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FDA Seeks Recall of 'All Natural' Potency Drugs

‘True Man Sexual Energy,’ ‘Energy Max’ dietary supplements targeted

November 5, 2007

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The U.S. Food and Drug Administration is requesting a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that the agency says contain potentially harmful, undeclared ingredients.

“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.

The products, often advertised as "all natural" alternatives to federally-approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure, the FDA said.

They contain substances similar to active ingredients in approved prescription drugs.

The FDA has not approved True Man or Energy Max, which are often advertised in newspapers, retail stores, and on the Internet, and their safety and effectiveness are unknown.

The recall request, targeting all products distributed under both labels, came in a letter to Yin Kao, president and owner of America True Man Health Inc., of West Covina, Calif.

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, advising consumers not to buy or use True Man or Energy Max products. This latest 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 said it is prepared to take further regulatory action should the firm fail to respond.

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