FDA Withdraws Notice of Proposed Rulemaking For Premium Cigars

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On June 11, 2021, the U.S. Food and Drug Administration (FDA) withdrew an advanced notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018 as part of the Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions, which is published twice a year. Nevertheless, FDA commissioned a study to obtain information similar to what it sought in the ANPRM. The study is scheduled to be complete in Spring 2022. Thus, there is still a chance FDA takes a modified approach with respect to premium cigars in the future.

As you may recall, FDA issued the ANPRM to “obtain information related to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and regulations regarding the sale and distribution of tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars.” 83 Fed. Reg. 12,901 (Mar. 26, 2018). According to the docket, 32,729 comments were received, including from organizations such as Cigar Rights of America, Altria Client Services, the Cigar Association of America, Inc., the National Association of Tobacco Outlets, Inc., Davidoff of Geneva USA, the International Premium Cigar and Pipe Retailers Association, and The Heritage Foundation. Despite the comments received, in an August 2020 court filing, FDA asserted that the comments “have not provided new data sufficient to address questions of whether the characteristics of premium cigars or their patterns of use may result in different health effects than other tobacco products.” Acad. of Pediatrics v. FDA, No. 8:18-cv-883-PWG, ECF No. 188, 2 (D.Md. Aug. 5, 2020). Thus, it is not surprising that FDA decided to withdraw the ANPRM.

You may also recall that in August 2020, the U.S. District Court for the District of Columbia prohibited FDA from enforcing the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the agency considers streamlined substantial equivalence process specifically for premium cigars. Cigar Assoc. of America, et al., v. FDA, Case No. 1:16-cv-01460(APM), 38 (D.D.C. Aug. 19, 2020). For purposes of the order, the Court defined a premium cigar to mean any cigar that meets the following criteria:

  • Is wrapped in whole tobacco leaf;
  • Contains a 100 percent leaf tobacco binder;
  • 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);
  • 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);
  • Has no filter, nontobacco tip, or nontobacco mouthpiece;
  • Does not have a characterizing flavor other than tobacco;
  • Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and
  • Weighs more than 6 pounds per 1,000 units.

Despite the withdrawal of the ANPRM, there is still an opportunity for FDA to develop a modified approach to premium cigars. According to the withdrawal announcement, “FDA has contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a comprehensive and systematic assessment and review of the scientific literature and provide a final report of the study results. The review will include analysis of data on both short-term and long-term health effects of ‘premium’ cigars. The NASEM review has begun and is expected to conclude in spring 2022.” FDA plans to provide a public update after it receives the results of the NASEM review. Of course, it remains to be seen when and how FDA will reconsider its approach to premarket review of premium cigars in light of the August 2020 court order.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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