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Several Health Issues Identified

The FDA has received at least 23 reports of serious health issues, including jaundice and elevated liver enzymes to permanent liver damage requiring transplant surgery. These were associated with Hydroxycut doses as directed on the bottle, according to Dr. Linda Katz of the FDA's food and nutrition division. At least one death has been directly attributed to the product; the death of a 19-year-old boy. The teenager died in 2007, and the death was reported to the FDA this March.

Several other health issues may be associated with the use of Hydroxycut supplements, including seizures, cardiovascular disease, and Rhabdomyolysis (muscle damage associated with kidney damage). Other patients experienced symptoms ranging 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. 

Hydroxycut Maker Issues Recall

The Food and Drug Administration said the maker of the dietary supplement has agreed to recall 14 Hydroxycut products. The product manufactured by Lovate Health Sciences Inc. of Oakville, Ontario, and distributed by Lovate Health Sciences USA Inc. of Blasdell, New York is voluntarily recalling the following products:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Natural
• Hydroxycut Max Liquid Capsules
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Liquid Shots
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets

Hydroxcut Cleanse and Hoodia Products are not included as part of the recall. 

Change in Hydroxcut Ingredients Partially to Blame for Safety Issues

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. 

Diet Supplement Regulation Lax

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. But regulators monitor aftermarket reports for signs of trouble, and in recent years companies have been put under stricter requirements to alert the FDA when they learn of problems.

The FDA relies on voluntary reports to detect such problems, and many cases are never reported, officials acknowledge.

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. 

About Hydroxcut

Available in grocery stores,  pharmacies, vitamin stores and across the web; Hydroxycut is advertised as made from natural ingredients.The Hydroxcut product line includes:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Capsules
• Hydroxycut Natural
• Hydroxycut Max Liquid Capsules
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Liquid Shots
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxcut Cleanse and Hoodia Products (not included in the recall).
  

At least 9 million packages of Hydroxcut were sold last year, the FDA said.  Hydroxycut is used by people trying to shed pounds and by body builders to sharpen their muscles.