0910-AI80 202410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Front-of-Package Nutrition Labeling

This proposed rule, if finalized, would require the front of food labels to display certain nutrition information to help consumers, including those who are busy and those with lower nutrition knowledge, make more informed dietary choices.  Front-of-package nutrition labeling is intended to complement the Nutrition Facts label on packaged foods by giving consumers additional context to help them quickly and easily identify foods that can help them build a healthy eating pattern. This proposed rule would also amend certain nutrient content claim regulations to align with current nutrition science and ensure consistency in labeling. This proposed rule is being developed as part of a broader, whole-of-government approach to help reduce the burden of chronic disease and advance health equity by helping to improve dietary patterns in the United States. Development of the proposed rule has been informed by, among other things, research findings and extensive public outreach and engagement, including a public meeting conducted by the Reagan-Udall Foundation for the FDA and listening sessions with a range of interested parties.

]]> Section 3(f)(1) Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined 21 CFR 101.6 (new) 21 U.S.C. 321 21 U.S.C. 343 21 U.S.C. 343 note 21 U.S.C. 371 Yes

HHS implemented its first mandatory nutrition labeling 32 years ago. The resulting Nutrition Facts label is iconic and 87% of American consumers report using the label.  However, many consumers, including those with lower nutrition literacy, may find additional information on food packaging helpful in identifying foods that will help them in constructing a healthy diet. This proposed rule, if finalized, could empower consumers with information to help them quickly identify foods that can help them build a healthy eating pattern and maintain healthy dietary practices.

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In general, our legal authority rests on the 1990 Nutrition Labeling and Education Act, which gave the Secretary the authority to require that certain nutrition information be conveyed to allow the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet.  (Nutrition Labeling and Education Act of 1990. Public Law 101-535, 104 Stat 2353, Sec. 2(b)(1)(A)).  Authority for certain aspects may also be found in section 403(f), 403(q), 403(a)(1), and 201(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, section 701(a) of the FD&C Act authorizes the promulgation of regulations for the efficient enforcement of the FD&C Act.

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The proposed rule, if finalized, is expected to generate compliance costs on affected entities, such as the cost to label packaged foods and the one-time costs to read and understand the rule. Benefits of this proposed rule, if finalized, would come from the value consumers receive from the information provided by the interpretive front-of-package label on food packages.  

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]]> NPRM 12/00/2024 YES Businesses Local State Yes Undetermined Yes Yes Mark Kantor Nutritionist 0910 Food and Drug Administration FDA 240 402-2082 mark.kantor@fda.hhs.gov Humans Foods Program, CPK1 RM 3D034, HFS-830, 5001 Campus Drive, College Park MD 20740