A popular line of supplements marketed as diet aids, "fat burners" and energy enhancers has been pulled after reports of severe injuries associated with the products.
"The 23 reports of adverse effects include liver damage, elevated liver enzymes (which indicates potential liver damage) and liver damage requiring a transplant. A 19-year-old man died after using Hydroxycut. "The death occurred in 2007," Katz says, "and was reported to the agency at the end of March 2009."
"Hydroxycut products contain a variety of ingredients and herbal extracts," Katz said. The FDA has not yet determined which ingredients or doses are associated with the liver problems, according to Katz.
Other reported health problems include cardiovascular problems, seizures, and serious muscle damage (rhabdomyolysis) that can cause kidney failure."
"Dietary supplements aren't as tightly regulated by the government as medications. Manufacturers don't need to prove to the FDA that their products are safe and effective before they can sell them to consumers...Katz said it has taken so long to get a handle on the Hydroxycut problem because the cases of liver damage were rare and the FDA has no authority to review supplements before they're marketed. "Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow," she said.
The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.
Health officials said they have been unable to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A medical journal report last month raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said it could potentially damage the liver."