Skin Authority, L.L.C. – FDA Warning Letter, Apr 19, 2022

The FDA issued a Warning Letter to Mr. Hilling concerning the distribution of skinauthority® Hyperpigmentation Treatment, a drug product intended to bleach and/or lighten skin. The product is cited as an unapproved new drug and a misbranded drug, violating sections 505(a) and 502(ee) of the FD&C Act, respectively. Its introduction into interstate commerce is prohibited under sections 301(d) and (a).

The product is classified as a drug due to its intended use for diagnosis, cure, mitigation, treatment, prevention of disease, and/or affecting body structure/function, specifically as a skin bleaching product. Claims like "Skin Lightener," "Hydroquinone (2%)," "Whitening Agent," and "fade spots, freckles, and hyperpigmentation" support this intended use.

As a skin bleaching drug, it falls under section 505G(a)(4) of the FD&C Act, deeming it not generally recognized as safe and effective (GRASE) per a 2006 proposed rule. Consequently, it is considered a new drug requiring an approved new drug application under section 505 of the FD&C Act since September 23, 2020. No such application is in effect for skinauthority® Hyperpigmentation Treatment.

The letter requires prompt corrective action within 15 working days, including specifying steps