November 27, 2022

Volume XII, Number 331

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FDA Proposes Updated Definition for “Healthy” Claim

  • On September 28, 2022, FDA announced that it had issued a proposed rule with criteria for when foods can be labeled with the claim “healthy” on their packaging. The proposed rule intends to align the definition of the “healthy” claim with the updated nutrition facts label, the current Dietary Guidelines for Americans, and current nutrition science.

  • The proposed definition would permit the “healthy” claim on food products that (1) contain a certain meaningful amount (determined using the daily recommended amount) of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines (e.g., fruit, vegetable, dairy), and (2) adhere to specific limits for certain nutrients like saturated fats, sodium, and added sugars. The threshold for the limits is based on the percent of the Daily Value for the nutrient and varies depending on the food group.

  • With the proposed rule, FDA intends to empower consumers and help foster a healthier food supply by encouraging manufacturers to reformulate their food products to meet the updated definition. The agency is also considering the development of a symbol that manufacturers could use to demonstrate that their products meet the “healthy” claim criteria.

  • The proposed rule follows the White House Conference on Hunger, Nutrition, and Health as well as the release of the national strategy to end hunger and reduce diet-related diseases by 2030. FDA notes that it intends to continue taking steps to improve nutrition and health and that the agency’s future planned actions include developing a front-of-package labeling system, making nutrition information more easily available when grocery shopping online, and working to lower the sodium content of food in the food supply.

  • FDA is accepting comments on the proposed rule until December 28, 2022. Comments may be submitted by mail or electronically at regulations.gov (FDA Docket # FDA-2016-D-2335). 

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 272
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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