FDA to Revisit the Nutrient Content Claim “Healthy”

By Riëtte van Laack –

On Sept. 27, 2016, FDA announced the availability of several documents regarding the “healthy” claim on foods.

Under the current regulation, the term “healthy” (or similar terms) – when used with an explicit or implicit claim or statement about a nutrient in the manner described in the regulation – is an implied nutrient content claim. 21 C.F.R. § 101.65(d). A food must meet certain requirements to be eligible for the “healthy” claim.

The “healthy” claim as an implied nutrient content claim got new attention in 2015, when FDA issued a Warning Letter to Kind LLC (Kind).  According to FDA, the bar products marketed by Kind as “healthy” did not meet the requirements for this claim because the fat content of the bars exceeded the limit for low fat claims. Kind subsequently submitted a Citizen Petition asking that FDA update the regulation to be more in line with the current Dietary Guidelines.

In the Sept. 27 announcements, FDA acknowledges that the regulation for “healthy” as a nutrient content claim is in need of an update. Since 1993, science has evolved and, among other things, Dietary Guidelines now draw distinctions among the types of fat (unsaturated fats vs saturated fats) in the diet. Also, as reflected in the updated nutrition labeling requirements, FDA now recognizes vitamin D and potassium as nutrients that should be encouraged in the diet. Therefore, FDA will review and consider revising the regulation. FDA announced two actions, i.e., the issuance of a guidance document and a request for information and comments.

Guidance: FDA Intent to Exercise Enforcement

FDA issued an immediately effective guidance which lays out conditions under which FDA intends to “exercise enforcement discretion relative to foods that use the implied nutrient content claim ‘healthy’ on their labels” while FDA is reconsidering the regulation defining “healthy.” Specifically, FDA’s Guidance announces that it intends to exercise enforcement discretion for products labeled as “healthy” that are not low in total fat, as long as the fat predominantly consists of unsaturated fats, and provided that the nutrition facts box declares the amounts of the poly and mono unsaturated fats. In addition, FDA intends to exercise enforcement discretion when the food contains less than ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, and fiber, but the food contains at least 10% of the DV per RACC of vitamin D or potassium. For labels that do not use the updated nutrition facts panel, the manufacturer may use the old DVs. If a manufacturer uses the updated nutrition facts panel, the updated DVs for potassium and vitamin D must be used. In addition, the relevant nutrient(s) must be declared in the nutrition facts box.

Request for Information and Comments

In the Federal Register notice requesting information and comments, FDA asks for input on the Citizen Petition by Kind and on a range of issues related to the “healthy” claim, including:

• Is the term “healthy” most appropriately categorized as a claim based only on nutrient content?
• What types of food, if any, should be allowed to bear the term ‘‘healthy?”
• What nutrient criteria should be considered for the definition of the term “healthy?”
• What are the public health benefits, if any, of defining the term “healthy” or other similar terms in food labeling?
• What is consumers’ understanding of the meaning of the term “healthy” as it relates to food?

FDA indicates that, in addition to this request, it will plan other forums for public input. These actions appear to be the first of various actions to update FDA regulations regarding nutrient content and health claims to conform to the updated nutrition labeling regulations published in May, 2016. The review and updating process will not happen overnight. As FDA stated, it “may take some time, but we want to get it right.”

Information and comments must be submitted by Jan. 26, 2017.