CAMP FOSTER, Okinawa — The Marine Corps warned troops on Okinawa Tuesday that a fitness supplement banned from military exchanges in 2011 following soldier deaths might have been a factor into an outbreak of liver disease.
The supplement OxyElite Pro is a common link in 24 cases of non-viral hepatitis in Hawaii and appears to now contain a substance that has not been safety tested for human consumption, according to the U.S. Food and Drug Administration. Two of the patients required liver transplants, and a third patient died.
OxyElite Pro and a variety of other fitness supplements that had contained the stimulant DMAA were pulled from military shelves following the collapse and death of three soldiers during training at Fort Bliss, Texas, two years ago.
A Department of Defense safety review, completed in June, found the ingredient DMAA increased the risk of serious injury for tens of thousands of servicemembers who used the supplements while working out. But the probe could find no conclusive link that DMAA played a significant role in the deaths, leaving unanswered questions over whether the stimulant could be deadly in rare cases.
As concerns rose over the stimulant DMAA —- also known as methylhexanamine —- the supplement industry claimed it was a natural extract of geranium flowers but the FDA warned that it was actually a synthetic stimulant which had not been properly tested for safety.
Under federal regulations, makers of dietary supplements can use any ingredients that are already part of the food supply but new synthetic drugs must go through rigorous and costly safety testing.
An FDA crackdown on DMAA resulted in companies reformulating the popular supplements and reintroducing them without the substance. OxyElite Pro is sold in both powder and pill form and is marketed as a way to reduce body fat.
Last week, the FDA sent a warning letter to Texas-based USPlabs saying its OxyElite Pro supplement now contains an ingredient called aegeline that has no history in the food supply and has not been properly tested for safety.
The company voluntarily stopped distribution of OxyElite Pro and is cooperating in an FDA investigation, according to the agency.
In a released statement, USPlabs said the cluster of hepatitis is a “mystery” and that it knew of no credible evidence linking its product to liver damage.
USPlabs said the aegeline questioned by the FDA is an alkaloid found in the Bael citrus fruit tree and that the tree’s extracts and fruit are used around the world in food and natural remedies.
“The ingredients [of OxyElite Pro] have been studied for safety, are consumed in the food supply and widely used in dietary supplements,” the company said.
The FDA is currently investigating any links between the liver problems and the original OxyElite Pro with DMAA as well as the newly formulated OxyElite Pro with a purple top and OxyElite Pro Super Thermo Powder, according to USPlabs. The original version with DMAA has not been manufactured or distributed since early 2013.
USPlabs has repeatedly denied that the DMAA-containing versions of OxyElite Pro and its other supplement, Jack3d, cause injuries when used as directed.
The Marine Corps warned Tuesday that servicemembers should immediately stop taking OxyElite Pro until the investigation into liver damage is completed.
“OxyElite Pro products are not carried in exchanges or gyms in Okinawa, but they are available throughout the U.S. and can be purchased over the Internet,” the service said in a public email announcement.