May 4, 2009
On May 1, the U.S. Food and Drug Administration warned consumers to immediately stop using Hydroxycut diet products, distributed by Iovate Sciences USA, after finding that the products are associated with reports of serious liver injuries. The company immediately agreed to a voluntary recall of 14 of its products.
The FDA's action is based on 23 reports of adverse effects, including liver damage, and one death, which occurred in 2007 and were reported to the FDA earlier this year. The FDA's ability to issue such warnings derives from its expanded authority under the 2007 Dietary Supplement and Non-Prescription Drug Consumer Protection Act, or SAER law. "These reports are helping FDA identify unsafe dietary supplements," FDA's Dietary Supplements Division Director Vasilios Frankos, Ph.D., said in a statement.
"FDA clearly has the authority to remove products," said John Hathcock, senior vice president of scientific and international affairs for the Council for Responsible Nutrition, a dietary supplements trade association based in Washington, D.C. "In fact, they have more authority than they exercised. They chose to issue a warning and let the company do the regulation, but they also have authority to declare an imminent hazard and take products from the market instantly."
Hathcock said it's not yet clear whether the number of adverse reports represents a higher statistical average of such problems among users of Hydroxycut versus nonusers, and that the primary ingredients in the recalled products have little or no evidence linking them to liver damage. "Adverse events reports are not a signal of cause and effect," he said.
A statement on the distributor's website read, in part, "While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products."
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