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FDA Regulations Struck Down
| FDA Regulations Struck Down Today United States District Court Judge Amit Mehta rendered a ruling, as part of the Premium Cigar Association’s litigation against the Food and Drug Administration, striking down the FDA’s decision to regulate premium cigars as arbitrary and capricious. This is the third major lawsuit with earlier challenges focused on particular regulatory consequences of the FDA’s decision to deem premium cigars involving warning labels and substantial equivalence and premarket review requirements. Plaintiffs (PCA, CRA, and CAA) were represented by Michael Edney of Steptoe & Johnson LLP. The Court agreed with the Plaintiffs that “the FDA’s decision not to exempt premium cigars altogether from regulation under the Final Deeming Rule was arbitrary and capricious.” As the Court explained, “In the end, instead of addressing the relevant data before it, the agency resorted to a common refrain to obscure the issue: “[T]here were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.” That statement was not accurate then, and despite litigation counsel’s efforts, it is not accurate now. Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it.” The Court also criticized the agency’s handling of data when the FDA asserted that youth were using premium cigars. Counsel will brief Judge Mehta on potential remedies for the defects in the agency’s decision to regulate premium cigars. later this month. “This is another example of membership dollars at work and how important it is for our association to continue to challenge the FDA in the courts. There is still work to be done, but this is welcomed news on the eve of our industry’s gathering,” said PCA President Greg Zimmerman. “The family-owned manufacturers and retailers that make and sell premium cigars have long believed the FDA mishandled its decision to regulate premium cigars,” said Edney. “We are grateful for the Court’s decision and the opportunity for further proceedings in this matter.” “We’d like to thank our industry partners, especially Cigar Rights of America for the many years of collaboration, support, and advocacy at all levels,” added PCA Executive Director Scott Pearce. The PCA will cover this decision in more detail and provide greater regulatory context during the Friday, July 8 Government Affairs session at the 2022 PCA Annual Convention & Trade Show. |
Drew Newman, general counsel and fourth-generation owner of J.C. Newman Cigar Co., issued the following statement in response to today’s decision:
In 2016, FDA decided to regulate premium cigars and apply the same massive and costly regulatory scheme that was developed for cigarettes onto handcrafted premium cigars. For the past five years, we have been living in regulatory purgatory, knowing that not only scientific evidence does not support regulating premium cigars like cigarettes but that complying with FDA regulation could crush America’s historic premium cigar industry, which is large comprised of small, family-owned businesses.
Congress gave FDA the authority to regulate tobacco to address youth access and addiction. For nearly a decade, we have presented evidence to FDA confirming that children do not smoke premium cigars, that adults enjoy premium cigars in moderation, and the health effects of such moderate use limited. Earlier this year, the National Academies of Science, Engineering, and Medicine issued a 520-page report on premium cigars and largely agreed with our analysis of the science. The National Academies analyzed the same studies that we shared with FDA and concluded that the overall risk of premium cigars is “modest.”
Today’s decision is a landmark ruling that will shape America’s premium cigar industry for generations. It is a vindication of the premium cigar industry’s long and relentless campaign to show that there is not a scientific basis for regulating premium cigars like cigarettes. It is an incredible relief knowing that Judge Mehta has concluded that FDA acted arbitrarily and capriciously in ignoring clear evidence on the use and health effects of premium cigars.
Although Judge Mehta’s opinion did not go as far as striking down FDA regulation of premium cigars today, we are hopeful that he will do so later this year after the parties submit arguments on the appropriate remedy and next steps later this month.
My family and I are very grateful to our industry’s three trade associations, the Cigar Association of America (CAA), Cigar Rights of America (CRA), and the Premium Cigar Association, for joining together to challenge FDA’s decision to regulate cigars in court five years ago. We are especially thankful to CRA, whose 2014 comments Judge Mehta cited as the primary basis for today’s decision and who funded the part of the litigation that led to today’s landmark decision. We appreciate Michael Edney’s advocacy in litigating this case for the past 5 years, and remain very grateful to Congresswoman Kathy Castor (D-FL) and Senator Marco Rubio (R-FL) for their unwavering support of Florida’s historic premium cigar industry in Congress.
