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Nutrition Facts and Requiring Mandatory Declaration of AGENCY: Food and Drug Administration, Supplement Facts Labels Added Sugars HHS 33742 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Rules and Regulations DEPARTMENT OF HEALTH AND MD 20740, 240–402–5429, email: f. How Total Carbohydrates Appears on the HUMAN SERVICES [email protected]. Label g. Calculation of Calories From SUPPLEMENTARY INFORMATION: Food and Drug Administration Carbohydrate Table of Contents 2. Sugars 21 CFR Part 101 a. Definition Executive Summary b. Mandatory Declaration [Docket No. FDA–2012–N–1210] Purpose of the Regulatory Action c. Changing ‘‘Sugars’’ to ‘‘Total Sugars’’ Summary of the Major Provisions of the d. DRV RIN 0910–AF22 Regulatory Action in Question e. Seasonal Variation in Sugars Content Costs and Benefits 3. Added Sugars Food Labeling: Revision of the I. Background a. Declaration Nutrition and Supplement Facts Labels A. Legal Authority (i) Comments on the Rationale for B. Need To Update the Nutrition Facts and Requiring Mandatory Declaration of AGENCY: Food and Drug Administration, Supplement Facts Labels Added Sugars HHS. II. Comments to the Proposed Rule and the (ii) Evidence on Added Sugars and Risk of ACTION: Final rule. Supplemental Proposed Rule, Our Chronic Disease Responses, and a Description of the Final (iii) New Evidence Presented in the 2015 SUMMARY: The Food and Drug Rule DGAC Report Administration (FDA or we) is A. Introduction b. The 2015 DGAC Analysis of Dietary amending its labeling regulations for B. General Comments Patterns and Health Outcomes conventional foods and dietary 1. Comments Seeking an Education c. Authority for Labeling supplements to provide updated Campaign or Program (i) Statutory Authority nutrition information on the label to 2. Comments Linking the Nutrition Facts (ii) Material Fact assist consumers in maintaining healthy Label to Specific Diseases (iii) Regulations Must Bear a Reasonable 3. Use of Household Measures Relationship to the Requirements and dietary practices. The updated 4. Impact on Other Regulations Purposes of the Statue information is consistent with current 5. Consumer Research d. Nutrient Density data on the associations between C. Comments on Legal Issues e. Reformulation nutrients and chronic diseases, health- 1. First Amendment f. Calories from Solid Fats and Added related conditions, physiological 2. Administrative Procedure Act Sugars endpoints, and/or maintaining a healthy 3. Federal Food, Drug, and Cosmetic Act g. Consumer Research and Consumer Use dietary pattern that reflects current 4. Recordkeeping Authority of Added Sugars Declaration public health conditions in the United 5. Miscellaneous Comments h. Voluntary Labeling States, and corresponds to new D. Factors for Mandatory or Voluntary i. How Added Sugars are Declared Declaration of Non-Statutory Nutrients (i) Changing ‘‘Sugars’’ to ‘‘Total Sugars’’ information on consumer understanding E. Calories (ii) Declaration of Added Sugars in and consumption patterns. The final 1. Calories From Fat Teaspoons rule updates the list of nutrients that are 2. Calories From Saturated Fat (iii) Distinguishing Between Naturally required or permitted to be declared; 3. Two Thousand Calories as the Reference Occurring and Added Sugars on the provides updated Daily Reference Caloric Intake Level Label Values and Reference Daily Intake 4. Percent DV Declaration for Calories (iv) Replacing ‘‘Sugars’’ With ‘‘Added values that are based on current dietary F. Fat Sugars’’ recommendations from consensus 1. Total Fat (v) Distinguishing Between Different Types reports; amends requirements for foods a. Definition of Sugars or Sweeteners b. Mandatory Declaration (vi) Warning Statements represented or purported to be c. DRV j. Variability in Sugar Content specifically for children under the age of d. Declaration of Total Fat k. Non-Enzymatic Browning and 4 years and pregnant and lactating 2. Saturated Fat Fermentation women and establishes nutrient a. Definition l. Impact on Nutrient Databases reference values specifically for these b. Mandatory Declaration m. International Labeling Guidelines population subgroups; and revises the c. DRV n. Definition of Added Sugars format and appearance of the Nutrition 3. Trans Fat (i) Fruit and Vegetable Juice Concentrates Facts label. a. Definition (ii) Intended Purpose of Sweetening b. Mandatory Declaration (iii) The ‘‘No Added Sugars’’ Nutrient DATES: Effective date: The final rule c. DRV Content Claim becomes effective on July 26, 2016. d. Declaring the Amount of Trans Fat (iv) Fruit Jellies, Jams, and Preserves Compliance date: The compliance date 4. Monounsaturated Fat and (v) Dried Fruits of this final rule is July 26, 2018 for Polyunsaturated Fat (vi) Other Sugars/Sweeteners manufacturers with $10 million or more a. Voluntary