FDA WARNING_LETTER - AMBI Enterprises LLC - April 19, 2022

The FDA issued a Warning Letter to Mr. Lennarz on April 13, 2022, concerning the distribution of AMBI® SKINCARE Fade Cream OILY SKIN and AMBI® SKINCARE Fade Cream NORMAL SKIN. These products are intended for skin bleaching and contain Hydroquinone 2% as an active ingredient.

The FDA determined these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, they violate section 505(a) as unapproved new drugs and section 502(ee) as misbranded drugs. The products are deemed new drugs under section 201(p)(1) and subject to the requirement of an approved new drug application under section 505, effective September 23, 2020. No FDA-approved application exists for these products.

The FDA cited product labels and website claims (ambi.com) as evidence of intended use for skin bleaching, such as "Fades dark spots for even, natural skin tone" and "Skin Bleaching Agent." The agency previously determined in a 2006 proposed rule that OTC skin bleaching drug products, including those with hydroquinone, are not generally recognized as safe and effective (GRASE).

The letter requires prompt corrective action within 15 working days, including investigating and preventing recurrence of violations. Failure to comply may result in legal action, including seizure