FDA requests comments on “healthy” definition and issues guidance regarding the use of the term “healthy” in the labeling of human food products.

• FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per serving.  (Fish and meat are required to contain 5 grams or less of total fat per serving and 2 grams or less of saturated fat per serving).  FDA received a Citizen Petition last December requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.

• Today, FDA announced that it is now officially requesting information and public comment on the use of the term “healthy” as a nutrient content claim on food labeling.  While FDA considers how to redefine the term “healthy”, food manufacturers may continue to use the term “healthy” on foods that meet the current regulatory definition. FDA has also issued a guidance document, effective today, stating that FDA does not intend to enforce the regulatory requirements for products that use the term “healthy” provided that certain criteria described in the guidance document are met.

• In its request for comment, FDA poses a series of nuanced questions, including – but not limited to:

  • whether the term “healthy” is most appropriately categorized as a claim based only on nutrient content;

  • whether nutrients for which intake is encouraged should be intrinsic to the foods, or whether the nutrients could be provided in part – or in total – via fortification; and

  • whether “healthy” is the best term to characterize foods that should be encouraged to build healthy dietary practices.

• The Agency also requests feedback on consumer perceptions of the term “healthy” as it relates to food and the public health benefits of defining the term “healthy” or similar terms in food labeling.

• FDA will be accepting comments on the “healthy” definition for 120 days following its imminent publication in the Federal Register.