Hydroxycut Recall Highlights Poor Oversight of Dietary SupplementsMay 4, 2009 | Parker Waichman LLP
Reports of liver damage and other problems associated with the Hydroxycut line of dietary supplements began filtering into the Food & Drug Administration (FDA) as early as 2002. Yet it wasn't until last week that the agency warned consumers to immediately stop using Hydroxycut supplements, and recalled 14 different products in the line. The lag between the first Hydroxycut liver injury reports to the FDA and the issuance of the recall points to serious gaps in the oversight of such dietary supplements.
According to the FDA safety alert issued on Friday, there have been 23 reports of serious liver problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant, linked to use of Hydroxycut products. In one case, a 19-year-old died as a result of Hydroxycut-associated liver damage. That death occurred in 2007, but was only reported to the agency in March.
The patients involved in the adverse event reports were otherwise healthy and their symptoms began after they started using Hydroxycut, the agency said. Many also became sick despite correctly following directions on the Hydroxycut label for recommended dosage.
In addition to liver problems, the FDA said on Friday it had also received reports of Hydroxycut users suffering seizures, cardiac problems, and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
According to a report from the FDA's Health Hazard Evaluations Board, the first report of liver damage linked to Hydroxycut was recorded in 2002. According to the FDA, it took the agency 7 years to spot the supplements' risk because such problems are rare. But critics of the agency point out that the FDA has no authority to review dietary supplements like Hydroxycut before they're marketed. According to the Associated Press, the FDA relies on voluntary reports to detect problems with supplements after they come to market, and many cases are never reported.
Meanwhile, the FDA has not been able to say which ingredients in Hydroxycut products might be causing the liver problems and other side effects. According to the agency, that's because the combination of ingredients used in Hydroxycut has changed over the years.
According to the Associated Press, one possible suspect is an ingredient derived from tropical fruit called hydroxycitric acid. One public health researcher told the Associated Press that at least one medical journal article has linked hydroxycitric acid to liver damage. The same expert also cautioned that other diet products that contain hydroxycitric acid are probably still on the market.