May 7, 2012 — Since the U.S. Food and Drug Administration (FDA) restricted sales of DMAA last week, the search is on for the next stimulant drug. Ten different companies were sent warning letters from the FDA, and some of these manufacturers have announced that they will be reformulating their product. Many consumers are concerned about significant DMAA health risks, which may include high blood pressure, cardiovascular problems, heart attacks, psychiatric disorders, nervous system disorders, and death. The FDA has received 42 adverse event reports related to DMAA.
DMAA (1,3-dimethylamylamine) is an ingredient in around 200 types of dietary supplements (including OxyElite Pro, Jack3D, and more), and sales of such products exceeded $100 million in 2010. Because there is a demand for pre-workout stimulants and weight-loss supplements, it is likely that there will be a new drug to replace DMAA.
It is possible that the “next DMAA” will be synephrine, a synthetically-produced mimic of a substance found in the bitter orange peel. Since the FDA banned ephedra, many weight-loss supplements were reformulated to contain synephrine. Although synephrine is legal, unfortunately, synephrine has side effects similar to DMAA health risks. These include high blood pressure, heart attack, and ischemic stroke.
Just because a dietary supplement is legal does not mean that it is safe. By law, all manufacturers of new ingredients in dietary supplements introduced after 1994 must submit a New Dietary Ingredient (NDI) notification to the FDA before selling their product, and the NDI must contain information about the health risks and safety. No manufacturer ever submitted an NDI with information about DMAA health risks. Even more alarming, the FDA has only received a few dozen NDIs, though there are thousands of new ingredients currently used in dietary supplements.
As we have seen with DMAA, the health risks may not be known until someone is seriously injured. Stimulant drugs are designed to influence a person’s mind and body. They reduce appetite while increasing concentration, endurance, physical activity, motivation, alertness, and more. However, stimulants are known to increase blood pressure and heart-rate, and they can also have adverse psychological effects such as anxiety, tension, and irritability.
DMAA was specifically marketed toward fitness enthusiasts without warnings about DMAA health risks. During periods of intense physical activity, blood pressure normally rises, and the heart-rate increases. DMAA and other stimulant drugs can increase blood pressure and heart-rate even further, to potentially life-threatening levels.
Two U.S. soldiers who died during military training exercises were found to have DMAA in their bloodstream. The soldiers both died of cardiovascular problems. In response, the Department of Defense banned sales of DMAA supplements. Even so, the products were not officially banned in the U.S.
DMAA is not technically banned in the U.S. The FDA has only cited the manufacturers for failing to provide an NDI. However, the FDA must review safety information in the NDI and approve DMAA for use in a dietary supplement. Because the FDA has received 42 adverse event reports, it is unlikely that they will approve DMAA for use in dietary supplements.
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