The Food and Drug Administration issued warnings May 3 to the manufacturers of unapproved products that claim to prevent, treat, and/or cure sexually transmitted diseases.
The products – which are sold primarily on the Internet but are available in some stores – are not FDA approved, and make unproven claims that they can be used to prevent, treat, or cure STDs, including genital herpes, genital warts, chlamydia, HIV, and AIDS, FDA officials announced during a media briefing.
Photo credit: U.S. Food & Drug Administration
The FDA has issued warnings to manufacturers of products that make unproven claims to treat or cure sexually transmitted diseases, including genital herpes, chlamydia, and HIV and AIDS. Manufacturers have 15 days to notify the FDA of steps they are taking to correct the violations.
The products are not being taken off the market immediately; but the FDA sent warning letters to 11 manufacturers notifying them that they are violating federal law by making unproven claims. The companies have 15 days to notify the FDA that steps have been taken to correct the violations. If they fail to do so, they may be subject to legal action, including seizure of the products and criminal prosecution, according to a statement issued by the FDA.
Health care professionals and consumers should be warned that no over-the-counter or online drugs or dietary supplements are available that treat or prevent STDs, said Howard Sklamberg, director of the Office of Enforcement within the FDA’s Office of Regulatory Affairs.
The targeted products include Medavir, Herpaflör, Viruxo, C-Cure, and Never an Outbreak. Others include Herpeset, Wartrol, and ImmuneGlory.
The FDA has not received any specific reports of injuries resulting from the use of these products, Mr. Sklamberg said during the briefing. But the agency is concerned about the adverse effects of delaying appropriate treatment for STDs, including transmission of STDs stemming from the use of these products. The FDA does not know where these products are made or what ingredients they actually contain, he added.
One Internet site selling Herpaflör for oral and genital herpes claimed that it had "seventeen top clinically tested ingredients in one superpotent formula," ranging from zinc sulfate and L-lysine to sage and a component of licorice root.
Health care professionals and consumers should report problems with or complaints about these products to the FDA's MedWatch program.