AHPA submits comments to FDA on proposed rule for “healthy” claims
February 23, 2023
Last week, the American Herbal Products Association (AHPA) submitted comments to the U.S. Food and Drug Administration (FDA) requesting revisions to the proposed rule updating the regulation governing “healthy” claims for food products, including dietary supplements. This proposed rule follows a 2016 Federal Register notice in which FDA invited comments on the term “healthy” as a nutrient content claim in the context of food labeling, to which AHPA also submitted comments.
The current regulation governs the use of the term “healthy” (and related terms, such as “healthful” or “healthier”) as an implied nutrient content claim on the label or in labeling of a food is codified at 21 C.F.R. § 101.65(d)(2). This regulation establishes specific criteria for these claims related to the levels of fat, saturated fat, cholesterol, and other nutrients present in different food categories permitted to make such claims.
“Dietary supplements are intended to support a healthy diet and lifestyle and, per the current dietary guidelines, a healthy diet can include herbs and herbal products,” said Robert Marriott, AHPA Director of Regulatory Affairs. “AHPA's position is that dietary supplements, unsweetened coffees and teas, and herbs and spices should be able to bear ‘healthy' claims. We have expressed this position to FDA in our comments, among other requests that support uses of the term ‘healthy' that will help consumers make beneficial diet choices.”
Dietary supplements should be able to bear “healthy” claims
Among the elements of its extensive comments, AHPA asserted that the proposed rule should not restrict the use of “healthy” claims on dietary supplements. Noting references to the necessity of dietary supplements in helping consumers meet the current U.S. Dietary Guidelines, AHPA argued that completely prohibiting the use of “healthy” claims on dietary supplements would be inconsistent with the goals of the proposed rule to promote healthy dietary practices and that a prohibition would create potential confusion regarding other lawful dietary supplements claims that use the word “healthy.”
In the event that FDA declined to exempt dietary supplements from the “healthy” claim requirements, AHPA also suggested two alternative proposals to address such claims for dietary supplements: (i) exempting them from the newly proposed food group equivalent requirements; or (ii) revising the proposed rule to specifically allow “healthy” claims on dietary supplements that contain vitamins and minerals referred to in regulation as “essential in human nutrition,” including nutrients of public health concern.
Unsweetened coffees and teas, herbs, and spices should also be permitted to bear “healthy” claims
AHPA also encouraged FDA to permit the use of “healthy” claims for unsweetened coffees and teas in line with nutritional evidence supporting their use as a healthy substitute for caloric or sugar-sweetened beverages.
Similarly, AHPA also encouraged FDA to permit the use of “healthy” claims for products consisting of single or mixed herbs and spices that do not include sodium, added sugars, or saturated fats, such as those used in flavoring home-cooked meals and dishes.
Requests for clarification and other enforcement revisions
Among its other comments, AHPA requested that FDA revise the proposed rule and associated communications to clarify that the final rule does not restrict use of the term “healthy” in the context of other lawful product claims (e.g., inclusion of the word “healthy” as part of lawful structure function claims). AHPA also recommended that FDA refrain from reducing sodium limits applicable to “healthy” claims due to a lack of new evidence supporting such a reduction. AHPA also requested further enforcement discretion for products already in commerce at the time of the revised rule's compliance date.
Continued engagement and advocacy
AHPA has closely followed FDA's proposed updates to the regulation of “healthy” label claims for several years and will continue to engage with the agency on this matter as it relates to dietary supplements and herbal products.
“AHPA and our members know dietary supplements and herbal products inside and out; these products can help consumers maintain healthy dietary patterns,” added Michael McGuffin, AHPA President. “As such, we will continue to advocate for these products to be able to bear ‘healthy' claims.”