DMAA supplements Jack3d, OxyElite Pro are drugs and aren’t healthy — health experts say. Consumers beware. In this fitness-crazy world that peddles getting six-pack abs as the ultimate life goal, another dietary supplement, popular with athletes and fitness enthusiasts, has been linked to cerebral hemorrhage, heart attacks and death.
The bestselling products, found in major retail chains like GNC and Vitamin Shoppe or sold online by websites like bodybuilding.com, include Jack3d, a “preworkout booster,” and OxyElite Pro, a fat burner.
Fitness buffs swear by these supplements because they contain 1,3-dimethylamylamine or DMAA, advertised to increase energy, concentration and metabolism. Many fitness enthusiasts love Jack3d, because, as advertised online, it does “give you the mad aggressive desire and ability to lift more weight, pump out more reps and have crazy lasting energy.”
But a growing number of health experts and even regulatory authorities across the globe say the supplements are not natural — and in fact, contain a powerful amphetamine-like stimulant that has potentially life-threatening side effects.
Health emergencies have been severe enough to prompt the United States Army to pull the supplements off the shelves of its military stores and to order a probe into the products.
“DMAA is illegal in the European Union and should be stripped from shelves,” says the United Kingdom’s Council for Responsible Nutrition (not affiliated with the U.S. CRN).
Health Canada has also classified DMAA as a drug that needs authorization, declaring that it isn’t naturally found in geranium—as the makers of the supplements claim. In addition, New Zealand’s Ministry of Health has moved to make DMAA available only to over-18s.
Last June (2011), the U.S. Anti-Doping Agency warned athletes that use of Jack3d (pronounced “jacked”) or OxyElite Pro could cause a positive result for methylhexaneamine, a prohibited stimulant.
The warning came after at least 76 international athletes since 2008 found themselves receiving bans from the International Association of Athletics Federation (IAFF) for DMAA doping violations. DMAA is listed as a banned stimulant by the World Anti-Doping Authority, the international body that regulates drug use by Olympic athletes. Several professional sports leagues have done so, as well.
So far, the U.S. Food and Drug Administration and the U.K.’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), have said they will consider investigating the products, adding to ongoing probes in Italy and France.
US army investigates deaths
On Feb. 2, the U.S. Army told the New York Times that it was looking into whether the products, available until recently at stores in the country’s military bases, played a role in the deaths of two soldiers.
A 22-year-old soldier had collapsed at an Army base in the Southwest U.S. during a training run with his unit and another 32-year-old soldier from the same base also collapsed after taking a physical fitness test.
Army spokesman Peter Graves said both soldiers, whom he declined to identify, died of heart attacks and DMAA was identified in both men’s toxicology reports.
The Army had also received some reports of rapid heartbeat, seizures, loss of consciousness and liver and kidney failure in other military personnel who have used products containing DMAA, Graves said.
Pending the completion of an Army safety review, the Defense Department took precautions and removed all products containing DMAA from stores on military bases, including more than 100 GNC shops, Graves said.
In higher dosages, DMAA is also used illicitly as a “party drug” and its use that way has been linked to emergency room visits.
In New Zealand, a 21-year old man suffered a “cerebral hemorrhage” shortly after taking two DMMA-laced “party pills” in 2010, according to health news site Nutra Ingredients. Testing revealed that the capsules contained 278 mg of DMAA.
But according to three doctors, writing in the New Zealand Medical Journal, this wasn’t the first case DMAA recreational use was linked to cerebral hemorrhage.
In a paper describing cases of DMAA-triggered cerebral hemorrhage, Dr. Paul Gee, Dr. Suzanne Jackson and Dr. Josie Easton note, “cerebral hemorrhage is associated with both episodic and chronic stimulant use.”
According to Nutra Ingredients, three cases of severe headache with vomiting and one case of cerebral hemorrhage, all associated with DMAA use, were also detailed by a New Zealand Ministry of Health document in 2009.
Exploiting lax rules
Makers of DMAA-containing supplements, as well as retailers, claim their products are dietary supplements, and under U.S. laws, dietary supplements don’t need FDA approval before they are sold. But the law applies for as long as the products only contain supplemental dietary ingredients like vitamins or minerals.
Several prominent professional sports and supplement industry experts say, however, that the companies that make and sell DMAA as a dietary supplements are exploiting lax regulations—and putting consumers at risk.
“How is this possibly being legally sold under the current rules for dietary supplements?” asks Travis Tygart, chief executive of anti-doping agency USADA and an advocate for tighter regulation of supplements.
Experts also urge the U.S. FDA should follow Health Canada’s lead and classify the product as a drug, which would mean it would approval from drug regulators.
Right now, DMAA exists in a “regulatory grey area” in the U.S. because there’s ongoing debate about whether it’s sourced from the geranium plant or not, a New York Times reports says.
Clearly, pharmaceutical industry history shows that DMAA is a drug. First manufactured synthetically by drug giant Eli Lily in the 1940s, it was sold as a nasal decongestant called Forthane in 1971, before it was pulled out of the market. But in today’s supplements, it’s commonly labeled as a derivative of the geranium plant.
