FDA WARNING_LETTER - Genomma Lab USA, Inc. - April 19, 2022

This FDA Warning Letter, dated April 13, 2022, addresses the firm's distribution of unapproved and misbranded drug products, specifically Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM. These products are intended for skin bleaching and contain Hydroquinone 2% as an active ingredient, making them drugs under section 201(g)(1)(B) and (C) of the FD&C Act.

The violations stem from the products being unapproved new drugs, introduced into interstate commerce in violation of section 505(a) and 301(d) of the FD&C Act. They are also misbranded under section 502(ee) and 301(a) of the FD&C Act. These skin bleaching products fall under section 505G(a)(4) of the FD&C Act, as they are subject to a proposed rule determining them not generally recognized as safe and effective (GRASE). Consequently, they are deemed new drugs requiring an approved new drug application under section 505 of the FD&C Act since September 23, 2020, which they lack.

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 and injunction,