March 6, 2020
Authored by: BCLP and Desmonne Bennett
Dietary supplement manufacturers seeking to explain and market their products must carefully craft statements on supplement labels to ensure compliance with the Food and Drug Administration’s (“FDA’s”) regulations regarding supplements.
The FDA permits supplements to so-called “structure-function claims,” which are claims that describe the role of a nutrient or dietary supplement “intended to affect the structure or function in humans” or characterize the “documented mechanism” by which the nutrient acts to maintain such structure or function, but do not claim to “diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” 21 U.S.C.A. § 343. Structure/function claims are permissible without pre-approval by the FDA if the statement satisfies three criteria:
(a) the manufacturer possesses “substantiation” that such statement is truthful and not misleading;
(b) the product label “prominently displays” the following statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”; and
(c) the manufacturer notifies the FDA within 30 days after the product is first marketed with the claim.
In contrast, “disease claims” are not permissible without FDA pre-market review and authorization under the rules for health claims or drugs, as appropriate. It is thus important to distinguish permissible structure/function claims from impermissible disease claims. A “disease” means “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension)