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 Iovate Health Sciences USA Inc, has voluntarily withdrawn 14 Hydroxycut products from the market following the FDA’s announcement on May 1, 2009 that it had received 23 user reports of liver damage, some severe enough to require liver transplants. A 19-year-old boy who used Hydroxycut died of liver failure.
The fourteen products now withdrawn are Hydroxycut:
- Regular rapid release tablets
- Caffeine-Free Rapid Release Capsules
- Hardcore Liquid Tablets
- Max Liquid Tablets
- Caffeine Free Beverage Packages
- Hardcore Drink Packs (Ignition Stix)
- Max Drink Packages
- liquid shots
- Hardcore RTDs (ready to drink)
- Max Aqua Shed
- 24
- carb control
- Natural
- 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 intended for bodybuilders looking to lose fat so that their muscles look more “cut”—in other words, 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 gourd-shaped fruit native to Indonesia. Its extract and bark are used in traditional Indian medicine, and as a seasoning for curries. Early studies with rats showed that hydroxycitric acid had an impressive ability to block the conversion of carbohydrates to fat while simultaneously suppressing appetite.
If it works for rats, it must work for humans, which is why supplement manufacturers added it to their products. They did not take the most basic steps that the FDA requires for prescription drugs, clinical trials to demonstrate 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, tested against a placebo, an inert substance, HCA produced no more weight loss than placebo. A study conducted in 2000 showed that HCA had no effect on reducing hunger or increasing satiety, the feeling of satiety.
It works for rats. It is not for humans. 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 HCA-containing Hydroxycut products. Thereafter, more reports continued to appear in the medical literature linking dietary supplements containing hydroxycitric acid to severe liver damage.
Rat Safe Dangerous for humans. 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, its involvement in dietary supplements, a $24 billion dollar business in the US, the FDA has no regulatory authority over supplements that come to market. It cannot review requiring human testing to determine safety and efficacy, the same actions the agency routinely takes with all prescription drugs. The agency can only verify manufacturers and monitor products once they are on the shelves.
The reports continued, and in May they did what the law allows. They announced 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 facts on its side. Iovate will take its products off the market.
People who have used Hydroxycut products and have experienced symptoms they believe to be related to its use should see their health care provider as soon as possible.