D.C. APPEALS COURT CAST DOUBT OVER FDA'S "PREMIUM CIGAR" APPEAL On September 13, 2024, a three-judge panel of the U.S. Court of Appeals for the District of Columbia heard arguments in the ongoing case **Cigar Association of America et al. v. United States Food and Drug Administration et al.**, a pivotal lawsuit for the premium cigar industry. This case, which began in 2016, challenges the FDA’s authority to regulate premium cigars under its 2016 deeming regulations. The lawsuit, led by the Cigar Association of America, Cigar Rights of America, and the Premium Cigar Association, gained momentum in July 2022 when a federal court ruled in favor of the cigar industry. The court found that the FDA had failed to adequately consider public comments before implementing the regulations, which subjected premium cigars—defined as large, handmade, and unflavored—to various restrictions, including testing requirements, user fees, and bans on giveaways for retail promotions or charitable events. During the recent hearing, the Department of Justice’s attorney, Lindsey Powell, representing the FDA, acknowledged a key point raised by the judges: if the FDA’s current rule-making process fails, there is nothing preventing the agency from restarting the process in line with the court’s concerns. Powell’s concession came in response to a judge’s observation that the issue wasn’t whether the FDA had the authority to regulate premium cigars, but rather a breakdown in the rule-making process itself. Michael Edney, the attorney representing the cigar industry, and Powell fielded questions from the panel, which included Judges Patricia Millett, Florence Y. Pan, and A. Raymond Randolph. Observers noted that the judges, particularly Randolph, appeared more receptive to Edney’s arguments than to the FDA’s. At one point, Randolph summarized Edney’s position, suggesting that the FDA had not properly addressed the data related to premium cigar use and potential health risks. In 2014, the FDA had sought public input on whether premium cigars—often characterized as expensive, large, and non-flavored—should be regulated differently from mass-market cigars. Although the Cigar Rights of America submitted data indicating that most premium cigar smokers consume them infrequently, and that smoking two premium cigars per day did not increase the overall mortality rate, the FDA ultimately decided not to differentiate between premium and mass-market cigars in its 2016 regulations. During the hearing, Powell argued that vacating the rule for premium cigars would create the impression that these cigars were safe and could undermine the Tobacco 21 age restrictions. One judge, however, dismissed some of these concerns, commenting that high-priced cigars are unlikely to be handed out freely as samples. The judges’ questions hinted that they may side with the cigar industry, potentially upholding the previous court ruling that vacated the FDA’s deeming regulations for premium cigars. If this ruling stands, the FDA could be required to restart its regulatory process, this time addressing the specific data submitted by the public regarding premium cigars. Another issue discussed was whether cigar companies could be refunded for the user fees they have already paid, which range from 5 to 10 cents per cigar. Both attorneys were hesitant to give definitive answers, with Edney suggesting that this issue might need to be decided by a different court. There is no set timeline for when the judges will issue their decision. However, the tone of the hearing suggests that the premium cigar industry may emerge victorious, with the court likely ruling that the FDA must restart its rule-making process.