FDA is advising consumers not to buy True Man or Energy Max, which are currently being marketed as dietary supplements in the United States. The federal agency says the products are in fact illegal drugs that contain potentially harmful unlabelled ingredients. Questionable sexual enhancement products sold as dietary supplements are part of the seedier side of the industry that is seen to take advantage of consumers' fears and their reluctance to speak to their doctors about sexual health. "Consumers should discontinue use of True Man and Energy Max and consult their health care professional about approved treatments for ED," said FDA in a written announcement, "FDA encourages men who experience ED to seek guidance from a health care professional." The authority alleges these products contain substances similar to active ingredients found in approved prescription drugs. Pharmaceuticals must go through a series of pre-market approvals, whereas dietary supplements need not. Under the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act, only ingredients not marketed in the US before October 1994 must be approved by the FDA before use in consumer products. "These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products," said Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure." FDA performed chemical analysis on the products and revealed that both True Man and Energy Max contain thione, which is similar in structure to sildenafil, the active ingredient in the ED pharmaceutical Viagra. The undeclared ingredient could pose a threat to consumers' health by interacting with nitrates found in prescription drugs such as nitroglycerin, thereby lowering blood pressure. Nitrates are used in medication for diabetes, high blood pressure, high cholesterol or heart disease.
The credibility of dietary supplements supporting erectile dysfunction (ED) will not likely be enhanced by the US Food & Drug Administration's release of a health risk alert pertaining to two products.