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May 1, 2012 DMAA News: FDA challenges marketing of DMAA products for lack of safety evidence

In Uncategorized on May 1, 2012 at 10:31 pm

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 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
“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 had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.

The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
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.
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3/7/2012 DMAA News and lawsuit notes

In Uncategorized on March 8, 2012 at 1:07 pm

Lead plaintiff Stephen Rush has sued Nutrex Research in Federal Court. This is the next lawsuit regarding DMAA.

Rush claims that Nutrex’s leading products, including “Hemo Black Rage,” “Hemo Black Rage Ultra Concentrate,” “Lipo Black 6 Ultra Concentrate,” “Lipo Black 6 Hers” and “Lipo Black 6 Hers Ultra-Concentrate” contain dangerous levels of the stimulant DMAA, also known as 1,3, dimethylamylamine, and as methylhexanamine, and as geranamine.

DMAA, whose 1944 patent claims to be derived from the oil of the geranium plant, is a dangerous central nervous system stimulant that is on the World Anti-Doping Agency and Major League Baseball lists of banned substances, according to the 37-page complaint. “DMAA is totally banned in Canada and New Zealand. Recently, DMAA has gained popularity with young people as a designer drug used in ‘party pills,'” according to the complaint.

DMAA was developed by Eli Lilly and marketed as a decongestant in the 1970s under the trade name Forthane, the complaint states.

Rush claims that the DMAA in Nutrex’s products is purely synthetic. “Significantly, recent studies have also concluded that there is no DMAA in geranium oil at all, that DMAA cannot be extracted from geranium oil, and that all DMAA on the market is synthetic,” the complaint states.

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