental caries. Therefore, the sugars, or sugar alcohol content Consumers may select from a variety of sugar content of foods with naturally (§ 101.9(c)(6)(ii)). Similar information such nutrient-dense foods as part of occurring sugars would not be under- on added sugars could also be useful to their overall dietary pattern in a way to reported. consumers who are trying to limit their

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intake of added sugars. Therefore, for added sugars. In its 1999 petition as supported quantitative intake proposed § 101.9(c)(6)(iii) would require well as in a published report (Ref. 75), recommendation for added sugars on that the phrase ‘‘Not a significant source CSPI recommended that FDA base a DV which a DRV for added sugars can be of added sugars’’ be placed at the for ‘‘added sugars’’ on suggested limits derived. Therefore, we are not bottom of the table of nutrient values if of added sugars published in the 1992 proposing a DRV for added sugars. a statement of the added sugars content USDA’s Food Guide Pyramid (Ref. 76). Accordingly, the proposed rule, if is not required and, as a result, is not CSPI determined that a DRV for added finalized, would declare added sugars declared. We are also proposing that a sugars based on a 2,000 calorie diet on the Nutrition Facts label only in statement of added sugars content would be 10 teaspoons or 40 g of added absolute amounts (in g), similar to the would not be required for products that sugars. Overall, comments submitted in declaration of total sugars. contain less than 1 gram of added sugars response to CSPI’s 1999 petition were in d. Compliance—As expressed in the in a serving if no claims are made about favor of this approach to setting a DRV preamble to the 1993 RDI/DRV final sweeteners, sugars, or sugar alcohol for added sugars. Comments in response rule, we are not aware of an analytical content (proposed § 101.9(c)(6)(iii)). to the 2007 ANPRM also recommended method that is capable of distinguishing In addition, for total carbohydrate, establishing a DV for added sugars (Ref. between added and intrinsically dietary fiber, soluble fiber, insoluble 47). occurring sugars in a food product (58 fiber, sugars, and sugar alcohol, when a We reviewed scientific evidence and FR 2206 at 2222). Thus, it is not serving of the food contains less than 1 recommendations of consensus reports, technologically feasible for us to rely on an analytical method to determine gram of the nutrient, FDA regulations in and disagree with the petitioner and § 101.9 permit the use the alternative compliance with the declaration of comments that there is currently a statements ‘‘Contains less than 1 gram’’ added sugars in foods that contain both sound scientific basis for the or ‘‘less than 1 gram,’’ and if a serving added sugars and naturally occurring establishment of a quantitative intake of the food contains less than 0.5 grams sugars. We recognize that enforcement recommendation upon which a DRV of the nutrient, the content may be of the mandatory declaration of added could be derived. The IOM did not set expressed as zero. Proposed sugars content will require an a DRI, such as a UL, for added sugars § 101.9(c)(6)(iii) would provide for alternative means of verifying (Ref. 68). The IOM suggested that no similar use of alternative statements, compliance and are proposing in more than 25 percent of energy should ‘‘Contains less than 1 gram’’ and ‘‘less § 101.9(g)(10) to include records be consumed from added sugars, but than 1 gram’’ for added sugars. In requirements related to the added sugars addition, if the serving contains less noted that a defined intake level at declaration in food. Similarly, in the than 0.5 g of added sugars, we are which inadequate micronutrient intakes other cases where there are not reliable proposing to permit the content to be occur could not be identified. The 2010 and appropriate analytical methods that expressed as zero (proposed DGA did not provide a quantitative will allow us to verify the amount of a § 101.9(c)(6)(iii)). intake recommendation for added given nutrient in a food (dietary fiber, b. Proposed Definition—The term sugars intake but did provide a vitamin E (tocopherol), and folate), we ‘‘added sugars’’ is not defined in FDA maximum intake level for solid fats and are also proposing to require regulations. Given our tentative added sugars at 13 percent of calories manufacturers make and keep certain conclusion to require mandatory for a 2,000 calorie diet based on food records necessary to verify the amount declaration of ‘‘added sugars’’ on the pattern modeling of the USDA Food of these nutrients present in a food (see Nutrition Facts label, we are proposing Patterns and also described the ‘‘DASH’’ proposed § 101.9(g)(10)). In the case of to define added sugars. In proposed (Dietary Approaches to Stop added sugars that are not subject to § 101.9(c)(6)(iii), we are proposing to Hypertension) eating plan which fermentation, when a mixture of define ‘‘added sugars’’ as sugars that are recommends 5 servings or less per week naturally occurring and added sugars is either added during the processing of of sweets and added sugars for a 2,000 present in the food, we are proposing foods, or are packaged as such, and calorie diet (Ref. 6). The USDA Food that a manufacturer must make and include sugars (free, mono- and Patterns, which provide recommended keep written records of the amount of disaccharides), syrups, naturally amounts of foods from each added sugars added to the food during occurring sugars that are isolated from that individuals should consume in the processing of the food, and if a whole food and concentrated so that order to meet their nutrient needs packaged as a separate ingredient, as sugar is the primary component (e.g., within a specific calorie level, specify packaged (whether as part of a package fruit juice concentrates), and other that the maximum amount of calories containing one or more ingredients or caloric sweeteners. This would include from solid fats and added sugars that packaged as a single ingredient) to single ingredient foods such as can be consumed at the 2,000 calorie verify the amount of added sugars individually packaged table sugar. Sugar level while staying within calorie limits present in the food (§ 101.9(g)(10)(iv)). alcohols are not considered to be added is 258 calories (Ref. 6). The solid fats (See section II.N for more details about sugars. Names for added sugars include: and added sugars limit at each calorie this requirement.) , corn sweetener, corn level in the USDA Food Patterns is i. Reactions during processing. Sugars syrup, dextrose, fructose, fruit juice determined by calculation through food in some foods may undergo chemical concentrates, glucose, high-fructose pattern modeling rather than on any changes mediated by chemical reactions corn syrup, honey, invert sugar, lactose, biomarker of risk of disease or other from non-enzymatic browning (i.e., maltose, malt sugar, , raw public health endpoint. However, an Maillard reactions and caramelization) sugar, turbinado, sugar, trehalose, and exact amount of calories for added and fermentation during food sucrose. This proposed definition of sugars is not detailed in either the processing. During these reactions, some added sugars includes what CSPI USDA Food Patterns or ‘‘DASH’’ eating sugars are metabolized or otherwise described as ‘‘added sugars’’ in the 2013 plans, as they represent templates that transformed and converted into CSPI petition. translate and integrate dietary compounds that are no longer c. Daily Value—Given our proposal to recommendations, rather than specific recognizable or detectable as sugars require the declaration of added sugars, quantitative intake recommendations through conventional analytical we also considered establishing a DRV (Ref. 6). Thus, we have no scientifically methods (Ref. 77). We expect that the

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amount of added sugars transformed products, wines with less than 7 percent We also recognize that some during non-enzymatic browning alcohol by volume, and that do manufacturers of these foods may not be reactions is insignificant relative to the not meet the definition of a malt able to use scientific data and initial levels of sugars (Ref. 78). beverage with sugars added before and information to verify the amount of Unlike browning reactions, during the fermentation process, it is added sugars in the finished food fermentation is a process that typically unclear to us whether, as with most product. We tentatively conclude that it involves the action of desirable fermented foods, the reduction in the is appropriate to include, as an microorganisms (e.g., yeasts and lactic amount of added sugars would be alternative to the use of scientific data acid bacteria) and to convert insignificant. In addition to the records and information for such verification, organic compounds, especially sugars we propose to require for added sugars proposed record requirements for the and other carbohydrates, to simpler in foods generally, under proposed amount of added sugars added to these compounds such as , § 101.9(g)(10), we recognize that there is products before and during fermentation , and ethyl alcohol (Refs. 52 a need to consider other types of records for the verification of the declaration of and 79). Typical foods that are subject related to added sugars content for a added sugars content (see proposed to fermentation during manufacturing yeast-leavened bakery product, wine § 101.9(g)(10)(v)(B)). As with other are , , yogurt, , with less than 7 percent alcohol by products containing added sugars, the vegetables, meats, and wine. Some volume, or a beer that does not meet the amount of sugars added before or during foods, such as sweetened, yeast- definition of a malt beverage when fermentation could be determined leavened breads and wines that are sugars are added to the food before or through information such as databases, processed through a fermentation step during the fermentation process (e.g. the recipes, formulations, or batch records. contain added sugars which will likely added sugars are present during Therefore, we are proposing, in be consumed by the microorganisms fermentation and the amount may be § 101.9(g)(10)(v), to require a during fermentation; other foods reduced by the fermentation process). manufacturer of yeast-leavened bakery processed through a fermentation step Because of the unique issues that may products, wines with less than 7 percent contain added sugars that will likely not be associated with a yeast-leavened alcohol by volume, and beers that do be consumed to a large extent, if at all, bakery product, wine with less than 7 not meet the definition of a malt during fermentation, for example, percent alcohol by volume, or a beer beverage with sugars added before and yogurt sweetened with sucrose. In that does not meet the definition of a during the fermentation process to make addition, many products processed malt beverage when added sugars are and keep records of added sugars through a fermentation step, such as present during the fermentation process necessary to determine the amount of cheese, do not contain added sugars to (Ref. 78), we are proposing a new added sugars present in the finished aid in fermentation or improve taste subparagraph (§ 101.9(g)(10)(v)) to food in one of two ways. The first would (Ref. 78). Therefore, we tentatively specifically address records require the manufacturer to make and conclude that the amount of added requirements for these products. keep records of all relevant scientific sugars present in foods prior to data and information relied upon by the undergoing fermentation, with the Some manufacturers of yeast-leavened manufacturer that demonstrates the exception of yeast-leavened bakery bakery products, wine with less than 7 amount of added sugars in the food after products, wines with less than 7 percent percent alcohol by volume, and beers fermentation and a narrative explaining alcohol by volume, and beers that do that do not meet the definition of a malt why the data and information are not meet the definition of a ‘‘malt beverage where sugar is added before or sufficient to demonstrate the amount of beverage’’ as defined by the Federal during the fermentation process would added sugars declared in the finished Alcohol Administration Act (27 U.S.C. likely have more detailed information food. When the manufacturer is relying 211(a)(7)) with sugars added during the about the reduction in added sugars upon scientific data and information fermentation process, will not be from the process for the products they from reference documents to determine significantly affected by virtue of the manufacture. Thus, we anticipate that the amount of added sugars in these food having undergone fermentation. manufacturers of some of these foods finished food products, the information We do not have adequate information to that undergo fermentation would be used must be specific to the type of assess the degradation of added sugars able to determine the amount of added fermented food manufactured. For during fermentation for yeast-leavened sugars in the finished food product. For example, if a manufacturer produces bakery products, wine with less than 7 example, manufacturers could choose to , the reference that the percent alcohol by volume, and beers determine through laboratory analysis manufacturer is relying upon would that do not meet the definition of a malt the amount of added sugars as well as need to show the amount of sugars beverage with sugars added before or naturally occurring sugars consumed in typically consumed in raisin bread that during the fermentation process. (Ref. their product during the fermentation undergoes fermentation. The second 78). process. Other manufacturers that are would require the manufacturer to make We request comments, including unable to conduct additional laboratory and keep records of the amount of available data and information, on our analyses of their product may rely on a added sugars added to the food before tentative conclusions with respect to scientific document (e.g., journal article and during the processing of the food, added sugars in products that are or reference book) showing the amount and, if packaged as a separate subjected to non-enzymatic browning of added sugars typically consumed ingredient, as packaged (whether as part reactions and fermentation. We during fermentation in a specific food of a package containing one or more specifically request data on the amount product (see proposed ingredients or packaged as a single of variability that occurs among various § 101.9(g)(10)(v)(A)). Manufacturers may ingredient). The records would need to types of products where added sugars use information gathered through be made available to FDA consistent are transformed into other compounds additional analyses or from scientific with the proposed requirements in as a result of chemical reactions during references to adjust the amount of § 101.9(g)(11). . sugars added in processing to achieve It is likely that the actual amount of ii. Records required to assess the desired taste and organoleptic added sugars remaining in yeast- compliance. For yeast-leavened bakery properties in the finished food product. leavened breads, wines with less than 7

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percent alcohol by volume, and beers mandatory. We considered comments such as and New Zealand. In that do not meet the definition of a malt received (Ref. 47) as well as arguments addition, the petition cited a survey that beverage after they undergo presented by the petition. showed that 78 percent of consumers fermentation will be less than the We tentatively conclude that surveyed thought that products with amount added before processing. We are declaration of sugar alcohols should sugar alcohol contained some sugar proposing in section II.N to allow for continue to be voluntary. Although a even when labeled ‘‘sugar free’’ and 69 reasonable deficiencies of added sugars quantitative intake recommendation for percent thought that the product under labeled amounts that are sugar alcohols is not available from contained some alcohol. We considered acceptable within current good relevant U.S. consensus reports, sugar the petition as well as comments in manufacturing practice in § 101.9(g)(6). alcohols have positive health effects response to the 2007 ANPRM (Ref. 80). Because the consumer is not generally when they replace sugars in the diet. We previously considered the use of harmed if the amount declared on the For example, there is well-established ‘‘polyol’’ (a contraction of nutrition label is a reasonable overage of evidence to indicate that replacing ‘‘polyalcohol’’) and determined that it the actual amount as indicated by sugars in the diet with sugar alcohols could be potentially more confusing to § 101.9(g)(6), when the manufacturer reduces the risk of dental caries, consumers than the term ‘‘sugar chooses, as the declaration, the amount including the evidence used to support alcohol.’’ However, we acknowledge of sugars added to these specific foods the health claims authorized by FDA on that consumers also may not be familiar before fermentation, the we consider the sugar alcohols and dental caries (72 FR with the term ‘‘sugar alcohol.’’ actual amount of added sugars in the 52783 at 52785; § 101.80). Therefore, we Therefore, in § 101.9(c)(6)(iii), we allow finished food product to be a reasonable tentatively conclude that sugar alcohols for the use of the name of the specific deficiency under § 101.9(g)(6). In some have public health significance and, in sugar alcohol in lieu of ‘‘sugar cases of these specific fermented foods, the absence of a quantitative intake alcohols,’’ provided that only one sugar when the amount of sugar added to a recommendation, voluntary declaration alcohol is present in the food, since product before fermentation is declared, is consistent with the factors we many of the sugar alcohols are listed as it will exceed the amount of total sugars consider for when voluntary declaration ingredients (e.g., , mannitol, in the finished food product determined is appropriate (section I.C.). xylitol) and hence may be more through laboratory analysis. This is due Accordingly, we are proposing to recognizable for consumers (58 FR 2079 to the fact that the amount of added continue to provide for the voluntary at 2100). sugars consumed during the declaration of sugar alcohols (in We continue to support the term fermentation process is not reflected in § 101.9(c)(6)(iii) redesignated as ‘‘sugar alcohols’’ rather than ‘‘polyols,’’ the declared amount. In such cases, the § 101.9(c)(6)(iv)). because ‘‘sugar alcohols’’ more we tentatively conclude that it may be We disagree with the petition that accurately describes the group of confusing to the consumer if the amount mandatory declaration of sugar alcohols substances encompassed in the of added sugars declared exceeds the is necessary to ensure that consumers definition in § 101.9(c)(6)(iii). ‘‘Polyols’’ amount of total sugars declared on the are not misinformed about includes non-carbohydrate Nutrition Facts label. Therefore, we are modifications to foods. Sugar alcohols polyalcohols, such as polyesters, proposing in § 101.9(g)(10)(v)(B) that the that are added to food must be listed in whereas ‘‘sugar alcohols,’’ as defined by amount of added sugars declared shall the ingredients list on food labels and, FDA, includes only carbohydrates. not exceed the amount of total sugars therefore, consumers will be informed Accordingly, we are not proposing to declared on the label. of their use in a product. We also change the term ‘‘sugar alcohols’’ when disagree with the comment that used on the Nutrition Facts label, as 4. Sugar Alcohols supported mandatory declaration when specified in § 101.9(c)(6)(iii) FDA regulations define sugar there is at least 1 gram of sugar alcohols redesignated as § 101.9(c)(6)(iv). alcohols, in part, as the sum of per serving due to gastrointestinal c. DRV—FDA regulations do not saccharide derivatives in which a problems at such a level. As warranted, provide a DRV for total sugar alcohols hydroxyl group replaces a ketone or FDA regulations require specific or for individual sugar alcohols. A aldehyde group (e.g., mannitol or labeling statements to accompany the quantitative reference intake sorbitol) (§ 101.9(c)(6)(iii)). use of certain sugar alcohols to provide recommendation for sugar alcohols is a. Voluntary Declaration—FDA information to consumers about any not available from current consensus regulations permit the voluntary gastrointestinal effects. For example, in reports and we have no basis on which declaration of sugar alcohols on the the case of mannitol and sorbitol, the to consider setting an appropriate DRV. Nutrition Facts label (§ 101.9(c)(6)(iii)). statement ‘‘Excessive consumption may Therefore, we are not proposing to set In 2005, we received a citizen petition have a laxative effect,’’ is required on a DRV for sugar alcohols. from the Sugar Association (Docket No. the label and labeling of a food whose d. Caloric Value—The caloric value 2005–P–0373) requesting, among other reasonably foreseeable consumption for carbohydrates, other than insoluble requests, mandatory declaration of sugar may result in a daily ingestion of 20 g fiber, is 4 kcal/g (§ 101.9(c)(1)(i)(C)). alcohols on the Nutrition Facts label for mannitol (21 CFR 180.25) and 50 g Sugar alcohols have been shown to have (http://www.regulations.gov/ for sorbitol (§ 184.1835 (21 CFR a caloric value lower than 4 kcal/g (Refs. #!docketDetail;D=FDA-2005-P-0373). 184.1835)). 81 and 82). The 2007 ANPRM asked for The petition stated that, without this b. Use of the Term ‘‘Sugar Alcohol’’— comment on (1) how the energy information, consumers would be In 1995, we received a citizen petition contribution of sugar alcohols should be misinformed about important submitted by the Calorie Control represented on the label since energy modifications to foods and cannot make Council requesting the use of the term values vary, and (2) what analytical informed decisions about their ‘‘polyols’’ in lieu of ‘‘sugar alcohols’’ methods could be used to determine the particular sensitivity to the potential (Docket No. FDA-1995-P-0142) (http:// energy contribution of sugar alcohols. effects of sugar alcohols on the body. In www.regulations.gov/ We considered comments received (Ref. the 2007 ANPRM, we asked whether the #!docketDetail;D=FDA-1995-P-0142). 47). We also considered relevant caloric declaration of sugar alcohols should The petition stated that ‘‘polyol’’ is a values recommended by the Life continue to be voluntary or made regulatory term used in other countries, Research Office (LSRO) that

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were determined by various methods, 2007 ANPRM asked for public comment is beneficial to human health. The including studies conducted in animals on whether the IOM dietary or declaration of dietary fiber that and human subjects, and based on the functional fiber definitions should accurately reflects the amount of fiber amount of energy metabolized or net become the FDA definition for dietary that provides a physiological effect that energy values (Refs. 81 and 82). LSRO fiber. We also asked whether it should is beneficial to human health would expert panel reports provided the develop criteria for identifying fibers assist consumers in maintaining healthy following caloric values for individual that demonstrate a physiological benefit, dietary practices. sugar alcohols: Isomalt (2.0 kcal/g), and, if so, what those criteria should be. We are proposing a single definition lactitol (2.0 kcal/g), xylitol (2.4 kcal/g), We received several comments (Ref. 47). for dietary fiber that is equivalent to the maltitol (2.1 kcal/g), sorbitol (2.6 kcal/ We considered IOM IOM’s definition for ‘‘total fiber,’’ rather g), hydrogenated starch hydrolysates recommendations, comments received, than IOM’s separate definitions of (3.0 kcal/g), and mannitol (1.6 kcal/g). and relevant international guidelines. ‘‘dietary fiber’’ and ‘‘functional fiber.’’ We support the use of the LSRO The Codex Alimentarius Commission Because both ‘‘dietary fiber’’ and caloric values for individual sugar adopted the following definition of ‘‘functional fiber’’ as defined by IOM are alcohols. The LSRO reports used dietary fiber in 2010 (Ref. 67): considered to have beneficial health appropriate methods and study design ‘‘Dietary fibre means carbohydrate effects, we tentatively conclude that criteria for measuring caloric value, and polymers 1 with ten or more monomeric there is little benefit for consumers in noted that human data were preferred units,2 which are not hydrolysed by the distinguishing between these two types and that animal data should be viewed endogenous enzymes in the small of fiber on the Nutrition Facts label. In as supplemental information. We do not intestine of humans and belong to the addition, the IOM itself recognized following categories: analytical limitations in distinguishing have any data that would question the • caloric values determined by the LSRO Edible carbohydrate polymers between ‘‘dietary fiber’’ and ‘‘functional reports for the specified sugar alcohols. naturally occurring in the food as fiber’’ and noted that the labeling of We did not identify any human studies consumed, ‘‘total fiber’’ would be more practical • Carbohydrate polymers, which have published since the release of the LSRO than labeling ‘‘dietary fiber’’ and been obtained from food raw material by reports that demonstrate that a different ‘‘functional fiber’’ separately (Ref. 24). physical, enzymatic or chemical means caloric value for any of these sugar The Codex definition includes a and which have been shown to have a alcohols would be more appropriate. minimum degree of polymerization (DP) physiological effect of benefit to health Therefore, we are proposing to amend for a carbohydrate of 10, and it also as demonstrated by generally accepted § 101.9(c)(1)(i)(F) to establish the provides that the inclusion of non- scientific evidence to competent following general factors for caloric digestible carbohydrates with 3 to 9 authorities, and values of sugar alcohols, using the monomeric units should be left to • Synthetic carbohydrate polymers national authorities. The IOM’s values recommended by LSRO: which have been shown to have a Isomalt—2.0 kcal/g, lactitol—2.0 kcal/g, definition for ‘‘total fiber’’ includes physiological effect of benefit to health those non-digestible carbohydrates of 3 xylitol—2.4 kcal/g, maltitol—2.1 kcal/g, as demonstrated by generally accepted sorbitol—2.6 kcal/g, hydrogenated to 9 DP (Ref. 24). scientific evidence to competent Because we seek to include in our starch hydrolysates—3.0 kcal/g, and authorities. definition non-digestible carbohydrates mannitol—1.6 kcal/g. Accordingly, we As with the IOM definition of ‘‘total with physiological effects that are are also proposing to amend fiber,’’ the 2010 Codex definition for beneficial to human health, regardless of § 101.9(c)(1)(i)(C) such that the 4 kcal/g ‘‘dietary fiber’’ includes naturally size, we are proposing to adopt a is not applied to sugar alcohols. occurring fibers and only those non- definition for total fiber that includes a 5. Dietary Fiber digestible carbohydrates added to food DP of ≥ 3, consistent with the IOM’s that have a physiological effect that is definition. a. Dietary Fiber beneficial to human health. Therefore, we are proposing to amend i. Definition. FDA regulations do not Dietary fiber represents a § 101.9(c)(6)(i) to include the following establish a definition for dietary fiber. heterogeneous group of compounds that definition for dietary fiber: (1) Non- There is no specific chemical definition vary in their carbohydrate composition, digestible soluble and insoluble for dietary fiber. Because of the linkages between carbohydrates, and carbohydrates (with 3 or more difficulties in accurately isolating the molecular weight. As stated previously, monomeric units) and lignin that are set of fibers relevant to health, in 2001, there is no specific chemical definition intrinsic and intact in plants; (2) the IOM established a panel to develop for dietary fiber. Therefore, considering isolated and synthetic non-digestible a new definition of dietary fiber (IOM the IOM and Codex definitions and carbohydrates (with 3 or more Panel on the Definition of Dietary Fiber comments received, as well as the role monomeric units) that FDA has granted or IOM Panel). Subsequently, the IOM of the dietary fiber declaration on the be included in the definition of dietary then issued a report defining ‘‘total Nutrition Facts label, we tentatively fiber, in response to a petition submitted fiber’’ as the sum of ‘‘dietary fiber’’ and conclude that a regulatory definition for to FDA under § 10.30 (21 CFR 10.30) ‘‘added fiber,’’ where ‘‘dietary fiber’’ dietary fiber should be one that demonstrating that such carbohydrates consists of non-digestible carbohydrates emphasizes its physiological effect that have a physiological effect(s) that is and lignin that are intrinsic and intact beneficial to human health; or (3) in plants, and ‘‘added fiber’’ (referred to 1 ‘‘When derived from a plant origin, dietary fibre isolated and synthetic non-digestible as ‘‘functional fiber’’ in the IOM may include fractions of lignin and/or other carbohydrates (with 3 or more compounds associated with in the Macronutrient Report) consists of plant cell walls. These compounds also may be monomeric units) that are the subject of isolated, non-digestible carbohydrates measured by certain analytical method(s) for dietary an authorized health claim. We invite that have beneficial physiological effects fibre. However, such compounds are not included comment on the proposed definition of in humans (Ref. 24). The IOM’s in the definition of dietary fibre if extracted and re- dietary fiber. introduced into a food.’’ (Ref. 67). definitions of ‘‘dietary fiber’’ and ‘‘total 2 ‘‘Decision on whether to include carbohydrates As proposed, under provisions 2 and fiber’’ only include those fibers that are from 3 to 9 monomeric units should be left to 3, manufacturers would be required to considered to have health benefits. The national authorities.’’ (Ref. 67). provide evidence to FDA to demonstrate

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the physiological effects that are concentrations, and improved laxation We reviewed comments (Ref. 47) beneficial to human health, of isolated (Ref. 66). The IOM DRI report noted that received as well as current AOAC and synthetic non-digestible consumption of certain dietary fibers, methods for dietary fiber and the carbohydrates added to food, and FDA particularly those that are poorly various analytes measured by these would have to grant a petition or fermented (i.e., insoluble fiber), improve methods in light of our proposed authorize a health claim before they can fecal bulk and laxation and ameliorate definition for dietary fiber. AOAC be considered as ‘‘dietary fiber’’ for (Ref. 66). In addition, methods, such as AOAC 985.29, 991.43 declaration on the Nutrition Facts label. soluble fiber plays a beneficial role in and 994.13, measure soluble and Manufacturers would use the citizen reducing the risk of heart disease (Ref. insoluble polysaccharides, lignin, petition process in § 10.30 or, in case of 66). ‘‘Dietary fiber’’ is identified as a higher molecular weight non-digestible a related health claim, the health claims nutrient of public health concern in the (DP > 12), and some petition process in § 101.70. We intend 2010 DGA. The 2010 DGA also , inulin and low to issue guidance to industry on emphasized the consumption of whole molecular weight non-digestible submissions to demonstrate grains, in part, because they are a source oligosaccharides (DP < 10). These physiological effects that are beneficial of dietary fiber, noting that choosing methods do not measure all non- to human health. whole grains that are higher in dietary digestible carbohydrates with a DP < 10. Under these proposed provisions, fiber has health benefits in addition to In contrast, newer methods (AOAC both b-glucan soluble fiber meeting nutrient needs (Ref. 6). 2009.01 and AOAC 2011.25) measure all (§ 101.81(c)(2)(ii)(A)) and b-fiber Given the health benefits of dietary low molecular weight non-digestible (§ 101.81(c)(2)(ii)(A)(6)) that are added fiber, we have no basis to conclude that carbohydrates (i.e., non-digestible to foods would meet the definition of the declaration of dietary fiber is no oligosaccharides) in addition to the dietary fiber and, therefore, would be longer necessary to assist consumers in higher molecular weight non-digestible included in the amount of dietary fiber maintaining healthy dietary practices. carbohydrates (Ref. 83). Thus, these declared on the Nutrition Facts label. Therefore, we are not proposing to newer, more inclusive AOAC methods We are proposing to list isolated and change our current requirement for the would be more consistent with our synthetic non-digestible carbohydrates mandatory declaration of dietary fiber in proposed definition. However, there is that have been determined by FDA to § 101.9(6)(i). no analytical method that can have a physiological effect that is With respect to the term used to distinguish non-digestible beneficial to human health, in declare dietary fiber content on the carbohydrates that have a beneficial § 101.9(c)(6)(i). Accordingly, we are Nutrition Facts label, we considered physiological effect from those that do proposing to amend § 101.9(c)(6)(i) to comments received in response to the not. list b-glucan soluble fiber and barley b- 2007 ANPRM (Ref. 47). The term We are proposing to amend fiber (as these substances are described ‘‘dietary fiber’’ has been listed on the § 101.9(c)(6)(i) to indicate that dietary in § 101.81(c)(2)(ii)(A) and Nutrition Facts label since 1993. One fiber content may be determined by (c)(2)(ii)(A)(6), respectively) as isolated survey pointed out by comments subtracting the amount of non-digestible and synthetic non-digestible suggests that both ‘‘fiber’’ and ‘‘dietary carbohydrates added during processing carbohydrates that have been fiber’’ are similarly acceptable by that do not meet the definition of determined by FDA to have a consumers (Ref. 47). Alternative terms dietary fiber (in proposed physiological effect that is beneficial to such as ‘‘natural fiber’’ or ‘‘isolated § 101.9(c)(6)(i)) from the value obtained human health and, therefore, must be fiber’’ would not be appropriate to using AOAC 2009.01, AOAC 2011.25 or included in the declaration of dietary declare all dietary fiber given that we an equivalent AOAC method of analysis fiber. Under this process, we would are proposing a definition of dietary as given in the ‘‘Official Methods of amend § 101.9(c)(6)(i) to list any fiber that includes both natural fiber and Analysis of the AOAC International’’ additional isolated and synthetic non- fiber that is added to food. Although the 19th Edition. If a product contains only digestible carbohydrates that FDA IOM used the term ‘‘total fiber,’’ there is non-digestible carbohydrates that meet determines have a physiological effect no evidence to suggest that this term is the proposed definition of dietary fiber, that is beneficial to human health, preferable to the term ‘‘dietary fiber.’’ using AOAC 2009.01, AOAC 2011.25, or through either the citizen petition Therefore, we are not proposing to an equivalent method would be process or the health claims petition change the current requirement to sufficient to quantify the dietary fiber process. declare dietary fiber using the term content of a food. However, if the ii. Mandatory declaration. Section ‘‘dietary fiber,’’ as specified in § 101.9(f). product contains both dietary fiber that 403(q)(1)(D) of the FD&C Act specifies, However, we request comment on this is included in the proposed definition in part, that for each serving size or issue, including consumer (e.g., naturally occurring fibers) and other unit of measure of a food, the understanding of the term ‘‘dietary non-digestible carbohydrates not amount of dietary fiber must be fiber’’ relative to other relevant terms. included in the definition (e.g., provided. Accordingly, FDA regulations iii. Analytical methods. Per FDA synthetic fibers without a physiological require the declaration of dietary fiber regulations, compliance with the effect that is beneficial to human on the Nutrition Facts label, as provided requirement for declaration of dietary health), neither AOAC 2009.01 or in § 101.9(c)(6)(i). fiber is determined using appropriate AOAC 2011.25 nor an equivalent AOAC We did not ask any questions about AOAC analytical methods (58 FR 2079 method would accurately quantify the the mandatory labeling of dietary fiber at 2113; § 101.9(g)(2)). In the 2007 dietary fiber that could be declared on in the 2007 ANPRM, and we received ANPRM, we noted the IOM Panel’s the Nutrition Facts label, because the no comments on this subject. Dietary consideration of analytical issues determination of fiber by these methods fiber is not an essential nutrient. related to dietary fiber, and asked would include the non-digestible However, it has physiological effects whether we should continue to use the carbohydrates that do not meet the that are beneficial to human health, AOAC International methods to proposed definition of dietary fiber. such as attenuation of postprandial determine the amount of dietary fiber To verify that the quantity of dietary blood glucose concentrations, and, if not, what other or additional fiber declared on the Nutrition Facts attenuation of blood cholesterol methods should be used. label includes only those fibers that

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meet the regulatory definition of dietary that soluble and insoluble fibers must and ‘‘insoluble fiber’’ with appropriate fiber, when a food contains a mixture of meet the proposed definition of dietary physicochemical terms as the non-digestible carbohydrates that meet fiber. Therefore, we are proposing in characterization of the properties of the proposed dietary fiber definition § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) that various fibers becomes standardized, and those that do not, we are proposing soluble fiber and insoluble fiber, such standardization has not yet in § 101.9(c)(6) and (g)(10) to require respectively, must meet the definition of occurred. In addition, as the comments manufacturers to make and keep written dietary fiber in paragraph 101.9(c)(6)(i). stated, does not predict records to verify the amount of added ii. Voluntary declaration. FDA fermentability (Ref. 47), which the IOM non-digestible carbohydrates that do not regulations permit, but do not require, recognized is a physicochemical meet the proposed definition of dietary the declaration of soluble fiber property that is linked to health fiber. See discussion in section II.N. (§ 101.9(c)(6)(i)(A)) and insoluble fiber benefits, and it is not known at what Such records would provide (§ 101.9(c)(6)(i)(B)) on the Nutrition level of viscosity a fiber begins to have information to verify that the amount of Facts label. In the 2007 ANPRM, FDA a physiological effect (Ref. 66). dietary fiber declared meets the asked whether the declaration of soluble Moreover, there are no currently proposed definition. The amount of and insoluble fiber should continue to available scientifically valid methods non-digestible carbohydrate measured be voluntary or made mandatory. We that FDA could use to measure the by AOAC 2009.01 or AOAC 2011.25 (or considered comments received (Ref. 47). amount of various fibers defined by an equivalent AOAC method) minus the While a quantitative intake their physicochemical properties in amount of added non-digestible recommendation is not available from various food matrices, whereas carbohydrate that has not been relevant U.S. consensus reports, there is scientifically valid methods to measure determined by FDA to have a well-established evidence showing that soluble and insoluble fiber are currently physiological effect that is beneficial to soluble and insoluble fibers have available. Therefore, we are not human health would reflect the amount distinct physiological effects that are proposing any changes to the use of of dietary fiber lawfully declared on the beneficial to human health. For terms ‘‘soluble fiber’’ and ‘‘insoluble label. example, the IOM noted that the body fiber’’ in the Nutrition Facts label. iv. DRV. The DRV for dietary fiber is of evidence indicates that non- iii. Analytical methods. Per FDA 25g (§ 101.9(c)(9)). We did not ask fermentable fiber sources (often isolated regulations, compliance with any specific questions in the 2007 ANPRM as insoluble fiber) promote laxation, and declaration of soluble or insoluble fibers and received no comments on the DRV improved laxation is an established is determined using appropriate AOAC for dietary fiber. In 2002, the IOM set an physiological effect that is beneficial to analytical methods (§ 101.9(g)(2)). While AI of 14 g/1,000 kcal for ‘‘total fiber’’ human health (Ref. 66). Therefore, we there are a number of traditional AOAC (Ref. 66). The AI was primarily based on tentatively conclude that soluble and methods available for measuring soluble the intake level that was associated with insoluble fibers that meet the definition fiber (e.g., AOAC 991.43 and 993.19) the greatest reduction in the risk of of dietary fiber have public health and insoluble fiber (e.g., AOAC 991.42 CHD. We are proposing to define dietary significance and, in the absence of and 991.43), as is the case with dietary fiber to include those fibers that have a quantitative intake recommendations, fiber, these methods cannot measure all physiological effect that is beneficial to are consistent with the considerations non-digestible carbohydrates with a DP human health (see section II.D.5.) and, for voluntary declaration explained in < 10. A newer method, AOAC 2011.25 as such, the AI for ‘‘total fiber’’ provides section I.C. Accordingly, we are (Ref. 83), can measure low molecular an appropriate basis for setting a DRV proposing to continue to provide for the weight non-digestible carbohydrates, as for dietary fiber declared on the voluntary declaration of soluble and well as separately measure soluble and Nutrition Facts label. insoluble fibers, as specified in insoluble non-digestible carbohydrates. Therefore, we are proposing to use 14 § 101.9(c)(6)(i)(A) and (B). However, as in the case of AOAC g/1,000 kcal as the basis for a DRV for With respect to the term used to 2009.01, AOAC 2011.25 (Ref. 83) cannot dietary fiber. Using a reference calorie declare dietary fiber content on the distinguish soluble and insoluble non- intake of 2,000 calories (see section Nutrition Facts label, in 2001, the IOM digestible carbohydrates that have a II.A.3.), we are proposing to amend Panel recommended that the terms physiological effect that is beneficial to § 101.9(c)(9) to set a DRV of 28 g (14g/ ‘‘soluble’’ and ‘‘insoluble’’ fiber be human health from those that do not. 1,000 kcal × 2,000 kcal/d) for dietary phased out and replaced with relevant We are proposing to amend fiber. descriptors of the physicochemical § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) to b. Soluble and Insoluble Fiber— properties of particular fibers (e.g., indicate that the soluble and insoluble Dietary fibers can be classified as being ‘‘viscous’’ or ‘‘fermentable’’ fiber to non-digestible carbohydrate content soluble or insoluble. Soluble fibers, replace ‘‘soluble’’ fiber), as the may be calculated by first using AOAC such as pectin and gums, dissolve in characterization of the properties of 2011.25, or an equivalent AOAC method water and are digested by the bacteria in various fibers becomes standardized of analysis. If a food contains only non- the large intestine. Insoluble fibers, such (Ref. 24). In the 2007 ANPRM, we noted digestible carbohydrates that meet the as and lignin, do not dissolve this recommendation and asked for proposed definition of dietary fiber (e.g., in water and are not digested by bacteria public comment on whether the terms contains naturally occurring fiber only), in the large intestine, adding bulk to the ‘‘soluble fiber’’ and ‘‘insoluble fiber’’ then AOAC 2011.25 or an equivalent stool for improved laxation. should be changed to ‘‘viscous’’ and AOAC method would measure the i. Definition. Like dietary fiber, FDA ‘‘nonviscous’’ fiber. amount of soluble or insoluble fiber that regulations do not establish definitions We considered the IOM can be declared on the Nutrition Facts for soluble or insoluble fiber. The 2007 recommendations as well as comments label. If a food contains a mixture of ANPRM did not ask questions about received (Ref. 47), and tentatively non-digestible carbohydrates that do definitions for soluble and insoluble conclude that the terms ‘‘soluble fiber’’ and do not meet the proposed dietary fiber and we did not receive any and ‘‘insoluble fiber’’ are most fiber definition, and the label of the food comments about them. Because soluble appropriate for reasons discussed in this declares soluble or insoluble fiber and insoluble fibers are components of document. While the IOM content, we are proposing to amend dietary fiber, we tentatively conclude recommended replacing ‘‘soluble fiber’’ § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) to

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require manufacturers to make and keep Insoluble non-digestible carbohydrates for voluntary declaration of ‘‘Other records to verify the amount of soluble are not included in the caloric carbohydrate’’ on the Nutrition Facts or insoluble non-digestible calculation. label based on the factors we consider carbohydrates that do not meet the We are also proposing a for the mandatory and voluntary proposed definition of dietary fiber that corresponding change to the declaration discussed in section I.C. have been added to the food product introductory text in § 101.9(c)(1)(i)(C) to ‘‘Other carbohydrate’’ represents during processing. (See discussion in exclude non-digestible carbohydrate different types of carbohydrate, and, section II.N.) from total carbohydrate. FDA unlike sugars and dietary fiber, iv. DRV. FDA regulations do not regulations require that the calories carbohydrates covered under this establish DRVs for soluble fiber or from total carbohydrate be calculated by heterogeneous category have no shared insoluble fiber. No DRIs were using the general factor of 4 kcal/g of physiological effects. Moreover, there is established for soluble or insoluble fiber carbohydrate less the amount of no well-established evidence to support during the IOM’s evaluation of a DRI for insoluble dietary fiber the role of particular types of dietary fiber (Ref. 66), and we have no (§ 101.9(c)(1)(i)(C)). We are proposing a carbohydrate that fall within the ‘‘other basis on which to derive an appropriate new definition of dietary fiber (see carbohydrate’’ category, such as starch DRV. Therefore, we are not proposing to section II.D.5.a.i.) that only allows for and oligosaccharides, in human health set a DRV for either soluble fiber or the declaration of dietary fibers that are that is based on reliable and valid insoluble fiber. added to foods that we have determined physiological or clinical endpoints. In v. Caloric value. Per FDA regulations, to have a physiological effect that is addition, a quantitative intake the caloric content of a food may be beneficial to human health, as ‘‘dietary recommendation for ‘‘Other calculated by, among other methods, fiber’’ on the Nutrition Facts label. carbohydrate’’ is not available from using the general factors of 4, 4, and 9 Therefore, the proposed new definition relevant consensus reports. Given the kcal/g for protein, total carbohydrate of dietary fiber would exclude soluble lack of public health significance or a less the amount of insoluble dietary and insoluble non-digestible quantitative intake recommendation for fiber, and total fat, respectively carbohydrates that do not meet the ‘‘other carbohydrate’’ as a category, (§ 101.9(c)(1)(i)(C)). Accordingly, proposed definition of dietary fiber. For consistent with the factors discussed in soluble fiber, which is encompassed the purposes of calculating calories from section I.C., we tentatively conclude within ‘‘total carbohydrate,’’ is assigned soluble non-digestible carbohydrate, the that ‘‘Other carbohydrate’’ should no a general factor of 4 kcal/g. We did not proposed factor of 2 kcal/g should apply longer be permitted to be declared on ask questions about the caloric value of to those soluble non-digestible the Nutrition Facts label. dietary fibers in the 2007 ANPRM, but carbohydrates that both do and do not Therefore, we are proposing to received a few comments on the caloric meet the proposed definition of dietary remove current § 101.9(c)(6)(iv) to value of soluble fiber, including that 4 fiber. To ensure that soluble non- remove the provision that allows for the kcal/g for soluble fiber was too high and digestible carbohydrates that do and do voluntary declaration of ‘‘Other that we should consider 2 kcal/g, which not meet the proposed definition of carbohydrate’’ on the Nutrition Facts is the caloric value identified by the dietary fiber are excluded from total label. We are also proposing to make a United Nations Food and Agriculture carbohydrate, such that a general factor corresponding revision to § 101.9(g)(4) Organization. We also received a citizen of 2 kcal/g is applied to these non- and (g)(6) to remove references to petition from the Calorie Control digestible carbohydrates, we are ‘‘Other carbohydrates.’’ We invite Council requesting that the caloric value proposing to amend § 101.9(c)(1)(i)(C) to comment on this issue, including any of soluble fiber be no more than 2 kcal/ require that calories from carbohydrate other data or factual information that we g (Docket No. FDA–1997–P–0232), be calculated using a general factor of 4 should consider in making a final based on the caloric contribution of kcal/g of total carbohydrate less the determination. energy yielding short chain fatty acids amount of non-digestible carbohydrates, that are produced as a result of colonic which includes soluble and insoluble E. Protein fermentation of soluble fiber (http:// non-digestible carbohydrates that do 1. Mandatory and Voluntary Declaration www.regulations.gov/ and do not meet the definition of dietary #!docketDetail;D=FDA-1997-P-0232). fiber (see also section II.D.1.f.). Section 403(q)(1)(D) of the FD&C Act We agree with the comments and the requires food labeling to bear nutrition petition supporting a caloric value of 2 6. Other Carbohydrate information about protein. FDA kcal/g for soluble fiber. The anaerobic FDA regulations define ‘‘other regulations require the declaration of fermentation of soluble fibers in the carbohydrate’’ as the difference between the amount of protein by weight, and colon has been shown to yield less total carbohydrate and the sum of provide for voluntary declaration of the energy than the 4 kcal/g obtained from dietary fiber, sugars, and sugar alcohol, percent DV for protein on the Nutrition aerobic of carbohydrates except that if sugar alcohol is not Facts label (§ 101.9(c)(7)(i)). In response (Ref. 66). In addition, the absorption of declared, ‘‘other carbohydrate’’ is to the 2007 ANPRM, one comment energy yielding short chain fatty acids defined as the difference between total supported the current approach, that are produced as a result of colonic carbohydrate and the sum of dietary whereas another comment fermentation of soluble fiber can vary, fiber and sugars (§ 101.9(c)(6)(iv)). recommended that FDA require the and data indicate that the average Examples of ‘‘other carbohydrate’’ labeling of the percent DV for protein. energy yield from soluble fibers is 1.5 to include starch and oligosaccharides. A We considered current scientific 2.5 kcal/g (Ref. 66). Therefore, we statement of the amount of ‘‘other evidence and comments received (Ref. tentatively conclude that 2 kcal/g is a carbohydrate’’ may be voluntarily 47). There is strong evidence based on reasonable estimate of the caloric value declared on the Nutrition Facts label valid physiological and clinical of soluble non-digestible carbohydrates. (§ 101.9(c)(6)(iv)). We did not ask endpoints that protein is an essential Accordingly, we are proposing to amend questions about the labeling of ‘‘other nutrient that is necessary for human § 101.9(c)(1)(i)(C) to establish a general carbohydrate’’ in the 2007 ANPRM, and health and growth (Refs. 6 and 84). factor of 2 kcal/g as the caloric value of we received no comments on this issue. Therefore, we tentatively conclude that soluble non-digestible carbohydrates. However, we reconsidered the provision the declaration of protein content

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remains necessary to assist consumers As discussed in section II.N.2., we see comments supported the approach in maintaining healthy dietary practices. a need to update the version of the recommended in the IOM Labeling In addition, because protein intake in Official Methods of Analysis of the Report and maintaining the DV of 50 g/ the U.S. population continues to be AOAC International that we use for d. adequate when compared to the EAR compliance purposes because newer, We considered current scientific absent a mandatory percent DV and sometimes better, analytical recommendations and agree with the declaration (Ref. 85), we tentatively methods for many nutrients are comments that supported the continued conclude that the declaration of protein included in versions of the methods that use of the current approach. First, as as a percent DV should remain have been published since the 15th explained in sections II.B. and II.D., we voluntary. Accordingly, we are not edition. We are, therefore, proposing to are not proposing to change the DRVs proposing any changes to the amend § 101.9(c)(7) to incorporate by for fat (30 percent of calories from fat or requirement for declaration of the reference the Official Methods of 65 g) or carbohydrate (60 percent of quantitative amount of protein and the Analysis of the AOAC International, calories from carbohydrate or 300 g). voluntary declaration of this amount as 19th ed. (2012) by removing ‘‘15th Ed. Applying the IOM Labeling Committee’s a percent DV on the Nutrition Facts (1990)’’ and adding in its place ‘‘19th recommended approach, given our label. Ed. (2012).’’ The 19th edition is the tentative conclusions on DRVs for fat most recent edition of the published 2. Analytical Methods and carbohydrates, that approach would AOAC methods, and includes both the result in no change to the DRV for Under § 101.9(c)(7), protein may be Kjeldahl and the /Dumas protein, i.e., 10 percent (100 ¥ (60 + calculated on the basis of 6.25 times the methods. While the petition requested 30)) of calories from protein. content of the food determined that the Agency amend § 101.9(c)(7) to Second, at 10 percent of caloric intake by the appropriate method of analysis as incorporate the 17th edition of the and using a reference energy intake of given in the Official Methods of AOAC methods, the 19th edition 2,000 calories, the DRV for protein is set Analysis of AOAC International, 15th includes all of the methods for protein at 50 g, which is relatively close to the ed. (1990), except when the official that were available in the 17th edition. procedure for a specific food requires IOM’s RDAs for men and women. The Thus, the proposed action is consistent RDAs, which represent values that meet another factor. On December 21, 2000, with the petition’s request. If a newer we received a citizen petition from the needs of almost all (97 to 98 percent) version of the Official Methods of individuals in a group, are set at 0.80 g/ Protein Technologies International, Inc. Analysis of the AOAC International is (FDA–2000–P–0569), requesting that kg for men and women who are 19 years published before publication of the final and older, 0.85 g/kg for boys and girls FDA amend the reference to the method rule (assuming that this rulemaking used to calculate protein content found 14 to 18 years of age, and 0.95 g/kg for does result in a final rule), we will boys and girls 4 to 13 years of age. Using in § 101.9(c)(7) to read ‘‘the appropriate consider, as appropriate, using the most reference weights established for age method of analysis as given in the recent version of the official AOAC and gender groups, the resulting values Official Methods of Analysis of the methods in the final rule. To the extent are 56 g/d for males and 46 g/d for AOAC International, 17th ed. (2000)’’ that the methods for protein females who are 19 years of age or older (http://www.regulations.gov/ determination in the newer version (not including pregnant and lactating #!docketDetail;D=FDA-2000-P-0569). differ from those provided in the 19th women), 52 g/d for males and 46 g/d for The petition explained that the only edition of the Official Methods of females between the ages of 14 through approved method for use in human food Analysis of the AOAC International, we 18 years of age, 34 g/d for males and in the 15th edition of the AOAC Official will consider the need to seek females between the ages of 9 and 13 Methods of Analysis was the Kjeldahl additional public comment on the method, which the petition stated version of the AOAC Methods of years, and 19 g/d for males and females involves the use of a mercury catalyst Analysis of the AOAC International that between the ages of 4 through 8 years. and, therefore, can be potentially is incorporated by reference in Thus, the DRV of 50 g for protein falls harmful to humans and the § 101.9(c)(7). within the range of the RDAs calculated environment. The petition asserted that using reference weights. the 17th edition of the AOAC Official 3. DRV We do not consider the midpoint of Methods of Analysis recognized an The DRV for protein is 50 g the AMDR of 22.5 percent of energy alternative method, the Combustion (§ 101.9(c)(9)) and represents 10 percent intake to provide the most appropriate method, also known as the Dumas of the 2,000 reference calorie intake basis for a DRV for protein. We have no method, to measure protein levels in level. The IOM Labeling Committee data to show that protein intakes are some human foods and that we should considered the IOM’s AMDR for protein inadequate or that setting a higher DRV permit its use for measuring protein (10 to 35 percent of energy intake for that is based on the midpoint of the content. adults) and the AMDRs for fat and AMDR is needed to prevent chronic We note that not all Kjeldahl methods carbohydrates, and recommended diseases such as cardiovascular disease, included in the Official Methods of setting the DV for protein based on the obesity, and sarcopenia, as asserted by Analysis of the AOAC contain a difference between total energy intake some comments (Ref. 47). The AMDR is mercury catalyst. Furthermore, the and the combined DVs for fat and a range of intakes for a particular energy Kjeldahl method is a well-recognized, carbohydrate (i.e., 100 percent of energy source that is associated with reduced standard method for determination of ¥ (DVfat + DVcarbohydrate). The 2007 risk of chronic diseases while providing protein content. In fact, it is the method ANPRM requested comment on whether adequate intakes of essential nutrients cited for use in determination of protein the DV for protein should be based on (Ref. 20). The DRV of 10 percent of digestibility in the ‘‘ (1) the approach recommended in the calories from protein falls within the Evaluation, Report of the Joint FAO/ IOM Labeling Report; (2) the midpoint AMDR. Thus, the DRV for protein falls WHO Expert Consultation on Protein of the AMDR for protein (i.e., 22.5 within a range of protein consumption Quality Evaluation’’ (Ref. 86) that is percent); or (3) the EAR or RDA for that is associated with a reduced risk of incorporated by reference in protein. We received comments on each chronic disease while providing § 101.9(c)(7)(ii). of these approaches (Ref. 47). Overall, essential nutrients.

