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'Cosmeceuticals': The Fine (Regulatory) Line Between Cosmetics and Drugs

When it comes to determining whether a product is a drug, a cosmetic, or both under the Federal Food, Drug and Cosmetic Act of 1938, the focus has been mostly on the marketing and promotional claims related to the product, at least based on available FDA guidance, case law, and recent enforcement actions. As the market for cosmeceuticals continues to grow, however, and if more products are formulated with ingredients found in FDA-approved prescription drugs, that focus could change.

34 minute read May 27, 2008 at 04:07 PM
By
Kimberly H. Clancy
'Cosmeceuticals': The Fine (Regulatory) Line Between Cosmetics and Drugs

In January 2008, Jan Marini Skin Research suspended U.S. sales of its product, Age Intervention Eyelash Conditioner, which had been marketed as a cosmetic product that could be used to make eyelashes look longer and increase eyelash growth.

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