Another Day, Another Adulterated Sex Supp

Posted By elissa on Dec 16, 2010 | 2 comments

From today’s FDA press release:

The U.S. Food and Drug Administration is warning consumers not to use Man Up Now capsules, marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.
 
Man Up Now claims to be “herbal” and “all natural,” and consumers may mistakenly assume the product is harmless and poses no health risk.
 
…The FDA analyzed Man Up Now and determined that it contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra.
 
…Man Up Now, distributed by Synergy Distribution LLC, is sold on Internet sites, online marketplaces, and possibly in retail outlets in single, double, and triple blister packs, and in six-, 12-, and 30-count capsule bottles.

While I imagine the potential for harm is small (no adverse events were reported), it’s completely unacceptable for manufacturers to be spiking their allegedly “all natural” supps (or ingredients) with prescription drugs.  And “Man Up” is far from an isolated incident… according to my recent newsletter from the American Botanical Council:

…This practice of adulterating or “spiking” what appears to be a fairly innocuous dietary supplement with active pharmaceutical ingredients (APIs) — i.e., actual or modified forms of pharmaceutical drugs — appears to have become more and more common in recent years. The FDA as well as responsible members of the dietary supplement industry, health professionals, and others have become increasingly concerned about this practice.

In today’s press conference, Joshua Sharfstein, MD, principal deputy commissioner at FDA, noted that there were about 300 different tainted products spiked with APIs for which the FDA has issued warning letters and/or recalls. These include 70 products recalled for sale in the area of sexual enhancement, 40 products recalled for weight loss, and 80 products recalled for body building.

The good news is that the industry is concerned, and is at least making the right noises… but it remains to be seen how trade groups like the American Herbal Products Association, Council for Responsible Nutrition, etc. intend to help clean up the market.