Dietary supplements containing dimethylamylamine, more popularly known as DMAA, are often distributed in products advertised to help reduce body fat. For example, LEAN-EFX, a product containing DMAA is “formulated to help reduce body fat and sculpt your body, producing a lean athletic build. Increased energy, an elevated mood.” Spirodex is a separate product advertised as a “mood and energy supplement”. The claims do vary by product. The FDA has brought a complaint against several manufacturers including GNC, stating that the products are not “natural stimulants” but rather new dietary supplements which must be proven safe. The FDA has stated that DMAA products may cause cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. A California class action was brought in February 2012, where motions to dismiss are now pending.
FDA NOTICE
On April 27, 2012, the FDA issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine (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:
"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.
As of May 2, it appears at least Spirodex from Gaspari Nutrition has been pulled off the market. On April 27, 2012, GNC spokesperson Greg Miller responded to the FDA complaint arguing that the action is both factually and legally unfounded, citing that GNC was unaware of any scientific or medical evidence which calls the safety of DMAA into question.
LITIGATION - DMAA CLASS ACTION FILED
At least one DMAA class action has been filed as of May 2, 2012 against manufacturers of DMAA containing products, such as GNC. The DMAA class action case number is 2:12-cv-01336-ODW-AJW and the DMAA class action case caption is Lynette Bates v. General Nutrition Centers Inc. filed in the Central District of California. The plaintiff is seeking class action status. The DMAA Class action was filed in February 2012, which seeks to form a national class on behalf of all domestic consumers of “C-4 Extreme,” a DNAA containing product manufactured by Cellucor, a Pennsylvania company. The DMAA class action claims that while the product is sold as a "dietary supplement" rather than a "drug" the DMAA contained in C-4 is wholly synthetic and not derived from the geranium plant. The DMAA class action is for alleged violations of California consumer protection remedies. The DMAA class action is for alleged breaches of implied and express warranties and for unjust enrichment. If you or someone you know take or has taken DMAA, please contact by clicking here or calling 1-800-621-1062. We are investigating a potential DMAA class action.
Friday, May 25, 2012 at 01:44PM