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


Plaintiff Cigar Association of America

Defendant U.S. Food and Drug Administration

Legislation Cited

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Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product