“This pharmaceutical chemical has absolutely no place in the supplement world,” Cohen told CNBC. “We’ve seen six years of inappropriate sales for something that should not have been there in the first place.”
The U.S. Military has already banned sales of the product to personnel while it conducts an investigation. In December, the Defense Department pulled 18 DMAA-based products from stores on military bases after two soldiers in the US Army died from heart attacks. An army spokeswoman told Stars & Stripes, an independent news organization that reports on the U.S. military, that DMAA was found in their bodies following toxicology reports. The Army later acknowledged to the New York Times that it had received “reports of liver and kidney failure, loss of consciousness and rapid heartbeat” among military members who took products containing DMAA.
Even though those stores on bases were GNC stores, the company says it is confident about the safety of DMAA-related products.
“Since the military raised questions about the safety of DMAA, we reviewed our adverse events reports, had Cantox, the independent toxicology lab, do a study on the safety of the products, reviewed published peer-reviewed studies, and requested any and all safety information from the military,” said Jerry Stubenhofer, senior vice president and chief legal officer for GNC, in a statement to CNBC.
“We have pursued and have not been able to find any evidence that DMAA is a safety issue,” Stubenhofer said. “Consumer safety is paramount to GNC and we would not be selling this product if we had any indication it was unsafe.”
Vitamin Shoppe spokeswoman Susan McLaughlin said the company would not comment, as the company is in a quiet period ahead of its earnings report next Tuesday.
One vendor is not waiting for the FDA action. Amazon.com spokeswoman Tracy Ogden told CNBC on Tuesday afternoon that “we are in the process of pulling products cited by the FDA that contain DMAA."
When the Canadian government banned DMAA last year, Amazon.com sent an e-mail to anyone who had purchased a DMAA product on its site, including those in the U.S., saying that “customers who have purchased this product are advised not to use the product, and should consult with a health care professional if they have concerns about their health.” Although at least one of those letters was sent in November, Amazon.com continued to sell at least 10 different products with DMAA in it.
USP Labs has produced seven studies including a total of 102 subjects which claim to exhibit no adverse effects from its products. Cohen says many of these studies fail to describe dosage and involve a small amount of test subjects over too short a period of time.
If the testing is doubted, the company appears to demonstrate that it has strength in numbers, estimating that “one billion plus servings of DMAA-containing dietary supplements have been consumed by satisfied customers.” A spokeswoman for USP Labs said executives would not be available for comment “for a couple days.” A lawyer representing the company did not return phone calls made by CNBC.
Despite its claims of a good safety record, USP Labs admits on its bottles that its product is not meant to be taken lightly.
A bottle of OxyElite Pro warns that the product "must be used with extreme caution, only by healthy adults capable of handling its true power." The warning label tells consumers to stop using OxyElite Pro after eight consecutive weeks.
But DMAA hardly has an unblemished safety record, the magnitude of which might be made more clear as there are currently lawsuits, against companies that make DMAA products, each of which argue that the supplement is marketed illegally and is dangerous to consumers. One company being sued, BPI Sports, has already reformulated its product, 1.M.R, without using DMAA.
What Users Say
In order to get back into working out, Matthew Crooks told CNBC he took pre-workout supplement Hemo Rage Black for two days. The pumped up feeling he said he had allowed him to push his body so far that he was diagnosed with rhabdomyolsis, an extreme case of muscle breakdown. “A normal (creatine kinease) count is below 200,” Crooks said. “At the time of admittance (to the hospital), mine was 135,000.” Crooks said he spent a full week in the hospital with an IV.
“In the eight months since then, my body is still weak,” he said.
A call and email to Nutrex, which makes Hemo Rage Black, were not returned.
Daniel Barrett, a 25-year old man from San Antonio told CNBC he took Jack3d for four months when he experienced palpitations and a rapid heartbeat heading home from a session at the gym. Barrett said upon arriving at the hospital, the doctor had speculated that the otherwise healthy Barrett was taking pre-workout pills.
“I remember him telling me I was lucky my heart didn’t explode,” said Barrett, who claims he sometimes supplemented the normal dosage suggested with an extra scoop.
Although Barrett made it through, he says that, eight months later, he still has palpitations and takes a beta blocker that doesn’t help when he gets even a little bit excited.
“This experience has been a nightmare,” Barrett said.
For every unhappy consumer, there seems to be a happy one.
“It’s fine,” said Andrew Borgschulte, who has used Jack3d. “But just like ephedra, people are stupid and take too much, which means the FDA needs to ‘protect us from ourselves.’”
As far as those who blame the FDA for not doing something about DMAA in the six years it was on the market, Fabricant said the organization is “doing everything it can with competing priorities and limited resources” as science continues to stay a step ahead.
Correction: An earlier version of this story referred to the Federal Food, Drug and Cosmetic Act in the sixth paragraph. It should have referred to Dietary Supplement Health and Education Act.