33742 Federal Register /Vol. 81, No. 103/Friday, …

1 33742 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Rules and regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA 2012 N 1210] RIN 0910 AF22 Food Labeling: Revision of the nutrition and Supplement Facts Labels AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA or we) is amending its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current data on the associations between nutrients and chronic diseases, health- related conditions, physiological endpoints, and/or maintaining a healthy dietary pattern that reflects current public health conditions in the United States, and corresponds to new information on consumer understanding and consumption patterns.

2 The final rule updates the list of nutrients that are required or permitted to be declared; provides updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amends requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups; and revises the format and appearance of the nutrition Facts label. DATES: Effective date: The final rule becomes effective on July 26, 2016. Compliance date: The compliance date of this final rule is July 26, 2018 for manufacturers with $10 million or more in annual food sales and July 26, 2019 for manufacturers with less than $10 million in annual food sales.

3 See section III, Effective and Compliance Dates, for more detail. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of July 26, 2016. FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food Safety and Applied nutrition (HFS 830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240 402 5429, email: SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Regulatory Action Summary of the Major Provisions of the Regulatory Action in Question Costs and Benefits I. Background A. Legal Authority B. Need To Update the nutrition Facts and Supplement Facts Labels II.

4 Comments to the Proposed Rule and the Supplemental Proposed Rule, Our Responses, and a Description of the Final Rule A. Introduction B. General Comments 1. Comments Seeking an Education Campaign or Program 2. Comments Linking the nutrition Facts Label to Specific Diseases 3. Use of Household Measures 4. Impact on Other regulations 5. Consumer Research C. Comments on Legal Issues 1. First Amendment 2. Administrative Procedure Act 3. Federal Food, Drug, and Cosmetic Act 4. Recordkeeping Authority 5. Miscellaneous Comments D. Factors for Mandatory or Voluntary Declaration of Non-Statutory Nutrients E. Calories 1. Calories From Fat 2. Calories From Saturated Fat 3. Two Thousand Calories as the Reference Caloric Intake Level 4.

5 Percent DV Declaration for Calories F. Fat 1. Total Fat a. Definition b. Mandatory Declaration c. DRV d. Declaration of Total Fat 2. Saturated Fat a. Definition b. Mandatory Declaration c. DRV 3. Trans Fat a. Definition b. Mandatory Declaration c. DRV d. Declaring the Amount of Trans Fat 4. Monounsaturated Fat and Polyunsaturated Fat a. Voluntary Declaration b. DRV c. Declaration of Individual Polyunsaturated Fatty Acids G. Cholesterol 1. Mandatory Declaration 2. DRV H. Carbohydrate 1. Total Carbohydrate a. Calculation of Total Carbohydrate b. Classification of Carbohydrates Based on a Chemical Definition or Physiological Effect c. Separate Declaration of Additional Individual Types of Carbohydrates d.

6 Mandatory Declaration e. DRV f. How Total Carbohydrates Appears on the Label g. Calculation of Calories From Carbohydrate 2. Sugars a. Definition b. Mandatory Declaration c. Changing Sugars to Total Sugars d. DRV e. Seasonal Variation in Sugars Content 3. Added Sugars a. Declaration (i) Comments on the Rationale for Requiring Mandatory Declaration of Added Sugars (ii) Evidence on Added Sugars and Risk of Chronic Disease (iii) New Evidence Presented in the 2015 DGAC Report b. The 2015 DGAC Analysis of Dietary Patterns and Health Outcomes c. Authority for Labeling (i) Statutory Authority (ii) Material Fact (iii) regulations Must Bear a Reasonable Relationship to the Requirements and Purposes of the Statue d.

7 Nutrient Density e. Reformulation f. Calories from Solid Fats and Added Sugars g. Consumer Research and Consumer Use of Added Sugars Declaration h. Voluntary Labeling i. How Added Sugars are Declared (i) Changing Sugars to Total Sugars (ii) Declaration of Added Sugars in Teaspoons (iii) Distinguishing Between Naturally Occurring and Added Sugars on the Label (iv) Replacing Sugars With Added Sugars (v) Distinguishing Between Different Types of Sugars or Sweeteners (vi) Warning Statements j. Variability in Sugar Content k. Non-Enzymatic Browning and Fermentation l. Impact on Nutrient Databases m. International Labeling Guidelines n. Definition of Added Sugars (i) Fruit and Vegetable Juice Concentrates (ii) Intended Purpose of Sweetening (iii) The No Added Sugars Nutrient Content Claim (iv) Fruit Jellies, Jams, and Preserves (v) Dried Fruits (vi) Other Sugars/Sweeteners (vii) Other Comments o.

8 Establishing a DRV and Mandatory Declaration of the Percent DV for Added Sugars (i) Mandatory Declaration of a Percent DV and Whether a DRV Should be Established (ii) DRV of 10 Percent of Total Calories From Added Sugars (iii) Food Pattern Modeling (iv) The Te Morenga et al. Meta-Analysis (v) The IOM Suggested Maximum Intake Level of 25 Percent or Less of Energy From Added Sugars (vi) DRV of 10 Percent of Total Calories (vii) Education p. Records VerDate Sep<11>2014 18:17 May 26, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\ 27 MYR2mstockstill on DSK3G9T082 PROD with RULES233743 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Rules and regulations 4.

9 Sugar Alcohols a. Voluntary Declaration b. Use of the Term Sugar Alcohols c. DRV d. Caloric Value 5. Dietary Fiber a. Dietary fiber (i) Definition (ii) Mandatory Declaration (iii) Analytical Methods (iv) DRV b. Soluble and Insoluble Fiber (i) Definition (ii) Voluntary Declaration (iii) Analytical Methods (iv) DRV (v) Caloric Value 6. Other Carbohydrate I. Protein 1. Mandatory and Voluntary Declaration 2. Analytical Methods 3. DRV 4. Miscellaneous Comments J. Sodium 1. Mandatory Declaration 2. DRV K. Fluoride 1. Voluntary Declaration 2. DRV 3. Miscellaneous Comments L. Essential Vitamins and Minerals of Public Health Significance 1. General Comments 2. Essential Vitamins and Minerals That Are Mandatory a.

10 Calcium b. Iron c. Vitamin A and Vitamin C 3. Essential Vitamins and Minerals That Are Voluntary a. Vitamin D b. Potassium 4. Other Essential Vitamins and Minerals a. Phosphorus b. Magnesium c. Vitamin K d. Choline e. Vitamin B12 M. Reference Daily Intakes for Vitamins and Minerals 1. Need to Update RDIs 2. Approach to Setting RDIs: EAR Versus RDA 3. Approach to Setting RDIs: Adequate Intake 4. Approach to Setting RDIs: Tolerable Upper Intake Level 5. Approach to Setting RDIs: Population- Weighted Versus Population-Coverage 6. Declaration of Absolute Amounts of Vitamins and Minerals 7. Issues Concerning Specific Vitamins or Minerals a. Vitamin K b. Chloride c. Potassium d.