The ingredient was the subject of a study recently conducted by Dr Pieter Cohen, a physician connected with the Harvard School of Medicine and a longtime critic of the dietary supplement industry, and published in the journal Drug Testing and Analysis. In his study, Cohen raised the issue of the ingredient’s chemical similarities to DMAA, another stimulant-like ingredient that was once common in preworkout formulas that was removed from military shelves after two soldiers died with DMAA in their systems. That ingredient was also the subject of a number of other adverse events reports and was mandated to be removed from the market by FDA.
Hair trigger on new ingredients?
Did the military’s prior experience with DMAA make it quicker to make a decision regarding products that contain DMBA? After all, so far as can be determined, to date no adverse events have been reported with DMBA, or 1,3-dimethylbutylamine. According to a statement by the relevant authority, the decision was based solely on Cohen’s research.
According to the statement from the Army & Air Force Exchange Service (AAFES), the agency “removed products containing DMBA on Oct. 14. The decision to remove these products was based on research recently published in the scientific journal Drug Testing and Analysis and is unrelated to any other product or ingredient.”
While the statement makes clear the antecendents of the decision, AAFES spokesmen Judd Antsey did tell NutraIngredients-USA, “You could say this demonstrates an abundance of caution.”
Another source, a career Army officer who asked not to be named, told NutraIngredients-USA that a big concern with new ingredients that come onto the market is what those ingredients might lead to in the blood stream. While he said he didn’t know much about DMBA in particular, he said not having enough information about new ingredients was a problem in and of itself.
“What we are concerned about are the metabolic byproducts,” the officer, a major who has done active tours overseas and has also supervised base operations in the US, told NutraIngredients-USA. “If we don’t know what those are, we don’t want soldiers failing drug tests as a result.”
Questioning the research
Marc Ullman, an attorney with the firm Ullman, Shapiro & Ullman, represents Driven Sports, a company that has a DMBA product on the market that was one of the products mentioned in Cohen’s study. Ullman took pains to point out after consultation, his client chose not to market the DMBA product, called Frenzy, in any markets under direct FDA jurisdiction. Ullman said his client’s product is not for sale in the US or on US military bases overseas and said firewalls are in place to prevent it from being ordered online from any of those locations. So while the AAFES decision does not impact his client in the short run, Ullman did have a lot to say about Cohen’s paper, which has cast a cloud over the ingredient, regardless of where it is sold.
“Cohen’s paper is a another ‘short communication,’ ” Ullman said. “As such, it was likely not subject to peer review—and if it was, such review would have been minimal.
“Its hypothesis is that because the molecular structure of DMBA looks like DMAA therefore people need to be afraid. That is an utterly unscientific conclusion. The structure of pseudo-ephedrine looks a lot like the structure of methamphetamine. The first is a commonly used nasal decongestant that is not addictive. It’s just a shallow argument that is given the veneer of credibility because of who the authors are,” he said.
“When people who are supposed to be experts like Dr Cohen and NSF International (which did some of the testing of the products in Cohen’s study) make this kind of statement, many in the military will think that it is better to be safe than sorry,” Ullman said.