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Finally, we consider the use of the that information about sodium content dependent effect of increased sodium population-weighted EAR to be on the food label can help consumers intake is elevated blood pressure and inappropriate. First, as the comments make appropriate food choices. the IOM noted that the relationship pointed out (Ref. 47), using the Therefore, we tentatively conclude between sodium intake and blood population-weighted EAR could lead to that declaration of sodium should pressure is continuous, making it inadequate consumption in some remain mandatory so consumers are difficult to set a precise UL because subpopulations, such as males 19 years provided information necessary to assist other environmental factors (weight, and older. In addition, the EARs for them in maintaining healthy dietary , potassium intake, dietary protein are expressed in terms of g/kg of practices. Accordingly, we are not pattern, and alcohol intake) and genetic body weight and based on consumption proposing to amend the current factors also affect blood pressure. The of good quality or ‘‘complete’’ protein. requirement for declaration of sodium ULs for sodium are 2,300 mg/d for all In order to calculate a DRV from the in § 101.9(c)(4). individuals ages 14 years and older, population-weighted EAR for the 2. DRV 1,900 mg/d for children 4 to 8 years old, purposes of nutrition labeling, a and 2,200 mg/d for adolescents 9 to 13 reference body weight would have to be a. Need to update the DRV—The DRV years old. The UL is not intended to be selected. Although we could use the for sodium is 2,400 mg (§ 101.9(c)(9)). a recommended intake level to EER predictive equations included in New scientific data and consensus encourage, but rather a level not to the IOM’s DRI macronutrient report reports on sodium published since the exceed. (Ref. 50) to determine a reference body 1993 final rule (58 FR 2206 at 2224) The IOM stated that the UL may be weight, these values may be highlight the need to reconsider the lower than 2,300 mg/d among certain inappropriate for the general U.S. DRV. Recent key consensus reports and groups who are at increased risk of the recommendations that FDA reviewed in population, which has a high percentage blood pressure-raising effects of reconsidering the DRV are as follows: of overweight individuals. The IOM increased sodium intake (e.g., older i. IOM DRI Report. In Labeling Report stated that deriving a individuals, African Americans, and 2005, the IOM established AIs and ULs individuals with hypertension, chronic label reference value for protein based for sodium (Ref. 10). The IOM found on values from the EER predictive kidney disease, or diabetes), but that data from dose-response trials for insufficient data prevented IOM from equations may not be appropriate for determining the daily requirement for large segments of the North American defining a specific UL for these groups. sodium were insufficient to establish an Instead, the IOM set the same UL for population for the same reason (Ref. 25). EAR for sodium and, thus, an RDA Therefore, we tentatively conclude these population groups as the one for could not be determined and an AI was that the DRV for protein should the general population (i.e., 2,300 mg/ set. The AIs for sodium are intake levels d), with the acknowledgment that the continue to be based on 10 percent of that meet or exceed the daily nutrient calories. Accordingly, we are not actual UL for this group may be lower. requirement, i.e., the recommended ii. IOM Report on the Strategies to proposing to change the DRV of 50 g for daily average intake levels that are protein. Reduce Sodium Intake in the United needed to meet the sodium needs of States (IOM Sodium Strategies Report). F. Sodium most healthy and moderately active After considering current trends in individuals, are 1,500 mg/d for 1. Mandatory Declaration hypertension, sodium consumption, individuals 9 to 50 years, 1,300 mg/d for sodium content of the food supply, and FDA regulations require the individuals 51 to 70 years, and 1,200 existing strategies for sodium reduction, declaration of sodium content on the mg/d for individuals older than 70 years the IOM developed various strategies for Nutrition Facts label (§ 101.9(c)(4)). The and for children 4 to 8 years of age. AIs reducing dietary sodium intake to levels 2007 ANPRM did not ask any questions meet or exceed the intake levels recommended by the 2005 DGA. Among about the mandatory declaration of required to meet nutrient needs and various recommendations to sodium, but one comment that there is no benefit in consuming a Government Agencies, food recommended the declaration of sodium nutrient in excess of its AI. manufacturers, consumers, and other should remain mandatory because the Data available to the IOM showed stakeholders, the IOM recommended information can help consumers who that; (1) a carefully planned diet that that FDA adopt 1,500 mg as the DV for are concerned about sodium and salt provided an average of approximately sodium, given that sodium is an make appropriate food choices. 1,500 mg/d of sodium can meet essential nutrient and that, unlike in Americans 4 years and older consume recommended intakes of other nutrients; 1993 (58 FR 2206 at 2224), a reference an average of approximately 3,650 mg (2) 1,500 mg/d exceeds the levels of value of adequacy is now available (i.e., sodium/d (NHANES 2003–2006), which sodium intake that have been associated the AI of 1,500 mg/d). is more than twice the amount required with effects of inadequacy, such as iii. 2010 DGA. The 2005 DGA made to meet their adequate intake (1,500 mg/ adverse effects on blood lipid a key recommendation for the general day for individuals 9 to 50 years old). concentrations and resistance; U.S. population to consume less than Evidence continues to support the and (3) 1,500 mg/d allows for sodium 2,300 mg/d of sodium and that association between increased sodium sweat losses in acclimatized individuals individuals with hypertension, African- consumption and increased blood who are exposed to high temperatures Americans, and middle-aged and older pressure. In 2005, the IOM noted the or who become physically active. The adults should aim to consume no more direct relationship between sodium AI does not apply to individuals who than 1,500 mg/d of sodium (Ref. 36). In intake and increased blood pressure are highly active and workers who are 2010, the DGAC evaluated evidence (Ref. 10). The 2010 DGAC and the 2013 exposed to heat stress that lose large considered in the 2005 DGAC report in IOM committee on Sodium Intake in volumes of sodium in sweat (Ref. 10). addition to new research on the Populations (Ref. 87) concluded that a ULs are the highest level of daily relationship between sodium intake and strong body of evidence has been nutrient intake that is likely to pose no blood pressure, focusing on the strength documented in adults that as sodium risk of adverse health effects to almost of the scientific evidence (Ref. 30). The intake decreases, so does blood pressure all individuals in the general population 2010 DGAC report noted that 1,500 mg/ (Ref. 30). We agree with the comment (Ref. 10). The major adverse and dose- d should be the intake goal for the

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general U.S. population. Further, the most protective. In this proposed rule, within a subgroup. Subgroups that have DGAC noted that, given the current U.S. we are responding to the petition’s been reported to have a high prevalence marketplace and the resulting request to reduce the DRV for sodium of salt sensitivity include individuals 51 excessively high sodium intake, it will from 2,400 mg to 1,500 mg. The years of age and older, African be challenging to achieve the lower petition’s other requests are outside the Americans, and individuals with level. The 2010 DGA, considering the scope of this rulemaking. hypertension, diabetes or chronic 2010 DGAC conclusions, recommended c. Comments to 2007 ANPRM—In the kidney disease. The 2010 DGA a reduction in sodium intake to less 2007 ANPRM, we asked whether a new recommended that Americans reduce than 2,300 mg/d and a further reduction DV for sodium should be based on the sodium intakes and also noted that to 1,500 mg/d among African UL or on the AI. We also asked whether these population subgroups, Americans, individuals with the UL, were it to be used, should reflect representing nearly half of the U.S. hypertension, diabetes, or chronic the same approach (population- population, would benefit from even kidney disease, and individuals ages 51 weighted or population-coverage) as the greater reductions in sodium intake than years or older. other DRIs. While a few comments the general population. We have iv. IOM Report on Sodium Intake in supported retaining the current DRV of considered the challenges related to Populations, Assessment of Evidence, 2,400 mg, the majority of comments lowering the DV for sodium. For 2013 (Ref. 87). The charge to the supported using the UL of 2,300 mg/d. example, lowering the value on which committee focused on literature Some other comments recommended the percent DV declaration is based published since 2003, therefore they setting a DV for sodium based on the AI would likely require efforts to ensure reviewed literature between 2003 and of 1,500 mg/d. One comment urged that consumer understanding of the new 2012. The committee assessed the we adopt a tiered two-phase, step-down percent DV declaration of sodium on the benefits and adverse outcomes (if any) approach establishing an interim DRV of Nutrition Facts label. Based on recent of reducing sodium intake, particularly 2,000 mg in 2013 and a final revised dietary recommendations from in the range of 1,500 to 2,300 mg/d, with DRV of 1,500 mg by 2020. See also (Ref. consensus reports, currently available an emphasis on the subgroups known to 47). scientific evidence, comments in be at increased risk of the blood d. Options Considered—When the response to the 2007 ANPRM, and the pressure-raising effects of increased Nutrition Facts label was developed in 2005 CSPI petition, we considered the sodium intake. Based on the review of the early 1990s, no RDA or Estimated following options for updating the DV studies that assessed cardiovascular Safe and Adequate Daily Dietary Intake for sodium: events and mortality, the committee (ESADDI) levels were available for (1) A DRV of 2,300 mg which reflects found that evidence from studies on consideration. While the National the UL for individuals aged 14 years and direct health outcomes is inconsistent Academy of Sciences established 500 older; and insufficient to conclude that mg/d as an estimated minimum (2) An RDI of 1,500 mg which reflects lowering sodium intakes below 2,300 requirement for healthy adults in 1989, the AI for individuals 9 to 50 years of mg/d will increase or decrease the risk the Agency relied on the age; and of CVD outcomes or all-cause mortality recommendation from 1989 National (3) Alternative approaches such as in the general U.S. population. The Research Council Report Diet and retaining a DRV of 2,400 mg, using a committee also concluded that the Health: Implications for Reducing tiered approach or setting a DRV of evidence from direct health outcomes Chronic Disease Risk (Ref. 88) that 1,900 mg based on the UL for children does not support recommendations for provided a quantitative intake 4 to 9 years of age. subgroups (people with diabetes, recommendation for salt, based on i. DRV of 2,300 mg/d. A DRV of 2,300 chronic kidney disease and pre-CVD) to blood pressure, that was equivalent to mg, which represents the UL for the lower their sodium intake to or even 2,400 mg/d as a value that consumers majority of the population (persons 14 below 1,500 mg/d. No relevant evidence should not exceed (58 FR 2206 at 2223, years of age and older), would be was found on health outcomes for the 2224). There is debate in the scientific consistent with both the 2005 and 2010 other population subgroups considered community about the appropriate DV DGA recommendations for sodium (i.e., African Americans and persons 51 for sodium, taking into account its intake for the general population, as years of age and older). essentiality in relatively small amounts well as the 2013 IOM report on Sodium b. CSPI petition—In 2005, we as well as its association with increased Intake in Populations. However, while a received a citizen petition from CSPI blood pressure at greater but varying DRV of 2,300 mg would reflect the UL (2005 CSPI petition) requesting, among levels of intake. that is applicable to 88 percent of the other sodium related issues, that FDA Current recommendations recognize U.S. population, including those who initiate rulemaking to reduce the DRV the benefits of reduced sodium intake in are susceptible to the blood pressure- for sodium from 2,400 to 1,500 mg the general population, despite the raising effects of sodium, it would (Docket No. FDA–2005–P–0196 heterogeneity among individuals in exceed the UL for children 4 to 13 years (formerly Docket No. 2005P–0450)) blood pressure responses to changes in of age which is 1,900mg/day for (http://www.regulations.gov/ sodium intake. Although several factors children 4–8 years of age and 2,000mg/ #!docketDetail;D=FDA-2005-P-0196). influence inter-individual variability in day for children 9–13 years of age. Citing the 2005 DGA, the petition blood pressure responses to changes in Setting the DV at 2,300 mg would requested that FDA adopt a DV of 1,500 dietary sodium, certain population classify the level as a DRV (rather than mg because that is the recommended groups have been reported to have a an RDI) and represent a reference intake maximum intake for roughly one-half of higher prevalence of salt sensitivity and level not to exceed. As such, it would the adult population (i.e., people with are considered to be most at risk of be consistent with our current and hypertension, African-Americans, and sodium-related chronic disease. Salt proposed approach to using DRVs for middle-aged and older people). sensitivity is the extent of change in other nutrients that should be limited in According to the petition, when blood pressure in response to a change the diet and for which there are recommended intake levels vary among in salt intake (Ref. 10). Salt sensitivity concerns of excess intake and risk of population groups, FDA has typically differs among subgroups of the chronic disease or health-related been conservative, choosing a DV that is population as well as among individuals conditions, for example, saturated fat

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and cholesterol. The current and for which AIs are established (e.g., therefore is a consideration in our proposed DRVs for saturated fat and vitamin K and choline) (see section II.I.). proposal. cholesterol are based on quantitative AIs are similar to RDAs in that they ANPRM comments pointed out intake recommendations and underlying meet the needs of essentially all challenges related to the feasibility of science that links the excess intake of members of the population. Thus, using achieving a DV of 1,500 mg given the these nutrients to specific adverse an AI as a quantitative intake current marketplace and patterns of health effects (Ref. 6) (see sections II.B.2 recommendation for setting an RDI sodium consumption as well as changes and II.C.). We do note, however, that would be consistent with the proposed in our nutrient content claims. If we unlike saturated fat and cholesterol, RDIs for other essential minerals that were to adopt a DV of 1,500 mg, we sodium is an essential nutrient and, in have AIs or RDAs, such as potassium anticipate that consumer education the DRI Electrolytes report, the IOM and calcium. Traditionally, we have efforts would be needed to help established an AI for sodium. based the RDI for essential nutrients on consumers understand that the updated Results from the FDA Health and Diet quantitative intake recommendations DV for sodium is a level to achieve Surveys have shown that consumers are that reflect the intake level necessary to rather than a level to consume less than aware that too much sodium is meet the daily physiological needs for and also that consuming in excess of unhealthy (Refs. 39 to 41) and this that nutrient. However, unlike the this level would not be helpful. awareness would suggest consumer consumption of other vitamins and Additionally, the IOM set the AI, in acceptance of a DV based on a level not minerals, the majority of the population part, at a level that would allow to exceed would be consistent with a consumes sodium at levels that exceed individuals to meet the recommended DRV of 2,300 mg. Changing the DRV the AI and the UL. This makes sodium intakes of other nutrients if they from 2,400 mg to 2,300 mg would likely unique in comparison to other vitamins adopted a carefully planned diet (Ref. result in less consumer confusion than and minerals for which people generally 10) and consumer education efforts changing the DRV to an RDI (a level to must strive to meet their daily needs. would need to communicate that 1,500 achieve) of 1,500 mg. Moreover, we In addition, an RDI of 1,500 mg would mg/d is a level that consumers should have no data to suggest that lowering be consistent with the 2010 IOM achieve rather than not exceed. While the reference value for the percent DV Sodium Strategies Report (Ref. 89). The the Agency is considering ways to could result in consumer confusion, as IOM recommended that FDA base the support the reduction of sodium in the claimed by a commenter (Ref. 47). DV for sodium on the AI of 1,500 mg/ food supply (76 FR 57050), significant ii. RDI of 1,500 mg. An RDI of 1,500 d. First, the IOM stated that using the AI changes in the food supply would be mg, based on the highest AI (i.e., among is consistent with the approach used for needed to achieve this goal. adults aged 19 to 50 years), would all other essential nutrients, where the An updated DV for sodium based on provide a daily average intake level that DV is based on a reference value of 1,500 mg/d would perhaps necessitate would reflect a low prevalence of adequacy rather than a reference value revising other relevant regulatory inadequate sodium intakes of healthy of safety. Second, although consumer requirements such as nutrient content and moderately active individuals while data were not provided, the IOM claims, however such revisions would allowing for adequate intakes of other strategies report argued that the use of be less likely if the DV was updated to essential nutrients. As opposed to 2,300 the AI could better inform consumers of 2,300 mg. Previously, our decision to mg, a DV of 1,500 mg would classify the the actual contribution of sodium retain the sodium level for a ‘‘healthy’’ level as an RDI representing a reference content to total sodium needs as an claim (§ 101.65) at 480 mg/reference intake level to achieve. The 2005 IOM essential nutrient. Third, the IOM stated amount customarily consumed (RACC) electrolytes report reviewed the that adopting the AI would avoid was based, in part, on technological evidence on low sodium intake and misleading consumers into thinking that barriers and product acceptance issues blood lipid concentrations and insulin the sodium content of foods is more by consumers with the more restrictive resistance and noted that the AI of 1,500 favorable than is actually the case. As level of 360 mg/RACC (70 FR 56828; mg/d exceeds the levels of sodium such, from a public health perspective, September 29, 2005). We acknowledge intake (typically less than 700 mg/d) the AI would provide a truer picture for concerns from comments that that have been associated in some the consumer of the contribution of the consumers may find it difficult to studies with adverse effects of blood particular foods in assembling a reduce dietary sodium levels to 1,500 lipid concentrations and insulin healthful diet and is preferable for this mg/d. resistance (Ref. 10). The 2005 IOM purpose over the UL. Finally, the IOM iii. Alternative approaches. electrolytes report reviewed the opined that lowering the DV might act A few comments suggested retaining evidence for plasma renin and as an incentive for companies to reduce 2,400 mg as the DRV for sodium. concluded that, in contrast to blood the sodium content of their foods Retaining the DRV of 2,400 mg would pressure, there is no consensus on the because reducing the DV would result exceed the UL for sodium for the entire interpretation of plasma renin activity in a higher value of percent DV declared population and there is no scientific and its role in guiding therapy for high on the label if sodium content remained evidence to support this level. blood pressure (Ref. 10). Similar to unchanged. Therefore, we do not consider 2,400 mg plasma renin activity, the evidence for The 2013 IOM Sodium Intake in an appropriate DRV for sodium going the role of sympathetic activity Populations Committee concluded that forward. Also, based on ANPRM and aldosterone is limited, and therefore the evidence was insufficient and comments, we considered setting an neither is recognized as surrogate inconsistent to recommend sodium interim DRV of 2,300 mg that would be endpoints for CVD risk. Therefore, the intake levels below 2,300 mg/d for the further lowered to an RDI of 1,500 mg AI of 1,500 mg/d exceeds the levels general U.S. population based on the over time, providing companies a longer associated with low sodium intake and direct outcomes of CVD or all-cause time to manufacture new foods or the previously discussed adverse effects. mortality. While this recommendation reformulate existing products to lower Using the population-coverage AI to does not address blood pressure or the sodium content. This approach set the RDI for sodium would be essentiality, it provides a level that the would address concerns regarding the consistent with the proposed RDIs for general population should seek to feasibility of individuals being able to other essential vitamins and minerals reduce their consumption to and meet an RDI of 1,500 mg given taste

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preferences and sodium content of foods 2,300 mg would be consistent with our fluoride in bottled water and dental in the current marketplace. A tiered current and proposed approach for other caries was submitted to us under section approach would help to gradually nutrients that should be limited in the 403(r)(2)(G) of the FD&C Act (Ref. 91). achieve the adequate intake level of diet and for which there are concerns of We did not object to the notification, 1,500 mg/d and would give excess intake and risk of chronic disease indicating that we considered the manufacturers time to develop lower and health-related conditions. Third, evidence submitted to be sufficient for sodium products and for consumers to consumers are generally aware that too bottled water that meets the standards of adjust their taste preferences. In much sodium is not healthy and identity and quality set forth in addition, this approach would be therefore the current consumer § 165.110 and the general requirements consistent with the 2010 DGAC education messaging is consistent with for health claims in § 101.14 to bear the recommendations which suggested that a DRV of 2,300 mg. claim (Ref. 91). Given that the positive reduction in sodium intakes to 1,500 For the reasons explained previously, health effects of fluoride are well- mg/d among Americans should occur we tentatively conclude that a DRV of established, we tentatively conclude gradually over time to allow for 2,300 mg for sodium is the most that declaration of fluoride content of a adjustments in taste perceptions and to appropriate DV to assist consumers in food can provide consumers with accompany changes in the sodium maintaining healthy dietary practices information to assist them in content of foods in the marketplace. and in understanding the relative maintaining healthy dietary practices. We tentatively conclude that there is significance of the sodium content However, as discussed in section II.G.2., inadequate justification in consensus within the context of a total daily diet. a DRV cannot be established based on reports or arguments presented by We invite comment on our available quantitative intake comments (Ref. 47) to propose a tiered consideration of various options and recommendations. Thus, while fluoride option. While levels of sodium intake tentative conclusions presented in this is a nutrient with public health may need to decrease gradually due to section. In particular, we invite significance, an appropriate quantitative time needed for modifications to the comment on: (1) The rationale for the intake recommendation is not available sodium content of the food supply and proposed DRV of 2,300 mg of sodium; for setting a DRV. consumer taste preferences, the DV for (2) whether an RDI of 1,500 mg would Therefore, consistent with the factors sodium should reflect an amount that be more appropriate and why; and (3) we consider for declaration of non- will assist consumers in maintaining whether any alternative approaches for statutory nutrients discussed in section healthy dietary practices and in selecting a DV for sodium and their I.C., we are proposing to amend understanding the relative significance public health bases for these approaches § 101.9(c)(5) to provide for voluntary of the percent DV for a particular food could be more appropriate and why. We declaration of fluoride. In addition, in the context of the total daily diet. are also interested in data and factual consistent with existing provisions for Moreover, DVs are based on scientific information on consumer voluntary declaration of other nutrients, data supporting healthy dietary understanding, interpretation, and use we are proposing that the declaration of practices, not on the levels of a nutrient of the percent DV of sodium declared on fluoride would be mandatory when a present in the food supply. food labels, including the understanding claim about fluoride is made on the We also considered using 1,900 mg/d, and potential influences of a DV that label or in labeling of foods. We are also the UL for children 4 to 8 years of age, reflects an RDI based on an AI (an intake proposing that when fluoride content is to set the DRV for sodium. Using the level to not consume less of), instead of declared, it must be expressed as zero lowest UL for a population above 4 a DRV based on a UL (an intake level when a serving contains less than 0.1 years of age is consistent with the not to exceed). mg of fluoride, to the nearest 0.1 mg population-coverage approach increment when a serving contains less discussed in section II.1.5. In this case, G. Fluoride than or equal to 0.8 mg of fluoride, and it is a population-coverage approach 1. Voluntary Declaration the nearest 0.2 mg when a serving that is protective for the age and gender contains more than 0.8 mg of fluoride, subpopulation with the lowest relative FDA regulations do not require or consistent with how we have UL, providing an intake level that is permit the declaration of fluoride on the approached incremental values for other likely to pose no risk for any age or Nutrition Facts label. In 1993, no U.S. nutrients that are present in food in gender subpopulations. This is in consensus report had set a quantitative small amounts. contrast to the population-coverage intake recommendation for fluoride. approach, using the RDA or AI for other The 2007 ANPRM did not ask questions 2. DRV essential vitamins and minerals, to regarding the declaration of fluoride, but FDA regulations do not provide an ensure that all age and gender several comments supported the RDI or DRV for fluoride. The 2007 subpopulations consume adequate voluntary declaration of fluoride in mg ANRPM discussed the DRIs for fluoride amounts. However, a DRV of 1,900 mg or mcg amounts (Ref. 47). We are and asked whether we should establish is not aligned with any considering in this proposed rule a DV, given the availability of an AI. We recommendations from consensus whether fluoride should be required or considered current recommendations reports including the 2010 IOM Sodium permitted to be declared or whether the and scientific evidence as well as Intake in Populations and was not lack of provisions should be comments received (Ref. 47). suggested by any comments. maintained. In 1997, the IOM established DRIs e. Proposed DV—After considering Fluoride is a nonessential nutrient, (AIs and ULs) for fluoride (Ref. 90). The the options discussed previously, we are but there is well established evidence AI was set at 3 mg/d for women 19 years proposing to set a DRV of 2,300 mg for for the role of fluoride in reducing the and older and 4 mg/d for men 19 years sodium based on the UL for individuals risk of dental caries (Ref. 90). The IOM or older, to represent the intake value ages 4 years of age and older (proposed set a quantitative intake that reduces the occurrence of dental § 101.9(c)(8)(iv)). First, a DRV of 2,300 recommendation for fluoride based on caries maximally in a group of mg would be consistent with the current its role in the reduction of risk of dental individuals without causing unwanted sodium intake recommendations from caries. Additionally, in 2006, a FDAMA . AIs for children are 0.7 mg/ consensus reports. Second, a DRV of notification for a health claim for d (1 through 3 years), 1 mg/d (4 through

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8 years), and 2 mg/d (9 through 13 H. Essential Vitamins and Minerals of national survey data on nutrient intake, years). In addition, the IOM set a UL for Public Health Significance and/or, when available, biomarkers of fluoride at 10 mg/d (0.1 mg/kg/d) for In addition to sodium, a statutorily nutrient status, provide evidence of individuals older than 8 years, based on required nutrient, FDA regulations inadequate intakes in the general data that suggest that increased risk of require the declaration of four essential healthy U.S. population (4 years of age developing early signs of skeletal vitamins and minerals, namely, vitamin and older). Furthermore, we consider fluorosis is associated with fluoride A, vitamin C, calcium, and iron whether a substantial prevalence exists intakes greater than 10 mg/d. The UL for (§ 101.9(c)(8)(ii)). Vitamins and minerals in the general population of a chronic children 4 through 8 years is 2.2 mg/d that may be declared voluntarily are disease, health-related condition, or based on risk of developing moderate vitamin D, vitamin E, vitamin K, nutrient deficiency with clinical enamel fluorosis. vitamin B , vitamin B , thiamin, significance that was linked to the A recent report highlighted the 6 12 riboflavin, niacin, folate, biotin, particular nutrient (e.g., potassium and potential adverse impact of excess risk of high blood pressure). pantothenic acid, phosphorus, iodine, fluoride intake (Ref. 92). These adverse To estimate the prevalence of nutrient magnesium, zinc, selenium, copper, impacts include moderate enamel adequacy or inadequacy in the U.S. manganese, chromium, molybdenum, fluorosis in children up to 8 years and population, we compared dietary intake skeletal fluorosis for individuals older chloride, and potassium. In 1993, we data with the EAR or AI (whichever is than 8 years. In 2010, the Environmental identified vitamins A and C, calcium, established by the IOM for a particular Protection Agency (EPA) published a and iron for mandatory declaration nutrient) (Ref. 96) and, when reliable report on exposure of fluoride from because we considered them to be biomarkers of nutritional status were various sources. This report provided a nutrients of public health significance available, we compared the biomarker benchmark of no more than 0.08 mg/kg/ based on their inadequate dietary survey data with the data on adequacy d of total fluoride intake to protect 99.5 intakes among specific segments of the of nutrient intake. The use of reliable percent of the population from severe U.S. population and because they were status biomarker data provides dental fluorosis (Ref. 92). These identified as nutrients of potential assessments of nutrient status, benchmark levels (e.g., 1.68 mg/d for 4 public health significance in consensus independent of subjective factors to 7 years; 2.56 mg/d for 7 to 11 years; reports (Refs. 88, 93 to 95) (58 FR 2079 associated with assessing nutrient 4.08 mg/d for 11 to 14 years of age; and at 2106). We continue to consider, intake, such as underreporting of food 5.6 mg/d for adults) are considerably consistent with the rationale put forth in intake (Ref. 97 pp. 373, 513, 534, 602, lower than the ULs set by IOM in 1997. 1993, that a vitamin or mineral’s public and 606). In the 2007 ANPRM, we Thus, although the IOM set AIs for health significance should be the key sought input on whether vitamin A, fluoride based on its role in reducing factor in mandatory labeling (58 FR vitamin C, calcium, and iron are still the risk of dental caries, more recent 2079 at 2106). considered to be of public health conclusions have highlighted concern In this section of the proposed rule, significance; and (2) whether there are about dental fluorosis associated with we discuss essential vitamins and other micronutrients of public health excess intakes. Because an RDI of 4 mg, minerals that are not expressly required significance. We received several using the population-coverage AI of 4 to be declared by statute (referred to as comments in response to these mg/d, exceeds or is equivalent to EPA’s ‘‘non-statutory’’). We are using our questions (Ref. 47). benchmark values for children 4 to 14 discretion, as described in this Based on our analysis of data, and years of age (1.68 to 4.08 mg/d), we are document, to propose mandatory considering the factors for mandatory not proposing to set a DRV for fluoride. declaration of certain non-statutory and voluntary declaration discussed in We considered concerns expressed by essential vitamins and minerals and section I.C. and the comments received, comments that a DRV should not be voluntary declaration of others. Our as discussed in this document, we are established because fluoride is not an tentative conclusions are based on an proposing to: (1) With respect to essential nutrient. That fluoride is not assessment of scientific data available essential vitamins and minerals that are essential is not, in itself, a justification for these nutrients, and consideration of currently required to be declared, retain for not establishing a DV for fluoride, the factors discussed in section I.C. mandatory declaration of calcium and because there is evidence demonstrating (explained in this document). The RDIs iron and provide for voluntary that dietary fluoride exposure is that we are proposing for the declaration declaration of vitamins A and C; and (2) beneficial to public health owing to its of vitamins and minerals are discussed with respect to essential vitamins and ability to inhibit the development of in section II.I. minerals that are permitted to be dental caries in both children and adults We conducted an analysis of available declared, require the declaration of (Ref. 90). However, we are not data to determine the public health potassium and vitamin D and retain proposing to set a DRV for fluoride for significance of non-statutory essential voluntary declaration of others. We other reasons as explained previously. vitamins and minerals. The 2010 DGA discuss these proposed changes in this We also do not consider that the DRV identified nutrients of public health document. for fluoride should be set at zero concern for the general U.S. population because of concerns with adverse health using criteria that are similar to factors 1. Essential Vitamins and Minerals That effects and toxicity, as suggested by a that FDA considered in its own analysis Are Mandatory comment. The IOM established an AI (Ref. 6). The factors and the evaluation a. Calcium—Calcium content must be for fluoride based on risk reduction of process used in our analysis, discussed declared as a percent DV on the dental caries. In addition, the ULs for in greater detail in Ref. 48, incorporate Nutrition Facts label (§ 101.9(c)(8)(ii)). children and adults that are set based on whether a DRI (i.e., RDA or AI) is based In 1993, we required the declaration of dental and skeletal fluorosis are greater on a chronic disease risk (e.g., calcium in nutrition labeling because: than zero. Moreover, FDA regulations osteoporosis), a health-related condition (1) There were a limited number of other than those related to nutrition (e.g., high blood pressure), or a nutrient calcium-rich foods in the food supply; labeling are intended to prevent deficiency with clinical significance (2) calcium intakes in the United States excessive addition of fluoride in foods (e.g., low iron storage leading to iron were generally marginal; (3) adequate (§§ 165.110 and 170.45). deficiency anemia) and whether calcium intakes are needed to allow for

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optimal bone mass development during In addition, we independently Serum ferritin is the major iron-storage childhood and young adulthood (55 FR reviewed data related to calcium intake compound and its concentration 29487 at 29501); and (4) calcium was and risk reduction of osteoporosis declines in the early stages of the identified as a nutrient of public health (§ 101.72) and authorized two health development of iron deficiency (Refs. significance in the 1990 IOM report claims for this association, signifying 100 and 101). Although low serum (Ref. 95) and in other consensus reports calcium’s critical role in the reduction ferritin concentration is an indicator of (Refs. 88,93,94) (58 FR 2079 at 2106). In of risk of this chronic disease in the early iron deficiency, it does not response to the 2007 ANPRM, many general healthy population. necessarily reflect the severity of iron comments maintained that calcium is In view of the benefits of adequate depletion as it progresses (Ref. 101). In still considered a nutrient of public calcium intake on bone health, reflected addition to determining serum ferritin, health significance, especially in bone in the IOM’s DRIs, relatively low intakes when relevant NHANES data were development, and therefore should be of calcium, and the high prevalence of available, we also considered iron retained as a mandatory nutrient on the osteoporosis and osteopenia among the deficiency based on estimating stored Nutrition Facts label. U.S. population, we tentatively body iron using the ferritin model and Our analysis of NHANES (2003–2006) conclude that calcium is a nutrient of the body iron model (Ref. 102). data shows that usual calcium intakes public health significance and its Compared to the ferritin model, the among the U.S. population continue to declaration continues to be necessary to body iron model is reported to produce be low. About 49 percent of individuals assist consumers in maintaining healthy lower estimates of prevalence of iron ages 4 years and older have usual dietary practices. Therefore, consistent deficiency, better predict anemia, and calcium intakes from conventional with the factors we consider for be less affected by , foods below the EAR, and 37 percent mandatory declaration of non-statutory although this model has some have intakes from both conventional nutrients (see section I.C.), we are not limitations (Ref. 103). Data from foods plus supplements below the EAR proposing any changes to the current NHANES 1999–2002 for the general (table 1). The 2010 DGA, too, recognized requirement for declaration of calcium U.S. population showed a prevalence of that low intakes of calcium are a public on the Nutrition Facts label, as specified iron deficiency, based on serum ferritin health concern for the general U.S. in § 101.9(c)(8)(ii). concentration (less than 15 nanograms population (Ref. 6). We are unable to b. Iron—Iron must be declared as a (ng)/mL), body iron stores (based on the consider biomarker data because percent DV on the Nutrition Facts label ferritin model), and iron deficiency sensitive biochemical indicators (§ 101.9(c)(8)(ii)). In 1993, we required anemia (defined as having iron reflecting calcium nutritional status are the declaration of iron because (1) iron deficiency and a low value) lacking. was identified as a nutrient of public of 8.3, 6.5 and 1.9 percent, respectively In setting DRIs for calcium, the IOM health significance in a 1990 IOM report (table 1). The IOM set age and gender reviewed various endpoints (e.g., bone (Ref. 95) and in other consensus reports specific DRIs (EARs and RDAs) based on health, cancer, cardiovascular disease (Refs. 88,93,94); and (2) iron deficiency factorial modeling, which included and diabetes), and bone health was the was a risk for certain segments of the basal iron losses, menstrual losses, fetal only endpoint with sufficient evidence U.S. population (i.e., young children, requirements in , increased to set a DRI (Ref. 22). Therefore, the IOM adolescents and women of childbearing requirements during growth for the set age- and gender-specific DRIs based age and pregnant women, especially expansion of blood volume, and/or on the level of calcium intake consistent those with low incomes) (58 FR 2079 at increased tissue and storage iron (Ref. with bone accretion, achieving and 2106). In response to the 2007 ANPRM, 100). Although the DRIs were not based maintaining bone calcium balance, comments suggested retaining the directly on a chronic disease risk, iron minimizing the degree of bone loss, and mandatory declaration of iron because it reducing the risk of fracture in later is a nutrient of concern for women of deficiency and low iron stores over time stages of life (Ref. 22). The DRIs for childbearing age identified by the 2005 will lead to iron deficiency anemia, an calcium assume adequate intakes of DGA (Ref. 36) and substantial numbers advanced stage of iron deficiency (Ref. vitamin D, a nutrient which is essential of adolescent females and women of 100). Anemia is associated with poor for promoting calcium absorption in the childbearing age are iron deficient. cognitive function, lower work gut and for maintaining adequate Our analysis of NHANES (2003–2006) performance, and low endurance in the calcium levels in the blood (Ref. 22). intake data shows that about 3.5 percent general population; delayed Building strong bones during childhood of the population ages 4 years and older psychomotor development in infants; and adolescence can help prevent (excluding pregnant and lactating and adverse pregnancy outcome (Ref. osteoporosis (the most common bone women) have inadequate iron intakes 100). disease) later in life. Adequate calcium from conventional foods (i.e., an intake Relevant biomarker data were intakes are needed to allow for optimal below the EAR), and about 3.3 percent available from NHANES 2003–2006 for bone mass development during have inadequate iron intakes from certain subpopulations such as women childhood and young adulthood and to conventional foods and dietary of childbearing age (12 to 49 years old). decrease rate of bone loss in adults (Ref. supplements (table 1). Subpopulation Analyses of these data showed that 22). An estimated 10 million Americans analyses of these NHANES 2003–2006 about 14 percent of women of over 50 years of age have osteoporosis, data shows that about 11.2 percent of childbearing age (12 to 49 years) had while another 34 million are at risk and women of childbearing age (12 to 49 serum ferritin concentration less than 15 an estimated 1.5 million people suffer years of age) continue to have intakes ng/mL, while 10 and 14.5 percent of an osteoporotic-related fracture each below the EAR, from conventional foods women had inadequate stores of body year (Ref. 98). Furthermore, based on only and 10.4 percent continue to have iron based on the body iron model or 2005–2006 NHANES data, about 5.3 intakes below the EAR from ferritin model, respectively (table 1). In million older men and women in the conventional foods plus dietary addition, about 4.7 percent of these United States have osteoporosis at the supplements (table 1). women had iron deficiency anemia. femur neck, and 34.5 million more have We also considered data for several Based on these prevalence rates, the osteopenia (low bone mass) in the femur status biomarkers related to iron absolute numbers of individuals with neck (Ref. 99). nutrition, in addition to intake data. iron deficiency in women of

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childbearing age using 2010 projected as a nutrient of concern (Ref. 36). Our carotenoids (i.e., a-carotene, b-carotene, U.S. Census data translate into 7.2 or analysis of intake data from NHANES and b-cryptoxanthin, which can be 11.6 million women of childbearing age 2003–2006 estimated that about 45 converted into vitamin A (retinol) in the (12 to 49 years of age) with inadequate percent of the general U.S. population body) in humans is to act as a source of iron stores based on body iron model or has usual vitamin A intakes from vitamin A in the diet (Ref. 18). ferritin model, respectively. About 3.76 conventional foods below the EAR, and Furthermore, there is no clear evidence million of these women are considered 34 percent have intakes from that suggests a protective association to have iron deficiency anemia. Thus, conventional foods plus dietary between dietary vitamin A or b-carotene iron continues to be of public health supplements below the EAR (table 1). and risk reduction of chronic diseases, significance among women of However, the prevalence of vitamin A such as cardiovascular disease and childbearing age and pregnant women, deficiency is not apparent. Only about (Ref. 105). In addition, evidence who account for 26 percent of the 0.3 percent of those ages 6 years and from large clinical trials suggests that b- general U.S. population. older (excluding pregnant and lactating carotene supplementation increases the Iron is also identified as a nutrient of women) have a serum retinol incidence of lung cancer in a high-risk public health significance in consensus concentration (a biomarker of vitamin A population (e.g., current or former reports. For example, Healthy People status) below 20 mcg/dL, a cutoff level smokers, asbestos workers) (Refs. 106 2020 identified iron as a nutrient of that is used as an indicator of vitamin and 107). Further, the IOM introduced public health significance among young A deficiency (table 1) (Refs. 6 and 105). mcg of RAEs (retinol activity children (1 to 4 years of age), women of Because serum retinol levels are tightly equivalents) as a new unit for childbearing age (12 to 49 years of age), regulated (homeostatically controlled) expressing vitamin A activity to account and pregnant women, and announced and do not always reflect total body for the reduced absorption for an objective of a ten percent reduction status, using serum vitamin A for provitamin A carotenoids, including b- in iron deficiency (using the body iron assessment of vitamin A status of carotene (Ref. 105). This new unit, model) by the year 2020 (Ref. 104). individuals may not be useful (Ref. 101). which would be the appropriate unit for Similarly, the 2010 DGA identified iron However, the distribution of serum declaring vitamin A on the Nutrition as a nutrient of concern among women retinol levels in a population plus the Facts label, takes into consideration capable of becoming pregnant and prevalence of individuals with serum vitamin A from all sources as well as the recommends choosing foods that supply retinol levels below a given cutoff point of b-carotene and other heme iron, which is more readily may offer a better picture of the vitamin provitamin A carotenoids (see section absorbed by the body, additional iron A status of a population (Ref. 101). II.J.3.). sources, and enhancers of iron Based on the analysis of distribution of Our analysis demonstrates that, even absorption such as vitamin C-rich foods serum retinol (NHANES 2003–2006), though vitamin A intakes appear to be (Ref. 6). and the prevalence of those below the low, vitamin A deficiency based on an Given the importance of the role of cutoff of 20 mcg/dL (0.3 percent), we assessment of vitamin A status is rare in iron in public health and continued estimated that the prevalence of vitamin the U.S. population. The IOM did not significance of inadequate intakes and A deficiency in the general U.S. set a quantitative intake deficiency among women of population is not apparent. recommendation for vitamin A based on childbearing age, a significant portion of The IOM recognized that vitamin A a public health endpoint. Thus, we the general healthy population, we deficiency is rarely seen in the healthy tentatively conclude that vitamin A is tentatively conclude that iron is a U.S. population (Ref. 105). Furthermore, no longer a nutrient of public health nutrient of public health significance the specific age and gender DRIs (EAR significance for the general U.S. and its declaration continues to be and RDA) set by the IOM were based on population. Therefore, consistent with necessary to assist consumers in the amount of dietary vitamin A the factors for declaration of non- maintaining healthy dietary practices. required to maintain adequate liver statutory nutrients (see section I.C.), we Therefore, consistent with the factors stores in well-nourished subjects, rather are proposing to amend 101.9(c)(8)(ii) to used for mandatory declaration of non- than on a specific adverse public health no longer require, but to permit statutory nutrients (see section I.C.), we endpoint (Ref. 105). The DRIs represent voluntary declaration of vitamin A on are not proposing any changes to the an amount that will assure vitamin A the Nutrition Facts label. However, current requirement for declaration of reserves to cover periods of increased vitamin A declaration would remain iron on the Nutrition Facts label, as needs such as stress and low vitamin A mandatory when vitamin A is added as specified in § 101.9(c)(8)(ii). intake (Ref. 105). In addition, the 2010 a nutrient supplement or claims are c. Vitamin A—Vitamin A must be DGA does not include vitamin A among made about it on the label or in labeling declared as a percent DV on the the list of nutrients of public health of foods. We are also not proposing to Nutrition Facts label (§ 101.9(c)(8)(ii)). concern for the general U.S. population change the current provision for In 1993, we required the declaration of (Ref. 6). voluntary declaration of the percent of vitamin A in nutrition labeling because We also considered whether any vitamin A that is present as b-carotene, (1) it was found in a limited number of changes are necessary to the provision as specified in § 101.9(c)(8)(vi). We foods within the food supply, and (2) a for voluntary declaration of the portion request comment about whether there is 1990 IOM labeling report (Ref. 95) of vitamin A activity derived from b- an appropriate alternative analysis to identified vitamin A as a nutrient of carotene, including whether its application of the factors in section I.C. potential public health significance and mandatory declaration is appropriate, as regarding the mandatory declaration of stated that certain subpopulations suggested by a comment. One comment vitamin A. (children under 5 years of age) were still noted that b-carotene intake, in d. Vitamin C—Vitamin C must be at risk of deficiency for this vitamin (58 particular, needs to be increased, but the declared as a percent DV on the FR 2079 at 2106). In response to the comment provided no further Nutrition Facts label (§ 101.9(c)(8)(ii)). 2007 ANPRM, several comments explanation. The IOM did not set DRIs In 1993, we required the declaration of recommended retaining the mandatory for b-carotene and other carotenoids due vitamin C because (1) a 1990 IOM declaration of vitamin A, with some to limited scientific data (Ref. 18). The labeling report (Ref. 95) identified noting that the 2005 DGA identified it only known function of provitamin A vitamin C as a nutrient of potential

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public health significance and stated capable of becoming pregnant choose concentrations above a defined level (40 that certain subpopulations were foods that are enhancers of iron to 50 nanomoles (nmol)/L) in order to considered at risk of deficiency (such as absorption, such as vitamin C-rich foods maintain bone health (Ref. 22). Vitamin elderly individuals on inadequate diets (Ref. 6). While we agree that vitamin C D has a role in bone health through and infants fed cow’s milk exclusively) enhances iron absorption, the calcium absorption and uptake by bones (58 FR 2079 at 2106), and (2) vitamin C prevalence of vitamin C deficiency in (Ref. 22). In addition, in 2008, we was thought to play a role in promoting this subpopulation is not apparent. Only authorized a health claim for calcium the intestinal absorption of non-heme about 6 percent of this subgroup had and vitamin D intake and reduced risk iron, meaning that vitamin C in the serum vitamin C concentrations below of osteoporosis (§ 101.72), signifying same food as iron was considered to 11.4 mmol/L (table 1). vitamin D’s critical role in the risk help prevent iron deficiency anemia, Based on the previous analysis and reduction of this chronic disease. while excess vitamin C was considered information, we tentatively conclude Vitamin D can be obtained through to increase the risk of excessive iron that while vitamin C intakes are low, dietary sources, such as fish (e.g., absorption (55 FR 29487 at 29501, July vitamin C deficiency is uncommon and salmon, rockfish, and ) and 19, 1990). In response to the 2007 vitamin C is no longer a nutrient of shellfish, which are the primary natural ANPRM about whether vitamin C is still public health significance for the food sources of vitamin D. FDA affirmed a nutrient of public health significance, general U.S. population. Therefore, certain uses of vitamin D food several comments recommended consistent with the factors we consider ingredients as Generally Recognized as retaining the mandatory declaration of for declaration of non-statutory Safe (GRAS) with specific limitations as vitamin C, with some stating that nutrients (see section I.C.), we are listed in § 184.1950. Under § 184.1(b)(2), vitamin C should be retained because it proposing to amend § 101.9(c)(8)(ii) to an ingredient affirmed as GRAS with is a nutrient of concern identified by the no longer require, but to permit specific limitations may be used in food 2005 DGA (Ref. 36), and is an enhancer voluntary declaration of vitamin C on only within such limitations, including of iron absorption for women of the Nutrition Facts label. However, the category of food, functional use, and childbearing age. vitamin C declaration would remain level of use. Any addition of the Our analysis of NHANES 2003–2006 mandatory when vitamin C is added as ingredient to food beyond the estimated that about 35 percent of the a nutrient supplement or claims are limitations set out in § 184.1950 general U.S. population has usual made about it on the label or in labeling requires either a vitamin C intakes below the EAR, from of foods. We request comment about regulation or an amendment of conventional foods only and 27.5 whether there is an appropriate § 184.1950. In this way, FDA can ensure percent have intakes below the EAR alternative analysis to the application of that the vitamin D ingredients are added from conventional foods and the factors in section I.C. regarding the to food at safe levels. For detail on supplements (table 1). While the mandatory declaration of vitamin C. estimating dietary intake of substances prevalence of inadequate intake is high, in food, see FDA’s Guidance for 2. Essential Vitamins and Minerals That prevalence of vitamin C deficiency is Industry: Estimating Dietary Intake of Are Voluntary not apparent in the U.S. population. Substances in Food (Ref. 109). Under Only about 6 percent of the general a. Vitamin D—The declaration of FDA regulations (§§ 172.380 (21 CFR population had serum vitamin C vitamin D content in nutrition labeling 172.380) and 184.1950), vitamin D can concentrations below 11.4 micromoles is voluntary, unless vitamin D is added be added in specific amounts to foods (mmol)/L, a cutoff level that is used as as a nutrient supplement or claims are such as breakfast , grain products an indicator of vitamin C deficiency made about it (§ 101.9(c)(8)(ii)). In 1993, and , fluid milks and milk (Ref. 97 p.534; Ref. 101). The EAR for we determined that vitamin D is not of products, and calcium-fortified juices. vitamin C is based on estimates of body particular public health significance in As for any vitamin or mineral, when pool or tissue levels of vitamin C that the United States because the human vitamin D is added to a food, the total are required for protection requirement for vitamin D could be met amount per serving must be declared in with minimal urinary loss, not on a with sufficient exposure to sunlight and the Nutrition Facts label. In addition to public health endpoint (Ref. 18). milk and other foods that were fortified dietary sources of vitamin D from The effects of vitamin C on risk of with vitamin D. As a result, deficiencies conventional foods and dietary chronic diseases, such as cardiovascular in this vitamin were very rare (58 FR supplements, vitamin D is synthesized disease or cancer, are not conclusive at 2079 at 2107). In response to the 2007 in the skin following direct exposure to this time (Ref. 18). We issued a letter of ANPRM about what, if any, other the sun. Therefore, sunlight exposure is enforcement discretion on qualified micronutrients are of public health an important source of vitamin D. health claims for vitamin C supplement significance, several comments Serum concentration of 25(OH)D is intake and reduced risk of cancers, in recommended vitamin D for mandatory widely considered as a biomarker of which we concluded that there was no declaration citing vitamin D total vitamin D nutritional status and is credible evidence on the risk reduction inadequacy; relationship of vitamin D to recommended to be used for assessing from vitamin C for most cancers chronic disease risk (e.g., rheumatoid vitamin D total exposure from all (squamous cell cancer of the esophagus, , multiple sclerosis, and cancers, sources, including conventional foods, colorectal, laryngeal, lung, oral cavity, such as prostate, breast, lung, colon, and dietary supplements, synthesis from pancreatic, pharyngeal, renal cell, and colorectal cancers); and the 2005 DGA, sun, and conversion of vitamin D from salivary gland cancers), and very limited which identified vitamin D as a nutrient adipose stores in liver (Ref. 22). Our evidence for an association between of concern for certain subpopulations analysis of NHANES 2003–2006 data vitamin C supplement intake and gastric (e.g., older adults, people with dark showed that about 18 percent of the U.S. cancer (Ref. 108). skin, and those exposed to insufficient population 4 years and older (excluding The 2010 DGA does not include band radiation) (Ref. 36). pregnant and lactating women) have vitamin C among the list of nutrients of The IOM set age and gender specific serum 25(OH)D levels below the 40 public health concern for the general DRIs (EAR and RDA) for vitamin D at a nmol/L (a level set by IOM as equivalent U.S. population (Ref. 6). However, the level that would achieve and maintain to EAR), which indicates an increased 2010 DGA recommends that women serum 25-hydroxy vitamin D (25(OH)D) risk of inadequate vitamin D exposure.

