Researcher Calls on FDA to Implement Ban on DMAA

Researcher Calls on FDA to Implement Ban on DMAAA leading medical researcher has added to the call for a full ban on the dietary and weight loss supplement additive dimethylamylamine (DMAA).

According to a Boston Globe report, a researcher at Harvard University Medical School has authored a “research letter” for publication in the journal Archives of Internal Medicine urging the Food and Drug Administration (FDA) to act on a warning letter the agency sent to 10 makers of supplements containing the additive DMAA.

Recently, the FDA notified 10 manufacturers of DMAA supplements to stop distributing their products until they can provide evidence of the additive’s safety. Manufacturers claim and promote their products containing DMAA as having medical qualities in that it can help a person lose weight. These supplements are marketed as both weight-loss and workout supplements.

The agency believes DMAA causes a narrowing of the arteries which can lead to heart attacks, stroke, or even sudden death. These supplements have been implicated in two recent deaths of U.S. soldiers who had traces of the chemical in their system after they died following a workout on military bases. These supplements have also been linked to other less serious complications but serious enough to warrant a warning letter from the FDA, including panic attacks, dizziness, and seizures.

While the FDA has imposed a strict deadline to remove these products from stores unless their makers can provide evidence that DMAA is medically safe, the Army has pledged to continue its review of the effects of the supplements on soldiers. The FDA established in its warning letter that making medical claims on these supplements requires any manufacturer to provide evidence that it is safe for human use and that risks of taking these products do not outweigh any potential benefits. Otherwise, the agency considers the products “adulterated” and does not permit their sale. Removing these claims would force purveyors of these DMAA supplements to find alternative retailers to market them, taking them out of health and fitness stores and relegated to convenience store counters, without those same health benefit claims attached.

In his letter to the journal, Dr. Pieter Cohen writes that DMAA has essentially replaced epheda in many dietary supplements and claims “in animal models DMAA has been shown to be more potent than ephedra.”

One major national retailer of health and fitness supplements, GNC, responded to the FDA’s warning letters last week even though it does not manufacture the products. The stores sell DMAA products like Jack3D and Oxy Elite Pro, according to The Globe report. In a statement last week, the store chain disputed the FDA’s charges that DMAA was unsafe.

Cohen’s letter states that little evidence exists on the exact dangers of DMAA but just as little evidence exists on its safety. He admitted in his letter than one patient of his who hadn’t experienced any side effects since taking the supplement felt it was safe because of where she purchased it.

This entry was posted in DMAA Supplements, Pharmaceuticals and tagged . Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.