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Hydroxycitric Acid, Bad Science and Liver Failure
Hydroxycitric acid (HCA) may be responsible for liver damage and liver failure in users of Hydroxycut products. Iovate Health Sciences USA Inc. voluntarily withdrew 14 Hydroxycut products from the market after the FDA announced on May 1, 2009 that it had received 23 reports of users suffering liver injury, some severe enough to require liver transplantation. A 19-year-old boy on Hydroxycut died of liver failure.
The 14 products that are now being withdrawn are Hydroxycut:
- Regular Rapid Release Capsules
- Caffeine-free immediate-release capsules
- Hardcore Liquid Capsules
- Max Liquid Capsules
- Decaffeinated Beverage Packets
- Hardcore Beverage Pack (Ignition Stix)
- Max Beverage Pack
- liquid injection
- Hardcore RTD (Ready to Drink)
- Maximum water shed
- twenty four
- carbohydrate control
- nature
- regular drink pack
Iovate markets these products as weight loss aids, to promote fluid loss, and as energy boosters and fat burners. Some products are aimed at bodybuilders looking to lose fat so their muscles appear more “cropped,” that is, chiseled.
The inclusion of hydroxycitric acid in products is a story of bad science and bad legislation that has the hands of drug safety regulators tied.
Hydroxycitric acid is a variant of citric acid found in Garcinia gum, A pale yellow, squash-like fruit native to Indonesia. Its extract and peel are used in traditional Indian medicine and as a curry seasoning. Early studies in rats have shown that hydroxycitric acid has an impressive ability to block the conversion of carbohydrates to fat while also suppressing appetite.
If it works in mice, it must work in humans, too, so supplement manufacturers add it to their products. They failed to take the most basic steps FDA requires of prescription drugs, clinical trials to demonstrate safety and efficacy in humans.
Other researchers did their homework. A 1998 report in the Journal of the American Medical Association said that when tested against a placebo, an inert substance, HCA was no more effective in weight loss than a placebo. A 2000 study showed that HCA had no effect on reducing hunger or increasing satiety (that is, the feeling of fullness).
Effective on mice. Not for humans. Supplement manufacturers have left HCA in their products, and they haven’t changed their claims.
2005 Annals of Internal Medicine Two cases of liver injury have been reported as a result of the use of Hydroxycut products containing HCA. Since then, more reports have continued to appear in the medical literature linking dietary supplements containing hydroxycitric acid to severe liver damage.
Safe for mice. dangerous to humans. Supplement manufacturers leave it in their products and haven’t changed their claims.
The FDA’s hands are tied. Since the passage of the Hatch-Harkin Act in 1994, when they dabbled in dietary supplements (a $24 billion business in the US), the FDA has no regulatory authority over marketed supplements. It cannot review requirements for human testing of safety and efficacy — a routine practice the agency conducts with all prescription drugs. The agency can only spot-check manufacturers and monitor products after they hit shelves.
They heeded the reports and did what the law allowed in May. They published reports of 23 cases of liver injury, including 1 death. They sent a “Dear Doctor” letter to healthcare providers across the country in which they said the Hydroxycut product posed a serious public health risk.
The FDA has solid science and facts. Iovate has withdrawn their product from the market.
People who have used Hydroxycut products and experience symptoms they believe are related to their use should consult their healthcare provider as soon as possible.
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