May 1, 2012 - The U.S. Food & Drug Administration (FDA) has issued stern warning letters to 10 manufacturers and distributors of dietary supplements containing dimethylamylamine (DMAA) for marketing products whose safety has not been proven.
The FDAʼs action was largely anticipated by plaintiff lawyers and their clients around the country. Over the past several months, a growing number of DMAA lawsuits have been filed in courthouses nationwide on behalf of individuals who have allegedly been injured after consuming dietary supplements containing the controversial ingredient.
"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 FDA statement said.
Earlier this year, the Department of Defense halted sales on products containing DMAA in military facilities following the deaths of two soldiers. In the summer of 2011, a 22- year-old soldier fell down and died during a jog at a military base in the Southwestern US. Months later, a 32-year-old soldier collapsed during a routine fitness test and later died after a month in the hospital. Test results revealed that both soldiers died from cardiac arrest after taking supplements containing DMAA.
Under current law, companies selling products containing certain ingredients that were not marketed in a dietary supplement before Oct. 15, 1994, are required to notify the FDA of their safety. According to the administration, absolutely no credible scientific evidence exists showing that DMAA is a safe ingredient, and the companies who received warning letters have failed to meet this basic requirement.
As defined by the Dietary Supplement and Health and Education Act (DSHEA) of 1994, synthetically-produced DMAA is not classified as a dietary ingredient, and is not legal for use in supplement products. DSHEA lists vitamins, minerals, amino acids, herbs, and other botanicals, "a dietary substance for use by man to supplement the diet," or a concentrate, metabolite, constituent, extract, or combination of those substances as dietary ingredients.
The United Natural Products Alliance (UNPA) has stated that supplement makers should not label DMAA as geranium oil, or as any other part of the geranium plant, due to the fact that only one questionable study is repeatedly referenced to show that the ingredient is a naturally occurring constituent of geranium oil (Ping, Z.; Jun, Q. & Qing, L. (1996), ʻA Study on the Chemical Constituents of Geranium Oil, Journal of Guizhou Institute of Technology 25 (1): 82–85).
The FDA warning letters were sent to these companies regarding the following DMAA- containing dietary supplements:
iSatori Global Technologies, LLC Muscle Warfare, Inc.
MuscleMeds Performance Technologies Nutrex Research
SEI Pharmaceuticals SNI LLC
USP Labs, LLC
Biorhythm SSIN Juice Lean Efx
Hemo Rage Black
Lipo-6 Black Ultra Concentrate Lipo-6 Black
Lipo-6 Black Hers Ultra Concentrate Lipo-6 Black Hers
OxyElite Pro Jack3d
Dimethylamylamine is structurally similar to amphetamine, and was originally synthesized as a nasal decongestant by pharmaceutical giant Eli Lilly in the 1940s. Although the company stopped marketing DMAA in the 1950s, medical literature from that era warned doctors that the substance was more potent in animals than ephedrine, an amphetamine-like stimulant. A growing number of professional sports and supplement industry experts have claimed that companies marketing DMAA as a dietary supplement are exploiting glaring legal loopholes and putting the safety of the public in jeopardy.
In February 2012, a DMAA class action lawsuit was filed in Los Angeles federal court. The complaint states that DMAA is “illegal and dangerous,” and that “experts in the industry have become concerned that this potent stimulant drug will lead to serious health issues and even death.”
The claim was filed on behalf of California resident Lynette Bates, who purchased a pre-workout dietary supplement called C4 Extreme, a product that allegedly promises ʻexplosive workouts.ʼ Among other things, the suit is accusing GNC and Cellucor Sports Nutrition of “making false and unsubstantiated representations concerning the efficacy, safety and legality of C4 Extreme.” Woodbolt International, Cellucorʼs parent company, is also named in the complaint.
Michael E. Schmidt is recognized as one of Americaʼs most passionate, accomplished and skilled trial lawyers. His law firm, Schmidt & Clark, LLP and The Senators Firm, LLP are currently accepting DMAA lawsuits in all 50 states. To learn more about this topic, please visit his website: http://www.schmidtandclark.com/dmaa-dimethylamylamine