FDA challenges marketing of DMAA products for lack of safety evidence

The U.S. Food and Drug Administration has issued warning letters to at least 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 the FDA. Also referred to as dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a “natural” stimulant.  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.  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 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.  The companies have a limited amount of time to respond to the FDA with the specific steps they will take to address the issues in the warning letters.

Some of the companies who were issued warnings include:

Exclusive Supplements – Product: Biorhythm SSIN Juice

Fahrenheit Nutrition – Product: Lean Flex

Gaspari Nutrition – Product: Spirodex

iSatori Global Technologies – Product: PWR

Muscle Warfare – Product: Napalm

Muscle Meds Performance Technologies – Product: Code Red

Nutrex Research – Products: HemoRage Black and Lipo- 6

SEI Pharmaceuticals – Products: MethylHex

SNI LLC – Product: Nitric Blast

USP Labs, LLC – Products: Oxy Elite Pro and Jack 3D

The attorneys at Balkan & Patterson, LLP are experienced in class action litigation and will act to protect consumers against corporate wrongdoers. If you believe you have potential for a class action involving DMAA or a similar product, please contact us immediately and we will review your case at no charge.

The law firm of Balkan & Patterson, LLP was founded in 2006 and is headquartered in Boca Raton, Florida, at 601 S. Federal Highway, Suite 302, with offices in Broward County. Mr. Balkan and Mr. Patterson can be contacted at (561) 750-9191. Additional information about Balkan & Patterson, LLP may be obtained from the firm’s website at www.balkanpatterson.com.