The Food and Drug Administration (FDA) has warned dieters and body builders to stop using Hydroxycut, a widely sold weight loss supplement. The FDA has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA in March 2009.

The FDA has stated that the maker of the dietary supplement has agreed to recall 14 Hydroxycut products. Sold in grocery stores and pharmacies, Hydroxycut is advertised as consisting of natural ingredients. At least 9 million packages were sold last year, the FDA said.

Side effects experienced by Hydroxycut users ranged from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver.

There was no immediate comment from the U.S. distributor of the diet pill, Iovate Health Sciences, headquartered near Buffalo, N.Y. The product is manufactured by a Canadian company.

Dietary supplements are not as tightly regulated by the government as medications. Manufacturers do not need to demonstrate to the FDA that their products are safe and effective before they can market them to consumers. But the FDA monitors aftermarket reports for adverse effects. In recent years companies have been put under stricter requirements to alert the FDA when health problems are reported.

It appears to have taken so long to identify the serious health issue with the consumption of Hydroxycut because the cases of liver damage were rare and the FDA has no authority to review supplements before they are marketed. As a result isolated adverse events are often difficult to follow. The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.

So far it has not been possible to determine which Hydroxycut ingredients are potentially toxic, partially because the formulation of the products has changed several times. A study in a medical journal, last month, raised questions about one ingredient, hydroxycitric acid, derived from a tropical fruit. The article said this fruit extract could potentially damage the liver.

Which products are covered by this voluntary recall?

The following products are covered by this voluntary recall:
• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Max Liquid Capsules
• 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

Does the advisory state that Hydroxycut-branded products should no longer be taken?

Yes. The FDA’s advisory states that, “Consumers who have these products are urged to stop using them.”

What if I want to return my Hydroxycut product. How do I do that?

For product refunds, consumers are directed to return their product directly to the place of purchase.