FDA Redefines the Term “Healthy” in Food Labeling

October 5, 2016

On Wednesday, September 28th, the FDA issued a final guidance document regarding the inclusion of the term “healthy” on the labels of food products.  The guidance, entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products,” informs food manufacturers of FDA’s “intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim ‘healthy’ on their labels which:

  1. Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  2. Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.”

The term “healthy” (and related terms, including “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) was defined in a final rule that was issued by the FDA on January 6, 1993.  The term can only be used on the labeling of food that meets certain nutritional conditions, and the specific nutritional criteria governing the use of the term vary for different food categories.

In light of the most recent nutrition science and the current dietary recommendations, FDA has decided to re-evaluate the regulatory criteria that are used for the implied nutrition content claim “healthy.”

Low Fat

Since 1993 when the Agency initially defined the term “healthy,” science and public health recommendations regarding dietary fat intake has evolved.  Today, we no longer recommend that consumers limit total fat intake, and we now encourage intakes of mono and polysaturated fats.  According to FDA’s guidance, “foods that use the term ‘healthy’ on their labels that are not low in total fat should have a fat profile makeup of predominantly mono and polyunsaturated fats.”

Any food bearing the nutritional claim “healthy” must meet the low fat requirement, provided that:

  1. “The amounts of mono and polyunsaturated fats are declared on the label.”
  2. “The amounts declared constitute the majority of the fat content.”

FDA feels as though this is important because it is significant for consumers to know that the total fat is mostly made up of fats that are encouraged by current dietary recommendations.

Beneficial Nutrients

FDA’s definition for the term “healthy” also includes a nutrient contribution criterion, which is focused on “foods providing a good or excellent source of nutrients for which there had been public health concern.”  In the past these nutrients were vitamin A, vitamin C, iron, calcium, and dietary fiber.  Over time, these have shifted and today the nutrients of public health concern include potassium and vitamin D, in addition to iron and calcium.  (This change is also reflected in the mandatory nutrients to be labeled in the Nutrition Facts Label.)

FDA states that it intends to “exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim ‘healthy’ contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the food instead contains at least ten percent of the DV per RACC of potassium or vitamin D.”  FDA also states that only manufacturers who have not yet updated their Nutrition Facts label are permitted to use the old DVs for potassium and vitamin D, and notes that any manufacturer who has already implemented the updated label must use the new, updated DVs.

As FDA has determined that prior public participation is neither feasible nor appropriate, this guidance is effective immediately.  Furthermore, FDA states that it intends to seek input on possible rulemaking to update the existing regulation regarding this claim, but since the rulemaking process can be lengthy, the guidance document was released in the interim so that it could exercise enforcement discretion until 21 CFR 101.65(d)(2) has been amended.

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