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Second workout supplement pulled from on-base stores

Oct. 18, 2013 - 03:34PM   |  
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A workout supplement that allegedly contains a derivative of methamphetamine has been pulled from GNC stores on military installations, according to exchange officials.

Craze, a pre-workout booster marketed by Driven Sports Inc., was removed from Marine Corps, Navy and Army and Air Force exchange GNC stores late this week following a report released Monday that said the product contains a substance similar to meth that has not been tested on humans.

The report, published online in the journal Drug Testing and Analysis by researchers from Harvard Medical School, NSF International and the Netherlands’ National Institute for Public Health and the Environment, say Craze contains a compound, N,alpha-diethylphenylethylamine, or N,alpha-DEPEA, that has a molecular structure similar to meth.

The substance, researchers say, is not listed on the label and has never been tested on humans.

“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.”

Driven Sports Inc., says the ingredient is different compound, N,beta-diethylphenylethylamine, derived from the dendrobium orchid and is among the list of ingredients.

“This is a related but very different substance from the one identified by NSF. It is also very difficult to distinguish these two substances unless you know precisely what you are looking for and are using the proper test methodology,” according to a company statement released Monday.

Company officials say the product is safe. “Since accusations were first made that Craze contained methamphetamine, Driven Sports has undertaken extensive analytical studies of Craze and its conclusions regarding the safety and composition of Craze have not changed: the product is safe and effective,” according to the statement.

Concerns about Craze arose late last year when two athletes who used it failed World Anti-Doping Agency drug tests and were banned from competition.

Those incidents prompted Cohen and his colleagues to run analyses on several samples of Craze. They found the products contained between 21 and 35 milligrams per serving of N,alpha-DEPEA.

The researchers also tested another supplement, Detonate by Gaspari Nutrition, and found it contains the same compound. Detonate is available online but is not sold in GNC stores or other outlets on military installations.

The news of the undeclared ingredient in Craze comes as the Centers for Disease Control and Prevention, the Hawaii Department of Health and the Food and Drug Administration are investigating an outbreak of acute non-viral hepatitis in Hawaii 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 metabolism booster touted as a weight-loss aid.

The Defense Department on Friday recommended that service members and families stop using OxyElite Pro or another USPLabs product, VERSA-1, that contains the same ingredient.

In a statement, DoD officials said troops and family members should heed Centers for Disease Control and Prevention as well as FDA guidance regarding the products, including seeing a health care provider if they feel they’ve been harmed by the product.

The FDA also sent a warning letter to Jacob Geissler, CEO of USPLabs, the company that markets OxyElite Pro, saying the product contains an unapproved ingredient, aegeline, and must immediately be removed from distribution.

The company said the ingredient is derived from the bael fruit and is a common food item worldwide.

This week, Navy and Marine Corps exchanges and on-base GNC stores stopped selling OxyElite Pro. The Army and Air Force Exchange Service stopped stocking it in December 2011 when a previous version contained a potentially dangerous ingredient, 1,3-dimethylamylamine, or DMAA.

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 must provide 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.”

On Tuesday, Driven Sports posted a notice on its website saying that while officials “continue to have no reason to believe that the Craze formula is anything but safe and effective when used responsibly” it has decided to suspend production and sale “until these issues are resolved.”

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