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Department of Health and Human Services Vol. 79 Monday, No. 41 March 3, 2014 Part II Department of Health and Human Services Food and Drug Administration 21 CFR Part 101 Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Proposed Rule VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 11880 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules DEPARTMENT OF HEALTH AND Reduction Act of 1995’’ section of this 7. Impact on Other Regulations HUMAN SERVICES document). C. Factors for Mandatory or Voluntary Declaration of Non-Statutory Nutrients 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. Calories 1. Calories From Fat RIN 0910–AF22 instructions for submitting comments. 2. Calories From Saturated Fat 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 paper 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. Cholesterol we) is proposing to amend its labeling must include the Agency name and 1. Mandatory Declaration regulations for conventional foods and Docket No. FDA–2012–N–1210 and RIN 2. DRV dietary supplements to provide updated 0910–AF22 for this rulemaking. All D. Carbohydrate nutrition information on the label to 1. Total Carbohydrate comments received may be posted 2. Sugars assist consumers in maintaining healthy without change to http:// dietary practices. The updated 3. Added Sugars www.regulations.gov, including any 4. Sugar Alcohols information is consistent with current personal information provided. For data on the associations between 5. Dietary Fiber additional information on submitting 6. Other Carbohydrate nutrients and chronic diseases or comments, see the ‘‘Comments’’ heading E. Protein health-related conditions, reflects of the SUPPLEMENTARY INFORMATION 1. Mandatory and Voluntary Declaration current public health conditions in the section of this document. 2. Analytical Methods United States, and corresponds to new Docket: For access to the docket to 3. DRV information on consumer behavior and read background documents or F. Sodium 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 Reference Daily Intake values that 2. DRV ‘‘Search’’ box and follow the prompts H. Essential Vitamins and Minerals 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 nutrient 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 Nutrition Facts label. 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, Potassium, Copper, and 1210, and/or Regulatory Information Supplement Facts Labels Chloride Number (RIN) 0910–AF22, by any of the 1. Rates of Chronic Disease 2. Folate 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 VerDate Mar<15>2010 19:06 Feb 28, 2014 Jkt 232001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\03MRP2.SGM 03MRP2 mstockstill on DSK4VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Proposed Rules 11881 3. Declaration of Non-Statutory Nutrients Following the passage of the Nutrition foods, whereas corresponding changes Other Than Essential Vitamins and Labeling and Education 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 Dietary Supplement ‘‘Calories from fat’’ because current M. Format Health and Education Act (DSHEA) of science 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.
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