FDA Warns: Beware of Bogus STD Products (dietary supplements)

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*FDA Warns: Beware of Bogus STD Products*

(Date Posted: 5/3/2011)

On May 3, 2011, the U.S. Food and Drug Administration (FDA) and the Federal

Trade Commission (FTC) announced a joint effort to remove products from the

market that make unproven claims to treat, cure, and prevent sexually

transmitted diseases (STDs). 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 (FD & C 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

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.”

Consumers should be aware that there are no over-the-counter or online drugs

or dietary supplements available to treat or prevent STDs. Appropriate

treatment of STDs can only occur under the supervision of a health care

professional. There are many FDA-approved medications available for treating

these conditions, but they do require a prescription.

“Our Warning Letters give these firms time to voluntarily comply with the

law,” said Dara Corrigan, the FDA’s associate commissioner for regulatory

affairs. “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.” For more information use the link

below.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253619.htm

--

Ortiz, MS, RD

*The FRUGAL Dietitian* <http://www.thefrugaldietitian.com>

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