Products Liability
The FDA reported that it has received 23 reports of liver problems with people taking Hydroxycut products. Because the FDA relies on voluntary reports to detect problems with dietary supplements, the FDA reporting system typically learns of only a small fraction of the injuries in these types of cases, so the number of injuries is likely to be substantially higher.
Is Hydroxycut Safe?
Many years ago, Hydroxycut was the suspect in the death of a teenage boy, according to the FDA. Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One user of Hydroxycut received a transplant and another was placed on a waiting list for a new liver. There is no definitive “proof” that Hydroxycut was the cause, but the patients were reportedly otherwise healthy and their symptoms began after they started using Hydroxycut. Since then, Hydroxycut no long contains ephedra.
In May 2009, the FDA issued a warning to consumers to stop using Hydroxycut products due to the risk of liver injury. The warning was based on the adverse event reports as well as other data. In response to the FDA warning, the manufacturer of Hydroxycut, Iovate Health Sciences, voluntarily recalled a number of their products.
Aside from liver injuries, there have been other health concerns and reports linked to Hydroxycut, including heart issues and rhabdomyolysis, a condition where muscle tissue breaks down and releases a protein into the bloodstream, which can lead to kidney damage.
In 2023, even after a number of Hydroxycut safety recalls, this brand has continued to sell well even though questions still remain and the safety and efficacy of this product. It may be that the green coffee extract in the product does help with weight loss. But no one knows for sure. As for safety, questions remain as to whether this product is safe now that in no longer contains ephedra.
What is Hydroxycut?
Hydroxycut is the brand name of 90% of weight loss drugs that have been taken by millions of consumers. Hydroxycut, which was sold at GNC, the Vitamin Shoppe, and even grocery stores, was packaged in different ways: pills, drinks, and powders. The purpose of Hydroxycut was to increase energy, burn calories and fat, and control appetite. Unlike pharmaceutical drugs and medical devices, which require a showing of safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need F.D.A. approval to go on sale. Manufacturers of dietary supplements are responsible for ensuring and documenting the safety and efficacy of their supplements without federal approval.
On May 1, 2009 the FDA released a warning on Hydroxycut products. The FDA had received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes to liver damage requiring liver transplantation. One death due to liver failure had been reported to the FDA.
Many have criticized how easy it is to get drugs and devices approved by the FDA even though they lack the safety data proving the safety of the drug or device. Multiply that concern by 1000 and you have the situation we have with supplements in this country. It is the Wild West.
Hydroxycut reportedly did/does help you lose weight, although that evidence is mostly anecdotal because the FDA requires so little data from supplement manufacturers. Hydroxycut also has a lot of caffeine (a powerful stimulant and appetite suppressant) which might explain why users have reported weight loss while taking Hydroxycut.
(One of the lawyers in our office purchased Hydroxycut, but never used the product; one of our paralegals took the product for years.)
- Hydroxycut settlement: If you bought a Hydroxycut supplement between May 2, 2009, and Feb. 15, 2017, you may be entitled to a cash payment, albeit a very small one, from the Hydroxycut class action settlement. There was also a class action settlement in Canada in 2015.
- More liver problems: Ocalvia lawsuits could be one of the next big mass torts in 2018.
Which Products are Covered by this Voluntary Recall?
The following products are covered by this voluntary recall:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Capsules
- Hydroxycut Max Liquid Capsules Hydroxycut Regular Drink Packets
- Hydroxycut Natural
Two other products, Hydroxycut Cleanse and Hydroxycut Hoodia, with different ingredients, are not affected by the recall.
Is There Speculation as to Why Hydroxycut Can Cause Liver Injury?
No one knows for certain why Hydroxycut would cause liver failure or jaundice.
But the theory is that prior to May 2009, Hydroxycut formulations contained Garcinia cambogia rind extract. The problem may be Garcinia which has been associated with both hepatocellular and cholestatic pattern of histologic liver injury; Hydroxycut also has produced what is called an immune-mediated pattern of liver injury.
But there is also concern about excessive use of hydroxycitric acid, which is derived from a tropic fruit. While harmless in the quantities you might get eating fruit, Hydroxycut may cause a hydroxycitric acid overdose, causing liver damage. Symptoms include:
- Jaundice
- Nausea
- Abdominal pain
- Brown urine
- Liver damage
- Seizures
- Cardiovascular disorders
Are There Other Concerns About Hydroxycut Beyond Liver Failure?
Hydroxycut users have suffered seizures, cardiovascular disorders, and rhabdomyolysis, a severe form of muscle damage that can lead to kidney failure.
The take-home message is that remains alive in 2023 is that you should be talking to your doctor before you take these kinds of supplements. Because they can be very dangerous. That is not a legal opinion. That is a common sense opinion that everyone should consider. You only get one body.
2023 Lookback
Iovate settled many of these lawsuits, although the specific terms and amounts of these settlements were often confidential. We are not aware of active litigation in 2023.