Declaration (vii) Other Comments in annual food sales and July 26, 2019 b. DRV o. Establishing a DRV and Mandatory for manufacturers with less than $10 c. Declaration of Individual Declaration of the Percent DV for Added million in annual food sales. See section Polyunsaturated Fatty Acids Sugars G. Cholesterol (i) Mandatory Declaration of a Percent DV III, Effective and Compliance Dates, for 1. Mandatory Declaration and Whether a DRV Should be more detail. The incorporation by 2. DRV Established reference of certain publications listed H. Carbohydrate (ii) DRV of 10 Percent of Total Calories in the rule is approved by the Director 1. Total Carbohydrate From Added Sugars of the Federal Register as of July 26, a. Calculation of Total Carbohydrate (iii) Food Pattern Modeling 2016. b. Classification of Carbohydrates Based on (iv) The Te Morenga et al. Meta-Analysis a Chemical Definition or Physiological (v) The IOM Suggested Maximum Intake FOR FURTHER INFORMATION CONTACT: Effect Level of 25 Percent or Less of Energy Blakeley Fitzpatrick, Center for Food c. Separate Declaration of Additional From Added Sugars Safety and Applied Nutrition (HFS– Individual Types of Carbohydrates (vi) DRV of 10 Percent of Total Calories 830), Food and Drug Administration, d. Mandatory Declaration (vii) Education 5100 Paint Branch Pkwy., College Park, e. DRV p. Records VerDate Sep<11>2014 18:17 May 26, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\27MYR2.SGM 27MYR2 mstockstill on DSK3G9T082PROD with RULES2 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Rules and Regulations 33743 4. Sugar Alcohols c. Terms Used to Declare Folate Insoluble Fiber, Sugars, Added Sugars, a. Voluntary Declaration 4. Vitamins A, D, and E and Sugar Alcohols b. Use of the Term ‘‘Sugar Alcohols’’ a. General Comments d. Protein c. DRV b. Specific Comments on the Units of e. Fluoride d. Caloric Value Measure for Individual Vitamins f. Vitamins and Minerals 5. Dietary Fiber 5. Niacin P. Dietary Supplements a. Dietary fiber O. Labeling of Foods for Infants, Young 1. Mandatory Dietary Ingredients (i) Definition Children, and Pregnant or Lactating 2. Folate and Folic Acid (ii) Mandatory Declaration Women 3. Units of Measure (iii) Analytical Methods 1. Age Range for Infants and Young 4. Order of Nutrients Declared on the Label (iv) DRV Children 5. Subpopulations b. Soluble and Insoluble Fiber 2. Mandatory Declaration of Calories and 6. Footnote (i) Definition Statutorily Required Nutrients 7. Miscellaneous Comments (ii) Voluntary Declaration a. Declaration of Saturated Fat and 8. Compliance Requirements for Dietary (iii) Analytical Methods Cholesterol Supplements (iv) DRV b. Percent DV Declaration Q. Format (v) Caloric Value 3. Declaration of Non-Statutory Nutrients 1. General Comments 6. Other Carbohydrate Other Than Essential Vitamins and 2. Increasing the Prominence of Calories I. Protein Minerals and Serving Size 1. Mandatory and Voluntary Declaration a. Voluntary Declaration of Calories From 3. Changing the Order of the ‘‘Serving 2. Analytical Methods Saturated Fat, and the Amount of Size’’ and ‘‘Servings Per Container’’ 3. DRV Polyunsaturated and Monounsaturated Declarations and Increasing the 4. Miscellaneous Comments Fat Prominence of ‘‘Servings Per Container’’ J. Sodium b. Voluntary Declaration of Soluble Fiber, 4. Right-Justifying the Quantitative 1. Mandatory Declaration Insoluble Fiber, and Sugar Alcohols Amounts Declared in the ‘‘Serving size’’ 2. DRV c. Mandatory Declaration of Trans Fat Statement K. Fluoride d. Mandatory Declaration of Added Sugars 5. Changing the ‘‘Amount per Serving’’ 1. Voluntary Declaration e. Voluntary Declaration of Fluoride Statement 2. DRV 4. Declaration of Essential Vitamins and 6. Declaration of ‘‘Calories From Fat’’ 3. Miscellaneous Comments Minerals 7. Presentation of Percent DVs L. Essential Vitamins and Minerals of a. Mandatory Declaration of Calcium and 8. Placement of ‘‘Added Sugars’’ Public Health Significance Iron 9. Declaration of Absolute Amounts of 1. General Comments b. Mandatory Declaration of Vitamin D and Vitamins and Minerals 2. Essential Vitamins and Minerals That Potassium 10. Single and Dual Column Labeling Are Mandatory c. Voluntary Declaration of Vitamin A and 11. The Footnote a. Calcium Vitamin C 12. Use of Highlighting With a Type b. Iron d. Voluntary Declaration of Other Vitamins Intermediate Between Bold or Extra Bold c. Vitamin A and Vitamin C and Minerals and Regular Type 3. Essential Vitamins and Minerals That 5. DRVs and RDIs for Infants Through 12 13. Addition of a Horizontal Line Beneath Are Voluntary Months of Age the Nutrition Facts Heading a. Vitamin D a. General Comments 14. Replacing ‘‘Total Carbohydrate’’ With b. Potassium b. Calories ‘‘Total Carbs’’ 4. Other Essential Vitamins and Minerals c. Total Fat 15. Alternative Visual
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