Bioactive Services LLC – FDA Warning Letter, Jul 1, 2026

On October 1, 2026, the FDA issued a warning letter to Bioactive Services USA, LLC (doing business as Herstat Inc.) following a July 2026 review of the company’s websites and social media accounts. The FDA identified "Herstat GST" as an unapproved new drug being marketed for the treatment of genital sores and symptoms associated with sexually transmitted infections (STIs).

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the product is classified as a drug because its labeling claims it can treat, mitigate, or prevent disease. Specifically, marketing materials suggested the product provides rapid relief for outbreaks and calms inflammation. The FDA determined the product is not generally recognized as safe and effective (GRASE) for these uses and lacks an approved marketing application. Furthermore, the product fails to conform to OTC Monograph M017 for external analgesics because its claims regarding genital sores exceed permitted indications. The agency emphasized that such products pose a public health risk by potentially delaying necessary medical care for STIs.

Herstat Inc. is required to submit a written response within 15 business days detailing the corrective actions taken to address these violations and the steps implemented to prevent their recurrence. Failure to comply may result in legal action, including product seizures or injunctions.