Company News, Regulations

New Warning Letter from FDA

Osea flagged for drug claims following website review.

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By: Christine Esposito

Editor-in-Chief

Malibu, CA-based Osea Internacional has been issued a warning letter by the US Food and Drug Administration (FDA) following a review of the brand’s (http://oseamalibu.com). The FDA contends that the company’s Blemish Balm, Essential Corrective Complex, Brightening Serum, and Sea Vitamin Boost are being marketed as drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or 21 U.S.C. § 321(g)(1)(C)].   Examples of ...

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