Popular Post El Presidente Posted January 24 Popular Post Posted January 24 https://news.bloomberglaw.com/health-law-and-business/fda-rule-regulating-premium-cigars-swept-aside-by-appeals-court Jan. 25, 2025, 3:08 AM GMT+10 FDA Rule Regulating Premium Cigars Swept Aside by Appeals Court Nyah Phengsitthy Cigars are displayed for sale at a store in Houston, Texas, U.S., on Thursday, Aug. 29, 2019. The FDA’s decision that it has the same authority over premium cigars as it does over other tobacco products such as regular cigars, e-cigarettes, and hookahs was rejected by a federal appeals court. Hand-rolled premium cigars shouldn’t be under the Food and Drug Administration’s regulation, according to an opinion filed Friday from the US Court of Appeals for the District of Columbia Circuit. “The FDA’s rationale was factually incorrect,” Judge A. Raymond Randolph wrote for the court. “We have held that ‘agency action is arbitrary and capricious if it rests upon a factual premise that is unsupported by substantial evidence.’” The order is a win for the Cigar Association of American and other plaintiffs that sued the agency in July 2016, arguing that unlike cigarettes and e-cigarettes, premium cigars shouldn’t be subject to the rule because they don’t appeal to younger people and aren’t associated with addiction. At issue before the appellate court was whether the FDA acted arbitrarily and capriciously when it deemed premium cigars under its jurisdiction. The FDA gained the authority to regulate the manufacturing, distribution, and marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009, but the agency in May 2016 finalized a rule implementing the law and deemed premium cigars subject to regulation. The US District Court for the District of Columbia in August 2023 ruled the FDA didn’t have exceptional circumstances to warrant sending the regulation back for correction without vacating it, which followed the court’s previous decision in July 2022 that the agency improperly glossed over industry arguments when it decided to include premium cigars in the deeming rule. The FDA in October 2023 appealed the district court opinion, arguing the order should be reversed and that sending the regulation back for correction without vacating it would be the appropriate remedy. The three-judge panel, however, ruled on Friday that “final Rule’s deficiencies are serious.” “‘In the past we have not hesitated to vacate a rule when the agency has not responded to empirical data or to an argument inconsistent with its conclusion,’” Randolph wrote, pointing to a older court decision. “And in dicta, we have suggested that a court ‘must vacate a decision that ‘entirely failed to consider an important aspect of the problem.’'” “In short, the district court did not abuse its discretion in vacating the FDA’s Rule as applied to premium cigars, provided that the relief does not permit refunding past user fee payments,” Randolph wrote. The opinion also wrestled with the FDA’s definition of premium cigars. “This is somewhat concerning because defining ‘premium cigars’ was, or should have been, an issue in the rulemaking. But we recognize that the district court’s determination that the FDA acted irrationally made it necessary to define ‘premium cigars’ with some precision,” Randolph wrote. The appeals court opinion reversed and remanded the case only so that the district court can invite briefing on the appropriate definition of “premium cigars” before entering a final order. “Given the centrality of this issue, we think the parties should have the opportunity to express their views before the district court determines—in effect—the permissible scope of the FDA’s existing rule,” Randolph wrote. “Of course, the FDA may separately begin a new rulemaking to redefine the ‘premium cigars’ carve-out or it may seek to regulate these products once again. But until then, and with the understanding that vacatur will not permit revisiting past user fee payments, we otherwise affirm the district court’s well-reasoned opinion in full.” The Cigar Association of America did not respond to immediate request for comment. Judges Patricia A. Millett and Florence Y. Pan joined the opinion. The case is Cigar Ass’n of America v. FDA, D.C. Cir., No. 23-05220, opinion filed 1/24/25. 1 4
The FDA’s decision that it has the same authority over premium cigars as it does over other tobacco products such as regular cigars, e-cigarettes, and hookahs was rejected by a federal appeals court. Hand-rolled premium cigars shouldn’t be under the Food and Drug Administration’s regulation, according to an opinion filed Friday from the US Court of Appeals for the District of Columbia Circuit. “The FDA’s rationale was factually incorrect,” Judge A. Raymond Randolph wrote for the court. “We have held that ‘agency action is arbitrary and capricious if it rests upon a factual premise that is unsupported by substantial evidence.’” The order is a win for the Cigar Association of American and other plaintiffs that sued the agency in July 2016, arguing that unlike cigarettes and e-cigarettes, premium cigars shouldn’t be subject to the rule because they don’t appeal to younger people and aren’t associated with addiction. At issue before the appellate court was whether the FDA acted arbitrarily and capriciously when it deemed premium cigars under its jurisdiction. The FDA gained the authority to regulate the manufacturing, distribution, and marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009, but the agency in May 2016 finalized a rule implementing the law and deemed premium cigars subject to regulation. The US District Court for the District of Columbia in August 2023 ruled the FDA didn’t have exceptional circumstances to warrant sending the regulation back for correction without vacating it, which followed the court’s previous decision in July 2022 that the agency improperly glossed over industry arguments when it decided to include premium cigars in the deeming rule. The FDA in October 2023 appealed the district court opinion, arguing the order should be reversed and that sending the regulation back for correction without vacating it would be the appropriate remedy. The three-judge panel, however, ruled on Friday that “final Rule’s deficiencies are serious.” “‘In the past we have not hesitated to vacate a rule when the agency has not responded to empirical data or to an argument inconsistent with its conclusion,’” Randolph wrote, pointing to a older court decision. “And in dicta, we have suggested that a court ‘must vacate a decision that ‘entirely failed to consider an important aspect of the problem.’'” “In short, the district court did not abuse its discretion in vacating the FDA’s Rule as applied to premium cigars, provided that the relief does not permit refunding past user fee payments,” Randolph wrote. The opinion also wrestled with the FDA’s definition of premium cigars. “This is somewhat concerning because defining ‘premium cigars’ was, or should have been, an issue in the rulemaking. But we recognize that the district court’s determination that the FDA acted irrationally made it necessary to define ‘premium cigars’ with some precision,” Randolph wrote. The appeals court opinion reversed and remanded the case only so that the district court can invite briefing on the appropriate definition of “premium cigars” before entering a final order. “Given the centrality of this issue, we think the parties should have the opportunity to express their views before the district court determines—in effect—the permissible scope of the FDA’s existing rule,” Randolph wrote. “Of course, the FDA may separately begin a new rulemaking to redefine the ‘premium cigars’ carve-out or it may seek to regulate these products once again. But until then, and with the understanding that vacatur will not permit revisiting past user fee payments, we otherwise affirm the district court’s well-reasoned opinion in full.” The Cigar Association of America did not respond to immediate request for comment. Judges Patricia A. Millett and Florence Y. Pan joined the opinion. The case is Cigar Ass’n of America v. FDA, D.C. Cir., No. 23-05220, opinion filed 1/24/25.
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