SkinPro – FDA Warning Letter, Apr 19, 2022

On April 13, 2022, the FDA issued a Warning Letter to Mr. Schmidt regarding the distribution of SKINPRO ULTRA BRIGHTENER HYDROQUINONE, a skin bleaching drug product. The FDA determined this product is an unapproved new drug and is misbranded, violating sections 505(a) and 502(ee) of the Federal Food, Drug & Cosmetic Act (FD&C Act), respectively.

The product is considered a drug under section 201(g)(1)(B) and (C) of the FD&C Act due to its intended use for skin bleaching, as evidenced by claims like "ULTRA BRIGHT LIGHTENING CREAM Maximum Strength Hydroquinone" and "works fast to eradicate dark spots and prevent future occurrences of hyperpigmentation and uneven skin tone."

SKINPRO ULTRA BRIGHTENER HYDROQUINONE is subject to section 505G(a)(4) of the FD&C Act, as it is not generally recognized as safe and effective (GRASE) per a 2006 proposed rule. Consequently, it is deemed a new drug requiring an approved application under section 505 of the FD&C Act since September 23, 2020. No such application exists, making its interstate commerce introduction a violation of section 301(d). Furthermore, it is misbranded under section 502(ee) and