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NHANES data collection normally does Therefore, consistent with the factors level that would maintain blood not include serum levels in the northern we consider for mandatory declaration pressure, reduce the adverse effects of regions of the United States in the of non-statutory nutrients (see section intake on blood winter months, when one would expect I.C.), we are proposing to amend pressure, and reduce the risk of a lower serum vitamin D level. § 101.9(c)(8)(ii) to require the mandatory recurrent kidney stones (Ref. 21). Therefore, analysis of NHANES data declaration of vitamin D on the According to the CDC, about one out of may underestimate the prevalence of Nutrition Facts label. We request three U.S. adults has high blood low serum vitamin D levels in the comment about whether there is an pressure (Ref. 113). Unites States population. Analysis of appropriate alternative analysis to the In 2000, a FDAMA notification for a NHANES 2005–2008 dietary data application of the factors in section I.C. health claim about potassium, blood showed that, about 94 percent of the regarding the mandatory declaration of pressure, and stroke was submitted to us U.S. population have usual vitamin D vitamin D. under section 403(r)(2)(g) of the FD&C intakes below the EAR from b. Potassium—The declaration of Act (Ref. 114). We did not object to the conventional foods only and 62 percent potassium content is voluntary, except notification and this meant that have intakes below the EAR from when a claim is made about it manufacturers could include the conventional foods and supplements (§ 101.9(c)(5)). In 1993, potassium did following claim ‘‘Diets containing foods (table 1). The IOM set the DRIs (e.g., not meet our considerations for that are good sources of potassium and EAR) assuming minimal sun exposure inclusion as a mandatory element of low in sodium may reduce the risk of (Ref. 22). nutrition labeling because no high blood pressure and stroke,’’ on the Furthermore, approximately 24 quantitative intake recommendations label or labeling of any food that meets percent of the U.S. population ages 4 were available in national consensus the eligibility criteria described in the years and older have serum 25(OH)D reports (58 FR 2079 at 2095). In notification and meets the general concentrations between 30 and 50 response to our question in the 2007 requirements for health claims nmol/L, levels that indicate risk for ANPRM about what, if any, other (§ 101.14(e)(6)). Thus, we recognize the inadequacy according to the IOM and micronutrients are of public health importance of potassium in the risk CDC (Refs. 22 and 101). Approximately significance, several comments reduction of these chronic diseases. The 32 percent of the U.S. population have supported mandatory declaration of 2010 DGA also concluded that serum 25(OH)D levels below 50 potassium on the Nutrition Facts label potassium is a nutrient of concern for nmol/L (a level set by IOM as equivalent because the 2005 DGA identified it as a the general U.S. population (Ref. 6). to RDA and associated with optimal nutrient of concern (Ref. 36). One In view of the benefits of adequate benefit for nearly all the population) comment also pointed out that scientific potassium intake in lowering blood (Ref. 22). Also, about 8 percent have evidence from three meta-analyses of pressure, reflected in IOM’s DRIs, and serum 25(OH)D levels below IOM’s over 30 clinical trials shows that high data indicating low likelihood of cutoff of 30 nmol/L and may be at potassium intake is associated with potassium adequacy and high increased risk of . reduced blood pressure in non- prevalence of hypertension among the Vitamin D deficiency results in hypertensive and hypertensive general population, we tentatively inadequate bone mineralization or individuals (Refs. 110 to 112). conclude that potassium is a nutrient of demineralization of the Our analysis of data from NHANES public health significance for the including , osteomalacia, and 2003–2006 shows that the usual mean general U.S. population and its osteoporosis (Ref. 22). The 2010 DGA, intakes of potassium from conventional declaration is necessary to assist too, highlighted vitamin D as a nutrient foods only (2,644 mg/d) and from consumers in maintaining healthy of concern for the U.S. population, in conventional foods plus dietary dietary practices. Therefore, consistent general, rather than for specific supplements (2,651 mg/d) are below the with the factors we consider for population groups alone (Ref. 6). population-weighted AI of 4,622 mg/d. mandatory declaration of non-statutory We do not agree with some comments Where the mean usual intake is at or nutrients (see section I.C.), we are that suggested that vitamin D intake above the AI, we consider that there is proposing to amend § 101.9(c)(8)(ii) to should be mandatory on the label probably a low prevalence of nutrient require the mandatory declaration of because of its relationship to disease inadequacy in the population assessed. potassium. risk reduction, generally. The IOM did However, where the mean usual intake 3. Other Essential Vitamins and not set DRIs for vitamin D based on its is below the AI, the population’s Minerals protective effect against diseases, such prevalence of inadequacy cannot be as cancers, cardiovascular disease, and estimated (Ref. 96). Therefore, the Several other essential vitamins and diabetes, because the scientific evidence likelihood of nutrient inadequacy minerals, in addition to vitamin D and does not support a role other than that cannot be estimated. Only about 1.9 potassium, may be declared on the associated with bone health (Ref. 22). percent of the general population has Nutrition Facts label, i.e., vitamin E, In view of the benefits of adequate usual potassium intakes above the AI vitamin K, vitamin B6, vitamin B12, vitamin D intakes on bone health, from conventional foods only and 2.4 thiamin, riboflavin, niacin, folate, reflected in the IOM’s DRIs, data percent has intakes above the AI from biotin, pantothenic acid, phosphorus, indicating inadequate intakes, poor conventional foods plus dietary iodine, magnesium, zinc, selenium, vitamin D status, and high prevalence of supplements (table 1), indicating that copper, manganese, chromium, osteoporosis and osteopenia (discussed the adequacy of intakes is very low. In molybdenum, and chloride. In response previously in the calcium section, (Refs. the absence of a sensitive biochemical to the 2007 ANPRM about what, if any, 98 and 99) among the general U.S. indicator of potassium nutritional other micronutrients are of public population, we tentatively conclude that status, we could not consider biomarker health significance, several comments vitamin D is a nutrient of ‘‘public health data to inform the determination of recommended mandatory declaration of significance,’’ as described in section prevalence of potassium deficiency. these voluntarily declared essential I.C., and its mandatory declaration is However, the IOM set age- and gender- vitamins and minerals: Vitamin E, necessary to assist consumers in specific AIs for potassium based on risk folate, vitamin B12, magnesium, and maintaining healthy dietary practices. of chronic disease. The AI was set at a phosphorus. The reasons cited in

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comments included: (1) The 2005 DGA tentatively concludes that calcium, iron, key factor in mandatory labeling (58 FR identification of these nutrients as vitamin D and potassium are nutrients 2079 at 2106), the proposed vitamins nutrients of concern (Ref. 36); (2) the of public health significance and their and minerals of public health need to provide information to patients; declarations on the Nutrition Facts label significance (i.e., potassium, calcium, (3) the need to heighten consumer are necessary to assist consumers in vitamin D, and iron) and dietary fiber awareness; and (4) the intakes of these maintaining healthy dietary practices. (listed on the label as a nutrient to nutrients are inadequate in the U.S. Calcium is considered a nutrient of increase) do represent various food population or subpopulations (Ref. 47). public health significance due to the groups. For example, potassium is Based on FDA’s analysis of available benefits of adequate calcium intake on found in most food groups, especially data using the factors we consider for bone health, and the relatively low vegetables, fruits, and milk and milk mandatory and voluntary declaration of intakes of calcium and the high products. Milk and milk products non-statutory nutrients (see section I.C.) prevalence of osteoporosis and contribute substantially to calcium and comments received on essential osteopenia among the U.S. population. intake. Sources of heme iron include vitamins and minerals that are currently Iron is considered a nutrient of public lean meat, poultry and seafood, while voluntarily declared, we are not health significance due to the continued the non-heme sources of iron come from proposing any changes to the current inadequate intakes and deficiency plants foods, such as beans, and provisions for voluntary declaration (for (using relevant biomarker data) among . Although vitamin D is mostly detailed information and the analysis of women of childbearing age, who found in fortified foods in the United each of the vitamins and minerals see comprise a significant portion of the States, such as fluid milk and some milk Ref. 115). We reviewed data related to general healthy U.S. population. products (e.g., yogurt), its natural the intake and status of nutrients where Although the DRIs for iron were not sources include seafood. Dietary fiber is available standards allow for such based on a chronic disease risk, iron generally found in most fruits and calculations (table 1). Consistent with deficiency and low iron stores over time vegetables, whole grains and beans. the factors (see section I.C.), essential will lead to iron deficiency anemia, an The 2010 DGA recommends vitamins and minerals (with the advanced stage of iron deficiency. increasing the amount and variety of exception of potassium and vitamin D Anemia is associated with poor seafood in place of some meat and discussed previously) that are cognitive function, lower work poultry (Ref. 6). As mentioned, fish/ voluntarily declared should continue to performance, and low endurance in the seafood is the primary source of be permitted to be voluntarily declared general population; delayed naturally occurring vitamin D (Ref. 6). (Ref. 115). Therefore, we are not psychomotor development in infants; Data shows that fish/seafood only proposing any changes to the provisions and adverse pregnancy outcome. provides 9 percent of the total vitamin for voluntary declaration of vitamin E, Vitamin D is considered a nutrient of D intake in the United States (Ref. 116). vitamin K, vitamin B , vitamin B , 6 12 public health significance due to the Therefore, we tentatively conclude that thiamin, riboflavin, niacin, folate, benefits of adequate vitamin D intake on biotin, pantothenic acid, phosphorus, the proposed mandatory declaration of bone health, data indicating inadequate vitamin D on the label would allow iodine, magnesium, zinc, selenium, intakes and status (both from total copper, manganese, chromium, consumers to understand the relative exposure (serum data) and dietary significance of the contribution of molybdenum, and chloride. intake data), and the high prevalence of In addition, several comments vitamin D from natural food sources, in osteoporosis and osteopenia among the recommended mandatory declaration of addition to fortified foods, in the U.S. population. Adequate intake of choline, which is currently not context of the total daily diet and also vitamin D is essential for promoting permitted to be declared on the is necessary to assist consumers in calcium absorption in the gut and for Nutrition Facts label. Based on the maintaining healthy dietary practices. maintaining adequate calcium levels in factors we consider (see section 1.C.) We are not aware of any unintended the blood and thus promoting bone and comments that asked us to provide consequences of mandatory listing, in health. Potassium is considered a for its declaration on the Nutrition Facts general, of vitamins and minerals. We nutrient of public health significance label (Ref. 115), we tentatively conclude invite comment, including the due to the benefit of adequate intake of that the voluntary declaration of choline submission of data and information on potassium in lowering blood pressure, is consistent with the factors we whether the mandatory listing of reducing the adverse effects of sodium consider for voluntary declaration (table vitamins and minerals somehow chloride intake on blood pressure and 1) and, therefore, we are proposing to impacts practices. We reducing the risk of recurrent kidney permit the voluntary declaration of invite comment on the proposed stones, and due to data indicating a low choline on the Nutrition Facts label. mandatory declaration of vitamin D, likelihood of potassium adequacy and a potassium, calcium and iron on the 4. Summary high prevalence of hypertension among label, including how we consider the In summary, based on an analysis of the general U.S. population. public health significance of each. We the factors FDA considered (as Although we continue to consider, also invite comment on whether the described in section I.C.), comments consistent with our rationale put forth presence of these nutrients presents received, and other data and in 1993, that a vitamin or mineral’s concerns related to label space or the information set forth previously, FDA public health significance should be the need for consumer education.

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TABLE 1—PREVALENCE OF ADEQUACY AND INADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS FOR ESSENTIAL VITAMINS AND MIN- ERALS AMONG THE U.S. POPULATION, AGES 4 YEARS AND OLDER [Excluding pregnant and lactating women] 1

Usual nutrient intake 2 Status biomarkers

% above weighted AI 5 (mean Weighted % Below weighted EAR 4 Nutrients 3 intake) EAR/AI Biomarker cutoff % Below cutoff Food plus Food plus Food supplement Food supplement

Vitamins

Choline 460 mg (AI) ...... 10 (mean = 10 (mean = NA ...... NA (NHANES 311 mg). 312 mg). 2005–2008). Folate ...... 304 mcg DFE 8.7 ...... 7.3 ...... Serum folate < 2 ng/ 0 mL. RBC folate < 95 ng/ 0.26 mL Women 12–49 yrs Serum folate < 2 ng/ 0 mL RBC folate < 95 ng/ 0.36 mL Niacin 67 ...... 11 mg NE ...... 2.1 ...... 1.7 ...... NA ...... NA Riboflavin 67 ... 0.9 mg ...... 1.5 ...... 1.3 ...... NA ...... NA Thiamin 67 ...... 0.9 mg ...... 5.6 ...... 3.8 ...... NA ...... NA Vitamin A ...... 531 mcg RAE 45 ...... 34 ...... Serum A < 20 mcg/dL 0.3 8 67 Vitamin B6 .. 1.1 mg ...... 9.4 ...... 7.3 ...... NHANES 2005–2006 10 < 20 nmol/L. Vitamin B12 ..... 1.9 mcg ...... 2.3 ...... 2.2 ...... Serum B12 < 200 2.0 picograms (pg)/mL. 19–50 yrs ...... 0.7–2.5 2 mcg (51 yrs Women 51 yrs 51 yrs and older ...... 3.3–5.2 and older). and older. 6.4–7.5 Men 51 yrs and older 0.6–0.7 Vitamin C ...... 61 mg ...... 35 ...... 27.5 ...... Serum C < 11.4 μmol/ 6.1 8 L. Women 12–49 Women 12–49 ...... Women 12–49 yrs ..... 6.00 yrs. yrs. 41 ...... 30 Vitamin D ...... 10 mcg ...... 93.7 (NHANES 62 (NAHNES ...... Serum 25 (OH)D: <40 17.6 2005–2008). 2005–2008). nmol/L. 30–50 nmol/L ...... 24 < 30 nmol/L ...... 8.3 Vitamin E ...... 11 mg a-to- 92 ...... 64 ...... Serum E < 11.6 μmol/ 0.9 8 copherol. L. Vitamin K 67 ... 95 mcg (AI) ...... 27.2 (mean = 30.9 (mean = NA ...... NA 82.9 mcg). 88 mcg).

Minerals

Calcium ...... 885 mg ...... 49 ...... 37 ...... NA ...... NA Copper 67 ...... 0.7 mg ...... 5.2 ...... 4.9 ...... NA ...... NA Iron (prob- See footnote 3 3.5 ...... 3.3 ...... NHANES 1999– ability ap- 2002 10. proach method) 9. Serum ferritin < 15 8.3 mcg/L. Ferritin model ...... 6.5 Anemia ...... 1.9 Women, 12–49 yrs NHANES 2003–2006: Women 12–49 Women 12–49 Serum Ferritin < 15 14 yrs. yrs. mcg/L 10 11.2 ...... 10.4 Body Iron model ...... 14.5 Ferritin Model Anemia 4.7 Iodine 67 ...... 91 mcg ...... 2.3 11 ...... 2.3 ...... Urinary iodine NHANES 2007–2008:

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TABLE 1—PREVALENCE OF ADEQUACY AND INADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS FOR ESSENTIAL VITAMINS AND MIN- ERALS AMONG THE U.S. POPULATION, AGES 4 YEARS AND OLDER—Continued [Excluding pregnant and lactating women] 1

Usual nutrient intake 2 Status biomarkers

% above weighted AI 5 (mean Weighted % Below weighted EAR 4 Nutrients 3 intake) EAR/AI Biomarker cutoff % Below cutoff Food plus Food plus Food supplement Food supplement

<50 ng/mL 12 ...... 8.7 8. <100 ng/mL 13 ...... Median = 165 ng/mL. Magnesium .... 283 mg ...... 56 ...... 53 ...... NA ...... NA. Phosphorus .... 640 mg ...... 3 ...... 2.6 ...... NA ...... NA. Potassium ...... 4,622 mg (AI) ...... 1.9 (mean = 2.4 (mean = NA ...... NA. 2,644 mg). 2,654 mg). Selenium 67 .... 43 mcg ...... 1.4 ...... 1.1 ...... NA ...... NA. Zinc 67 ...... 7.7 mg ...... 13.4 ...... 9.1 ...... NA ...... NA. NA = Data is not available in NHANES; mg = milligrams; mcg = micrograms; DFE = Dietary folate equivalents; NE = Niacin equivalents; RAE = Retinol activity equivalents. 1 All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003–2006 unless otherwise is reported. All data analysis are based on ages 4 years and older (excluding pregnant and lactating women), unless reported otherwise. 2 Usual nutrient intake distributions from conventional foods or conventional foods plus supplements are determined using the National Cancer Institute statistical method for all nutrients except iron (see footnote 9 to this table and Ref. 48). 3 Weighted Estimated Average Requirement (EAR) and Adequate Intake (AI) for all nutrients (except iron) are based on the U.S. population ages 4 years and older using U.S. Census Bureau, Population Projection for 2005, Middle Series Data (NP–D1–A) (Ref. 48,117). For iron, the published IOM tables (tables I–6 and I–7) of probability of iron requirement distribution were used (Ref. 100). 4 EAR cut-point method used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy. 5 For nutrients with an AI, prevalence of nutrient adequacy was determined when mean usual nutrient intakes are at or above the AI or based on the percent of those above the AI. 6 The Agency did not receive any comments for these nutrients (which voluntary declaration is permitted) in response to the 2007 ANPRM. In addition, dietary intake or status biomarker data were not provided in the NHANES database for chromium, biotin, pantothenic acid, molyb- denum, manganese and chloride and, therefore, these nutrients are not listed in this table. 7 The DRIs for these nutrients were not based on a public health endpoint (e.g., chronic disease). 8 Ages 6 years and older. 9 Probability approach method was used to determine the prevalence of nutrient inadequacy for iron. The PC–SIDE software developed by the Iowa State University was used to determine the usual intake distribution for iron. 10 Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum fer- ritin, and erythrocyte protoporphyrin). Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to fer- ritin. Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. NHANES 1999–2002 did not measure transferrin receptor, therefore body iron model could not be analyzed for the general population (ages 4 years and older). NHANES 2003–2006 did not measure all iron biomarkers for all ages (4 years and older), thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during this time period. 11 Iodine nutrient intake data are calculated from the Total Diet Study 2003–2008 and intake data are calculated from NHANES 2003–2008 (http://www.nutrientdataconf.org/PastConf/NDBC36/7–3_Juan_NNDC2012.pdf). 12 One criterion for iodine adequacy is that not more than 20 percent be below the urinary iodine cutoff of 50 ng/mL (indicator of moderate defi- ciency) (Ref. 118). 13 WHO categories for median urinary iodine concentrations are widely used to define iodine intake (Ref. 118). Median intake levels below 100 ng/mL may indicate mild .

I. Reference Daily Intakes for Vitamins recognized that nutritional needs vary revised many of the previously set RDAs and Minerals considerably among consumers, but for vitamins and minerals. Four types of noted that no other viable option existed DRIs are relevant to the discussion on 1. Need To Update RDIs other than a single reference value (58 RDIs for vitamins and minerals: EAR, RDIs used to calculate the percent FR 2206 at 2213). Thus, RDIs are RDA, AI, and UL. We describe each of DVs for vitamins and minerals that are intended as general food labeling these DRIs in section I.B.2. According to required or permitted to be declared on reference values and are not intended to the new DRI reports, some nutrients that the Nutrition Facts label are codified in represent dietary allowances for had RDAs now have an AI because it § 101.9(c)(8)(iv). We established the individuals (55 FR 29476 at 29478). was determined that data were not RDIs in 1993 and in 1995, and While RDIs are not precise values for sufficient to set a new RDA (e.g., explained our rationale and relevant certain age and sex groups, they vitamin K), whereas others that had considerations during those function as an overall population ESADDIs now have either an RDA rulemakings (58 FR 2079; 60 FR 67164; reference to help consumers judge a (copper and molybdenum) or an AI see also Ref. 1). We noted specifically food’s usefulness in meeting overall (manganese, fluoride, and chromium). that the purpose of establishing RDIs for daily nutrient requirements or The IOM Labeling Report (Ref. 25) vitamins and minerals was to provide recommended consumption levels and recommended that FDA use a ‘‘label reference values’’ intended to to compare nutrient contributions of population-weighted EAR or, in its help consumers to understand nutrient different foods (55 FR 29476). absence, a population-weighted AI as levels in the context of the total daily IOM reports published since 1997 the basis for establishing DVs for diet, to compare foods, and to plan provide new information for our use in vitamins and minerals. In developing general diets (58 FR 2206 at 2213). We reconsidering the RDIs. The DRIs these recommendations, the IOM

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indicated that the reference values on Dietary Planning Report have been the thiamin, vitamins A B6, B12, C, D, and food labeling are to enable consumers to subject of much debate in the scientific E, and zinc (Refs. 16 to 19,22). compare the nutrient content of community, and several review articles The EAR, by definition, is the median different food products and to about the basis for selecting the DRI requirement that is most likely to be determine the relative contributions of a values that are most appropriate for close to an individual’s actual needs food to an overall health promoting diet. setting DVs (i.e., RDIs) have been within a particular life stage and gender The IOM Labeling Committee did not published in scientific journals (Refs. group, with the needs of half of the consider that the information in 119 to 126). individuals within that group falling nutrition labeling is used to plan The 2007 ANPRM asked for public above or below the EAR. The EAR is a individual diets. The IOM comment on whether the DV should be quantitative intake recommendation recommended that the DVs should be based on an EAR or RDA; how AIs that is used to derive target nutrient based on a population-weighted value of should be used for determining DVs for intake goals for the planning of diets for the EAR for the different life stage and vitamins and minerals without an EAR groups, but is not used as a target intake gender groups so that the DVs are or RDA; and whether DVs should be goal for individuals. Examples of representative of the various population based on a population-coverage or planning for groups include planning groups in proportion to their population-weighted approach. We diets in an assisted living facility for contribution to the overall population. received several comments both on the senior citizens or planning menus for a A DV defined this way would represent overall approach for setting the RDIs school nutrition program (Ref. 26). a central value of the requirements of and on the DRIs for specific vitamins However, the EAR is not intended to be the population, with individual and minerals (Ref. 47). a target intake level for individuals requirements varying around this value. We tentatively conclude that the because an individual does not know The IOM Labeling Committee further existing RDIs for vitamins and minerals how their needs relate to the EAR. stated that the EAR represents the most should be revised based on the DRIs set While the RDA may not be the best estimate of any given individual’s accurate representation of the true by the IOM that reflect the most current nutrient requirement, which is usually contribution of food to total nutrient science regarding nutrient requirements. unknown, the RDA was developed as a needs of the general population, Our consideration of the DRIs, relevant target intake level for individuals and is whereas the RDA provides an recommendations, and comments designed to meet the nutrient needs of exaggerated impression of Americans’ received in updating the RDIs is practically all (97 to 98 percent) daily needs and, thus, would presented in this document. systematically under-represent the true individuals within a life stage and contribution of an individual food to 2. Approach to Setting RDIs: EAR gender group. Therefore, if the RDI were many consumers’ needs. The IOM Versus RDA to be based on the EAR, the RDI would not meet the daily nutrient requirements Labeling Committee concluded that the The percent DV advises the consumer for some consumers and understate EAR is the best estimate of any given how much of the recommended intake target intake levels. In contrast, an RDI individual’s requirements, because the of that nutrient is provided by the food that is based on a RDA would meet the EAR is the median of the estimated (58 FR 2206 at 2213). The DV for the distribution of requirements for a daily nutrient requirements for the nutrient, on which the percent DV majority of all individuals 4 years of age particular life stage and gender group. declaration is based, is not to be Therefore, the IOM Labeling Committee and older. As we explained during the interpreted as a precise recommended NLEA rulemaking, while RDIs are not stated that setting the DV at the EAR is intake level for an individual; it is for precise values for specific age and sex most likely to help individuals use as a general guide or reference value groups, they function as an overall understand nutrition information about that can help the consumer judge a population reference to help consumers vitamins and minerals on the Nutrition food’s usefulness in meeting overall judge a food’s usefulness in meeting Facts label in the context of their total daily nutrient requirements or overall daily nutrient requirements or daily diet. The IOM Labeling Committee recommended consumption levels and recommended consumption levels and further recommended that, in the to compare nutrient contributions of to compare nutrient contributions of absence of an available EAR, a different foods (55 FR 29476). We different foods (55 FR 29476). An RDI population-weighted AI should be used established the RDIs for vitamins and based on the RDA would mean that a as the basis for a DV. minerals based primarily on RDAs, and product with 100 percent of the DV The IOM Dietary Planning Report using other available recommendations would have a higher probability of noted that intake goals (i.e., RDAs) for those vitamins and minerals for meeting an individual’s nutrient needs should be translated into dietary plans which an RDA was not established (55 than if the RDI was based on the EAR. to help individuals choose foods that FR 29476; 58 FR 2206; 60 FR 67164). In addition, consumers have indicated will make up a healthful diet. The IOM Overall, comments to the 2007 ANPRM that they use the label, among other Dietary Planning Report gave several supported continuing to use the RDA as things, to make dietary judgments about examples of dietary plans such as the the basis for the DVs for vitamins and a food and to plan meals. Our 2008 Diet Nutrition Facts label, United States minerals, whereas some other comments and Health Survey reported that, among Food Guide Pyramid and the Dietary supported using the EAR instead (Ref. consumers who use the label when they Guidelines for Americans that are 47). buy a product for the first time, 62 intended to help consumers choose Considering the purpose of the DV, percent often or sometimes use the label foods that are part of a healthful diet and for the reasons explained in this to help in planning; 85 percent (Ref. 26). This report noted that when document, we tentatively conclude that often or sometimes use the label to get food guides such as those mentioned RDAs, when available, continue to a general idea of the nutritional content previously are used, reference standards provide the most appropriate basis for of the food; and 90 percent often or for nutrients, such as RDAs, are establishing RDIs. RDAs are available sometimes use the label to see how high implicitly used in planning individual for calcium, copper, folate, iodine, iron, or low the food is in things like calories, diets (Ref. 26). The recommendations in magnesium, molybdenum, niacin, salt, vitamins, or fat (Ref. 41). A series the IOM Labeling Report and the IOM phosphorus, riboflavin, selenium, of surveys conducted by the

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International Food Information Council expressed in our fortification policy children 4 to 8 years of age (see tables over the past several years also showed (§ 104.20). The addition of nutrients to 11a and 11b of the 2007 ANPRM). that approximately 65 percent of foods is also governed by the Therefore, we tentatively conclude respondents used the Nutrition Facts requirements established in food that RDAs, when available, provide the label to decide whether to purchase or standards of identity (21 CFR parts 130 most appropriate basis for establishing consume a food, and different to 169), nutrition quality guidelines (21 RDIs. Using corresponding RDAs, individuals focus on different aspects of CFR part 104), substitute food proposed § 101.9(c)(8)(iv) would update the label (e.g., calories, fat, or sodium) regulations (§ 101.3(e)), and relevant the RDIs for calcium, copper, folate, (Refs. 127 to 130). specifications in food additive and food iodine, iron, magnesium, molybdenum, We recognize that the substance regulations (for example, folic niacin, phosphorus, riboflavin, recommendations of the 2003 IOM acid (§ 172.345) and vitamin D selenium, thiamin, vitamins A, B6, B12, Labeling Report (Ref. 25) differ from the (§§ 184.1950 and 172.380)). Consistent C, D, and E, and zinc, as shown in table conclusions of the 2003 IOM Planning with our previous position (58 FR 2206 2. We request comment on our analysis Report (Ref. 26). The IOM Labeling at 2210), we acknowledge that some and request data and factual Report recommends using the EAR as manufacturers may fortify products to a information, including any additional the basis for developing DVs, whereas specific percentage of the DV (e.g., 25 data on what role, if any, the basis of the the IOM Planning Report indicated that percent) and, to the extent this practice DV (EAR or RDA) has in consumption the RDAs are appropriate targets for continues, nutrient levels in these foods of nutrients above the UL and in nutrient intakes for individuals. would be affected by updated RDI discretionary fortification of foods. Inadequate intakes of some nutrients values. Changing the basis from the continue to be of public health current RDA approach to EARs would 3. Approach to Setting RDIs: Adequate significance, as noted by the 2010 DGA, lower RDIs for many important Intake which identified potassium, calcium, nutrients. Regardless of whether the We consider that, in the absence of and vitamin D as nutrients of public basis for the RDI is the RDA or EAR, RDAs, AIs represent the best estimate of health concern for general U.S. manufacturers must comply with adequate daily nutrient intake level population and iron, folic acid, and relevant regulations, and we urge them based on available science and, as such, vitamin B12 for certain segments of the to follow the principles stated in our they provide an appropriate basis for population (Ref. 6). Based on these fortification policy. With respect to the selecting RDIs for those vitamins and concerns of inadequate nutrient intakes, concern for risk of excessive intakes of minerals where available data are we find that the IOM Dietary Planning vitamins and minerals, we conducted a insufficient to determine RDAs. While Report discussion supports the use of thorough analysis of available data to the prevalence of inadequacy of a RDAs as the basis for establishing determine whether intakes of vitamins nutrient with an AI cannot be reference values for the purposes of food and minerals from both foods and determined, AIs, like RDAs, are goals for labeling. We continue to believe that dietary supplements exceed established nutrient intakes and AIs are expected to given the greater coverage provided by ULs. An analysis of NHANES (2003– meet the nutrient needs of most healthy the RDAs compared to the EARs, more 2006) data showed that usual total people. The IOM noted that usual individuals who use the percent DV nutrient intakes (from both conventional individual intakes for a nutrient that are information to select foods, compare foods and dietary supplements) at the equal to or above the AI can be assumed foods, or plan diets will have greater 90th percentile do not exceed the ULs assurance that their nutrient needs are adequate (Ref. 25). We acknowledge that for most vitamins and minerals at any being met (58 FR 2206 at 2213). RDAs there is more uncertainty with an AI age group, except for zinc intake, and AIs, not EARs, are also cited in both than an EAR or RDA. However, in the vitamin A (preformed), iodine intake the 2010 DGA and the USDA’s Food case of nutrients without established and folic acid intake among children 4 Patterns, which were formerly known as RDAs, AIs reflect the most current to 8 years (Ref. 132). the MyPyramid Food Patterns (Refs. 6 scientific recommendations for intake and 131). It is important to reiterate, While there were a few exceptions, (Ref. 25). however, that the RDIs are not the same we have determined that such intakes Moreover, using the AIs (where RDAs as RDAs. The RDAs are recommended are not of public health significance, are not available) would ensure intake levels set for different age and and for some nutrients, are not a result consistency in the basis of setting RDIs. gender groups, whereas the RDIs are of discretionary fortification. Therefore, We agree with comments to the ANPRM intended to provide an overall we do not consider that the existing that RDIs for vitamins and minerals and population reference value for use in approach of using RDAs as the basis for consequently, percent DVs declared on calculating the percent DV for the food RDIs leads to widespread the label, should have comparable label that can help consumers overconsumption of vitamins and meanings in order to enable consistent understand the nutritional content of minerals. Moreover, about half of the use. RDIs should not be based on foods in the context of the total daily proposed RDIs decrease when compared average requirements (i.e., EAR) for diet (55 FR 29476 at 29481 and 58 FR to the current RDIs (table 2) because some nutrients, but goals for intakes 2206 at 2213). many of the new RDAs and AIs (i.e., RDAs) for others. AIs, in the Finally, we considered the potential established by the IOM are now lower absence of RDAs, would provide for the RDIs to influence the vitamin or than previously set RDAs or ESADDIs. uniformity in setting RDIs for vitamins mineral content of foods, as suggested Most of the RDIs proposed in this and minerals based on goals for their by several comments (Ref. 47). We are rulemaking that would increase (i.e., intakes. Most of the comments in not persuaded that using an EAR will calcium, vitamin D, dietary fiber, and response to the 2007 ANPRM supported promote rational fortification and that potassium) have also been proposed by the AI as the basis for the DV for those using the RDA as the basis for the RDI FDA to be nutrients of public health nutrients for which no EARs or RDAs will lead to overconsumption of significance for the general U.S. have been established (i.e., biotin, vitamins and minerals, as was suggested population (see section II.H.). chloride, choline, chromium, by a comment (Ref. 47). FDA’s Furthermore, none of the RDIs proposed manganese, pantothenic acid, principles of rational fortification are in this rulemaking exceed the ULs for potassium, and vitamin K) (Ref. 47).

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Therefore, we tentatively conclude considered recommendations of current health significance, and for some that AIs provide an appropriate basis for consensus reports, scientific review nutrients, are not as a result of selecting RDIs for those vitamins and articles, and comments to the 2007 fortification (see accompanying Ref. minerals where available data are ANPRM. We presented a comparison of 115). Furthermore, because many of the insufficient to determine RDAs. potential RDIs based on the various new RDAs and AIs established by the Accordingly, we are proposing to use established DRIs and applying the IOM are now lower than previously set AIs to set the RDIs for biotin, chloride, population-coverage versus population- RDAs or ESADDIs, the RDIs based on a choline, chromium, manganese, weighted approaches (see tables 11A population-coverage RDA for many pantothenic acid, potassium, and and 11B of the 2007 ANPRM). As nutrients will decrease (see table 2). We vitamin K. discussed in this document, we consider that, from a public health tentatively conclude that RDIs for perspective, it is more important for the 4. Approach to Setting RDIs: Tolerable vitamins and minerals should continue DV of vitamins and minerals to cover Upper Intake Level to be based on a population-coverage the intake needs of most consumers The UL is the highest average daily approach, using the highest RDA and, than it is for certain age and gender intake level likely to pose no risk of where an RDA has not been established, groups to be covered by the DV based adverse health effects for nearly all the highest AI. on their proportion of the overall people in a particular group. As intake We continue to agree with the population. We are also not aware of increases above the UL, potential risk of rationale we set forth in 1993 that the any data indicating that use of a adverse effects may increase (Ref. 96). population-coverage approach would population-coverage approach versus a The UL can be used to estimate the sufficiently cover the vulnerable or at- population-weighted approach results percentage of the population at potential risk groups (58 FR 2206 at 2211). Using in increases in nutrient consumption. risk of adverse effects from excess the highest age and gender group RDA/ Therefore, we tentatively conclude that nutrient intake (Ref. 25). However, the AI value (i.e., a population-coverage the population-coverage approach using UL is not intended to be a approach) would avoid a higher risk of the highest RDA or, in its absence, the recommended level of intake for nutrient inadequacy among certain highest AI continues to provide an vitamins and minerals where excess segments of the population because appropriate basis for setting RDIs for intake is not a concern, as there is such a value is not derived from vitamins and minerals. We are generally (with the exception of folate in averaging the requirements for proposing to amend § 101.9(c)(8)(iv) to the prevention of neural tube defects) no populations with lower needs (children update RDIs as presented in table 2. established benefit for consuming and elderly) and those with greater amounts of nutrients above the RDA or needs (adolescents or adults). While 6. Declaration of Absolute Amounts of AI (Ref. 96). Therefore, we do not incidences of deficiency diseases, such Vitamins and Minerals consider the UL to be an appropriate as , are now rare, intakes and Currently, mandatory nutrients and, basis for setting RDIs. However, as the status biomarkers of certain nutrients when declared, voluntary nutrients IOM noted, ULs can be used to plan continue to be inadequate and of public must be declared by their absolute diets to ensure usual intakes of vitamins health significance (see section II.H.). amounts in weight on the Nutrition and minerals are below the UL for Although, for some nutrients, the Facts label, except for vitamins and individuals or to plan diets for groups population-coverage RDA approach minerals (other than sodium and to minimize the proportion of the would result in RDIs that are higher potassium) (see § 101.9(d)(7)(i)). Thus, population at risk of excess nutrient than the nutrient requirements for some except when the linear label format is intake (Ref. 25). consumers, RDA, by definition, is the used (§ 101.9(j)(13)(ii)(A)(2)), listings for Therefore, we tentatively conclude target intake goal for nutrient intakes for sodium and potassium (when declared) that the UL does not provide an individuals. In addition, as noted by one appear above the third bar and include appropriate basis for establishing RDIs comment, unlike the population- both weight amounts and percent DVs, for vitamins and minerals. As noted weighted approach, the population- while vitamins A and C, calcium, and previously (sections II.I.2. and II.I.3.), coverage approach would not be iron appear below the third bar and we tentatively conclude that the RDAs susceptible to changes in age include percent DVs only. In the case of and, for nutrients where an RDA has not demographics of the population. dietary supplements, both the been established, AIs are the most Therefore, any future revisions to RDIs quantitative amount by weight and appropriate quantitative intake would be based primarily on new percent DV (if available) are required to recommendations for setting RDIs that scientific data related to nutrition or be declared on the Supplement Facts can help consumers to plan general new dietary recommendations, and we label (§ 101.36(b)(2)(ii) and (iii)). The diets and understand the nutritional would not need to revise RDIs solely 2007 ANPRM invited comment on content of the foods they buy in the based on the availability of new census whether the absolute amounts (e.g., context of the total daily diet. data. grams or milligrams) of mandatory and We also considered concerns that the voluntary vitamins and minerals should 5. Approach to Setting RDIs: population-coverage approach may lead be included on the Nutrition Facts and Population-Weighted Versus to excessive intakes of nutrients. As in Supplement Facts labels (72 FR 62149 at Population-Coverage the case of the RDA approach (discussed 62170). Most comments supported As discussed in the 2007 ANPRM, we previously), we find such concerns including the absolute amounts of these set the RDIs based on a population- unfounded. Intakes of vitamins and nutrients in addition to the requirement coverage approach, after concluding that minerals generally do not exceed the of listing percent DVs. this approach was more appropriate ULs under current RDIs that are based Research suggests that consumers, in than a population-weighted approach, on a population-coverage RDA general, and physicians who prescribe in part, so that vulnerable or at-risk approach. In a few instances where total nutrient supplements for specific groups would be sufficiently covered by usual intakes of vitamins and minerals medical reasons have difficulty the DV (72 FR 62149 at 62150). In by children 4 to 8 years exceed understanding how percent DVs relate determining an approach for setting corresponding ULs, we have determined to the absolute amounts of nutrients RDIs in this proposed rule, we that such intakes are not of public listed on the Nutrition Facts label (Ref.

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133). More recently, in a report on requirements for the declaration of ‘‘Contains less than 2 percent of the labeling and fortification, the IOM potassium in § 101.9(c)(5), and replace Daily Value of this (these) nutrient recommended listing both absolute the section with requirements for the (nutrients).’’ Alternatively, the amounts (e.g., mg/serving) and percent declaration of fluoride. Requirements statement ‘‘Not a significant source of DVs to assist consumers who have for the declaration of quantitative (listing the vitamins or minerals difficulty understanding how to amounts of other nutrients with an omitted)’’ (‘‘not a significant source’’ interpret the percent DV declaration established RDI discussed in this statement) may be placed at the bottom (Ref. 25). This IOM report also stated document will apply to potassium, if of the table of nutrient values. that absolute amounts declaration for all finalized. As previously discussed, micronutrients would maintain The quantitative amounts by weight manufacturers have the option of using consistency in how nutrients are per serving of vitamins and minerals are an asterisk (or symbol), instead of a declared on the Nutrition Facts label. also required to be declared on the declaration of zero, that directs the Based on the IOM’s recommendation, Supplement Facts label consumer to a statement indicating that research findings, and comments (§ 101.36(b)(2)(ii)). The amounts of the product is not a significant source of received, we are proposing to require vitamins and minerals, excluding certain vitamins or minerals found at that, similar to the requirement for sodium and potassium, that are declared the bottom of the table of nutrient dietary supplements on the Supplement Facts label are the values when the calculated percent DV (§ 101.36(b)(2)(i)(A)), all vitamins and amount of the vitamin or mineral is less than 2 percent. We are concerned minerals declared on the Nutrition Facts included in one serving of the product, that it may be confusing to consumers label must include their quantitative using the units of measurement and if the manufacturer chooses to declare amounts (in addition to the requirement levels of significance given in the quantitative amount of a vitamin or for corresponding percent DV § 101.9(c)(8)(iv). Section mineral as zero, and also chooses to use declaration) (proposed § 101.9(c)(8)). We 101.36(b)(2)(ii)(B) also specifies that for an asterisk referring the reader to a request comments on this tentative declaration of vitamins and minerals on statement at the bottom of the label conclusion, and seek input on the the Supplement Facts label, zeros instead of in the percent DV column on appropriate placement of the following decimal points may be the Nutrition Facts label. Therefore, we quantitative amounts of nutrients on the dropped, and additional levels of are proposing to require that, when a Nutrition Facts label. significance may be used when the product contains less than 2 percent of Further, with the proposed number of decimal places indicated is the RDI for a vitamin or mineral, the requirement for declaration of absolute not sufficient to express lower amounts manufacturer must declare the amounts of vitamins and minerals, it is (e.g., the RDI for zinc is given in whole quantitative amount of the vitamin or necessary to establish when a vitamin or mg, but the quantitative amount may be mineral and the percent DV in the same mineral is present in an insignificant declared in tenths of a mg). manner. For example, if a serving of the amount as well as increments for For conventional foods, FDA specifies product contains less than 2 percent of declaration of the quantitative amounts in § 101.9(c)(8)(iii) that the percent DV the RDI for calcium, both the of vitamins and minerals on the declaration for vitamins and minerals quantitative amount and the percent DV Nutrition Facts label. In determining present at less than 2 percent of the RDI for calcium may be listed as zero or an requirements for vitamins and minerals is not required for nutrition labeling, but asterisk (or symbol) directing the present in insignificant quantities, as may be declared as zero or by the use consumer to a statement at the bottom well as increments for declared vitamins of an asterisk (or other symbol) that of the label may be used in place of both and minerals, we looked to refers to another asterisk (or symbol) the quantitative amount and the percent requirements that have already been that is placed at the bottom of the table DV declaration for calcium. established for declaration of and that is followed by the statement We see no reason to provide different quantitative amounts of sodium and ‘‘Contains less than 2 percent of the declaration increments for the Nutrition potassium, vitamins and minerals Daily Value of this (these) nutrient Facts label than those that have already declared on the Supplement Facts label, (nutrients).’’ Alternatively, the been established for the declaration of and percent DVs. statement ‘‘Not a significant source of quantitative amounts of vitamins and Quantitative amounts in milligrams (listing the vitamins or minerals minerals on the Supplement Facts label may currently be listed on the Nutrition omitted)’’ may be placed at the bottom in § 101.36(b)(2)(ii). Therefore, we Facts label for only two minerals: of the table of nutrient values. tentatively conclude that, as with the Sodium, a mandatory nutrient For the purpose of determining when declaration of quantitative amounts of (§ 101.9(c)(4)) and potassium a vitamin or mineral is present in an vitamins and minerals on the (§ 101.9(c)(5)), which may be voluntarily insignificant amount, we tentatively Supplement Facts label, the levels of declared on the Nutrition Facts label. conclude that the cutoff used for significance given in § 101.9(c)(8)(iv) We require in § 101.9(c)(4) and (c)(5) declaration of percent DV of less than 2 should be used. Zeros following decimal that when a serving contains less than percent of the RDI (§ 101.9(c)(8)(iii)) can points may be dropped, and additional 5 mg of sodium or potassium, the value reasonably be applied to the declaration levels of significance may be used when shall be declared as zero; when a of quantitative amounts of vitamins and the number of decimal places indicated serving contains 5 to 140 mg of sodium minerals on the Nutrition Facts label. is not sufficient to express lower or potassium, the declared value shall We find that, if a product contains less amounts (e.g., the RDI for zinc is given be rounded to the nearest 5 milligram than 2 percent of the RDI per serving, it in whole mg, but the quantitative increment; and when a serving contains is appropriate to express the declared amount may be declared in tenths of a greater than 140 mg of sodium or vitamin or mineral quantitative amount mg). potassium, the declared value shall be as zero. The manufacturer may choose We acknowledge that for some rounded to the nearest 10 mg increment. to use an asterisk (or other symbol), vitamins and minerals with RDIs that We are now proposing to establish an instead of a declaration of zero, that contain three or four digits (e.g., RDI for potassium. Since potassium will refers to another asterisk (or symbol) phosphorous has a proposed RDI of now have an RDI, rather than a DRV, we placed at the bottom of the table and 1,250 mg), a difference of 1 mg per are proposing to remove the specific that is followed by the statement serving may not be meaningful in terms

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of health impacts. We request comment the current DV for sodium and (2) the be established. Thus, we are proposing on whether quantitative amounts for DV for chloride should be based on the in § 101.9(c)(8)(iv) to set an RDI of 550 nutrients with RDI values that contain same DRI (AI versus UL) as used to set mg for choline based on the population- three or four digits should be rounded, a DV for sodium. coverage AI. what the rounding increments should A few comments supported setting a e. Vitamin B —We are proposing to be, and data to support suggested DRV for chloride on an equimolar basis 12 lower the RDI for Vitamin B from 6 to rounding increments for such vitamins to the UL for sodium. We disagree 12 2.4 mg/day which reflects the and minerals. because the UL for chloride was not based on adverse effects associated with population-coverage RDA for Vitamin 7. Issues Concerning Specific Vitamins excess intake of chloride. Furthermore, B12. The RDAs for Vitamin B12 were and Minerals the UL was not based on a public health established by the IOM in 2000. The In this section, we address issues endpoint specific to chloride intake, IOM noted that 10 to 30 percent of related to RDIs for specific vitamins and which is a basis for setting a DRV. individuals older than 50 years of age minerals, including those received in Because chloride is an essential mineral are estimated to have atrophic gastritis comments to the 2007 ANPRM. We and has age- and gender-specific AIs, we with low stomach acid secretion which discussed the declaration of these tentatively conclude that chloride can decrease the bioavailability of vitamins and minerals in section II.H. should remain a RDI and be based on naturally occurring vitamin B12 in food (and in accompanying Ref. 115). population-coverage AI (see section (Ref. 17). The bioavailability of a. Vitamin K—There are three general II.I.5.). Therefore, we are proposing to crystalline vitamin B12 that is added to forms of vitamin K: Phylloquinone set an RDI for chloride using the food is not altered in people with this (vitamin K1), menaquinone (vitamin K2), population-coverage AI of 2,300 mg/d condition. While the IOM set an RDA of and menadione (vitamin K3). For (proposed § 101.9(c)(8)(iv)). 2.4 mg/d that can be met by consuming labeling purposes, there is no specific c. Potassium—The DRV of 3,500 mg/ natural and crystalline forms of vitamin definition for vitamin K. The AIs for d for potassium was established based B12 and is for all adults, it was noted vitamin K are based on median intakes on its beneficial health effects (e.g., that it is advisable that individuals older from NHANES data, which specifically reduction in blood pressure) (55 FR than 50 years of age meet their RDA represents the intake of phylloquinone, 29487 at 29500). We established a DRV mainly by consuming foods fortified the major form of vitamin K in the diet rather than an RDI because an RDA for with crystalline vitamin B12 or vitamin (Ref. 134). The AI for vitamin K does not specific age and gender groups was not B12-containing supplements. If the RDI account for the intake of menaquinone established at that time. In 2005, the is lowered from 6 to 2.4 mg, it is possible or menadione because (1) NHANES data IOM established age- and gender- that the fortification level in foods, such only includes phylloquinone content of specific AIs for potassium based on data as ready-to-eat breakfast cereals, may be foods, (2) the contribution of showing that potassium lowers blood lowered, decreasing the overall amount menaquinones, which can be produced pressure, blunts the adverse effects of of crystalline vitamin B in the food by bacteria in the gut, to the 12 sodium chloride intake on blood supply. Given the current level of maintenance of vitamin K status has not pressure, reduces the risk of recurrent fortification in food, less than 1 percent been established, and (3) menadione is kidney stones, and possibly decreases of men and 6.4 to 7.5 percent of women a synthetic form of vitamin K that can bone loss (Ref. 136). Because potassium older than 50 years of age consume be converted to a form of menaquinone is an essential mineral and age- and below the EAR for vitamin B , while in animal tissues. Because the AI for gender-specific AIs are available, we 12 only 3 to 5 percent of men and women vitamin K is specific to phylloquinone, tentatively conclude that an RDI should in this age group have serum vitamin our proposed RDI for vitamin K, 120 be established in place of the DRV. mcg in proposed § 101.9(c)(8)(iv), that is Therefore, using the population- B12 levels that are considered to be based on the AI pertains only to coverage AI, we are proposing to inadequate (2003–2006 NHANES) (table phylloquinone. establish an RDI for potassium of 4,700 1). Reflecting the current food supply b. Chloride—The RDI for chloride of mg/d (proposed § 101.9(c)(8)(iv)). and regulations, data from NHANES 3,400 mg/d (§ 101.9(c)(8)(iv)) was d. Choline—FDA regulations do not (2003–2006) indicate that ready-to-eat established in 1995 and is based on the establish a reference value for choline. is the primary source of midpoint of the range (1,700 to 5,100 In 1998, the IOM established age- and crystalline B12 added to food, providing mg/d) of the ESADDI set in the 1980 gender-specific AIs for choline based on approximately 14.6 percent of the total RDA report (Ref. 135; 59 FR 427). The intakes necessary to maintain liver vitamin B12 consumed by individuals 51 RDI for chloride is proportional to the function (Ref. 137). In 2001, we received years of age and older (Ref. 139). Dietary DRV for sodium, considering that a FDAMA notification under section supplements appear to be an important chloride losses tend to parallel losses of 403(r)(2)(G) of the FD&C Act for the use contributor of vitamin B12 for this age sodium and almost all dietary chloride of certain nutrient content claims for group because the mean increase in comes from sodium chloride (60 FR choline (Ref. 138). The FDAMA vitamin B12 intake ranged between 2.5 67164). The IOM set AIs and ULs for notification identified the DV for and 4.7 mg/d when comparing intake chloride on an equimolar basis to the AI choline as 550 mg, which was based on from food only compared to food plus and UL for sodium (Ref. 10). The 2007 the population-coverage AI for choline. dietary supplements (NHANES 2003– ANPRM requested comment on whether Because the IOM established age- and 2006) (table 1). We request comment (1) the DV for chloride should continue gender-specific AIs for choline, we and data on lowering the RDI for to be an RDI, or should be a DRV like tentatively conclude that an RDI should vitamin B12 to 2.4 mg.

