UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA _________________________________________
) CIGAR ASSOCIATION OF ) AMERICA, et al., ) ) ) Plaintiffs, ) v. ) ) U.S. FOOD AND DRUG ) ADMINISTRATION, et al., ) ) Defendants. ) _________________________________________ )
Case No. 16-cv-01460 (APM)
MEMORANDUM OPINION I. The court (at long last) 1 returns to this long-running dispute over the U.S. Food and Drug Administration’s (“FDA”) decision to regulate, or “deem,” premium cigars under the Family Smoking Prevention and Tobacco Control Act of 2009 (“TCA”). In July of 2022, the court held that the FDA’s decision to deem premium cigars was arbitrary and capricious insofar as the agency failed to consider data before it concerning the use of premium cigars and the health effects of such use. Cigar Ass’n of Am. et al. v. U.S. Food & Drug Admin. (Cigar IV), 2022 WL 2438512 (D.D.C. July 5, 2022). Because the issue of remedy had not been briefed, the court reserved on that question and invited further briefing from the parties. Since then, Plaintiffs have asked the court to vacate the FDA’s decision to deem premium cigars. The FDA, on the other hand, has urged the court to remand without vacatur.
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The court apologizes to the parties for the length of time it has taken to issue this decision.