Clinical Formula LLC – FDA Warning Letter, Apr 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(
ID · f3cbc070-327f-46ff-8e26-5ccde5f19ef2
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