Terramed – FDA Warning Letter, Jul 1, 2026

On October 1, 2026, the FDA issued a warning letter to Terramed following a July 2026 review of the company’s website. The agency determined that Terramed is marketing several products—including Genital Herpes Intimate Wash, HerpCare Ointment, HerpCare Spray, and HerpCare Genital Wart Remover Ointment—as unapproved new drugs. The primary violation is the company’s claim that these products can treat or relieve symptoms of sexually transmitted infections (STIs), such as genital herpes and warts. Under the Federal Food, Drug, and Cosmetic Act, any product intended to treat a disease is classified as a drug and must undergo FDA review to prove it is safe and effective. The FDA emphasized that there are no approved over-the-counter treatments for STIs, and marketing such products poses a significant public health risk. Consumers relying on these products may forgo essential medical care, leading to severe complications or the continued spread of infections. The agency also noted that labeling products as "homeopathic" does not exempt them from these regulations. Terramed is required to investigate the root causes of these violations and implement corrective measures. The company must submit a written response within 15 business days detailing the steps taken to ensure compliance. Failure to address these issues promptly may result in legal action, including the seizure of products or an injunction to stop distribution.