September 19, 2021

Volume XI, Number 262

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FDA Notice Concerning “Healthy” Symbol

  •  Since launching in 2018, the FDA Nutrition Innovation Strategy (NIS) has included the possibility of FDA introducing a new symbol that could be used to convey the nutrient content claim “healthy” on packaged foods, as well as related plans to update the regulatory definition of “healthy” at 21 CFR 101.65(d).  Currently, the term may be used as an implied nutrient content claim on the label or in labeling of a food that meets certain nutrient conditions, including specific criteria for nutrients to limit in the diet, such as saturated fat.  In the interim, while FDA works on the updated rule, as discussed here, FDA issued a guidance document stating that FDA does not intend to enforce the regulatory requirements for foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

  • On May 7, 2021, FDA announced the availability of a procedural notice regarding plans to conduct three consecutive quantitative research studies—an experimental study and two surveys—to explore consumer responses to draft Front of Pack (FOP) symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim ‘‘healthy.’’  The first study will be a controlled, randomized experiment that will use a 15-minute web-based questionnaire to collect information from 5,000 U.S. adult members of an online consumer panel maintained by a contractor.  The second and third studies (surveys) will each utilize a 10-minute questionnaire to test sets of draft FOP symbols in a sample of 1,000 U.S. adult participants from an online consumer panel.

  • There is no news on any FDA progress in updating the regulatory definition of “Healthy.”  Comments on FDA’s proposed collection of information for the study, ‘‘Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim ‘Healthy’ on Packaged Foods,” are due by July 6, 2021.  After public comments are received, FDA’s consumer research plans will be submitted for approval from the Office of Management and Budget (OMB).

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 130
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About this Author

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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