The Food and Drug Administration (FDA) is advising consumers not to purchase or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States. Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

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 that are 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 that these ingredients can interact with medications and dangerously lower their blood pressure.”

Both products are distributed and packed by America True Man Health Inc. of West Covina, Calif. True Man is advertised on the Internet for sale today at $30 for 10 capsules.

FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil in a popular, FDA-approved drug for ED.

True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in another popular FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.

A review of the ingredient statements for both products revealed that neither piperadino vardenafil nor thione analog of sildenafil are listed as an ingredient, even though one or more of those ingredients is present in the products.

Consumers should report adverse events related to these products to MedWatch, the FDA’s voluntary reporting program:
www.fda.gov/medwatch/report.htm