The Food and Drug Administration (FDA), Centers for Disease Control and Prevention and Hawaii Department of Health (DOH) have launched an investigation into an increasing number of reports of liver failure allegedly linked to use of the dietary weight-loss supplement OxyELITE Pro, manufactured by the Dallas, Texas-based USPlabs LLC. According to FDA, 29 cases of acute non-viral hepatitis with an unknown cause have been identified in Hawaii. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants, and one person has died. Hawaii DOH reported that at least 24 of the patients said that they had used OxyELITE Pro during the 60 days before they became ill.  

FDA is reviewing patient medical records and histories as well as analyzing the composition of product samples collected from some of the patients. The agency is also inspecting the facilities where the product is made and reviewing production and product distribution records. In response to USPlabs’ claims that counterfeit versions of OxyELITE Pro have been circulating throughout the United States, FDA also plans to investigate whether counterfeit products may be linked to any of the hepatitis cases.  

In the meantime, FDA indicated in an October 11, 2013, letter to USPlabs CEO Jacob Geissler that a dietary ingredient known as aegeline could have played a role in the illnesses and warned that it is not aware of any “history of use or other evidence of safety establishing that aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of OxyELITE Pro [].”  

FDA has advised consumers to stop using any dietary supplement product labeled as OxyELITE Pro while the investigation continues, and USPlabs has stopped distributing the product. According to a USPlabs statement, “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.” See USPlabs LLC News Release, October 8, 2013; Natural Products Insider, October 14, 2013.