A motion to reconsider filed by Hi-Tech Pharmaceuticals in its case with FDA over the legality of DMAA (1, 3-dimethylamylamine) as a dietary ingredient has been denied.
The June 2 order from U.S. District Court for Northern Georgia turned away Hi-Tech’s three primary arguments against the April 2017 summary judgment, including the notion the court “encroached on the policy making prerogative of Congress” by ruling that a substance must have a history of being extracted in usable quantities to qualify as a “botanical.”
In denying the motion to reconsider, Federal Judge Willis B. Hunt Jr., said that in the absence of any statutory, legislative or case law guidance on the term “botanical,” the court considered the term’s ordinary meaning.
“Under that meaning, a botanical—and by extension, a constituent of a botanical—is something that comes from a plant, and none of the DMAA ever placed in a product for sale has come from a plant,” Hunt decided.
Hunt further clarified that his summary judgment did not question whether DMAA could be extracted in commercial quantities, but whether there was a history of doing so. “DMAA in the marketplace has never come from a plant,” he said, thus knocking down Hi-Tech’s second argument.
The company’s third argument was about not knowing the ability to extract in usable quantities was important, but Hunt again noted it was the ability to do so, but the history doing so.
“The question is whether someone has extracted DMAA from geraniums or some other plant and placed that DMAA in a product, and it is obvious from the record that no one has done that,” Hunt hammered home his point. “If someone had, there would not have been a dispute regarding whether DMAA was a botanical in the first instance.”
The court battle over DMAA may now move to the 11th Circuit Court of Appeals, as Wheat has vowed to take this case as far as he can, while continuing to conduct business as usual, including selling DMAA in dietary supplements.