Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 101</CFR> <DEPDOC>[Docket No. FDA-2016-D-2335]</DEPDOC> <RIN>RIN 0910-AI13</RIN> <SUBJECT>Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is issuing this final rule updating the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices. This final rule revises the requirements for when the term “healthy” can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that are particularly useful as the foundation of a nutritious diet that is consistent with dietary recommendations. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This rule is effective February 25, 2025. The compliance date of this final rule is February 25, 2028. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the final rule:</E> Vincent de Jesus, Office of Nutrition and Food Labeling (HFS-803), Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD, 20740, 240-402-1450; Denise See or Barbara Little, Office of Policy, Regulations, and Information (HFS-024), Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. <E T="03">With regard to the information collection:</E> Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Final Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Final Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP> <FP SOURCE="FP-2">III. Background</FP> <FP SOURCE="FP1-2">A. Need for the Regulation/History of This Rulemaking</FP> <FP SOURCE="FP1-2">B. Summary of Comments to the Proposed Rule</FP> <FP SOURCE="FP1-2">C. General Overview of the Final Rule</FP> <FP SOURCE="FP-2">IV. Legal Authority</FP> <FP SOURCE="FP-2">V. Comments on the Proposed Rule and FDA Response</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. General Comments</FP> <FP SOURCE="FP1-2">C. Food Group Equivalents</FP> <FP SOURCE="FP1-2">D. Nutrients to Limit</FP> <FP SOURCE="FP1-2"> E. Combination Foods ( <E T="03">i.e.,</E> Mixed Products, Main Dish Products, and Meal Products) </FP> <FP SOURCE="FP1-2">F. Beverages</FP> <FP SOURCE="FP1-2">G. The Term “Healthy” and Related Terms or Derivatives of “Healthy”</FP> <FP SOURCE="FP1-2">H. Nutritional Context</FP> <FP SOURCE="FP1-2">I. Records Requirements</FP> <FP SOURCE="FP1-2">J. Effective and Compliance Dates</FP> <FP SOURCE="FP1-2">K. Legal Comments</FP> <FP SOURCE="FP1-2">L. Miscellaneous Comments</FP> <FP SOURCE="FP-2">VI. Economic Analysis of Impacts</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Overview of Benefits, Costs, and Transfers</FP> <FP SOURCE="FP-2">VII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">VIII. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">IX. Federalism</FP> <FP SOURCE="FP-2">X. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XI. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Final Rule</HD> This final rule updates the requirements for when the term “healthy” can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that can serve as the foundation of a nutritious diet that is consistent with current dietary recommendations. Consumers rely on food labels when navigating the marketplace to make informed choices about the foods they purchase for themselves and their families. FDA plays an important role in ensuring that the labels or labeling of food for human consumption, including claims on labels or labeling that market a food, are accurate, truthful, and not misleading. One such claim that FDA has regulated is the term “healthy” on product labels. Since 1994, we have recognized that when a manufacturer uses labeling that describes a product as “healthy” in the nutritional context, it is making an implicit claim about the level of nutrients in the product. In particular, such a claim implies that the nutrient content of the food may help consumers maintain healthy dietary practices. Given that nutrition science has evolved since the 1990s, this final rule updates the definition of “healthy” to be consistent with current nutrition science and Federal dietary guidance to help ensure that consumers have access to more complete, accurate, and up-to-date information on food labels. This final rule is also consistent with the longstanding purpose of this implied nutrient content claim to indicate that the nutrient levels of a food may help consumers maintain healthy dietary practices and furthers FDA's goals in accordance with its statutory mandate to prevent misleading labeling and reduce consumer confusion that can result from the use of inconsistent definitions for nutrient content claims. In addition, updating the “healthy” nutrient content claim is one initiative action listed in the White House National Strategy on Hunger, Nutrition, and Health under the pillar of empowering all consumers to make and have access to healthy choices (Ref. 6). FDA, as part of this whole-of-government approach, broadly seeks to help reduce the burden of diet-related chronic diseases. Doing so will advance health equity, because diet-related chronic diseases are experienced disproportionately by certain racial and ethnic minority groups and those with lower socioeconomic status. For further discussion regarding the scope of the problem Americans face from diet-related chronic diseases, please see the proposed rule, 87 FR 59168 at 59170. We are committed to accomplishing these goals, in part, by prioritizing nutrition initiatives that can help improve dietary patterns in the United States. An important aspect of reducing the burden of diet-related chronic diseases, as well as advancing health equity, is helping consumers access nutrition information that allows them to identify healthier choices. As discussed further in section V. (“Comments on the Proposed Rule and FDA Response”), nutrient content claims, such as “healthy,” as well as other claims made on labels or in the labeling of foods act as quick signals on food packages. These statements may help consumers, particularly those with lower nutrition or health literacy, quickly and easily identify foods that can be the foundation of a healthy dietary pattern. Additionally, as discussed further in section V. (“Comments on the Proposed Rule and FDA Response”), our review of the products available in the current marketplace demonstrates that the updated “healthy” criteria allow affordable, accessible, and culturally preferred  <SU>1</SU> <FTREF/> nutrient-dense foods within different food groups and subgroups to bear the “healthy” claim, including frozen, canned, dried, and other shelf-stable products. This final rule is one part of FDA's broader commitment to help reduce diet-related chronic diseases and also to advance health equity by helping consumers to identify foods that can be the foundation of a healthy dietary pattern. While there has been consistency in many of the recommendations in Federal dietary guidelines and the underlying nutrition science on which they are based, we intend to remain aligned with the most current nutrition science reflected in Federal dietary guidelines and will continue to update our regulations and policies, as appropriate. <FTNT> <SU>1</SU>  The term “culturally preferred foods” is used here to describe safe and nutritious foods that meet the diverse tastes and needs of customers based on their cultural identity (Ref. 46). </FTNT> <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD> This final rule updating the definition of “healthy” includes provisions that: • Establish parameters for use of the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim on the label or in labeling of a food that suggests that a food, because of its nutrient content, may help consumers maintain healthy dietary practices, where there is also implied or explicit information about the nutrition content of the food on the label or in the labeling (§ 101.65(d)(1) and (3)) (21 CFR 101.65(d)(1) and (3))). • Establish a framework based on food groups and nutrients to limit (NTL) for the “healthy” claim. • Establish that “food group,” for the purposes of the “he ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 731k characters. 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