FDA WARNINGS & CLASS ACTIONS ON MANUFACTURERS

Friday, 04 May 2012 07:33
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FDA Warning Sparks New DMAA Supplement Class Action Lawsuits
By Kimberly Mirando

An FDA crackdown on supplement manufacturers using DMAA in their products has sparked a new wave of class action lawsuits seeking damages for consumers misled into believing the products were safe.

The DMAA class action lawsuits target seven recipients of FDA warning letters over supplements containing synthetic DMAA (1.3-Dimethylamylamine), a stimulant the lawsuits claim is illegal and dangerous and has been linked to several deaths.

"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.

The FDA warned the manufacturers and distributors to immediately cease distribution of supplements containing DMAA, or else face enforcement action "without further notice."

The new DMAA class action lawsuits were filed against:

SNI (Nitric Blast)
MuscleMeds Performance Technologies (Code Red)
Exclusive Supplements (BIORhythm SSIN)
SEI Pharmaceuticals (MethylHex 4,2)
Gaspari Nutrition (Spirodex)
Nutrex Research (Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black)
iSatori Global Technologies (PWR)

According to the FDA, synthetically produced DMAA is “not a dietary ingredient and is not, therefore, eligible to be used as an active ingredient in dietary supplements.” The agency also raised serious safety concerns about the stimulant, saying it can cause dangerous increases in blood pressure that could lead to a “cardiovascular event.”

We’ve reported before on the dangers of DMAA when BPI Sports was hit with a class action lawsuit last November. (See “BPI Sports DMAA Supplement Class Action Lawsuit.”)

Like BPI, many supplement makers had been claiming on their product labels that the DMAA used in their products was derived naturally from geranium oil, when in fact it was produced synthetically. This constitutes false advertising, the BPI class action lawsuit said.

Despite the FDA warning, however, the dietary supplement industry “remains united on this issue, and is adamantly opposed to the FDA’s position on the use of [DMAA],” a GNC spokesman said.

“The FDA has not produced any evidence of safety issues with this ingredient. To the contrary, GNC is aware of a number of published, peer reviewed studies that show that DMAA is perfectly safe when taken as directed,” he added.

We’ll keep you updated on the progress of the DMAA supplement class action lawsuits.

The cases are Anthony Velasco v. SEI Pharmaceuticals, Inc.; Derick Barkum v. iSatori Global Technologies, Inc.; Jason McKenna v. Nutrex Research, Inc.; Andrew Velasco v. Gaspari Nutrition, Inc.; John Calvin Anthony Baker v. MuscleMeds Performance Technologies; Herbert Reyes v. SNI; and Jose de la Rosa v. Exclusive Supplements.