ROCKVILLE, Md. The Food and Drug Administration on Friday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men’s Formula Capsules, stating that they are considered illegal drug products that contain potentially harmful, undeclared ingredients.
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, of West Covina, Calif.
“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure,” stated Janet Woodcock, 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, a substance similar to the active ingredient in the approved erectile-dysfunction drug Viagra; or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra. 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. 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, the agency stated.