Fall 2020 PCA Magazine

10 PCA The Magazine | AUTUMN 2020 PREMIUMCIGARS.ORG News + Notes N E W S + N O T E S A Win for the Cigar Industry: Mehta Decision Explained On Aug. 19, in the case of Cigar Association of America, the Premium Cigar Association, and Cigar Rights of America v. United States Food and Drug Administration et al. , Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, ruled in favor for the premium cigar industry and against the FDA. The Court held that the FDA—in the Final Deeming Rule—completely mishandled the important question of how premium cigars should proceed through the premarket review process. The Court concluded that the FDA failed to engage in “reasoned decision- making” regarding premium cigars, in violation of federal law. According to the Court, the FDA’s “incorrect and conclusory assertion that its hands were tied” in response to the premium cigar industry’s requests for a more tailored regulatory review process “was arbitrary.” Accordingly, the FDA enjoined application of the premarket review requirements until the agency goes back and addresses the important questions regarding premium cigars ignored in the Final Deeming Rule. Premium cigar manufacturers, therefore, did not have to file for premarket approval by the Sept. 9, 2020, deadline. “This is another monumental victory for the premium cigar industry,” says Scott Pearce, PCA executive director. “We congratulate our legal team, led by Mike Edney of Steptoe & Johnson, on an important victory that protects the livelihood of PCA members across the country. Both our retail members and associate members provided important strategy and guidance in our legal, legislative and regulatory appeals to define premium cigars and showcase their distinctiveness from the courts to Capitol Hill.” Says Glynn Loope, CRA executive director: “Judge Mehta’s opinion is a testament to the virtue of the public comments filed over the years with the FDA by our industry alliance, and the failure of the FDA to not only respond, but to recognize the suggestions made to address the fairness of the proposed regulations. The efforts of the advocacy strategies initiated by CRA and PCA served as the foundation for this decision, proving that you always have to carry your message to both ends of Pennsylvania Avenue, and the courthouse that sits in the middle.” Here is a summary of the decision and impact points moving forward: Court Findings & Decision: – While the FDA solicited comments on different options for exempting or regulating premium cigars in the proposed deeming regulation, the agency did not adequately address in the final deeming regulation industry comments on a potential streamlined approach to compliance with premarket review requirements under the substantial equivalence (“SE”) pathway for this category of products. By inviting and receiving comments, the FDA had an obligation to meaningfully address relevant, substantial comments, and the FDA’s response mischaracterized the comments as requesting