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TABLE 2—CURRENT AND PROPOSED RDIS FOR NUTRITION LABELING [Based on a 2,000 calorie intake for adults and children 4 or more years of age]

Nutrient Current RDIs Proposed RDIs

Vitamins: Biotin ...... 300 micrograms ...... 30 micrograms. Choline ...... 550 1 milligrams ...... 550 milligrams. Folate ...... 400 micrograms ...... 400 micrograms DFE. Niacin ...... 20 milligrams ...... 16 milligrams NE. Pantothenic acid ...... 10 milligrams ...... 5 milligrams. Riboflavin ...... 1.7 milligrams ...... 1.3 milligrams. Thiamin ...... 1.5 milligrams ...... 1.2 milligrams. Vitamin A ...... 5,000 International Units ...... 900 micrograms RAE. Vitamin B6 ...... 2.0 milligrams ...... 1.7 milligrams. Vitamin B12 ...... 6 micrograms ...... 2.4 micrograms. Vitamin C ...... 60 milligrams ...... 90 milligrams. Vitamin D ...... 400 International Units ...... 20 micrograms. Vitamin E ...... 30 International Units ...... 15 milligrams. Vitamin K ...... 80 micrograms ...... 120 micrograms. Minerals: Calcium ...... 1,000 milligrams ...... 1,300 milligrams. Chloride ...... 3,400 milligrams ...... 2,300 milligrams. Chromium ...... 120 micrograms ...... 35 micrograms. Copper ...... 2.0 milligrams ...... 0.9 milligrams. Iodine ...... 150 micrograms ...... 150 micrograms. Iron ...... 18 milligrams ...... 18 milligrams. Magnesium ...... 400 milligrams ...... 420 milligrams. Manganese ...... 2.0 milligrams ...... 2.3 milligrams. Molybdenum ...... 75 micrograms ...... 45 micrograms. Phosphorus ...... 1,000 milligrams ...... 1,250 milligrams. Potassium 2 ...... 3,500 milligrams ...... 4,700 milligrams. Selenium ...... 70 micrograms ...... 55 micrograms. Zinc ...... 15 milligrams ...... 11 milligrams. RAE = Retinol activity equivalents; 1 RAE = 1 mcg retinol, 12 mcg b-carotene, or 24 mcg a- carotene, or 24 mcg b-cryptoxanthin. NE = Niacin equivalents, 1 mg niacin = 60 mg of . DFE = Dietary folate equivalents; 1 DFE = 1 mcg food folate = 0.6 mcg of folic acid from fortified food or as a supplement consumed with food. 1 A notification was submitted under section 403(r)(2)(G) of the FD&C Act in 2001 for the use of certain nutrient content claims for choline. These statements identify the daily value for choline as 550 mg. This value is based on the AI set by the IOM of the NAS in 1998 (Refs. 138 and 137). 2 These minerals currently have a DRV and we are proposing to establish an RDI.

J. Units of Measure, Analytical Methods, (sodium, potassium, chloride) or with the 2010 DGA, which provides and Terms for Vitamins and Minerals micrograms (copper) (Refs. 21,140). The recommendations for sodium and As discussed in this document, the IOM Labeling Committee recommended potassium in milligram units (Ref. 6). IOM set DRIs using new units of that the current requirement for units of We tentatively conclude that there is no measure for vitamin A, vitamin E, and measurement used in the declaration of advantage to change the units of folate, as well as provided these nutrients should be changed to be measure for sodium, potassium, copper, recommendations on the use of consistent with the units used in the or chloride from those currently in use. International Units (IUs), and new DRI reports. In response to the 2007 Thus, we are not proposing any changes expression of weight amounts for ANPRM that asked about whether the to the units used for declaring these sodium, potassium, copper, and units of measure should be changed for nutrients on the Nutrition Facts label. these nutrients, we received comments chloride (Refs. 17 to 19,25). The new 2. Folate and Folic Acid units of measure for vitamin A, vitamin that generally supported maintaining E, and folate affect how total amount of the current units of measure. a. Units of Measure—The RDI for each nutrient is measured. The 2007 We considered the IOM Labeling ‘‘folate’’ is listed in ‘‘micrograms’’ ANPRM asked several questions about Committee recommendations and (§ 101.9(c)(8)(iv)). Folate represents the these issues. We discuss our comments received. When expressed as sum of naturally occurring folate and reconsideration of the units of measure, ‘‘g’’ units, rather than in ‘‘mg’’ units, synthetic folic acid that has been added analytical methods, and terms used in significant differences in the amounts of to foods. In 1998, the IOM set the RDA declaration of specific vitamins and sodium or potassium could appear for folate expressed as mcg Dietary minerals in this section. inconsequential or less significant. For Folate Equivalents (DFE) (Ref. 141). The example, amounts declared as 0.2 g and IOM Labeling Committee recommended 1. Sodium, Potassium, Copper, and 0.5 g may not seem as significantly that the units used for folate (mcg) in Chloride different as 200 mg and 500 mg. nutrition labeling should be consistent The absolute amount declaration for Furthermore, units of measure for these with the units in the new DRI report sodium, potassium, copper, and nutrients have been in use since 1993 (mcg DFE) (Ref. 25). In response to the chloride must be expressed in mg and consumers may be already familiar 2007 ANPRM, in which we asked for (§ 101.9(c)(8)(iv) and (c)(9)). However, in with the units used on the label. In comment on this issue, a few comments the DRI reports for these nutrients, these addition, the use of milligrams for supported retaining the current units nutrients are expressed as grams sodium and potassium is consistent (mcg) for folate and one comment noted

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that the use of the term DFE on the label conventional food products. There is a D, and mg a-tocopherol for vitamin E. would be unfamiliar to consumers and difference in folate activity between We agree that IUs should be replaced could be confusing (Ref. 47). The IOM naturally occurring folate and synthetic with units that are consistent with the developed the new term, DFE, to folic acid that is added to fortify foods. DRIs. In addition, because DRIs form the account for the greater bioavailability of When a conventional food product basis for the proposed RDIs for these synthetic folic acid that is added to contains a mixture of naturally vitamins (see section II.I.), using the fortified foods or dietary supplements occurring folate and synthetic folic acid new units would also correspond with than folate that occurs naturally in foods that has been added, available analytical the proposed RDIs for vitamins A, D, (food folate). As defined by the IOM, methods do not allow for verification of and E. We discuss issues relevant to mcg DFE is equivalent to mcg food the declared amount of mcg DFEs on the vitamin A and vitamin E units of folate + (1.7 × mcg synthetic folic acid) Nutrition Facts label. To calculate DFEs, activity in this document. (Ref. 141). The current unit of measure it is necessary to know both the amount a. Units of Vitamin A Activity—The (mcg) does not take into account the of folate and folic acid in the food RDI for vitamin A is 5,000 IU difference in the bioavailability of folate product. Therefore, proposed (§ 101.9(c)(8)(iv)). Because the vitamin and folic acid. In addition, mcg DFE § 101.9(g)(10) would require A activity of provitamin A carotenoids declaration would provide a more manufacturers to make and keep records (e.g., b-carotene) is less than pre-formed accurate representation of the amount of to verify the amount of folic acid added vitamin A (retinol), the following folate in foods that contain both to the food and folate in the finished conversions were developed: One mcg naturally occurring folate and added food, when a mixture of both naturally retinol = 3.33 IU vitamin A activity from folic acid. For example, the standards of occurring folate and added folic acid are retinol (Ref. 105) and 10 IU b-carotene identity for certain enriched foods present in the food. (See section II.N.) = 3.33 IU retinol (Ref. 105). Because the require the addition of folic acid (21 We invite comment on available vitamin A activity of b-carotene in CFR parts 136, 137, and 139) and, these scientifically valid methods that are dietary supplements is greater than b- foods contain both food folate and capable of measuring folic acid and carotene in food, ten IU of b-carotene is synthetic folic acid. folate separately. based on 3.33 IU of vitamin A activity Therefore, we are proposing to amend c. Terms to Declare Folate—’’Folic × 3 (the relative vitamin A activity of b- § 101.9(c)(8)(iv) such that mcg DFE acid’’ or ‘‘folacin’’ are identified as carotene in supplements versus diets). would be used to declare the amount of synonyms of folate and can be added in The RDA in mcg Retinol Equivalents total folate (food folate and synthetic parentheses after folate or can be listed (RE) for vitamin A is equivalent to 1 folic acid) on the Nutrition Facts label. without parentheses in lieu of ‘‘folate’’ mcg retinol or 6 mcg of b-carotene (i.e., Section 101.36(b)(2)(ii)(B) for the on the Nutrition Facts label carotene:retinol equivalency ratio of 6:1) labeling of dietary supplements (§ 101.9(c)(8)(v)) or in the Supplement and considers 3 mcg of dietary b- includes a reference to § 101.9(c)(8)(iv), Facts label (§ 101.36(b)(2)(B)(2)). carotene to be equivalent to 1 mcg of which, as proposed, designates the units Consistent with the proposed purified b-carotene in supplements (i.e., of measure for declaration of folic acid amendments related to the units of a carotene:retinol equivalency ratio of as mcg DFE units (see section II.L.). measure for folate that take into account 3:1). We are aware that education efforts the differences between folate and folic A comment to the 2007 ANPRM noted should be provided to assist with acid, we are reconsidering appropriate that the IU for vitamin A does not take consumer understanding of the new terms for declaration of folate content in into account the recent information on ‘‘equivalent’’ units of measurement for foods and dietary supplements. We are the bioavailability of dietary provitamin folic acid. For example, using the new proposing to (1) eliminate the synonym A carotenoids that was used to define units, a dietary supplement that now ‘‘folacin’’ specified in §§ 101.9(c)(8)(v) retinol activity equivalents (RAEs) for declares 400 mcg of folic acid would and 101.36(b)(2)(B)(2); (2) require, in these carotenoids (Ref. 105). The unit of declare the same amount as 680 mcg proposed § 101.9(c)(8)(vii), that the term measure associated with the RDA for DFE or 170 percent of the proposed RDI. ‘‘folate’’ be used in the labeling of vitamin A is mcg RE. We agree that the One option to help ensure consumer conventional foods that contain either IU for vitamin A does not reflect the understanding would be to allow the folate only or a mixture of folate and carotene:retinol equivalency ratio. RAEs declaration of the amount of folic acid folic acid; and (3) require that the term consider 6 mcg of dietary b-carotene to in parenthesis similar to that permitted ‘‘folic acid’’ be used in the labeling of be equivalent to 1 mcg of purified b- for the percent of vitamin A as b- dietary supplements only. As proposed, carotene in supplements (i.e., a carotene (§ 101.9(c)(8)(vi)). For example, conventional foods would not be carotene:retinol equivalency ratio of 6:1) for a conventional food that contains permitted to use the term ‘‘folic acid.’’ because more recent evidence suggests both folic acid and folate, the total mcg that the bioavailability of b-carotene is 3. Vitamins A, D, and E DFE could be declared and in approximately half of what was parenthesis indicate how much is from International Units (IUs) are used for previously considered for setting mcg folic acid. We invite comment on this the labeling of vitamins A, D, and E on RE. A change in units does not present approach. the Nutrition and Supplements Facts any challenges to AOAC methods used b. Analytical Methods—Because we labels (§§ 101.9(c)(8)(iv) and for measuring provitamin A carotenoids are proposing to amend the units used 101.36(b)(2)(ii)(B)). The IOM Labeling and vitamin A in foods or dietary for declaring the sum of folate and folic Committee recommended that the units supplements. acid, we considered the availability and for these nutrients should be changed to Therefore, proposed § 101.9(c)(8)(iv) limitations of analytical methods be consistent with the units in the new would change the units of measure for necessary to measure each nutrient DRI reports, i.e., mg Retinol Activity vitamin A to replace ‘‘IU’’ with ‘‘mcg,’’ separately for calculating mcg DFE. Equivalents for vitamin A, mg for representing mcg RAE. In addition, Available analytical methods (e.g., vitamin D, and mg a-tocopherol for because the difference in the AOAC 960.46, 944.12, and 2004.05) vitamin E (Refs. 18,22,25,140). In bioconversion of b-carotene to vitamin cannot distinguish between naturally response to the 2007 ANPRM, several A will be accounted for with the occurring folate in conventional food comments supported replacing IUs with proposed declaration of vitamin A and folic acid that is added to mcg RAE for vitamin A, mg for vitamin content as ‘‘mcg’’ (representing mcg

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RAE), we are not proposing to preclude methods would be needed for DRV for protein for children 4 or more the declaration of b-carotene in individually measuring naturally years of age, and an RDI for protein for conventional foods as vitamin A. A occurring vitamin E (RRR-a-tocopherol) each of the following subpopulations: corresponding change for dietary and all rac-a-tocopherol acetate in food (1) Children less than 4 years of age; (2) supplements is made in proposed products. Current AOAC methods infants; (3) pregnant women; and (4) § 101.36(b)(2)(i)(B)(3). cannot individually measure these two lactating women (§ 101.9(c)(7)(iii)). In b. Units of Vitamin E Activity—The forms of vitamin E. In addition, it is the preamble to the 1993 DRV/RDI final RDI for vitamin E is 30 IU necessary to know the amount of both rule, we included a table listing RDIs for (§ 101.9(c)(8)(iv)). Before 1980, one IU of RRR-a-tocopherol and all rac-a- various nutrients for these vitamin E activity was defined as 1 mg tocopherol acetate in a food product to subpopulations, based on the 1968 NAS of dl-a-tocopherol acetate by the U.S. calculate vitamin E equivalents for RDAs (58 FR 2206 at 2213). These RDIs Pharmacopeia (USP) (Ref. 142). After declaration as mg a-tocopherol. It is not also appear in FDA’s Food Labeling 1980, the IU was changed to the USP possible to determine the amount of Guide (Ref. 144) and we are aware that unit where one USP unit of vitamin E RRR-a-tocopherol in a food product by some manufacturers use these RDIs in was still defined as having 1 mg of all subtracting the amount of all rac-a- labeling foods represented or purported rac-a-tocopherol acetate. Therefore tocopherol acetate from the total amount to be specifically for these there is no longer an IU for vitamin E of vitamin E declared. Therefore, when subpopulations. (Ref. 142). One comment to the 2007 a conventional food contains a mixture We are reconsidering the ANPRM said that the current RDI of 30 of all rac-a-tocopherol acetate and RRR- requirements for the labeling of foods, IU underestimates the amount of a-tocopherol, we are proposing to other than , represented vitamin E naturally present in foods. We require manufacturers to verify the or purported to be specifically for agree. The RDA for vitamin E is 15 mg/ declared amount of both all rac-a- infants, children under 4 years of age, d of a-tocopherol (Ref. 143). a- tocopherol acetate and RRR-a- and pregnant and lactating women, in Tocopherol is the only form of vitamin tocopherol in the finished food product light of current recommendations in E that is maintained in blood and has (proposed § 101. 9(g)(10)). (See section consensus reports and proposed biological activity. There are eight II.N.) We invite comment on available changes to the Nutrition Facts label stereoisomers of a-tocopherol (RRR, validated methods that are capable of discussed in sections II.A. to II.J., and RSR, RRS, RSS, SRR, SSR, SRS, SSS). Of individually measuring all rac-a- comments to the 2007 ANPRM. We are the eight, only RRR a-tocopherol occurs tocopherol acetate and RRR-a- proposing various changes, which we naturally in foods. Commercially tocopherol. discuss in this document. available vitamin E that is used to fortify For the reasons stated previously, we 1. Age Range for Infants and Young foods and used in dietary supplements are proposing to amend § 101.9(c)(8)(iv) Children contains of either the natural to replace IUs for the RDIs for vitamin RRR- or, more commonly, mixtures of A, vitamin D, and vitamin E with mcg FDA regulations use the age ranges the 8 stereoisomers (all rac a-tocopherol RAE for vitamin A, mg for vitamin D, ‘‘less than 2 years of age’’ and ‘‘less than acetate). Four of the eight stereoisomers and mg a-tocopherol for vitamin E. 4 years of age’’ to establish labeling of a-tocopherol are not maintained in requirements for foods represented or K. Labeling of Foods for Infants, Young human plasma or tissues (SRR, SSR, purported to be specifically for infants Children, and Pregnant or Lactating SRS, and SSS). Thus, the new RDA for and young children (§ 101.9(j)(5)). The Women vitamin E is limited to the four 2R 2007 ANPRM did not ask for comments stereoisomeric forms (RRR, RSR, RRS The general labeling requirements for on this issue, but several comments and RSS) of a-tocopherol (Ref. 143). foods in § 101.9(c) apply to foods for (Ref. 47) recommended that we change These four forms of a-tocopherol are infants, young children, and pregnant the current age categories to infants 7 to found in nonfortified and fortified and lactating women with certain 12 months and young children 1 conventional foods and dietary exceptions. For example, foods, other through 3 years (13 through 48 months), supplements. The all rac-a-tocopherol than infant formula, represented or consistent with the age ranges used in acetate in fortified foods or dietary purported to be specifically for infants the IOM’s age-specific DRI supplements has one-half the activity of and children less than 4 years of age are recommendations. RRR-a-tocopherol naturally found in not permitted to include declarations of In general, we consider it appropriate foods or the 2R stereoisomeric forms of percent DV for the following nutrients: to adopt the same age categories as those a-tocopherol. Unlike the IU, the new Total fat, saturated fat, cholesterol, used in the IOM DRIs for infants and IOM measure of vitamin E activity, mg sodium, potassium, total carbohydrate children because our proposed DVs are a-tocopherol accounts for this difference and dietary fiber (§ 101.9(j)(5)(ii)(A)). based on these age-specific DRIs. With in activity between naturally occurring There are additional exceptions to respect to the infant category, the and synthetic vitamin E. Therefore, labeling for foods, other than infant nutritional requirements of infants 0 to proposed § 101.9(c)(8)(iv) would change formula, represented or purported to be 6 months should be met almost the units of measure for vitamin E to specifically for infants and children less exclusively by breast milk or infant replace ‘‘IU’’ with ‘‘mg,’’ representing than 2 years of age. For example, these formula (Refs. 145 and 146). Therefore, mg of a-tocopherol. Section foods are also not permitted to declare regulations for the labeling of foods, 101.36(b)(2)(ii)(B) for the labeling of calories from fat, calories from saturated other than infant formula, represented dietary supplements includes a fat, saturated fat, polyunsaturated fat, or purported to be specifically for reference to § 101.9(c)(8)(iv), which, as monounsaturated fat and cholesterol on infants 0 to 6 months of age are not proposed, designates the units of the Nutrition Facts label necessary or appropriate. However, measure for declaration of vitamin E as (§ 101.9(j)(5)(i)). infants are transitioning to eating solid ‘‘mg.’’ FDA regulations do not include DRVs foods by 7 through 12 months. There are Because of the difference in vitamin E or RDIs for nutrients, generally, for a number of foods in the marketplace activity between all rac-a-tocopherol infants, children under 4 years of age, or identified for this age group. Therefore, acetate and RRR-a-tocopherol, AOAC pregnant and lactating women. we are proposing a separate category of methods or other validated analytical However, there are requirements for a foods represented or purported to be

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specifically for infants 7 through 12 on food products for children less than of the FD&C Act and we have no basis months. 2 years of age. on which to not require or permit their With respect to children 1 through 3 As discussed in section II.K.1., we are declaration as discussed previously; and years of age, using the DRI age range proposing new categories of infants 7 (2) these nutrients are essential in would result in infants no longer being through 12 months and children 1 fostering growth and maintaining good the lower end of the age range in the through 3 years of age. We are health during a critical stage of human category of infants and children less considering, in this proposed rule, development and physiology (Ref. 147 than 2 years and less than 4 years of age whether there is a need to require or p. 71) and, therefore, their mandatory as specified in § 101.9(j)(5). Young permit the declaration of calories from declaration can assist in maintaining children who are 1 year of age would be fat, saturated fat, and cholesterol in the healthy dietary practices. Therefore, we the lower end of the age range. labeling for foods represented or are proposing to remove current Assigning DVs for children 1 through 3 purported to be specifically for these § 101.9(j)(5)(i) and revise and re- years of age would ensure consistency subpopulations. In section II.A.1., we designate current § 101.9(j)(5)(ii) as with the 1 through 3 year toddler age discuss our intent to revise § 101.9(j)(5)(i). category established for RACCs § 101.9(c)(1)(ii) to no longer require and We request comment on our tentative specified in § 101.12(a)(2). Moreover, not permit the declaration of calories conclusions and any available relevant because the growth velocity in height is from fat on the Nutrition Fact label. empirical research as to whether the most similar for children 1 through 3 Therefore, if these proposed changes are proposed declaration of saturated fat years of age, we consider it appropriate finalized, the exceptions in and cholesterol for these subpopulations to revise the age range to include § 101.9(j)(5)(i) would no longer be is likely to be confusing to consumers or children of these ages into a single needed. otherwise result in restriction of fat category for food labeling purposes (Ref. With respect to saturated fat and intakes among infants 7 through 12 15). cholesterol, we did not require or permit months or children 1 through 3 years of the labeling of any fat or fatty acid on age. Therefore, we are proposing to revise foods represented or purported to be Currently, foods consumed by the exceptions for requirements for specifically for children less than 2 pregnant and lactating women must nutrition labeling provided in years because consensus reports noted declare statutorily required nutrients, § 101.9(j)(5)(i) and the exception to the the need for the higher percentage of including calories, calories from fat, requirement for the format used for calories from fat for this subpopulation total fat, saturated fat, cholesterol, nutrient information on food labeling in and that nutrient guidelines on fats, sodium, total carbohydrate, sugars, § 101.9(d)(1) for foods represented or cholesterol and calories for children less dietary fiber, and protein. Women of purported to be specifically for infants than 2 years of age is inappropriate (58 reproductive age consume the same and children less than 4 years of age. FR 2079 at 2150). A recent consensus foods as the general population and, in Specifically, we are proposing to replace report continues to recommend that fat general, continue consuming similar the current category of infants and intake in infants less than 12 months of foods during pregnancy and lactation. children less than 4 years with infants age should not be restricted; however, We tentatively conclude that, except for 7 through 12 months and children 1 there is no discussion or the declaration of calories from fat, the through 3 years of age. recommendation about not providing declaration of statutorily required 2. Mandatory Declaration of Calories nutrient guidelines for fat and nutrients should be mandatory because and Statutorily Required Nutrients cholesterol to children under the age of the declaration of calories and these 2 years (Ref. 146). While fat is still nutrients is mandated by section 403(q) Currently, foods, other than infant considered to be an important source of of the FD&C Act and we have no basis formula, represented or purported to be calories for infants and young children, on which to not require or permit their specifically for infants and children less recent evidence suggests that a diet with declaration as discussed previously. than 4 years must declare statutorily saturated fat less than 10 percent of Accordingly, we are proposing to required nutrients, including calories, calories and cholesterol intake less than require the mandatory declaration of calories from fat, total fat, saturated fat, 300 mg/d can safely and effectively calories, and the amount of total fat, cholesterol, sodium, total carbohydrate, reduce the levels of total and LDL saturated fat, trans fat, cholesterol, sugars, dietary fiber, and protein. For cholesterol in healthy children (Ref. sodium, total carbohydrate, dietary foods, other than infant formula, 146). This type of diet may have similar fiber, sugars, and protein on foods represented or purported to be for effects when started in infancy and represented or purported to be infants and children less than 2 years, sustained throughout childhood into specifically for infants 7 through 12 the declaration of certain statutorily adolescence (Ref. 146). Furthermore, the months of age, children 1 through 3 required nutrients, which include 2010 DGA recommended that years of age, and pregnant and lactating calories from fat, saturated fat, and Americans 2 years of age and older women, and permit the declaration of cholesterol, is not required or permitted consume less saturated fatty acids and calories from saturated fat such that (§ 101.9(j)(5)(i)). less than 300 mg/d of cholesterol (Ref. these nutrients would be subject to the a. Declaration of Saturated Fat and 6). same requirements applicable to foods Cholesterol—One comment to the 2007 We tentatively conclude that, except for the general population. ANPRM noted that the diet of U.S. for the declaration of calories from fat, A comment to the 2007 ANPRM infants is nutritionally adequate with the declaration of statutorily required requested that we permit the use of a negligible risk of nutrient deficiency nutrients that include saturated fat and footnote statement about not limiting fat and recommended continuing to require cholesterol on the label of foods intake on foods represented or the declaration of calories and the represented or purported to be purported to be specifically for infants amount of total fat, total carbohydrate, specifically for infants 7 through 12 and children less than 2 years to enable dietary fiber, sugars, and total protein months and children 1 through 3 years consumers to make informed choices, on the Nutrition Facts label of foods for of age should be mandatory because: (1) should the Agency decide to propose infants. Another comment supported The declaration of calories and these the mandatory declaration of saturated mandatory declaration of saturated fat nutrients is mandated by section 403(q) fat for infants and children less than 2

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years. The comment noted that protein sources (Ref. 150). However, the physiological endpoints are generally saturated fat should not be limited in level and quality of protein present in not available for infants 7 to 12 months. the diets of children less than 2 years of a food remain an important Therefore, for foods represented or age. The comment provided no consideration in food selection for purported to be for these infants, we are consumer data about such a footnote infants because infant diets are derived not considering consensus reports in the statement. At this time, we are not from a limited number of foods (55 FR way described in section I.C., but, proposing to require a footnote stating 29487 at 29499). For example, at 6 to 11 rather, we are considering other types of that total fat and other types of fat months of age, approximately 46 information that are available from should not be limited in infants and percent of the total protein intake comes consensus reports applicable to this children less than 2 years in response to from sources other than breast milk, subpopulation. With respect to certain this comment. However, we request formula, and cow’s milk (e.g., baby nutrition declaration requirements, we comments and information on how foods and meats) (Ref. 149). The determined there was not sufficient consumers would understand and use percentage increases at ages 12 to 24 evidence to propose a change to the the amount of saturated fat and months to 63 percent (Ref. 149). regulations. In addition, we determined cholesterol declared on the Nutrition Calculating the percent DV for protein that, in some cases, there is not Facts label, as well as on the need for incorporates a measure of protein sufficient evidence to propose different an explanatory footnote to accompany quality (e.g., a corrected protein amount requirements for foods represented or the declaration of saturated fat and obtained from the protein digestibility- purported to be specifically for infants cholesterol, on foods represented or corrected score) (§ 101.9 7 through 12 months than for foods purported to be specifically for infants (c)(7)(i)). Thus, the percent DV represented or purported to be 7 through 12 months or children 1 declaration is a useful tool to indicate specifically for children 1 through 3 through 3 years. protein quality to the consumer. As years of age. b. Percent DV Declaration—Currently, such, we disagree that the percent DV For foods represented or purported to the percent DV declaration is not declaration for protein should be be specifically for children 1 through 3 permitted on the food label for foods, voluntary. Because of the importance of years of age and pregnant and lactating other than infant formula, represented adequate high quality protein in the women, we considered the factors in or purported to be specifically for diets of infants and young children, we section I.C. to determine whether to infants and children less than 4 years tentatively conclude that the percent DV propose the mandatory or voluntary (which includes infants and children declaration for protein is necessary to declaration of non-statutory nutrients. less than 2 years) for total fat, saturated assist consumers in maintaining healthy Most advisory consensus and policy fat, cholesterol, sodium, potassium, total dietary practices among infants and reports on which we rely for the general carbohydrate, and dietary fiber young children 1 through 3 years of age. population apply to children 2 years of (§ 101.9(j)(5)(ii)). Percent DV is required age and older and pregnant and for protein and vitamins and other 3. Declaration of Non-Statutory lactating women, unless noted minerals. We tentatively conclude that Nutrients Other Than Essential otherwise (e.g., 2010 DGAC and health it is appropriate to require declarations Vitamins and Minerals claims (§ 101.14(e)(5)). While the of percent DV for those nutrients for Foods, other than infant formula, recommendations in these reports are which we are establishing a DRV or RDI represented or purported to be for 2 years of age and older, we are for infants 7 to 12 months, for children specifically for infants and children less using the information in these 1 through 3 years of age, and for than 2 years of age are not permitted to consensus reports for considering the pregnant and lactating women (see the declare calories from saturated fat and factors in section I.C. for children 1 discussion in this document for the the amount of polyunsaturated fat and through 3 years of age because it is not nutrients in each subpopulation for monounsaturated fat (§ 101.9(j)(5)(i)), expected that the role of these nutrients which FDA is establishing a DRV or whereas soluble fiber, insoluble fiber, in health would be markedly different RDI). This change is reflected in re- and sugar alcohols can be voluntarily between 1 and 2 year olds. Moreover, designated § 101.9(j)(5)(i). The percent declared. Polyunsaturated fat, the IOM has established the DRI ranges DV, as discussed in section II.B.3., monounsaturated fat, soluble fiber, for 1 to 3 year olds. provides information in a manner which insoluble fiber, and sugar alcohols can a. Voluntary Declaration of Calories enables consumers to understand the be voluntarily declared on the label of From Saturated Fat, and the Amount of relative significance of nutrition foods represented or purported to be Polyunsaturated and Monounsaturated information in the context of a total specifically for children 2 through 4 Fat—For infants 7 to 12 months, there daily diet. years of age, and pregnant and lactating are no specific recommendations One comment to the 2007 ANPRM women. provided about calories from saturated suggested that the percent DV Section I.C. includes a discussion of or polyunsaturated or monounsaturated declaration for protein should be the factors that we consider in fat. However, as discussed previously, voluntary for all infant products, unless proposing the requirements for there is some evidence to suggest that a claim is made for protein because declaration of non-statutorily required reduction of total and LDL cholesterol protein intake and quality appear to be nutrients on the Nutrition Facts label of levels can occur with reducing saturated adequate for infants (Refs. 148 and 149). foods (e.g., polyunsaturated fat, fat intake to less than 10 percent of As we previously stated, protein is of monounsaturated fat, soluble fiber, calories, beginning in infancy and critical importance in maintaining good insoluble fiber, and sugar alcohols). sustained throughout childhood into health because it supplies essential These factors include the availability of adolescence (Ref. 146). Furthermore, amino acids and is a principal source of information from consensus reports, consensus reports provide no discussion calories along with fat and carbohydrate including evidence for the public health or recommendation about not providing (55 FR 29487 at 29499). Current significance of a nutrient. Consensus nutrient guidelines for fatty acids to evidence suggests that protein intake is reports that provide information about children under the age of 2 years and adequate in infants and young children the relationship between nutrients and there is no evidence to suggest that and the majority of protein sources in chronic diseases, heath-related infants 7 through 12 months of age their diets constitute high quality conditions, or health-related would be different than children 1

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through 3 years of age. Therefore, we insoluble fiber, and sugar alcohols on consumption of added sugars for the tentatively conclude that there is no the label of foods represented or U.S. population 2 years of age and older, basis to continue to provide an purported to be specifically for infants but not for infants and children under exception that does not permit the 7 to 12 months, children 1 through 3 age two. However, we would not expect declaration of calories from saturated years of age, or pregnant and lactating the recommendations for added sugars fat, or polyunsaturated and women. for a 2 year old to be different from that monounsaturated fats on foods c. Mandatory Declaration of Trans of a 1 year old because we do not expect represented or purported to be Fat—Trans fat is required to be declared the role of added sugars in health to be specifically for infants and children less on the Nutrition Facts label and markedly different between children 1 than 2 years of age. regulations do not provide exceptions and 2 year olds. Moreover, the IOM has Quantitative intake recommendations for foods represented or purported to be established DRI ranges for 1 through 3 are not available from relevant U.S. specifically for infants, young children, year olds because growth velocity is consensus reports for monounsaturated or pregnant and lactating women. One most similar during this age range (Ref. and polyunsaturated fats for children 1 comment to the 2007 ANPRM 15). Further, mandatory declaration of through 3 years of age or pregnant and recommended eliminating mandatory added sugars would be important for lactating women. There is well- trans fat labeling when total fat is foods for infants 7 through 12 months, established evidence to indicate that declared as 0 g in the Nutrition Facts as it is for the general population, to replacing saturated fatty acids with label of foods for infants. assist consumers in choosing nutrient- polyunsaturated and monounsaturated As explained in section II.B.3., we are dense foods for infants 7 through 12 fatty acids reduces blood LDL not proposing any changes to the months during this phase of accelerated cholesterol levels and, therefore, the risk mandatory declaration of trans fat in the growth and development. Moreover, we of CVD (Ref. 6). Because labeling of foods intended for the do not have any information that monounsaturated and polyunsaturated general population. The relationship providing added sugars information on fats have public health significance between the consumption of trans fat the Nutrition Facts label of foods when they replace saturated fat, and risk of CHD is well established marketed to the subpopulations of consistent with the factors we consider (Refs. 6 and 49). Cardiovascular disease infants 7 through 12 months and for voluntary declaration discussed in is also known to begin in childhood children 1 to 3 years of age would not section I.C., we tentatively conclude (Refs. 146 and 151). Thus, we assist in maintaining healthy dietary that not permitting the declaration of tentatively conclude that declaration of practices. polyunsaturated and monounsaturated trans fat continues to be necessary to Therefore, we are proposing the fat on foods represented or purported to assist consumers in maintaining health mandatory declaration of added sugars be specifically for children less than 2 dietary practices, including among on the Nutrition Facts label of foods years of age in § 101.9(j)(5)(i) is no infants, young children, and pregnant represented or purported to be longer necessary. and lactating women. specifically for infants 7 through 12 Therefore, we are proposing to revise Trans fat declaration is voluntary months, children 1 through 3 years of § 101.9(j)(5)(i) to remove the exceptions when the total fat content of a food is age, and pregnant and lactating women. for the declaration of calories from less than 0.5 g (§ 101.9(c)(2)(ii)). In We request comment on our tentative saturated fat, and the amount of addition, if a manufacturer does not conclusion. polyunsaturated fat and declare the trans fat content because e. Voluntary Declaration of Fluoride— monounsaturated fat on foods total fat amount is less than 0.5 g, then FDA regulations do not provide for the represented or purported to be the statement ‘‘Not a significant source declaration of fluoride on the Nutrition specifically for children less than 2 of trans fat’’ must be placed at the Facts label of any foods. For the reasons years of age. If finalized, these bottom of the table of nutrient values. discussed in section II.G., we are declarations would be the same as the This statement indicates why proposing to permit voluntary proposed voluntary declarations for information that is required to be declaration of fluoride on the labeling of foods for the general population (see declared is omitted and provides foods for the general population based sections II.A.2, II.B.4, and II.B.5., necessary information to assist in on the factors we consider in section I.C. respectively). making healthy dietary choices (55 FR and fluoride’s role in reducing the risk b. Voluntary Declaration of Soluble 29487 at 29502). The statement is also of dental caries. Because fluoride Fiber, Insoluble Fiber, and Sugar helpful in minimizing space provides protection against dental caries Alcohols—As discussed in section II.D., requirements for labels that do not meet by strengthening the tooth enamel while quantitative intake the simplified label format requirements before and after teeth appear (Ref. 90) recommendations are lacking for soluble (58 FR 2079 at 2084). and because excessive fluoride intake fiber, insoluble fiber, and sugar Therefore, we are not proposing any can cause dental fluorosis in young alcohols, there is well established changes to the mandatory declaration of children (Ref. 92), we tentatively evidence for the role of these nutrients trans fat on the label of foods conclude that the declaration of fluoride in chronic disease risk, risk of a health- represented or purported to be on foods represented or purported to be related or a physiological endpoint (i.e., specifically for infants, children 1 specifically for children 1 through 3 CHD, laxation or dental caries) (Ref. 66 through 3 years of age, or pregnant and years of age, and pregnant and lactating and §§ 101.76, 101.77, 101.80, and lactating women. women can assist in maintaining 101.81). There is no evidence to suggest d. Mandatory Declaration of Added healthy dietary practices. While that the role of these nutrients would be Sugars—Whereas FDA regulations do evidence on dental caries is lacking for different among infants 7 through 12 not provide for the declaration of added infants 7 through 12 months of age, months, children 1 through 3 years of sugars on the Nutrition Facts label, as there is no reason to expect the role of age, or pregnant and lactating women explained in section II.D.3., we are fluoride in the protection against dental compared to the general population. proposing to require the mandatory caries to be different from other age Accordingly, we are not proposing declaration of added sugars on the groups. Therefore, proposed any changes to the provisions for the Nutrition Facts label. The 2010 DGA § 101.9(c)(5) would permit the voluntary voluntary declaration of soluble fiber, provides recommendations for declaration of fluoride on foods

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represented or purported to be rationale as we set forth and proposed development of eating patterns that are specifically for infants 7 through 12 for the general population because associated with adequate calcium intake months of age, children 1 through 3 scientific and policy considerations are later in life is important (Ref. 153) given years of age, and pregnant and lactating generally the same and the DGA that calcium intakes are inadequate for women. recommendations apply to Americans 2 the majority of the population (see table years of age and older. While NHANES 1). Intakes of calcium, which is 4. Declaration of Essential Vitamins and data were collected in lactating women, necessary for growth and bone Minerals these data are not included in our development, are inadequate among The declarations of vitamin A, analysis in this document because the children. Similar to the general vitamin C, calcium, and iron are sample size of lactating women was population, approximately 20 percent of required on the Nutrition Facts label, small and, thus, we could not reliably pregnant women consumed less than and there are no specific exceptions to estimate mean intake and status of this the EAR for calcium from conventional this requirement for foods represented population. However, the conclusions foods as well as from conventional or purported to be specifically for made about nutrient inadequacy during foods and supplements (table 5). infants and children less than 2 years pregnancy are applied to lactating Consistent with the factors we and children less than 4 years of age, women since the needs of essential consider for essential vitamins and and pregnant and lactating women. We vitamin and minerals are increased for minerals (see section I.C.), we considered the factors for mandatory both pregnant and lactating women. tentatively conclude that calcium is a and voluntary declaration of nutrients Therefore, we are proposing the nutrient of public health significance for discussed in section I.C., as applicable, requirements related to essential children 1 through 3 years of age, and to determine whether to propose to vitamins and minerals in the labeling of pregnant and lactating women. Because require or permit certain vitamins and foods for pregnant women and those for calcium is important for growth and minerals in the labeling of foods for foods for lactating women should be the development, we tentatively conclude infants, children, and pregnant and same. Accordingly, we are proposing to that calcium is of public health lactating women. remove the provision in § 101.9(c)(8)(i) significance for infants 7 through 12 The AIs for essential vitamins and that requires separate declaration of months of age. As such, we agree with minerals (and RDAs for iron and zinc) percent DVs based on both RDI values the comment that recommended for infants 7 to 12 months of age are for pregnant women and for lactating mandatory declaration of calcium for based on the average intake of nutrients women in the labeling of foods foods purported to be specifically for that infants consumed from breast milk, represented or purported to be for use young children. complementary foods, and/or by both pregnant and lactating women. We are not proposing any changes to supplements with the understanding We did not ask questions related to the mandatory declaration of iron on that these sources provided sufficient this issue in the 2007 ANPRM, but foods for the general population (see amounts of the nutrients to meet the received some comments which we section II.H.1.). Although the EAR and infant’s daily needs (Refs. 18, 22, and considered in reaching our tentative RDA are based on daily iron 23). Therefore, the AIs (as well as the conclusions discussed in this document. requirements and not directly on RDAs for iron and zinc) for infants were a. Mandatory Declaration of Calcium chronic disease risk, iron deficiency is not based on endpoints related to and Iron—We are not proposing any associated with delayed normal infant chronic disease risk, or a health-related changes to the mandatory declaration of motor function (i.e., normal activity and conditions or health-related physiology. calcium on foods for the general movement) and mental function (i.e., Furthermore, because the AI represents population (see section II.H.1.). The AI normal thinking and processing skills) intakes that are considered adequate for calcium for infants 7 through 12 (Ref. 100). Our analysis of NHANES and are based on average nutrient months of age is based on average 2003–2006 data estimated that about 18 intakes from breast milk, foods, and/or calcium consumption of these nutrients, percent of infants ages 7 to 12 months supplements, the presence of an AI rather than chronic disease risk, health have usual iron intakes below the EAR, indicates that there is not a public related-condition, or physiological based on intakes from conventional health concern about adequate intake of endpoints (Ref. 152). For children 1 foods only and 4 percent of infants ages that nutrient. Therefore, we could not through 3 years of age, and pregnant and 7 to 12 months have usual iron intakes determine public health significance for lactating women, the RDAs for calcium below the EAR based on intakes from a nutrient during infancy based on an AI are based, in part, on bone health (Ref. conventional foods and supplements for infants. Instead, we considered the 22). One comment to the 2007 ANPRM (table 3). importance of the nutrient in recommended mandatory declaration of For children 1 through 3 years of age, establishing healthy dietary practices calcium and iron for labeling of foods about 1 percent of children have usual during infancy for later in life, as well for young children. iron intakes below the EAR, based on as the relevant available information for Our analysis of NHANES 2003–2006 intakes from conventional foods only children 1 through 3 months of age that data estimated that infants ages 7 to 12 and 0.4 percent of children have usual may also be applicable to infants. For months have usual calcium intakes iron intakes below the EAR based on nutrients with an RDA for infants 7 above the AI (table 3). Our analysis of intakes from conventional foods and through 12 months of age (i.e., iron and NHANES 2003–2006 estimated that supplements (table 4). The IOM set the zinc), we considered the factors for about 12 percent of children 1 through EAR by modeling components of iron mandatory and voluntary labeling 3 years of age had usual intakes of requirements. While total iron intakes described in section I.C. to determine calcium below the EAR, based on appear adequate, the prevalence of iron whether to propose mandatory or intakes from conventional foods only deficiency in children ages 1 to 2 years voluntary labeling for the nutrient. (table 4). The percentage did not change has been reported to be 14.4 percent and For the declaration of essential when supplements were included. We the prevalence of iron deficiency vitamins and minerals for children 1 are unable to consider biomarker data anemia in children younger than 5 years through 3 years of age and pregnant and because sensitive biochemical has been reported to be 14.9 percent lactating women, we propose the same indicators reflecting calcium nutritional (Refs. 74 and 154). Therefore, we agree considerations based on the same status are lacking. Promoting the with the comment that recommended

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mandatory declaration of iron in the section II.H.1.). The AI for vitamin D for intake and reduced risk of osteoporosis labeling of foods for young children. infants was based on maintenance of (§ 101.72), signifying vitamin D’s critical Inadequate iron intakes during serum 25(OH)D concentrations at a level role in the risk reduction of this chronic pregnancy are also of public health to achieve and maintain serum 25(OH)D disease for individuals 2 years of age significance because of the adverse concentrations above a defined level (30 and older. We also tentatively conclude effects for both the mother and the fetus to 50 nmol/L) in order to meet the needs that vitamin D is of public health (such as maternal anemia, premature of the majority of the infants and significance for infants 7 through 12 delivery, low , and support bone accretion (Ref. 22). DRIs months of age based on its importance increased perinatal ) (EAR and RDA) for vitamin D were for growth and development during (Ref. 15). Our analysis of data collected established at a level to achieve and infancy. by NHANES 2003–2006 estimated that 5 maintain serum 25(OH)D concentrations We are proposing to require the percent of pregnant women 14 to 50 above a defined level (40 to 50 nmol/L) declaration of potassium on foods for years of age had usual iron intakes in order to maintain bone health for the general population (see proposed below the EAR based on intakes from children 1 through 3 years of age and § 101.9(c)(8)(ii) and section II.H.1.). The conventional foods and 4 percent of pregnant women (Ref. 22). AI for infants is based on average pregnant women 14 to 50 years of age Serum 25(OH)D data were not potassium intake from breast milk had usual iron intakes below the EAR available in NHANES 2003–2006 for and/or complementary foods. The AI for based on intakes from conventional infants ages 7 to 12 months. Our the other life-stage and gender groups is foods and supplements (table 5). The analysis of NHANES 2003–2006 dietary set at a level to maintain blood pressure, EAR for iron for pregnant women was data shows that 28.7 and 33.6 percent of reduce the adverse effects of sodium based on estimates of iron stores needed infants ages 7 to 12 months have usual chloride intake on blood pressure, and during the first trimester (Ref. 100). Our vitamin D intakes above the AI from reduce the risk of recurrent kidney analysis of 2003–2006 NHANES data conventional foods and conventional stones (Ref. 21). indicate that among pregnant women foods plus supplements, respectively Our analysis of NHANES 2003–2006 aged 12 to 49 years, 25 percent were (table 3). shows that 99 percent of infants ages 7 iron deficient and 13 percent had iron Our analysis of NHANES 2003–2006 to 12 months have usual potassium deficiency anemia. For the purpose of data shows that about 3 percent of intakes above the AI (table 3). Only 7 this analysis, iron deficiency was based children 1 through 3 years of age had percent of children 1 through 3 years of on two out of three cutoffs of iron serum 25(OH)D levels below 40 age (table 4) and 4 percent of pregnant deficiency variables (transferrin nmol/L (a level set by IOM as equivalent women (table 5) had usual potassium saturation, serum ferritin, and to EAR, see section II.H.2.a). Analysis of intakes above the AI from conventional erythrocyte protoporphyrin) (Ref. 155). NHANES 2005–2008 dietary data shows foods or conventional foods plus dietary While intakes appear adequate for most that, assuming minimal sun exposure, supplements, indicating that the individuals, the prevalence of iron about 82 percent of these children had adequacy of intakes is very low. In the deficiency and iron deficiency anemia usual vitamin D intakes below the EAR absence of a sensitive biochemical indicates that iron deficiency is of from conventional foods only and 66 indicator of potassium nutritional public health significance for pregnant percent had usual intakes below the status, we could not consider biomarker women. As discussed in section II.H.1., EAR from conventional foods and data to inform the determination of iron is of public health significance for supplements (table 4). For pregnant prevalence of potassium deficiency. In women of childbearing age. Therefore, women, 15 percent had serum 25(OH)D 2000, a FDAMA notification for a health we tentatively conclude that iron is a levels below 40 nmol/L, while about 88 claim about potassium, blood pressure, nutrient of public health significance for percent of pregnant women had usual and stroke was submitted to us under lactating women as well. vitamin D intakes below the EAR from section 403(r)(2)(g) of the FD&C Act Because calcium and iron have conventional foods only and 48 percent (Ref. 114). Foods may bear the following quantitative intake recommendations had usual intakes below the EAR from claim ‘‘Diets containing foods that are and are considered to have public conventional foods and supplements good sources of potassium and low in health significance for infants 7 through (table 5). In addition to data on vitamin sodium may reduce the risk of high 12 months, children 1 through 3 years D status and intake, we considered other blood pressure and stroke,’’ on the label of age, and pregnant and lactating scientific and policy considerations, or labeling of any food product that women, we tentatively conclude that such as the importance of the nutrient meets the eligibility criteria described in the declaration of calcium and iron is in establishing healthy dietary practices the notification and meets the general necessary to assist consumers in for later life for children 1 through 3 requirements for a health claim maintaining healthy dietary practices. years of age and pregnant and lactating (§ 101.14(e)(6)). This health claim Accordingly, proposed § 101.9(c)(8)(ii) women. Vitamin D has a role in bone pertains to the general population 2 would require the mandatory health through calcium absorption and years of age and older. Thus, we declaration of calcium and iron on foods uptake by bones (Ref. 22). Deficiency recognize the importance of potassium represented or purported to be results in inadequate bone in the risk reduction of these chronic specifically for infants 7 to 12 months, mineralization or demineralization of diseases for children 2 years of age and children 1 through 3 years of age, or the skeleton including rickets, older. Therefore, we tentatively pregnant and lactating women; we are osteomalacia, and osteoporosis (Ref. 22). conclude that potassium is of public not providing for any exceptions for Therefore, we tentatively conclude that health significance to children 1 these subpopulations from the vitamin D has public health significance through 3 years of age, and pregnant and requirement for declaration of calcium in children 1 through 3 years of age and lactating women. We have no basis to and iron applicable to foods for the pregnant women based on the high conclude that the public health general population. prevalence of inadequate intakes of significance of potassium among infants b. Mandatory Declaration of Vitamin vitamin D and its important role in bone 7 through 12 months of age would be D and Potassium—We are proposing to development and health (Ref. 22). In different than the science-based require the declaration of vitamin D on addition, in 2008, we authorized a evidence for children 1 through 3 years foods for the general population (see health claim for calcium and vitamin D of age and consider it important to

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establish healthy dietary practices for infants or lactating women. Therefore, choline on foods represented or later life. Because of the benefits of we tentatively conclude that vitamin A purported to be specifically for infants adequate potassium intake in lowering and vitamin C are not of public health 7 to 12 months, children 1 through 3 blood pressure, data indicating low significance among infants 7 through 12 years of age, or pregnant and lactating likelihood of potassium adequacy, and months of age, children 1 through 3 women, under the requirements of this importance of establishing healthy years of age, and pregnant and lactating section, unless they are added to foods dietary practices for later life, we women. Thus, we agree with a comment as a nutrient supplement or if the label tentatively conclude that potassium is a that supported voluntary declaration of or labeling makes a claim about them, nutrient of public health significance for vitamins A and C in the labeling of in which case the nutrients would have infants 7 through 12 months of age, foods for young children. An AI for to be declared. children 1 through 3 years of age, and older infants was provided by the IOM 5. DRVs and RDIs for Infants 7 Through pregnant and lactating women. with the assumption that vitamin A and 12 Months of Age We are proposing to require the vitamin C intakes are adequate during labeling of vitamin D and potassium on infancy. Accordingly, similar to our FDA regulations do not include DRVs foods represented or purported to be proposal for voluntary declaration of or RDIs for nutrients for infants 7 specifically for infants 7 through 12 vitamins A and C in the labeling of through 12 months of age, except an RDI months of age, children 1 through 3 foods for the general population, we are for protein of 14 g for infants. We years of age, or pregnant and lactating proposing to permit, but not require, the reviewed scientific evidence and women based on the quantitative intake declaration of vitamin A and vitamin C recommendations, as well as comments recommendations for vitamin D and on foods represented and purported to in response to the 2007 ANPRM to potassium and the public health be specifically for infants 7 through 12 consider establishing DRVs and RDIs for significance of these nutrients. months, children 1 through 3 years of nutrients for infants 7 through 12 Consequently, we are not providing for age, or pregnant and lactating women. months of age and to consider revisions any exceptions for these subpopulations As for other voluntary nutrients, the to the current RDI for protein. a. Calories—We have not established from the general requirement for declaration of these nutrients would be a reference calorie intake level for declaration of vitamin D and potassium required when these nutrients are added infants and children less than 2 years of in proposed § 101.9(c)(8)(ii). as nutrient supplements or claims are age. For the general population, a c. Voluntary Declaration of Vitamin A made about them (proposed reference calorie intake level is and Vitamin C—We are proposing to no § 101.9(c)(8)(ii)). longer require the declaration of vitamin necessary when using a percent of A and vitamin C on foods for the general d. Voluntary Declaration of Other calories approach to calculating the population (see section II.H.1.). None of Vitamins and Minerals—As discussed DRV for nutrients, such as total fat and the DRIs (AIs or RDAs) for vitamin A in section II.H.3., for the general carbohydrate. There is no quantitative were based on chronic disease risk, a population, we are proposing to permit intake recommendation for calories for health related-condition, or health- the voluntary declaration of vitamin E, infants and we are not aware of other related physiological endpoints. One vitamin K, vitamin B6, vitamin B12, scientific data and information on comment to the 2007 ANPRM stated thiamin, riboflavin, niacin, folate, which we could rely to establish that that intakes of vitamins A and C among biotin, pantothenic acid, phosphorus, level. Therefore, we are not proposing to young children appear to be adequate iodine, magnesium, zinc, selenium, establish a reference calorie intake level (Ref. 148) and supported voluntary copper, manganese, chromium, for infants 7 to 12 months. declaration of these nutrients in the molybdenum, chloride, and choline b. Total Fat—The IOM set an AI of 30 labeling of foods for this subpopulation. (proposed § 101.9(c)(8)(ii)). Vitamins g/d for fat for infants 7 through 12 Our analysis of data from NHANES and minerals other than iron, calcium, months of age based on the average 2003–2006 shows that less than 2 vitamin D and potassium for infants intake of human milk and percent of children had usual vitamin A either have DRIs that are not based on complementary foods (Ref. 49). There intakes below the EAR from chronic disease risk, heath-related was no AI available in 1993. The current conventional foods or conventional conditions, or health-related AI provides a basis on which we can foods plus dietary supplements (table physiological endpoints or are not determine an appropriate DRV for total 4). While 36 percent of pregnant women shown to have public health fat for this subpopulation that can assist had usual intakes below the EAR from significance due to the prevalence of a consumers in maintaining healthy conventional foods and 22 percent had clinically relevant nutrient deficiency. dietary practices among this usual intakes below the EAR for For infants 7 to 12 months, children 1 subpopulation. Therefore, we are conventional foods plus dietary through 3 years of age, and pregnant and proposing to amend § 101.9(c)(9) to supplements, only 1 percent of these lactating women, we tentatively include a DRV of 30 g for fat for infants women had serum vitamin A levels that conclude that the essential vitamins and 7 through 12 months of age. were considered to be indicative of a minerals, other than iron, calcium, c. Saturated Fat, Trans Fat, vitamin A deficiency (table 5). vitamin D and potassium, do not have Cholesterol, Dietary Fiber and Sugars— While quantitative intake public health significance and there is There are no quantitative intake recommendations are available for no basis for the declaration of these recommendations from U.S. consensus vitamins A and C, neither of these nutrients to be different from that reports available for saturated fat, trans vitamins is considered to have public proposed for the general population. fat, cholesterol, dietary fiber, and sugars health significance for children 1 Accordingly, proposed § 101.9(c)(8)(ii) for infants. We are not aware of other through 3 years of age and pregnant would allow the voluntary declaration scientific data and information on women. There is a very low prevalence of vitamin E, vitamin K, vitamin B6, which we could rely to establish DRVs of inadequate intakes of vitamins A and vitamin B12, thiamin, riboflavin, niacin, for these nutrients for infants 7 through C or inadequate status among children folate, biotin, pantothenic acid, 12 months of age. Accordingly, we are 1 through 3 years of age or pregnant phosphorus, iodine, magnesium, zinc, not proposing to establish DRVs for women, and we have no evidence to selenium, copper, manganese, these nutrients for infants 7 through 12 indicate that this would be different for chromium, molybdenum, chloride, and months of age.

