M & M Beauty and Wellness, LLC

Warning LetterOpen

Michelle Messer M & M Beauty and Wellness, LLC PO Box 204 Adel , IA 50003 United States michelle@mandmbeautyandwellness.comIssued Apr 13, 2022Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateApr 13, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: M & M Beauty and Wellness, LLC
Location: Michelle Messer M & M Beauty and Wellness, LLC PO Box 204 Adel , IA 50003 United States michelle@mandmbeautyandwellness.com
FEI Number: N/A
Country: United States
Issue Date: April 13, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

M & M Beauty and Wellness, LLC distributed "BEST age spot remover lightening perfection crème," an unapproved new drug containing 2% hydroquinone that was intended for skin bleaching and lightening age spots, in violation of section 505(a) of the Federal Food, Drug & Cosmetic Act. The product was also misbranded under section 502(ee) of the FD&C Act because it lacked required FDA approval before being introduced into interstate commerce. The company made drug claims on the product label and website describing its skin-lightening uses, which established the product's intended use as a drug requiring pre-market approval.

M & M Beauty and Wellness, LLC FDA Warning Letter, April 13, 2022