Weight Loss Products: FDA health warning against the use of Hydroxycut

On 1 May 2009 the U.S. Food and Drug Administration (FDA) issued a warning to the US public to immediately stop using fourteen Hydroxycut weight loss products; manufactured by Iovate Health Sciences Inc. of Oakville, Ontario, and distributed by Iovate Health Sciences USA Inc. of Blasdell, New York. Hydroxycut products are marketed as fat burners, energy enhancers and low carb diet aids. The FDA reports that over 9 million of these products were sold in 2008. These products were widely available in grocery stores, health food stores and pharmacies. The reason for this warning issued by the FDA is that some of the Hydroxycut products specifically have been associated with a number of serious liver injuries and one death.

Twenty three incidents of serious health problems ranging from jaundice and elevated liver enzymes (an indicator of potential liver injury), to liver damage requiring liver transplant have been reported to the FDA. One of the incidents described to the FDA was the death of a 19 year old man due to liver failure, apparently directly related to the use of Hydroxycut products. Some of the other serious health problems reportedly brought on by the use of these products include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

While these occurrences were rare, incidents of liver injury were reported even in cases where consumers were strictly adhering to the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice and brown urine. Jaundice patients also often notice a yellowing of the skin or whites of the eyes. Other symptoms of liver injury include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, and are advertised to be made from natural ingredients. Typical applications of these products are fat burners, energy-enhancers, and diuretics under the Iovate and MuscleTech brand names. Consumers who are still using any of the products identified as dangerous to use, are advised to stop use immediately, and to return the products to where they have been purchased. While the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has volunteered to recall all the products listed below:

  • 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

It was made clear in the press release that Hydroxycut Cleanse and Hoodia products are not affected by this recall.

It was noted the FDA has not yet determined the exact ingredients, dosages, or other health-related factors that may be associated with increased risk in the use of Hydroxycut products. The products contain a variety of ingredients and herbal extracts. Health care professionals and consumers are encouraged to report serious adverse side effects or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.


Please note that a reformulated version of Hydroxycut is now available on supermarket shelves, barely 2 months after the recall. The new product still poses health risks since it may not have been properly tested, and it may also not be as effective as it used to be. You can read more about this new product in this question about the safety of Hydroxycut Advanced.

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1 Responses to “Weight Loss Products: FDA health warning against the use of Hydroxycut”

  • Well you know. I am sick and tired of all the overreactions on a couple of incidences. We live in an absolute nanny state! Sure, there may be some people that are be predisposed to problems in using some products due to specific conditions or genetics sensitivities. But for 99% us us they are fine and can make a real difference. I’d just like to say, warning or not, Hydroxycut works for me and I will keep on using it!

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