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d. Polyunsaturated Fat, g/d. Accordingly, we are proposing to subpopulation. We consider it Monounsaturated Fat, Insoluble Fiber, revise § 101.9(c)(9) to establish an RDI of appropriate to use RDAs and, in the Soluble Fiber, Insoluble Fiber, Added 11 g for protein for infants 7 through 12 absence of RDAs, AIs to determine Sugars, and Sugar Alcohols— months of age. appropriate micronutrient RDIs for Quantitative intake recommendations g. Sodium—For the general infants. While there is more certainty from U.S. consensus reports are not population, we are proposing to with RDAs than AIs, both RDAs and AIs available for polyunsaturated fat, establish a DRV for sodium based on the are sufficient for setting RDIs, because monounsaturated fat, insoluble fiber, IOM’s UL (section II.F.). The IOM did they both represent intake levels that are soluble fiber, added sugars, or sugar not set a UL for sodium for infants 7 expected to meet or exceed the nutrient alcohols for infants. We are not aware of through 12 months of age due to needs of the majority of infants (Ref. other scientific data and information on insufficient data on adverse effects of 157). which we could rely to establish DRVs chronic overconsumption in this age We also considered and rejected an for these nutrients for this group (Ref. 10). We are not aware of approach, as suggested by a comment, subpopulation. Accordingly, we are not other scientific data and information on where the highest reference value proposing to establish DRVs for these which we could rely to establish a DRV available would be used for each nutrients for infants 7 through 12 for sodium for this subpopulation. nutrient, irrespective of whether it is an months of age. Therefore, we are not proposing a DRV RDI based on the 1968 RDAs, a current e. Total Carbohydrate—The IOM has for sodium for infants 7 through 12 RDA, or a current AI. The IOM set an AI of 95 g/d for carbohydrates for months of age. established DRIs based on scientific infants 7 through 12 months of age h. Fluoride—As discussed in section knowledge that update and supersede based on the average intake of human II.G., although the IOM set an AI for previous RDA recommendations. milk and complementary foods (Ref. fluoride, the AIs for infants 7 through 12 Because DRIs are available for infants 7 68). There was no AI available in 1993. months and children 1 through 3 years through 12 months of age, we are The current AI provides a basis on are close to the EPA benchmarks for proposing to use these current which we can determine an appropriate total fluoride intake (Ref. 92). We are quantitative intake recommendations DRV for total carbohydrate for this not proposing a DRV for fluoride for use (i.e., AIs and RDAs) for setting RDIs for in the labeling of foods for the general subpopulation that can assist consumers infants. in maintaining healthy dietary practices population because of a concern about Accordingly, we are proposing to among this subpopulation. Therefore, excess intakes associated with dental amend § 101.9(c)(8)(iv) to include a we are proposing to amend § 101.9(c)(9) fluorosis (section II.G.). Therefore, we listing of RDIs for vitamin A, vitamin C, to establish a DRV of 95 g for total tentatively conclude that a DRV for vitamin D, vitamin E, vitamin K, carbohydrate for infants 7 through 12 fluoride is not warranted for infants 7 vitamin B , folate, choline, riboflavin, months of age. through 12 months. The use of such a 12 f. Protein—The DV for protein for DRV to calculate percent DV may have niacin, vitamin B6, calcium, iron, infants is an RDI, rather than a DRV. the unintended effect of consumers thiamin, biotin, pantothenic acid, Before 1993, we established the RDIs for selecting foods with higher fluoride phosphorous, iodine, magnesium, zinc, protein for all age groups based on the amounts, which are not necessary or selenium, copper, manganese, 1989 RDA. In 1993, we changed the RDI advised. Accordingly, we are not chromium, molybdenum, chloride, and for protein for the general population to proposing to establish a DRV for potassium for infants 7 months through a DRV in response to comments that fluoride for infants 7 through 12 months 12 months of age. suggested the DV for protein should be of age. We invite comment on the adequacy consistent with the ‘‘percent of calories’’ i. Vitamins and Minerals—As noted of the proposed RDIs for vitamins and approach used for the other energy- previously in the introduction to section minerals for older infants. yielding macronutrients, total fat and II.K., while not included in current 6. DRVs and RDIs for Children 1 total carbohydrate (58 FR 2206 at 2216). regulations, the preamble to the 1993 Through 3 Years of Age However, we retained the RDI for DRV/RDI final rule provides a table infants, and based it on the highest 1968 listing RDIs for infants (58 FR 2206 at FDA regulations do not include DRVs RDA value (14 g/d for infants), to be 2213), which is also provided in FDA’s or RDIs for nutrients for children 1 consistent with a population-coverage Food Labeling Guide (Ref. 144). We through 3 years of age, except an RDI for approach (58 FR 2206 at 2216). reviewed current quantitative intake protein of 16 g for children less than 4 We find no reason to change the recommendations for vitamins and years of age. We reviewed scientific approach of using the RDI for infants 7 minerals for infants and considered evidence and current recommendations, through 12 months. However, we comments received in response to the as well as comments in response to the consider it appropriate to revise the RDI 2007 ANPRM (Ref. 47) to determine 2007 ANPRM to consider establishing to rely on current quantitative intake appropriate RDIs for vitamins and DRVs and RDIs for nutrients for this recommendations. In 2002, the IOM minerals to be established in regulations subpopulation and to consider revisions established an RDA for infants 7 for infants 7 through 12 months of age. to the current RDI for protein. through 12 months of 1.2 g/kg/d based We consider it important to establish a. Calories—We have not established on nitrogen balance studies and using a RDIs for infants 7 through 12 months of a reference calorie intake level for reference body weight of 9 kg (Ref. 84). age because infants in this age range nutrition labeling for children ages 1 This reference body weight is also transition from a diet of mostly breast through 3 years. Several comments to consistent with current growth charts milk and infant formula to infant cereal the 2007 ANPRM supported for infants (Ref. 156). The value 1.2g/kg/ and baby foods (Ref. 147 p. 71) and establishing a DV for calories g×9 kg equals 10.8 g/d or a rounded labeling foods for this subpopulation specifically for young children 1 value of 11 g/d. In addition, protein with percent DV declarations can assist through 3 years of age. Citing the IOM intakes are well above the current and parents in making nutritious food and AAP/AHA caloric intake proposed RDI. Mean protein intake for choices. The DRIs (AIs and RDAs) recommendations (Refs. 50 and 71), one infants 6 to 11 months of age was 22 provide a basis on which to determine comment recommended 1,050 calories g/d (Ref. 150), well above the RDA of 11 RDIs for vitamins and minerals for this as the DV for calories and supported

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rounding it down to 1,000 calories to of calories for saturated fat, 2 percent of The IOM based AIs for n-6 linoleic and facilitate use by consumers. calories for trans fat based on estimates n-3 a-linolenic acid on U.S. median We consider it appropriate to of mean trans fat intake for the U.S. intake levels because of the lack of establish a reference calorie intake level population 3 years of age and older, and linoleic and a- linolenic acid deficiency for children 1 through 3 years of age less than or equal to 300 mg/d for in non-institutionalized populations in because, as discussed in this document, cholesterol based on the 2005 DGA the United States (Ref. 49). we are proposing to set DRVs using recommendation. For children 1 through 3 years of age, quantitative intake recommendations Cardiovascular disease is known to DRIs or other data and information are that are based on calories (e.g., total fat, begin in childhood (Refs. 146 and 151). not available on which we could rely to saturated fat, and dietary fiber). Current The 2010 DGA recommends that establish DRVs for polyunsaturated fat, recommendations from the IOM, AHA, Americans 2 years of age and older monounsaturated fat, sugars, added AAP, and the 2010 DGA for caloric consume less than 10 percent of calories sugars, insoluble fiber, soluble fiber, and intake range from 800 to 900 calories/d from saturated fat and less than 300 mg/ sugar alcohols. Therefore, we tentatively for children 1 year old, approximately d of cholesterol (Ref. 6). Based on these conclude that there is no basis for 1,000 calories/d for children 2 years of recommendations, we tentatively setting DRVs for these nutrients. age, and from 1,000 to 1,200 calories/d conclude that it is appropriate to set a Accordingly, we are not proposing for children 3 years of age (Refs. 6, 50, DRV of 10 g for saturated fat, based on DRVs for polyunsaturated fat, including and 71) . We consider that an average 10 percent of total calories from n-3 or n-6 polyunsaturated fatty acids, of the range of these caloric intake saturated fat and using the proposed monounsaturated fat, sugars, added recommendations (800 to 1,200 calories/ reference calorie intake level of 1,000 sugars, soluble fiber, insoluble fiber, or d), i.e., 1,000 calories/d, provides a calories/d which equals 11 g, rounded sugar alcohols for children 1 through 3 reasonable reference calorie intake level. down to 10 g, and a DRV of 300 mg for years of age. Therefore, we are proposing to amend cholesterol for children 1 through 3 e. Total Carbohydrate—There is not a § 101.9(c)(9) to provide a reference years of age. The comment provided no DRV for total carbohydrate for children calorie intake level of 1,000 calories/d rationale for using an upper range of 15 1 through 3 years of age. One comment for children 1 through 3 years of age. percent of calories from saturated fat. to the 2007 ANPRM suggested that we b. Total Fat—There is no DRV for total We have no information to indicate that establish a DV for carbohydrates using fat for children ages 1 through 3 years. applying the level of 10 percent of 59 percent of calories from One comment to the 2007 ANPRM calories from saturated fat to this carbohydrates, or 154 g using the recommended that 35 percent of the subpopulation is restrictive, as the method of calculation by difference. recommended 1,050 calories or 41 g/d comment asserted. Accordingly, we are As discussed in section II.D.1., we are of fat be used to as the DRV for fat proposing to amend § 101.9(c)(9) to proposing a DRV for total carbohydrate because it is the midpoint of the AAP/ establish a DRV of 10 g for saturated fat for the general population based on the AHA recommendation and the IOM and a DRV of 300 mg for cholesterol for percentage of calories in a 2,000 calorie Acceptable Macronutrient Distribution children 1 through 3 years of age. diet remaining after the sum of the DRV Range (AMDR) for 1 through 3 year olds. Current recommendations from the for fat (30 percent) plus the DRV for We agree that 35 percent of calories IOM (Ref. 49) and 2010 DGA (Ref. 6) protein (10 percent) have been from fat for children 1 through 3 years recommend keeping trans fat intake as subtracted. We also consider this of age, the midpoint of the IOM AMDR low as possible but do not provide any method to be appropriate for setting a of 30 to 40 percent, serves as an specific appropriate levels of intake. DRV for total carbohydrate for children appropriate basis on which to set the Thus, consistent with our discussion in 1 through 3 years of age. Total calories DRV for total fat. This approach to section II.B.3., we disagree with the (100 percent) minus the proposed DRV calculating the DRV for total fat is comment that suggested setting a DRV for total fat (35 percent of calories) and consistent with our proposed approach for trans fat and, therefore, we are not the proposed DRV for protein (5 percent to setting the DRV for total fat for the proposing to establish a DRV for trans of calories) equals 60 percent of calories general population. Thirty-five percent fat in response to this comment. from total carbohydrate. A value of 60 is also consistent with AHA and AAP d. Polyunsaturated Fat, percent of total calories from total recommendations that 30 to 40 percent Monounsaturated Fat, Sugars, Added carbohydrates also falls within the IOM of calories consumed by children 12 Sugars, Insoluble Fiber, Soluble Fiber, AMDR recommendation of 45 to 65 through 24 months of age and 30 to 35 and Sugar Alcohols—There are no DRVs percent of calories from carbohydrates percent of calories consumed by for polyunsaturated fat, for children 1 through 3 years of age. children 24 through 48 months of age monounsaturated fat, sugars, added Therefore, we tentatively conclude that should come from fat (Ref. 71). sugars, insoluble fiber, soluble fiber, or an appropriate DRV for total Therefore, we tentatively conclude that sugar alcohol for children 1 through 3 carbohydrate is 60 percent of calories 35 percent of total calories from fat (i.e., years of age. One comment to the 2007 (i.e., 150 g using the proposed reference 39 g using the proposed reference ANPRM recommended establishing a calorie intake level of 1,000 calories/d). calorie intake level of 1,000 calories/d) DV for n-3 polyunsaturated fatty acids Accordingly, we are proposing to amend is an appropriate DRV for total fat for (a-linolenic acid) of 700 mg/d because § 101.9(c)(9) to set a DRV of 150 g for children 1 through 3 years of age. a- linolenic acid is essential to the total carbohydrate for children 1 Accordingly, we are proposing to amend human diet and children 1 through 3 through 3 years of age. § 101.9(c)(9) to establish a DRV of 39 g years of age are below recommended f. Dietary Fiber—There is not a DRV for fat for children 1 through 3 years of intake levels. We disagree that a DRV for dietary fiber for children 1 through age. should be set for n-3 polyunsaturated 3 years of age. One comment to the 2007 c. Saturated Fat, Trans Fat, and fatty acids for children 1 through 3 years ANPRM recommended using 15 g/d as Cholesterol—There are no DRVs for of age for the same reasons that we are the basis of the DRV for dietary fiber, saturated fat, trans fat, or cholesterol for not proposing a DRV for these fatty based on the AI of 14 g/1,000 calories children 1 through 3 years of age. Once acids for the general population (see and a 1,050 calorie diet. We agree that comment to the 2007 ANPRM suggested section II.B.). We recognize the essential the AI of 14 g/1,000 calories for dietary using the midpoint of 10 to 15 percent nature of a-linolenic acid in the diet. fiber for children 1 through 3 years of

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age (Ref. 66) should be used to set a ANPRM recommended basing the DRV comments received in response to the DRV for dietary fiber to be consistent for sodium on the IOM’s UL of 1,500 2007 ANPRM (Ref. 47) to determine with how other proposed DRVs are mg/d for children 1 through 3 years of appropriate RDIs for vitamins and being set. Given that we are proposing age to be consistent with minerals for children 1 through 3 years a reference calorie intake level of 1,000 recommendations from AAP and AHA of age. calories/d for this subpopulation, we are (Ref. 71). The IOM’s quantitative intake proposing to amend § 101.9(c)(9) to The IOM derived the UL for children recommendations (AIs and RDAs) establish a DRV of 14 g for dietary fiber 1 through 3 years of age by extrapolation provide a basis on which to determine for children 1 through 3 years of age. from the adult UL of 2,300 mg/d based RDIs for vitamins and minerals for this g. Protein—The RDI for protein for on observational studies showing that subpopulation. In addition, where data children less than 4 years of age was blood pressure increases with age into on functional indicators of nutritional based on the 1989 RDA for protein of 16 adulthood and the recognition that risk status were available, the IOM relied on g/d (§ 101.9(c)(7)(iii)). One comment to factors for CVD, such as high blood such data and determined that available the 2007 ANPRM recommended pressure and atherosclerosis, occur in evidence was sufficient to establish maintaining the DV of 16 g for protein childhood (Ref. 10). We agree with the appropriate RDAs and AIs for vitamins because the RDA for protein of 13 g/d comments noting that 1,500 mg is an and minerals for this subpopulation. for toddlers 1 through 3 years of age appropriate DRV for sodium for Therefore, we disagree with a comment appears low relative to the amount of children 1 through 3 years of age. to the 2007 ANPRM that suggested that protein from a diet pattern consistent Consistent with the proposed approach more population-specific data based on with dietary guidance from AAP/AHA. for the general population, we are functional indicators of nutritional We consider it appropriate to proposing to amend § 101.9(c)(8)(iv) to status are needed before establishing the determine whether changes are establish a DRV of 1,500 mg for sodium RDIs for vitamins and minerals. necessary to the current RDI taking into for children 1 through 3 years of age. We consider it appropriate to use account current recommendations and i. Fluoride—There is not a DV for RDAs and, in the absence of RDAs, AIs protein intakes. Protein intakes are well fluoride for children 1 through 3 years to determine appropriate micronutrient above the current RDI. Mean protein of age. One comment to the 2007 RDIs for children 1 through 3 years of intake for children 12 to 23 months of ANPRM suggested that fluoride should age. As such, we agree with comments age was 44 g/d (Ref. 150), well above the not have a DV because it is not found that suggested using RDAs to determine RDA of 13 g/d and the midpoint of the abundantly in food. We disagree with the RDIs for selenium and vitamin E and AMDR of 5 to 20 percent calories from this comment. Whether a nutrient is AIs to determine the RDIs for choline, protein (i.e., 12.5 percent of calories found abundantly in food is not a vitamin K, and manganese, which do from protein or 31 g/d) (Ref. 84). The consideration for FDA in setting DVs. not have established RDAs. The RDA, protein AMDR for children 1 through 3 The IOM recognized fluoride as a trace when available, is the best estimate of years of age is 5 to 20 percent of calories mineral that is important for public an intake level that will meet the and the RDA is approximately 5 percent health by setting an AI based on nutrient goals of practically all of calories (Ref. 84). While the RDA is evidence of its role in reducing the risk consumers who would use the Nutrition lower than the amount of protein of dental caries. Facts label. AIs have less certainty than consistent with guidance from AAP/ However, we tentatively conclude RDAs, but they represent goals for AHA, we explain in section II.B.2.c. that that a DRV should not be established for nutrient intake for individuals and we do not consider the menu modeling fluoride. Although the IOM set an AI for provide the best estimate based on approach used to develop this guidance fluoride, the AI for children 1 through current science for use in setting RDIs appropriate to determine DRVs because 3 years of age is close to the EPA for such nutrients. it does not permit the selection of DRVs benchmarks for maximum total fluoride Finally, we disagree with comments that are based on scientific evidence intake (Ref. 92). In addition, we are not suggesting we use 1,800 or 2,000 mg/d related to actual public health proposing a DRV for the general potassium as the basis for the RDI for outcomes. In light of the proposed population because of concern about potassium because it is inconsistent reference calorie intake level and the excess intakes associated with dental with the proposed approach for the approaches used for the proposed DRVs fluorosis (see section II.G.). The use of general population. The comments did for fat and carbohydrate that are based such a DRV to calculate percent DV may not explain why data collection on on percent of calories, we tentatively have the untoward effect of consumers mean potassium intake should be the conclude that, as with the general selecting foods with higher fluoride basis for the DV in lieu of the AIs and population, the DV for protein for amounts, which are not necessary or RDAs. In addition, promoting the children 1 through 3 years of age should advised. Therefore, we tentatively development of eating patterns that will be a DRV, rather than an RDI (using the conclude that a DRV for fluoride is not be associated with adequate potassium RDA). Therefore, we tentatively warranted for children 1 through 3 years intake later in life is important because conclude that a DRV for protein should of age. Accordingly, we are not chronic conditions such as elevated be based on 5 percent of 1,000 calories proposing a DRV for fluoride for blood pressure, bone demineralization, or 50 calories which equals 12.5 g or, children 1 through 3 years of age. and kidney stones likely result from when rounded up, is 13 g. Accordingly, j. Vitamins and Minerals—As inadequate potassium intakes over an we are proposing to amend explained earlier, while not included in extended period of time, including § 101.9(c)(7)(iii) to establish a DRV for our regulations, the preamble to the childhood (Ref. 136). The AI for protein of 13 g for children 1 through 3 1993 DRV/RDI final rule provides a potassium is 3,000 mg/d and we years of age. table listing RDIs for children less than consider it an appropriate basis for h. Sodium—For the general 4 years of age (58 FR 2206 at 2213), establishing a RDI for potassium for population, we are proposing to which is also provided in FDA’s Food children 1 through 3 years of age. establish a DRV based on the UL for Labeling Guide (Ref. 144). We reviewed Therefore, using the RDAs and AIs, sodium (section II.F.). There is no DRV current quantitative intake we are proposing to amend for sodium for children 1 through 3 recommendations for vitamins and § 101.9(c)(8)(iv) to establish RDIs as set years of age. Two comments to the 2007 minerals for infants and considered forth previously for vitamin A, vitamin

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C, vitamin D, vitamin E, vitamin K, c. Trans Fat, Polyunsaturated Fat, AI has been established for fluoride, we vitamin B12, folate, choline, riboflavin, Monounsaturated Fat, Soluble Fiber, are not proposing to establish a DRV for niacin, vitamin B6, calcium, iron, Insoluble Fiber, Sugars, Added Sugars, fluoride for the general population for thiamin, biotin, pantothenic acid, and Sugar Alcohols—There are no DRVs the reasons discussed in section II.G. phosphorous, iodine, magnesium, zinc, for trans fat, polyunsaturated fat, Similarly, because the AI for fluoride for selenium, copper, manganese, monounsaturated fat, soluble fiber, pregnant and lactating women is not chromium, molybdenum, chloride, and insoluble fiber, sugars, added sugars, or different from the general population potassium for children 1 through 3 years sugar alcohol for pregnant and lactating (Ref. 90), we are not proposing a DRV of age. women. As discussed in sections II.B. for fluoride for pregnant and lactating We invite comment on the adequacy and II.D., we are not proposing DRVs for women. of the proposed RDIs for vitamins and these nutrients for the general f. Vitamins and Minerals—While not minerals for children 1 through 3 years population because of a lack of included in FDA regulations, the of age. quantitative intake recommendations. preamble to the 1993 DRV/RDI final rule Similarly, quantitative intake 7. DRVs and RDIs for Pregnant and provides a table listing RDIs for recommendations are lacking for these Lactating Women pregnant and lactating women (58 FR nutrients for pregnant and lactating 2206 at 2213), which is also provided in a. Calories—The reference calorie women. Therefore, we are not proposing FDA’s food labeling guide (Ref. 144). We intake of 2,000 used for the general to establish DRVs for trans fat, reviewed current quantitative intake population applies to pregnant and polyunsaturated and monounsaturated recommendations for vitamins and lactating women (§ 101.9(c)(9)). The fat, soluble fiber, insoluble fiber, sugars, minerals for pregnant and lactating calorie needs for pregnant and lactating added sugars, or sugar alcohols for women and considered comments women are similar to the general pregnant and lactating women. received in response to the 2007 population and few products are d. Protein—FDA established RDIs of ANPRM (Ref. 47) to determine purported for pregnant and lactating 60 g protein for pregnant women and 65 appropriate RDIs for vitamins and women. Therefore, we tentatively g protein for lactating women minerals for pregnant and lactating conclude that it is appropriate to (§ 101.9(c)(7)(iii)) based on the highest women. establish a reference calorie intake level 1989 RDAs for pregnant and lactating for setting DRVs for pregnant and women (58 FR 2206 at 2216). The IOM For the same reasons stated for the lactating women that is the same as for established 71 g/d protein as the RDA general population (see section II.I.), we the general population. Accordingly, we for pregnant and lactating women based consider it appropriate to establish RDIs are proposing to use the 2,000 reference on the needs for maternal and fetal for pregnant and lactating women for calorie intake level for setting DRVs for development and human milk vitamins and minerals that have DRIs, pregnant and lactating women production. Because the RDA for using population-coverage RDAs and (§ 101.9(c)(9)). protein during both pregnancy and AIs, instead of population-weighted b. Total Fat, Saturated Fat, lactation is the same (Ref. 84) and given EARs. In addition, we are proposing to Cholesterol, Total Carbohydrate, that most foods represented or establish a single set of RDIs intended Sodium, and Dietary Fiber—FDA purported to be specifically for pregnant for both pregnant women and lactating regulations do not provide DRVs for women are also represented or women because nutrient needs during total fat, saturated fat, cholesterol, total purported to be specifically for lactating pregnancy and lactation are similar carbohydrate, sodium, and dietary fiber women, we tentatively conclude that it (Refs. 16, 17, 21, 22, 140). Moreover, for pregnant and lactating women. is appropriate to establish a single RDI most foods represented or purported to Quantitative intake recommendations of 71 g applicable to both pregnant and be specifically for pregnant women are, for total fat, saturated fat, cholesterol, lactating women. We tentatively at the same time, represented or total carbohydrate, sodium, and dietary conclude that the DV for protein for purported to be specifically for lactating fiber for pregnant and lactating women pregnant and lactating women should women and, as such, using one set of are generally similar to the general remain an RDI (using the RDA) instead RDIs would address practical concerns population (Refs. 6 and 23). Therefore, of a DRV because the DRV approach related to limited space on food labels. we tentatively conclude that the DRVs used to calculate protein for the general Therefore, we are proposing to amend for total fat, saturated fat, cholesterol, population based on 10 percent of 2,000 § 101.9(c)(8)(iv) to establish RDIs as set total carbohydrate, sodium, and dietary calories, which equals 50 g of protein/ forth previously for vitamin A, vitamin fiber for pregnant and lactating women d, falls short of the recommended C, vitamin D, vitamin E, vitamin K, should remain the same as for the protein needs of pregnant and lactating vitamin B12, folate, choline, riboflavin, general population. Accordingly, we are women of 71 g/d. Therefore, we are niacin, vitamin B6, calcium, iron, proposing to amend § 101.9(c)(9) to proposing to amend § 101.9(c)(7)(iii) to thiamin, biotin, pantothenic acid, establish DRVs for pregnant and establish an RDI of 71 g for protein for phosphorous, iodine, magnesium, zinc, lactating women using the proposed pregnant and lactating women. selenium, copper, manganese, DRVs for the general population for total e. Fluoride—There is no DRV for chromium, molybdenum, chloride, and fat, saturated fat, cholesterol, total fluoride for the general population or for potassium for pregnant and lactating carbohydrate, sodium, and dietary fiber. pregnant and lactating women. While an women.

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TABLE 3—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND FROM TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENTS) OF U.S. INFANTS 7 THROUGH 12 MONTHS OF AGE 1

Usual nutrient intake 2

Nutrients EAR 3 % Below the EAR 4 Food Total intake

Iron ...... 6.9 mg ...... 17.8 3.7 Zinc ...... 2.5 mg ...... 0.1 0.1

AI 3 ...... % Above AI 5

Choline ...... 150 mg ...... 23.5 23 .5 Folate ...... 80 mcg ...... 100 100 Niacin ...... 4 mg ...... 99 .9 99 .9 Riboflavin ...... 0.4 mg ...... 100 100 Thiamin ...... 0.3 mg ...... 99 .9 99 .9 Vitamin A ...... 500 mcg ...... 86 .9 87.5 Vitamin B6 ...... 0.3 mg ...... 99.9 99 .9 Vitamin B12 ...... 0.5 mg ...... 99 .8 99.8 Vitamin C ...... 50 mg ...... 90 .1 94 Vitamin D ...... 10 mcg ...... 28 .7 33 .6 Vitamin E ...... 5 mcg ...... 67 70 .6 Vitamin K ...... 2.5 mcg ...... 100 100 Calcium ...... 260 mg ...... 99 .6 99 .6 Copper ...... 220 mcg ...... 100 100 Magnesium ...... 75 mg ...... 97 .6 97 .6 Phosphorus ...... 275 mg ...... 98 .9 98 .9 Potassium ...... 700 mg ...... 98 .8 98 .8 Selenium 6 ...... 20 mcg ...... 9 .9 9 .9 1 All prevalence of nutrient inadequacy or adequacy and status biomarker data is based on NHANES 2003–2006 except for vitamin D and choline (NHANES 05–08). 2 Usual nutrient intake distributions from conventional foods are determined using the National Cancer Institute statistical method for all nutri- ents except iron (see footnote 9 to table 1 and Ref. 48). 3 The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for infants ages 7–12 months are established by the Insti- tute of Medicine http://www.iom.edu/Activities/Nutrition/SummaryDRIs/∼/media/Files/Activity%20Files/Nutrition/DRIs/New%20Material/2_ %20RDA%20and%20AI%20Values_Vitamin%20and%20Elements.pdf. 4 The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy for iron and zinc. For iron, refer to Table I–5 Probability of inadequate iron intakes (Refs. 100 and 158). 5 For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at or above the AI. 6 We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response to the ANPRM. In addition, die- tary intake and/or biomarker data were not provided in NHANES database for chromium, biotin, iodine, pantothenic acid, molybdenum, man- ganese and chloride and, therefore, these nutrients are not listed in this table.

TABLE 4—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPU- LATION OF CHILDREN 1 THROUGH 3 YEARS OF AGE 1

Usual nutrient intake 2

4 Nutrient % below EAR Status biomarker 3 EAR Total % Below Food intake Biomarker cutoff cutoff

Folate ...... 120 mcg ...... 0.1 0.1 Serum folate < 2 ng/mL RBC folate < 95 ng/mL ..... 0.01 0.17 Niacin ...... 5 mg ...... 0.6 0.6 N/A ...... N/A Riboflavin ...... 0.4 mg ...... 0 0 N/A ...... N/A Thiamin ...... 0.4 mg ...... 0 0 N/A ...... N/A Vitamin A ...... 210 mcg ...... 1.9 1.5 N/A ...... N/A Vitamin B6 ...... 0.4 mg ...... 1.5 1.1 Serum B6 (pyridoxal 5′ ) < 20 nmol/L ...... 2.57 Vitamin B12 ...... 0.7 mcg ...... 0 0 Serum B12 < 200 pg/mL ...... 0.2 Vitamin C ...... 13 mg ...... 1.9 1.3 N/A ...... N/A Vitamin D ...... 10 mcg ...... 82.0 66.5 Serum 25(OH)D ...... 8.2 2.9 < 50 nmol/L ...... 0.8 < 40 nmol/L ...... < 30 nmol/L ...... Vitamin E ...... 5 mg ...... 84.6 61.6 Serum E < 516 mcg/dL ...... 1.3 Calcium ...... 500 mg ...... 11.7 11.7 N/A ...... N/A Copper ...... 260 mcg ...... 0.2 0.2 N/A ...... N/A Iron ...... 3 mg ...... 1.0 0.42 Serum ferritin < 12 mcg/L (99–02) 5 ...... 17.7 Iron deficiency (Ferritin model, 99–02) ...... 7.9

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TABLE 4—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPU- LATION OF CHILDREN 1 THROUGH 3 YEARS OF AGE 1—Continued

Usual nutrient intake 2

% below EAR 4 Status biomarker Nutrient 3 EAR Total % Below Food intake Biomarker cutoff cutoff

Anemia (99–02) ...... 1.8 Serum ferritin < 12 mcg/L (03–06) ...... 23.3 Iron deficiency (Body iron model, 03–06) ...... 9.5 Magnesium ...... 65 mg ...... 0 0 N/A ...... N/A Phosphorus ...... 380 mg ...... 0.2 0.2 N/A ...... N/A Selenium 6 ...... 17 mcg ...... 0 0 N/A ...... N/A Zinc ...... 2.5 mg ...... 1.4 1.2 N/A ...... N/A

AI 3 ...... % Above AI 7

Choline ...... 200 mg ...... 46.4 48.5 N/A ...... N/A Potassium ...... 3000 mg ...... 6.5 6.5 N/A ...... N/A Vitamin K ...... 30 mcg ...... 50.9 51.2 N/A ...... N/A N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms. 1 All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003–2006 except for vitamin D and choline intakes (2005–2008); serum pyridoxal-5′-phosphate (2005–2006); serum tocopherol for age 3 years (1999–2002), and serum ferritin (1999–2002). 2 Usual nutrient intake distributions from conventional foods are determined using the National Cancer Institute statistical method for all nutri- ents except iron (see footnote 9 to table 1 and Ref. 48). 3 The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for children 1–3 years of age are established by the Insti- tute of Medicine. Units are in mg/d or mcg/d http://www.iom.edu/Activities/Nutrition/SummaryDRIs/∼/media/Files/Activity%20Files/Nutrition/DRIs/ New%20Material/2_%20RDA%20and%20AI%20Values_Vitamin%20and%20Elements.pdf. 4 The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy. For iron, refer to Table I–5 Probability of inadequate iron intakes (Ref. 100). 5 Serum ferritin analysis changed from the Biorad assay to the Roche assay in 2003. Serum ferritin for 2003–2006 using the Biorad assay was adjusted to be comparable to those 2004–2006 data using the Roche assay. Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin, NHANES 1999–2002) (Refs. 155 and 159). Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to ferritin using NHANES 2003–2006 data. NHANES 1999–2002 did not measure transferrin receptor; therefore body iron model could not be analyzed for this time frame. NHANES 2003–2006 did not measure all iron biomark- ers for all ages, thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during this time period. 6 We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response to the ANPRM. In addition, die- tary intake and/or biomarker data were not provided in NHANES database for chromium, biotin, iodine, pantothenic acid, molybdenum, man- ganese and chloride and, therefore, these nutrients are not listed in this table. 7 For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at or above the AI.

TABLE 5—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPU- LATION OF PREGNANT WOMEN 14–50 YEARS OF AGE 1

Usual nutrient intake 2

% below EAR 4 Status biomarker Nutrient Weighted EAR 3 Total % below Food intake Biomarker cutoff cutoff

Folate ...... 520 mcg ...... 39.6 27.5 Serum folate < 2 ng/mL ...... 0.28 RBC folate < 95 ng/mL ...... 0 Niacin ...... 14 mg ...... 3.7 2.6 N/A ...... N/A Riboflavin ...... 1.2 mg ...... 3.6 3.1 N/A ...... N/A Thiamin ...... 1.2 mg ...... 10.4 6.1 N/A ...... N/A Vitamin A ...... 549 mcg ...... 36.4 22 Serum A < 20 mcg/mL ...... 1.0 Vitamin B6 ...... 1.6 mg ...... 28.3 15.7 Serum B6 (Pyridoxal 5’ phosphate) < 20 nmol/L ...... 0 Vitamin B12 ...... 2.2 mcg ...... 1.6 1.1 Serum B12 < 200 pg/mL ...... 4.1 Vitamin C ...... 70 mg ...... 21.7 11.2 Serum C < 11.4 μmol/L ...... 0.4 Vitamin D ...... 10 mcg ...... 87.6 47.6 Serum 25(OH)D < 50 nmol/L ...... 16.9 < 40 nmol/L ...... 6.4 < 30 nmol/L ...... 3.7 Vitamin E ...... 12 mg ...... 94.8 51 Serum E < 516 mcg/dL ...... 0.6 Calcium ...... 835 mg ...... 20.7 18.9 N/A ...... N/A Copper ...... 0.79 mcg ...... 4.4 4.1 N/A ...... N/A Iron ...... 22 mg ...... 5.3 3.71 Serum ferritin < 15 mcg/L ...... 26.1 5 Iron deficiency —Body iron model ...... 16.4 —Ferritin model Anemia ...... 25.1

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TABLE 5—PREVALENCE OF NUTRIENT INADEQUACY AND ADEQUACY (FROM CONVENTIONAL FOODS AND WATER) AND TOTAL INTAKE (CONVENTIONAL FOODS, WATER, AND SUPPLEMENT) AND STATUS BIOMARKERS OF THE U.S. POPU- LATION OF PREGNANT WOMEN 14–50 YEARS OF AGE 1—Continued

Usual nutrient intake 2

% below EAR 4 Status biomarker Nutrient Weighted EAR 3 Total % below Food intake Biomarker cutoff cutoff

12.8 Magnesium ...... 295 mg ...... 57.2 55.0 N/A ...... N/A Phosphorus ...... 583 mg ...... 0.3 0.3 N/A ...... N/A Selenium 6 ...... 49 mcg ...... 0.7 0.7 N/A ...... N/A Zinc ...... 9.5 mg ...... 15.9 12.8 N/A ...... N/A

Weighted AI 3 % Above AI 7

Choline ...... 450 mg ...... 13.5 13.6 N/A ...... N/A Potassium ...... 4700 mg ...... 3.9 3.9 N/A ...... N/A Vitamin K 6 ...... 89 mcg ...... 34.5 36.1 N/A ...... N/A N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms. 1 All prevalence of nutrient adequacy or inadequacy and biomarker data is based on NHANES 2003–2006 except for vitamin D and choline in- takes (2005–2008); serum pyridoxal-5’-phosphate (2005–2006); serum tocopherol (1999–2002), and serum ferritin (1999–2002). Biomarker data are for pregnant women 12 through 49 years of age. 2 Usual nutrient intake distributions from conventional foods are determined using the National Cancer Institute statistical method for all nutri- ents except iron (see footnote 9 to table 1 and Ref. 48). 3 The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for pregnant women 14–50 years of age are established by the Institute of Medicine. Units are in mg/d or mcg/d http://www.iom.edu/Activities/Nutrition/SummaryDRIs/∼/media/Files/Activity%20Files/Nutrition/ DRIs/New%20Material/2_%20RDA%20and%20AI%20Values_Vitamin%20and%20Elements.pdf. 4 The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy. For iron, refer to Table I–5 Probability of inadequate iron intakes (Ref. 100). 5 Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to ferritin using NHANES 2003–2006 data. Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin, NHANES 1999–2002) (Refs. 155 and 159). Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. 6 We did not receive any comments for these nutrients (for which voluntary declaration is permitted) in response to the ANPRM. In addition, di- etary intake and/or biomarker data were not provided in NHANES database for chromium, biotin, iodine, pantothenic acid, molybdenum, man- ganese and chloride and, therefore, these nutrients are not listed in this table. 7 For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at or above the AI.

