Viagra diet supplements recalled by FDA

Rockville, MD – The US FDA has requested a recall of three dietary supplements advertised as “all-natural” alternatives to approved erectile-dysfunction (ED) medications. True Man Sexual Energy Nutrient Capsules, Energy Max Supplement Men’s Formula Capsules, and Encore Tabs are illegal drug products containing analogs of marketed ED medications and as such could interact with other medicines to cause dangerously low blood pressure, says the FDA.

True Man and Energy Max have been found to contain a thione analog of Sildenafil (Viagra, Pfizer) or, in the case of True Man, piperadino vardenafil, an analog of another prescription drug for ED, Vardenafil (Levitra, Bayer/GlaxoSmithKline). Encore Tabs have been found to contain aminotadalafil, an analog of another ED medication, Tadalafil (Cialis, Lilly). These undeclared ingredients may interact with some prescription medicines such as nitroglycerin, often taken by men with diabetes, hypertension, hypercholesterolemia, and coronary heart disease, says the agency.

“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure,” says Dr Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research. Customers who have either product in their possession should stop using it immediately and contact their healthcare provider if they have experienced any problems that may be related to taking this product, the agency says.

The True Man, Energy Max, and Encore products are the latest additions to a long list of dietary supplements that the FDA has warned consumers against. In July 2006, the agency analyzed 17 products marketed online to treat ED and found that many of them contained nondietary chemicals, including active ingredients used in FDA-approved drugs. Supplements that the agency warned against using at that time included: Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, and 4EVERON. More recently, FDA issued another warning on a product called Zencore, from Bodee LLC Inc (Century City, CA), the same manufacturer that distributes Encore Tabs. And Health Canada warned consumers against use of Encore Tabs this summer, again because of adulteration with analogs of prescription drugs for ED.

Company issues voluntary recall but continues to advertise products

The FDA first issued a health risk alert on True Man and Energy Max in May of this year, advising consumers not to buy or use the supplements. Both products are distributed and packed by America True Man Health Inc (West Covina, CA) and advertised in newspapers, retail stores, and on the internet.

Although America True Man Health Inc has now issued a voluntary recall of the supplements, it implies that the problem is due to contamination of specific batches by expressly limiting the recall to products with expiration dates up to and including December 2010 [5]. It says it has switched suppliers “and is testing all shipments received before resale to any customers and regrets any inconvenience.”

The company is still advertising Energy Max on the homepage of its website and has a link to a copy of a “detailed analytical report” prepared by Flora Research Laboratories, Oregon, on April 23, 2007, which states: “Sildenafil, vardenafil, tadalafil, and acetildenafil (an analog of sildenafil) were not detected in the sample. No peaks were detected in the sample of common analogs to ED drugs.” And it is still promoting True Man in the products section accessed via the homepage of its website.

In the forum of theheart.org, however, Jim Neal-Kababick (Flora Research Labs) makes the point that such reports pertain only to the samples tested and can in no way ensure that other material besides that under test is not adulterated. “Companies manufacturing dietary supplements often have numerous lots of material on the market, and lot homogeneity is a serious issue compared with most pharmaceutical products. The analytical work conducted by our laboratory is not to be utilized in any way that suggests Flora Research Laboratories is certifying, ensuring, or approving any product lot as uniform, pure, or free from adulteration,” he notes.

Both FDA and American True Man Health Inc say any adverse events related to the supplements should be reported to MedWatch, the FDA’s voluntary reporting program.

Viagra diet supplements recalled by FDA

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