August 10, 2023
Yesterday’s final decision by US District Judge Amit P. Mehta in CAA et al v FDA (plaintiffs Cigar Association of America, Cigar Rights of America, and Premium Cigar Association), completely struck down all U.S. Food & Drug Administration (FDA) regulations on premium cigars. This is a historic day for our industry and the culmination of fifteen years of meticulous work, and tens of thousands of man-hours by Cigar Rights of America (CRA). CRA solely funded and led this final challenge that has now accomplished the most significant tobacco regulatory repeal in modern history. We are thrilled to announce this victory, which was made possible by the commitment and support of CRA’s members, as we have worked to protect the right to make and enjoy premium cigars.
The foundation of this decision stretches back to two key arguments established by CRA in our 2014 advocacy against the FDA’s Deeming rule. At that time, we presented scientific evidence that premium cigars are different, and FDA should consider exempting them. We showed that premium cigars are not used by youth and FDA had failed to show any evidence that they posed increased risks of mortality. Based on that science, our regulatory and lobbying teams were able to pressure FDA into including an exemption, Option 2.
Although the Agency decided to ignore that evidence, in yesterday’s decision, Judge Mehta specifically cited CRA’s comments as providing “multiple reasons for selecting Option 2” and found that FDA “failed to consider data before it [which had been presented by CRA] concerning the use of premium cigars.” FDA’s failure to answer our challenge led Judge Mehta to find that the Agency had acted “arbitrarily and capriciously” and to order that premium cigars be immediately removed from FDA’s power entirely.
What’s Next for Premium Cigars
FDA will have 60 days to appeal Judge Mehta’s ruling, but with no evidence or science to support their case, we do not expect them to do so. Should they choose to appeal, we are confident that we will ultimately prevail and will be completely exempt from FDA’s rules, requirements, and fees.
With respect to the “User Fees” that manufacturers have paid to the Agency since 2016, and which Judge Mehta estimates at $15 – 20 million per year, the ruling anticipates that we will be exempt from payment in the future. Whether this action might open the door to recouping the fees manufacturers have already paid remains to be determined, but will be closely watched. Turning away FDA’s concern with this outcome, he stated that “[o]n balance, the future fallout that the FDA may face from vacatur does not outweigh the financial and other burdens the premium cigar industry has had to shoulder.”
While today is a day for our community to celebrate, we must remain vigilant and aware that FDA will not rest. Although this ruling will exempt premium cigars from all current FDA regulation, the Agency retains the right to start from scratch and begin the process all over again.
With the wind of this decision at our backs, CRA will not stop our work to prevent that from happening. We will meet with FDA in coming days to press them to drop premium cigars from their strategic plan; we will stave off increases in taxation of our products; and we will ensure that our products are separated out of Federal law. With the continued support of our members and the facts on our side, I know that we will continue to succeed in that mission.
Michael E. Copperman
Director of Regulatory and Legislative Affairs
Cigar Rights of America