1 of 8
After a decade-long regulatory battle, the cigar industry has secured a formal definition of a premium cigar. Photo credit: Soscenic-Photography, Pexels.
2 of 8
CRA board secretary Drew Newman, JC Newman Cigar Co.
3 of 8
Joshua Habursky, PCA c.e.o.
4 of 8
Scott Pearce, CAA president.
5 of 8
Azim Chowdhury, partner and tobacco industry legal expert, Keller and Heckman.
6 of 8
Mike Copperman, executive director and federal regulatory and legislative affairs director at Cigar Rights of America.
7 of 8
Gary Pesh, president of CRA board.
8 of 8
Premium cigars remain exempt from FDA oversight for now, while all other cigar categories continue to fall under the agency’s regulatory authority. Photo credit NickWinslow CC3.0
It took a decade, multiple appeals, and one very persistent judge. But the US cigar industry finally has its answer. A federal court has formally defined a “premium cigar” and, in doing so, has drawn a clear regulatory line that keeps handmade cigars outside the reach of the US Food and Drug Administration, at least for now.
In a ruling issued in April 2026, Judge Amit P. Mehta of the US District Court for the District of Columbia adopted a narrow, eight-part definition of premium cigars—reaffirming his earlier decision to vacate FDA’s 2016 Deeming Rule as applied to premium cigars. The decision resolves the final outstanding question in Cigar Association of America et al. v. US Food and Drug Administration et al., a case that has shaped the regulatory future of the premium cigar segment since 2016.
“After years of litigation, this court in 2023 vacated the Deeming Rule as applied to a category of products known as ‘premium cigars,’” Mehta wrote in his decision. “The DC Circuit affirmed this court’s vacatur of the Deeming Rule as it relates to ‘premium cigars.’ But the Circuit also ruled that this court should have sought the parties’ input before adopting a definition of the term… On remand, the court invited briefing as instructed. Having now considered the parties’ positions, the court adopts the same definition of ‘premium cigars’ it did before and enters this final order vacating the Deeming Rule as to cigar products covered by that definition.”
The court also described the ruling as “(hopefully) … the final chapter” in the litigation—though that caveat leaves the door open to what may still come next. “Having now considered the parties’ positions,” Mehta added, the court was satisfied that maintaining the existing definition was the appropriate course rather than attempting to redraw the category from the bench.
For now, however, the line is clear. Hand-made, unflavored cigars that meet the definition are excluded, and everything else is included.
“Judge Mehta reached the right result. The court appropriately preserved the current premium cigar definition and declined to expand it in a way that would sweep flavored cigars into the exemption,” said Azim Chowdhury, a partner and tobacco industry legal expert at the law firm of Keller and Heckman LLP in Washington, DC. “Any future change should occur through notice-and-comment rulemaking, where FDA can fully evaluate the record, the science, and the public-health implications.”
The eight-part definition
At the center of the ruling is a definition that has been debated, litigated, and operationalized for years, but never fully settled until now.
To qualify as a “premium cigar,” a product must:
- Be wrapped in a whole tobacco leaf
- Contain a 100% leaf tobacco binder
- Contain at least 50% long-filler tobacco by weight
- Be handmade or hand-rolled
- Have no filter, non-tobacco tip, or non-tobacco mouthpiece
- Have no characterizing flavor other than tobacco
- Contain only tobacco, water and vegetable gum
- Weigh more than six pounds per 1,000 units
The definition—first introduced as a “working definition” in 2020—has been widely adopted by regulators and the industry. It now carries the full force of a federal court order. That distinction is significant. Cigars that meet all eight criteria remain exempt from FDA requirements, including premarket authorization, user fees, and marketing restrictions under the Deeming Rule.
Those that do not—including flavored cigars and most machine-made products—remain firmly within FDA’s regulatory framework. The court’s decision to retain the existing definition was deliberate, grounded in legal and practical considerations. “The court also agrees with the agency that, if a definitional refinement is appropriate, rulemaking, not judicial fiat, is the better way to achieve it,” Mehta wrote. “Unlike the FDA, this court lacks the expertise to rigorously evaluate the public health consequences of [Cigar Association of America] CAA’s proposed changes.
