FDA issues health risk alert for True Man and Energy Max products         

[May 12, 2007]  ROCKVILLE, Md. -- From the U.S. Food and Drug Administration:

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) -- are illegal drug products that contain potentially harmful, undeclared ingredients. The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

Consumers should discontinue use of True Man and Energy Max and consult their health care professional about approved treatments for ED. FDA encourages men who experience ED to seek guidance from a health care professional.

FDA has not approved True Man and Energy Max; therefore the safety and effectiveness of these products are unknown. Both products are often advertised as "all natural" alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.

"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."

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.

FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil, the active ingredient in Viagra, an FDA-approved drug for ED. Substances like this are called analogs because they have a structure similar to another drug and may cause similar side effects and drug interactions.

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.

True Man is sold in boxes containing a 10-capsule blister pack. Energy Max is sold in boxes containing two 10-capsule blister packs. Both products are distributed and packed by America True Man Health, Inc., West Covina, Calif. 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
[phone]
Fax: [phone]
Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787

For more information, visit:

www.fda.gov/bbs/topics/
NEWS/2006/NEW01409.html

www.fda.gov/foi/warning_letters/g5911d.htm

[Text copied from U.S. Food and Drug Administration news release]