FDA WARNING_LETTER - Skin PS Brands - April 19, 2022

This FDA Warning Letter, dated April 13, 2022, was issued to Ms. Lisse concerning her firm's distribution of the Dark Spot Fix drug product, intended for skin bleaching and lightening. The FDA determined that Dark Spot Fix is an unapproved new drug and is misbranded, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The product is considered a drug due to its intended use for fading dark discolorations and brightening complexion. As a skin bleaching product, it falls under section 505G(a)(4) of the FD&C Act, which deems such products not generally recognized as safe and effective (GRASE) based on a 2006 proposed rule. Consequently, Dark Spot Fix is an unapproved new drug, violating section 505(a), and its introduction into interstate commerce is prohibited under section 301(d). Furthermore, it is misbranded under section 502(ee) because it lacks an approved application and does not comply with section 505G requirements, making its interstate commerce introduction prohibited under section 301(a). The firm is responsible for investigating and correcting these violations promptly. Failure to do so may result in legal action, including seizure and injunction, and could lead to FDA withholding approval for export certificates or pending drug applications. A written response detailing corrective actions and recurrence prevention is required within 15 working days.