By Timothy S. Donahue

Top Takeaways:

• Court decision: Judge affirms narrow “premium cigar” definition, excluding flavored and machine-made products
• Regulatory impact: Handmade, unflavored cigars remain outside FDA deeming rules—for now
• Industry divide: Ruling sides with CRA/PCA over broader definition pushed by CAA

A decade-long legal fight over how the U.S. Food and Drug Administration regulates cigars has reached a critical turning point with a federal court finally defining what qualifies as a “premium cigar.”

U.S. District Judge Amit P. Mehta ruled that premium cigars will remain outside the scope of FDA regulation for now, adopting a narrow definition that excludes flavored cigars and most machine-made cigars.

The decision resolves the final outstanding issue in a case that began in 2016—what exactly constitutes a premium cigar—and effectively locks in the framework first set forth in Mehta’s 2023 ruling, which vacated the FDA’s application of its deeming regulations to the category.

“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 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.”

Under the court’s definition, a cigar must meet a strict set of criteria to qualify as “premium,” including being wrapped in whole tobacco leaf, using a 100% leaf binder, containing at least 50% long-filler tobacco, being handmade, and having no characterizing flavor other than tobacco.

That means most traditional handmade cigars remain exempt from FDA requirements, including premarket authorization, user fees, and certain marketing restrictions—while flavored cigars and machine-made products remain subject to those rules.

“This ruling provides long-overdue clarity for the industry, regulators, and lawmakers,” said Mike Copperman of 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.”

The court’s decision also reinforces a key 2023 finding—that the FDA failed to justify regulating premium cigars the same way it regulates mass-market tobacco products. Judge Mehta relied heavily on the administrative record compiled during the FDA’s rulemaking process, a point industry groups emphasized.

“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.”

The ruling also reveals a long-running divide within the cigar industry. While CRA and the Premium Cigar Association (PCA) supported the narrower definition adopted by the court, the Cigar Association of America (CAA) advocated a broader standard that would have allowed flavored cigars and other products to qualify for exemption.

The CAA argued that the existing definition was too restrictive and difficult to enforce, particularly regarding the concept of “characterizing flavor.” However, Mehta rejected those arguments, finding that the group failed to demonstrate real-world enforcement issues and noting that such determinations are better handled through the FDA’s rulemaking process rather than by the court.

The case itself—Cigar Association of America et al. v. FDA—has been winding through the courts since 2016. A federal appeals court upheld Mehta’s earlier ruling in 2025 but sent the case back to address the unresolved definition question, setting up this latest decision.

“As of right now, the CAA Board will need to deliberate on what this means and go from there. We have not had any discussions about the appeal and no decisions either way have been made about it,” said Scott Pearce, president of the CAA. “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.”

Importantly, the ruling does not permanently exempt premium cigars from regulation. The FDA retains the authority to revisit the issue and initiate a new rulemaking process that could attempt to regulate the category again, provided the process addresses the deficiencies identified by the court.

For now, however, the regulatory status quo remains the same. Handmade, unflavored cigars that meet the court’s definition remain outside the FDA’s oversight, while all other cigar products continue to fall under the agency’s deeming rules.

“This decision ensures that family-owned manufacturers, small business retailers, and adult consumers are no longer left in regulatory limbo,” Pesh said.

Whether that clarity holds may depend on what happens next. The ruling could still be appealed—most likely by the CAA—and the FDA could revisit the issue through future rulemaking.