Consumers Challenge DMAA Safety After DOD Bans Products
This article was originally published in The Tan Sheet
Executive Summary
Complaints against GNC Holdings Inc., manufacturer Cellucor Sports Nutrition and Woodbolt Distribution and against USPLabs rely on DOD’s decision to ban sales of the product at military exchanges and moves by Canadian regulators to support their arguments.
Consumer class-action complaints alleging false advertising and other consumer protection law violations by manufacturers and retailers of dietary supplements containing the stimulant 1,3-dimethylamylamine are piggybacking on the Department of Defense’s ban of the products.
The two suits were filed Feb. 15 in the U.S. District Court for the Central District of California. Consumer class action lawsuits often follow regulatory action, and California has one of the strongest consumer protection statutes in the country, making it an attractive venue in which to pursue litigation (Also see "Class Action Claims Often Follow Regulatory Action, Industry Litigation" - Pink Sheet, 30 Jan, 2012.).
In a complaint against [GNC Holdings Inc.], manufacturer Cellucor Sports Nutrition and Woodbolt Distribution, plaintiff Lynette Bates says the DMAA in C-4 Extreme does not meet the definition of a dietary supplement laid out in the Dietary Supplement Health and Education Act.
Bates and plaintiffs in a separate lawsuit against USPLabs LLC, all California residents, rely on DOD’s decision to ban sales of the product at military exchanges and moves by Canadian regulators to support their position (Also see "U.S. Military Investigates Supplement Ingredient DMAA, Bans Sales" - Pink Sheet, 9 Jan, 2012.). Neither complaint has been certified with class action status.
DMAA has no established history in the food supply, is not a substance for use in the human diet and is not a concentrate, constituent or combination of vitamin, mineral, herb or other botanical, according to Bates’ complaint filed by the Glancy Binkow & Goldberg firm of Los Angeles and the Abbey Spanier Rodd & Abrams firm of New York.
Bates disputes that any DMAA is a constituent of the geranium plant. She adds even if it were, it would be adulterated. DMAA was not marketed as a dietary ingredient before Oct. 15, 1994, the cutoff established by DSHEA for ingredients that do not require a new dietary ingredient notification, the complaint says.
The filing for a class action alleges violations of California’s Consumer Legal Remedies Act and of the state’s business and professional codes, specifically false advertising and unfair competition; breach of implied warranty; breach of express warranty; and unjust enrichment.
The Bates suit seeks to stop GNC and the other defendants from continuing the allegedly illegal business practices in addition to damages and attorneys’ fees.
NDI Draft Guidance Reemerges
The lawsuit against USPLabs, filed for Govinda Hogan and Catherine Giasone by the Kirtland & Packard firm of El Segundo, Calf., alleges DMAA not only does not meet the criteria established in DSHEA, but also is not a supplement because it does not meet the standards FDA laid out in its NDI notification draft guidance.
“Even if defendant’s DMAA is a dietary ingredient and was marketed as a dietary ingredient in the United States before October 15, 1994, it was not marketed in the same chemical composition or structure as in defendant’s products as clarified in [the NDI draft guidance],” the plaintiffs state.
Industry stakeholders and congressional allies have asked FDA to withdraw the draft guidance; the agency’s apparent ban on synthetic botanicals and the requirement that firms re-file notifications with every product reformulation are among the most common complaints .
Hogan and Giasone also allege USPLabs’ product was not prepared, packaged or held in accordance with FDA’s current good manufacturing practices.
USPLabs violated California’s business practices laws – false advertising and unfair competition – and the Consumer Legal Remedies Act, the plaintiffs say. They seek damages, attorneys’ fees and to stop USPLabs from continuing these practices.
The firm March 7 touted five published clinical trials supporting the safe use, when used as directed, of its Jack3d and OxyElite Pro products, which contain DMAA. Dallas-based UPSLabs also cited two other studies conducted on the ingredient alone, saying a total of 102 subjects participated in the seven studies and more than 1 billion servings of DMAA-containing supplements have been consumed.