Tobacco Asia

40 tobaccoasia Issue 4, 2026 July / August By Timothy S. Donahue It took a decade, multiple appeals, and one very persistent judge. But the US cigar industry finally has its answer. A federal court has for- mally 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. U.S. 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 Deem- ing 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 par- ties' 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." Where the Line Gets Lit: the US Finally Defines a 'Premium' Cigar The court also described the ruling as "(hopefully) … the final chapter" in the litiga- tion—though that caveat leaves the door open to what may still come next. "Having now con- sidered 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 premi- um 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 "work- ing 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 re- main exempt from FDA requirements, including premarket authorization, user fees, and marketing restrictions under the Deeming Rule. Those that do not—including flavored ci- gars 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 appro- priate, 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 Associa- tion of America] CAA's proposed changes. "The FDA has convincingly shown that the suggested modifications would attract substantial After a decade-long regulatory battle, the cigar industry has secured a formal definition of a premium cigar. Credit: Soscenic-Photography, Pexels.

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