GNC to stop selling supplement linked to liver damage

The health and nutrition store GNC told the Honolulu Star-Advertiser today it now plans to voluntarily stop selling the dietary supplement OxyELITE Pro in its Hawaii stores while state and federal officials investigate a possible link between the product and serious liver damage.

On Tuesday, at least one GNC location on Oahu, at Ala Moana Center, did not plan to comply with the state Department of Health’s request that all retailers voluntarily stop selling the product during the investigation, DOH deputy Director of Environmental Health Gary Gill said.

A spokesman for GNC said Tuesday in an email statement sent to the Star-Advertiser that the company would “continue to sell the OxyELITE product in its stores until such time that either USPlabs or the FDA recall the product.”

The company this morning amended that statement to say that while it still believes the product is safe, “nonetheless, GNC will voluntarily remove the OxyELITE Pro product from sale in its Hawaii stores during this investigation.”

Health department staff traveled store to store Tuesday appealing to local retailers to voluntarily remove all formulas of the marketed “fat burner” OxyELITE Pro from their shelves while the state continues to work with the Food and Drug Administration and Centers for Disease Control to investigate the precise cause of the rash of cases.

“We feel at this point in time that we have enough of an association between (OxyELITE Pro) and the cases that we are investigating that we feel it is time to take more formal action,” state health director Loretta Fuddy said at a news conference Tuesday.

So far, there have been 29 confirmed cases of liver inflammation and liver failure linked to consuming a dietary supplement, 11 hospitalizations, two liver transplants, and one death, DOH said. OxyELITE Pro was the sole supplement used in 24 of those cases.

Sonnette Marras died last week after taking OxyELITE Pro for several weeks to lose weight gained during her last pregnancy, said her sister, Jeanette Kaipo. Marras, 48, of Maui, had seven children, ranging in age from 1 to 26, Kaipo said.

Dallas-based USPlabs LLC, which manufactures the OxyELITE Pro product line, announced Tuesday that it had voluntarily stopped national distribution of two of its OxyELITE Pro formulas “out of an abundance of caution” because of the Hawaii investigation. The company said it stopped producing a third formula earlier this year after the FDA in April 2012 warned that one of its ingredients, DMAA (also known as 1,3-dimethylamylamine), was being used illegally.

The FDA issued a warning in April of this year that “one company that has yet to agree to such action, USPlabs, has responded to the FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions.”

GNC was also at the center of that situation, as The New York Times reported in June that the company continued to sell its inventory of DMAA products even after USPlabs announced it would comply with the FDA’s request to stop making them.

The FDA in July oversaw the destruction of OxyELITE Pro DMAA products at GNC facilities in Pennsylvania and Arizona, and that the company was expected to soon after destroy its remaining supply in South Carolina, the agency said in a July 30 blog post written by the director of the agency’s Division of Dietary Supplement Programs. Dr. Daniel Fabricant cautioned, however, that “some products with DMAA may remain available on the Internet or store shelves while we continue working on this problem.”