FDA Says People Should Stop Using the Diet Products Immediately
May 1, 2009 -- Fourteen Hydroxycut products, marketed as fat burners, low-cost diet aids, and energy enhancers, are being recalled voluntarily by the manufacturer after the FDA received 23 reports of serious liver injuries ranging from jaundice to death.
The FDA announced the recall today at a news conference.
The recalled products include:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Caplets
- Hydroxycut Max Liquid Caplets
- Hydroxycut Regular Drink Packets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Natural
Hydroxycut and Liver Problems
At the news conference, Linda Katz, MD, interim chief medical officer of the FDA's Center for Food Safety and Applied Nutrition, said the agency urges consumers to discontinue use of the Hydroxycut products. Not affected by the recall are Hydroxycut Cleanse and Hoodia 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.
Hydroxycut Recall: Industry Response
A message on the toll-free number of Iovate Health Sciences USA Inc. lists the recalled products. Jamie Moss, a spokesperson for the company, says the company is issuing a statement.
The statement also says that the company conducts internal analyses of individual ingredients and medical, scientific and toxicological literature reviews on the safety of product ingredients.
On its web site, the company has posted a statement along with answers to common questions. In part, it says: “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.”