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FDA recalls tainted supplements

This article was originally published in The Tan Sheet

Executive Summary

The agency recalls products marketed as sexual enhancement, weight-loss and muscle-gain supplements because of threats to consumer safety. On Nov. 9, RockHard Labs of Atlanta voluntary recalled RockHard Weekend for erectile dysfunction, which FDA said contained the undeclared ingredient sulfoaildenafil. FDA recently warned against use of Imulsaria's Stiff Nights, which it said contains the same active ingredient (1"The Tan Sheet" Nov. 9, 2009, In Brief). The agency also announced Nov. 12 that Westminster, Calif.-based GMP Herbal Products voluntarily recalls Pai You Guo, labeled as a weight-loss supplement, in which FDA found the appetite suppressant sibutramine, contained in the Rx obesity drug Meridia, and the suspected carcinogen phenolphthalein (2"The Tan Sheet" Nov. 16, 2009, In Brief). Finally, FDA said Nov. 12 that a number of products made by Oviedo, Fla.-based IDS Sports, including Bromodrol and Ripped Tabs TR, contain steroids and are recalled. Steroids sold as "supplements" is an area of particular concern within the supplement industry (3"The Tan Sheet" Oct. 26, 2009)

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FDA warns consumers that Impulsaria's Stiff Nights, sold as a dietary supplement for erectile dysfunction, contains sulfoaildenafil - a chemical similar to the active ingredient in Viagra. The Grand Rapids, Mich., company distributes the product on Web sites and in retail stores in bottles with six, 12 or 30 red capsules and in blister packs of one or two capsules. Asked whether the agency is considering enforcement activity against Impulsaria, a spokeswoman would not comment on the case, but said, "FDA takes these types of violations very seriously and considers all of its enforcement options when considering how to address them.

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