The Food and Drug Administration announced Sunday that USPlabs is recalling certain OxyElite Pro sports supplement products that have been linked to an outbreak of liver illnesses, including one death.
The action follows a letter the FDA sent Wednesday notifying the Dallas-based dietary supplement maker that if it did not recall the supplements voluntarily, the agency would order the company to stop distribution of the products immediately and notify other distributors and retailers to stop selling them.
"We took this step to ensure that adulterated and harmful products do not reach the American public," FDA Deputy Commissioner Michael Taylor said.
The products covered by the recall include certain packages of OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Super Thermo Powder. The products are sold for weight loss.
Last month, the FDA warned USPlabs that it deemed OxyElite Pro and another of the company's supplements, VERSA-1, to be adulterated because they include an ingredient called aegeline. The FDA said it considers aegeline, a compound found in an Asian tree, to be a new dietary ingredient that lacks a history of use or other evidence of safety in the United States before 1994, a key regulatory date for grandfathering supplements.
USPlabs disagreed and on Nov. 4 sent a response letter to FDA saying the compound has been used safely for centuries. Still, the company said it was discontinuing use of the ingredient in the United States because of negative publicity. The company said it had destroyed its distribution center inventory of all supplements containing aegeline and would be reformulating the products.
The FDA in its Nov. 6 letter to USPlabs told the company that a review of liver illnesses reported in Hawaii indicate a connection to the OxyElite Pro products now being recalled. The FDA's review of 46 medical records provided by the Hawaii Department of Health indicated that 27 patients - 58% - had taken an OxyElite Pro product before they became ill. Of those 27 patients who had taken OxyElite Pro, 63% said it was the only supplement they used.
As of Wednesday, the Centers for Disease Control and Prevention said it had confirmed 56 cases of liver illnesses since April 1 in the outbreak linked to OxyElite Pro. Most of the cases have been identified in Hawaii, where the state's only liver transplant center was the first to notice a pattern of severe hepatitis among otherwise healthy people. Sarah Park, Hawaii's state epidemiologist, told USA TODAY last week it's unclear whether aegeline or another compound in the products is at the root of the outbreak.
The FDA said Sunday that it continues to warn consumers not to take any supplements labeled OxyElite Pro or VERSA-1. The agency said consumers who think they have been harmed should contact a doctor. They can file a report with the FDA by calling 1-800-FDA-1088.
For more information about OxyElite Pro and other dietary supplements in USA TODAY's "Supplement Shell Game" series, go to supplements.usatoday.com.