May 04, 2011
The U.S. Food and Drug Administration and the Federal Trade Commission warned several companies to remove products from the market for making bogus claims about treating and preventing sexually transmitted diseases.
“There are no no NO consumer products and dietary supplements to treat STDs that are available over the counter,” emphasized Howard Sklamberg, director of FDA’s Office of Enforcement and Regulatory affairs, explaining that the only way to treat an STD is by using an FDA-approved prescription drug obtained from a licensed health care provider.
The agencies issued joint letters to 12 companies warning that they are violating federal law by selling 30 products claiming to treat and even cure several STDs including herpes, HIV, AIDS, chlamydia and genital warts. The companies have 15 days to voluntarily comply with the law and notify the FDA of the actions they have taken to correct the violations noted in the letters. The products, which are sold online and in retail, have not been tested by the FDA for safety and effectiveness. If they don’t comply, legal action may result, including seizure, injunction or criminal prosecution.
“These illnesses need to be detected appropriately and accurately and treated properly by a medical professional,” explained Dr. Jeffrey P. Engel, state director North Carolina Department of Health and Human Services, explaining “STDs are not just a threat to individual health but to public health because any individual can spread a disease that isn’t properly treated.”
“The Internet can be a toxic wasteland for consumer products,” said Richard Cleland, of the FTC, adding that “health scams that endanger public health will not be tolerated.”
Products claiming treatment of disease fall under the jurisidiction of the FDA under the Federal Food, Drug, and Cosmetic Act and under the Federal Trade Commission Act making unsubstantiated claims is illegal.
The FDA and FTC held a joint press briefing to announce the actions as part of their new Fraudulent STD Products Initiative. The joint action is the first step toward preventing unproven items from being sold as treatments for STDs and preventing consumers from being mislead by false claims.