Hydroxycut Recall—The FDA’s double standard

On May 1, consumers were urged by the FDA to immediately stop using fourteen Hydroxycut weight loss products. The manufacturer recalled Hydroxicut after the FDA received 23 reports of liver damage under the Adverse Event Reporting system that now includes dietary supplements—several reports of jaundice, one incident that required a liver transplant, and one death.


According to David Seckman, CEO and executive director for the Natural Products Association, one of the fundamental principles of the Dietary Supplement Health and Education Act of 1994 (DSHEA) is providing consumers with more information so they can make informed decisions to maintain and improve their health. “This prompt action shows that the current DSHEA works and that the Adverse Event Reporting (AER) law that we helped to pass is working to enable the agencies to detect signals of any threat to the public health. Thus, the industry is more than appropriately regulated and necessary consumer protections are in place.”

The FDA’s action does, however, highlight the double standard afforded to over-the-counter medications. In 2005, University of Washington researchers found that liver toxicity from over-the-counter acetaminophen poisoning is by far the most common cause of acute liver failure in the United States—the data suggest that consistent use of as little as 7.5 g/day of acetaminophen could lead to severe hepatic injury—yet the only FDA action was to have a warning statement added to the label.
With death now an acceptable side effect of prescription medication, one wonders if vested interests have had a role to play in the FDA’s actions regarding consumer safety. Take a moment to sign the AAHF petition to reform the FDA now.