Army study of DMAA's effect on soldiers will continue
By TRAVIS J. TRITTEN | STARS AND STRIPES Published: May 3, 2012
CAMP FOSTER, Okinawa — The Army will continue a study into the effects of the bodybuilding supplement DMAA on soldiers despite a federal government order last week halting public distribution of the substance over safety concerns, the Department of Defense said Thursday.
The military has an “intense interest” in what the Army Public Health Command’s ongoing research might say about the safety and servicemember use of the amphetamine-like substance, which was sold at military exchanges until it was pulled from shelves in December after the deaths of two soldiers, according to DOD spokeswoman Cynthia Smith.
As part of the review, the Army will ask soldiers to complete surveys about “past health events potentially associated with dietary supplement use, including use of DMAA,” she said.
On April 27, the U.S. Food and Drug Administration announced that it sent letters ordering 10 fitness supplement manufacturers to immediately stop distributing products that contain DMAA, which is sold as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, because the substance has not been proven safe and might trigger heart attacks.
The move came after months of mounting concern over the popular fitness supplement and its possible link to the servicemember deaths. The two soldiers suffered heart attacks and died last year during physical training with their units at an Army base in the United States. Autopsies on the soldiers found DMAA in their systems.
The Army said it launched its review after recording a number of other serious health effects among known users of DMAA, including “kidney and liver failure, seizures, loss of consciousness, heat injury and muscle breakdown during exertion, and rapid heartbeat.”
The service is “proceeding with our scientific review of dietary supplement use and potentially related health outcomes,” Smith wrote in an email response. “We do not plan to stop it, as the use and safety of these stimulant products remain matters of intense interest to the DOD.”
The research is expected to be completed this fall; the DOD has declined to provide more details, saying it does not want to influence the results.
Meanwhile, the fate of DMAA remains uncertain.
Manufacturers are currently barred from distributing DMAA supplements in the U.S. and have until May 9 to respond to the FDA’s determination that the substance has not been proven safe. The regulatory agency said it has received 42 public complaints about products containing DMAA, indicating it might be linked to other serious health effects including nervous system and psychiatric disorders as well as death.
Fitness supplement retailer GNC said in a statement that the FDA has not provided scientific or medical evidence that DMAA is unsafe, according to the Pittsburgh Post-Gazette.
“When taken as directed, we believe that DMAA has the same effect on the body as drinking two cups of coffee,” the company said.
The burden of proof, however, lies with the manufacturers, according to the FDA.
“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated,” Daniel Fabricant, director of the FDA’s Dietary Supplement Program said in a news release last week.
GNC did not reply to requests for comment from Stars and Stripes. USPlabs, maker of the popular DMAA supplements Jack3d and OxyElite Pro, referred questions to GNC.
At least one manufacturer of DMAA supplements has said it will discontinue use of the substance in its products.