L. Dietary Supplements comments to the 2007 ANPRM that are supplement when they are present in relevant to the Supplement Facts label. amounts that exceed the amount that FDA regulations specific to dietary We expect that the proposed DVs for can be declared as zero in the nutrition supplement nutrition labeling appear in infants 6 through 12 months, children 1 labeling of foods in accordance with § 101.36. Many requirements in § 101.36 through 3 years, pregnant and lactating § 101.9(c). are consistent with the requirements for women, and individuals 4 years of age Section § 101.9(c)(8)(ii) requires the nutrition labeling of conventional and older may result in reformulation of vitamin A, vitamin C, calcium, and iron foods in § 101.9 and there are references dietary supplement products. to be declared on food labels. As throughout § 101.36 to requirements Reformulations could impact intakes of discussed in section II.H., we are established in § 101.9. As discussed vitamins and minerals for all age proposing to amend § 101.9(c)(8)(ii) to previously, we are proposing several groups. We invite comment, including allow for voluntary declaration of amendments to § 101.9 that, if finalized, the submission of data and other factual vitamins A and C and to require would result in significant changes to information, on the reformulation of mandatory declaration of calcium, the content and format of the Nutrition dietary supplement products that may vitamin D, potassium, and iron. In Facts label. For consistency, we are result from proposed changes to the addition, we are proposing to eliminate proposing to amend § 101.36 so that the DVs, as well as information on the the mandatory declaration of ‘‘Calories content and format of the Supplement potential consequences of such from fat’’ on the Nutrition Facts label Facts label corresponds with that of the reformulations. (see section II.A.1.). Nutrition Facts label. The IOM Labeling Our proposed changes to the We are proposing to update the list of Report included a recommendation that Supplement Facts label in light of (b)(2)-dietary ingredients to maintain the Supplement Facts label should use proposed changes to the Nutrition Facts consistency with the proposed the same DVs as the Nutrition Facts label are described in this document. requirements for nutrition labeling of label. In light of the IOM foods in § 101.9. Therefore, proposed recommendation, we requested 1. Mandatory Dietary Ingredients § 101.36(b)(2)(i) would: (1) No longer comment in the 2007 ANPRM on In § 101.36(b)(2), we established a list require declaration of vitamin A, whether the Supplement Facts label of dietary ingredients that have an RDI vitamin C, or Calories from fat; (2) should use the same DVs as the or a DRV as established in require vitamin D and potassium; (3) Nutrition Facts label, as suggested in the § 101.9(c)(8)(ii) that are referred to as the require the declaration of added sugars; IOM labeling report. We received no ‘‘(b)(2)-dietary ingredients.’’ These 15 and (4) retain the other (b)(2)-dietary comments in response to this question. nutrients must be listed in the ingredients as mandatory declarations. We also did not receive any other Supplements Facts label for a dietary We are also proposing to amend

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§ 101.36(b)(2)(i), (b)(2)(i)(B)(1), and supplements as vitamin A (http:// statement at the bottom of the label that (b)(2)(iii)(G) to remove the requirement www.regulations.gov/ says ‘‘Percent Daily Values are based on for declaration of ‘‘Calories from fat.’’ # !docketDetail;D=FDA-2005-P-0126). a 2,000 calorie diet.’’ This statement is The petition maintained that the only accurate for products meant for 2. Folate and Folic Acid declaration of vitamin A on dietary children and adults that are 4 years of We are proposing to only allow the supplement labels is misleading when age and older. The proposed DRVs for use of the term ‘‘folic acid’’ for the the supplement contains mostly b- total fat, total carbohydrate, dietary labeling of dietary supplements. Folate carotene because only a small amount of fiber, and protein for children 1 through is a nutrient found in conventional b-carotene is converted by the liver into 3 years of age are based on a 1,000 foods, whereas folic acid is the synthetic vitamin A. We do not see a need to calorie diet. Therefore, when a product form of folate that is added to fortified preclude the declaration of b-carotene as that is represented or purported to be for conventional foods and dietary vitamin A, because the difference in the children 1 through 3 years of age supplements. As discussed in section bioconversion of b-carotene to vitamin contains a percent DV declaration for II.J.2., ‘‘folic acid’’ or ‘‘folacin’’ are A will be accounted for with the total fat, total carbohydrate, dietary identified as synonyms of folate and can proposed declaration of vitamin A fiber, or protein, we are proposing to be used on the Nutrition Facts label content as ‘‘mcg’’ (representing mcg require in § 101.36(b)(2)(iii)(D) that a (§ 101.9(c)(8)(v)) or in the Supplement RAE) (see section II.J.3.). Therefore, we symbol be placed next to the percent DV Facts label (§ 101.36(b)(2)(i)(B)(2)). are not proposing to preclude the declaration that refers the consumer to However, because of the difference in declaration of b-carotene in dietary a statement at the bottom of the label bioavailability between naturally supplements as vitamin A. that says ‘‘Percent Daily Values are occurring folate, and synthetic folic based on a 1,000 calorie diet.’’ acid, we are proposing to amend 4. Order of Nutrients Declared on the In addition, we are proposing to § 101.9(c)(8)(v) such that the term Label amend § 101.36(b)(2)(iii)(E) to change ‘‘folate’’ would be used in the labeling For dietary supplements, the categories of infants and children of conventional foods that contain either § 101.36(b)(2)(i)(B) specifies that less than 4 years of age to infants 7 folate alone or a mixture of folate and vitamins and minerals must be declared through 12 months of age and children folic acid. As discussed in section in a specific order on the Supplement 1 through 3 years of age. II.J.2.c., we consider only the term ‘‘folic Facts label. We are now proposing to Finally, because we are proposing acid’’ to be appropriate for use in the establish an RDI for choline in section DRVs for various nutrients for infants 7 labeling of dietary supplements. I.7. Therefore, it is necessary to add through 12 months, children 1 through Therefore, we are proposing to amend choline to the list of ordered nutrients 3 years, and pregnant and lactating §§ 101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to in § 101.36(b)(2)(i)(B). We are proposing women (see section II.K.), we are specify that ‘‘folic acid’’ is the term used to require that, when declared, choline proposing to amend § 101.36(b)(2)(iii)(F) to declare folic acid content of dietary shall follow potassium on the label. such that the requirement for an asterisk supplements; and to remove ‘‘folate’’ noting that a DV has not been 5. Subpopulations and ‘‘folacin’’ from the list of synonyms established would be applicable to that may be used to declare folic acid on We discussed several changes in foods for these subpopulations only the Supplement Facts label. section II.K. that will affect dietary when a DRV has not been established supplement labeling currently required for a nutrient (i.e., for saturated fat, 3. Units of Measure for infants, children under 4 years of cholesterol, or dietary fiber for dietary In section II.J.3., we are proposing to age, and pregnant and lactating women. supplements that are represented or amend § 101.9(c)(8)(iv) to replace ‘‘IU’’ To maintain consistency with the purported to be for use by infants 7 for the RDIs for vitamin A, vitamin D, proposed requirements for nutrition through 12 months). Proposed and vitamin E with mcg RAE for labeling of foods in § 101.9, we § 101.36(b)(2)(iii)(F) states: ‘‘For vitamin A, mcg for vitamin D, and mg tentatively conclude that it is declared subcomponents that have no a-tocopherol for vitamin E. In addition, appropriate to revise the appropriate DRVs, a symbol (e.g., an asterisk) shall in section II.J.2., we are proposing to sections of § 101.36 that pertain to be placed in the ‘‘Percent Daily Value’’ quantify and declare folate and folic labeling requirements for foods, other column that shall refer to the same acid in ‘‘mcg DFE’’ instead of ‘‘mcg.’’ In than infant formula, that are represented symbol that is placed at the bottom of the interest of maintaining consistency or purported to be specifically for the nutrition label, below the last heavy in nutrition labeling of foods and infants 7 through 12 months, children 1 bar and inside the box, and followed by dietary supplements, we are proposing through 3 years, and pregnant and the statement ‘‘Daily Value not to amend § 101.36(b)(2)(i)(B)(3) to lactating women. Therefore, we are established.’’ require that when b-carotene is included proposing to amend § 101.36(b)(2)(iii) to in parentheses following the percent read as follows: ‘‘The percent of the 6. Footnote statement for vitamin A, it should be Daily Value of all dietary ingredients As discussed in section II.M, we are declared using ‘‘mcg’’ (representing mcg declared under paragraph (b)(2)(i) of proposing to modify the footnote on the RAE) as the unit of measure. In this section shall be listed, except that Nutrition Facts label. We are planning addition, under § 101.36(b)(2)(ii)(B), the the percent DV for protein may be to conduct consumer studies related to proposed units of measure for vitamin omitted as provided in § 101.9(c)(7); no the footnote on the Nutrition Facts label. D, vitamin E, and folate in percent DV shall be given for The current footnote statement required § 101.9(c)(8)(iv) would be used in the subcomponents for which DRVs have for the Supplement Facts label differs declaration of vitamin D, vitamin E, and not been established (e.g., sugars).’’ from that which is currently required on folic acid in the Supplement Facts label. When the percent DV is declared for the Nutrition Facts label. We expect that In 2005, we received a citizen petition total fat, saturated fat, total consumers that purchase dietary (Docket No. FDA–2005–P–0126 carbohydrate, dietary fiber, or protein, supplements would be more interested (formerly Docket No. 2005P–0293)) we require that a symbol be placed next in information about the amount of requesting us to preclude the to the percent DV declaration for these specific micronutrients contained in declaration of b-carotene in nutrients that refers the consumer to a dietary supplements and would be less

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focused on the caloric reference value best meets the NLEA requirements that the serving size information; (4) used in determining the percent DV for nutrition information should enable the changing the phrase ‘‘Amount Per macronutrients. Based on the results of public to readily observe and Serving’’ to ‘‘Amount Per ll’’ with the the consumer study, we will consider comprehend such information. In blank filled in with the serving size; (5) whether it is necessary to make addition, a simple format allows removing the declaration of ‘‘Calories corresponding changes to the footnote consumers to search for accurate from fat’’; (6) modifying the presentation used on the Supplement Facts label nutrition information with minimum of the ‘‘% DV’’ information by changing when certain macronutrients are effort, and provides information in a its position to the left of the name of the declared. We invite comment on succinct manner that maximizes nutrient on certain labels, and whether we should consider changes to understanding. separating it from the list of nutrients the footnote statement on the Although the original intent of the with a vertical line; (7) declaring Supplement Facts label to be consistent format rule to meet the requirements ‘‘Added Sugars’’ as an indented listing with any changes to the footnote and objectives of the NLEA for format directly beneath the listing for ‘‘Sugars’’; statement in the Nutrition Facts label. has not changed, FDA is proposing (8) declaring the quantitative amounts certain changes to the format because of (in addition to percent DVs) of M. Format new information that has become mandatory vitamins and minerals and, Nutrition information must be available to us since 1993. The new when declared, voluntary vitamins and presented on food labels in a specific information includes results of minerals; (9) requiring dual column format (see e.g., § 101.9(d)–(f) and (j)). consumer research including studies labeling under certain conditions; (10) The elements of format related to the that we conducted (Ref. 164), trends in modifying the footnote; (11) requiring Nutrition Facts label include such health conditions (especially obesity), that all nutrients not currently features and graphic design principles comments received in response to the highlighted in bold or extra bold type be as the type style (i.e., font) and size of 2005 and 2007 ANPRMs, and highlighted in a type that is the type (i.e., point); use of boldface, recommendations from FDA’s Obesity intermediate between bold or extra bold lines, and bars; arrangement of Working Group (OWG) (Ref. 165). We and regular (i.e., semi-bold) type; (12) information in one or more columns; are using this notice of proposed adding a horizontal line directly column headings; presence of a footnote rulemaking to re-examine aspects of the beneath the ‘‘Nutrition Facts’’ heading; and use of a symbol (such as an asterisk) current label format to determine which, and (13) replacing the listing of ‘‘Total to designate a footnote; and whether if any, design changes may facilitate Carbohydrate’’ with ‘‘Total Carbs.’’ We nutrition information is listed as a how information is conveyed to discuss each of these proposed percentage or in absolute (i.e., consumers. amendments in this document. In quantitative) amounts. The elements of We are not proposing an extensive addition, we are requesting comments format also include the alignment of reformatting of the Nutrition Facts label. on other issues related to the Nutrition information; whether indentations are The original design, which took into Facts label format, including the use of used in listing nutrient data; and the use account fundamental design principles an alternative format design or requiring of white space (or negative space) where for communicating complex ideas with the use of a specific font. no image or text exists. White space clarity, precision, and efficiency, are Although the discussion in this helps to isolate an element of the label largely being retained (Ref. 166). Rather, document focuses primarily on the that demands attention and provides a our tentative views, tentative format of the standard Nutrition Facts hierarchy and pacing of information for conclusions, and proposed changes label illustrated in § 101.9(d)(12), we the reader (Ref. 160). The format may include our consideration of graphic also discuss certain modifications that differ from package to package design principles such as alignment, we are proposing to be applied to other according to the amount of space on the consistency, repetition, and contrast, label formats to maintain consistency package that is available for labeling, as and place an emphasis on highlighting with the new format of the standard described and detailed in the relevant key nutrients and key information and Nutrition Facts label. These other sections in this document. removing or modifying parts of the label modifications pertain to formats for The format of the Nutrition Facts label to assist consumers in maintaining packages of products that contain two or was informed by a number of factors, healthy dietary practices (Ref. 167). We more separately packaged foods that are including consumer research conducted consider our proposed changes to the intended to be eaten individually (e.g., by FDA (Refs. 161 to 163); consideration Nutrition Facts label to be visually variety packs of cereals and snacks) or of the environment in which consumers appealing and inviting. In general, the that are used interchangeably for the typically use the label (i.e., grocery goal is to continue to display the same type of foods (e.g., round ice stores); the diversity of consumers for information in a simple manner that is cream containers (§ 101.9(d)(13)); whom the label is intended (i.e., with legible, readable, and follows a logical formats that apply to subpopulations respect to education, age, hierarchy. This presentation should (§ 101.9(e) and § 101.9(j)(5)); the socioeconomic status, etc.); and serve as a visual guide to the reader that simplified format (§ 101.9(f)); the tabular comments and data received on this allows the eye to easily scan the label display on packages that do not have issue in response to a 1990 proposed while the actual effort of reading is sufficient continuous vertical space rule, as discussed in the 1993 final rule reduced. (§ 101.9(d)(11)(iii)); and the tabular entitled Food Labeling: Mandatory Toward that end, we are proposing display (§ 101.9(j)(13)(ii)(A)(1)) and Status of Nutrition Labeling and the following changes to the format of linear display (§ 101.9(j)(13)(ii)(A)(2)) Nutrient Content Revision, Format for the Nutrition Facts label: (1) Increasing for small packages. Nutrition Label (58 FR 2079 at 2114– the prominence of calories and serving 2144) (the format rule). Research studies size; (2) reversing the order of the 1. Increasing the Prominence of Calories consistently confirmed that simple ‘‘Serving Size’’ declaration and the and Serving Size formats are easier to comprehend and ‘‘Servings Per Container’’ declaration The ability to determine the caloric require less consumer effort than and increasing the prominence of content of packaged foods is important complex information formats. A simple ‘‘Servings Per Container’’; (3) right- for all consumers, especially those who format is one that minimizes clutter and justifying the quantitative amounts of are trying to control their total caloric

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intake and manage their weight. more accurately determine the number shall immediately follow the identifying Inasmuch as overweight and obesity are of calories per container (Ref. 164). heading of ‘‘Nutrition Facts.’’ In major public health problems in the We tentatively conclude that the addition, ‘‘Serving Size’’ and ‘‘Servings United States and are fundamentally a proposed changes to the number of Per Container’’ must be in a type size no direct result of calorie consumption calories per serving and the number of smaller than 8 point (§ 101.9(d)(1)(iii)). exceeding energy expenditure, we are servings per container would result in As mentioned previously, we are interested in increasing consumer these declarations serving as an anchor interested in taking steps to increase attention to the calorie content of to the Nutrition Facts label by focusing consumer attention to the calorie packaged foods. the reader’s attention to this information content in packaged foods, such as by Current FDA regulations require and therefore would assist consumers to increasing the prominence of this ‘‘Calories’’ to be declared in a type size effectively use this information in the information as suggested by the OWG. no smaller than 8 point Nutrition Facts label (Ref. 171). Consumer research on information (§ 101.9(d)(1)(iii)) and highlighted in Accordingly, we are proposing to revise displays suggests that accuracy of bold or extra bold type or other § 101.9(d) to increase the type size for judgments and quality of decisions are highlighting (§ 101.9(d)(1)(iv)). While ‘‘Calories’’ and the numeric value for improved when information displays calorie information is mandatory on the ‘‘Calories.’’ We are also proposing that closely match the judgment and Nutrition Facts label, it is possible that the numeric value for calories be decision needs of consumers (Refs. 172 modifying the Nutrition Facts label to highlighted in bold or extra bold type in and 173). With respect to the Nutrition give more prominence to calories may order to draw attention to this Facts label, an important consumer need benefit consumers in weight control and information, emphasize the importance is to identify the number of servings per maintenance, as noted by the OWG in of calories on the label, and maintain container of a packaged food. Therefore, its final report entitled ‘‘Calories Count’’ consistency with the bolded declaration placing ‘‘Servings Per Container’’ above (Ref. 165). for ‘‘Calories.’’ We invite comment on ‘‘Serving Size’’ would be expected to The OWG recommended, in part, that these tentative conclusions. help consumers find the number of FDA issue an ANPRM to solicit We also consider it appropriate to servings per container with less effort comments on how to give more make corresponding changes to the than is now needed. Listing ‘‘ll prominence to calories on the food prominence of calories on the servings per container’’ with the blank label. The OWG suggested possible Supplement Facts label, when filled in with the actual number of changes to the Nutrition Facts label, ‘‘Calories’’ is declared. Although the servings directly beneath the ‘‘Nutrition such as increasing the prominence of majority of dietary supplement products Facts’’ heading, and highlighting it in ‘‘Calories’’ and ‘‘Serving Size,’’ contain a negligible amount of calories, bold or extra bold type would also help providing a percent DV for calories, and and therefore calories are not declared increase awareness that the information eliminating the ‘‘Calories from fat’’ on most Supplement Facts labels, we presented in the Nutrition Facts label declaration, which may detract from the note that some dietary supplement does not refer to the contents of the emphasis on total calories. The OWG products may contain a significant entire package when the label indicates recommended that we obtain amount of calories and macronutrients. that there is more than one serving per information on the effectiveness of these We are concerned that a small number container. Further, listing ‘‘Serving options on consumer understanding and of dietary supplement products, size’’ in the same proximity to where behavior related to calorie intake (Ref. especially those in liquid form, could the actual nutrient information is 165). After issuing the 2005 ANPRM, in contribute a significant amount of located on the label would help which we solicited comment on the calories and other macronutrients to the consumers understand that this nutrient OWG recommendations, we received diet when consumed regularly. For such several comments that generally products, our tentative view is that it information pertains to the particular supported increasing the prominence of may be necessary for the Supplement serving size that is declared. Proximity calories on the Nutrition Facts label. Facts label to have a format similar to is a graphic design principle that asserts These comments suggested various the format being proposed for the that items closer together are perceived approaches for doing so, and pointed Nutrition Facts label with respect to to be more related (Ref. 167). This, in out the need for additional research to increasing the prominence of turn, would help consumers grasp the fully understand the effects of potential information for calories. We invite relative significance of a particular food label changes on consumer comment on whether any of the changes product in the context of their daily understanding and behavior (Ref. 47). that are being proposed to the Nutrition diet. We considered available data from Facts label in the following sections Therefore, based on the available data consumer research and comments should also be required for certain and information discussed previously, received in response to the ANPRMs. products with Supplement Facts labels including graphic design principle, of Research conducted for warning labels that list calories and/or other proximity we tentatively conclude that and drug label formats has consistently macronutrients, and if so, under what reversing the order of the declarations of demonstrated that increasing type size, conditions and for which dietary ‘‘Servings Per Container’’ and ‘‘Serving among other things, increases attention supplement products should such Size’’ would help consumers more to, and improves understanding of labeling be required. readily observe and comprehend the warning information, especially for nutrition information appearing in the older consumers and those with limited 2. Changing the Order of the ‘‘Serving Nutrition Facts label, allow consumers vision (Refs. 168 to 170). Also, our Size’’ and ‘‘Servings Per Container’’ to search for information with a research on food labels with two Declarations and Increasing the minimum of effort, and assist servings per container found that Prominence of ‘‘Servings Per Container’’ consumers in their food purchasing labeling changes that highlighted the Current regulations specify that decisions and in maintaining healthy number of servings per container (via information on serving size, consisting dietary practices. Accordingly, we are text or a dual column) served as cues to of a statement of the serving size proposing to re-designate § 101.9(d)(3)(i) consumers that the product contained (§ 101.9(d)(3)(i)) and the number of as § 101.9(d)(3)(ii), re-designate more than one serving and helped them servings per container (§ 101.9(d)(3)(ii)), § 101.9(d)(3)(ii) as § 101.9(d)(3)(i), and

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make changes in how the serving size information is stated immediately serving size actually is by declaring information is capitalized on the label adjacent to the ‘‘Serving Size’’ ‘‘Amount per ll’’ with the blank filled so that no capital letters are used, except declaration, as seen in current in with the actual serving size in for the first letter in ‘‘Serving size.’’ § 101.9(d)(12). By keeping the proposed household units as indicated in the (Current § 101.9(d)(3)(i) and (d)(3)(ii) ‘‘Serving size’’ declaration left-justified ‘‘Serving size’’ declaration. To further specify that information on serving size while right-justifying the corresponding facilitate use of the Nutrition Facts be capitalized and listed as ‘‘Serving numerical values, the proposed change label, as mentioned in section 2, we are Size’’ and ‘‘Servings Per Container.’’) would create white space on the proposing to move the ‘‘Serving size’’ We also are proposing to require that the Nutrition Facts label that would result declaration closer to the proposed declaration of ‘‘ll servings per in a less cluttered appearance, ‘‘Amount per ll’’ listing. We also are container’’ (with the blank filled in with heightened focus and emphasis, and proposing to require that the ‘‘Amount the actual number of servings) be improved readability (Ref. 160). This per ll’’ information be highlighted in highlighted in bold or extra bold type, design feature would provide enhanced semi-bold, rather than in bold or extra and be in a type size no smaller than 11 emphasis to the information about bold, in order not to detract from the point (except for the tabular and linear serving size, allowing this information calories information. In addition, we are displays for small packages) (proposed to be more noticeable and thereby proposing that the type size of the § 101.9(d)(3)(i)) and that the serving size facilitating its access and use by ‘‘Amount per ll’’ declaration be no information must be in a type size no consumers. We invite comment on this smaller than 8 point (except for the smaller than 8 point (except for the tentative conclusion. linear display for small packages). We linear display for small packages) invite comment on our tentative 4. Changing the ‘‘Amount Per Serving’’ (proposed § 101.9(d)(3)(ii)). We conclusions. Statement tentatively conclude that these proposed 5. Declaration of ‘‘Calories from Fat’’ changes would lessen the effort of Current regulations specify that the consumers to locate this information, Nutrition Facts label shall include a We have tentatively concluded that a and assist them in accurately identifying subheading designated as ‘‘Amount Per declaration of calories from fat on the the calorie amounts and nutrient Serving’’ and that this subheading shall Nutrition Facts label is not necessary to contents of packaged food products. be separated from the serving size assist consumers in maintaining healthy Current regulations regarding serving information by a bar (§ 101.9(d)(4)) and dietary practices and, consequently, we size information for dietary be highlighted in bold or extra bold type are proposing to remove the current supplements is described in or other highlighting (§ 109(d)(1)(iv)). requirement for declaration of ‘‘Calories § 101.36(b)(1). When taking dietary We are proposing, based in part on the from fat’’ (see section II.A.1.). Our supplements, consumers need to know consumer research previously cited Consumer research (Ref. 164), which how much of the product to take (e.g., (Refs. 172 and 173), to change the evaluated a label format that did not 1 capsule, 2 tablets, 1 packet). This ‘‘Amount Per Serving’’ declaration to contain the ‘‘Calories from fat’’ information, which is currently ‘‘Amount per ll’’ with the blank filled statement, found that the lack of this provided in the ‘‘Serving Size’’ line of in with the actual serving size expressed information had no effect on consumers’ the Supplement Facts label, is more in household units, and to increase the judgments of product healthfulness, important for the consumer to know type size. These changes would make it accuracy in identifying nutrient than the number of servings (e.g., 100 easier for label users to judge the contents of products, or perceptions of tablets) contained in the package. We amounts of nutrients per serving the label. These findings support our received no comments recommending because it removes the need for label proposal to remove the ‘‘Calories from that the serving size or servings per users to refer back to the unit of the fat’’ declaration from the Nutrition Facts container information on the serving size which is currently declared label. just below the Nutrition Facts heading Supplement Facts label should be made 6. Presentation of Percent DVs more prominent or noticeable. and which would be declared under the Therefore, our tentative conclusion is number of servings per container in the The format for listing nutrients with that there is no need to propose proposed label formats. DRVs on the Nutrition Facts label, changing the order of how serving size Other studies suggest that consumers including the quantitative amount by and servings per container are listed on are often confused by serving size weight and percent DVs, is described in the Supplement Facts label, or to make information as it is currently presented § 101.9(d)(7). In establishing the amendments in the type size or on the Nutrition Facts label (Refs. 174 requirements for percent DV capitalization corresponding to our and 175). Therefore, specifying the declaration, we considered that this proposed changes for this information actual serving size in the listing of information would help consumers on the Nutrition Facts labels. We invite ‘‘Amount per ll’’ declaration would evaluate the nutrient characteristics of a comment on these tentative be expected to help consumers more single product (e.g., how high or low a conclusions. readily observe and comprehend the particular product is in certain nutrients nutrition information appearing in the or the extent to which it contributes 3. Right-Justifying the Quantitative label. Based on the reasons provided, toward daily nutritional goals) and Amounts Declared in the ‘‘Serving size’’ we tentatively conclude that changing assist them in making choices between Statement the ‘‘Amount Per Serving’’ statement to products (58 FR 2079 at 2121). We have also tentatively concluded, ‘‘Amount per ll’’ with the blank filled Consumer research at that time of based on design considerations, that the in with the actual serving size and rulemaking for the Nutrition Facts label label statement for ‘‘Serving size’’ in increasing the type size would assist (Ref. 162) indicated that the percent DV both household unit (§ 101.9(b)(5), consumers in using the information and information improved consumers’ refers to a common household measure may lessen the time and effort needed abilities to make correct dietary such as a cup, tablespoon, piece or slice) to locate the target information. judgments about a food in the context of and gram amounts must be right- Accordingly, we are proposing to amend a total daily diet. Research also justified on the same line that ‘‘Serving § 101.9(d)(4) by requiring that the indicated that percent DV information size’’ is listed. Currently, this numerical Nutrition Facts label specify what the helped consumers to verify the accuracy

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of front-panel claims (Ref. 163). We not proposing to change the We tentatively conclude that the received comments on the format of the requirements for the declaration of proposed rearrangement would assist Nutrition Facts label in response to the percent DV for all nutrients, as specified consumers by helping them to 2007 ANPRM (Ref. 47) that suggested in § 101.9(c)(8) and § 101.9(d)(7). understand the nutrition information on modifying the way percent DV is As discussed previously, percent DV the label in the context of a total daily presented to facilitate greater use of this is intended to help consumers make diet. We are unaware of any consumer information, although one comment dietary decisions. Therefore, we survey data concerning this particular suggested that the percent DV should tentatively conclude that making the proposed change related to consumer not be used on the label. Other percent DV more prominent may make understanding and use of the comments noted the need for additional the information even more useful to information. Although, we are aware consumer research and a comprehensive consumers than it is now. One potential that the prevalence of inadequate consumer education program. approach to making the percent DV numeracy (defined as ‘‘the ability to We continue to believe that the more prominent is to rearrange the comprehend, use, and attach meaning to percent DV information on the Nutrition positions of the columns listing the numbers’’ (Ref. 176) and low literacy in Facts label can serve a number of useful percent DV information. As currently the population have been persistent purposes, including helping consumers described in § 101.9(d)(6), and concerns regarding the ability of to compare foods; determine if a serving § 101.9(d)(7) the percent should be consumers to comprehend health- of food is high or low in a particular arranged on the right of certain related information, it is unclear to what nutrient; and make dietary trade-offs Nutrition Facts label formats. For labels extent the changes we are proposing to among food choices throughout the day. displaying the tabular format (proposed the positioning of the % DV from its As such, we do not agree that the § 101.9(d)(11)(iii)), the standard format current placement would have on percent DV declarations should be (proposed § 101.9(d)(12)), the format for overall consumer use or understanding. eliminated from the Nutrition Facts infants 7 to 12 months of age (proposed We are also aware that the prominence label. We are proposing to switch using § 101.9(j)(5)(i)), the tabular format for of the percent DV first could potentially the ‘‘% Daily Value’’ to the ‘‘% DV’’ in small packages, (proposed make the Nutrition Facts label appear the column that is above the nutrient § 101.9(j)(13)(ii)(A)(1)), the linear less user-friendly particularly to listings. The ‘‘% DV’’ is used on some display (proposed frequent users of Nutrition Facts labels, of nutrition facts labels for smaller § 101.9(j)(13)(ii)(A)(2)), and the who have grown accustomed to the packages and we think this will help simplified format (as described in format and organization of the existing with maintaining consistency among the current § 101.9(f)), we propose to list Nutrition Facts label. In addition, we labels. In addition we are adding a percent DVs in a column to the left of acknowledge that moving the % DVs to hairline rule (see discussion in this the names of the nutrients and their the left could potentially draw document) to differentiate the DVs from quantitative amounts, with a thin consumer attention from nutrients that the nutrients and using ‘‘% DV’’ as the vertical line separating the ‘‘% DV’’ do not have a DV. We invite comment header which maintains the alignment column from the list of nutrients. and data on the tentative conclusion to of the heading over the DV column. The rearrangement is based on the shift the ‘‘% DV’’ to the left of the Therefore based on the graphic design graphic design principles of primacy Nutrition Facts label. principle of alignment (Ref. 167) and in (which asserts that initial items in a list On all dual column labels, including order to promote consistency of the are stored more efficiently in memory those (1) for two or more forms of the labels we tentatively conclude to use than items listed later), proximity same food (proposed § 101.9(e)(5)); (2) ‘‘% DV’’ as the column header over the (which asserts that elements positioned displaying nutrition information per numerical listing of the nutrients DVs close together are perceived as a single container and per unit, in addition to (proposed § 101.9(d)(7)(ii)) . group), and the importance of white nutrition information per serving We have considered alternative terms space (which, among other things, is (proposed § 101.9(e)(6)(i); (3) using the that may be more readily used by designers to isolate an element tabular display (proposed understandable than Daily Value, such that demands attention) (Ref. 160 and § 101.9(e)(6)(ii)), and; (4) that provide as Daily Guide or Daily Need, and invite 167), and the fact that English text is the aggregate display (proposed comment on these or other terms. The read from left to right. The addition of § 101.9(d)(13)(ii)), we propose to list the issue of using an appropriate single term a vertical hairline rule to the right of the names of nutrients on the right side of to refer to all of the reference values in ‘‘% DV’’ column assists in chunking this the % DV column, followed by the the nutrition label was previously information, thereby accentuating it and quantitative (weight) amounts of each discussed in the format rule (58 FR 2079 further distinguishing it from the nutrient. In each of these labels, we at 2124), in which we explained our nutrient name and the quantitative propose to use thin vertical lines to rationale for deciding upon the single weight information. Chunking is a separate the information in the ‘‘% DV’’ term ‘‘Daily Value.’’ We also request technique for combining multiple units column from the information in the comment on whether the word of information into a limited number of column containing the quantitative ‘‘percent’’ (or the % symbol) should units or chunks so that the information weights. Further, we propose to use the precede whatever term is used in the is easier to process and remember) (Ref. same style of thin vertical lines to column heading where the percent DVs 167). Based on these design principles, separate each of the dual columns and are listed, as specified in current positioning the % DV to the left of the aggregate display columns from each § 101.9(d)(6). Since the % symbol is label should increase consumers focus other. The use of these vertical lines currently included next to the on the % DV. Displaying the % DV in helps to differentiate the columns and numerical values that are listed in this this manner would assist consumers in make the information easier for column, including the word ‘‘percent’’ understanding the relevant contribution consumers to read and identify (Ref. or the % symbol in the column heading of a nutrient in a food to the diet by 167). We invite comment on this may be redundant and, after considering highlighting the % DV information on tentative conclusion. comments, we may remove that the label more than on the current label As described in the Dietary requirement in a final rule. For the format (where % DV is listed on the Supplement Health and Education Act reasons explained previously, we are right of the label). of 1994, dietary supplements are

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products taken by mouth containing proposed amendments that would would be Nutrition Facts labels for ‘‘dietary ingredients’’ that are intended require percent DV declarations for foods in small packages that have a total to supplement the diet. They may macronutrients, we invite comment on surface area available to bear labeling of contain not only vitamins and minerals, the appropriate placement of percent 40 or less square inches. Because of but also herbs or other botanicals and DVs in the labeling of foods for infants space limitations, we are not proposing amino acids, as well as concentrates, 7 through 12 months, children 1 any changes to the tabular display metabolites, constituents, and extracts through 3 years of age, and pregnant and (§ 101.9(j)(13)(ii)(A)(1)) and the linear of these dietary ingredients (section lactating women. We are considering display (§ 101.9(j)(13)(ii)(A)(2)) on 201(ff) of the FD&C Act). Thus, many listing the percent DV to the left of the packages that have a total surface area dietary supplement products contain name of any nutrient that has a DV, as available to bear labeling of 40 or less few or no dietary ingredients with DRVs shown in proposed § 101.9(j)(5)(i), square inches, where vitamins and or RDIs, and therefore would not list similar to the placement of the minerals (other than sodium) would any percent DVs on the Supplement declaration of percent DVs in the have to be declared only as percent DVs. labeling of foods for the general Facts label. Further, consumers taking 9. Single and Dual Column Labeling dietary supplements may find population. Therefore, we are proposing information about the quantitative that the percent DV for protein would There are currently multiple amounts of dietary ingredients in the no longer be listed with the vitamins provisions for voluntary dual column product to be of equal or greater and minerals at the bottom of the label labeling. For example, there is dual importance than a percent DV listing, as currently required. column labeling that presents nutrition information per serving size and per 100 even if a DV existed for an ingredient 7. Placement of ‘‘Added Sugars’’ contained in the dietary supplement. g or 100 mL, or per 1 oz. or 1 fl oz. of Therefore, we are not proposing any As discussed in section II.D.3., we are the food as packaged or purchased changes in the position of the percent proposing to require the declaration of (§ 101.9(b)(10)(i)). Dual column labeling DV listing on the Supplement Facts added sugars as an indented line item is mandatory for products that are label relative to the position of the underneath the declaration of total promoted on the label, or in advertising, nutrient and dietary ingredient sugars on the Nutrition Facts label. If for a use that differs in quantity by information. As mentioned previously, finalized, added sugars would be the twofold or greater from the use upon we are proposing to require that the first mandatory nutrient required to be which the reference amount was based listed in a double indentation format on (e.g., liquid cream substitutes promoted Nutrition Facts labels that include dual the Nutrition Facts label. FDA for use with breakfast cereals) columns contain vertical lines regulations permit the voluntary (§ 101.9(b)(11)). We are also proposing separating the percent DV information declaration of ‘‘soluble fiber’’ and for foods that are commonly combined from the quantitative amounts per ‘‘insoluble fiber’’ as double indented with other ingredients or that are weight listings in each of the dual listings under ‘‘dietary fiber’’ cooked otherwise prepared before eating columns, and to separate the dual (§ 101.9(c)(6)(i)). We are planning to to present the percent DVs and the columns from each other. We invite conduct a consumer study (78 FR quantitative amounts for both the food comment on whether there is a need to 32394, May 30, 2013) that will include, in the ‘‘as purchased’’ form and for the include vertical lines that are similarly among other things, questions regarding ‘‘as prepared’’ form in § 101.9(h)(4). placed on Supplement Facts labels for the declaration of added sugars on the We are proposing under certain multiple vitamins in packets Nutrition Facts label. The results of this conditions (i.e., when the package (§ 101.36(e)(11)(iii)) and for dietary study will help enhance our contains at least 200 percent and up to supplements that list ‘‘per serving’’ and understanding of how consumers would and including 400 percent of the ‘‘per day’’ information comprehend and use this new applicable reference amount (§ 101.36(e)(11)(viii)). information. We will publish the results customarily consumed) to require dual Current § 101.9(j)(5)(ii)(A), (j)(5)(ii)(C), of the study when they become column labeling where nutrition and (j)(5)(ii)(D) include certain available. We are interested in receiving, information would be presented based provisions for the presentation of as part of any comment, other available both on the serving size and on the percent DV for nutrients on the research data and other factual entire package or unit of food. This is Nutrition Facts label of foods information relevant to this issue, described in a proposed rule entitled represented or purported to be including the proposed double indented ‘‘Food Labeling: Serving Sizes of Foods specifically for infants and children less placement of added sugars below total That Can Reasonably Be Consumed At than 4 years of age. In particular, the sugars. One Eating Occasion; Dual Column percent DVs for protein, vitamins, and Labeling; Updating, Modifying, and minerals are listed in a separate section 8. Declaration of Absolute Amounts of Establishing Certain Reference Amounts of the Nutrition Facts label below the Vitamins and Minerals Customarily Consumed; Serving Size for quantitative information by weight for A declaration of the quantitative Breath Mints; and Technical protein. As discussed in section II.K., amount by weight is required for both Amendments’’ (serving size proposed we are proposing changes to the mandatory and voluntary nutrients that rule) that is published elsewhere in this nutrition labeling of foods represented are declared on the Nutrition Facts issue of the Federal Register. or purported to be specifically for label, except for vitamins and minerals In addition to proposing dual-column infants 7 through 12 months, children 1 (other than sodium and potassium) labeling per serving and per container through 3 years of age, and pregnant and which must be declared only as percent (or unit, as applicable) for all nutrition lactating women. These include, among DVs. As discussed in section II.I.6., we information on the label, we are other things: (1) Establishing RDIs and are proposing to require the declaration considering two additional options that DRVs that are used in determining the of the absolute amounts for all would require nutrition information per percent DVs declared on the label; and mandatory and voluntary vitamins and serving and per container for only (2) allowing for certain percent DV minerals, in addition to the requirement certain declarations but not all label declarations that are currently excluded for percent DV declaration. An declarations for containers of food or in § 101.9(j)(5)(ii)(A). Given these exception to this proposed requirement units of food, as applicable, containing

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at least 200 percent and up to and vary with caloric intake whereas others more and less healthful products when including 400 percent of the applicable do not. Specifically, only the DRVs for they are given an explanation about RACC. The first option is for a label that the macronutrients (i.e., total fat, percent DVs than when they are not includes calorie information per serving saturated fat, total carbohydrate, dietary (Ref. 177). Therefore, it is our tentative and per container (or unit, as fiber, and protein) differ according to view that a new footnote statement applicable) following the serving size calorie needs while the current DRVs for containing informational text to help information in the Nutrition Facts label. cholesterol, sodium, and potassium, as consumers interpret the meaning of the With this option, the remaining well as the RDIs for essential vitamins percent DV and use the DVs is needed. nutrition information would be listed on and minerals, do not vary according to Such information may include a a per serving basis only and in a single caloric intake, and therefore are the definition of the percent DV, a succinct column below the calorie information same for both the 2,000 and 2,500 statement regarding calorie intake, and/ per serving and per container. The calorie levels listed in the footnote. or an explanation of when the percent second option is to provide nutrition Finally, a statement indicating that the DV signifies a relatively high or low information per serving and per kcal/g for fat, carbohydrate, and protein level of a nutrient, such as the ‘‘5/20 container (or unit, as applicable) for are 9, 4, and 4, respectively, is permitted rule,’’ which we describe in this calories, saturated fat and sodium to be declared below the DRVs table document. In addition, it is our tentative following the serving size information (§ 101.9(d)(10)). view that such a footnote statement in the Nutrition Facts label and the Several comments to the 2007 should be simple and easy to remaining nutrition information would ANPRM suggested deleting either the understand, as simplified information is be listed on a per serving basis in a entire footnote or the DRVs table from more useful and accessible to single column below the dual column the footnote, and stated that the footnote consumers than complex information provided for calories, saturated fat and information is not readily useable or (Ref. 178). sodium declarations. These options may understood by consumers and may be We also recognize that the footnote specifically highlight the calorie content potentially confusing. Other comments appearing in small type size at the alone, and the calorie content, saturated recommended replacing the footnote bottom of the label may have made it fat content, and sodium content, with a short, simple statement that less noticeable to consumers and respectively, for both the serving size directs consumers to the USDA’s therefore of less use than if it had been and the entire container of food (or unit, MyPyramid Web site (which has now larger and otherwise more noticeable. as applicable). These options would been replaced with ChooseMyPlate.gov) Therefore, it is our tentative view that focus on a smaller number of nutrients for further information. We do not agree increasing the type size, bolding key presented per serving and per container with these latter comments, as elements of the footnote (space of food (or unit, applicable) that the U.S. information on the Nutrition Facts label permitting), and adding a bar clearly population should limit for those foods should be available to the consumer at separating it from the micronutrient with at least 200 percent and up to and the time of product purchase or information directly above will assist including 400 percent of the RACC. We consumption. consumers in using the information. question whether consumers would be The percent DV is not described in Again, we request comment on the more inclined to use dual column the footnote or anywhere else on the impact such changes would have on labeling for a smaller set of nutrients. Nutrition Facts label and we are enhancing consumers’ use of the We invite comment and data on dual interested in whether such a description percent DV. We will consider comments column labeling as proposed in this rule would help improve consumer we receive and whether to include such as well as the options presented for understanding of the percent DV changes in the final rule. providing nutrition information per information. In addition, as one We also consider that a succinct serving and per container (or unit, as comment pointed out, a recent study by statement about daily calorie intake applicable) for only certain declarations. the International Food Information (2,000 calories) is a necessary part of the We will consider whether to require Council Foundation entitled ‘‘Food footnote because 2,000 calories is one of these options in the serving size Label and Consumer Research Project’’ consistent with widely used food plans final rule after considering comments on showed that some consumers did not (76 FR 19192 at 19209), the percent DV the serving size proposed rule. understand what was being conveyed in of certain nutrients (e.g., total fat, total the percent DV explanatory footnote and carbohydrate, and dietary fiber) is based 10. The Footnote others thought that the DRVs table on 2,000 calories, and 2,000 calories The Nutrition Facts label requires an changed according to the content of approximates the estimated energy need asterisk following the ‘‘% Daily Value’’ each food and beverage product. for adults who are sedentary to declaration that refers to a footnote Therefore, although data indicate that moderately active. However, we statement that reads: ‘‘*Percent Daily the DRVs table is not well understood recognize that a succinct statement Values are based on a 2,000 calorie diet. by consumers, it also appears unlikely about daily calorie intake should not Your Daily Values may be higher or that consumers would understand this suggest that the percent DV of all lower depending on your calorie needs’’ information any better if calorie values nutrients is linked to a 2,000 calorie (§ 101.9(d)(9)(i)). Below this footnote, a were lowered or if a separate listing for diet. table that lists DRVs for total fat, men and women were provided, as was As previously discussed in section saturated fat, cholesterol, sodium, total suggested by some comments. II.M.7, we are planning to conduct carbohydrate, and dietary fiber based on Therefore, we are proposing to remove consumer research on various format 2,000 and 2,500 calorie diets must be the requirement for the footnote table issues, including percent DV provided (§ 101.9(d)(9)(i)). This table listing the DRVs for total fat, saturated information in the footnote area. We was originally included in the Nutrition fat, cholesterol, sodium, total agree that consumer education programs Facts label to assist consumers in carbohydrate, and dietary fiber for 2,000 are important, and have offered such estimating their own quantitative and 2,500 calorie diets that is specified programs on our Web site to a variety dietary needs relative to the reference in § 101.9(d)(9)(i). of audiences, including young DVs (58 FR 2079 at 2127). It was also We also note that consumers are individuals (Ref. 179). We will consider intended to communicate that some DVs better able to discriminate between additional efforts, as appropriate. In an

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effort to provide consumers with a 11. Use of Highlighting With a Type concluded that a 0.25 point hairline rule general approach for using the percent Intermediate Between Bold or Extra shall be inserted directly beneath the DV to evaluate the nutrient content in Bold and Regular Type Nutrition Fact heading on all label foods, we have explained on our Web Currently, only nutrients that are not formats, with the exception of the linear site that, as a general frame of reference, indented (i.e., ‘‘Calories,’’ ‘‘Total Fat,’’ display for small packages. We invite a 5 percent DV or less is low and a 20 ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total comment on this tentative conclusion. percent DV or more is high (often called Carbohydrate,’’ and ‘‘Protein’’) on the 13. Replacing ‘‘Total Carbohydrate’’ the ‘‘5/20 rule’’) (Ref. 180). Even though Nutrition Facts label are required to be With ‘‘Total Carbs’’ this general frame of reference has been highlighted in bold or extra bold type or publicized and advocated by the 2010 Nutrition information declared on the other highlighting (§ 101.9(d)(1)(iv)). We Nutrition Facts label must be presented DGA (Ref. 6) and various Web sites (Ref. have tentatively concluded, based on using the nutrient names specified in 181), it is unclear whether consumers design considerations of highlighting § 101.9(c) or § 101.9(j)(13)(ii)(B). are aware of the ‘‘5/20 rule,’’ and to information in Bold type (Ref. 167) According to § 101.9(c)(6), the nutrient what extent it can improve consumer would help differentiate the name of the name used for listing information about judgments about what constitutes high nutrient from its absolute amount, that the carbohydrate content of a product is or low levels of nutrients in foods since all of the other nutrients listed on the ‘‘Total Carbohydrate.’’ Certain quantitative information about food Nutrition Facts label, including those abbreviations, as specified in constituents is difficult for consumer to that are indented and the vitamins and § 101.9(j)(13)(ii)(B), may be used on the interpret (Ref. 180). The ‘‘5/20 rule’’ also minerals, should also be highlighted in Nutrition Facts label on packages that closely approximates FDA regulations order to set them apart from other have a total surface area available to for nutrient content claims that provide information that appears in the bear labeling of 40 or less square inches. criteria for the terms ‘‘low’’ (§§ 101.61 Nutrition Facts label. The key nutrients In addition, the term ‘‘carb’’ is and 101.62) and the terms ‘‘rich in’’ and that are not indented above would still commonly used as a shortened term or ‘‘excellent source’’ (§ 101.54). Thus, the be highlighted in a font that is bolder acronym for ‘‘carbohydrate’’ (Ref. 183). ‘‘5/20 rule’’ could assist consumers in than the indented nutrients, so the Although the current abbreviation for choosing foods that are high in specific overall style of the Nutrition Facts label ‘‘Total carbohydrate’’ is ‘‘Total carb,’’ nutrients they want to consume more of will not change. Accordingly, we are we found that ‘‘total carbs’’ was (e.g., calcium) and/or low in nutrients proposing to amend § 101.9(d)(1)(iv) to extensively preferred over ‘‘total carb’’ they want to eat less of (e.g., saturated remove the restriction that prohibits any as a Google search term during the past fat). To inform our decision on how best other information on the label to be 15 years, suggesting that ‘‘carbs’’ is the to construct the new footnote, including highlighted, and to require that all more commonly used term by the its content and format, we plan to voluntary nutrients specified in general public (Ref. 184). As previously conduct consumer research during this § 101.9(c), including the vitamins and discussed, we are interested in rulemaking that will test consumer minerals listed in § 101.9(c)(8)(iv), maximizing the amount of white space reactions to a definition of percent DV, appear in a type intermediate between on the Nutrition Facts label and in a succinct statement on calories, and bold and regular type (if bold type is maintaining a simple format that several statements related to the ‘‘5/20 used) or between extra bold and regular minimizes clutter and enables the rule’’ (77 FR 32120, May 31, 2012, and type (if extra bold type is used) on the public to readily observe and 78 FR 32394). We will make the results Nutrition Facts label. comprehend the nutrition information of this study available for public review 12. Addition of a Horizontal Line that is presented. For the reasons set and comment. We request comments, Beneath the Nutrition Facts Heading forth previously, we tentatively including available data and conclude that using the term ‘‘Total The current label requires that the information (such as experimental Carbs’’ instead of ‘‘Total Carbohydrate’’ Nutrition Facts heading be set in a type evidence) related to this issue. would help achieve these objectives. size larger than all other print size in the Accordingly, we are proposing to amend We are not aware of data gathered nutrition label (§ 101.9(d)(2)) but does § 101.9(c)(6) and § 101.9(j)(13)(ii)(B) by since the NLEA’s implementation on not require that this heading be set apart requiring that the total carbohydrate whether listing information about from the rest of the label with a content in a serving be listed as ‘‘Total converting gram amounts of fat, horizontal hairline rule, which is a thin Carbs’’ instead of ‘‘Total Carbohydrate’’ carbohydrate, and protein to calories line. Horizontal lines are used or ‘‘Total Carb’’ and that this listing be has been useful to consumers. We are throughout the Nutrition Facts label as used on all label formats. We invite not proposing changes to this aspect of a key graphic element to divide space, comment on this tentative conclusion. the footnote specified in § 101.9(d)(10). direct the eye, and give the label a However, we request comments and unique and identifiable look. The 14. Alternative Visual Formats/Fonts supporting data on whether or not this repeated use of horizontal lines helps We considered the utility of calorie conversion information should develop the organization of the label, alternative visual presentation formats, continue to be optional on the Nutrition strengthens the label’s unity, in response to some comments that Facts label, and whether there are any accentuates width, and promotes suggested using charts or graphs to data suggesting that consumers do or do stability (Ref. 182). The addition of a facilitate consumer understanding (Ref. not use this information. We may hairline rule immediately below the 47). During the development of the consider deleting this optional Nutrition Facts heading directs the current label format, we examined requirement in the final rule if we reader’s eye to the serving size alternative graphic designs, including determine the information is not useful. information, further emphasizes the graphs, and determined that the current We will consider corresponding changes information about servings, and helps format was optimal (Ref. 185). Since to the footnote requirements for the break the information into small 1993, we reviewed two published Supplement Facts label consistent with chunks, thus making it easier to process studies that explored alternative any changes to the footnote on the and remember the information (Ref. graphical formats (Refs. 172 and 186). Nutrition Facts label. 167). Accordingly, we have tentatively These studies provided limited and

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mixed evidence in support of the tested ensure the readability of the Nutrition of the composite is greater than 20 formats. For example, one study (Ref. Facts label. percent in excess of the value for that 186) did not investigate how graphical nutrient declared on the label. In formats would perform when addition, no regulatory action will be individuals have to compare the based on a determination of a nutrient healthfulness of more than one product value that falls above this level by a simultaneously. The other study (Ref. factor less than the variability generally 172) demonstrated that when recognized for the analytical method participants used the test labels to used in that food at the level involved. compare two products, the alternative One comment to the 2007 ANPRM graphical format was not unequivocally asked us to reevaluate the level of superior to a format resembling the variance permitted for nutrient content standard Nutrition Facts format, and declarations, particularly for added nutrients of concern such as sodium, indeed the graphical display appeared sugar, and fat. Expressing concern that to be inferior to the Nutrition Facts-type the current practice could result in the format in supporting consumers’ ability provision of inaccurate and misleading to calculate the number of servings of a information to consumers, the comment food that would provide the daily value recommended that if we are unable to of particular nutrients. Therefore, in the reduce the amount of permitted absence of conclusive evidence to variability, we should, at a minimum, support alternative graphical layouts, require food processors to include a we are not proposing any changes to the disclosure on the food label. basic format of the Nutrition Facts label In determining the allowances for as specified in § 101.9(d)(12). However, variability in § 101.9(g), we considered we invite comment on an alternative variability in the nutrient content of concept for the Nutrition Facts label foods, analytical variability inherent to format that indicates ‘‘quick facts’’ (e.g., test methods used to determine amount of total carbohydrate, fat and compliance, and statistical probability protein) about a product’s nutrient (38 FR 2125 at 2128, January 19, 1973). content first, and then explicitly points In addition, we evaluated compliance out nutrients to ‘‘avoid too much’’ of as procedures and found them to be well as nutrients to ‘‘get enough’’ of as statistically sound and adequate. The a way to categorize the nutrient comment provided no information to declarations in the Nutrition Facts label. support a change to the current level of We previously considered this concept variance or the use of a disclosure of separating nutrients out on the label statement in this context. and would like to reconsider it (Ref. Therefore, we are not proposing to 163). We request comment on how this change the level of variance allowed in display may or may not convey the § 101.9(g)(5) in response to the information in a manner which enables comment. the public to readily observe and 2. Methods Used To Determine comprehend such information and Compliance whether separating and placing nutrients such as ‘‘ ‘‘Total Fat and N. Compliance Under § 101.9(g)(2), a composite of 12 ‘‘Saturated Fat’’ under different subsamples, each taken from 12 Section 101.9(g) provides information different randomly chosen shipping headings would help or hinder about how we determine compliance consumer’s understanding of the cases are analyzed by appropriate with our nutrition labeling methods as given in the ‘‘Official Nutrition Facts label. We are also requirements, including the methods of interested in comments on what Methods of Analysis of the AOAC analysis used to determine compliance, International,’’ 15th Ed. (1990) to headings could be used and how to reasonable excesses and deficiencies of categorize all of the nutrients. determine compliance with the nutrients, and acceptable levels of requirements in § 101.9, unless a Additionally, we are seeking variance from declared values. Based on particular method of analysis is comment on whether a specific type the proposed changes to other sections specified in § 101.9(c). If no AOAC style should be required for the of § 101.9 (discussed in sections II.A. to method is available or appropriate, we Nutrition Facts label. Currently, we II.M.) and taking into account comments use other reliable and appropriate specify in § 101.9(d)(1)(ii)(A) that the in response to the 2007 ANPRM, we are analytical procedures (see § 101.9(g)(2)). type style should be a ‘‘single easy-to- proposing several changes to § 101.9(g), The current edition (19th Ed.) of the read type style’’ but no specific type which we discuss in this document. ‘‘Official Methods of Analysis of the style is required. However, in 1. Level of Variance Allowed for the AOAC International’’ includes many § 101.9(d)(1) we urge that certain type Label Declaration of Specific Nutrients updates to the 15th Edition. styles (i.e., Helvetica Black, Helvetica When we issued § 101.9(g) related to Regular, Franklin Gothic Heavy) and Section 101.9(g)(5) establishes that a compliance with nutrition labeling other graphic design features be used, as food with a label declaration of calories, requirements, the most current version described in appendix B to title 21, part sugars, total fat, saturated fat, trans fat, of the AOAC methods was its 15th 101, of the Code of Federal Regulations. cholesterol, or sodium shall be deemed edition and, therefore, we identified the We request comment on whether a to be misbranded under section 403(a) 15th edition in our regulation. Newer specific font should be required to of the FD&C Act if the nutrient content and better methods of analysis have

