A federal appeals panel upheld a lower court's ruling that millions of dollars' worth of dietary supplements seized by the Food and Drug Administration from embattled Hi-Tech Pharmaceuticals was properly subject to forfeiture under federal law.

But the 2-1 opinion sets up a further challenge from the Norcross-based supplement company and its CEO, Jared Wheat, who has been battling the FDA for years and faces separate criminal charges related to his marketing of other products.

An opinion published Friday by the U.S. Court of Appeals for the Eleventh Circuit Court said the additive at the heart of the FDA's complaint against Hi-Tech and Wheat, 1,3-Dimethylamylamine was not permitted under Food Drug and Cosmetic Act amendments that allow plant-based substances to be marketed as dietary supplements, even though the substance can be found in trace amounts in geraniums.

Hi-Tech had argued that, even though the DMAA it used is laboratory-produced, it should be allowed to fly under the exception even though there is no reported instance of geranium-based DMAA ever being produced for market consumption. 

The company also argued that the substance is "generally recognized as safe" and should not be regulated as a food additive at all. 

The opinion was written by District Judge Robert Hinkle of Florida's Northern District, sitting by designation, with the full concurrence of Judge Gerald Tjoflat.

The case "presents a genuine factual dispute over whether trace amounts of DMAA are naturally contained in geraniums," wrote Hinkle. "On the one hand, studies have found trace amounts of DMAA in geraniums … and the record includes competent testimony that there is no known pathway by which geraniums could produce DMAA.

"Either way, it is clear that DMAA is not contained in geraniums in amounts greater than could reasonably be characterized as trace amounts," he wrote.

The FDCA and Dietary Supplement Health and Education Act "provides favorable treatment for 'dietary supplements,' defined to include any 'botanical' or 'constituent' of a botanical. This case presents the question whether these terms apply to a substance that was invented in a laboratory and is artificially produced for commercial sale but that, entirely coincidentally, may be found in trace amounts in a plant."

"We hold that the terms do not extend this far," Hinkle wrote.

Judge Adalberto Jordan concurred only in part, writing in a dissent that the trial court was wrong to grant the FDA summary judgment upholding the seizure. 

"This is a difficult case, and in my opinion there is no 'right' or 'wrong' answer to the principal statutory question we confront," Jordan wrote. "The majority opinion sets out one plausible interpretation of [the law], but I read the statute differently."

The statute's text, Jordan said, does not support the conclusion "that a 'constituent' of a 'botanical' must have a history of being extracted in usable quantities" or "must have been derived from a plant for use in a medicinal, cosmetic, or dietary product."

Whether DMAA is a "constituent" of geraniums should be decided at trial instead of on summary judgment, Jordan said. 

In an email response to a query to Hi-Tech's lawyers, the company said it would ask for an en banc hearing on the issue "as we believe Judge Jordan's dissent was the correct interpretation. and noted that Hinkle—as a designated judge—will not be part of that rehearing.

"If we are unsuccessful we will appeal to the U.S. Supreme Court," said the statement.

Hi-Tech and Wheat's counsel includes Jack Wenik of Epstein Becker & Green in Newark, N.J.; Arthur Leach of Alpharetta's Arthur Leach Attorney at Law; Bruce Harvey Law Firm principal Bruce Harvey and Atlanta sole practitioner E. Vaughn Dunnigan.   

The forfeiture action is being prosecuted by James Harlow and Claude Scott with the Department of Justice's Consumer Protection Branch in Washington, D.C., and David O'Neal of the U.S. Attorney's Office for the Northern District of Georgia. 

A DOJ spokesman in Atlanta declined to comment on the case. 

As detailed in the opinion and other filings, in 2012 the FDA—which considers DMAA an "amphetamine  derivative"—began sending warning letters to marketers of dietary supplements containing the substance that they were "adulterated" and unsafe.

Some companies stopped selling the products, but Hi-Tech did not, and in 2013 FDA inspectors seized about $3 million worth of products including bulk geranium powder and finished products with names like Black Widow, Lipodrene Hard Core and Yellow Scorpion. 

The FDA initiated civil forfeiture proceedings in Georgia's Northern District, and Wheat and Hi-Tech filed their own declaratory judgment action seeking the products return.

In April 2017, Senior Judge Willis Hunt Jr. of the U.S. District Court for the Northern District of Georgia granted the government summary judgment and ordered the substances forfeited; Hi-Tech appealed to the Eleventh Circuit. 

That appeal was pending when the government sought and obtained a criminal indictment against Wheat, Hi-Tech and an employee for wire fraud and money laundering and violations of FDCA regulations regarding anabolic steroids and another drug.

The indictment did not mention DMAA, but, in executing search warrants in late 2017, agents said they saw "large quantities of DMAA-containing products and raw materials in plain view." 

A federal magistrate issued warrants and agents seized what were described as five tractor-trailer loads of DMAA-containing products worth what Hi-Tech said was about $19 million from its facilities.

Last year, Hi-Tech sought the return of the seized merchandise from the 2017 sweeps, arguing that the items "are perishable and must be stored and contained in a particular manner to avoid spoilage." 

In May, U.S. Magistrate Judge Catherine Salinas of Georgia's Northern District ordered that the seized goods be returned to Hi-Tech, but she warned that bond provisions demanding that they not be marketed or distributed are still in effect and that the defendants "must proceed with extreme caution to ensure full compliance with those orders."