Synedrex Class Action Alleges Illegal Stimulant Ingredient

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A class action lawsuit alleges that dietary supplements Synedrex and Metabolic Nutrition ESP contain the stimulant MethylPentane Citrate, which is illegal because it was not previously approved by the U.S. Food and Drug Administration.

The complaint against Synedrex manufacturer IQ Formulations LLC and distributor Europa Sports Products Inc. contends that the defendants violated the federal Food, Drug and Cosmetic Act (FDCA), as well as various state consumer protection laws by deceptively marketing the supplement.

According to the complaint, “both Synedrex and E.S.P. contain an unlawful ingredient, MethylPentane Citrate, and for that reason, each Product is similarly adulterated for purposes of the FDCA, and similar state laws, and is unsafe for human consumption, and cannot be lawfully sold to consumers.”

The Synedrex class action lawsuit states that the market for items like diet pills and meal replacement is more than $3 billion a year. The class action asserts that IQ Formulations has tried to set its product apart from this crowded market by including an illegal ingredient, MethylPentane Citrate, which is also known as DMBA.

The complaint explains that the FDCA requires dietary supplements to only contain ingredients that “have been present in the food supply” without alteration, or there is a history of use or “other evidence of safety” that is provided to the Food and Drug Administration (FDA) at least 75 days before selling the supplement.

The class action alleges that Synedrex failed both of those tests. In April of 2015, the FDA issued warning letters to several companies about using DMBA, “which had not been submitted for notification to the FDA.” The complaint claims that IQ Formulations and its exclusive distributor Europa Sports Products similarly have been using DMBA without prior submission or approval from the FDA.

“Defendants were fully aware that DMBA was an NDI, but nevertheless included DMBA as an unlawful dietary ingredient in its Synedrex and E.S.P. Products,” according to the class action.

Plaintiff Joshua DeBernardis states that he lives in Grayslake, Illinois, and purchased Synedrex online from Walgreens in September of 2015 for $37.99. Plaintiff Christina Damore is a resident of New York, and bought Synedrex in 2015 and 2016 online from NaturalBodyInc.com for $59.95 a container. Both plaintiffs claim that they “would not have purchased the Products if they had been aware of its misleading labeling, and the true nature and quality of the Products.”

The illegal supplement lawsuit requests certification of a Class of all persons in the U.S. who purchased Synedrex or Metabolic Nutrition ESP. The complaint also asks for two subclasses for Illinois and New York residents, under their specific state consumer protection statutes. The class action seeks restitution, punitive damages and an injunction stopping the defendants from their unlawful business practices.

DeBernardis and Damore are represented by Rachel Soffin and Jonathan B. Cohen of the Morgan & Morgan Complex Litigation Group, Joseph J. Siprut and Micheal L. Silverman of Siprut PC, and Nick Suciu III of Barbat, Mansour & Sucui PLLC.

The Synedrex Dietary Supplement Illegal Stimulant Class Action Lawsuit is Joshua DeBernardis, et al.  v. IQ Formulations LLC, et al., Case No. 1:17-cv-21562, in the U.S. District Court for the Southern District of Florida, Miami Division.