FDA Proposed Rule for Term “Healthy” on Foods

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Silver Springs, MD—The U.S. Foods and Drug Administration (FDA) has issued a proposed rule for the use of the term “healthy” on human food products and opened the issue up for public comment for 120 days. Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C), a food is deemed misbranded if it bears a claim “either express or implied, that characterize the level of a nutrient which is of a type required to be declared in nutrition labeling.” As defined by FD&C, “healthy” constitutes a nutrient content claim suggesting “that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations.” This is appropriate “if the food meets certain nutrient conditions, and the claim is made with an explicit or implicit claim or statement about a nutrient (e.g., ‘healthy, contains 3 grams of fat’).”

KIND recently came under fire from FDA for its use of “healthy” on the label while not meeting the required nutritional parameters to legally bear this claim. KIND complied with FDA and was eventually granted permission to use the term “healthy” in reference to their brand philosophy, but not their nutritional value. Critics of FDA have deemed the agency’s definition of healthy to be outdated and this new rule seems to concede this criticism. In the guidance, FDA writes, “Because the science supporting public health recommendations for intake of various nutrients has evolved, as reflected in the updated Nutrition Facts Label, FDA intends to exercise enforcement discretion with respect to some of the criteria for bearing the implied nutrient content claim ‘healthy.’”

Under the new rule, food bearing the claim “healthy” meets the low fat requirement on the condition that the amounts of their mono- and polyunsaturated fatty acids are declared on the label and that these fats make up a majority of the fat content. However, they maintain the current rule that foods bearing “healthy” on the label “contain at least 10 percent of the DV per RACC of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the food instead contains at least 10 percent of the DV per RACC of potassium or vitamin D.”

Published in WholeFoods Magazine November 2016