What is “Healthy Food”? FDA May Know the Answer – JD Supra

On September 28, 2022, the U.S. Food and Drug Administration issued a Proposed Rule to revise the criteria for when foods can be labeled with the nutrient content claim “healthy.”1 Since 1994, FDA has recognized that when a manufacturer describes a product as “healthy” on its label, it is implying an amount of nutritional content worth noting.2 Such practices tend to imply that the nutrient content of the food may help consumers maintain healthy dietary practices. However, the current definition of “healthy” allows manufacturers to use the claim on some foods that contain levels of nutrients not believed conducive to maintaining healthy dietary practices. Relying on the evolution of nutrition and dietary science knowledge since the 1990s, when FDA first established a definition for the implied nutrient content claim “healthy,” the Proposed Rule would update the definition of “healthy,” when used as a nutrition content claim, to be consistent with current research.
Under the existing regulation, there are specific criteria for individual nutrients found in a food that must be met for the label of that food to bear the claim “healthy.” These include limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts of nutrients whose consumption is encouraged, such as vitamin A and dietary fiber. The proposed, updated criteria for including “healthy” as a claim on a food’s label are intended to promote healthy dietary patterns by requiring that food products contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines, 2020-2025, in order to be labeled “healthy.” The comment period for the Proposed Rule ends December 28, 2022.
Terms Subject to the Definition of “Healthy”
Food Groups
Nutrients to Limit
Revisions to 21 C.F.R § 101.65
[1] See 87 FR 59168, available electronically at (last accessed Nov. 11, 2022).
[2] In the Federal Register of May 10, 1994, FDA published a final rule entitled “Food Labeling: Nutrient Content Claims, Definition of Term: Healthy” amending § 101.65(d) to define the term “healthy” as an implied nutrient content claim under section 403(r) of the FD&C Act (59 FR 24232).
[3] In this rule, the phrase “food group” refers to the groups of foods recommended in the Dietary Guidelines, 2020-2025, which include vegetables, fruits, dairy, grains, protein foods, as well as oils.
[4] See 21 C.F.R. § 101.65(d)(2)(i)(A)-(F)).
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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