A further voluntary recall of products sold to support erectile dysfunction (ED) has been announced by the FDA, sending out the message that the federal agency will follow-up on errant products.
America True Man Health Incorporated has expanded the voluntary recall of its True Man's Sexual Energy Nutriment Men's formula to include its Energy Max dietary supplement. In May of this year, the US Food & Drug Administration (FDA) issued a health risk alert for both the True Man and Energy Max products, stating it contained pharmaceutical ingredients.
Products marketed as dietary supplements to support sexual enhancement or weight loss have tended to come under particular fire from both FDA and the Federal Trade Commission (FTC) as both categories seem to draw on industry outliers because they are emotionally sensitive topics for consumers.
"The Food and Drug Administration …is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States," announced FDA in a May warning. "Both products -- touted as sexual enhancement products and as treatments for erectile dysfunction (ED) -- are illegal drug products that contain potentially harmful, undeclared ingredients."
FDA performed a chemical analysis on the products at the time and revealed that both True Man and Energy Max contain thione, which is similar in structure to sildenafil, the active ingredient in the ED pharmaceutical Viagra.
Because the federal authority has not approved either True Man and Energy Max, it says it can not establish the safety of these products, which were often advertised as "all natural" alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.
The undeclared ingredient could pose a threat to consumers' health - according to FDA - by interacting with nitrates found in prescription drugs such as nitroglycerin, thereby lowering blood pressure. Nitrates are used in medication for diabetes, high blood pressure, high cholesterol or heart disease.
Based in West Covina, California, America True Man Health has extended its recall to include Energy Max, following an FDA to owner and president Yin Kao earlier this month in which the agency requested the recall of both products. While complying with the order, the company is not acknowledging any adverse events.
"The recall is being done notwithstanding that the company is unaware of any adverse effects having been reported or associated with the product," said FDA in its most recent statement.
Customers with these products in their possession are being advised to stop using them immediately and consult their physician with any problems related to the product.
The FTC announced settlements totalling $25mn with four well-known weight-loss pill marketers in January. The agency targeted the companies for making unsubstantiated claims to consumers.
The settlements required the marketers of Xenadrine EFX, One A Day Weight Smart, Cortaslim and TrimSpa change their ad claims and cough up the fines for both civil penalties and consumer redress.