FDA WARNING_LETTER - Confer With - August 12, 2025

The FDA issued a warning letter to 81 Rivington St, London, regarding the distribution of Vivant True Tone, a skin bleaching product. The inspection revealed that Vivant True Tone is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and is misbranded under section 502(ee). The product is marketed as a treatment for hyperpigmentation and other skin conditions, containing hydroquinone as an active ingredient, which the FDA has not recognized as safe and effective for over-the-counter use.

The regulatory framework cited includes sections 505(a), 502(ee), 301(d), and 301(a) of the FD&C Act, which prohibit the introduction of unapproved and misbranded drugs into interstate commerce. The FDA requires the company to investigate the causes of these violations, prevent their recurrence, and ensure compliance with federal law. The company must respond in writing within 15 working days, detailing corrective actions taken or planned. Failure to comply may result in legal action, including seizure and injunction, and could impact the approval of future drug applications.

The letter emphasizes the company"s responsibility to address these issues promptly and provides an opportunity for the company to submit additional information or reasoning if they believe their products are not in violation. The response should be directed to the FDA"s Office of Unapproved Drugs and Labeling Compliance.