The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) yesterday announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases. Among the products targeted in today’s action are Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak.
The agencies issued multiple letters to companies warning that their products violate federal law. These products, sold online and in retail outlets, have not been evaluated by the FDA for safety and effectiveness. 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 companies that received the warning letters claim that 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 all drug products under the Federal Food, Drug, and Cosmetic Act as they are offered for the treatment of disease. These drug products, which are offered for the treatment of STDs, may not be introduced into interstate commerce without an FDA-approved new drug application (NDA).
“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 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.”
For more information: www.fda.gov/STDfraud