According to Dr. Pieter Cohen, a Harvard Medical School assistant professor of medicine who studies tainted dietary supplements, medical literature in the 1950s warned doctors that DMAA was more potent in animals than ephedrine, an amphetamine-like stimulant.
Dr. Cohen, also an internist at the Cambridge Health Alliance, tells the New York Times he was worried over the results of a recent study that showed OxyElite Pro triggered cold sweats, increased blood pressure and other health responses that may foreshadow serious heart problems.
“Unfortunately, what we have now is pharmacological levels of an amphetamine derivative easily available,” he says.
Not from geranium oil
Currently, the U.S. FDA has joined European investigations being conducted in Italy and France into the source of DMAA in the dietary supplement-products—and these will likely to be banned if they are found to have DMAA that is synthetically sourced.
Only a single 1996 study from China shows that DMAA is naturally occurring in geranium oil, but researchers from Australia’s National Measurement Institute studied the supplements and concluded that labeling these as containing geranium oils was nothing more than a “marketing ploy.”
According to Ed Wyszumiala, general manager of dietary supplements programs at the NSF International, the nonprofit group that provides environment and health standards development services, there isn’t any new evidence supporting the 1996 study. “I haven’t seen any published research supporting it,” he tells the health news site Nutra Ingredients.
And even if it was “hypothetically true” that the supplements in question have DMAA that is sourced from geranium, he points out, and “you would need thousands and thousands of tons of geranium starting material to produce even a tiny quantity of DMAA.”
Aside from the fact that this would be costly and prohibitive, it does not appear to be the practical solution. “You can’t go out and buy metric tons of this stuff,” he says.
One billion doses is good proof
In a statement, USPlabs in Dallas, maker of the supplements in question, says there was no medical evidence to suggest the products are dangerous when used as directed. The company says it stands by the safety of its products and is fully cooperating with the inquiry by the Defense Department.
“There have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among people who used the products as directed, says Kerri Toloczko, a USPlabs spokeswoman in a statement.
USPlabs is run by Jacobo E. Geissler, who, according to the company’s website, studied nutrition at Texas A&M. Court records show that in 2003, before he started USPlabs, Mr. Geissler was criminally charged in Texas with buying illegal steroids, the New York Times reports. He pleaded no contest and served a term of community service.
Last December (2011), a class-action suit was filed in California against USPLabs, and on behalf of all persons who purchased Jack3d and OxyELITE at any time during the past four years. Also in California, a similar class suit has been filed against BPI Sports LLC, maker of 1.M.R.
DMAA is also known as methylhexaneamine, dimethylpentylamine (DMP), 4-methylhexan-2-amine, Geranamine, and geranium oil, extract, or stems and leaves.
Other products sold as dietary supplements that openly list these substances on their labels are Lipo-6-Black and Hemo-Rage Black (Nutrex), Spriodex (Gaspari Nutrition), F-10 (Advanced Genetics), Clear Shot (E-Pharm), 1.M.R. (BPI Sports)—aside from Jack3d and OxyElite Pro (USP Labs).
The problem with supplement industry
It’s illegal in the U.S., but marketing drugs in the guise of supplements is a widespread problem that’s keeping Federal authorities struggling to identify these products, some of them black-market goods.
There’s little evidence to back up the fantabulous claims made by makers of many dietary supplements and proof that they provide real health benefits is scarce.
But multivitamins, gingko biloba and other legal supplements make up a growing, multibillion industry. Market research firm Nutrition Business Journal estimates that in 2010, Americans spent US$28.1 billion on these supplements, up from US$21.3 billion five years ago.
Millions of dollars more are spent every year on black-market products—especially those that are marketed for weight loss, bodybuilding and sexual enhancement.
The FDA says some of these products contain compounds like the active drug in Viagra, synthetic steroids, laxatives—and amphetamines. Health officials say such products can cause heart attacks and strokes, can damage the kidneys and liver, and have actually led to a few deaths in the U.S.
Trade groups are worried that tainted supplements are destroying the industry as a whole.
“We want to protect consumers, but we also don’t want to alarm consumers so they stay away from the whole marketplace,” Steve Mister, president of the Council for Responsible Nutrition, a trade group in Washington that represents supplement manufacturers and ingredient suppliers tells the New York Times in a report.
Consumers wanting to avoid serious health risks from dubious products should buy recognized brands—like Centrum, One A Day and Nature Made—from its members, Mister advises. Buyers should avoid supplements that make miracle claims, he says.
But the truth is, tainted products are not merely a fringe problem. Three years ago, major chains had to withdraw from their stores StarCaps, a weight-loss brand marketed as a papaya-based supplement, after reports showed that it contained a powerful diuretic. And now, the furor over Jack3d and OxyElite Pro.
Meanwhile, trying to get tainted products off the market is expensive and time-consuming for the FDA, which has to buy the suspect products and test them in an agency lab.
Consumers—who find it hard to distinguish genuine dietary supplements from the “bad ones” because they are marketed with the same enthusiastic claims—are left at risk.