On September 28, 2016, the Food and Drug Administration (FDA) published in the Federal Register a notice [Docket No. FDA-2016-D-2335] announcing the availability of a guidance for industry entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance for Industry.’ The guidance advises manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by FDA regulations. More specifically, the guidance advises food manufacturers of our intent 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.
Comments on FDA guidances may be submitted in electronic format or in writing at any time,
On the same date, the FDA published in the Federal Register a document [Docket No. FDA-2016-D-2335] announcing the establishment of a docket to receive information and comments on the use of the term “healthy” in the labeling of human food products. This action is consistent with FDA’s recently released 2016-2025 Foods and Veterinary Medicine (FVM) Program’s strategic plan with specific goals for nutrition and other planned and recent activity including the issuance of final rules updating certain of FDA’s nutrition labeling regulations. In addition, the FDA received a citizen petition asking that it update, among other things, its nutrient content claim regulations to be consistent with current federal dietary guidance. In particular, the petitioners request that FDA 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. FDA invites public comment on the term “healthy”, generally, and as a nutrient content claim in the context of food labeling and on specific questions contained in this document.
Submit either electronic or written comments by January 26, 2017.