Court Blocks FDA Product Approval Requirements for Premium Cigars

Great News for the cigar industry! Here is the news alert posted by Cigar Rights of America and the Premium Cigar Association:

WASHINGTON, D.C. – Today, in the case of Cigar Association of America, the Premium Cigar Association (“PCA”), and Cigar Rights of America (“CRA”) 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 addressed the important questions regarding premium cigars ignored in the Final Deeming Rule. Premium cigar manufacturers will not have to file for premarket approval by the September 9th, 2020. The Court relayed upon a definition of premium cigar utilized by the FDA in an August 5, 2020 filing:

    a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units.”

The definition is endorsed by PCA and CRA and will provide relief to most products sold at premium cigar retail stores and lounges. Notably the definition does not include a price minimum, flavors, or cigars that are machine manufactured.

“This is another monumental victory for the premium cigar industry. 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. This comes on the heels of legal victories striking down warning labels for premium cigars. 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 Scott Pearce PCA Executive Director.

Glynn Loope, executive director of CRA, stated upon the release of the opinion, “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, consumer messaging and the Administration pressure and Congressional advocacy brought out by our collective lobbying efforts. FDA failed to not only respond to these comments, but also 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.”