A weight-loss supplement made by a Dallas company is the subject of government investigations and a recall in Hawaii.
Two dozen people in Hawaii suffered acute hepatitis and liver failure after using OxyElitePro.
The U.S. Food and Drug Administration issued a statement:
"The FDA advises consumers to stop using any dietary supplement products labeled as OxyElite Pro while the investigation continues."
USP Labs makes the product. Company spokesman Michael Petruzzello issued this statement:
"The company stands by the safety of all of its products. The company is cooperating with FDA on reports coming out of Hawaii. The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market. We know of no credible evidence linking OxyELITE Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements. The studies and consumption history show no negative liver issues."
The product is sold online and at retailers. Despite the government warning, it was featured at the check out counter Thursday at the GNC store on Lovers Lane in Dallas.
GNC spokesperson Laura Brophy provided an e-mail:
- OxyELITE Pro is a third party product, distributed by USP Labs, that is widely sold through numerous retailers and internet sites across the country.
- USP Labs has warranted to GNC that the product is safe for consumption and compliant with all applicable laws.
- GNC is not aware of any scientific or medical evidence that establishes that the OxyElite Pro product is unsafe.
- The FDA has not asked USP Labs to recall the OxyElite Pro product.
- Nonetheless, GNC will voluntarily remove the OxyElite Pro product from sale in its Hawaii stores during this investigation.
Employees of the FDA have been furloughed in the current government shutdown. But FDA spokesman Steven Immergut said in an e-mail:
"Regarding the shutdown, FDA is doing what it can under this difficult situation to protect public health. As is the case with this investigation, the agency is conducting "for cause" inspections where we believe an imminent threat to health exists."
The Cooper Aerobics Center in Dallas specializes in weight loss.
Dietitian Meridan Zerner said Cooper recommends changes in diet and exercise before any supplements because supplements can have health consequences.
"You just don't know what you're getting in a lot of these supplements," she said.
"If the FDA is recommending that people be cautious and not take the supplement while they have a chance to review it, then absolutely nobody should be taking that."