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“Healthy” Regulatory Definition To Be Revised?

FDA has defined the term, “healthy” (and related terms, including “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”), when used as an implied nutrient content claim in labeling human food products, at 21 C.F.R. § 101.65(d)(2).

Today, FDA published a Federal Register notice announcing that the agency has established a docket to receive information and comments on the use of the term “healthy” in the labeling of human food products.  As basis, FDA notes the Foods and Veterinary Medicine Program’s Strategic Plan for Fiscal Years 2016–2025, its Nutrition Facts Panel final rules, the 2015-2020 Dietary Guidelines for Americans, and a December 1, 2015 Citizen Petition received from KIND LLC.

In March 2015, FDA’s Center for Food Safety and Nutrition (CFSAN) issued a Warning Letter to KIND LLC because the labels and labeling of KIND’s nutrition bars bore a variety of nutrient content claims, including “healthy,” but the products did not meet the requirements to make such claims.  CFSAN issued a Closeout Letter to the company on April 20, 2016 after an evaluation of the corrective actions taken in response to the 2015 Warning Letter.

The Citizen Petition requested that FDA:

  • Amend § 101.65(d)(2) so that the term “healthy” or related terms may be used if the food “meets the following conditions for fat, saturated fat, and cholesterol exclusive of the fat and saturated fat contributed to the food product by the following foods, provided that such foods are used in their whole form or have been processed in such a way that did not materially degrade their nutritional value: Fruits, vegetables, nuts, seeds, legumes, whole grains, and seafood; and the food meets the following conditions for other nutrients”;
  • Amend § 101.65(d) (pertaining to general nutritional claims) to “clarify that a labeling claim that a food is useful in maintaining healthy dietary practices is an implied nutrient content claim only if the claim is immediately adjacent to an implicit claim or statement about a nutrient”;
  • Amend § 101.65(b) (pertaining to label statements that are not implied claims) to “clarify that a statement that claims that a food is useful in maintaining healthy dietary practices and that does not appear immediately adjacent to an explicit or implicit claim or statement about a nutrient is generally not an implied nutrient content claim, but is instead a dietary guidance statement”; and
  • While the rulemakings to amend § 101.65 are pending, issue a guidance document to “clarify that a statement about the usefulness of a food, or a category of foods, in maintaining healthy dietary practices is a dietary guidance statement that is not subject to the requirements in FDA’s nutrient content claim regulations unless it is an implied nutrient content claim because it is immediately adjacent to an explicit or implicit claim or statement about a nutrient.”

FDA’s Federal Register notice lists specific information and comments that the agency hopes to receive.  The comment period is open for 120 days.

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