May 7, 2012 — The U.S. Food and Drug Administration (FDA) has recently withdrawn approval of DMAA (1,3-dimethylamylamine), a synthetically-produced stimulant drug that is currently an ingredient in approximately 200 dietary supplements. These products are mostly sold as pre-workout stimulants or weight-loss aids, though DMAA is also an ingredient in many party pills sold over the internet. Despite DMAA health risks, sales of products containing DMAA topped $100 million in 2010 alone.
The FDA is now warning that DMAA health risks may include elevated blood pressure, cardiovascular problems (heart attacks), psychiatric disorders, nervous system disorders, and death. The FDA has received 42 adverse event reports. Two soldiers who had DMAA in their bloodstream died from cardiovascular events during routine training.
DMAA is a synthetically-produced stimulant drug, similar to amphetamines and ephedrine, but much weaker. Stimulant drugs are designed to affect both the body and the mind. Mentally, stimulants decrease appetite and increase endurance, motivation, concentration, alertness, and more. Physically, stimulants elevate heart-rate, increase blood pressure, and increase movement.
These “benefits” may also cause some severe DMAA health risks. DMAA is marketed toward fitness enthusiasts, who use it as a pre-workout energy enhancer. It is an ingredient in OxyElite Pro, Jack3D, and more. However, exercise and DMAA may be a fatal combination. Exercise naturally increases heart-rate and blood pressure. DMAA can increase these even more, to potentially dangerous levels.
Many people are now seeking “clean” stimulants to avoid life-threatening DMAA health risks. Some companies are now re-formulating their products without DMAA. The product C4 Extreme, for example, is now DMAA-free. Another supplement, K-OTIC, was mistakenly included in the Department of Defense’s list of supplements banned on military bases. K-OTIC does not actually contain DMAA.
It is possible that new drugs will be reformulated to contain other stimulants, such as synephrine. Synephrine is a synthetically-produced copy of a botanical ingredient in the bitter orange peel. Since the FDA banned ephedra, synephine has been used in many weight-loss supplements. However, similar to the DMAA health risks, synephrine can cause increased blood pressure, heart attack, and ischemic stroke.
As we have seen with DMAA, just because a product is legal does not mean that it is safe. While consumers are becoming more aware of these risks, some people are concerned that the next big stimulant drug scandal is just around the corner. The workout supplement market is littered with small companies that produce a product, sell it, and then disappear.
Under U.S. law, dietary supplements that contain ingredients introduced after 1994 must submit a New Dietary Ingredient (NDI) notification to the FDA which includes safety information. However, despite the fact that there are thousands of new dietary supplements, the FDA has only received a few dozen NDI notifications. This means that it is highly likely that there are new ingredients in dietary supplements with unknown, potentially dangerous side effects.
Do I have a DMAA Lawsuit?
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