BGP, LLC – FDA Warning Letter, May 11, 2021

The FDA and FTC issued a Warning Letter to Biocence.com on May 19, 2021, following reviews of their website and social media. The letter addresses the sale of "BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug," marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions. The product is deemed an unapproved new drug under section 505(a) of the FD&C Act and misbranded under sections 502(a) and (ee), with its interstate commerce prohibited by sections 301(a) and (d). It is considered a "new drug" as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. The product fails to conform to the 1994 Tentative Final Monograph (TFM) for topical antiseptics and its amendments, primarily because its active ingredient, "Biocence Botanical Complex," was not a proposed active ingredient, and its labeling makes unapproved claims. Additionally, the company's website and social media misleadingly imply FDA endorsement or approval, constituting further misbranding. Biocence is required to immediately cease the sale of all unapproved products for COVID-19 and other conditions. They must email FDA within 48 hours detailing corrective actions and documentation, and similarly contact the FTC regarding unsubstantiated claims. Failure to comply may lead to legal actions, including seizure and injunction, addition to FDA's public warning list, and potential civil penalties up to $43,792 per violation from the FTC, along with consumer refunds.