Cigar Association of America v. U.S. Food and Drug Administration

Plaintiffs, cigar trade associations, challenged the decision of the Food and Drug Administration (FDA) to regulate, or “deem”, premium cigars subject to the agency’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act of 2009. As background, the FDA issued a Final Rule on August 8, 2016, deeming all products meeting the statutory definition of a “tobacco product” to be subject to its regulatory authority, including premium cigars (the “Deeming Rule”).

Plaintiffs challenged the Deeming Rule alleging that the FDA did not consider comments provided in the rulemaking phase regarding usage patterns- asserting that premium cigars did not pose the same public health concerns as other tobacco products. The Court found that FDA’s failure to consider the data was a significant error.

The FDA argued that vacating the Deeming Rule would leave premium cigars unregulated at the federal level and maintaining the status quo would not impose significant burdens on premium cigar manufacturers. The Court recognized the importance of these consequences but found that they were not disruptive enough to warrant remand without vacating the decision.

The Court vacated the FDA’s decision to deem premium cigars, concluding a seven-year conflict between the cigar industry and FDA. The Court defined premium cigars as those that: (1) are wrapped in whole tobacco leaf; (2) contain a 100 percent leaf tobacco binder; (3) contain at least 50 percent (of the filler by weight) long filler tobacco; (4) are handmade or hand rolled; (5) have no filter, non-tobacco tip, or non-tobacco mouthpiece; (6) do not have a characterizing flavor other than tobacco; (7) contain only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weigh more than 6 pounds per 1,000 units.

Cigar Association of America, et al. v. U.S. Food and Drug Administration, et al., No. 16-cv-01460, U.S. District Court for the District of Columbia (2023)

  • United States
  • Aug 9, 2023
  • U.S. District Court for the District of Columbia
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Parties

Plaintiff Cigar Association of America

Defendant U.S. Food and Drug Administration

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"With respect to impact on public health, the FDA starts with the fact that vacatur would mean premium cigar sales to youth under the age of 21 will no longer be unlawful under federal law. But this concern is mitigated by the fact that existing state laws limit sales to youth and minors. Pls.’ Br. at 8. For example, all 50 states prohibit the sale of premium cigars to persons under 18 years old. Pls.’ Reply in Supp. of Pls.’ Mot. for Summ. J., ECF No. 256, at 30 n.10. Additionally, all but 12 states and four territories prohibit their sale to 18- to 20-year-olds.6 Although state laws will not bar sales to all young adults under 21, vacatur will make premium cigars newly legally available to only a small segment of the population. As for the availability of machine vending and free samples of premium cigars, the FDA has not shown to what extent premium cigars are distributed in those ways, particularly to reach young adults and minors. See 81 Fed. Reg. at 29,054 (stating that restricting free samples of premium cigars “will eliminate a pathway for youth to access tobacco products”). Given the higher individual cost of a premium cigar, it is unlikely that premium cigars are commonly sold through vending machines. And, presumably, the same state laws that restrict sales of tobacco products to youth under 18 or 21 also prohibit giving those products away for free as samples to youth. Finally, although limiting the FDA’s ability to enforce the law as to false or misleading labeling of premium cigar products is a legitimate concern, the agency has not shown that there is a history of mislabeling products in the premium cigar industry. The FDA has given the court no reason to think that its inability to police false or misleading labeling is likely to open the floodgates to mislabeled premium cigars. Additionally, in a different context, the FDA has said that premium cigars are its “lowest [enforcement] priorit[y]” relative to other tobacco products used with greater frequency by youth. See FDA’s August 2020 Notice to Court, ECF No. 209, at 3 (stating that premium cigars were the agency’s lowest enforcement priority with respect to the premarket authorization requirement). The agency has not said otherwise with respect to the labeling of premium cigars."