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The decades-long lawsuit that was filed by the cigar industry against the FDA’s regulation, Cigar Association of America et al. v. United States Food and Drug Administration et al., may have reached a conclusion on April 15, 2026, although its outcome remains uncertain.
The lawsuit, which was filed in July 2016, was effectively resolved in August 2023. However, the government appealed a lower court decision, which was affirmed in January 2025. The appeals court subsequently sent the case back to the lower court to determine the true definition of a “premium cigar.”
Judge Amit P. Mehta, who has presided over the case since its inception, upheld the definition that was established in 2020. This means most handmade cigars that lack added flavouring won’t be subject to the FDA’s deeming regulations, encompassing product approval, user fees, and other restrictions. Only flavoured cigars and machine-made cigars continue to be subject to these regulations.
Despite the potential final decision, the regulation of cigars hasn’t undergone significant changes. The existing rules remain applicable as of writing.
Any cigar that meets the following criteria is exempt from the FDA’s deeming regulations:
This definition, which was hastily presented to a different federal court as part of a separate federal lawsuit, was adopted by Mehta as part of the litigation brought by three cigar trade groups against the FDA: the Cigar Association of America (CAA), Cigar Rights of America (CRA), and the Premium Cigar Association (PCA).
Following the appeals court’s decision, Michael Edney, who is the longtime lead attorney for the CRA and PCA plaintiffs in this lawsuit, attempted to cut the definition debate. He argued that the existing definition could remain without further legal scrutiny.
However, the court disagreed, leaving Mehta to determine whether to retain the 2020-era definition or establish a new one. Notably, the FDA was amenable to maintaining the existing definition. This leaves the CAA as the sole party advocating for a different definition.
The CAA contended for a concise and expansive definition that would allow other cigars, particularly facilitating the qualification of flavoured cigars for an effective FDA-exempt status. It posits that the current definition presents challenges in enforcement and potential impossibility due to the use of specific ingredients, such as vegetable gum, or the use of certain tools, which could violate the fourth part of the definition.
Furthermore, the CAA argues that the defining characteristic of flavoured cigars, namely the presence of a “characterizing flavour other than tobacco,” is unattainable due to the ambiguity surrounding the definition of “characterizing flavour.”
To the CAA’s surprise, Mehta dismissed these arguments, asserting that the CAA failed to provide concrete instances of these potential issues causing the confusion it suggested. Additionally, Mehta contended that the FDA’s rulemaking process and specialized staff would be more adept at addressing these nuances than he would.
According to Mehta, the court concurs with the agency that if a definitional refinement is warranted, then rulemaking and not judicial fiat is the more appropriate method to achieve it.
He further added that, unlike the FDA, the court lacks the expertise to rigorously assess the public health implications of CAA’s proposed modifications. The agency has convincingly demonstrated that the suggested alterations would attract substantial public commentary. The agency’s subject-matter experts would take advantage of these comments to make a reasoned decision that safeguards public health and considers the risks and benefits to both users and non-users of tobacco products.
Mehta’s ruling does not imply that handmade, unflavoured cigars are permanently exempt from the FDA’s regulations. At any time, the agency could initiate the rulemaking process and rectify the errors that led to its decision in 2023. But, given the current regulatory approach of the Trump administration, that does not appear likely in the immediate future.
Furthermore, today’s ruling could still be appealed, although it is likely that this would only come from the CAA.
Moreover, there is the matter of user fees.
Cigar companies were required to pay user fees to the FDA, which are small charges applied to each cigar as well as other tobacco products that fund the agency’s regulation of tobacco products. These fees were established by Congress and are also utilized in other FDA-regulated industries, such as medical devices, and were estimated to be between 5 and 10 cents per cigar and applied to cigars sold from August 2016 to 2023.
However, once the court determined that the FDA lacked the authority to regulate “premium cigars,” the agency announced that it would no longer apply them to premium cigars. By that point, companies had paid over $100 million in user fees for “premium cigars” during the seven-year period when the FDA was regulating these tobacco products.
Cigar companies are highly interested in recovering this money. However, both the attorneys and judges in this case have been non-committal regarding the process for doing so. Previously, Edney suggested that the issue was for a different court to decide, which could imply another chapter in this dispute, but not one for Judge Mehta.
