The Food and Drug Administration and the Federal Trade Commission are taking aim at products that make bogus claims to treat, cure and prevent sexually transmitted diseases, the agencies announced today.
These products sold over-the-counter, online and at retail outlets have not been evaluated by the FDA for safety and effectiveness.
The agencies issued multiple letters to companies warning that their products violate federal law. The joint action is the first step in keeping these unproven items from being sold to the public and preventing consumers from being misled, the agencies said.
Among the products targeted in today's action are Medavir, Herpaflor, Viruxo, C-Cure and Never An Outbreak.
Companies that received the warning letters claim their products treat a range of STDs , including herpes, chlamydia, genital warts, HIV and AIDS . While some of the companies market these products as dietary supplements, these products are classified as drugs, since they are offered for the treatment of disease. Drug products may not be introduced into interstate commerce without FDA approval.
"These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available," said Deborah M. Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "Consumers who buy these products may not seek the medical attention they need and could spread infections to sexual partners."
Further, under the Federal Trade Commission Act it is illegal to make such unsubstantiated treatment claims.
"These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act," said David Vladeck, director of the FTC's Bureau of Consumer Protection. "They also should know that health scams that endanger public health will not be tolerated."
Consumers should be aware that there are no over-the-counter or online drugs or dietary supplements available to treat or prevent STDs, the agencies said. Appropriate treatment of STDs can only occur under the supervision of a health care professional. There are many FDA-approved medications available for treating these conditions, but they do require a prescription.
The Warning Letters inform the companies that they have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
Pass it on: There are no over-the-counter or online drugs or dietary supplements that treat or prevent STDs. The FDA and FTC are taking action against companies that market such products.
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