Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) and its President and Chief Operating Officer filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from continuing to seek removal of DMHA products from commerce through the issuance of warning letters and “pressure… to remove and destroy DMHA containing products.” Plaintiffs allege that FDA has failed to meet its burden of proof in showing adulteration, as required by section 402(f)(1) of the FFDCA, and that the agency is circumventing its statutory obligation to engage in rulemaking to “formally ban” DMHA.
Plaintiffs argue that DMHA “is a natural constituent of walnut trees” with “an extensive history of use in dietary supplements,” and that “there is a significant body of scientific evidence supporting the safety of DMHA for human consumption.” Although Plaintiffs do not explicitly state whether the DMHA in their products is naturally derived or synthetically produced, they assert that “[d]ietary ingredients include both naturally occurring and synthetically produced versions of the same ingredient,” and that “FDA has recognized the equivalence of natural vs. synthetically produced dietary ingredients in the context of several vitamins and other ingredients.”
Plaintiffs allege that FDA’s actions violate the Administrative Procedure Act in that they are contrary to law, exceed the agency’s statutory authority, and are arbitrary and capricious. Plaintiffs further allege that FDA’s actions violate the Fifth Amendment by depriving Plaintiffs of due process.
As noted in the complaint, Hi-Tech is already engaged in litigation with the government over the regulatory status of DMAA. That case is currently under review by the 11th Circuit Court of Appeals. We’ll be keeping an eye on both cases as the litigation unfolds.