Beginning of the End for DMAA?

Posted By elissa on Apr 29, 2012 | 1 comment

Straight from the horse’s mouth:

FDA challenges marketing of DMAA products for lack of safety evidence

Agency cites ten companies in warning letters

The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.

Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a “natural” stimulant.

…The FDA letters noted that 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 agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.

The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.

The companies have 15 business days to respond to the FDA with the specific steps they will take to address the issues in the warning letters.

The companies that received warning letters are: Exclusive Supplements, Fahrenheit Nutrition, Gaspari Nutrition, iSatori Technologies, Inc., Muscle Warfare, Inc., Muscle Meds Performance Technologies, Nutrex Research, SEI Pharmaceuticals, SNI LLC and USP Labs, LLC.