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In Congress, allies of the cigar industry are pushing legislation to fully exempt premium cigars from FDA flavor regulation.
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For years, courts have depended on an FDA-created eight-point working definition, which states (among other things) that a cigar is wrapped in whole tobacco leaf, uses a 100% tobacco binder, contains at least 50% long-filler tobacco, weighs more than 6 pounds per 1,000 cigars, and has no flavor besides tobacco.
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Defining what constitutes as premium cigars will determine how FDA can regulate them going forward.
For almost 10 years, the cigar industry has been in a regulatory battle with the US Food and Drug Administration. In its latest move, the Cigar Association of America (CAA) filed a brief on June 6, urging a federal court to adopt a broader definition of “premium cigar.” The filing responds to a January 2025 ruling by the US Court of Appeals for the DC Circuit, which upheld a lower court’s decision to strike down FDA regulations on premium cigars and ordered the lower court to establish an official definition of “premium cigar.”
It’s been a tumultuous back and forth. The case, Cigar Association of America et al. v. FDA, began in 2016 when CAA, Cigar Rights of America (CRA), and the Premium Cigar Association (PCA) jointly sued to challenge FDA’s 2016 “deeming rule” that brought cigars under federal tobacco control. US district judge Amit P. Mehta ultimately ruled in 2023 that FDA’s decision to regulate premium cigars was unlawful, noting the agency had ignored evidence that premium cigars are used infrequently and pose different health risks than combustible cigarettes.
FDA appealed, but the DC Circuit agreed that FDA’s action was “arbitrary and capricious,” leaving Judge Mehta’s vacatur (nullification) of the rule in place. The only remaining task was to clearly define what qualifies as a “premium cigar” for exemption from regulation.
That technical definition is at the heart of the debate. For years, courts have depended on an FDA-created eight-point working definition, which states (among other things) that a cigar is wrapped in whole tobacco leaf, uses a 100% tobacco binder, contains at least 50% long-filler tobacco, weighs more than 6 pounds per 1,000 cigars, and has no flavor besides tobacco. The CAA argues this standard was never thoroughly tested through the proper rulemaking process and is too strict.
In its new brief, CAA proposes simplifying the criteria to a five-point test that notably removes the flavor ban and relaxes certain technical requirements (such as the long-filler content rule), while clarifying that cigars rolled using vintage hand-operated machines still count as “made manually.” This change could allow some infused or flavored cigars to be classified as premium cigars. They are currently excluded under the existing definition.
CAA’s brief argues that the previous FDA definition is rife with “multiple ambiguities and unjustifiably narrow qualifiers” not supported by science. One key point of contention is the flavor restriction. Regulators have never formally defined what a “characterizing flavor” is, the CAA notes, making an outright flavor ban arbitrary and hard to enforce.
"The government has never clearly defined what a ‘characterizing flavor’ actually is,” the CAA wrote in its filing, pointing out that even traditional premium cigars are often described with flavor notes (for example, cream or chocolate) despite containing no additives. To strengthen its case, CAA cited studies by NERA Economic Consulting and Consilium Sciences showing that youth consumption of premium cigars – whether flavored or unflavored – is virtually nonexistent. In other words, expanding the definition to include flavored hand-rolled cigars would not lead to underage smoking or worse health outcomes, according to industry data.
CAA president Scott Pearce welcomed the chance to finally establish a proper definition. “The Circuit Court recognized that the definition of a premium cigar was never fully vetted either through FDA rulemaking or through litigation,” Pearce said, adding that the court’s remand allows the industry to present “science, law, and fact to support a proper definition.”
For the premium cigar sector, getting the definition right is essential to uphold Judge Mehta’s ruling. CAA warns that FDA’s earlier narrow definition – with its gray areas and subjective parts – could threaten the legal protections premium cigars gained in court if some products fall outside the definition due to technicalities.
“CAA fully supports a definition that includes all cigars the marketplace has for decades recognized as premium,” Pearce said, emphasizing that surveys have found no evidence of youth use of premium cigars, even those that are hand-rolled and flavored. “Therefore, excluding those products would be arbitrary and counter to the spirit and intent of the vacatur ruling.”
Not everyone in the industry agrees with CAA’s push to expand the category. CAA’s co-plaintiffs, CRA and PCA, generally prefer sticking with the original eight-point definition that excluded flavored cigars, considering that approach safer for gaining regulatory relief. Earlier this year, PCA and CRA (along with FDA) petitioned to adopt the working definition as final, aiming to avoid a fight over flavors – a move the appeals court rejected in March.
The split mainly depends on the type of members: CAA’s membership includes companies known for flavored and infused cigars, while CRA and PCA represent manufacturers and retailers focused on traditional, unflavored, handmade cigars. The long-standing conflict over flavors existed before the lawsuit and has now become a key issue in court.
In response to the submitted definition for the court in early August, FDA, CRA, and PCA expressed opposition to the CAA proposal. FDA warned that adopting CAA’s changes would complicate the regulatory process and undermine public health efforts. FDA officials raised concerns that CAA’s definition could pave the way for more flavored cigars to be marketed without regulation, despite the agency’s previous efforts to ban flavored products.
Legal representatives for CRA and PCA echoed FDA’s concerns, stressing that expanding the definition could disrupt the regulatory framework established by the court. Michael Edney, who represents both groups, stated that CAA’s arguments about allowing flavored cigars are an attempt to “open the door” to products that do not align with the characteristics of traditional premium cigars. He noted that CRA and PCA’s position was in line with the earlier court decisions, which focused on maintaining strict definitions to preserve public health protections.
What’s at stake is the scope of cigars that will stay free from FDA oversight. If Judge Mehta adopts a broader definition, then premium cigars falling under that category – potentially including certain flavored, hand-rolled sticks – will continue to be exempt from costly FDA requirements like pre-market authorization applications, user fees, strict manufacturing standards, and large health warning labels. A narrower definition, on the other hand, could leave some cigar products outside those regulations (or worse, inside future FDA flavor bans).
The outcome will directly affect cigar manufacturers and retailers: a broader definition shields a larger portion of their products from regulation, while a narrower one might satisfy public health critics but reduce the “premium” safe harbor. As CAA Chairman Javier Estades said, the fight is about protecting century-old cigar traditions. “The way we cultivate, age, and cure tobacco and roll cigars has not really changed for the last 100 years,” Estades stated, arguing that the court’s decision “should protect all these cigars – the ones consumers find in the humidors of thousands of retail stores across the country.”
CAA’s response to FDA, CRA, and PCA briefs will be due by September 13, after which Judge Mehta will consider all arguments and issue a final ruling on the definition. That ruling will likely determine how the FDA can regulate premium cigars going forward.
Meanwhile, the fight isn’t just in court: in Congress, allies of the cigar industry are pushing legislation to fully exempt premium cigars from FDA regulation. Once the court’s definition is established, it could either support those legislative efforts or undermine their foundation. For now, the premium cigar industry anxiously awaits a legal definition that could shape its future and may finally settle whether flavored high-end cigars qualify as “premium.”