The U.S. Food and Drug Administration yesterday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products, often advertised as ``all natural'' alternatives to approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure. They contain substances that have similar structures to active ingredients in approved prescription drugs.
The FDA has not approved True Man or Energy Max, and their safety and effectiveness are unknown.
The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health Inc., of West Covina, Calif.
The products are often advertised in newspapers, retail stores, and on the Internet.
“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer and acting director of the FDA’s Center for Drug Evaluation and Research.
As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.
The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
The FDA issued an alert on May 10, 2007, (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html) advising consumers not to buy or use True Man or Energy Max products. Today’s recall request comes as a result of the company previously failing to notify all of their consignees and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules. FDA is prepared to take further regulatory action should the firm refuse to accede to this request.
FDA chemical analysis has shown that Energy Max contains thione, an analog of sildenafil, a substance similar to the active ingredient in the approved ED drug Viagra. In addition, FDA investigators found that True Man contains the same analog or an analog of vardenafil, the active ingredient Levitra, another approved ED treatment. Neither of the analogs used in True Man or Energy Max are components of FDA-approved drug products.
Customers who have either product in their possession should stop using it immediately and contact their health care provider if they have experienced any problems that may be related to taking this product.
Consumers should report adverse events related to these products to MedWatch, the FDA's voluntary reporting program:
www.fda.gov/medwatch/report.htm
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