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FDA cracks down on bogus STD drugs

The US Food and Drug Administration is partnering with the US Federal Trade Commission on an effort to get unapproved products for sexually transmitted diseases (STDs) off the market

The US Food and Drug Administration (FDA) is partnering with the US Federal Trade Commission (FTC) on an effort to get unapproved products for sexually transmitted diseases (STDs) off the market.

The two federal agencies are targeting products that make unproven claims to treat, cure, and prevent STDs including herpes, chlamydia, genital warts, HIV and AIDS. They have issued a number of warning letters giving manufacturers of the products 15 days to notify the FDA of the corrective action they have taken. Failure to take appropriate action could result in product seizure and criminal prosecution, the letters state.

The list of products that are being targeted includes three popular herpes products that are sold online: Medavir; Herpaflor, which is advertised as a combination of "seventeen of the most researched and proven herpes killers in a single formula"; and Viruxo, which is sold on a website that promises users that they will never have another herpes outbreak again.

The FDA noted that some of the products are sold as dietary supplements, but because they claim to treat diseases, they are considered by the federal agency to be drugs and cannot be sold without marketing 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 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."

There are no over-the-counter or online drugs or dietary supplements available to treat or prevent STDs, the FDA stressed, noting that there are many FDA-approved medications for treating the conditions, but that they require a prescription.

The Hispanic Health Network, the nation's leading Hispanic health advocacy group, released a statement praising the FDA and FTC for the action. The group issued a bulletin noting that consumers can call its toll-free hotline for advice about getting STDs treated using legitimate medicines under the guidance of a healthcare professional.

5th May 2011

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