A key court hearing regarding the cigar industry’s lawsuit over regulations by the U.S. Food & Drug Administration (FDA) has been moved from a courtroom to video conference due to coronavirus COVID-19.
Update (March 16, 2020) — The hearing will now take place as scheduled but via video conference.
Earlier today, the U.S. Court of Appeals for the Fourth Circuit informed the parties of Cigar Association of America et al. v. United States Food and Drug Administration et al. that it would not be hearing briefs next Wednesday, as had been originally scheduled.
“The court made a decision this afternoon to cancel arguments, we have not entered orders but we have contacted counsel,” a spokesperson for the court told halfwheel. “Arguments have been canceled, either to be rescheduled for a later date or decided on the briefs (which will be) determined by the panels.”
The March 18 hearing was over the May 12, 2020 deadline for substantial equivalence, that date was moved up from August 2021 to May of this year by a federal court in Maryland last year. This hearing was part of the lawsuit from three cigar trade groups: Cigar Association of America (CAA), Cigar Rights of America (CRA) and the Premium Cigar Association (PCA).
Substantial equivalence is expected to be the main approval process for cigars once FDA’s regulations are fully in effect. In short, a manufacturer would argue that its product is substantially equivalent to an already approved or grandfathered product, and as such poses no additional health risks and does not market towards children.
In January, the Fourth Circuit denied a motion to stay the May 2020 deadline, i.e. to indefinitely delay it, but it agreed to accelerate the proceedings, noting that it understood the importance of making a decision before May.
There are other lawsuits regarding the May 2020 deadline including ones from the e-cigarette industry and most notably, an appeal from FDA itself objecting to the accelerated timeline.
Also in January, FDA announced that traditional cigars were amongst the agency’s “lowest priority” when it comes to tobacco regulation. It indicated that it would still adhere to the May 12, 2020 deadline but it would not “prioritize enforcement” for those applications. It’s unclear what that means in practice, but it seems likely FDA is planning to apply less scrutiny to cigars than products like e-cigarettes.
Update (March 16, 2020) — The hearing will now take place via videoconference. This story was originally published on March 13, 2020.