October 9, 2013 — USPLabs, the Texas-based manufacturer of OxyElite Pro, is no stranger to the U.S. Food and Drug Administration (FDA) or criticism about the safety of their dietary supplements. For years, they made millions selling supplements laced with DMAA, an illegal stimulant drug that has been linked to deadly side effects.
In early 2013, USPLabs agreed to re-formulate OxyElite Pro without DMAA. Beginning in May, health officials began linking OxyElite Pro to liver injuries, including non-viral hepatitis (liver inflammation). By September, at least 29 were reported, including 24 in people who reported using OxyElite Pro.
USPLabs issued the following statement regarding the outbreak:
“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.”
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