A warning letterwritten by the Food & Drug Administration last week to ten companies that produce pre-workout supplements with the ingredient dimethylamyamine (DMAA) has sent shockwaves through the industry, not only for the producers of the products but to consumers who have taken them.
The FDA said in the letter that the companies had failed to demonstrate that DMAA was safe and, perhaps more significantly, failed to even prove that DMAA was in fact a dietary supplement. The FDA has given the companies 15 days to answer the organization’s questions about the ingredient.
But the move has already prompted one major retailer, Amazon, to stop carrying the DMAA products.
And shares of the top vendors that market and sell products with DMAA in it, including OxyElite Pro, Jack3d (pronounced “Jacked”), Muscle Warfare Napalm and Hemo Rage Black, dropped on Monday. Shares of GNC closed down 4.7 percent, while Vitamin Shoppe fell 3.7 percent as investors speculated on the potential damage should products with the ingredient be pulled from the market entirely.
In order for that to happen, the FDA doesn’t even have to prove that DMAA is unsafe. All it has to prove is that DMAA isn’t derived from a plant, mineral, vitamin or herb. That would mean that DMAA in fact is not defined as a dietary supplement and therefore, as a drug, needs pre-market approval by the FDA.
Marketers of the products that use DMAA as an ingredient claim that it’s a dietary supplement because it is derived from the oil within the geranium plant. They cite a 1996 study from China. As geranium oil has been used in food, the companies who make DMAA work under the assumption that they don’t have to get FDA approval, which is needed for any new dietary supplement not used in food before 1994, as required by the Dietary Supplement Health and Education Act (DSHEA).
Those that make dietary supplements do not need to seek FDA approval before marketing and selling them, but the FDA does have the power to question the safety of these products and, if necessary, remove them from the marketplace, as it did with ephedra in 2004.
In the letters written to the companies the FDA stated that it simply didn’t have the evidence that DMAA deserved to be classified as a dietary supplement. The companies are now pressed with coming up with the data that shows otherwise.
They can also try to prove that DMAA is in fact connected to the geranium plant even though at least seven studies failed to find the connection and the American Herbal Products Association (AHPA), the only national trade association that is focused on herbs and herbal products, informed its members that DMAA should not be labeled as a product of geranium as of January of this year.
They also have to prove that DMAA occurs naturally in geraniums. “Strawberries have lead in them, but that doesn’t mean you can make lead a dietary ingredient,” said Daniel Fabricant, director of the FDA’s Dietary Supplement Program.
If the companies fail to make their case, the FDA can immediately begin to order that the sales be halted or start to seize products. That would follow what Health Canada, the FDA equivalent in Canada, already concluded in July of last year, when it banned DMAA. It concluded that it was not in fact a dietary supplement and instead was a drug that needed further approval.
DMAA was first brought to market in the 1940s by pharmaceutical giant Eli Lilly and was used in a nasal decongestant until the early 70s.
It is only within the last six years that DMAA exploded as an ingredient in pre-workout supplements. The first products that contained the substance included "The Clear Shot," which were developed by Patrick Arnold, the famous BALCO chemist who made "the clear" that sprinter Marion Jones and baseball player Barry Bonds took.
Those who have used DMAA-based products told CNBC they felt like they could run through a wall and lift weights that they maintain they couldn’t lift if they hadn’t been taking the substance.
“When it was studied in animals in the 1940s, it was deemed to be less potent than amphetamine, but more potent than ephedra,” said Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who specializes in the dangers of dietary supplements.
Amphetamine is found in prescription medications such as ADHD drugs like Adderall and Dexedrine. Its most common name by those that use the drug illegally is speed. Amphetamine, which previously used to be called greenies by athletes because of the color of the pill, is considered a performance-enhancer and is banned by the World Anti-Doping Agency.
In part to respond to studies that dispute DMAA’s origins, USP Labs, makers of OxyElite Pro and Jack3d, say on a Web site it created, called dmaaresearch.com , that results have been skewed since the studies did not specifically use Chinese geraniums.
“This substance that is being produced has nothing to do with plants,” said Cohen, who is also a general internist at the Cambridge Health Alliance, a network of hospitals in Boston. “It does not exist in nature and has never been used in the form it is being used in now,” said
Dr. Cohen says there have not been many formal complaints about DMAA-based products because people don’t know that they have the ability to report it to the likes of GNC or the FDA. Cohen himself said he has filed some of what makes up the 42 “adverse event reports” that the FDA has received.
Cohen says he has seen many patients, who have admitted to him they were using pre-workout products, whose symptoms mirror that of amphetamine use: Young men who come in to see him with everything from a panic attacks and cold sweats to chest pains to tingling in their extremities.
'NO PLACE IN THE SUPPLEMENT WORLD"
“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.