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DMAA Class Action Suits Follow FDA Warnings

SAN DIEGO—Following FDA warning letters sent to various marketers of DMAA (dimethylamylamine) products, which detailed numerous ways the agency considered the products illegally marketed, plaintiffs have filed class action lawsuits against several of the companies that received the FDA letters. In one such suit, plaintiff Anthony Velasco alleged he bought MethylHex 4,2 and relied the efficacy and safety information provided by the product's developer/marketer, Florida-based SEI Pharmaceuticals.  The suit alleges the defendant's  fraudulent behavior resulted in million of dollars wrongfully taken from the product's consumers in California and nationwide.

Velasco said if he had known the product contained a dangerous ingredient—DMAA, as vilified in the FDA warning letters—he would not have purchased the product. Specifically, the plaintiff argued the product in question was marketed as providing an "elevated sense of wellbeing, improved mood, CLEAN energy, suppressed appetite and heightened focus." In addition, the product was marketed as "a powerful CNS [central nervous system] stimulant, for added energy, increased clarity and a boost in physical performance, especially valuable to athletes during calorie restriction or when a high level of focus is needed." Further, the suit alleges the defendants failed to warn of the dangers associated with DMAA.

Also highlighted in the suit was the synthetic source of DMAA, an issue FDA cited in its warning letters as evidence the ingredient is not a legal dietary ingredient. Velasco's suit calls DMAA illegal and dangerous due to its synthetic origin and presence in a natural product. Further, the suit alleges the synthetic nature of DMAA renders the product adulterated under the Federal Food , Drug and Cosmetic Act (FFDCA), which follows the FDA warning letter argument. The suit also argues the defendants were responsible for providing evidence of the product's safety, which it failed to do, and also failed to submit a required new dietary ingredient (NDI) notification.

Besides pointing to all the offenses also detailed in the FDA warning letters, the lawsuit actually references the warning letter SEI received, as well as the reported 42 adverse event reports FDA received on DMAA use, including cardiac, nervous system and psychiatric disorders, as well as death.

FDA wasn't the only prior actor name-dropped in the suit. Velasco cited the US Military's removal of DMAA products from Army,  Air Force and Navy Exchange stores at bases worldwide after two soldiers suffered heart attacks and died in 2011 during physical training and after DMAA use.

For more information, check out the seminar " Claims Substantiation and Compliance ," May 9, from 9am to 11am, at SupplySide MarketPlace in NYC. Speakers include: David Barnes, Ph.D., Director of Research, Standard Process, and Justin J. Prochnow, Esq., Shareholder, Greenberg Traurig LLP.

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