In a shocking about-face, the judge overseeing the Texas cigar industry’s lawsuit against the FDA has reversed her own decision, opting instead to transfer the case to Washington D.C. There the case will be decided by Judge Amit P. Mehta of United States District Court for the District of Columbia, the same judge who ruled in favor of the FDA back in May.
In her order, which was filed last night, Judge Kimberly Priest Johnson withdrew her May 22 order that denied the government’s motion to transfer the case to Washington D.C.
“In light of the arguments presented in the [government’s] objections, and upon further review of the proceedings in Cigar Association of America, et al. v. United States Food and Drug Administration, the court withdraws the May 22 order and finds the Defendants’ Motion to Transfer is Granted,” wrote Judge Priest Johnson.
Unsurprisingly, the premium cigar industry was not happy with the judge’s decision.
“While this is a separate case from the one IPCPR is currently involved in in DC District Court, the association is disappointed to see the decision coming out of Texas,” said Daniel Trope, senior director of federal government affairs for the International Premium Cigar & Pipe Retailers association.
In her order, Priest Johnson wrote that the FDA “established the requisite commonality of questions, subject matter, and core issues” necessary to grant a transfer. Furthermore, she reasoned that the cigar industry’s recent appeal in the Washington D.C.-based Cigar Association lawsuit demonstrates that the two cases do indeed overlap.
“That motion appears to be fully briefed and ripe for decision before the court. Thus, the crux of the present lawsuit—the FDA’s failure to treat premium cigars differently from other cigars and to exempt premium cigars from the warning requirement—is squarely before the court in Cigar Association,” Judge Priest Johnson wrote.
While the news was a bit of a shock to the industry, there remains some optimism that this case transfer could be a positive for the final decision on how the FDA’s regulation will affect premium cigars. In his decision of Cigar Association handed down in May, Judge Mehta called out the FDA for its “grossly unfair” actions against the premium cigar industry.
“The cigar industry has expended millions of dollars in designing and creating new, conforming packaging, a fact that the FDA does not contest,” Mehta wrote, in spite of the FDA being in a period where it is seeking comments from the public as pertains to premium cigars—comments that could result in a change to those requirements. “Why is the agency insisting that the premium cigar industry expend millions of dollars to conform to regulatory mandates that might be rescinded only months after their effective date? The FDA provides no satisfactory response to either question. Whatever the answers, one thing is certain: Requiring the premium cigar industry to incur substantial compliance costs while the agency comprehensively reassesses the wisdom of regulation, before the warnings requirements go into effect, smacks of basic unfairness. In the court’s view, the prudent course would be for FDA to stay the warnings requirement as to premium cigars.”
Trope said: “We of course were encouraged by [Judge Mehta’s] recognition that the FDA’s decision to proceed with the pending warning label deadline ‘smacks of basic unfairness.’ We certainly aren’t taking anything for granted, however, as we’ve seen significant challenges in all the various legal proceedings to date concerning the Deeming Rule.”