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October 21, 2013
DALLASUSPlabs LLC, whose dietary supplement OxyElite Pro has been linked to an outbreak of hepatitis in Hawaii, maintains an ingredient found in the product is safe.
The FDA recently warned USPlabs that aegeline has no evidence of safety. But USPlabs contends aegelinean alkaloid of the citrus fruit tree Baelis safe and that the Hawaii outbreak "remains a mystery".
"Not only has Bael been used in foods around the world for thousands of years, but more recent scientific studies of aegeline show no adverse health effects, including any harm to liver functions," the company said in a statement forwarded Oct. 16 to INSIDER.
USPlabs also denied its product is responsible for an outbreak of acute non-viral hepatitis and liver failure that has led to hospitalizations, two liver transplants and one death.
"There is no objective evidence to link OxyELITE Pro to these cases of illness," the company said. "At this point, speculation and unscientific theories only hurt the ability to identify the cause of the injuries in question and risks skewing the investigation away from the actual causes of injury, which is not helpful for the people of Hawaii."
In an Oct. 11 letter, FDA warned USPlabs that health findings "suggest a causal connection" between its product and the outbreak. Hawaii officials who are investigating the cases are unaware of patients who ingested excessive amounts of the supplement or medical conditions that would predispose the individuals to liver failure.
In a statement Oct. 8, USPlabs revealed it was taking OxyElite Pro off the U.S. market "out of an abundance of caution." USPlabs said officials are investigating the original OxyELITE Pro with DMAA, OxyELITE Pro with the Purple Top" and OxyELITE Pro Super Thermo Powder. However, USPlabs explained it hasn't made or distributed OxyELITE Pro with DMAA since early this year.
FDA has said it is looking into whether counterfeit versions of OxyElite Pro are linked to the outbreak. Other agencies investigating the outbreak include the Hawaii State Department of Health and Centers for Disease Control and Prevention (CDC).
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