On Apr. 27, 2012, the FDA sent warning notices to 10 drug companies manufacturing and distributing dietary supplements that contain dimethylamylamine, also known as DMAA. The FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.
Under law, manufacturers of dietary ingredients are responsible for notifying the FDA within 75 days of marketing their products with evidence that supplements containing new dietary ingredients are safe. "Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that..." said Daniel Fabricant, PhD, Director of the FDA’s Dietary Supplement Program, in an FDA press release.The FDA warned the pharmaceutical companies that because synthetically-produced DMAA is not a dietary ingredient, it is “not eligible to be used as an active ingredient in dietary supplements.”
According to the FDA, 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.” Forty-two adverse event reports regarding products containing DMAA have been reported.