FDA WARNING_LETTER - Clinical Formula LLC - April 19, 2022

The FDA issued a Warning Letter to Mr. Kutanakit on April 13, 2022, concerning the manufacturing of Clinical Formula™ Bleaching Lotion. This product, intended to bleach and/or lighten skin, is cited as an unapproved new drug and a misbranded drug.

The product is deemed a drug under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act due to claims like "BLEACHING LOTION," "Skin Lightener," and "For Bleaching of Hyperpigmented Skin" with Hydroquinone 2% as an active ingredient. It falls under section 505G(a)(4) of the FD&C Act, as it is subject to a proposed rule (71 FR 51146) determining that OTC skin bleaching products, including those with hydroquinone, are not generally recognized as safe and effective (GRASE).

Consequently, Clinical Formula™ Bleaching Lotion is considered a new drug requiring an approved new drug application under section 505 of the FD&C Act, effective September 23, 2020. No such application is in effect, violating section 505(a) and prohibiting its interstate commerce under section 301(d). Furthermore, it is misbranded under section 502(ee) and 505G(