Cosmetic, food, dietary supplement, and other consumer products, even without therapeutic claims, may now be subject to regulation as drugs or medical devices under the U.S. Food and Drug Administration’s (FDA) recent final rule (86 Fed. Reg. 41,383) amending its regulations defining intended use. The final rule, which was published on August 2, 2021, and went into effect September 1, provides that FDA can find that an “article” is subject to FDA regulation under the drug or medical device provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) based on any ingredients or other design or compositional features, even where the manufacturer is not making drug or medical device claims for the “article.” The preamble accompanying the final rule also expands the definition of intended use to include any “relevant” evidence and addresses the circumstances in which a cosmetic, food, or dietary supplement clinical trial could require an investigational new drug exemption (IND). Continue reading

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