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been subsequently validated and RRR-a-tocopherol and all rac-a- In order to verify the nutrient recognized as ‘‘official’’ methods in the tocopherol acetate); and (6) folate (when composition of a packaged food, the current 19th edition (2012) of the a food product contains both folate and manufacturer would need to ensure that Official Methods of Analysis of the folic acid). As discussed in sections the records it provides to us to verify the AOAC International. Accordingly, we II.D.3. (added sugars), II.D.5.a. declared amount of each of these are proposing to amend § 101.9(g)(2) by (dietary fiber), II.D.5.b. (soluble and nutrients, under the circumstances removing ‘‘15th Ed. (1990)’’ and adding insoluble fiber), II.J.2. (folate), and II.J.3. described, substantiate the nutrient in its place ‘‘19th Ed. (2012)’’ to specify (vitamin E) composition of the specific food and, as that we will analyze composites ‘‘by Under current § 101.9(g)(9), FDA may appropriate, can distinguish among the appropriate methods as given in the permit the use of an alternative means same or similar product the ‘‘Official Methods of Analysis of the of compliance or additional exemptions manufacturer has in the marketplace AOAC International,’’ 19th Ed. (2012).’’ when it is not technologically feasible, that may contain differing amounts of If a newer edition of the Official or some other circumstance makes it the declared nutrient. For example, the Methods of the AOAC International is impracticable, for firms to comply with manufacturer may have to distinguish published before issuance of a final rule, the requirements of § 101.9. In such a among different fruit juice products and assuming that we issue a final rule, case, under § 101.9(g)(9), firms must with different amounts of added sugars we intend to finalize this rule with the submit a request in writing to FDA for or the same fruit juice product with newer edition, as appropriate, provided the use of an alternative means of different formulations. Most there are no substantive changes in the compliance or for a labeling exemption. manufacturers should already have the newer edition requiring additional We are proposing an alternative type of records needed to validate the comment. approach for assessing compliance of declared amount of each of these the declared amount of each of the 3. Records Requirements nutrients. The records requirements nutrients identified previously under provide flexibility in what records the Current § 101.9(g)(2) sets forth the circumstances we describe, given manufacturer makes available to us to requirements for composite sampling the nature of the information necessary verify the declared amount of these and analysis to determine compliance to determine compliance and the nutrients for a particular marketed with labeling declarations. Specifically, number of foods potentially affected, product. In the absence of an accurate unless a specific analytical method is because there is no suitable analytical and reliable analytical method for identified by regulation, composites are method available to measure the quantifying the amount of these analyzed by the appropriate AOAC quantity of each such nutrient as nutrients for nutrition labeling under method (15th Edition) or, if no AOAC declared on the label or in labeling. We the circumstances described, only the method is available or appropriate, by are proposing to require the manufacturer will have the information other reliable and appropriate analytical manufacturer to make and keep records, required to determine the accuracy of procedures. For certain nutrients subject identified in proposed § 101.9(g)(10), the declared amount. The information to this proposed rule, however, there is that are necessary to verify the declared contained in manufacturers’ records is no AOAC official method of analysis or amount of each of these nutrients on the an accurate and practical method for other reliable or appropriate analytical Nutrition Facts label. In proposed assuring that the nutrient declarations procedure that is available for us to § 101.9(g)(10) and (g)(11), we are comply with section 403(q) of the FD&C verify the amount of the declared proposing that manufacturers must Act. Under section 403(q) of the FD&C nutrient on the Nutrition Facts label and make and keep written records, as Act, a food must bear, in its label or ensure that the declared nutrient specified for each of the nutrients and labeling, the amount of the nutrient the amount is truthful, accurate and under the circumstances described in food contains. The purpose of providing complies with all applicable labeling proposed § 101.9(g)(10)(i–vii), that are the nutritional value of the food is to requirements, including the necessary to verify the declared amount. assist consumers in maintaining health requirements in § 101.9(g). Specifically, We tentatively conclude that the records dietary practices. Moreover, the nutrient there is no suitable analytical procedure will provide the manufacturer and FDA declaration must be truthful and not available to measure the quantity of: (1) with the necessary means to determine misleading under sections 403(a)(1) and Added sugars (when a food product compliance with § 101.9(g) 201(n) of the FD&C Act. contains both naturally occurring sugars requirements related to nutrient and added sugars and for specific foods declaration. Under section 701(a) of the FD&C Act, containing added sugars, alone or in The manufacturer is in the best we may issue regulations for the combination with naturally occurring position to know which of its records efficient enforcement of the FD&C Act sugars, where the added sugars are provide the documentation required in order to ‘‘effectuate a congressional subject to fermentation); (2) dietary fiber under the circumstances described objective expressed elsewhere in the (when a food product contains both previously for us to determine Act’’ (Association of American non-digestible carbohydrate(s) that compliance. Some of the required Physicians and Surgeons, Inc. v FDA, meets the proposed definition of dietary records may appropriately include one 226 F. Supp. 2d 204 (D.D.C. 2002) fiber and non-digestible carbohydrate(s) or more of the following: Analyses of (citing Pharm. Mfrs. Ass’n. v FDA, 484 that does not meet the definition of databases, recipes or formulations, or F. Supp. 1179, 1183 (D. Del. 1980). The dietary fiber); (3) soluble fiber (when a batch records. We recognize that the proposed record requirements for these mixture of soluble fiber and added non- nutrient profile of processed foods that nutrients, under the circumstances digestible carbohydrate(s) that does not have added sugars, dietary fiber, soluble described, are designed to ensure that meet the definition of dietary fiber are fiber, insoluble fiber, vitamin E, or the nutrient declarations are accurate, present in a food); (4) insoluble fiber folate/folic acid can vary depending on truthful and not misleading, based on (when a mixture of insoluble fiber and the recipe or formulation, the suppliers information known only to the non-digestible carbohydrate(s) that does of ingredients, etc. Therefore, the manufacturer, and to facilitate efficient not meet the definition of dietary fiber amount of nutrients in a food may and effective action to enforce the are present in a food); (5) vitamin E change if a manufacturer changes requirements when necessary. Our (when a food product contains both ingredient suppliers or changes a recipe. authority to establish records

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requirements has been upheld under foods (21 CFR 113.100), acidified foods photocopying or other means of other provisions of the FD&C Act where (21 CFR 114.100), fruit juice (§ 111.120), reproduction, and that records required we have found such records to be and seafood (§ 111.123). Therefore, the may be retained either as original necessary (National Confectioners record retention period we propose to records, true copies (such as Assoc. v. Califano, 569 F.2d 690, 693– require to verify certain nutrient photocopies, pictures scanned copies, 94 (D.C. Cir. 1978). The records we declarations may include records that microfilm, microfiche, or other accurate propose to require are only for foods for manufacturers are required to make and reproductions of the original records) or which an AOAC or other reliable and keep for the same or longer periods electronic records. Where reduction appropriate analytical method is not under other requirements. The proposed techniques, such as microfilming are available. They allow us to verify the record requirements for purposes of used, suitable reader and photocopying declared amount of each of these verifying nutrient declarations of such equipment would need to be readily nutrients and that such amount is nutrients are separate and distinct from available. All electronic records truthful and not misleading. Thus, the other record requirements. Generally, maintained under § 101.9 would need to proposed records requirements assist in manufacturers are required to make and comply with part 11 of this chapter the efficient enforcement of the FD&C keep records for a minimum of 2 years (§ 101.9(g)(11)). We note that Part 11 Act. (21 CFR 1.360(d)), which the Agency would apply to any electronic records The authority granted to us under considers a reasonable period of time for that are maintained to comply with the sections 701(a), 403(q), 403(a)(1) and most foods to be available for purchase proposed requirements. We advise that 201(n) of the FD&C Act not only in the marketplace. the use of electronic records is includes authority to establish records Thus, we are proposing to require that voluntary and thus, a paper record requirements, but also includes access manufacturers must make and keep system could be used to comply with to such records. Without such authority, written records to verify the declaration these proposed recordkeeping the nutrient declarations for these of: (1) The amount of added sugars requirements. The proposed specific nutrients that we have when both naturally occurring and requirements for electronic records determined are necessary to assist added sugars are present in a food (in extend to electronic signatures. We consumers in maintaining healthy issued final guidance for industry on § 101.9(c)(6)(iii)); (2) the amount of dietary practices under section this topic. The guidance, entitled ‘‘Part added non-digestible carbohydrate(s) 403(q)(2)(A) of the FD&C Act are, 11, Electronic Records; Electronic that does not meet the proposed practically speaking, not enforceable. Signatures Scope and Application,’’ sets definition of dietary fiber when the Without access to such records, we out the Agency’s enforcement policies dietary fiber present in a food is a would not know whether the amount with respect to certain aspects of part mixture of non-digestible carbohydrates declared on the label or in the labeling 11. The guidance is available at http:// that do and that do not meet the of each of these nutrients, under the www.fda.gov/RegulatoryInformation/ definition of dietary fiber (in circumstances described, is truthful and Guidances/ucm125067.htm. This § 101.9(c)(6)(i)); (3) the amount of added not misleading under sections 403(a)(1) guidance would apply to any electronic and 201(n). The introduction or delivery soluble non-digestible carbohydrate(s) record, including electronic signatures, for introduction into interstate that does not meet the proposed established or maintained to meet a commerce of a misbranded food is a definition of dietary fiber when the proposed requirement in this rule, if prohibited act under section 301(a) of soluble dietary fiber present in a food is finalized as proposed. We request the FD&C Act. Thus, in order for us to a mixture of soluble non-digestible comment on the proposed requirements determine whether the food is carbohydrates that do and that do not for the types of records that must be misbranded and the manufacturer has meet the definition of dietary fiber (in made and kept and the length of time committed a prohibited act, we must § 101.9(c)(6)(i)(A)); (4) the amount of that the records must be kept. have access to the manufacturer’s added insoluble non-digestible records that we are requiring be kept carbohydrate(s) that do not meet the 4. Inclusion of Potassium as a Mineral under sections 403(q), 403(a) and 201(n) proposed definition of dietary fiber Potassium is specified as a Class I and of the FD&C Act. when the insoluble dietary fiber present Class II nutrient in § 101.9(g)(4)(i) and We anticipate that manufacturers may in a food is a mixture of insoluble non- (g)(4)(ii), respectively. This nutrient is have concerns about the confidentiality digestible carbohydrates that do and the only vitamin or mineral that is of the information inspected by us that do not meet the definition of specifically listed under the description under this proposal. We would protect dietary fiber (in § 101.9(c)(6)(i)(B)); (5) of both Class I and Class II nutrients. confidential information from the amount of all rac-a-tocopherol Potassium is a mineral for which an RDI disclosure, consistent with applicable acetate added to the food and RRR-a- is being proposed (§ 101.9(c)(8)(iv)) and statutes and regulations, including 5 tocopherol in the finished food when a the absolute amount would be required U.S.C. 552(b)(4), 18 U.S.C. 1905, and 21 mixture of both forms of vitamin E are to be declared along with a percent DV CFR part 20. present in a food (in § 101.9(g)(10)(i)); on the Nutrition Facts label. We Finally, it is necessary for the and (6) and the amount of folic acid tentatively conclude that there is no aforementioned records to be made added to the food and the amount of need to separately list potassium under available for review and copying while folate in the finished food when a the description of Class I and Class II the product is available for purchase in mixture of both forms are present in a nutrients because it is encompassed the marketplace. The shelf life of food (in § 101.9(g)(10)(ii)). We are also within the category, mineral. Therefore, packaged foods varies by product. Due proposing, in § 101.9(g)(11), that such we are proposing to remove specific to the significant number of packaged records must be kept for a period of 2 inclusion of the term ‘‘potassium’’ food products in the marketplace, there years after introduction or delivery for within § 101.9(g)(4), (g)(4)(i), (g)(4)(ii), could be a wide variety of shelf introduction of the food into interstate and (g)(6) such that it would be covered among packaged foods. Some foods are commerce. In addition, we are under ‘‘mineral’’ and any listing of subject to specific records requirements, proposing to require that such records potassium on the Nutrition Facts label such as dietary supplements (§ 111.605 must be provided upon request, during would have to meet the specific (21 CFR 111.605)), low acid canned an inspection, for official review and compliance requirements for minerals

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under § 101.9(g)(4), (g)(4)(i), (g)(4)(ii), permitted analytical variability would 403(a) of the FD&C Act if the nutrient and (g)(6). be applicable. Accordingly, we are composite is greater than 20 percent in proposing to amend § 101.9(g)(5) to excess of the added sugars value 5. Requirements for Other Carbohydrate, include ‘‘added sugars (when the only declared on the label, and within Soluble and Insoluble Fiber, Added source of sugars in the food is added § 101.9(g)(6) such that reasonable Sugars, and Sugar Alcohols sugars)’’ among the list of nutrients. deficiencies of added sugars would be The labeling requirements for Class I In § 101.9(g)(6), reasonable excesses of permitted; (6) include soluble and and Class II nutrients are provided in certain nutrients over labeled amounts insoluble fiber and sugar alcohols section § 101.9(g)(4). For the reasons are acceptable within current good within § 101.9(g)(6) such that reasonable discussed in section II.D.6., we are manufacturing practice. In addition, excesses of these nutrients would be proposing to revise § 101.9(c)(6)(iv) to reasonable deficiencies of certain other permitted; and (7) consistent with the remove the provision for voluntary nutrients under labeled amounts are tentative conclusion in section II.D.6., declaration of ‘‘Other carbohydrate.’’ acceptable within current good remove references to ‘‘Other Accordingly, we are proposing to manufacturing practice. Consistent with carbohydrates’’ in § 101.9(g). remove compliance requirements this approach, we are proposing to related to ‘‘Other carbohydrate’’ in allow, in § 101.9(g)(6), reasonable O. Technical Amendments § 101.9(g)(4) and (g)(6). excesses over the labeled amount of 1. Changing the Name of the Program Dietary fiber is included as both a soluble and insoluble fiber and sugar Office Class I and Class II nutrient because alcohols when they are acceptable food products may contain only non- within current good manufacturing Since publication of the regulations digestible carbohydrates that meet the practice, and reasonable deficiencies for nutrition labeling, the name of the definition of dietary fiber and that may under labeled amounts of added sugars office at the Center for and be naturally occurring or that may be when they are acceptable within current Applied Nutrition that is responsible for added to fortified or fabricated foods. good manufacturing practice. As with developing regulations and answering The same is true for soluble and other nutrients added to fortified or questions related to nutrition labeling as insoluble fiber, yet these nutrients are fabricated foods, we expect that when a well as for maintaining some of the not specifically listed as Class I or Class food product contains added sugars, references discussed throughout § 101.9 II nutrients. Therefore, we are proposing when all of the dietary fiber (both has changed. The Office of Nutritional to include soluble and insoluble fiber in soluble and insoluble) is added non- Products, Labeling and Dietary § 101.9(g)(4) as both Class I and Class II digestible carbohydrate that meets the Supplements is now called the Office of nutrients. definition of dietary fiber, when all of Nutrition, Labeling and Dietary Section § 101.9(g)(5) specifies that a the vitamin E is all rac-a-tocopherol Supplements. We are proposing to food with a label declaration of calories, acetate, and when only folic acid is update the name of the office sugars, total fat, saturated fat, trans fat, present in a food, the declared amount throughout § 101.9. cholesterol or sodium shall be deemed must be a least equal to the amount of to be misbranded under section 403(a) 2. Changing the Publication Date of the nutrient added to the food. Report Incorporated by Reference of the FD&C Act if the nutrient content In summary, we are proposing the of the composite is greater than 20 following changes related to Section § 101.9(c)(7)(ii) provides that percent in excess of the value for that compliance: (1) Amend § 101.9(g)(2) to the protein digestibility-corrected amino nutrient declared on the label. The cite the 19th edition of the Official acid score ‘‘shall be determined by nutrients listed in this section can have Methods of Analysis of the AOAC methods given in sections 5.4.1, 7.2.1, a negative impact on health in the International as the reference for and 8.00 in ‘‘Protein Quality Evaluation, general U.S. population if consumed in appropriate methods used to determine Report of the Joint FAO/WHO Expert excess and/or there are current dietary compliance with amounts of nutrients Consultation on Protein Quality recommendations to reduce the declared on the Nutrition Facts label; (2) Evaluation,’’ , 1990, except that consumption of these nutrients. amend § 101.9(c)(6)(i), (c)(6)(iii), (g)(10), when official AOAC procedures Therefore, we are ensuring in (g)(10)(i), and (g)(10)(ii) to establish described in section (c)(7) of this § 101.9(g)(5) that foods do not contain general recordkeeping requirements paragraph require a specific food factor excessive amounts of these nutrients of when records are necessary to verify other than 6.25, that specific factor shall which the consumer is not aware. information related to dietary fiber, be used.’’ We incorporated the ‘‘Report Current dietary recommendations added sugars, folate, and vitamin E of the Joint FAO/WHO Expert acknowledge that Americans consume provided on the label; (3) remove Consultation on Protein Quality excess amounts of added sugars and specific inclusion of the term Evaluation’’ by reference in encourage reducing intake of calories ‘‘potassium’’ within § 101.9(g)(4), § 101.9(c)(7)(ii). Although the referenced from added sugars. As discussed in (g)(4)(i), (g)(4)(ii), and (g)(6) such that report was written in 1989, it was section II.D.3., added sugars, like potassium would covered under published in 1991. We are, therefore, naturally occurring sugars, can ‘‘mineral’’ and any listing of potassium proposing to change the publication contribute to dental caries. As with the on the Nutrition Facts label would meet date of the report that is incorporated by other nutrients listed in § 101.9(g)(5), we the specific compliance requirements reference from 1990 to 1991. have an interest in ensuring that foods for minerals under § 101.9(g)(4), (g)(4)(i), 3. Plain Language Edits do not contain excessive amounts of (g)(4)(ii), and (g)(6); (4) when all of added sugars that are not declared on dietary fiber in a food product meets the On October 13, 2010, the President the label. Therefore, we are proposing to proposed definition of dietary fiber, signed the Plain Writing Act of 2010 include added sugars in § 101.9(g)(5). In include soluble and insoluble fiber as requiring that Federal Agencies use some food products, the only source of both Class I and Class II nutrients under ‘‘clear Government communication that sugars may be added sugars. In such § 101.9(g)(4); (5) include added sugars the public can understand and use.’’ On cases, an analytical method could be within § 101.9(g)(5) such that the label January 18, 2011, the President issued used to determine the amount of added declaration of added sugars will be an Executive Order (E.O. 13563 (75 FR sugars in the food product and the deemed misbranded under section 3821)—Improving Regulation and

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Regulatory Review) that requires that of the final rule’s publication in the a significant economic impact on a the government must ensure that Federal Register with a compliance date substantial number of small entities. regulations are accessible, consistent, 2 years after the effective date. We Section 202(a) of the Unfunded written in plain language, and easy to recognize that it may take industry time Mandates Reform Act of 1995 requires understand. In an effort to make the to analyze products for which there may that we prepare a written statement, requirements of § 101.9 easier to be new mandatory nutrient declarations, which includes an assessment of understand, we are proposing to make make any required changes to the anticipated costs and benefits, before editorial changes that do not change the Nutrition Facts label (which may be proposing ‘‘any rule that includes any meaning or intent of the language in coordinated with other planned label Federal mandate that may result in the § 101.9(g)(3)(ii); (g)(4)(i); (g)(4)(ii); and changes), review and update their expenditure by State, local, and tribal (g)(5). records of product labels, and print new governments, in the aggregate, or by the In § 101.9(g)(3)(ii), we are revising the labels. A compliance date that is 2 years private sector, of $100,000,000 or more current language to clarify that when a after the effective date is intended to (adjusted annually for inflation) in any nutrient or nutrients are not naturally provide industry time to revise labeling one year.’’ The current threshold after occurring (exogenous) in an ingredient to come into compliance with the new adjustment for inflation is $141 million, that is added to a food, the total amount labeling requirements while balancing using the most current (2012) Implicit of such nutrient(s) in the final food the need for consumers to have the Price Deflator for the Gross Domestic product is subject to Class I information in a timely manner. We Product. We have determined that the requirements rather than Class II invite comment on the proposed proposed rules on nutrition labeling, requirements. It is not explicitly stated compliance date. taken as a whole, meet this threshold. in the current regulation that such a The analysis that we have performed nutrient would be subject to Class I IV. Analysis of Impacts to examine the impacts of the proposed requirements. We have examined the impacts of this rules under Executive Order 12866, In § 101.9(g)(4)(i) and (g)(4)(ii), the proposed rule under Executive Order Executive Order 13563, the Regulatory definitions include a list of vitamins 12866, Executive Order 13563, the Flexibility Act, and the PRA (see section and minerals that are being defined as Regulatory Flexibility Act (5 U.S.C. V.) are included in the PRIA (Ref. 187) and are available at http:// Class I or Class II vitamins and minerals 601–612), the Unfunded Mandates followed by compliance requirements www.regulations.gov (Docket No. FDA– Reform Act of 1995 (Pub. L. 104–4) and for those nutrients. This differs from the 2012–N–1210). We invite comment on the Paperwork Reduction Act of 1995 definition provided in § 101.9(g)(3)(i) the PRIA. (PRA) (44 U.S.C. 3501–3520). Executive and (g)(3)(ii) in that the definitions Orders 12866 and 13563 direct us to V. Paperwork Reduction Act of 1995 provided in § 101.9(g)(3)(i) and (g)(3)(ii) assess all costs and benefits of available are about whether a nutrient is added or This proposed rule contains regulatory alternatives and, when naturally occurring. We are proposing to information collection provisions that regulation is necessary, to select remove ‘‘Class I’’ and ‘‘Class II’’ from the are subject to review by the Office of regulatory approaches that maximize beginning of sections § 101.9(g)(4)(i) and Management and Budget (OMB) under net benefits (including potential (g)(4)(ii) and to state instead that when the PRA. A description of these the list of nutrients provided in those economic, environmental, public health provisions is given in the PRIA (Ref. sections meets the definition of a Class and safety, and other advantages; 187) available at http:// I or Class II nutrient provided for in distributive impacts; and equity). We www.regulations.gov (Docket No. FDA– § 101.9(g)(3)(i) and (g)(3)(ii), the are publishing two proposed rules on 2012–N–1210) with an estimate of the declaration of those nutrients must meet nutrition labeling in the Federal annual reporting, recordkeeping, and certain requirements. The proposed Register. We have developed one third-party disclosure burden. Included change is being made to prevent comprehensive Preliminary Regulatory in the burden estimate is the time for confusion by having two different Impact Analysis (PRIA) (Ref. 187) that reviewing instructions, searching definitions of a ‘‘Class I’’ and ‘‘Class II’’ presents the benefits and costs of the existing data sources, gathering and nutrient for compliance with nutrition two proposed nutrition labeling rules maintaining the data needed, and labeling requirements. taken together; the PRIA is available at completing and reviewing each In § 101.9(g)(5), we are proposing to http://www.regulations.gov (Docket No. collection of information. remove the words ‘‘Provided, That’’. FDA–2012–N–1210). The full economic We invite comments on these topics: These words do not provide further impact analyses of FDA regulations are (1) Whether the proposed collection of clarification and they add additional no longer (as of April 2012) published information is necessary for the proper complexity to the section that is not in the Federal Register but are performance of FDA’s functions, necessary. submitted to the docket and are including whether the information will available on this site. We believe that have practical utility; (2) the accuracy of III. Proposed Effective and Compliance the cumulative impact of the proposed FDA’s estimate of the burden of the Dates rules on nutrition labeling, taken as a proposed collection of information, We intend that any final rule resulting whole, represent a significant regulatory including the validity of the from this rulemaking, as well as any action as defined by Executive Order methodology and assumptions used; (3) final rule resulting from the proposed 12866. ways to enhance the quality, utility, and rule entitled ‘‘Food Labeling: Serving The Regulatory Flexibility Act clarity of the information to be Sizes of Foods That Can Reasonably Be requires Agencies to analyze regulatory collected; and (4) ways to minimize the Consumed At One-Eating Occasion; options that would minimize any burden of the collection of information Dual-Column Labeling; Updating, significant impact of a rule on small on respondents, including through the Modifying, and Establishing Certain entities. Additional costs per entity of use of automated collection techniques, Reference Amounts Customarily the proposed rule are small, but not when appropriate, and other forms of Consumed; Serving Size for Breath negligible, and as a result we conclude information . Mints; and Technical Amendments’’ that the proposed rules on nutrition To ensure that comments on become effective 60 days after the date labeling, taken as a whole, would have information collection are received,

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OMB recommends that written food or component of the food (section With respect to added sugars, we comments be faxed to the Office of 6(c)(2) of the Nutrition Labeling and request comments on our tentative Information and Regulatory Affairs, Education Act of 1990, Pub. L. 101–535, conclusions and proposed provisions OMB, Attn: FDA Desk Officer, FAX: 104 Stat. 2353, 2364 (1990)). If this for mandatory declaration of added 202–395–7285, or emailed to proposed rule is made final, the final sugars, the placement of this [email protected]. All rule would create requirements that fall information as double indented line comments should be identified with the within the scope of section 403A(a) of below total sugars, and means to verify title ‘‘Record Retention, Reporting, and the FD&C Act. compliance. We also invite comment, Third-Party Disclosure Requirements for including the submission of available VIII. Comments the Declaration of Added Sugars, research, on whether calories from Dietary Fiber, Soluble Fiber, Insoluble Interested persons may submit either added sugars should be declared on the Fiber, Vitamin E, and Folate/Folic electronic comments regarding this Nutrition Facts label in lieu of a gram Acid.’’ document to http://www.regulations.gov declaration of added sugars to aid In compliance with the PRA, we have or written comments to the Division of consumers in maintaining healthy submitted the information collection Dockets Management (see ADDRESSES). It dietary practices. We also invite provisions of this proposed rule to OMB is only necessary to send one set of comment on products that are subjected for review. These requirements will not comments. Identify comments with the to non-enzymatic browning reactions be effective until we obtain OMB docket number found in brackets in the and fermentation, and the amount of approval. We will publish a notice heading of this document. Received variability that occurs among various concerning OMB approval of these comments may be seen in the Division types of products where added sugars requirements in the Federal Register. of Dockets Management between 9 a.m. are transformed into other compounds and 4 p.m., Monday through Friday, and as a result of chemical reactions during VI. Analysis of Environmental Impact will be posted to the docket at http:// food processing; (b) with respect to We have carefully considered the www.regulations.gov. dietary fiber, we invite comment on the potential environmental effects of this We invite comment on all aspects of proposed definition of dietary fiber and action. We have concluded that the the proposed rule, including the need retaining the term ‘‘dietary fiber.’’ We action will not have a significant impact for, and appropriateness of, the various invite comment, including the on the human environment, and that an provisions proposed in this rule and our submission of information on consumer environmental impact statement is not accompanying rationale. Specifically: understanding of the term ‘‘dietary required (Refs. 188 and 189). Our (1) We invite comment on our use of fiber’’ relative to other relevant terms; finding of no significant impact and the the most recent consensus reports and and (c) we are proposing to eliminate evidence supporting that finding, whether the information and data on the provision for voluntary declaration contained in an environmental which FDA relies from such reports for of ‘‘Other carbohydrate’’ on the assessment, may be seen in the Division proposed changes is consistent with Nutrition Facts label, and tentatively of Dockets Management (see ADDRESSES) current scientific information, the conclude that the proposed amendment between 9 a.m. and 4 p.m., Monday factors for considering mandatory and is unlikely to have a significant impact through Friday. voluntary declaration of non-statutory on industry or consumers. We invite nutrients, and whether there is an VII. Federalism comment on this issue, including the appropriate alternative analysis to submission of any other data or factual We have analyzed this proposed rule application of these factors regarding (a) information that we should consider in in accordance with the principles set no longer permitting mandatory making a final determination. forth in Executive Order 13132. Section declaration (i.e., vitamins A and C); (b) (5) We invite comment on our 4(a) of the Executive Order requires requiring the declaration of a nutrient tentative conclusions related to sodium Agencies to ‘‘construe * * * a Federal that is currently voluntary (e.g., vitamin discussed in section II.G., including the statute to preempt State law only where D), and; (c) continuing the voluntary proposed DRV. In particular, we invite the statute contains an express labeling of macronutrients (e.g., comment on: (a) The rationale for the preemption provision or there is some monounsaturated and polyunsaturated proposed DRV of 2,300 for sodium; (b) other clear evidence that the Congress fats); whether a RDI of 1,500j mg would be intended preemption of State law, or (2) We invite comment on the more appropriate and why, and; (c) where the exercise of State authority tentative conclusion to no longer permit alternative approaches for selecting a conflicts with the exercise of Federal the declaration of ‘‘Calories from fat’’ on DV for sodium and their public health authority under the Federal statute.’’ the Nutrition Facts label and on the basis for these approaches. We are also Section 403A of the FD&C Act (21 tentative conclusion not to establish a interested in comment, including data U.S.C. 343–1) is an express preemption DRV for calories and include a percent and factual information on consumer provision. Section 403A(a) of the FD&C DV for the declaration of calories, which understanding, interpretation, and use Act provides that: ‘‘* * * no State or are discussed in section II.A; of the percent DV of sodium declared on political subdivision of a State may (3) In section II.B., we addressed food labels, and the understanding and directly or indirectly establish under various issues related to the declaration potential influences of a DV that reflects any authority or continue in effect as to of total fat and related nutrients. We an RDI based on an AI (an intake level any food in interstate commerce—(4) invite comment on the proposed to not consume less of), instead of a any requirement for nutrition labeling of definition of fatty acids, as well as on DRV based on a UL (an intake level not food that is not identical to the our tentative conclusion that acetic, to exceed); requirement of section 403(q) * * *.’’ propionic, and butyric acids should not (6) In section II.H., we are proposing The express preemption provision of be excluded from the definition of total to: (a) Retain mandatory declaration of section 403A(a) of the FD&C Act does fat; calcium and iron; (b) provide for not preempt any State or local (4) We invite comment on various voluntary declaration of vitamins A and requirement respecting a statement in issues related to the declaration of C; (c) require the declaration of the labeling of food that provides for a carbohydrates and related nutrients, potassium and vitamin D; and (d) retain warning concerning the safety of the which are discussed in section II.D.: (a) voluntary declaration of several other

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vitamins and minerals. We are also saturated fat and cholesterol in the assist consumers in using the proposing to require that all vitamins nutrition labeling of foods for infants information and may lessen the time and minerals declared on the Nutrition and young children and whether there and effort needed to locate the target Facts label must include their is a need for an explanatory footnote to information and improve the accuracy quantitative amounts (in addition to the accompany such proposed mandatory of judgments about the calorie amounts requirements for corresponding percent declaration; (c) our tentative conclusion and nutrient contents of packaged food DV declaration). We invite comment on that declaration of added sugars should products; (g) the double indented these tentative conclusions, including be mandatory on foods represented or placement of added sugars below total the appropriate placement of the purported to be specifically for infants sugars and invite available research data quantitative amounts of nutrients on the 7 through 12 months of age, children 1 formation; (h) our tentative view that Nutrition Facts label, including data and through 3 years of age, and pregnant and increasing the type size, bolding key other available information on the lactating women; and (d) adequacy of elements of the footnote (space impact of mandatory labeling of the proposed RDIs for vitamins and permitting), and adding a bar clearly vitamins and minerals on food minerals for older infants and children separating it from the micronutrient fortification. We invite comment on the 1 through 3 years of age. information directly above will assist proposed mandatory declaration of (11) We invite comment, including consumers in using the information; (i) vitamin D, potassium, calcium and iron available data and other information on our tentative view on the need for a on the label, including how we consider the reformulation of dietary supplement footnote statement for enhancing the public health significance of each. products that may result from proposed consumers’ use and understanding of We also invite comment on whether the changes to the DVs, as well as the percent DV; (j) using data provided information on the potential presence of these nutrients presents consumer research we plan to conduct consequences of such reformulations; concerns related to label space or the during this rulemaking that will test need for consumer education. We also (12) We invite comment on whether we should consider changes to the consumer reactions to a definition of invite comment on whether the percent DV, a succinct statement on presence of these nutrients presents footnote statement ‘‘Percent Daily Values are based on a 2,000 calorie diet’’ calories, and several statements related concerns related to label space or the to the ‘‘5/20 rule’’; (k) whether or not need for consumer education. used on dietary supplement labels to be this calorie conversion information (7) In section II.I., we are proposing to consistent with any changes to the should continue to be optional on the use population-coverage RDAs, when footnote statement in the Nutrition Facts available, or AIs as the basis for label. Nutrition Facts label, and whether there establishing RDIs. We invite comment (13) We invite comment on (a) are any data suggesting that consumers on our analysis and rationale, including including the use of an alternative do or do not use this information; (l) available data and information related to format design or requiring the use of a alternative terms that may be more our analysis, and any available data on specific font; (b) our tentative readily understandable than Daily what role, if any, the basis of the DV conclusion that emphasizing both the Value, such as Daily Guide or Daily (EAR or RDA) has on consumption of number of calories per serving and the Need; (m) whether the word ‘‘percent’’ nutrients above the UL and in number of servings per container will (or the % symbol) needs to precede discretionary fortification of foods; we serve as an anchor to highlight this whatever term is used in the column request comment on lowering the RDI of information and grab the reader’s heading where the percent DVs are listed; (n) whether there is a need to B12 to 2.4 mg. attention, and therefore will assist (8) In section II.I.6, whether consumers to effectively use this include vertical lines that are similarly quantitative amounts for nutrients with information in the Nutrition Facts label; placed on Supplement Facts labels for RDI values that contain three or four (c) whether any of the changes that are multiple vitamins in packets digits should be rounded, what the being proposed to the Nutrition Facts (§ 101.36(e)(11)(iii)) and for dietary rounding increments should be, and label should also be required for certain supplements that list ‘‘per serving’’ and data to support suggested rounding products with Supplement Facts labels ‘‘per day’’ information increments for such vitamins and that list calories and/or other (§ 101.36(e)(11)(viii)); (o) the minerals. macronutrients, and if so, under what appropriate placement of percent DVs in (9) We invite comment on issues conditions and for which dietary the labeling of foods for infants 7 related to units of measure, supplement products should such through 12 months, children 1 through nomenclature, and analytical methods, labeling be required; (d) our tentative 3 years of age, and pregnant and which are discussed in section II.J.; view that there is no need to propose lactating women; (p) our tentative (10) We invite comment on issues changing the order of how serving size conclusion to insert a 0.25 point related to nutrition labeling for foods and servings per container are listed on hairline rule directly beneath the represented or purported to be the Supplement Facts label, or to make Nutrition Fact heading on all label specifically for infants 7 through 12 amendments in the type size or formats, with the exception of the linear months of age, children 1 through 3 capitalization corresponding to our display for small packages; (q) listing years of age, and pregnant and lactating proposed changes for this information the total carbohydrate content in a women, which are addressed in section on the Nutrition Facts labels; (e) our serving as ‘‘Total Carbs’’ instead of II.K., including (a) any available tentative conclusion that, based on ‘‘Total Carbohydrate’’ or ‘‘Total Carb’’ relevant empirical research as to design considerations, the label and its listing used on all label formats; whether the proposed declaration of statement for ‘‘Serving size’’ in both (r) an alternative concept for the saturated fat and cholesterol for infants household units and gram amounts Nutrition Facts label format that and children 1 through 3 years of age is should be right-justified on the same indicates ‘‘quick facts’’ about a likely to be confusing to consumers or line that ‘‘Serving size’’ is listed; (f) our product’s nutrient content and otherwise result in restriction of fat tentative conclusion that changing the explicitly points out nutrients to ‘‘avoid intakes among these subpopulations; (b) ‘‘Amount Per Serving’’ statement to too much’’ of as well as nutrients to ‘‘get how consumers would understand and ‘‘Amount per___’’ with the blank filled enough’’ of, and; (s) whether a specific use the information on amounts of in with the actual serving size would font should be required for the Nutrition

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Facts label. We request comment on American Medical Association. and Amino Acids (Macronutrients), how this display may or may not convey 2010;303:242–249. Summary’’, Washington, DC: National the information in a manner which 9. National Institutes of Health, National Press; 2002. pp. 1–19. enables the public to readily observe Heart Lung and Blood Institute in 21. Institute of Medicine (IOM) of the cooperation with The National Institute National Academies. ‘‘Dietary Reference and comprehend such information and of Diabetes and Digestive and Kidney Intakes for Water, Potassium, Sodium, whether separating and placing Diseases. (1998) ‘‘Clinical Guidelines on Chloride, and Sulfate’’, Washington, DC: nutrients such as ‘‘Total Fat’’ and the Identification, Evaluation, and National Academies Press; 2005. ‘‘Saturated Fat’’ under different Treatment of Overweight and Obesity in 22. Institute of Medicine (IOM) of the headings would help or hinder Adults: The Evidence Report; NIH National Academies. ‘‘Dietary Reference consumer’s understanding of the Publication No. 98–4083’’. Retrieved Intakes for Calcium and Vitamin D’’, from http://www.nhlbi.nih.gov/ Washington, DC: National Academies Nutrition Facts label. We also are _ interested in comments on what guidelines/obesity/ob gdlns.pdf. Press; 2011. 10. Institute of Medicine (IOM) of the 23. Institute of Medicine (IOM) of the headings could be used and how to National Academies. ‘‘Dietary Reference National Academies. ‘‘Dietary Reference categorize all of the nutrients. Intakes for Water, Potassium, Sodium, Intakes for Energy, Carbohydrate, Fiber, IX. 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Labeling: A Systematic Review’’. Public 188. U.S. Food and Drug Administration. infant formula) purported to be Health Nutrition. 2005;8:21–28. ‘‘Environmental Assessment for the specifically for infants 7 through 12 176. Fagerlin A., Peters E. ‘‘Quantitative Revision of the Nutrition and months, children 1 through 3 years of Information (Chapter 7)’’. In: Supplement Facts Labels’’, February age, and pregnant and lactating women, Communicating Risks and Benefits: An 14,2014. shall contain information about the Evidence-Based User’s Guide Ed. 189. U.S. Food and Drug Administration. Fischhoff, B., Brewer, N.T., Downs, J.S., ‘‘Finding of No Significant Impact for the level of the following nutrients, except eds. Silver Spring, MD: U.S. Food and Proposed Revisions to the Nutrition and for those nutrients whose inclusion, and Drug Administration, U.S. Department of Supplement Facts Labels’’, February 13, the declaration of the amounts, is Health and Human Services; 2011; 2014. voluntary as set forth in this paragraph. pp.53–62. No nutrients or food components other 177. Li, F., Miniard, P.W., Barone, M.J. ‘‘The List of Subjects in 21 CFR Part 101 than those listed in this paragraph as Facilitating Influence of Consumer Food labeling, Nutrition, Reporting either mandatory or voluntary may be Knowledge on the Effectiveness of Daily Value Reference Information’’. Journal of and recordkeeping requirements. included within the nutrition label. the Academy of Marketing Science. Therefore, under the Federal Food, Except as provided for in paragraphs (f) 2000;28:425–436. Drug, and Cosmetic Act and under or (j) of this section, nutrient 178. Riis J., Ratner R. ‘‘Simplified Nutrition authority delegated to the Commissioner information shall be presented using the Guidelines to Fight Obesity’’. In: of Food and Drugs, it is proposed that nutrient names specified and in the Leveraging Consumer for 21 CFR part 101 be amended as follows: following order in the formats specified Effective Health Communications—The in paragraphs (d) or (e) of this section. Obesity Challenge Ed. Batra, R., Keller, PART 101—FOOD LABELING (1) * * * P.A., Strecher, V.J., eds. Armonk, NY: (i) * * * Society for Consumer Psychology, M.E. ■ 1. The authority for 21 CFR part 101 (A) Using specific Atwater factors Sharp; 2011. 179. U.S. Food and Drug Administration. continues to read as follows: (i.e., the Atwater method) given in table (2014) ‘‘Spot the Block Campaign’’. Authority: 15 U.S.C. 1453, 1454, 1455; 21 13, ‘‘Energy Value of Foods—Basis and Retrieved from http://www.fda.gov/food/ U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. Derivation,’’ by A. L. Merrill and B. K. ingredientspackaginglabeling/ 243, 264, 271. Watt, United States Department of labelingnutrition/ucm281746.htm. ■ Agriculture (USDA) Handbook No. 74 180. U.S. Food and Drug Administration. 2. In § 101.9: ■ (slightly revised, 1973), which is (March 13, 2013) ‘‘A Key to Choosing a. Revise paragraphs (c) introductory text, (c)(1)(i)(A), (c)(1)(i)(C) through (E) incorporated by reference in accordance Healthful Foods: Using the Nutrition with 5 U.S.C. 552(a) and 1 CFR part 51 Facts on the Food Label’’. Retrieved from (c)(2) introductory text, (c)(5), (c)(6)(i), http://www.fda.gov/Food/ (c)(6)(iii) and (iv), (c)(7), (c)(8) and is available from the Office of ResourcesForYou/Consumers/ introductory text, (c)(8)(i), (c)(8)(ii) Nutrition, Labeling, and Dietary ucm079449.htm. introductory text, (c)(8)(iii) through (v), Supplements (HFS–800), Center for 181. U.S. Food and Drug Administration, (c)(9), (d)(1) introductory text, Food Safety and Applied Nutrition, Office of Nutrition Labeling and Dietary Food and Drug Administration, 5100 Supplements. ‘‘Memorandum to the File: (d)(1)(ii)(C), (d)(1)(iii) through (v), (d)(2), (d)(3)(i) and (ii), (d)(4) through (8), Paint Branch Pkwy., College Park, MD Documentation of Web sites that Use the 20740, or may be inspected at the (d)(10) through (12), (d)(13)(ii), (e), (f) 5/20 Rule’’, 2014. National Archives and Records introductory text, (f)(2)(ii), (f)(4) and (5), 182. White A. The Elements of Graphic Administration (NARA). For Design. 2nd Ed. New York, NY: Allworth (g) introductory text, (g)(2), (g)(3)(ii), information on the availability of this Press, 2011;pp. 167–169, 187. (g)(4) through (8), (h)(3)(iv), (h)(4) material at NARA, call 202–741–6030, 183. Dictionary.com Unabridged. (2014) introductory text, (j)(5)(i), (j)(5)(ii) or go to: http://www.archives.gov/ ‘‘Carb’’. Retrieved from http:// introductory text, (j)(5)(ii)(A), dictionary.reference.com/browse/carb. federal_register/code_of_federal_ (j)(13)(ii)(A)(1) and (2), (j)(13)(ii)(B) and 184. Google. (2014) Google Trends Search regulations/ibr_locations.html.; Terms ‘‘Total Carb’’ and ‘‘Total Carbs’’. (C), and (j)(18)(iv) introductory text. ■ b. Remove paragraph (c)(1)(ii), * * * * * Retrieved from http://www.google.com/ (C) Using the general factors of 4, 4, trends/. redesignate paragraph (c)(1)(iii) as 185. Kessler D.A., Mande J.R., Scarbrough E., (c)(1)(ii), and revise newly designated and 9 calories per gram for protein, total et al. ‘‘Developing the ‘‘Nutrition Facts’’ paragraph (c)(1)(ii); carbohydrate (less the amount of non- Food Label’’. Harvard ■ c. Remove paragraph (c)(6)(iv), digestible carbohydrates and sugar Review. 2003;4:13–24. redesignate paragraph (c)(6)(iii) as alcohols), and total fat, respectively, as 186. Viswanathan, M., Hastak, M., Gau, R. (c)(6)(iv), and add new paragraph described in USDA Handbook No. 74 ‘‘Understanding and Facilitating the (c)(6)(iii); (slightly revised 1973) pp. 9–11, which Usage of Nutritional Labels by Low- ■ is incorporated by reference in Literate Consumers’’. Journal of Public d. Add paragraphs (c)(1)(i)(F), (c)(8)(vii), (g)(10), and (g)(11); accordance with 5 U.S.C. 552(a) and 1 Policy Marketing. 2009;28:135–145. CFR part 51 (the availability of this 187. U.S. Food and Drug Administration. ■ e. Remove and reserve paragraph ‘‘Preliminary Regulatory Impact Analysis (d)(9); incorporation by reference is given in (PRIA) for the Food Labeling: Revision of ■ f. Remove paragraphs (e)(3)(i) and paragraph (c)(1)(i)(A) of this section). A the Nutrition and Supplement Facts (e)(3)(ii); and general factor of 2 calories per gram for Labels Notice of Proposed Rulemaking ■ j. Remove paragraphs (j)(5)(ii)(B) soluble non-digestible carbohydrates (Docket No. FDA–2012–N–1210) and through (j)(5)(ii)(D), and redesignate shall be used. The general factors for Food Labeling: Serving Sizes of Foods paragraph (j)(5)(ii)(E) as (j)(5)(ii)(B). caloric value of sugar alcohols provided That Can Reasonably Be Consumed At The revisions read as follows: in paragraph (c)(1)(i)(F) of this section One Eating Occasion; Dual-Column shall be used; Labeling; Updating, Modifying, and § 101.9 Nutrition labeling of food. (D) Using data for specific food factors Establishing Certain Reference Amounts for particular foods or ingredients Customarily Consumed; Serving Size for * * * * * Breath Mints; and Technical (c) The declaration of nutrition approved by the Food and Drug Amendments Notice of Proposed information on the label and in labeling Administration (FDA) and provided in Rulemaking (Docket No. FDA–2004–N– of food for adults and children over the parts 172 or 184 of this chapter, or by 0258)’’, 2014. age of 4 years, and on foods (other than other means, as appropriate;

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(E) Using bomb calorimetry data (i) ‘‘Dietary fiber’’: A statement of the with paragraphs (g)(10) and (g)(11) of subtracting 1.25 calories per gram number of grams of total dietary fiber in this section to verify the declared protein to correct for incomplete a serving, indented and expressed to the amount of dietary fiber in the label and digestibility, as described in USDA nearest gram, except that if a serving labeling of food when a mixture of Handbook No. 74 (slightly revised 1973) contains less than 1 gram, declaration of dietary fiber, and added non-digestible p. 10, which is incorporated by dietary fiber is not required or, carbohydrate(s) that does not meet the reference in accordance with 5 U.S.C. alternatively, the statement ‘‘Contains definition of dietary fiber, is present in 552(a) and 1 CFR part 51 (the less than 1 gram’’ or ‘‘less than 1 gram’’ the food. availability of this incorporation by may be used, and if the serving contains (A) ‘‘Soluble fiber’’ (VOLUNTARY): A reference is given in paragraph less than 0.5 gram, the content may be statement of the number of grams of (c)(1)(i)(A) of this section); expressed as zero. Dietary fiber is soluble dietary fiber in a serving may be declared voluntarily except that when a or defined as non-digestible soluble and insoluble carbohydrates (with 3 or more claim is made on the label or in labeling (F) Using the following general factors monomeric units) and lignin that are about soluble fiber, label declaration for caloric value of sugar alcohols: intrinsic and intact in plants; isolated shall be required. Soluble fiber must Isomalt—2.0 calories per gram, and synthetic non-digestible meet the definition of dietary fiber in lactitol—2.0 calories per gram, xylitol— carbohydrates (with 3 or more this paragraph (c)(6)(i). Soluble fiber 2.4 calories per gram, maltitol—2.1 monomeric units) that FDA has granted may be determined using AOAC calories per gram, sorbitol—2.6 calories be included in the definition of dietary 2011.25 or an equivalent method of analysis as given in the ‘‘Official per gram, hydrogenated starch fiber, in response to a petition submitted hydrolysates—3.0 calories per gram, and Methods of Analysis of the AOAC to FDA under § 10.30 (21 CFR 10.30) mannitol—1.6 calories per gram. International,’’ 19th Ed. (2012), which is demonstrating that such carbohydrates incorporated by reference in accordance (ii) ‘‘Calories from saturated fat’’ or have a physiological effect(s) that is with 5 U.S.C. 552(a) and 1 CFR part 51 ‘‘Calories from saturated’’ beneficial to human health; or isolated in paragraph (g)(2). The manufacturer (VOLUNTARY): A statement of the and synthetic non-digestible must make and keep records in caloric content derived from saturated carbohydrates (with 3 or more accordance with paragraphs (g)(10) and fat as defined in paragraph (c)(2)(i) of monomeric units) that are the subject of (g)(11) of this section to verify the this section in a serving may be declared an authorized health claim. Except as voluntarily, expressed to the nearest 5- declared amount of soluble fiber in the provided for in paragraph (f) of this label and labeling of food when a calorie increment, up to and including section, if dietary fiber content is not 50 calories, and the nearest 10-calorie mixture of soluble fiber and added non- required, and as a result not declared, digestible carbohydrate(s) that does not increment above 50 calories, except that the statement ‘‘Not a significant source amounts less than 5 calories may be meet the definition of dietary fiber is of dietary fiber’’ shall be placed at the present in the food. Soluble fiber expressed as zero. This statement shall bottom of the table of nutrient values in be indented under the statement of content shall be indented under dietary the same type size. Dietary fiber content fiber and expressed to the nearest gram, calories as provided in paragraph (d)(5) may be determined by subtracting the of this section. except that if a serving contains less amount of non-digestible carbohydrates than 1 gram, the statement ‘‘Contains (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A added during processing that do not statement of the number of grams of less than 1 gram’’ or ‘‘less than 1 gram’’ meet the definition of dietary fiber from may be used as an alternative, and if the total fat in a serving defined as total the value obtained using AOAC lipid fatty acids and expressed as serving contains less than 0.5 gram, the 2009.01, AOAC 2011.25, or an content may be expressed as zero.’’ triglycerides where fatty acids are equivalent method of analysis as given aliphatic carboxylic acids consisting of (B) ‘‘Insoluble fiber’’ (VOLUNTARY): in the ‘‘Official Methods of Analysis of A statement of the number of grams of a chain of alkyl groups and the AOAC International,’’ 19th Ed. insoluble dietary fiber in a serving may characterized by a terminal carboxyl (2012), which is incorporated by be declared voluntarily except that group. Amounts shall be expressed to reference in accordance with 5 U.S.C. when a claim is made on the label or in the nearest 0.5 (1/2) gram increment 552(a) and 1 CFR part 51 in paragraph labeling about insoluble fiber, label below 5 grams and to the nearest gram (g)(2). The following isolated and declaration shall be required. Insoluble increment above 5 grams. If the serving synthetic non-digestible carbohydrate(s) fiber must meet the definition of dietary contains less than 0.5 gram, the content have been determined by FDA to have fiber in this paragraph (c)(6)(i). shall be expressed as zero. physiological effects that are beneficial Insoluble fiber may be determined using * * * * * to human health and, therefore, shall be AOAC 2011.25 or an equivalent method (5) ‘‘Fluoride’’ (VOLUNTARY): A included in the calculation of the of analysis as given in the ‘‘Official statement of the number of milligrams amount of dietary fiber: b-glucan soluble Methods of Analysis of the AOAC of fluoride in a specified serving of food fiber (as described in International,’’ 19th Ed. (2012), which is may be declared voluntarily, except that § 101.81(c)(2)(ii)(A)) and barley b-fiber incorporated by reference in accordance when a claim is made about fluoride (as described in § 101.81(c)(2)(ii)(A)(6)). with 5 U.S.C. 552(a) and 1 CFR part 51 content, label declaration shall be Manufacturers may submit a citizen in paragraph (g)(2) of this section. The required. Fluoride content shall be petition in accordance with the manufacturer must make and keep expressed as zero when the serving requirements of § 10.30 to request that records in accordance with paragraphs contains less than 0.1 milligrams of FDA allow for the declaration of the (g)(10) and (g)(11) of this section to fluoride, to the nearest 0.1-milligram gram amount of an isolated and verify the declared amount of insoluble increment when the serving contains synthetic non-digestible carbohydrate or fiber in the label and labeling of food less than or equal to 0.8 milligrams of a health claim petition in accordance when a mixture of insoluble and added fluoride, and the nearest 0.2 milligram- with the requirements of § 101.70 for an non-digestible carbohydrate(s) that does increment when a serving contains more isolated and synthetic non-digestible not meet the definition of dietary fiber than 0.8 milligrams of fluoride. carbohydrate. The manufacturer must is present in the food. Insoluble fiber (6) * * * make and keep records in accordance content shall be indented under dietary

