FDA Warns of Marketing Cosmetics with Drug Claims

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The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) governs the regulation of drugs and cosmetic products. The Act defines a cosmetic, in part, as something designed for the, “cleansing, beautifying, promoting attractiveness, or altering the appearance [of a person].” By contrast, the Act defines a drug, in part, as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease," or “intended to affect…
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FDA Regulation of OTC Sunscreen Products

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Have you ever wondered who ensures the safety of your sunscreen? With many people, including pregnant women and children, choosing to wear sunscreen on a daily basis throughout the summer months, it is imperative that the sunscreen on the market is safe and effective. With that in mind, on November 26, 2014, Congress enacted the Sunscreen Innovation Act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen with the U.S. Food & Drug Administration (“FDA”). The Sunscreen Innovation Act does not relax the FDA’s scientific standards for evaluating safety and effectiveness of sunscreen ingredients. It…
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