In a last-minute filing made on Tuesday, today’s hearing in Cigar Association of America et al. v. United States Food and Drug Administration et al., a joint lawsuit filed by three cigar trade groups against FDA, was rescheduled.
Today’s planned hearing has now been delayed until May 23, 2022 at 10:00 a.m. No reason was given for the delay in an entry made to the U.S. District Court for the District of Columbia’s filing system yesterday.
While the lawsuit has been active since it was filed in 2016, the in-person court proceedings have been sporadic. This will be the first time the two sides have met for oral arguments in more than a year and the first time these two sides have met in person since before the coronavirus COVID-19 pandemic began. Unlike the hearings in 2020-2021, this hearing will not be broadcast on the internet as coronavirus COVID-19 restrictions have been loosened within the court.
The May 2022 hearing will be an important one for a number of reasons. First, the hearing will likely see the plaintiffs—the cigar trade groups—go on the offensive regarding what it believes was FDA mishandling of procedural requirements that the agency was required to do before enacting the deeming regulations in 2016. Furthermore, this is the first hearing since the recently published report from an FDA-funded study on premium cigars by the National Academy of Sciences, Engineering, and Medicine (NASEM). Within the last two weeks, both sides have submitted briefings to the court related to the NASEM report.
The second page of the cigar industry’s brief makes it clear that it believes the NASEM report only helps its arguments in this case:
The NASEM report further illustrates that the FDA erred in its 2016 Final Rule when it concluded “there were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.”
For more information about the upcoming hearing, click here.