Regulations

Kalani Gets an FDA Warning Letter

FDA says its Sun Mousse SPF 50 makes drug claims.

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By: TOM BRANNA

Editor

The US Food and Drug Administration issued a Warning Letter to Kalani Sunwear. FDA reviewed the company’s product labeling, social media accounts and website. It concluded Kalani Sunwear Sun Mousse SPF 50 makes drug claims. According to FDA, the formula is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B). FDA said 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...

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