FDA Maintains Pressure Against Adulterated ED Supplements
This article was originally published in The Tan Sheet
Executive Summary
FDA says its seizure of $74,000 in mislabeled erectile dysfunction supplements from SEI Pharmaceuticals July 24 demonstrates the steps the agency will take when a company fails to heed a warning about an allegedly adulterated product
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FDA says its seizure of $74,000 in mislabeled erectile dysfunction supplements from SEI Pharmaceuticals July 24 demonstrates the steps the agency will take when a company fails to heed a warning about an allegedly adulterated product. Further, an industry legal expert says firms that do not issue voluntary recalls of adulterated dietary supplements may eventually face federal prosecution. In a May warning letter, FDA says it found hydroxyhomosildenafil - an analog of sildenafil, the active ingredient in Rx ED drug Viagra - in SEI's Xiadafil VIP tablets. That finding, FDA says, made SEI's supplement an unapproved new drug (1 'The Tan Sheet' June 2, 2008, In Brief). FDA says Miami-based SEI committed to halting distribution of the supplement, but did not recall tablets already on shelves, despite the warning letter. An SEI representative contacted at the company's headquarters declined requests for comment. In a release, Margaret O'Keefe Glavin, FDA Office of Regulatory Affairs chief, says the seizure of SEI's product "shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers." Next Move To Court? Food and drug attorney Marc Ullman said he was "stunned" that SEI would refuse to recall a product after an FDA warning, unless the firm had strong evidence of an error in the agency's test results. "In the absence of such evidence existing, I'm not surprised at all at FDA's actions," he added. The SEI case is the latest action by FDA against companies marketing supplements containing undisclosed Rx ingredients for treating ED. Ullman says, given the apparent pattern of the agency's crackdowns against ED products making "extreme claims," it may eventually "be appropriate for FDA to try and refer a case for prosecution" by the Department of Justice. Unfolding Regulatory Pattern Since Rx ED products potentially can interact with nitrates in other drugs to effectively lower blood pressure to dangerous levels, FDA has made a point of seizing products when firms fail to act on their own (2 (Also see "FDA Action On Sexual Supplements Should Spur Better Self-Policing – UNPA" - Pink Sheet, 28 Jan, 2008.), p. 11). In April, FDA announced the seizure of $100,000 in ED products from Puerto Rico-based Shangai Distributors after the firm ignored a warning letter (3 (Also see "“Promising” Trend: FDA Acts On Unapproved Drugs, Tainted Supplements" - Pink Sheet, 14 Apr, 2008.), p. 6). Health Canada has likewise issued warnings about supplements containing the prescription ED ingredients sildenafil and tadalafil (4 (Also see "Online Sales Of Unapproved Sex Enhancement Supplements Trouble Canada" - Pink Sheet, 20 Aug, 2007.), p. 15). Specifically, the Canadian agency has advised against using Encore's Zencore Tabs , Herbal Health's Excite for women , Ultimates for men and Natural Health Solutions' Adam , among others (5 'The Tan Sheet' March 17, 2008, In Brief). Industry Looks Inward Unadulterated ED supplements are not known to work as effectively as Rx products, and the United Natural Products Association has gone so far as to say there is no such thing as a natural ED product. Given that marketing products such as Xiadafil VIP violates the Dietary Supplement Health and Education Act, UNPA and other industry groups advocate for more self-regulation to keep adulterated sexual enhancement supplements off shelves. The Center for Science in Public Interest has taken a double-pronged approach in advocating action against tadalafil- and sildenafil-containing products. Containing Rx ingredients, ED supplements such as Zencore and Vitogen's Axcil would be in violation of the Food, Drug and Cosmetic Act. Conversely, CSPI asserts that, without the ingredients, the products' sexual performance claims would be unsubstantiated under the Federal Trade Commission Act (6 (Also see "CSPI Urges Recalls Of Zencore, Axcil Pending Ingredient, Ad Claims Reviews" - Pink Sheet, 27 Aug, 2007.), p. 10). - Dan Schiff ([email protected]) |