Hi-Tech Pharmaceuticals finds itself as the defendant in a proposed class action lawsuit that alleges some of the supplement maker’s dietary products contain undisclosed DMHA, an illegal stimulant.
Filed in California’s Northern District by three plaintiffs, the lawsuit alleges that Hi-Tech Pharmaceuticals has a long history of including “illegal and unsafe ingredients” in its supplements, the lineup of which includes Ultimate Orange, HydroxyElite, Lipodrene Elite, Lipodrene Hardcore, Lipodrene Xtreme, and Fastin-XR, among others. According to the complaint, the defendant used to make its products with DMAA, another “powerful and dangerous” stimulant used commonly by bodybuilders, banned by the World Anti-Doping Agency and Major League Baseball, and linked to the deaths of a number of U.S. military servicemembers. Thereafter, the case continues, the FDA and a Georgia federal court seized $19 million worth of DMAA from Hi-Tech Pharmaceuticals “in order to protect consumers” before the component was affirmed in 2013 as illegal.
In late 2017, the lawsuit says, Hi-Tech Pharmaceutical owner Jared Wheat and director of contract manufacturing John Brandon Schopp were indicted in Georgia for wire fraud and money laundering. According to the lawsuit, wrapped into the individuals’ conditions of release was a ban on Hi-Tech Pharmaceuticals selling products that contain DMAA “or its chemical equivalent.”
What followed, the plaintiffs say, was the defendant’s replacement of DMAA with DMHA. The problem, the lawsuit stresses, is that with regard to the compounds’ illegality and safety, “there is no difference between DMAA and DMHA,” which have similar structures and thus produce similar effects in humans. As the lawsuit tells it, the FDA was none too pleased with the defendant’s substitution of one illegal compound with another:
“On April 10, 2019, the FDA sent a warning letter to Hi-Tech regarding the use of the DMHA ingredient in its products. The warning letter states that DMHA ‘is not generally recognized as safe under its conditions for use in HiTech’s dietary supplement products.’ The FDA explained that there is no evidence that ‘DMHA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has been chemically altered.’ Moreover, the FDA concluded that ‘dietary supplements containing DMHA as a new dietary ingredient are adulterated … because there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.’”
The plaintiffs argue that they and proposed class members are “unsuspecting purchasers” of Hi-Tech Pharmaceuticals supplements that contain a generally unsafe ingredient. The lawsuit looks to cover a class of consumers in the U.S., as well as California- and New York-only subclasses, who bought Hi-Tech Pharmaceuticals supplements.