May 4, 2011 -- Two federal agencies are cracking down on bogus claims made by companies that tout their products as treatments, cures, or preventive medications for sexually transmitted diseases such as herpes, genital warts, and HIV, the virus that causes AIDS.
The FDA and the Federal Trade Commission (FTC) announced a joint effort to remove “dangerous” products that make such claims, specifically, Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak.
Letters were sent to companies that make the products, warning that they are violating federal law because they have not been evaluated for safety and effectiveness by the FDA.
The FDA says the joint action is intended to prevent consumers from being misled.
According to a statement posted on the FDA’s web site, the companies that received the warning letters claim their products treat a range of STDs, including herpes, chlamydia, genital warts, HIV, and AIDS.
Some of the companies market their products as dietary supplements. But the products are considered drugs under the Federal Food, Drug and Cosmetic Act because they claim to treat diseases.
“These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available,” the FDA’s Deborah M. Autor, JD, says in a news release. “Consumers who buy these products may not seek the medical attention they need and could spread infections to sexual partners.”
The Federal Trade Commission says it is also illegal to make unsubstantiated treatment claims.
“These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act,” says 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.”
The federal announcement warns consumers to be aware that there are no over-the-counter drugs or dietary supplements available to prevent or treat STDs. Many FDA-approved medications are available but they all require prescriptions.
Dara Corrigan, JD, the FDA’s associate commissioner for regulatory affairs, says the warning letters give the companies time to voluntarily comply with federal law. He says the agency will “continue to take aggressive enforcement action against firms that market false treatments or cures that may lead to significant public health consequences.”
The companies have 15 days to notify the FDA of steps they have taken to correct violations. Failure to do so could result in legal action, including seizure and injunction, or criminal prosecution.
The FDA says warning letters were sent to Immuneglory Arenvy Laboratories Inc., San Bruno, Calif.; Viruxo, Morriston, Fla.; Masterpeace Inc., North Canton, Ohio; International Institute of Holistic Healing, Mesquite, Texas; PolyDNA and gene-eden, Rochester, N.Y.; Chlamydia-Cure, Sunnyvale, Calif.; EverCLR3, Blaine, Wash.; Pacific Naturals, Burbank, Calif.; Derma Remedies, Bunker Hill, W.Va.; Flor Nutraceuticals, Dallas; Medavir Medical Advances Inc., Windemere, Fla.; and Lesa Sverid, East Wareham, Mass.
Products are sold under more than 20 names, such as Herpaflor, C-Cure, Medavir, O2xygen Force, Gene-Eden, Essaic Tonic Liquid Drops and Detox Formula.
The FDA recommends that people who think they might have used or are currently using a fraudulent STD product to stop using and discard the product and see a health care professional.