Premium Cigar News and Notes

By Cody Carden - 9/14/2023

On August 9, 2023, U.S. District Judge Amit Mehta fundamentally altered the tobacco regulation landscape when he struck down all U.S. Food & Drug Administration (FDA) regulations on premium cigars. 

This historic day for the premium cigar industry was the culmination of fifteen years of work and tens of thousands of man-hours by Cigar Rights of America (CRA) advocating for premium cigars and fighting back against FDA’s regulation of the industry.

During the deeming regulation's comment period, CRA was the lone voice making science-based arguments during the rule-making process, which proved foundational to Judge Mehta’s decision. CRA was so dedicated to this effort because FDA’s improper deeming of premium cigars inhibited manufacturers’ ability to create novel cigars and treated century-old family-owned small business premium cigar manufacturers as if they produced the same product as machine-made mass-market cigars and cigarillos. 

Because of this strident belief that science would win out, CRA achieved the most significant tobacco regulatory repeal in modern history and, with it, opened all new legislative potentials for our industry at the state and federal level.

This victory is not just a rebuke to FDA’s attempts at unscientific overregulation, it also provides critical support for CRA’s efforts when engaging with lawmakers. Members of Congress have historically been responsive to CRA’s arguments in theory, but have hesitated to be the first branch of the federal government to acknowledge how premium cigars are differentiated from mass-market tobacco products and vaping. 

With the Mehta decision in hand, CRA now enters the fall legislative session with the wind at our backs and a clear mandate from the courts to respect the unique facets of premium cigars, which make them unique in the tobacco industry. 

As a result, we look forward to continuing to fight for your cigar rights with the hard-earned support of the Federal Courts setting the definition of premium cigars.

CRA’s legislative team is already on the ground implementing our advocacy plan and leveraging our coalition of alliances to enable your voices to be heard in Congress and to build support for memorializing a federal definition for premium cigars like the one Judge Mehta adopted (see footnote below).

We will not stop until we have educated every Member of Congress about the Mehta decision and achieved our goal of securing legislation which exempts premium cigars from FDA regulation once and for all.

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.

In gratitude,

Michael E. Copperman

Director of Regulatory and Legislative Affairs

Cigar Rights of America