FDA Warns Public about Dangerous Sex Products

WASHINGTON—A number of sexual aids marketed online as dietary supplements actually contain undeclared pharmaceutical ingredients, according to the Food and Drug Administration (FDA), which warned these erectile dysfunction (ED) and sexual performance products are actually illegal drugs that should not be purchased or consumed. The agency reported Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx and 4EVERON have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients. FDA advised customers to discontinue their use of the products and consult a physician, adding anyone seeking ED remedies should first consult with a health care provider.

Tests conducted by the agency revealed Zimaxx contains sildenafil, which is the active pharmaceutical ingredient in Viagra, a prescription drug approved in the United States to treat ED. In the other products, it found chemical analogues of either sildenafil or vardenafil, the active ingredient in the ED prescription drug Levitra. FDA noted there is no mention of any of these ingredients in any of the illegal products’ labeling.

FDA stated the deception poses a threat to consumers because the undeclared ingredients may interact with nitrates, which are commonly used by consumers with diabetes, high blood pressure, high cholesterol or heart disease.

“These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products,” Steven Galson, M.D., director of FDA’s Center for Drug Evaluation and Research. “This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.”

The Council for Responsible Nutrition (CRN) noted FDA is continuing its efforts to use the tools provided to the agency under the Dietary Supplement Health and Education Act (DSHEA) by taking enforcement actions against companies that are illegally marketing drugs as dietary supplements. “We look to FDA to continue these kinds of actions because companies not playing by the rules creates a potentially dangerous situation for consumers, and also unfairly tarnishes the reputation of the dietary supplement industry,” said Judy Blatman, vice president of communications for CRN (www.crnusa.org). “This is an important warning to companies that if they plan to market dietary supplements, those products must conform to dietary supplement regulations.”