Overview: The U.S. Food and Drug Adminstration (FDA) is questioning the safety of dimethylamylamine (DMAA), an ingredient used in dietary supplements marketed as a “natural” stimulant. The agency has contacted 10 manufacturers who have failed to prove that the ingredient, and subsequently their product, was safe. DMAA became a concern after two Army soldiers taking the product died suddenly last year.
|Exclusive Supplements||Biorhythm SSIN Juice|
|Fahrenheit Nutrition||Lean Efx|
|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 Hers Ultra Concentrate
Lipo-6 Black Hers
|SEI Pharmaceuticals||MethylHex 4,2|
|SNI LLC||Nitric Blast|
|USP Labs, LLC||Oxy Elite Pro
Reported Side Effects & Complications
- Cardiovascular events (i.e. heart attack)
- Liver and kidney failure
- Loss of consciousness
- Rapid heartbeat
FDA Warns 10 Manufacturers
In a letter issued April 27th, the FDA warned 10 companies (see above) their product contained an ingredient whose safety had yet to be demonstrated. The law states that ingredients marketed in a dietary supplement after October 15, 1994 require a notification submitted to the FDA as a New Dietary Ingredient (NDI), with evidence demonstrating the safety of the product. This notification is to be submitted 75 days before the product is marketed; the listed companied have failed to do this. Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program commented on these violations. “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,” according to the FDA news release.
Additionally, the agency notes that under the Dietary Supplement Health and Education Act of 1994 (DSHEA), synthetically produced DMAA does not count as a “dietary ingredient” (which is defined as a vitamin, mineral, amino acid or herb) and therefore cannot be an active ingredient in dietary supplements.
In its warning, the FDA pointed out 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 also received reports of nervous system disorders, psychiatric disorders and death in some DMAA users, although the cause has not been conclusively determined.
Suspicions Raised After Two Deaths
Last year, two soldiers using DMAA products died during physical activity; a 22-year old had collapsed in the middle of a training run last summer and a 32-year old collapsed after a physical fitness test in the fall. DMAA was found in both soldiers’ toxicology reports, but a definitive cause has not been established.