April 19, 2017
Hi-Tech Pharmaceuticals Inc., a dietary supplement manufacturer whose products are sold by such retailers as CVS, GNC and Walmart, has requested reconsideration of a court ruling that its products containing DMAA (1, 3-dimethylamylamine) are adulterated. The company argued a federal judge reached a conclusion that was not grounded in the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Earlier this month, Judge Willis B. Hunt, Jr., found evidence DMAA had been detected in geranium plants, siding with Hi-Tech. Nonetheless, he ultimately ruled against the Norcross, Georgia-based company and for FDA in a years-long fight over the legality of DMAA, a controversial ingredient whose safety has been contested.
In using the term “botanical" in DSHEA, Hunt observed, “Congress intended that there must be at least some history of the substance in question having been extracted in usable quantities from a plant or a plant-like organism."
DMAA, the judge determined, didn’t meet the requirement above. He observed DMAA is only present, at best, in “miniscule amounts" and has never been extracted from geranium plants for a commercial purpose.
However, in their April 17 motion for reconsideration, Hi-Tech and its owner, Jared Wheat, stated through their attorneys that nothing in DSHEA, its legislative history or the case law imposes the requirement “that a substance only qualifies as dietary ingredient if it can be extracted in ‘usable quantities.’"
“In fact, DSHEA clearly states that the ‘constituents’ of a botanical are considered a dietary ingredient and sets no quantitative threshold for what constitutes a constituent of a botanical," declared the motion, which contended the judge failed to analyze what meets the definition of a constituent of a botanical under DSHEA. “Simply put, the court’s conclusion otherwise impermissibly interjected its policy opinions in place of statutory interpretation."
According to Hi-Tech and Wheat, the government itself “took the position" that DMAA would qualify as a dietary ingredient under the law if it were present in geraniums, even in trace amounts.
“In fact, the government’s answer acknowledged that the mere fact that the DMAA used in claimants’ products is synthetic has no bearing on whether DMAA qualifies as a dietary ingredient so long as it is a constituent of the geranium plant," Wheat and Hi-Tech proclaimed in their motion.
Such an acknowledgement by the government would be at odds with a 2016 document published by FDA. In its new dietary ingredient (NDI) guidance, FDA asserted synthetic botanicals don’t qualify as dietary ingredients—a position Hunt basically rejected in spite of his ruling against Hi-Tech.
In their motion for reconsideration, Hi-Tech and Wheat also argued Hunt improperly decided the following factual issue based on an incomplete record: “whether DMAA can be extracted from geraniums in ‘usable quantities.’"
Hi-Tech and Wheat cited one of their experts, who noted patent applications had been “filed to commercially extract DMAA from geraniums." The patent applications reportedly described an extraction method that would achieve a DMAA concentration of 1 to 3 percent.
The patent applications and expert testimony created a disputed factual issue “regarding the ability to extract DMAA from geraniums in ‘usable quantities,’" noted Hi-Tech and Wheat, who argued they should have been permitted to offer additional evidence on the issue.
“Until the court issued its April 3 order, the ability to extract DMAA from geraniums in a ‘usable quantity’ was not in dispute amongst the parties, and claimants were unaware that the court would consider this issue dispositive in its analysis," Hi-Tech and Wheat declared.
Hi-Tech and Wheat requested Hunt grant their motion for reconsideration and vacate the April 3 court order. Hi-Tech and Wheat also asked the judge grant their own motion for summary judgment and dismiss the government’s seizure action, lift the government’s detention of their DMAA goods, and grant summary judgement on their claims in an Administrative Procedure Act complaint.
The government is expected to respond to the motion in the coming weeks.
Hi-Tech said it will seek relief with the U.S. Court of Appeals for the Eleventh Circuit if its motion is denied. In a press release, the company also reaffirmed its pledge to supply its customers DMAA until the dispute is resolved in the courts.
FDA and the U.S. Justice Department on Wednesday declined requests for comment.
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