FDA Issues Alert on Two Sex Products

WASHINGTONThe Food and Drug Administration (FDA) has advised consumers not to purchase or use True Man or Energy Max products, which are touted as sexual enhancement products and as treatments for erectile dysfunction (ED), but promoted and sold as dietary supplements throughout the United States. According to the agency, both are illegal drug products that contain potentially harmful, undeclared ingredients, substances called analogs that have similar structures to active ingredients in approved prescription drugs. FDA is encouraging consumers to discontinue use of these two products and consult their health care professional about approved treatments for ED.

FDA chemical analysis revealed Energy Max contains thione analog of sildenafil, a substance with a structure similar to the active ingredient in Viagra, an FDA-approved drug for ED. Similarly, they found True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra, another FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.

The danger, according to FDA scientists, is the undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels;.men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

These products threaten the health of the people using them because they contain undeclared chemicals similar to the active ingredients used in FDA-approved prescription drug products, said Steven Galson, M.D., MPH, director of the FDA's Center for Drug Evaluation and Research. The risk is even more serious because consumers may not know these ingredients can interact with medications and dangerously lower their blood pressure.