DOD has yet to release findings of DMAA study
March 16, 2013
CAMP FOSTER, Okinawa — Pvt. Michael Sparling took the bodybuilding and weight-loss supplement Jack3d for a boost just before a run with his new unit in June 2011.
During the three-and-a-half-mile run, the 22-year-old soldier collapsed, lost consciousness and began foaming at the mouth. He was pronounced dead of a heart attack and heat stroke several hours later at a nearby hospital.
Sparling’s family claims Jack3d, which contains the substance DMAA, directly contributed to their son’s death, according to a lawsuit filed in California last month against the supplement’s maker, USPlabs, and retailer GNC. Army toxicology tests confirmed DMAA was in the soldier’s system and the service’s autopsy pointed to it as a contributing cause but was inconclusive.
Both USPlabs and GNC maintain that supplements containing the substance are safe when used as directed and they continue to sell them.
More than a year and a half has passed since Sparling and another soldier died after taking DMAA, and their deaths remain clouded in controversy.
The Department of Defense may hold the answer to whether the supplement is safe. But it has yet to release the results of a landmark study on DMAA, which is sold in bodybuilding and weight-loss supplements as 1,3-dimethylamylamine, methylhexanamine or geranium extract.
The safety probe started in December 2011 after the deaths were first reported by Stars and Stripes. The date for the release of the results has been delayed numerous times — without explanation — over the past six months.
“This study has now been completed, and the compiled report is currently undergoing internal review,” DOD spokeswoman Cynthia Smith wrote in an email statement March 8.
“Once all leaders and stakeholders have been apprised of the results, the report will be released to the public,” Smith wrote.
Smith described it as the “first population-based, epidemiologic study to look for any association [between] DMAA and clinician-identified adverse medical events.”
The Army-led probe could determine whether the substance played a role in the soldiers’ deaths or in other servicemember ailments, including kidney and liver failure, seizure, loss of consciousness, heat injury and muscle breakdown. It is now marketed as a natural dietary supplement, which requires few federal safety checks.
The DOD pulled 18 products containing DMAA from store shelves on military bases around the world in 2011 due to the deaths, but Jack3d and other supplements are still easily available online.
DMAA, which has effects similar to amphetamines, proved immensely popular after hitting the fitness market about 2006. GNC, which has stores on many military bases as well as retail shops across the United States, said it has sold at least 440 million doses since 2007.
With DMAA’s fate unresolved, Sparling’s mother and father filed suit Feb. 13 in San Diego County court in hopes of spurring action, lawyer Anne Andrews said. The suit claims USPlabs and GNC knew the Jack3d supplement could cause “serious harm or death” and requests a jury trial and compensation for damages.
“The goal of this case is to call attention to what happened and get these products banned,” she said.
Andrews claims the supplement companies preyed on servicemembers who “want to be fighting machines” by promising results from a product that is dangerous and ineffective.
“GNC knows full well what’s in this product,” she said. “Selling this on these bases is such appalling behavior, to make military members victims.”
GNC spokesman Greg Miller said the retailer does not comment on pending litigation, but has no reason to believe that DMAA supplements are unsafe.
“The military has been reviewing DMAA for approximately 12 months and has yet to produce any scientific or medical evidence to support a safety concern,” he wrote in an email to Stars and Stripes.
He said the third-party DMAA products it does sell are widely available at other retail outlets.
In a statement, USPlabs said it “extends heartfelt sympathies to the [Sparling] family in their times of loss” but stands by the safety and effectiveness of Jack3d when used as directed. Jack3d and other DMAA supplements come in pill form or a powder that is mixed with water and ingested.
The company has pointed to short-term studies published on peer-reviewed, open-access Internet journals that show Jack3d and its sister product, OxyElite Pro, do not negatively affect blood pressure, liver and kidney function or heart rate.
However, the U.S. Food and Drug Administration announced last year that it had received dozens of reports linking DMAA to psychiatric and nervous system disorders as well as death. Stopping short of an all-out ban, it warned companies to stop manufacturing DMAA products because of potentially fatal side effects and indicated the substance might be synthetic instead of natural.
Many discontinued their products or reformulated them. USPlabs and GNC are among those that have continued to sell DMAA supplements.
Michael Sparling’s mother and father testified March 4 before the New York State Senate in favor of legislation that would ban the supplements there. Bill sponsor Sen. Jeff Klein is hoping to follow the example the state set by outlawing the fitness supplement ephedra before the FDA banned the dangerous stimulant nationwide in 2004, Klein’s spokesman Eric Soufer told Stars and Stripes.
Pieter Cohen, an assistant professor of medicine at Harvard Medical School who also testified on the legislation, told Stars and Stripes that DMAA’s effects are consistent with ephedra and the substance should be banned until it can be regulated as a new pharmaceutical drug.
He lauded the DOD for pulling Jack3d and other DMAA supplements off shelves during its safety probe.
“To me, it is so noncontroversial. This is a product that should never be in supplements in the first place,” Cohen said. “We don’t need to wait until there are more deaths.”