M & M Beauty and Wellness, LLC – FDA Warning Letter, Apr 19, 2022

This FDA Warning Letter, dated April 13, 2022, addresses Ms. Messer regarding the distribution of "BEST age spot remover lightening perfection crème," a drug product intended to bleach and/or lighten skin.

The FDA determined this product is an unapproved new drug and is misbranded. It is considered a drug under sections 201(g)(1)(B) and (C) of the FD&C Act due to its intended use as a skin bleaching product, evidenced by claims on its label and website (e.g., "Lightens dark spots," "maximum strength hydroquinone").

Specifically, the product contains hydroquinone, an active ingredient in skin bleaching drugs, which was determined not generally recognized as safe and effective (GRASE) in a 2006 proposed rule (71 FR 51146). Under section 505G(a)(4) of the FD&C Act (CARES Act), such products are deemed new drugs requiring an approved application for marketing as of September 23, 2020. Since no FDA-approved application exists for "BEST age spot remover lightening perfection crème," its introduction into interstate commerce violates section 505(a) and 301(d) of the FD&C Act. Furthermore, it is misbranded under section 502(ee) and 301(a) of the FD&C