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fiber and expressed to the nearest gram, of the term ‘‘sugar alcohol,’’ the name of Copies may be obtained from AOAC except that if a serving contains less the specific sugar alcohol (e.g., INTERNATIONAL, 481 North Frederick than 1 gram, the statement ‘‘Contains ‘‘xylitol’’) present in the food may be Ave., suite 500, Gaithersburg, MD less than 1 gram’’ or ‘‘less than 1 gram’’ used in the nutrition label provided that 20877, or may be inspected at the may be used as an alternative, and if the only one sugar alcohol is present in the National Archives and Records serving contains less than 0.5 gram, the food. Sugar alcohol content shall be Administration (NARA). For more content may be expressed as zero.’’ indented and expressed to the nearest information on the availability of this * * * * * gram, except that if a serving contains material at NARA, call 202–741–6030, (iii) ‘‘Added Sugars’’: A statement of less than 1 gram, the statement or go to: http://www.archives.gov/ _ _ _ _ the number of grams of added sugars in ‘‘Contains less than 1 gram’’ or ‘‘less federal register/code of federal _ a serving, except that label declaration than 1 gram’’ may be used as an regulations/ibr locations.html. of added sugars content is not required alternative, and if the serving contains (i) A statement of the corrected for products that contain less than 1 less than 0.5 gram, the content may be amount of protein per serving, as gram of added sugars in a serving if no expressed as zero. determined in paragraph (c)(7)(ii) of this claims are made about sweeteners, (7) ‘‘Protein’’: A statement of the section, calculated as a percentage of the sugars, added sugars, or sugar alcohol number of grams of protein in a serving, RDI or DRV for protein, as appropriate, content. If a statement of the added expressed to the nearest gram, except and expressed as Percent of Daily Value, sugars content is not required and, as a that if a serving contains less than 1 may be placed on the label, except that such a statement shall be given if a result, not declared, the statement ‘‘Not gram, the statement ‘‘Contains less than protein claim is made for the product, a significant source of added sugars’’ 1 gram’’ or ‘‘less than 1 gram’’ may be or if the product is represented or shall be placed at the bottom of the table used as an alternative, and if the serving purported to be specifically for infants of nutrient values in the same type size. contains less than 0.5 gram, the content 7 through 12 months or children 1 Added sugars shall be defined as sugars may be expressed as zero. When the through 3 years of age. When such a that are either added during the protein in foods represented or declaration is provided, it should be processing of foods, or are packaged as purported to be for adults and children placed on the label adjacent to the such, and include sugars (free, mono- 4 or more years of age has a protein statement of grams of protein and and disaccharides), syrups, naturally quality value that is a protein aligned under the column headed occurring sugars that are isolated from digestibility-corrected amino acid score ‘‘Percent Daily Value,’’ and expressed to a whole food and concentrated so that of less than 20 expressed as a percent, the nearest whole percent. However, the sugar is the primary component (e.g., or when the protein in a food percentage of the RDI for protein shall fruit juice concentrates), and other represented or purported to be for not be declared if the food is caloric sweeteners. Added sugars children greater than 1 but less than 4 represented or purported to be content shall be indented under sugars years of age has a protein quality value specifically for infants 7 through 12 and expressed to the nearest gram, that is a protein digestibility-corrected months and the protein quality value is except that if a serving contains less amino acid score of less than 40 less than 40 percent of the reference than 1 gram, the statement ‘‘Contains expressed as a percent, either of the standard. less than 1 gram’’ or ‘‘less than 1 gram’’ following shall be placed adjacent to the (ii) The ‘‘corrected amount of protein may be used as an alternative, and if the declaration of protein content by (gram) per serving’’ for foods serving contains less than 0.5 gram, the weight: The statement ‘‘not a significant represented or purported for adults and content may be expressed as zero. When source of protein,’’ or a listing aligned children 1 or more years of age is equal a mixture of naturally occurring and under the column headed ‘‘Percent to the actual amount of protein (gram) added sugars is present in the food, and Daily Value’’ of the corrected amount of per serving multiplied by the amino for specific foods containing added protein per serving, as determined in acid score corrected for protein sugars, alone or in combination with paragraph (c)(7)(ii) of this section, digestibility. If the corrected score is naturally occurring sugars, where the calculated as a percentage of the Daily above 1.00, then it shall be set at 1.00. added sugars are subject to Reference Value (DRV) or Reference The protein digestibility-corrected fermentation, the manufacturer must Daily Intake (RDI), as appropriate, for amino acid score shall be determined by make and keep records in accordance protein and expressed as a Percent of methods given in sections 5.4.1, 7.2.1, with paragraphs (g)(10) and (g)(11) of Daily Value. When the protein quality and 8.00 in ‘‘Protein Quality Evaluation, this section to verify the declared in a food as measured by the Protein Report of the Joint FAO/WHO Expert amount of added sugars in the label and Efficiency Ratio (PER) is less than 40 Consultation on Protein Quality labeling of food. percent of the reference standard Evaluation,’’ Rome, 1991, except that (iv) ‘‘Sugar alcohol’’ (VOLUNTARY): (casein) for a food represented or when official AOAC procedures A statement of the number of grams of purported to be specifically for infants described in this paragraph (c)(7) sugar alcohols in a serving may be 7 through 12 months, the statement ‘‘not require a specific food factor other than declared voluntarily on the label, except a significant source of protein’’ shall be 6.25, that specific factor shall be used. that when a claim is made on the label placed adjacent to the declaration of The ‘‘Report of the Joint FAO/WHO or in labeling about sugar alcohol or protein content. Protein content may be Expert Consultation on Protein Quality sugars when sugar alcohols are present calculated on the basis of the factor 6.25 Evaluation’’ as published by the Food in the food, sugar alcohol content shall times the nitrogen content of the food as and Agriculture Organization of the be declared. For nutrition labeling determined by the appropriate method United Nations/World Health purposes, sugar alcohols are defined as of analysis as given in the ‘‘Official Organization is incorporated by the sum of saccharide derivatives in Methods of Analysis of the AOAC reference in accordance with 5 U.S.C. which a hydroxyl group replaces a International,’’ 19th Ed. (2012), which is 552(a) and 1 CFR part 51 and is ketone or aldehyde group and whose incorporated by reference in accordance available from the Office of Nutrition, use in the food is listed by FDA (e.g., with 5 U.S.C. 552(a) and 1 CFR part 51, Labeling, and Dietary Supplements mannitol or xylitol) or is generally except when the official procedure for a (HFS–800), Center for Food Safety and recognized as safe (e.g., sorbitol). In lieu specific food requires another factor. Applied Nutrition, Food and Drug

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Administration, 5100 Paint Branch use the RDIs that are specified for the percent and up to and including the 50- Pkwy., College Park, MD 20740, or may intended group. For foods represented percent level. Quantitative amounts and be inspected at the National Archives or purported to be specifically for both percentages of vitamins and minerals and Records Administration (NARA). infants 7 through 12 months and present at less than 2 percent of the RDI For more information on the availability children 1 through 3 years of age, the are not required to be declared in of this material at NARA, call 202–741– percent of Daily Value shall be nutrition labeling but may be declared 6030, or go to: http://www.archives.gov/ presented by separate declarations by a zero or by the use of an asterisk (or federal_register/code_of_federal_ according to paragraph (e) of this other symbol) that refers to another regulations/ibr_locations.html. For section based on the RDI values for asterisk (or symbol) that is placed at the foods represented or purported to be infants 7 through 12 months and bottom of the table and that is followed specifically for infants 7 through 12 children 1 through 3 years of age. When by the statement ‘‘Contains less than 2 months, the corrected amount of protein such dual declaration is used on any percent of the Daily Value of this (these) (grams) per serving is equal to the actual label, it shall be included in all labeling, nutrient (nutrients)’’ or ‘‘Contains < 2 amount of protein (grams) per serving and equal prominence shall be given to percent of the Daily Value of this (these) multiplied by the relative protein both values in all such labeling. The nutrient (nutrients).’’ Alternatively, quality value. The relative protein percent Daily Value based on the RDI except as provided for in paragraph (f) quality value shall be determined by values for pregnant and lactating of this section, if vitamin D, calcium, dividing the subject food protein PER women shall be declared on food iron, or potassium is present in amounts value by the PER value for casein. If the represented or purported to be less than 2 percent of the RDI, label relative protein value is above 1.00, it specifically for pregnant and lactating declaration of the nutrient(s) is not shall be set at 1.00. women. All other foods shall use the required if the statement ‘‘Not a (iii) For the purpose of labeling with RDI for adults and children 4 or more significant source of ll (listing the a percent of the DRV or RDI, a value of years of age. vitamins or minerals omitted)’’ is placed (ii) The declaration of vitamins and 50 grams of protein shall be the DRV for at the bottom of the table of nutrient adults and children 4 or more years of minerals as a quantitative amount by weight and percent of the RDI shall values. Either statement shall be in the age, a value of 11 grams of protein shall same type size as nutrients that are be the RDI for infants 7 through 12 include vitamin D, calcium, iron, and potassium in that order, for infants 7 indented. The quantitative amounts of months, a value of 13 grams shall be the vitamins and minerals, excluding DRV for children 1 through 3 years of through 12 months, children 1 through 3 years of age, pregnant and lactating sodium, shall be the amount of the age, and a value of 71 grams of protein vitamin or mineral included in one shall be the RDI for pregnant and women, and adults and children 4 or more years of age. The declaration of serving of the product, using the units lactating women. of measurement and the levels of (8) Vitamins and minerals: A vitamins and minerals as a quantitative significance given in paragraph (c)(8)(iv) statement of the amount per serving of amount by weight and percent of the of this section, except that zeros the vitamins and minerals as described RDI shall include any of the other following decimal points may be in this paragraph, expressed as a vitamins and minerals listed in dropped, and additional levels of quantitative amount by weight using the paragraph (c)(8)(iv) of this section when significance may be used when the appropriate unit of measure provided in they are added as a nutrient paragraph (c)(8)(iv) of this section and supplement, or when a claim is made number of decimal places indicated is as a percent of Daily Value calculated as about them. Other vitamins and not sufficient to express lower amounts a percent of the RDI provided in minerals need not be declared if neither (e.g., the RDI for zinc is given in whole paragraph (c)(8)(iv) of this section. the nutrient nor the component is milligrams, but the quantitative amount (i) For purposes of declaration of otherwise referred to on the label or the may be declared in tenths of a percent of Daily Value as provided for labeling or advertising and the vitamins milligram). in paragraphs (d), (e), and (f) of this and minerals are: (iv) The following RDIs, section, foods represented or purported * * * * * nomenclature, and units of measure are to be specifically for infants 7 through (iii) The percentages for vitamins and established for the following vitamins 12 months, children 1 through 3 years, minerals shall be expressed to the and minerals which are essential in and pregnant and lactating women shall nearest 2-percent increment above 10 human nutrition:

RDI

Nutrient Unit of measure Adults and chil- Infants 7 Children 1 Pregnant and ≥ through 12 dren 4 years months through 3 years lactating women

Vitamin A ...... Micrograms RAE 1 (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) ...... 20 10 15 15 Vitamin E ...... Milligrams (mg) ...... 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 2 (mg) ...... 16 4 6 18 Vitamin B6 ...... Milligrams (mg) ...... 1.7 0.3 0.5 2.0 Folate 3 ...... Micrograms DFE 4 (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

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RDI

Nutrient Unit of measure Adults and chil- Infants 7 Children 1 Pregnant and ≥ through 12 dren 4 years months through 3 years lactating women

Phosphorous ...... 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 1500 2300 Potassium ...... Milligrams (mg) ...... 4,700 700 3000 5100 Choline ...... Milligrams (mg)...... 550 150 200 550 Protein ...... Grams (g) ...... N/A 11 N/A 5 71 A percent daily value must be declared on the label for bolded nutrients. 1 RAE = Retinol activity equivalents; 1 RAE = 1 microgram retinol, 12 micrograms b-carotene, or 24 micrograms a-carotene, or 24 micrograms b-cryptoxanthin. 2 NE = Niacin equivalents, 1 milligram niacin = 60 milligrams of tryptophan. 3 ‘‘Folic Acid’’ must be used for purposes of declaration in the labeling of dietary supplements. It must also be declared in mcg DFE. 4 DFE = Dietary folate equivalents; 1 DFE = 1 microgram food folate = 0.6 micrograms folic acid from fortified food or as a supplement con- sumed with food = 0.5 micrograms of a supplement. 5 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant and lactating women.

(v) The following synonyms may be Riboflavin—Vitamin B2 name of the synthetic form of the added in parentheses immediately * * * * * nutrient, ‘‘folic acid’’ shall be used following the name of the nutrient or (vii) When the amount of folate is when the nutrient is declared in the dietary component: declared in the labeling of a labeling of dietary supplements. Calories—Energy conventional food, the nutrient name (9) The following DRVs, ‘‘folate’’ shall be listed for products nomenclature, and units of measure are Vitamin C—Ascorbic acid containing either folate alone or a established for the following food Thiamin—Vitamin B1 mixture of folate and folic acid. The components:

DRV Food component Unit of measurement Adults and Infants 7 Children 1 Pregnant and children ≥ 4 through 12 through 3 lactating years months years women

Fat ...... Grams (g) ...... 1 65 30 2 39 1 65 Saturated fatty acids ...... Grams (g) ...... 1 20 N/A 2 10 1 20 Cholesterol ...... Milligrams (mg)...... 300 N/A 300 300 Total carbohydrate ...... Grams (g) ...... 1 300 95 2 150 1 300 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 1 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant 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 packages as provided for in paragraph (iii) Information required in in paragraph (c) of this section shall be (j)(13) of this section. In the interest of paragraphs (d)(7) and (d)(8) of this presented on foods in the following uniformity of presentation, FDA section shall be in type size no smaller format, as shown in paragraph (d)(12) of strongly recommends that the nutrition than 8 point, except the type size for this section, except on foods where the information be presented using the this information required in the linear tabular display is permitted as provided graphic specifications set forth in display for small packages as shown in for in paragraph (d)(11) of this section, appendix B to part 101. paragraph (j)(13)(ii)(A)(2) of this section on which dual columns of nutrition * * * * * shall be no smaller than 7 point. information are declared as provided for Information required in the footnote (ii) * * * in paragraph (e) of this section, on those statement shall be no smaller than 7 food products on which the simplified (C) At least nine points leading (i.e., point, except the type size for this format is required to be used as space between two lines of text) except information required in the tabular provided for in paragraph (f) of this that at least 12 points leading shall be display for small packages as shown in section, on foods for infants 7 months to utilized for the information required by paragraph (j)(13)(ii)(A)(1) of this section, 12 months of age and children 1 through paragraphs (d)(7) and (d)(8) of this for the linear display for small packages 3 years of age as provided for in section as shown in paragraph (d)(12), as shown in paragraph (j)(13)(ii)(A)(2) of paragraph (j)(5) of this section, and on and this section, and for the simplified foods in small or intermediate-sized * * * * * format as shown in paragraph (f)(5) of

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this section shall be no smaller than 6 paragraph (d)(3)(i) of this section and this section shall be no smaller than 6 point. Information required in shall separate each nutrient and its point, and there shall be no bar paragraph (d)(5) of this section for the corresponding percent Daily Value separating this information from the ‘‘Calories’’ declaration shall be required in paragraphs (d)(7)(i) and serving size information in both of these highlighted in bold or extra bold and (d)(7)(ii) of this section from the displays for small packages. shall be in a type size no smaller than nutrient and percent Daily Value above (5) Information on calories shall 16 point except the type size for this and below it, as shown in paragraph immediately follow the heading information required in the tabular (d)(12) of this section. ‘‘Amount per’’ followed by the serving display for small packages as shown in (2) The information shall be presented size and shall be declared in one line. paragraph (j)(13)(ii)(A)(1) of this section, under the identifying heading of If ‘‘Calories from saturated fat’’ is the linear display for small packages as ‘‘Nutrition Facts’’ in the nutrition label declared, it shall be indented under shown in paragraph (j)(13)(ii)(A)(2) of and, except for labels presented ‘‘Calories’’ and shall be in a type size no this section, and the required according to the format provided for in smaller than 8 point. information shown in paragraphs paragraphs (d)(11)(iii), (d)(13)(ii), (6) The column heading ‘‘% DV,’’ (d)(11)(iii) and (e)(6)(ii) of this section (e)(6)(ii), (j)(13)(ii)(A)(1), and followed by an asterisk (e.g., ‘‘% DV*’’), shall be in a type size no smaller than (j)(13)(ii)(A)(2) of this section, unless shall be separated from information on 12 point. The numeric amount for the impractical, shall be set the full width calories by a bar as shown in paragraph information required in paragraph (d)(5) of the information provided under (d)(12) of this section. The position of of this section shall also be highlighted paragraph (d)(7) of this section, as this column heading shall allow for a in bold or extra bold type and shall be shown in paragraph (d)(12) of this list of nutrient names and amounts as in a type size no smaller than 24 point, section. described in paragraph (d)(7) of this except the type size for this information (3) * * * section to be to the right of, and below, required in the tabular display for small (i) ‘‘llservings per container’’: The this column heading, except for labels packages as shown in paragraph number of servings per container, with a dual or multiple column format (j)(13)(ii)(A)(1) of this section, the linear except that this statement is not as shown in paragraphs (d)(13)(ii), display for small packages as shown in required on single serving containers as (e)(5), (e)(6)(i), and (e)(6)(ii) the ‘‘% DV’’ paragraph (j)(13)(ii)(A)(2) of this section, defined in paragraph (b)(6) of this column will appear to the right of the and for the required information shown section or on other food containers list of nutrient names. The column in paragraph (e)(6)(ii) of this section when this information is stated in the heading described in this paragraph shall be in a type size no smaller than net quantity of contents declaration. The shall not appear on the linear display 20 point. The information required in information required in this paragraph for small packages as shown in paragraph (d)(6) of this section shall be shall be highlighted in bold or extra paragraph (j)(13)(ii)(A)(2) of this section. in a type size no smaller than 7 point. bold and be in a type size no smaller (7) Except as provided for in When provided, the information than 11 point except the type size shall paragraphs (d)(13)(ii), (e)(5), (e)(6)(i), described in paragraph (d)(10) of this be no smaller than 10 point for this (e)(6)(ii), and (j)(13) of this section, section shall be in a type size no smaller information as shown in paragraph nutrient information for both mandatory than 6 point. (j)(13)(ii)(A)(1) and no smaller than 7 and any voluntary nutrients listed in (iv) The headings required by point as shown in paragraph paragraph (c) of this section that are to paragraphs (d)(2), (d)(3)(i), and (d)(6) of (j)(13)(ii)(A)(2) of this section. This be declared in the nutrition label shall this section (i.e., ‘‘Nutrition Facts,’’ ‘‘__ information shall be set the full width be declared as follows: servings per container,’’ and ‘‘% DV*’’), of the label as shown in paragraph (i) The name of each nutrient, as the calorie information, and the names (d)(12) of this section. specified in paragraph (c) of this of all nutrients that are not indented (ii) ‘‘Serving size’’: A statement of the section, shall be given in a column and according to requirements of paragraph serving size as specified in paragraph followed immediately by the (c) of this section (i.e., ‘‘Calories,’’ (b)(7) of this section. The serving size as quantitative amount by weight for that ‘‘Total Fat,’’ ‘‘Cholesterol,’’ ‘‘Sodium,’’ specified in paragraph (b)(7) of this nutrient appended with a ‘‘g’’ for grams, ‘‘Total Carbs’’ and ‘‘Protein’’), and the section must be right justified as shown ‘‘mg’’ for milligrams, or ‘‘mcg’’ for percentage amounts required by in paragraph (d)(12) of this section. The micrograms as shown in paragraph paragraph (d)(7)(ii) of this section shall information required in this paragraph (d)(12) of this section. The symbol ‘‘>’’ be highlighted in bold or extra bold type shall be in a type size no smaller than may be used in place of ‘‘less than.’’ or other highlighting (reverse printing is 8 point except the type size shall be no (ii) A listing of the percent of the DRV not permitted as a form of highlighting) smaller than 7 point for this information as established in paragraphs (c)(7)(iii) that prominently distinguishes it from as shown in paragraph (j)(13)(ii)(A)(2) of and (c)(9) of this section shall be given other information. The names of all this section. in a column aligned under the heading nutrients that are indented according to (4) A subheading ‘‘Amount per’’ ‘‘% DV’’ established in paragraph (d)(6) the requirements of paragraph (c) of this followed by the serving size shall be of this section with the percent section (i.e., ‘‘Saturated Fat,’’ ‘‘Trans separated from the serving size expressed to the nearest whole percent Fat,’’ ‘‘Dietary Fiber,’’ ‘‘Sugars,’’ and information by a bar as shown in for each nutrient declared in the column ‘‘Added Sugars’’) and the mandatory paragraph (d)(12) of this section and described in paragraph (d)(7)(i) of this and any voluntary vitamins and shall be highlighted in a type that is section for which a DRV has been minerals (except sodium), shall be intermediate between bold or extra bold established, except that the percent for highlighted in a type that is type and the type for all other protein may be omitted as provided in intermediate between bold or extra bold information, and be in a type size no paragraph (c)(7) of this section. The type and the type for all other smaller than 8 point, except the type percent shall be calculated by dividing information. size for this information required in the either the amount declared on the label (v) A hairline rule that is centered linear display for small packages as for each nutrient or the actual amount between the lines of text shall separate shown in paragraph (j)(13)(ii)(A)(2) and of each nutrient (i.e., before rounding) ‘‘Nutrition Facts’’ from the servings per the tabular display for small packages as by the DRV for the nutrient, except that container statement required in shown in paragraph (j)(13)(ii)(A)(1) of the percent for protein shall be

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calculated as specified in paragraph information by a hairline. This to accommodate any remaining vitamins (c)(7)(ii) of this section. The numerical information may be presented and minerals to be declared or the value shall be followed by the symbol horizontally as shown in paragraph information required in the footnote for percent (i.e., %). (d)(12) of this section (i.e. ‘‘Calories per statement, the remaining information (8) Nutrient information for vitamins gram: fat 9, carbohydrate 4, protein 4’’) may be moved to the right and set off and minerals (except sodium) shall be or vertically in columns. by a line that distinguishes it and sets separated from information on other (11)(i) If the space beneath the it apart from the nutrients and the nutrients by a bar and may be arrayed information on vitamins and minerals is percent DV information given to the left. vertically as shown in paragraph (d)(12) not adequate to accommodate the The caloric conversion information of this section (e.g., Vitamin D 2mcg information required in the footnote provided for in paragraph (d)(10) of this (10%), Calcium 260mg (20%), Iron 8mg statement, the information required in section may be presented beneath either (45%), Potassium 235mg (5%)) or may the footnote statement may be moved to side or along the full length of the be listed in two columns. When listed the right of the column required in nutrition label. horizontally in two columns, vitamin D paragraph (d)(7)(ii) of this section and and calcium should be listed on the first set off by a line that distinguishes it and (iii) If there is not sufficient line and iron and potassium should be sets it apart from the percent Daily continuous vertical space (i.e., listed on the second line. Value information. The caloric approximately 3 in) to accommodate the (9) [Reserved] conversion information provided for in required components of the nutrition (10) Caloric conversion information paragraph (d)(10) of this section may be label up to and including the mandatory on a per gram basis for fat, carbohydrate, presented beneath either side or along declaration of potassium, the nutrition and protein may be presented beneath the full length of the nutrition label. label may be presented in a tabular the information required in the footnote (ii) If the space beneath the mandatory display as shown in the following statement, separated from that declaration of potassium is not adequate sample label.

(12) The following sample labels mandatory plus voluntary provisions of illustrate the mandatory provisions and paragraph (d) of this section.

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

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* * * * * combined with another ingredient as (e) Nutrition information may be shown in paragraph (e)(5) of this presented for two or more forms of the section). same food (e.g., both ‘‘as purchased’’ (3) When the dual labeling is and ‘‘as prepared’’) or for common combinations of food as provided for in presented for two or more forms of the paragraph (h)(4) of this section, for same food, for combinations of food, for different units (e.g., slices of bread or different units, or for two or more per 100 grams) as provided for in groups for which RDIs are established, paragraph (b) of this section, or for two the percent DV and quantitative or more groups for which RDIs are information shall be separated by established (e.g., both infants 7 through vertical lines as shown in paragraph 12 months and children 1 through 3 (e)(5) of this section. years of age) as shown in paragraph (4) Nutrient information for vitamins (e)(5) of this section. When such dual and minerals (except sodium) shall be labeling is provided, equal prominence separated from information on other shall be given to both sets of values. nutrients by a bar and shall be arrayed Information shall be presented in a vertically in the following order: format consistent with paragraph (d) of Vitamin D, calcium, iron, potassium as this section, except that: (1) Following the serving size shown in paragraph (e)(5) of this information there shall be two or more section. column headings accurately describing (5) The following sample label the amount per serving size of the form illustrates the provisions of paragraph of the same food (e.g., ‘‘Per 1⁄4 cup mix’’ (e) of this section: and ‘‘Per prepared portion’’), the (6) When dual labeling is presented combinations of food, the units, or the for a food on a per serving basis and per RDI groups that are being declared as container basis as required in paragraph shown in paragraph (e)(5) of this (b)(12)(i) of this section or on a per section. serving basis and per unit basis as (2) The information required in required in paragraph (b)(2)(i)(D) of this paragraph (d)(7)(ii) and the quantitative section, the percent Daily Value as information by weight as required in required in paragraph (d)(7)(ii) and the paragraph (d)(7)(i) of this section shall quantitative information by weight shall be presented for the form of the product be presented in two columns, and the as packaged and for any other form of percent DV and quantitative information the product (e.g., ‘‘as prepared’’ or shall be separated by vertical lines as

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shown in the displays in paragraph information on other nutrients by a bar iron, and potassium as shown in the (e)(6)(i) of this section. and shall be arrayed vertically in the following sample labels. (i) Nutrient information for vitamins following order: Vitamin D, calcium, and minerals shall be separated from

(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.

(f) The declaration of nutrition added sugars, protein, vitamin D, insignificant amounts) shall be included information may be presented in the calcium, iron, and potassium. at the bottom of the nutrition label. simplified format set forth herein when * * * * * a food product contains insignificant (2) * * * amounts of eight or more of the following: Calories, total fat, saturated (ii) Any other nutrients identified in fat, trans fat, cholesterol, sodium, total paragraph (f) of this section that are carbohydrate, dietary fiber, sugars, present in the food in more than added sugars, protein, vitamin D, insignificant amounts; and calcium, iron, and potassium; except * * * * * that for foods intended for infants 7 (4) If any nutrients are declared as months to 12 months of age and provided in paragraphs (f)(2)(iii), children 1 through 3 years of age to (f)(2)(iv), or (f)(3) of this section as part which paragraph (j)(5)(i) of this section of the simplified format or if any applies, nutrition information may be nutrition claims are made on the label presented in the simplified format when or in labeling, the statement ‘‘Not a a food product contains insignificant significant source of ll_’’ (with the amounts of six or more of the following: blank filled in with the name(s) of any Calories, total fat, sodium, total nutrient(s) identified in paragraph (f) of carbohydrate, dietary fiber, sugars, this section that are present in

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carbohydrate, dietary fiber, soluble provided by use of an FDA approved fiber, insoluble fiber, polyunsaturated or database that has been computed monounsaturated fat shall be deemed to following FDA guideline procedures be misbranded under section 403(a) of and where food samples have been the Federal Food, Drug, and Cosmetic handled in accordance with current Act (the act) unless it meets the good manufacturing practice to prevent following requirements: nutrition loss. FDA approval of a (i) When a vitamin, mineral, protein, database shall not be considered granted or non-digestible carbohydrate(s) (when until the Center for Food Safety and the food contains only non-digestible Applied Nutrition has agreed to all carbohydrates (soluble or insoluble) that aspects of the database in writing. The meet the definition of dietary fiber) approval will be granted where a clear meets the definition of a Class I need is presented (e.g., raw produce and nutrient, the nutrient content of the seafood). Approvals will be in effect for composite must be formulated to be at a limited time, e.g., 10 years, and will least equal to the value for that nutrient be eligible for renewal in the absence of declared on the label. significant changes in agricultural or (ii) When a vitamin, mineral, protein, industry practices. Approval requests total carbohydrate, polyunsaturated or shall be submitted in accordance with monounsaturated fat, or non-digestible the provisions of § 10.30 of this chapter. carbohydrate(s) (when the food contains Guidance in the use of databases may be only non-digestible carbohydrates found in the ‘‘FDA Nutrition Labeling (5) Except as provided for in (soluble or insoluble) that meet the Manual—A Guide for Developing and paragraphs (j)(5) and (j)(13) of this definition of dietary fiber) meets the Using Data Bases,’’ available from the section, nutrient information declared definition of a Class II nutrient, the Office of Nutrition, Labeling, and in the simplified format shall be nutrient content of the composite must Dietary Supplements (HFS–800), Center presented in the same manner as be at least equal to 80 percent of the for Food Safety and Applied Nutrition, specified in paragraphs (d) or (e) of this value for that nutrient declared on the Food and Drug Administration, 5100 section. label. No regulatory action will be based Paint Branch Pkwy., College Park, MD (g) Compliance with this section shall on a determination of a nutrient value 20740 or by going to http:// be determined as follows: that falls below this level by a factor less www.fda.gov. * * * * * than the variability generally recognized * * * * * (2) The sample for nutrient analysis for the analytical method used in that (10) The manufacturer must make and shall consist of a composite of 12 food at the level involved. keep written records (e.g., analyses of subsamples (consumer units), taken 1 (5) A food with a label declaration of databases, recipes, formulations, or from each of 12 different randomly calories, sugars, added sugars (when the batch records) to verify the declared chosen shipping cases, to be only source of sugars in the food is amount of that nutrient on the Nutrition representative of a lot. Unless a added sugars), total fat, saturated fat, Facts label as follows: particular method of analysis is trans fat, cholesterol, or sodium shall be (i) When a mixture of dietary fiber, specified in paragraph (c) of this deemed to be misbranded under section and added non-digestible section, composites shall be analyzed by 403(a) of the act if the nutrient content carbohydrate(s) that does not meet the appropriate methods as given in the of the composite is greater than 20 definition of dietary fiber, is present in ‘‘Official Methods of Analysis of the percent in excess of the value for that the food, a manufacturer must make and AOAC International,’’ 19th Ed. (2012), nutrient declared on the label. No keep written records of the amount of which is incorporated by reference in regulatory action will be based on a non-digestible carbohydrate(s) added to accordance with 5 U.S.C. 552(a) or 1 determination of a nutrient value that the food that does not meet the CFR part 51 or, if no AOAC method is falls above this level by a factor less definition of dietary fiber. available or appropriate, by other than the variability generally recognized (ii) When a mixture of soluble fiber reliable and appropriate analytical for the analytical method used in that and added non-digestible procedures. The availability of this food at the level involved. carbohydrate(s) that does not meet the incorporation by reference is given in (6) Reasonable excesses of vitamins, definition of dietary fiber is present in paragraph (c)(7) of this section. minerals, protein, total carbohydrate, the food, a manufacturer must make and (3) * * * dietary fiber, soluble fiber, insoluble keep written records necessary to verify (ii) Class II. Naturally occurring fiber, sugar alcohols, polyunsaturated or the amount of the non-digestible (indigenous) nutrients. When a nutrient monounsaturated fat over labeled carbohydrate(s) added to the food that or nutrients are naturally occurring amounts are acceptable within current does not meet the definition of dietary (indigenous) in an ingredient that is good manufacturing practice. fiber. added to a food, the total amount of Reasonable deficiencies of calories, (iii) When a mixture of insoluble fiber such nutrient(s) in the final food sugars, added sugars, total fat, saturated and added non-digestible product is subject to class II fat, trans fat, cholesterol, or sodium carbohydrate(s) that does not meet the requirements, except that when a under labeled amounts are acceptable definition of dietary fiber is present in nutrient or nutrients are not naturally within current good manufacturing the food, a manufacturer must make and occurring (exogenous) in an ingredient practice. keep written records necessary to verify that is added to a food, the total amount (7) Compliance will be based on the the amount of the non-digestible of such nutrient(s) in the final food metric measure specified in the label carbohydrate(s) added to the food that product is subject to class I statement of the serving size. does not meet the definition of dietary requirements. (8) Alternatively, compliance with the fiber. (4) A food with a label declaration of provisions set forth in paragraphs (g)(1) (iv) When a mixture of naturally a vitamin, mineral, protein, total through (g)(6) of this section may be occurring and added sugars is present in

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the food, a manufacturer must make and either as original records, true copies (e)(5): Provided, that, the type and keep written records of the amount of (such as photocopies, pictures, scanned quantity of the other ingredients to be added sugars added to the food during copies, microfilm, microfiche, or other added to the product by the user and the the processing of the food, and if accurate reproductions of the original specific method of cooking and other packaged as a separate ingredient, as records), or electronic records which preparation shall be specified packaged (whether as part of a package must be kept in accordance with part 11 prominently on the label. containing one or more ingredients or of this chapter. These records must be * * * * * packaged as a single ingredient). accurate, indelible, and legible. Failure (j) * * * (v) When the amount of added sugars to make and keep the records or provide added to yeast-leavened bakery (5)(i) Foods, other than infant the records to appropriate regulatory formula, represented or purported to be products, wines with less than 7 percent authorities, as required by this alcohol by volume, or beer that does not specifically for infants 7 through 12 subparagraph, would result in the food months and children 1 through 3 years meet the definition of a ‘‘malt being misbranded under section beverage,’’ as defined by the Federal of age shall bear nutrition labeling. The 403(a)(1) of the act. nutrients declared for infants 7 through Alcohol Administration Act (27 U.S.C. (h) * * * 12 months and children 1 through 3 211(a)(7)), is reduced through the (3) * * * years of age shall include calories, total process of fermentation, manufacturers (iv) Nutrition information may be fat, saturated fat, trans fat, cholesterol, must: provided per serving for individual sodium, total carbohydrates, dietary (A) Make and keep records of all foods in the package, or, alternatively, fiber, sugars, added sugars, protein, and relevant scientific data and information as a composite per serving for the following vitamins and minerals: relied upon by the manufacturer that reasonable categories of foods in the Vitamin D, calcium, iron, and demonstrates the amount of added package having similar dietary uses and potassium. sugars in the food after fermentation and similar significant nutritional a narrative explaining why the data and characteristics. Reasonable categories of information are sufficient to foods may be used only if accepted by demonstrate the amount of added sugars FDA. In determining whether a declared in the finished food, provided proposed category is reasonable, FDA the data and information used is will consider whether the values of the specific to the type of fermented food characterizing nutrients in the foods manufactured; or proposed to be in the category meet the (B) Make and keep records of the compliance criteria set forth in amount of added sugars added to the paragraphs (g)(3) through (g)(6) of this food before and during the processing of section. Proposals for such categories the food, and if packaged as a separate may be submitted in writing to the ingredient, as packaged (whether as part Office of Nutrition, Labeling and Dietary of a package containing one or more Supplements (HFS–800), Center for ingredients or packaged as a single Food Safety and Applied Nutrition, ingredient) and in no event shall the Food and Drug Administration, 5100 amount of added sugars declared exceed Paint Branch Pkwy., College Park, MD the amount of total sugars on the label. (vi) When a mixture of all rac-a- 20740. tocopherol acetate and RRR-a- * * * * * tocopherol is present in a food, (4) If a food is commonly combined manufacturers must make and keep with other ingredients or is cooked or written records of the amount of all rac- otherwise prepared before eating, and a-tocopherol acetate added to the food directions for such combination or and RRR-a-tocopherol in the finished preparations are provided, another food. column of figures may be used to (vii) When a mixture of folate and declare nutrition information on the folic acid is present in a food, basis of the food as consumed in the (ii) Foods other than infant formula, manufacturers must make and keep format required in paragraph (e) of this represented or purported to be written records of the amount of folic section; e.g., a dry ready-to-eat cereal specifically for infants 7 through 12 acid added to the food and folate in the may be described with the percent Daily months of age shall bear nutrition finished food. Value and the quantitative amounts for labeling, except that: (11) Records necessary to verify the cereal as sold (e.g., per ounce), and (A) Such labeling shall not declare a certain nutrient declarations that are the percent Daily Value and the percent Daily Value for saturated fat, specified in paragraph (g)(10) of this quantitative amounts for the cereal and trans fat, cholesterol, sodium, dietary section must be kept for a period of at milk as suggested in the label (e.g., per fiber, sugars, or added sugars. least 2 years after introduction or ounce of cereal and 1⁄2 cup of vitamin * * * * * delivery for introduction of the food D fortified skim milk); and a mix into interstate commerce. Such records may be labeled with the percent Daily (13) * * * must be provided to FDA upon request, Value and the quantitative amounts for (ii) * * * during an inspection, for official review the dry mix (per serving) and the (A) * * *. and photocopying or other means of percent Daily Value and the quantitative (1) The following sample label reproduction. Records required to verify amounts for the serving of the final cake illustrates the tabular display for small information on the label may be kept when prepared, as shown in paragraph packages.

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

(B) Using any of the following § 101.36 Nutrition labeling of dietary technological reasons, contain only abbreviations: supplements. individual amino acids. Serving size—Serv size * * * * * * * * * * Servings per container—Servings (b) * * * (B) The names of dietary ingredients Calories from saturated fat—Sat fat cal (1) Serving size. (i) The subheading that are declared under paragraph Saturated fat—Sat fat ‘‘Serving Size’’ shall be placed under (b)(2)(i) of this section shall be Monounsaturated fat—Monounsat fat the heading ‘‘Supplement Facts’’ and presented in a column aligned on the Polyunsaturated fat—Polyunsat fat aligned on the left side of the nutrition left side of the nutritional label in the Cholesterol—Cholest label. The subheading ‘‘Servings Per order and manner of indentation Total carbohydrate—Total carbs Container’’ and the actual number of specified in § 101.9(c), except that Dietary fiber—Fiber servings shall be highlighted in bold or calcium and iron shall follow extra bold type. The serving size shall Soluble fiber—Sol fiber pantothenic acid, and sodium and be determined in accordance with Insoluble fiber—Insol fiber potassium shall follow chloride. This §§ 101.9(b) and 101.12(b), table 2. Sugar alcohol—Sugar alc results in the following order for Serving size for dietary supplements vitamins and minerals: Vitamin A, (C) Omitting the footnote statement shall be expressed using a term that is and placing another asterisk at the vitamin C, vitamin D, vitamin E, appropriate for the form of the vitamin K, thiamin, riboflavin, niacin, bottom of the label followed by the supplement, such as ‘‘tablets,’’ vitamin B6, folic acid, vitamin B12, statement ‘‘Percent Daily Values are ‘‘capsules,’’ ‘‘packets,’’ or based on a 2,000 calorie diet.’’ biotin, pantothenic acid, calcium, iron, ‘‘teaspoonfuls.’’ phosphorous, iodine, magnesium, zinc, * * * * * * * * * * selenium, copper, manganese, (18) * * * (2) * * * (i) The (b)(2)-dietary chromium, molybdenum, chloride, (iv) A notice shall be filed with the ingredients to be declared, that is, total sodium, potassium, and choline. The Office of Nutrition, Labeling, and calories, total fat, saturated fat, trans fat, (b)(2)-dietary ingredients shall be listed Dietary Supplements (HFS–800), Center cholesterol, sodium, total carbohydrate, according to the nomenclature specified for Food Safety and Applied Nutrition, dietary fiber, sugars, added sugars, in § 101.9 or in paragraph (b)(2)(i)(B)(2) Food and Drug Administration, 5100 protein, vitamin D, calcium, iron, and of this section. Paint Branch Pkwy., College Park, MD potassium, shall be declared when they (1) When ‘‘Calories’’ are declared, 20740 and contain the following are present in a dietary supplement in they shall be listed first in the column information, except that if the person is quantitative amounts by weight that of names, beneath a light bar separating not an importer and has fewer than 10 exceed the amount that can be declared the heading ‘‘Amount Per Serving’’ from full-time equivalent employees, that as zero in nutrition labeling of foods in the list of names. When ‘‘Calories from person does not have to file a notice for accordance with § 101.9(c). Calories saturated fat’’ are declared, they shall be any food product with annual sales of from saturated fat, polyunsaturated fat, indented under ‘‘Calories.’’ fewer than 10,000 total units: monounsaturated fat, soluble fiber, (2) The following synonyms may be * * * * * insoluble fiber, and sugar alcohol may added in parentheses immediately ■ 3. In § 101.36: be declared, but they shall be declared following the name of these (b)(2)- ■ a. Revise paragraphs (b)(1)(i), (b)(2)(i) when a claim is made about them. Any dietary ingredients: Vitamin C (ascorbic introductory text, (b)(2)(i)(B), (b)(2)-dietary ingredients that are not acid), thiamin (vitamin B1), riboflavin (b)(2)(ii)(A), (b)(2)(iii) introductory text, present, or that are present in amounts (vitamin B2), and calories (energy). (b)(2)(iii)(D) through (G), (b)(3)(ii)(A), that can be declared as zero in Energy content per serving may be (c)(4), (e) introductory text, (e)(8), § 101.9(c), shall not be declared (e.g., expressed in kilojoule units, added in (e)(11)(i) through (viii), (e)(12), (f)(2), amounts corresponding to less than 2 parentheses immediately following the and (i)(1); and percent of the RDI for vitamins and statement of caloric content. ■ b. Remove paragraph (i) introductory minerals). Protein shall not be declared (3) Beta-carotene may be declared as text. on labels of products that, other than the percent of vitamin A that is present The revisions read as follows: ingredients added solely for as beta-carotene, except that the

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declaration is required when a claim is that is placed at the bottom of the (ii) * * * made about beta-carotene. When nutrition label, below the bar required (A) These amounts shall be expressed declared, the percent shall be declared under paragraph (e)(6) of this section using metric measures in appropriate to the nearest whole percent, and inside the box, that is followed by units. immediately adjacent to or beneath the the statement ‘‘Percent Daily Values are * * * * * name vitamin A (e.g., ‘‘Vitamin A (90% based on a 1,000 calorie diet.’’ (c) * * * as beta-carotene)’’). The amount of beta- (E) The percent of Daily Value shall (4) The sample label shown in carotene in terms of micrograms (mcg) be based on RDI or DRV values for paragraph (e)(11)(v) of this section may be included in the parentheses adults and children 4 or more years of illustrates one method of nutrition following the percent statement (e.g., age, unless the product is represented or labeling a proprietary blend of dietary ‘‘Vitamin A (90% (810 mcg) as beta- purported to be specifically for infants ingredients. carotene)’’). 7 through 12 months of age, children 1 (ii) * * * through 3 years of age, or pregnant and * * * * * (A) The amounts shall be expressed in lactating women, in which case the (e) Except as provided for small and the increments specified in § 101.9(c)(1) column heading shall clearly state the intermediate sized packages under through (c)(7), which includes intended group. If the product is for paragraph (i)(2) of this section, increments for sodium. persons within more than one group, information other than the title, * * * * * the percent of Daily Value for each headings, and footnotes shall be in group shall be presented in separate (iii) The percent of the Daily Value of uniform type size no smaller than 8 columns as shown in paragraph all dietary ingredients declared under point. A font size at least two points (e)(11)(ii) of this section. paragraph (b)(2)(i) of this section shall greater shall be used for ‘‘Calories’’ and (F) For declared subcomponents that the heading ‘‘Calories’’ and the actual be listed, except that the percent of the have no DRVs or RDIs, a symbol (e.g., Daily Value for protein may be omitted number of calories per serving shall be an asterisk) shall be placed in the highlighted in bold or extra bold type. as provided in § 101.9(c)(7); no percent ‘‘Percent Daily Value’’ column that shall of the Daily Value shall be given for Type size no smaller than 6 point may refer to the same symbol that is placed be used for column headings (e.g., subcomponents for which DRVs or RDIs at the bottom of the nutrition label, have not been established (e.g., sugars). ‘‘Amount Per Serving’’ and ‘‘% Daily below the last heavy bar and inside the Value’’) and for footnotes (e.g., ‘‘Percent * * * * * box, and followed by a statement ‘‘Daily Daily Values are based on a 2,000 (D) If the percent of Daily Value is Value not established.’’ calorie diet). declared for total fat, saturated fat, total (G) When calories or calories from * * * * * carbohydrate, dietary fiber, or protein, a saturated fat are declared, the space symbol shall follow the value listed for under the ‘‘% DV’’ column shall be left (8) If the product contains two or those nutrients that refers to the same blank for these items. When there are no more separately packaged dietary symbol that is placed at the bottom of other (b)(2)-dietary ingredients listed for supplements that differ from each other the nutrition label, below the bar which a value must be declared in the (e.g., the product has a packet of required under paragraph (e)(6) of this ‘‘% DV’’ column, the column may be supplements to be taken in the morning section and inside the box, that is omitted as shown in paragraph and a different packet to be taken in the followed by the statement ‘‘Percent (e)(11)(vii) of this section. When the ‘‘% afternoon), the quantitative amounts Daily Values are based on a 2,000 DV’’ column is not required, but the and percent of Daily Value may be calorie diet.’’ If the product is dietary ingredients listed are subject to presented as specified in this paragraph represented or purported to be for use paragraph (b)(2)(iii)(F) of this section, in individual nutrition labels or in one by children 1 through 3 years of age, the symbol required in that paragraph aggregate nutrition label as illustrated in and if the percent of Daily Value is shall immediately follow the paragraph (e)(11)(iii) of this section. declared for total fat, total carbohydrate, quantitative amount by weight for each * * * * * dietary fiber, or protein, a symbol shall dietary ingredient listed under ‘‘Amount (11) * * * follow the value listed for those Per Serving.’’ BILLING CODE 4160–01–P nutrients that refers to the same symbol (3) * * * (l) Multiple vitamins

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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:

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BILLING CODE 4160–01–C comply with the requirements of this need of such special allowances shall (f) * * * section, FDA may permit alternative make their request in writing to the (2) When it is not technologically means of compliance or additional Office of Nutrition, Labeling and Dietary feasible, or some other circumstance exemptions to deal with the situation in Supplements (HFS–800), Food and Drug makes it impracticable, for firms to accordance with § 101.9(g)(9). Firms in

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Administration, 5100 Paint Branch other than infant formula, represented Dated: February 24, 2014. Pkwy., College Park, MD 20740. or purported to be specifically for Leslie Kux, * * * * * infants and children less than 2 years of Assistant Commissioner for Policy. (i)(1) Dietary supplements are subject age. [FR Doc. 2014–04387 Filed 2–27–14; 8:45 am] to the special labeling provisions * * * * * BILLING CODE 4160–01–C specified in § 101.9(j)(5)(i) for foods

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