FDA challenges marketing of DMAA products for lack of safety evidence
Agency cites ten companies in warning letters
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:
Exclusive Supplements Biorhythm SSIN Juice
Fahrenheit Nutrition Lean Efx
Gaspari Nutrition Spirodex
iSatori Global Technologies, LLCle 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 Jack D
"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.
The companies have 15 business days to respond to the FDA with the specific steps they will take to address the issues in the warning letters.
For Immediate Release: April 27, 2012 Media Inquiries: Siobhan DeLancey, 301-796-4668 or 202-510-4177, firstname.lastname@example.org; Tamara Ward, 301-796-7567, email@example.com Trade Press Inquiries: Sebastian Cianci, 240-402-2291, firstname.lastname@example.org Consumer Inquiries: 888-INFO-FDA
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