There are several products on the market which falsely claim to prevent, cure or treat STDs (sexually transmitted diseases) – these products should not be on the market and the FDA (Food and Drug Administration) has announced a joint effort with the FTC (Federal Trade Commission) to stop their sale. Examples include Viruxo, C-Cure, Never an Outbreak, Herpaflor and Medavir.

Several letters were sent today to makers and sellers of products, warning them that they are violating federal law. You are not allowed to make a medical claim about a product if there is no proof, and then expect to be able to sell it to people. The FDA says these products have never been assessed for safety and efficacy.

This FTC/FDA joint action is the start of a campaign to protect the public from being misled, as well as preventing these products from being sold.

Letters were sent to companies that make unfounded claims regarding the following illnesses and conditions: Even though some of these products claim to be dietary supplements, as far as the Federal Food, Drug, and Cosmetic Act is concerned they are drugs because they claim to treat illness. Unless they have been approved by the FDA, they are not allowed to be sold.

Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, said:

“These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available. Consumers who buy these products may not seek the medical attention they need and could spread infections to sexual partners.”

The Federal Trade Commission Act does not allow companies or people to make unsubstantiated treatment claims regarding products being sold.

David Vladeck, director of the FTC’s Bureau of Consumer Protection, said:

“These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act. They also should know that health scams that endanger public health will not be tolerated.”

The FDA stresses that no online or OTC product exists for the treatment and prevention of STDs, neither are there any dietary supplements.

Suitable STD treatment needs to be done under the supervision of a trained health care professional. All FDA-approved STD products require a doctor’s prescription, the FDA adds.

Dara Corrigan, the FDA’s associate commissioner for regulatory affairs, said:

“Our Warning Letters give these firms time to voluntarily comply with the law. The FDA will continue to take aggressive enforcement action against firms that market false treatments or cures that may lead to significant public health consequences.”

In the Warning Letters, the FDA gives these companies 15 days to respond, explaining what they are going to do to address the violations. If they do not, they could face legal action which could include “seizure and injunction, or criminal prosecution.”

If you know about a problem with any of these products, the FDA encourages you to report it to MedWatch.



Source: Food and Drug Administration, Federal Trade Commission

Written by Christian Nordqvist