Well Done

Recently, the US Food and Drug Administration (FDA) announced its plan to redefine the implied nutrient content claim “healthy” by issuing a new guidance document—Use of the Term “Healthy” in the Labeling of Human Food Products¹ (Guidance).

The Guidance is effective immediately and states that FDA will exercise enforcement discretion when the claim “healthy” is used on the labeling of certain food products. Specifically, FDA will exercise enforcement discretion for food labels that display the “healthy” implied nutrient content claim and that

• are not low in fat, provided that the amounts of mono and polyunsaturated fats are declared on the label, and the amounts declared constitute the majority of the fat content; or
• contain at least 10% of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Applicable FDA regulations state that use of the term “healthy” or related terms (such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) are implied nutrient content claims that can be made if the food meets certain nutritional requirements.² The requirements for bearing a “healthy” claim include specific levels for maximums on total fat, saturated fat, cholesterol, and sodium, as well as minimums for vitamin A, vitamin C, calcium, iron, protein, and fiber.

FDA states two reasons why the Guidance is being issued:

First, the Guidance is being issued to align with the Final Rules that modified the Nutrition Facts Panel labeling requirements.³ Through these Rules, the Nutrition Facts Panel format has been revised to include a requirement to declare values for potassium and vitamin D. Thus, these nutrients have been added to those that would support a “healthy” claim.

Second, FDA is attempting to harmonize the science underlying the rules with the 2015–2020 Dietary Guidelines for Americans.⁴ Previously, foods could not make a “healthy” claim if they contained more than three grams of fat and one gram or less of saturated fats. In the 2015–2020 Dietary Guidelines for Americans, the focus shifted away from limiting total fat intake to encouraging intakes of mono and polyunsaturated fats. Thus, FDA will exercise enforcement discretion for foods that are not low in fat (i.e., contain more than three grams of fat and more than one gram of saturated fat), but contain a fat profile makeup of predominantly mono and polyunsaturated fats.

FDA also states in the Guidance that it is re-evaluating the regulatory criteria for use of the implied nutrient content claim “healthy” and will seek input on possible future rulemaking to update the existing regulations. In the interim, FDA will exercise enforcement discretion for certain expanded “healthy” nutrient content claims.

¹US Food & Drug Admin., Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry (Sept. 2016) http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.
²21 C.F.R. § 101.65(d).
³See Food Labeling: Revision of the Nutrition and Supplement Facts Labels, 81 Fed. Reg. 33742 (May 27, 2016); Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments, 81 Fed. Reg. 34000 (May 27, 2016).
⁴US Dept. of Health and Human Svcs, US Dept. of Ag. 2015–2020 Dietary Guidelines for Americans. 8th Ed. (Dec. 2015) http://health.gov/dietaryguidelines/2015/guidelines/.