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Old 03-19-2013, 12:09 PM   #1
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Default Sports Supplement Linked to Cardiac Issues, Death

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The Army is investigating a popular workout booster ingredient called dimethylamylamine (DMAA) and its potential link to the deaths of two soldiers at US military bases. Americans spend more than $100 million a year on sports supplements containing DMAA, which is also known as “geranium extract” because it can supposedly be found in Chinese geraniums.

“This is the most dangerous ingredient sold today in supplements in the United States," Dr. Pieter Cohen, an internist at Harvard Medical School, told NPR.

Among the products that contain DMAA—a powerful stimulant—are Jack3d, advertised on the GNC website as providing “ultra-intense muscle-gorging strength, energy, power & endurance,” and OxyElite Pro.

DMAA has been banned by the World Anti-Doping Agency, the National Collegiate Athletic Association, and Major League Baseball, but is still sold at GNC, the Vitamin Shoppe, and other stores.

Cardiac Arrest After Using Jack3d
Last year, Private Michael Lee Sparling went into cardiac arrest after running for about 10 minutes with his unit at Fort Bliss, Texas. The 22-year-old soldier had taken the recommended dose of Jack3d, bought at a GNC store on the base, prior to exercising, according to the New York Times. Sparling had recently completed basic training and was reportedly in excellent physical shape.

Another soldier, 32, at the same base also died last year after taking a physical fitness test. Toxicology reports showed that both soldiers had used DMAA.

Case reports about the two deaths appeared in the journal Military Medicine, in a paper stating in part, “Our cases highlight concerns that DMAA in combination with other ingredients may be associated with significant consequences, reminiscent of previous adverse events from other sympathomimetic drugs previously removed from the market,” such as ephedra, a stimulant that was banned after the FDA linked it to increased risk for heart problems and stroke.

Starling’s parents have filed a wrongful death suit against UPS Labs (the maker of Jack3d) and GNC (where the supplement was purchased) alleging that the companies deceptively marketed the workout booster as safe and effective, while failing to warn customers of its potential risks, the New York Times reports.

As a precaution, the Defense Department has removed all DMAA products from stores on military bases, including more than 100 GNC outlets, according to an Army spokesman.

FDA Warning Letters About Heart Attack Risk
Last year, the FDA sent warning letters to 10 manufacturers and distributors of dietary supplements containing DMAA—including USPlabs, LLC—charging that they were marketing products without submitting required evidence of safety.

Specifically, the warning letters stated that, “DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.”

The FDA also warned the companies that synthetic DMAA is not a “dietary ingredient” and therefore is “not eligible to be used in a dietary supplement.”

As of mid-February of this year, the FDA has received about 80 reports of health problems in people who took DMAA supplements, including five deaths: three in people who took Jack3d; one in a user of OxyElite, a fat-burning supplement also made by USPlabs, and one in a consumer who used both products, according to the New York Times.

The reports also described people being hospitalized for heart attacks, heart failure, kidney failure, and liver failure. However, the FDA emphasizes that these anecdotal reports don’t prove any cause-and-effect relationship between the supplements and these disorders.

Death of a Marathon Runner
Claire Squires, 30, collapsed and died during the final leg of the 2012 London Marathon. In an inquest report released in January the coroner stated, “She had taken a supplement containing DMAA, which, on the balance of probabilities, in combination with extreme physical exertion caused acute cardiac failure, which resulted in her death."

"My hope is that the coverage of this case and the events leading up to Claire's death will help publicize the potentially harmful effects of DMAA during extreme exertion,” according to BBC News. Squires’ boyfriend said that she’d put a scoop of a DMAA product in her water bottle before the race.

DMAA products have been withdrawn from several European countries and in August, 2012, the Food Standards Agency warned people not to consume the stimulant, saying that it could be fatal or cause serious health problems, BBC News reports.

DMAA is also listed on product packaging as geranium extract, geranamine, methylhexanamine, and 4-methylhexane-2-amine.


GNC Responds to Safety Concerns
When I contacted GNC, spokesperson Laura Brophy sent the following responses by email:

•GNC has no reason to believe that DMAA is unsafe.
•GNC, as a matter of corporate policy, does not comment on pending litigation.
•GNC sells legal products that are widely available at a variety of retail outlets, both in-store and online, and that comply with all relevant regulatory guidelines in the markets in which they are sold.
•GNC brand products are clearly labeled in terms of ingredients and possible restrictions on use, including age of the consumer.
•Different professional sports leagues and sports regulatory bodies have different guidelines for use of specific supplements or ingredients. We do believe that it is an athlete's responsibility to conform to the rules and regulations of his or her league or sport.
•However, through a partnership with the globally renowned HFL Sports Science accredited laboratory, GNC now provides Banned Substance Free/HFL Testing throughout GNC’s performance nutrition line, eliminating the concern athletes, parents, coaches, and trainers may have relative to banned substances in organized sports.
•Other products sold by GNC are manufactured by third party vendors. With third party products, GNC is simply the retailer and, like all retailers, relies upon the representations and contractual warranties made by the vendor that the products are safe and compliant with all applicable laws and regulations. Questions with respect to the sourcing of ingredients should be directed to the manufacturers of the product that contain those ingredients.
•GNC, as a responsible retailer, complies with all regulatory mandates and requests, including product recalls.
•GNC does not manufacture any private label products that include DMAA as an ingredient.
Sports Supplement Linked to Cardiac Issues, Death | Yahoo! Health
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Last edited by BigJosh; 03-19-2013 at 12:32 PM.
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