Feds Crack Down on Sham STD Drugs
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced a joint effort last week to stamp out these products, all of which make unproven claims to treat, cure and prevent STDs such as herpes, HIV and AIDS.The bogus drugs targeted by the FDA and FTC include Medavir, Herpaflor, Viruxo and Never An Outbreak, none of which have been evaluated by the FDA for safety and effectiveness. The companies peddling these drugs online and in stores, along with the others on the list, were sent letters warning them their products violate federal law.
"These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available," Deborah M. Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research, said in a statement. "Consumers who buy these products may not seek the medical attention they need and could spread infections to sexual partners."
The companies sent warning letters all claim their products treat a range of STDs, including herpes, chlamydia, genital warts, HIV and AIDS. In fact, the FDA has never approved over-the-counter drugs or dietary supplements to treat or prevent STDs, and all FDA-approved medications for STDs require a prescription.
Although some of the companies market their products as dietary supplements, all of them are considered drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act), since they're promoted as treatments for disease. Making unsubstantiated treatment claims is also illegal under the FTC Act.
"These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act," David Vladeck, director of the FTC's Bureau of Consumer Protection, said in a statement. "They also should know that health scams that endanger public health will not be tolerated."
The websites of Medavir, Herpaflor, Viruxo and Never An Outbreak all carry a version of the following disclaimer in fine print at the bottom of their websites: "Statements on this website have not been evaluated by the FDA."
However, all of them also carry a "100% money back guarantee," while Medavir makes the following claim on its FAQ page: "An official FDA Clinical Trial demonstrated that Medavir can delay or prevent outbreaks, and reduce healing time substantially when sores do occur."
Medavir did not immediately respond to requests for comment by Consumer Ally.
The warning letters give the companies 15 days to notify the FDA of the steps they've taken to correct the violations; failure to comply may result in legal action, including seizure and injunction, or criminal prosecution.
"Our warning letters give these firms time to voluntarily comply with the law," Dara Corrigan, the FDA's associate commissioner for regulatory affairs, said in a statement. "The FDA will continue to take aggressive enforcement action against firms that market false treatments or cures that may lead to significant public health consequences."
Consumers and health-care professionals who wish to file a complaint or report a problem with these products should notify MedWatch, the FDA's voluntary reporting program, or call (800) FDA-1088. The full list of products making false promises can be viewed here.