A two-year Defense Department review of body-building supplements containing 1,3-dimethlyamylamine, or DMAA, has concluded that there is insufficient evidence to prove the ingredient caused the deaths of three soldiers in 2011 and 2012.
But the Pentagon safety panel study also found that DMAA poses enough of a health risk that it should remain banished from military store shelves — a conclusion made moot in April when the FDA ordered manufacturers to stop selling products containing DMAA in the U.S.
The military pulled all DMAA supplements from store shelves in 2011 after two soldiers, Pvt. Michael Sparling, 22, and Sgt. Demekia Cola, 31, died of heart failure during physical training at Fort Bliss, Texas.
In early 2012, the Army Public Health Command launched a study to determine what role, if any, DMAA played in the service members’ deaths.
While the investigation was underway, a third soldier, Pfc. David Artis, died of heat stroke in July 2012; Army officials also linked DMAA use to his death.
Army and DoD researchers wrapped up their review in December 2012; the study recently was published online by the DoD Human Performance Resource Center.
“Although direct causality cannot be concluded, the seriousness of the observed adverse medical events and deaths where service members had used DMAA containing products led Safety Review Panel members to assess DMAA-associated health risk as low to moderate,” the report notes.
In the review, safety panel members studied existing scientific research on DMAA as well as adverse medical reports associated with the ingredient filed with the FDA and DoD.
They also compared cases of soldiers who experienced health problems often linked with DMAA use, such as irregular heartbeat and increased blood pressure as well as kidney or liver failure, comparing them with random control subjects.
The panel found that in general, products containing DMAA, such as the best-selling original formulas of Jack3d and OxyElite Pro, presented a low risk of harm to healthy service members.
But it also found that patients who experienced multiple adverse health events were nearly twice as likely to have used a DMAA supplement than those with only one adverse health problem.
“There does appear to be a significant association of DMAA use, particularly high frequency DMAA use, and multiple adverse events. Further, the deaths, hepatic failure, myocardial infarction, heat stroke and rhabdomyolysis, seizure and stroke temporally associated with service members’ use of these products suggest that some individuals may be predisposed to severe health consequences after using DMAA,” according to the report, edited by Col. John Lammie, director of health policy and services, force projection, U.S. Army Medical Command.
The FDA sent letters to manufacturers in April warning them that DMAA was an unapproved dietary ingredient. It reached its conclusions after receiving 42 reports of health problems ranging from cardiac and nervous system disorders to psychiatric problems in consumers using products containing DMAA.
USPlabs initially balked and continued to make Jack3d and OxyElite Pro with DMAA. But it later decided to reformulate the products, and in July voluntarily destroyed $8 million worth of the two supplements after the FDA had administratively seized the company stockpile.
In late July, supplement retailer GNC, which operates a large number of stores on military bases, agreed to destroy its stock of DMAA supplements.
On Aug. 5, however, in response to the Pentagon safety panel study, GNC president Joseph Fortunato issued a statement reiterating the company’s belief that DMAA is a safe supplement.
“GNC is delighted that the military’s review of DMAA products validated what we already knew; namely, that products containing DMAA do not cause adverse medical events. This is a perfect example of how unjustified criticism of dietary supplements is simply not supported by sound science,” Fortunato said in a release.
Fans of Jack3d and OxyElite Pro defend the products as effective workout-boosters and fat-burners.
“I would like to know how many of these deaths are associated with not following the directions on the label and taking too much? If the people had heart problems they should’ve not been taking this product in the first place,” Air National Guard Staff Sgt. Steve Jawback, a user of original Jack3d, wrote in an email to Military Times.
The panel noted that in all three of the soldier deaths, there was no evidence of misuse or overuse. And although all three cases occurred in the Southwest where temperatures can reach triple digits for much of the summer, the ambient temperature was between 70 and 80 degrees at the times of their deaths.
The FDA continues to urge consumers not to use any supplements containing DMAA. The number of adverse health reports it has received since first issuing warnings to manufacturers has risen to 86, and includes reports of psychiatric disorders, heart problems, nervous system disorders, and death.
“FDA does not have any information to demonstrate that consuming DMAA is safe,” officials wrote in July 16.
Duffy MacKay, a naturopath with the Council for Responsible Nutrition, said he had not seen the Defense Department conclusions but said the industry respects FDA rulings.
“The FDA has determined it is not a legal dietary ingredient and we respect that. It’s FDA’s role to enforce and identify safety risks,” MacKay said.
DoD officials encourage service members to check out the Human Performance Resource Center’s website to find out more about the potential health risks of supplements.
Operation Supplement Safety aims to educate personnel about individual supplements and promote informed decision-making on a wide range of products.
Service members also can access the Natural Medicines Comprehensive Database, an alphabetical list of supplements and ingredients containing evidence-based information on supplements.