by JANET ST. JAMES / WFAA
DALLAS –– Federal safety investigators will inspect the USPlabs in Dallas, where the popular dietary supplement OxyElite Pro is manufactured.
According to alerts issued by the Food and Drug Administration and the Centers for Disease Control, the supplement is linked to 29 cases of hepatitis that have led to two liver transplants and one death of a user in Hawaii. So far, 11 people have been hospitalized and more cases across the country are being investigated.
According to the USPlabs website, OxyElite Pro is "designed to give you the energy, focus and appetite suppression support needed to help you get your best body ever!”
Unlike medicine, dietary supplements do not need FDA approval before being produced and sold to the general public. A statement from USPlabs says, “The company stands by the safety of all of its products" and"nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market."
As a precaution, the company has ceased domestic distribution of certain varieties of OxyElite Pro. Federal officials say consumers should stop taking it. North Texas health departments say that there are no local investigations into liver failure or hepatitis associated with the dietary product.
The CDC and FDA could not be reached for an update on their investigation due to the government shutdown.
"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. Due to multiple products within the OxyELITE Pro brand, it may be confusing as to which products are being looked at. The specific products are the original OxyELITE Pro with DMAA, OxyELITE Pro with the “Purple Top” and OxyELITE Pro Super Thermo Powder.
"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 company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii.”