The Food and Drug Administration has sent warning letters to about a dozen companies selling non-prescription products that claim to treat or cure HIV, genital warts, and herpes, but have not been proven to treat any disease.
Makers of drugs including Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak, among others, were issued letters from the FDA and the Federal Trade Commission to stop making the unproven claims. The so-called medications are sold online and in retail stores, but were never evaluated by the FDA for safety and effectiveness.
The companies will have 15 days to notify the FDA of steps they plan to take to correct the violations cited. If they fail to communicate these steps to the FDA, the companies may face legal action including seizure and injunction, or criminal prosecution. The government agency is also asking those who have taken the drugs to report complaints or problems to its voluntary reporting program at MedWatch or 800-FDA-1088.
Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, called the drugs dangerous in a statement Tuesday.
"Consumers who buy these products may not seek the medical attention they need and could spread infections to sexual partners," she added.