Regulations

Supergoop! Issued FDA Warning Letter

Agency notes the product makes SPF claims, which are drug claims.

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By: TOM BRANNA

Editor

The US Food and Drug Administration issued a Warning Letter to Supergoop!. The Agency reviewed the Play SPF 50 Body Mousse label and website. FDA concluded the mousse makes drug claims. “Supergoop! PLAY SPF 50 BODY MOUSSE” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C)...

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