The US Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) launched the investigation after 29 cases of acute non-viral hepatitis were reported on the islands, 11 of which led to hospitalizations, two cases have received liver transplants and one person has died.
Twenty-four of these cases share a common link to a dietary supplement product labeled as OxyElite Pro, said FDA.
Liver issues are a ‘complete mystery’
In a statement to NutraIngredients-USA, USPlabs LLC, the company behind the product, said it 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,” stated the company.
“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.”
According to the FDA, the Dallas, Texas-based company has also informed the Agency that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time. FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.
The product is sold nationwide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. The CDC is reportedly investigating other cases of liver injury nationwide that may be related.
The USPLabs statement continued: “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."
While the investigation is ongoing, the FDA is advising consumers to stop using any dietary supplement products labeled as OxyElite Pro.
“The epidemiological investigation is being conducted by the Hawaii DOH and the CDC,” explained FDA in astatement. “As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients.
“Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records.”