The U.S. Food and Drug Administration (FDA) has opened a docket and released industry guidance on the use of the term “healthy” in the labeling of human food products. Responding to Kind LLC’s citizen petition asking the agency to align its nutrient content claim regulations with federal dietary guidance, FDA invites “public comment on the term ‘healthy’, generally, and as a nutrient content claim in the context of food labeling.”

Current regulations reportedly establish “the parameters for use of the implied nutrient content claim ‘healthy’ or related terms… on the label or in labeling of a food to suggest that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions, and the claim is made with an explicit or implicit claim or statement about a nutrient.” Among other things, the conditions take into account serving- size regulations and set criteria for nutrients to limit—including fat, cholesterol and sodium—as well as those to encourage.

The citizen petition asks FDA to “amend the regulation defining the nutrient content claim ‘healthy’ with respect to total fat intake and amend the regulation to emphasize whole foods and dietary patterns rather than specific nutrients.” In particular, the petition seeks to permit “healthy” claims on foods that meet fat, saturated fat, and cholesterol criteria exclusive of total fat or saturated fat content derived from whole fruits, vegetables, nuts, seeds, legumes, whole grains, and seafood—or foods in these categories that “have been processed in such a way that did not materially degrade their nutrition value.”

Meanwhile, FDA has asked stakeholders to weigh in on a number of questions, including: (i) “Is the term ‘healthy’ most appropriately categorized as a claim based only on nutrient content?”; (ii) “If criteria other than nutrient content (e.g., amount of whole grain) are to be included in the definition of the term ‘healthy,’ how might we determine whether foods labeled ‘healthy’ comply with such other criteria for bearing the claim?”; (iii) “What types of food, if any, should be allowed to bear the term ‘healthy?’”; (iv) “Is ‘healthy’ the best term to characterize foods that should be encouraged to build healthy dietary practices or patterns?; (v) “What nutrient criteria should be considered for the definition of the term ‘healthy?’.” The agency also seeks input on consumer and industry perceptions regarding a changed definition of “healthy.”

In addition, FDA clarifies in its industry guidance that it intends “to exercise enforcement discretion with respect to the implied nutrient content claim ‘healthy’ on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ‘low fat’, or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.” See Federal Register, September 28, 2016.