April 17, 2012 — The U.S. Food and Drug Administration (FDA) has sent warning letters to 10 different manufacturers of dietary supplements containing DMAA. The products have recently come under scrutiny after being linked to two deaths and dozens of severe adverse event reports. Supplement manufacturers have held onto the claim that DMAA is a natural substance derived from the geranium plant, has been used in food for years, and millions of doses have been consumed without problem. In the warning letters, the FDA contends 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.”
The FDA also took aim at the claim that DMAA has been used in the food supply for many years. “There is no information demonstrating that DMAA was lawfully marketed as a dietary ingredient in the U.S. before October 15th 1994, nor is there any information demonstrating that it has been present in the food supply as an article used in food in a form in which the food has not been chemically altered.”
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements that contain ingredients introduced after 1994 must submit a New Dietary Ingredient (NDI) notification to the FDA 75 days before the product is sold. The notification must provide the FDA with evidence regarding the safety of the new ingredient.
The manufacturers of DMAA have never provided the FDA with an NDI notification, and therefore, products containing DMAA are illegally adulterated. The ten manufacturers have 15 days to respond to the warning letters, or they will face enforcement action without any more warnings.
The following manufacturers received warnings:
- USP Labs, LLC (Oxy Elite Pro, Jack3D)
- 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, and Lipo-6 Black Hers)
- SEI Pharmaceuticals (MethylHex 4,2)
- SNI LLC (Nitric Blast)
The FDA also took the opportunity to note that DMAA side effects may be life-threatening or deadly. “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 FDA has received 42 severe adverse event reports linked to DMAA. Although the reports do not prove that DMAA caused the events, they are a warning sign. They also contradict manufacturers’ and retailers’ claims that only a few adverse events have ever been reported. The FDA has been notified about incidents including cardiac disorders, nervous system disorders, psychiatric disorders, and death.
In 2011, DMAA was discovered in the bloodstream of two U.S. soldiers who died of severe heart attacks during physical training exercises. In response, the Department of Defense banned the sales of DMAA-containing dietary supplements on all U.S. military bases.
DMAA is still legal in the U.S. It is mostly marketed toward fitness enthusiasts who like to take energy-boosting supplements before working out. It has stimulant effects similar to amphetamines, but much weaker. DMAA supplements are also marketed toward people who are looking to lose weight. DMAA is also sold as a recreational drug, sold mostly over the internet as party pills.
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