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Iovate recalls 14 Hydroxycut products following FDA warning to consumers.

On Behalf of | May 4, 2009 | Firm News

Created: 04 May 2009

The Wall Street Journal (5/2, Favole) reported, “Consumers should ‘immediately stop’ using Hydroxycut weight-loss products amid concerns they may cause jaundice and liver failure, the U.S. Food and Drug Administration said Friday.” Responding to “23 serious reports of health problems with Hydroxycut products and one death in a 19-year-old male who had used the weight-loss products,” regulators are “strongly” advising “people against using 14 Hydroxycut products,” according to Linda Katz, interim chief medical officer in the FDA’s food safety and nutrition division. The Los Angeles Times (5/2, Stein) reported that Hydroxycut manufacturer, Iovate Health Sciences Inc., is “recalling most of its Hydroxycut products from the market.” Meanwhile, regulators remain unsure “which ingredients or dosages could be causing the problems,” as “the recalled products contain several ingredients, among them herbal extracts.” The health problems reported to the FDA included “jaundice, elevated liver enzymes, liver damage (requiring a transplant), seizures, and cardiovascular disorders.” The New York Times (5/2, B3, Singer) reported that two Iovate products, “Hydroxycut Cleanse and Hoodia, with different ingredients, are not affected by the recall.” The company’s move follows “a series of incidents that raise the question of whether the Food and Drug Administration has adequate authority to regulate the dietary supplement industry and provide consumer protection.” Dietary supplements, “which can offer general health benefits but cannot claim to treat specific diseases or symptoms,” do not require “FDA approval to go on sale.” The AP (5/2, Alonso-Zaldivar) reported, however, that “regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems.” Katz noted that “part of the problem is that the FDA looks at dietary supplements from a post-market perspective,” relying on “voluntary reports to detect…problems.” Bloomberg News (5/2, Larkin Gaoette) and the Los Angeles Times (5/1, Stein) Booster Shots blog also covered the story.