In Wake of FDA Crackdown, New DMAA Class Action Lawsuits Filed in California

Tweet

Four DMAA supplement manufacturers who received warning letters from the FDA late last month have been slapped with class action lawsuits alleging their products are ‘illegal and dangerous.’ The litigation process will be watched closely, as the cases center around a hotly-debated point of contention regarding new dietary ingredients (NDIs): that synthetic versions of botanical derivatives are not classified as dietary ingredients, and are therefore not permitted for use in supplement products.

DMAA Update 7/16/12: Researchers from the University of Texas, Arlington, recently tested and compared a number of DMAA-containing dietary supplements against commercially available geranium extracts, and detected no presence of the controversial substance in the geranium samples. The source of DMAA is a hot button issue as of late, because it could ultimately determine the outcome of a string of class action lawsuits filed against DMAA manufacturers and distributors. Click here to learn more.

DMAA Update 6/20/12: This week, Food Standards Australia New Zealand (FSANZ) warned Australians not to consume dietary supplements containing the controversial ingredient dimethylamylamine (DMAA). The Australian Federal Department of Health and Ageing and the Advisory Committee on Medicines Scheduling are considering a ban on the substance, and are set to meet at the end of the month when the problem will be ‘urgently discussed.’ Click here to learn more.

DMAA Update 5/14/12: Despite a recent FDA crackdown on DMAA-containing bodybuilding products, the Army will continue its research into the effects of the controversial dietary supplement ingredient. According to a Department of Defense (DOD) spokesperson, the military has an ‘intense interest’ in the results of the Army Public Health Command’s ongoing research on DMAA. Click here to learn more.

DMAA Update 5/8/12: Ten days after the FDA sent letters to a number of dietary supplement manufacturers requesting safety information on their DMAA-containing products, Harvard researcher Dr. Pieter Cohen is calling for an outright nationwide ban on the controversial ingredient. “The main message about DMAA is that it should be avoided,” says Cohen, who is an internist at Cambridge Health Alliance and an assistant professor of medicine at Harvard Medical School in Boston. “This ingredient should never have been in supplements in first place.” Click here to learn more.

DMAA Update 5/7/12: As DMAA’s future regulatory status appears bleak, dietary supplement manufacturers are scrambling to come up with effective alternatives. But the question remains, will DMAA’s replacement be safe to use as directed, or something just as controversial? Click here to learn more.

Free DMAA Lawsuit Evaluation: If you or a loved one has suffered a serious injury you feel may have been caused by a DMAA-containing dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the supplement and we can help.

What’s the problem?

May 4, 2012 – The new DMAA lawsuits, which were filed in the U.S. District Court, Southern District of California, are against the following companies:

• 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)

These claims follow previously filed DMAA class action lawsuits against GNC, Cellucor Sports Nutrition, Woodbolt Distribution, BPI Sports and USP Labs.

While plaintiffs contend that DMAA is synthetically produced and therefore cannot be legally sold as a dietary supplement ingredient, they also allege that it is not safe, citing passages from the FDA warning letters as well as a U.S. military probe following the deaths of two soldiers who had the substance in their systems. All four class action lawsuits are seeking damages and a jury trial.

Specifically, the lawsuits allege violation of false advertising laws, California’s unfair competition laws, and the Consumer Legal Remedies Act. The cases are:

• Anthony Velasco vs SEI Pharmaceuticals Inc.
• Derick Barkum vs Isatori Global Technologies Inc.
• Jason McKenna vs Nutrex Research Inc.
• Andrew Velasco vs Gaspari Nutrition Inc.

Much of the pending litigation, as well as the future of DMAA itself, will depend on whether scientific research can prove definitively that the ingredient is a natural derivative of geranium. Currently, there is only one highly questionable study repeatedly referenced which concludes that DMAAA is naturally occurring:

• Ping, Z.; Jun, Q. & Qing, L. (1996), ‘A Study on the Chemical Constituents of Geranium Oil,’ Journal of Guizhou Institute of Technology 25 (1): 82–85.

Despite being widely cited by supplement makers, reputable analytical testing experts have found the Ping study not to be scientifically credible, and of little realistic value.

However, all hope may not be lost for DMAA manufacturers. Forthcoming research corroborating Ping’s conclusions is expected to be published soon, according to American Herbal Products Association (AHPA) president Michael McGuffin.

“In AHPA’s view, if DMAA exists in geranium through the plant’s own synthesis processes, human-synthesized DMAA is also a lawful dietary ingredient.”

The firms targeted in the new wave of class action lawsuits have yet to respond publicly to the charges.

Do I Have a DMAA Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DMAA lawsuits. We are handling individual litigation nationwide and currently accepting new DMAA side effects cases in all 50 states.

Free DMAA Lawsuit Evaluation: If you or a loved one has suffered a serious injury you feel may have been caused by DMAA, you should contact our law firm immediately. You may be entitled to compensation by filing a DMAA injury suit and we can help.