FDA WARNING_LETTER - Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. - April 19, 2022

The FDA issued a Warning Letter to Ms. Pedrazzini concerning her subsidiary, Neoteric Cosmetics, Inc., for distributing ALPHA® SKIN CARE Dual Action Fade Cream. This product is an unapproved new drug and misbranded under the Federal Food, Drug & Cosmetic Act (FD&C Act).

The product is deemed a drug due to its intended use for skin bleaching, with claims like "Dual Action Skin Lightener," "Helps to fade the dark spots," and containing "2% Hydroquinone, a proven skin lightener." These claims, found on the product label and website, indicate its intent to affect body structure/function and treat/mitigate disease.

As a skin bleaching drug, it falls under section 505G(a)(4) of the FD&C Act, which deems it not generally recognized as safe and effective (GRASE) per a 2006 proposed rule. Consequently, it is considered a new drug requiring an approved application under section 505 of the FD&C Act since September 23, 2020. No such approval exists for ALPHA® SKIN CARE Dual Action Fade Cream, violating section 505(a) and 301(d).

Furthermore, the product is misbranded under section 502(ee) and 301(a) because it is a nonprescription drug subject to section 505G but lacks an approved application