| FDA challenges marketing of DMAA products for lack of safety evidence Agency cites ten companies in warning letters The US 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 companies receiving warning letters and their product names are: Company Product(s) 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 "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 and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA's Dietary Supplement Program. Specifically, the warning letters cite the companies for marketing products for which a notification ... |
