PCA Magazine Summer 2022

16 PCA The Magazine | VOLUME 3 2022 PREMIUMCIGARS.ORG ADVOCATE Deeming Rule Found ‘Arbitrary and Capricious’ In July, United States District Court Judge Amit Mehta rendered a ruling, as part of the PremiumCigar Association’s litigation against the Food and Drug Administration (FDA), striking down the FDA’s decision to regulate premiumcigars 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, Cigar Rights of America and Cigar Association of America) 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. PCA President Greg Zimmerman said, “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.” Michael Edney, attorney representing the premium cigar industry added, “The family-owned manufacturers and retailers that make and sell premium cigars have long believed the FDAmishandled its decision to regulate premium cigars,” “We are grateful for the Court’s decision and the opportunity for further proceedings in this matter.” Josh Habursky Deputy Executive Director [email protected] Glynn Loope Director of State Affairs [email protected] PCA Files Comments Opposing FDA's Proposed Flavored Cigar Rule Over the summer, PCA filed public comments opposing the FDA’s proposed rule entitled “Tobacco Product Standard for Characterizing Flavors in Cigars.” The proposed rule would prohibit the manufacture, distribution and sale of cigars, or any of their components or parts, with a characterizing flavor other than tobacco. However, the evidence on which FDA relied in issuing the proposed rule does not demonstrate that use of flavored cigar products inherently poses an increased health risk relative to use of cigars without non-tobacco “characterizing flavors.” Further, FDA erroneously claimed that banning such products will improve health equity, particularly among certain subpopulations. In its comments, PCA raised specific concern over the proposed rule’s impact on an advertiser’s or retailer’s ability to describe the flavor profile of any cigar. The comments also criticized the fact that FDA failed to clearly define “characterizing flavor.” Rather, FDA identified non-binding factors that, if present, would indicate the presence of a characterizing flavor. These non-binding factors appear so vague and subjective in nature so as to render the rule, at worst, unconstitutionally vague and, at best, exceedingly difficult for industry to implement and for FDA to enforce consistently. PCA’s comment also calls out FDA’s failure to adequately conduct an economic impact assessment on minority-owned small businesses. In addition, FDA failed to consider the broad international impact that the product standard would have on commerce, immigration and economic stability for U.S. allies in tobacco- and cigar-producing countries. Greg Zimmerman, president of the PCA, stated: “There is something inherently wrong about targeting communities for additional regulation based on race. Our retailers are part of the social fabric of the communities where they operate. They have a right to support their consumers’ product choices, whether they are premium cigars or flavored cigars.” Scott Pearce, executive director of the PCA, also noted: “FDA has a mechanism to prevent youth access