Today, the United States Court of Appeals for the District of Columbia issued its decision in CAA et al. v. FDA. The decision, published today, resolved the question of whether the FDA’s authority to regulate premium cigars would be reinstated. In a unanimous decision, the Court upheld the earlier removal of the FDA’s regulatory authority. The opinion held that “the final Rule’s deficiencies [were] serious” and struck the FDA’s regulatory authority over premium cigars.
In addition to upholding the lower court’s decision removing FDA’s regulatory authority, the court has remanded the case for further proceedings to establish a clear and appropriate definition of premium cigars while the question of retroactive user fees was not resolved. The Court’s decision did recognize the FDA’s continued ability to re-start the rule-making process which could result in the re-regulation of premium cigars in the future.
Cigar Rights of America says it is currently reviewing the court’s decision and will provide a comprehensive analysis in the coming days. CRA and the PCA remain committed to protecting the interests of premium cigar consumers, retailers, and manufacturers while continuing to advocate for a fair and reasonable regulatory framework.
“This is another affirmation of FDA’s missteps regarding the regulation of premium cigars and the necessity of this lawsuit,” said Joshua Habursky, the Executive Director of PCA. “There are still procedural items ahead, but the biggest question on the Deeming Rule is a significant victory.”
“I would like to thank our counsel Michael Edney, PCA government affairs staff, and our stakeholder partners for supporting this lawsuit and securing this victory,” added Scott Regina President of the Premium Cigar Association
“We are encouraged by the court’s acknowledgment that the FDA’s previous approach to regulating premium cigars was fundamentally flawed, and we are deeply grateful for this favorable ruling. This decision underscores the critical need for a clear and appropriate federal definition of premium cigars to ensure future regulations accurately reflect their unique characteristics.” said Mike Copperman, Executive Director of Cigar Rights of America.
Drew Newman, fourth-generation owner and general counsel of J.C. Newman Cigar Co. issued the following statement:
“Today is a huge day for America’s historic premium cigar industry because it ensures that adults will continue to have the right to enjoy a premium cigar for generations to come. Today, my family rolls premium cigars the same way that my great-grandfather did a century ago. Our only goal is to continue handcrafting premium cigars in the United States for another four generations and 130 years. Today’s monumental decision freeing us from government overregulation will allow us to do just that.
Today’s decision recognizes a simple fact, that premium cigars are different from cigarettes and all other tobacco products. FDA overlooked this in 2016 when it decided to regulate premium cigars and treat them just like cigarettes. FDA’s decision made no sense and would have subjected premium cigars to a comprehensive set of strict, cumbersome, and costly regulatory requirements, including product testing, manufacturing standards, premarket review, and health warning labels. Because these regulations were designed for mass-market products like cigarettes, it would have been impossible for our company and other premium cigar makers to survive.
Eighteen months ago, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia concluded that the FDA acted arbitrarily and capriciously when it decided to regulate premium cigars like cigarettes in 2016. Judge Mehta explained that FDA ignored evidence from the U.S. Centers for Disease Control and Prevention and the National Cancer Institute showing the premium cigars are enjoyed infrequently and pose a lower health risk than cigarettes and other tobacco products. FDA appealed Judge Mehta’s decision and today, a unanimous panel of the U.S. Court of Appeals for the D.C. Circuit agreed with Judge Mehta and affirmed his ‘well-reasoned opinion.’
The Court of Appeals explained that FDA’s decision to regulate premium cigars ‘rested on a false factual premise’ because the agency ‘did not examine the relevant data’ on premium cigars, including ‘evidence that premium cigar use poses a less urgent public health risk than associated with any other tobacco product.’ In upholding Judge Mehta’s decision, the Court of Appeals remanded the case back to Judge Mehta to consider if the definition ‘premium cigar’ he adopted is the correct or should be adjusted further. This issue will be considered in the months ahead.
This has been an eleven-year David-versus-Goliath battle between the small, family businesses that handcraft premium cigars and a large government bureaucracy. Although today’s decision provides enormous relief and should be celebrated, the fight to protect the right to enjoy premium cigars is not over. My father, uncle, and I wish to express our deepest thanks to the three plaintiffs in this case, the Cigar Association of America, Cigar Rights of America, and the Premium Cigar Association, for leading this effort. We are also tremendously grateful for Congresswoman Kathy Castor (D-FL) and former Senator and now Secretary of State Marco Rubio (R-FL) and for their tireless advocacy in Congress in support of America’s historic premium cigar industry.”
