Hydroxycitric acid (HCA) is the likely cause of liver damage and liver failure for users of Hydroxycut products. Iovate Health Sciences USA Inc, voluntarily withdrew 14 Hydroxycut products from the market following the FDA's announcement on May 1, 2009 that it had received 23 reports of users with liver damage, some so severe as to require a liver transplant. A 19-year-old boy taking Hydroxycut died of liver failure.
The fourteen products that have now been withdrawn from the market are Hydroxycut:
- Regular rapid release capsules
- Decaffeinated rapid release capsules
- Hardcore liquid capsules
- Maximum liquid capsules
- Caffeine-free drink packs
- Hardcore Potion Packs (Ignition Stix)
- Max drink packs
- Liquid shots
- Hardcore RTDs (Ready To Drink)
- Max Aqua Barn
- 24
- Carbohydrate Control
- Naturally
- Regular drink packages
Iovate marketed the products as weight loss aids, to promote fluid loss, and as an energy enhancer and fat burner. Some products were aimed at bodybuilders who want to lose fat so that their muscles look more "cut", that is, sharply defined.
The inclusion of hydroxycitric acid in the product is a story of bad science and bad legislation that has tied the hands of drug safety regulators.
Hydroxycitric acid is a variant of citric acid found in Garcinia gummy gutta, a yellowish, pumpkin-shaped fruit native to Indonesia. The extract and rind are used in traditional Indian medicine and as a curry condiment. Early studies in rats showed that hydroxycitric acid had an impressive ability to block the conversion of carbohydrates to fat while also suppressing appetite.
If it works for rats, it must work for humans, which is why the supplement manufacturers added it to their products. They haven't taken the most basic steps that the FDA requires for prescription drugs, clinical trials to show both safety and efficacy in humans.
Other researchers did their homework. A report in the Journal of the American Medical Association in 1998 reported that when tested with a placebo, an inert substance, HCA caused no more weight loss than the placebo. A 2000 study showed that HCA had no effect whatsoever on reducing hunger or increasing satiety, the feeling of fullness.
Works for rats. Not for humans. The supplement manufacturers left HCA in their products and did not change their claims.
In 2005 the Annals of Internal Medicine reported two cases of liver damage from the use of Hydroxycut products containing HCA. Since then, more and more reports have appeared in the medical literature linking dietary supplements containing hydroxycitric acid to severe liver damage.
Safe for rats. Dangerous to humans. The supplement manufacturers left it in their products and did not change their claims.
The hands of the FDA were tied. Since the passage of the Hatch-Harkin Act in 1994, their involvement in dietary supplements, a $24 billion dollar business in the US, the FDA has no regulatory authority over supplements coming to market. It cannot assess that human testing is required for safety and efficacy -- the very actions the agency routinely performs with all prescription drugs. The agency can only spot-check manufacturers and check products as soon as they hit the shelves.
They followed the reports and in May they did what the law allows. They announced the reports of 23 cases of liver damage, including one death. They sent a "Dear Doctor" letter to healthcare providers across the country, calling Hydroxycut products a serious public health risk.
The FDA had solid science and the facts on its side. Iovate withdrew their products from the market.
People who have used Hydroxycut products and experienced symptoms they believe are related to their use should consult their healthcare provider as soon as possible.
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