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FDA posted warning letters to 7 companies for selling dietary supplements with claims that caused products to be drugs, violating Federal Food, Drug, and Cosmetic Act FD&C Act. Products to diagnose, cure, treat, prevent disease are subject to same requirements as drugs.
Monday, February 22, 2021 FDA will evaluate claims and other information on a dietary supplement’s website to establish the product’s “intended use.” In general, a dietary supplement is allowed to make claims about having an effect on the “structure” or a “function” of the human body. If FDA finds that the product is intended for use in the cure, mitigation, treatment, or prevention of disease, it will be deemed a “drug” under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). FDA routinely takes enforcement action against su...