U.S. Officials Take Aim at Questionable STD Products
Makers of preparations claiming to prevent, treat sexually transmitted infections warned by FDA, FTC
TUESDAY, May 3, 2011 (HealthDay News) -- The U.S. Food and Drug Administration and the U.S. Federal Trade Commission are cracking down on manufacturers of over-the-counter products that claim to treat, cure or prevent sexually transmitted diseases.
The agencies jointly sent letters to companies including Medavir, Herpaflor, Viruxo, C-Cure and Never An Outbreak, warning that their products are unproven and violate federal law, the FDA said in a news release issued Tuesday.
"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 the FDA's Center for Drug Evaluation and Research, said in the release.
Chlamydia, genital warts, herpes, HIV and AIDS are among the diseases that the products -- sold online and through retail outlets -- claim to treat. However, the only FDA-approved medications available to treat these conditions require a prescription and supervision of a health-care professional, the agency said.
Because the products have not been evaluated for safety and effectiveness, people who buy them may not get needed treatment and could then infect their sexual partners, Autor said.
The items are considered drug products under the Federal Food, Drug, and Cosmetic Act because they are sold to treat disease, and they violate interstate commerce law if they lack an FDA-approved new drug application, the FDA explained. Further, under the Federal Trade Commission Act it is illegal to make unsubstantiated treatment claims, regulators said.
"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. Health scams that endanger public health will not be tolerated, he added.
The letters are the first step in removing the unproven products from the market. The companies have 15 days to inform the FDA of measures they're taking to correct the alleged violations or face possible legal action.
The U.S. National Library of Medicine has more about sexually transmitted diseases.