The FDA is warning consumers not to purchase or use a dietary supplement called Ultimate Body Tox because it contains sibutramine, a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. Health care professionals are encouraged to report adverse events related to the use of this product.
Sibutramine substantially increases blood pressure and pulse rate in some people and may present a significant risk for anyone with a history of coronary heart disease, congestive heart failure, arrhythmias, or stroke. The drug can also interact, in life-threatening ways, with other medications a consumer may be taking.
If you purchased Ultimate Body Tox, do not use it. It is packaged in 45 count bottles. It was sold nationwide over the internet and in North Carolina.
Take this product to a drug disposal facility in your community or take it back to the place of purchase for a refund. No illnesses or injury have been reported to date. You can report any adverse effects from this product to the FDA’s MedWatch Online Voluntary reporting Form.
This notification is also intended to inform the public about a growing trend of dietary supplements or conventional foods that contain hidden drugs and chemicals. These types of products are usually promoted for sexual enhancement, weight loss, and body building. Worse, they are often represented as being “all natural.”
The FDA does not test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Dietary supplement manufacturers are not required to get approval from the FDA before they market their products. The oddly named Dietary Supplement Health and Education Act of 1994 established that supplements made with ingredients that were marketed in the U.S. before 1994 can be sold without any evidence that they are effective or safe.
All that the government can do is try to remove products if they are shown to contain unsafe ingredients after the fact. Consumers should exercise caution before they buy any product that claims health benefits.