“The FDA has convincingly shown that the suggested modifications would attract substantial public commentary,” emphasizing that agency experts would be responsible for making “a reasoned decision that protects the public health and accounts for risks and benefits to both users and non-users of tobacco products.” That language effectively reinforces the regulatory boundary: courts define the framework, while federal agencies control its evolution.
A familiar divide
For much of the premium cigar sector, the ruling delivers what is scarce throughout the nicotine industry: certainty. “This ruling provides long-overdue clarity for the industry, regulators, and lawmakers,” said Mike Copperman, executive director and federal regulatory and legislative affairs director at Cigar Rights of America (CRA). “After nearly two decades of litigation and advocacy, the courts have definitively recognized what science, history, and common sense have long established, that premium cigars are fundamentally different.”
CRA leadership presented the decision as the culmination of sustained engagement with regulators. “This outcome validates the evidence-based arguments CRA has advanced for years,” said Gary Pesh, president of CRA’s board. “It reinforces that regulatory policy must be grounded in data, not ideology, and that one-size-fits-all tobacco regulation does not work. This decision ensures that family-owned manufacturers, small business retailers, and adult consumers are no longer left in regulatory limbo.”
The Premium Cigar Association (PCA) echoed that view, highlighting the operational clarity the ruling provides. “After nearly a decade of litigation, this decision provides clarity for retailers, manufacturers, and consumers who have had to operate under significant regulatory uncertainty,” said Joshua Habursky, PCA’s c.e.o. “Premium cigars clearly represent a distinct product category, and this outcome reflects the importance of considering those differences in any regulatory framework.”
Others in the industry framed the ruling more personally. “For more than a decade, the premium cigar industry has been living in purgatory while we challenged the FDA’s decision to regulate premium cigars like cigarettes,” said Drew Newman, fourth-generation owner and general counsel of J.C. Newman Cigar Co. “The parties could choose to appeal Judge Mehta’s decision, but I do not think that is likely to happen.”
The outcome also underscores a persistent divide within the industry. CAA had pushed for a broader definition—one that would have allowed flavored cigars and certain machine-assisted products to be classified as “premium.”
“The FDA has not defined what a ‘characterizing flavor’ actually means,” CAA argued in court filings, contending that the current definition is vague and difficult to enforce. The court rejected that argument.
Mehta found that CAA failed to cite any instances of confusion or enforcement breakdown and concluded that the concerns raised did not justify rewriting the definition through judicial action. CAA could still appeal the decision.
“As of right now, the CAA Board will need to deliberate on what this means and go from there,” said Scott Pearce, CAA president. “We have not had any discussions about the appeal, and no decisions either way have been made about it. “And while this order means that products meeting this definition are not subject to FDA’s regulatory authority or user fees, we are going to be diligently scrutinizing how the FDA may still utilize its deeming authority in the future to regulate premium cigars.”
Newman said an appeal is unlikely. “The parties could choose to appeal Judge Mehta’s decision, but I do not think that is likely to happen,” Newman said. “At any time, FDA could decide to start the process of trying to regulate premium cigars again and impose costly and burdensome requirements like graphic health warnings, product testing, premarket review and more fees.”
Stability, with strings attached
Despite its significance, the ruling does not close the book on regulation—it only defines the current chapter. Premium cigars remain outside FDA’s oversight—for now.
All other cigars remain subject to the regulatory agency’s oversight. The agency retains full authority to revisit the category through a new rulemaking process, provided that the process addresses the shortcomings identified in the court’s earlier decision. “This action will accelerate the administrative process… and allow DEA to proceed in the most expeditious manner consistent with federal law,” Mehta noted while discussing broader regulatory processes, reinforcing that agencies—not courts—drive future policy shifts.
There are also unresolved financial questions. From 2016 to 2023, cigar companies paid more than US$100 million in FDA user fees for products that have since been deemed outside the agency’s authority. Whether—or how—that money will be returned remains unclear.
For now, the industry has clarity—but not stability. “Premium cigars clearly represent a distinct product category,” Habursky said. “This outcome reflects the importance of considering those differences in any regulatory framework.” That framework is now defined. What happens next will determine how long it holds.