FDA: Stop Using Hydroxycut Immediately

Saturday May 2, 2009 (foodconsumer.org) -- Federal drug regulators released a health advisory on Friday, May 1 to warn consumers to immediately stop using Hydroxycut products, which have been sold as weight loss dietary supplements, due to safety concerns.

The U.S. Food and Drug Administration issued the warning after it received reports on 23 cases of serious health problems including potential liver injury and at least one death from liver failure associated with use of Hydroxycut in recommended usages.

"Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite," the FDA says on http://www.fda.gov/consumer/updates/hydroxycut050109.html

Hydroxycut, manufactured by Iovate Health Sciences Inc., of Oakville, Ontario, were top-selling weight loss dietary supplements. Last year about nine million of packs of Hydroxycut were sold in the states, according to media reports.

The key ingredients of Hydroxycut include Garcinia cambogia extract, chromium polynicotinate caplets and Gymnema sylvestre extract. The company cites two 8-week studies on its currently unavailable website showing that those who used its products lost more than 10 pounds on average compared to slightly over 3 pounds in those who did not take the weight loss pills.

Iovate says on its website "The number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years referenced by the FDA. Iovate’s own assessment of the potential risk associated with the use of these products differs from that expressed by the Agency."

"Every product marketed by Iovate is evaluated during its development for the safety of its individual ingredients. Additionally, independent third-party experts from the leading independent scientific firm specializing in ingredient assessment, toxicology and product safety for the nutritional and pharmaceutical industry review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace. Only after this external review is completed does Iovate release a formula."

Nevertheless, the company says "out of an abundance of caution and because consumer safety is Iovate’s top priority, Iovate is voluntarily recalling these Hydroxycut-branded products." There are 14 products subject to the recall, but two other products, Hydroxycut Cleanse and Hoodia are not affected by the recall, according to the FDA.

The FDA could not find any ingredient that is toxic enough to cause any injury to the liver because its says the formula kept changing and contained proprietary blends. Ano Lobb, a researcher who studied Hydroxycut, was cited in a media report as saying that the problem may be associated with an ingredient called hydroxycitic acid derived from a tropic fruit that has been asscociated with liver problems.

The FDA added that none of the 23 reported cases had any risk factors or diseases associated with liver disease or injury. In some instances, discontinuation of the Hydroxycut product resulted in recovery of liver function.

In the United States, dietary supplements are sold without pre-market approval by the FDA. The regulators take action against a dietary supplement only after adverse effects are reported.

For more information, visit  

* Consumer Update: Warning on Hydroxycut Products

* Consumer Advisory
* Consumer Q&As

(Written by David Liu and edited by Sheilah Downey)