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“Smacks of basic unfairness”: Despite Unsatisfactory Responses from FDA, Court Rules Against American Premium Cigar Industry
May 15th, 2018The FDA has notched a court win over the American premium cigar industry.
The action comes in response to a series of legal motions filed against the FDA’s Deeming Rule by three groups representing the premium cigar industry: The Cigar Association of America (CAA), International Premium Cigar & Pipe Retailers Association (IPCPR) and the Cigar Rights of America. The groups had looked to the court for relief under the First Amendment regarding a series of looming FDA rules, including massive cigar box health warning labels and exorbitant user fees.
U.S. District Court Judge Amit P. Mehta ruled in favor of the FDA on these complaints.
The judge’s decision comes in response to a partial summary judgment motion filed this past October, when the cigar groups asked the court to stay FDA’s requirements for the upsized warning labels and fees, and to examine whether the agency followed proper practices to enact the Deeming Rule.
Interestingly, Judge Mehta lambasted FDA for actions he called “grossly unfair” to the premium cigar industry. “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insisting that the premium cigar industry expend millions of dollars to conform to regulatory mandates that might be rescinded only months after their effective date?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,” he wrote (The FDA is currently seeking another round of public comments regarding some of their requirements). “The court’s displeasure with the FDA’s handling of the status of premium cigars, no doubt, provides little consolation to the industry. But the court can do no more. Its hands are tied by both the law and the posture of the case.”
Rocky Patel commented immediately: “He felt that he could not rule against the warning stickers based on the applicable law as alleged in the plaintiff’s present complaint, but it seems he provided a pathway under a different set of applicable causes of legal action under which plaintiffs could possibly seek relief.”
Judge Mehta did, however, give a lifeline to tobacconists who blend pipe tobacco in their stores; FDA had previously required those retailers to register as “manufacturers,” but Mehta struck down that particular regulation.
An appeal from the cigar industry is expected.