Last week, attorneys from three cigar trade groups filed a motion seeking to delay the implementation of the U.S. Food & Drug Administration’s (FDA) warning label requirements.
The motion seeks for either an injunction of the warning label requirements or a postponement of the warning labels—set to take effect Aug. 10, 2018—until 60 days after the court rules on the motion. It’s the latest in a lawsuit filed by the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers’ Association (IPCPR).
This is a response to a ruling last month by the U.S. District Court for the District of Columbia. In that ruling, the court sided with FDA on nearly all parts of a motion for summary judgment.
Despite ruling against the cigar industry, the court disagreed with much of the process FDA has gone about for cigar regulations.
“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,” wrote U.S. District Court Judge Amit P. Mehta in his opinion. “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.”
Those comments and others like them play a large part in the most recent motion.
In the motion, the plaintiffs argue there is a precedent for issuing an injunction when a party is challenging the regulatory power of an agency. It goes further to argue that in certain cases, the plaintiffs do not need to show a likelihood of winning the appeal in order to receive the injunction.
Much of the argument centers around how FDA enacted the law and argued its court cases. The plaintiffs argue that the process has been long, unpredictable and at times, extremely opaque particularly when it comes to delaying certain regulations. This was compounded by the decision by FDA to announced that it was considering reevaluating the premium cigar regulations, a process that was just extended.
Attorneys for the three cigar trade groups argue that cigar companies “have been and are now being forced to expend millions of dollars to bring themselves into compliance with regulatory directives that the agency very well may change.”
As part of the motion, attorneys for the cigar trade groups consulted their FDA counterparts who are opposed to the motion.
This is one of two active lawsuits regarding FDA’s regulations of premium cigars. A separate lawsuit in Texas is scheduled to begin oral arguments later this month.