A popular sports supplement sold as a workout booster to help users “train beyond” their limits contains a banned substance derived from methamphetamine, according to tests conducted by researchers from Harvard Medical School and elsewhere and published Monday in the journal Drug Testing and Analysis.
Whether the product, a powder called Craze, poses any health risks remains unknown because it has never been tested in rigorous studies. But the finding adds to growing concerns about workout supplements after another supplement, OxyELITE Pro, was linked last week to 24 cases of liver failure in Hawaii and one death.
Two athletes who used Craze last year were banned from international competitions after failing World Anti-Doping Agency drug tests. That prompted the Harvard researchers to purchase Craze from a GNC store and two websites, and their testing found that the products contained 21 to 35 milligrams per serving of a stimulant called N,alpha-diethylphenylethylamine, or N,alpha-DEPEA.
Though not officially on the World Anti-Doping Agency’s banned substance list, the synthetic chemical is considered by the agency to be an amphetamine-like substance that, if detected on drug tests, could be grounds to disqualify athletes from competition.
“It’s a dose you would expect to see in a pharmaceutical,” said Dr. Pieter Cohen, a Harvard assistant professor of medicine and physician at Cambridge Health Alliance, if N,alpha-DEPEA was on the market as a stimulant medication. Yet, the chemical is not listed anywhere on the product label as an ingredient.
Driven Sports, manufacturer of Craze, lists more than a dozen other ingredients on the package, including caffeine and creatine, both typically found in other workout supplements. The named ingredients also include dendrobium extract and chemicals in that extract that are chemically similar to N,alpha-DEPEA, Cohen said, but do not act like an amphetamine.
Marc Ullman, an attorney representing Driven Sports, said in an interview that the company, “on the surface,” does not agree with the study finding. “We’re talking about some very complicated analytical work, and we haven’t had the opportunity to have our experts review the nature of the analytical testing being done and whether the methods were validated,” he said.
Driven Sports has had its product tested by a different lab, he said, which did not find any evidence of the banned chemical.
Matt Cahill, the Driven Sports owner, has served time in prison for selling and transporting a highly toxic industrial chemical packaged as a weight loss supplement that resulted in a young woman’s death. He is facing a federal criminal charge for marketing a body-building supplement that allegedly contained an unapproved new drug linked to liver problems. “Mr. Cahill adamantly denies any wrongdoing,” Ullman said in response to the latest charge.
Last year, Craze was designated “New Supplement of the Year” by the website Bodybuilding.com.
Another sports supplement called Detonate — which also lists dendrobium on its label — was also found to contain N,alpha-DEPEA in tests conducted by NSF International, a nonprofit health organization that certifies consumer products.
“Folks who use these products are unknowingly participating in an unsponsored clinical trial to test whether they have harmful effects,” said John Travis, an NSF researcher who was also a coauthor on the study conducted on Craze.
Detonate’s manufacturer, Gaspari Nutrition, did not respond to a request for an interview.
Whether supplements containing N,alpha-DEPEA will remain on the market is up to the US Food and Drug Administration. The agency could force the removal of Craze and Detonate if they include ingredients not disclosed on the label. Cohen said he sent the results from his study to the FDA in May.
FDA spokesman Steve Immergut said the agency could not provide a response to the Craze study due to the government shutdown. The FDA, though, issued a warning letter on Friday to product manufacturer USP Labs informing the company that its dietary supplements OxyElite Pro and Versa-1 are considered “adulterated” because they contain aegeline, a new ingredient for which the company has provided no evidence of safety.
“Failure to immediately cease distribution of these products may result in enforcement action by the FDA,” wrote the agency in its letter.
USP Labs said in a statement that it is “cooperating with [the] FDA on reports coming out of Hawaii. The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro.” It pulled OxyELITE Pro from store shelves and websites, but as of Sunday, Versa-1 was still available for purchase.
Although dietary supplements are less loosely regulated than FDA-approved drugs, consumers can look for those certified by NSF International to help ensure that the product label truthfully reveals the supplement’s ingredients.
“We conduct toxicological analyses to look for harmful ingredients and to verify the formulation,” said Ed Wyszumiala, general manager of the group’s dietary supplement certification program. “We also do antidoping certification” to reassure athletes that they are not taking a banned supplement. Neither Craze nor Detonate had NSF certification, he added.
Such certification might have helped bodybuilder Rob Riches, who has blamed Craze for a failed drug test that banned him from competition for six months after his April win at a British national championship competition.
“I had no knowledge that this pre-workout powder contained an ingredient that would jeopardize my competition outcome,” he wrote in a statement posted on his website.