Organicare Nature's Science, LLC – FDA Warning Letter, Oct 1, 2026

In a warning letter dated October 1, 2026, the U.S. Food and Drug Administration (FDA) notified OrganiCare, LLC (also operating as OrganiCare Nature’s Science, LLC) of significant violations regarding the marketing of its products. Following a July 2026 review of the company"s website and social media accounts, the FDA determined that the products “HClear for him” and “FemiClear Genital Herpes Symptoms” are being sold as unapproved new drugs. The primary violation involves the company making unauthorized medical claims that these products can treat, mitigate, or prevent sexually transmitted infections (STIs), specifically genital herpes. Marketing materials claimed the ointments could kill 99.9% of herpes simplex viruses and provide fast relief for symptoms such as itching, tingling, and burning. The FDA emphasized that there are no approved over-the-counter drugs for treating STIs. Marketing such products without clinical oversight poses a significant public health risk, as consumers might delay professional medical treatment for serious conditions. These actions violate the Federal Food, Drug, and Cosmetic Act, which prohibits the introduction of unapproved new drugs into interstate commerce. Although the company labeled the products as "homeopathic," the FDA clarified that these items do not meet the legal requirements for that category and still require formal approval. OrganiCare is required to respond to the FDA within fifteen business days. The response must outline the specific steps taken to correct the violations and the measures implemented to prevent their recurrence. Failure to comply may lead to legal actions, including product seizures or court injunctions.