4EVERON is not on, says FDA
contents of several sexual health supplements sold via the Internet
in a first-of-its-kind survey and subsequently issued a warning, in
which it calls them illegal drugs.
The US Food & Drug Administration cautioned consumers not to purchase or consume the so-called dietary supplements 4EVERON, Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, or Actra-Rx, because they contain active ingredients "similar or identical" to some found in prescription drugs.
This clampdown could reassure the supplement industry the FDA is protecting consumer health, and as such the industry's reputation, by weeding out rogue products. In the past, concerns have been raised over the FDA's effectiveness as a post-market watchdog, leading to campaigns for increased industry self-regulation.
In its survey, the FDA analyzed 17 dietary supplements marketed on the Internet to treat erectile disfunction and enhance sexual performance in men.
In an industry fighting to be taken seriously - be it by applying for the right to use FDA-approved health claims on packaging or through research - it is easy to point fingers at the plethora of potentially bogus products sold over the internet, where marketers use the allure of anonymity to sell supposed sexual health products.
Advertised as a "new, breakthrough super-potent dietary supplement" containing the "world's most erotic herbs and Amino Acids", Zimaxx was actually found to contain active pharmaceutical ingredient sildenafil. Sildenafil is used in the popular prescription drug Viagra to treat erectile disfunction.
The other products, which also initially slipped under the FDA's radar, were found to contain chemical variants of either sildenafil or another drug ingredient for erectile disfunction, vardenafil. None of the product labels mention any of these ingredients.
Unlike the lengthy pre-market approval process which pharmaceuticals must go through in the US, dietary supplements are only subject to post-market approval as the need arises. This means, under current regulations, a product may not come to the FDA's attention until adverse reactions are reported.
But industry groups like the Council for Responsible Nutrition (CRN) assert that by taking action like it has with these products, the FDA is proving the current legislative framework is effective.
"FDA is demonstrating that DSHEA works and that under its watch the agency won't allow drug products to masquerade as supplements - that there will be consequences," said CRN spokesperson Judy Blatman, referring to the 1994 Dietary Supplements Health & Education Act that regulates the industry.
In its statement, the FDA makes no mention of the other ten products analyzed in the survey - likely because the risk associated with the culprit products was that they contain drug ingredients.
"This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Dr Steven Galson, director of FDA's Center for Drug Evaluation and Research.
The undeclared chemical ingredients could interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels, according to FDA. Therefore consumers who often take nitrates - such as those with diabetes, high blood pressure, high cholesterol, or heart disease - are especially at risk.
No herbal ingredients were referred to in the FDA warning.
The FDA has sent warning letters to the product marketers banning their products as illegal drugs. The authority recently stopped a shipment of 4EVERON from entering the US.
