“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," said Joe Fortunato, GNC CEO.
In the review, military researchers interviewed more than 1,700 service members, including 10 who reported adverse events connected with DMAA. They also reviewed reports from the four deaths of soldiers who were found to have dimethylamylamine in their blood streams. Of those four deaths, one soldier was found to have had coronary artery disease and two others were reported to have had sickle trait.
FDA warning letters
The military researchers also reviewed literature connected to DMAA, including warning letters from the Food and Drug Administration to makers of DMAA-containing products. In those letters, FDA asserted that there is no evidence that DMAA was on the market before Oct. 15, 1994, meaning that the ingredient should have a NDI notification on file. As no DMAA manufacturer has submitted such a notification, FDA’s conclusion is that the ingredient is unlawful.
The DOD interviews found that those who suffered multiple heat injuries, seizures, brain hemorrhages or other serious health problems were twice as likely to have used DMAA as those with a single injury. They concluded that this supported the finding of elevated risk, but also said the risk posed by the ingredient overall was low, given the high number of service members who have used DMAA products. The authors said DMAA use in the military may have been as high as 15%.
Still, the authors concluded that, “some individuals may be predisposed to severe health consequences after using DMAA.”
Their final assessment of the association of DMAA with adverse events was not quite the ringing endorsement that Fortunato alluded to. The authors stated: “The existing evidence does not conclusively establish that DMAA-containing substances are causally-associated with adverse medical events. However, a consistent theme among the studies is that DMAA use potentially affects cardiovascular function, just as other sympathomimetic stimulants. Without further rigorous study designs developed to evaluate the safety of DMAA, especially in patients with concomitant use of other substances, co-morbid conditions and high frequency use, the magnitude of the association of DMAA with adverse medical events is uncertain.”
Requiem for an ingredient
In summary, the authors supported the military’s ongoing ban of DMAA. DMAA containing products have not been sold on bases since 2011. In any case, it has become something of a moot point. As the DOD study was being conducted, DMAA was disappearing from the market.
As far as can be determined, no firms are currently manufacturing or selling DMAA products in the US, following FDA’s warning letters to manufacturers and distributors of DMAA products in August 2012 and it's subsequent actions to remove the ingredient from the market. USP Labs, manufacturer of the highest profile DMAA containing product, Jack3d, was the last manufacturer to cease using the ingredient. And GNC, after first saying it would sell through its backlog of DMAA products, recently agreed to destroy its remaining inventory following FDA’s seizure of some DMAA products at one of the company’s warehouses in New Jersey.
The full report can be read here.