FDA Cites 10 Companies For DMAA Products Sold Without Evidence Of Safety
April 30th, 2012 // 2:41 pm @ jmpickett
Cracking down on dietary supplements containing a substance popularly known as DMAA, the U.S. Food and Drug Administration on Friday issued warning letters to 10 distributors and manufacturers, citing the companies for marketing the products without submitting evidence of their safety to the agency.
DMAA is dimethylamylamine, aka 1,3-dimethylamylamine, geranium extract, or methylhexanamine. It is frequently described as a so-called natural stimulant, the FDA said.
“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law [i.e., the Dietary Supplement Health and Education Act of 1994] to provide evidence of the safety of their products. They haven’t done that, and that makes the products adulterated,” said Daniel Fabricant, director of the FDA’s Dietary Supplement Program.
The FDA warning letters advised the companies the agency is unaware of either evidence or history of use that indicates DMAA is safe.
The warning letters noted that DMAA is known to constrict blood vessels, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath to tightening in the chest to heart attack.
The FDA has received 42 adverse-event reports on products containing DMAA. Although these reports do not establish that DMAA was the cause of the events, some of these incidents were associated with cardiac disorders, nervous-system disorders, psychiatric disorders, and death.
Signed by Michael W. Roosevelt, acting director of the Office of Compliance in the Center for Food Safety and Applied Nutrition at the FDA, the warning letters were sent to the following companies (whose affected products appear in parentheses):
— Exclusive Supplements (Biorhythm SSIN Juice).
— Fahrenheit Nutrition (Lean Efx).
— Gaspari Nutrition (Spirodex).
— iSatori Global Technologies LLC (PWR).
— Muscle Warfare Inc. (Napalm).
— MuscleMeds Performance Technologies (Code Red).
— Nutrex Research (Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers).
— SEI Pharmaceuticals (MethylHex 4,2).
— SNI LLC (Nitric Blast).
— USP Labs LLC (Oxy Elite Pro, Jack3D).
