Researchers report they've found an unlisted substance similar to methamphetamine in the workout supplements Craze and Detonate. (Alison Young / USA Today)
A dietary supplement implicated in positive drug tests in athletes and sold at GNC stores on some military installations contains a substance similar to methamphetamine that has never been tested on humans, according to a new study.
Craze, marketed by Driven Sports Inc., contains an ingredient the company says comes from a dendrobium orchid. But researchers at Harvard Medical School, NSF International and the National Institute for Public Health and the Environment, Netherlands, say the compound, N,alpha-diethylphenylethylamine, or N,a-DEPEA, is made in a lab and has a molecular structure similar to meth.
The researchers are asking the Food and Drug Administration consider warning consumers.
An attorney for Driven Sports said Monday that the company has tested the product extensively and found that “Craze did not induce any harmful effects on clinical laboratory parameters” and that “no adverse events were reported.”
Marc Ullman added that the paper published by Cohen and colleagues “falls well short of the standards that the scientific community and public at large should expect.”
“Extensive analytical work by a Drug Enforcement Agency-registered lab in Michigan and a Swedish laboratory retained by Driven Sports indicate the presence of [another form of diethylphenylethylamine] N-beta DEPEA in Craze. This is a related but very different substance,” Ullman said.
“Alarmingly we have found a drug in a mainstream sports supplement that has never been studied in humans,” said Dr. Pieter Cohen, an assistant professor at Harvard Medical School. “The health risk of using supplements adulterated with a drug should not be underestimated.”
The researchers also tested another supplement, Detonate by Gaspari Nutrition, and found it contains the same compound.
Craze was named “New Supplement of the Year” in 2012 by bodybuilding.com, but it has come under scrutiny since athletes, including fitness model Rob Riches, failed a drug test at a bodybuilding competition.
Riches, who has built a reputation for being a drug-free bodybuilder, blamed it on Craze, according to a USA Today investigation.
The U.S. Anti-Doping Agency and other international organizations tested Craze and found an amphetamine-like compound in the supplement.
In the most recent report, published today in Drug Testing and Analysis, the researchers noted that a different substance — N,N-diethylphenylethylamine — is listed on the Craze label, but that the substance actually found is N,a-DEPEA and is not listed.
The findings appear to confirm analysis conducted earlier this year at the Swedish National Lab of Forensic Science, SKL, which found the same substance.
The news of the undeclared ingredient comes as the Centers for Disease Control and Prevention, the Hawaii Department of Health and the FDA are investigating an outbreak of acute non-viral hepatitis in Hawaii possibly linked to the workout supplement OxyElite Pro.
Since May, Hawaii has seen 29 cases of acute hepatitis without any known cause. According to the state’s Department of Health, 24 of those who fell ill were or had been taking OxyElite Pro, a popular “fat-burner” supplement touted as a metabolism booster and weight loss aid.
The FDA is advising consumers to stop using anything labeled as OxyElite Pro while officials investigate. It also is advising those who think they have become ill as a result of taking a dietary supplement to notify their doctor.
USPlabs, distributor of OxyElite Pro, has told the FDA it believes fake versions of the product are being sold in the U.S. and “have been on the market for a while.”
Last summer, after USA Today published an extensive report on Craze and Driven Sports founder Matt Cahill, the company released a statement regarding Craze, saying it is a “legal supplement that provides people with the tool to enhance their workouts.”
“Craze conforms to all U.S. federal regulatory requirements and is proven safe when used as directed … Driven Sports has commissioned extensive testing of Craze from a reputable, independent laboratory, which conclusively establishes that the product does not contain any illegal stimulants,” according to the statement.
The FDA does not regulate dietary supplements as tightly as it does food and medications. By law, companies that make and sell supplements are responsible for determining that they are safe. In the case of a new ingredient, a firm mustprovide the FDA with the evidence it relies on to substantiate safety or effectiveness, according to the agency.
Manufacturers and organizations that represent the dietary supplement industry argue that the system works because companies must police themselves to stay in business and are required to meet safety and efficacy standards.
But Cohen said enforcement is needed to better protect consumers.
“I wouldn’t say we need more regulation — we need better regulation,” he said. “We have no functioning system to detect harm, and we rely on private investigators and researchers like me to do the work.”
A number of stores, including Walmart, have removed Craze from their shelves. It is available at some GNC stores at military exchanges. Detonate is available online.