Hawaii Department of Health officials are asking local retailers to voluntarily remove OxyElite Pro from shelves while an ongoing investigation of cases of liver failure and acute hepatitis is conducted.
State health officials said today that they also are advising the public to discontinue use of the weight-loss supplement.
USPlabs, which makes the OxyElite Pro product line, told the Honolulu Star-Advertiser today that it has stopped distributing two of its supplements “out of an abundance of caution” because of the Hawaii investigation.
While saying that they don’t believe their products are responsible for the liver illnesses in Hawaii, the company said it was cooperating with the U.S. Food and Drug Administration regarding “reports coming out of Hawaii.”
The FDA said it began investigating whether counterfeits of the product were related to the cases of acute hepatitis after USPlabs informed the agency it believed counterfeit versions of OxyElite Pro were being sold.
The Health Department is investigating 29 cases of acute hepatitis and liver failure that have occurred in the state from May through October and may be related to the use of diet supplements for weight loss and/or muscle building. The cases under investigation include two individuals who had to have liver transplants and one death.
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.
“Twenty-four cases reported using OxyElite Pro before their illness,” said Dr. Sarah Park, state epidemiologist. “No other supplement or medication has been identified in common among more than two patients.”
Health Director Loretta Fuddy said, “The department continues to urge people who use dietary or nutritional supplements for weight loss and/or muscle gain to talk with their doctor or health care provider. Anyone who develops symptoms such as abdominal pain or discomfort, fatigue, loss of appetite, nausea and /or vomiting, and yellow skin or eyes, should consult their doctor immediately.”
In its written statement today, USPlabs said the company stands by its product.
“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,” the company said in a statement. “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 company said that because there are multiple products within the OxyELITE Pro brand — the original OxyELITE Pro with DMAA, OxyELITE Pro with the “Purple Top” and OxyELITE Pro Super Thermo Powder — it may be confusing as to which products are being investigated.
The original formula of OxyElite Pro included the ingredient DMAA, which the FDA banned for use in dietary supplements in April 2012.
The FDA had received 86 reports of illnesses or death associated with supplements containing DMAA since 2008, including heart problems and nervous system or psychiatric disorders.
The FDA in April issued a warning updating consumers that it was “using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.”
According to that warning on the FDA.gov website, all but one of the producers of DMAA products agreed to stop using the ingredient.
“The 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,” the warning says. “However, after reviewing the studies provided by USPlabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”
The New York Times reported in June that USPlabs soon after agreed to stop making DMAA products for business reasons, but the company continued to distribute its remaining stock, worth about $8 million. The FDA later told the Times that USPlabs destroyed all remaining stock at a company warehouse in Dallas on July 2.
USPlabs said today that the original version with DMAA has not been manufactured or distributed since early 2013. “Out of an abundance of caution, the company has ceased domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder until the investigation has been completed,” the statement said.
But, “the company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii,” it said.
The Associated Press contributed to this report.