FDA ‘Healthy’ Claim Proposal Should Include Supplements and Functional Foods, says CRN

FEBRUARY 16, 2023

Consumers benefit from understanding the array of options for meeting their nutritional needs 

WASHINGTON, DC – The Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement and functional food industry, today submitted comments to FDA on its proposed rule updating the “healthy” implied nutrient content claim.  

CRN’s comments to FDA emphasized the value of including dietary supplements and functional foods in the final rule and urged the agency to reconsider its “food groups-only” approach.

CRN Vice President, Regulatory and Nutrition Policy, Haiuyen Nguyen explains, “Because FDA took a food groups-based approach to defining ‘healthy,’ there’s a missed opportunity for providing consumers information on a wider variety of innovative, healthy products, including functional foods and dietary supplements, and how they could play a role in supporting healthy diets that help prevent nutrition-related chronic diseases.” She adds, “Dietary supplements contain added nutrients and are typically not able to meet the proposed requirements for products to contain recommended food groups in order to make the ‘healthy’claim, and CRN’s comments suggest an additional approach.” 

CRN’s comments note:

  • An additional approach based on "nutrients to encourage" and "nutrients to limit" is needed to allow a variety of formulated foods and dietary supplements that can contribute to overall consumption of a variety of nutrients important for maintaining and supporting good health to bear the “healthy” claim.
  • FDA’s regulation defining this claim should be appropriately flexible to facilitate manufacturers in providing healthy, innovative products that meet diverse consumer needs and preferences.

CRN’s comments also called for FDA to clearly and narrowly define the “nutrition context” of the “healthy” nutrient content claim to avoid misinterpretations of the term “healthy” when appropriately used in other contexts, in a manner that is truthful and not misleading, including in structure/function claims, health claims, qualified health claims, general consumption guidance, and company and brand names.

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing more than 200 dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. For more information, visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn.