Hydroxycitric Acid (HCA) is the likely cause of liver damage and liver failure for users of Hydroxycut products. Iovate Health Sciences USA Inc., has voluntarily withdrawn 14 Hydroxycut products from the market after the FDA's announcement May 1, 2009 that it had received 23 reports of users suffering liver damage, some so severe that they required liver transplants. One 19-year-old boy who used Hydroxycut died of liver failure.
The fourteen products now withdrawn are Hydroxycut:
- Regular Rapid Release Caplets
- Caffeine-Free Rapid Release Caplets
- Hardcore Liquid Caplets
- Max Liquid Caplets
- Caffeine-Free Drink Packets
- Hardcore Drink Packets (Ignition Stix)
- Max Drink Packets
- Liquid Shots
- Hardcore RTDs (Ready-to-Drink)
- Max Aqua Shed
- Carb Control
- Regular Drink Packets
Iovate marketed the products as weight loss aids, for promoting fluid loss, and as an energy-enhancer and fat burner. Some products were targeted for body-builders who seek to lose fat so 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 gummi-gutta, a yellowish, pumpkin-shaped fruit native to Indonesia. Its extract and rind are used Indian traditional medicine, and as a curry condiment. Early studies with rats showed Hydroxycitric Acid had an impressive ability to ability to block the conversion of carbohydrates into fat while also suppressing appetite.
If it works for rats, it must work for humans, and so the supplement manufacturers added it to their products. They failed to take the most basic steps that the FDA requires for prescription drugs, clinical trials to demonstrate both safety and efficacy in human animals.
Other researchers did their homework. A report in the Journal of the American Medical Association in 1998 reported that, tested against a placebo, an inert substance, HCA did not produce any more weight loss than the placebo. A study in 2000 showed that HCA did not have any effect on reducing hunger or increasing satiety, the feeling of fullness.
Works for rats. Does not for humans. The supplement manufacturers left HCA in their products, and they did not change their claims.
In 2005 the Annals of Internal Medicine reported two cases of liver damage from use of Hydroxycut products containing HCA. From then on, more reports continued to show up in the medical literature linking dietary supplements containing Hydroxycitric Acid to sever liver damage.
Safe for rats. Dangerous for humans. The supplement manufacturers left it in their products, and did not change their claims.
The FDA's hands 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 can not review require human testing for safety and efficacy-the very actions the agency processes routinely with all prescription medications. The agency can only spot-check manufacturers, and monitor products once they are on the shelves.
They followed the reports, and in May they did what the law permits. 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, in which they called 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 have experienced symptoms that believe are related to its use should consult their health care provider as soon as possible.