Washington, D.C.—In September 2022, the Food and Drug Administration (FDA) announced its proposal calling for an update to the definition for the implied nutrient content claim “healthy.” FDA proposed that the claim 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.

FDA explained that, if finalized, this would "revise the requirements for when the term 'healthy' can be used as an implied claim in the labeling of human food products to indicate that a food's level of nutrients may help consumers maintain healthy dietary practices by helping them achieve a total diet that conforms to dietary recommendations."

Industry on FDA proposed rule updating the “healthy” implied nutrient content claim

In February, the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA) were among those who submitted comments to FDA on its proposed rule. 

In its comments, CRN emphasized the value of including dietary supplements and functional foods in the final rule. The trade association urged the agency to reconsider its “food groups-only” approach.

“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,” said CRN Vice President, Regulatory and Nutrition Policy, Haiuyen Nguyen. “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.” 

Among the points made by CRN:

  • "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.
  •  FDA should "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."

In its comments, AHPA requested that FDA exempt “dietary supplements” as a category from the Proposed Rule. As AHPA explained: "The Proposed Rule could potentially prohibit the use of 'healthy' on any dietary supplement, as dietary supplements would not, in most cases, comply with the food group equivalent requirements." 

AHPA outlined the necessity of dietary supplements in helping consumers meet the current U.S. Dietary Guidelines, and argued: ..."prohibiting the use of 'healthy' claims on dietary supplements would be inconsistent with the goals of the proposed rule to promote healthy dietary practices and that a prohibition would create potential confusion regarding other lawful dietary supplements claims that use the word 'healthy.'"

“Dietary supplements are intended to support a healthy diet and lifestyle and, per the current dietary guidelines, a healthy diet can include herbs and herbal products,” said Robert Marriott, AHPA Director of Regulatory Affairs, in an announcement. “AHPA’s position is that dietary supplements, unsweetened coffees and teas, and herbs and spices should be able to bear ‘healthy’ claims. We have expressed this position to FDA in our comments, among other requests that support uses of the term ‘healthy’ that will help consumers make beneficial diet choices.”