Cigar Associations Appeal Case Against FDA

On Monday, plaintiffs Cigar Association of America, Premium Cigar Association, and Cigar Rights of America filed a notice of appeal to the District of Columbia Circuit seeking review of its trial court losses to the U.S. Food and Drug Administration (FDA). The case concerns the FDA’s 2016 rule that deemed all categories of cigar products subject to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA).

The plaintiffs are associations that “represent cigar manufacturers, importers, distributors, suppliers, and consumers, as well as premium cigar and tobacco retail shops.” They submitted comments to the FDA when it first proposed the rule in 2014, which set forth two options: subject all cigar products to the TCA, or all cigar products except premium cigars.

The industry groups argued that TCA strictures should not apply to premium cigars, proffering “studies showing that premium cigar users have far lower disease and mortality rates than consumers of cigarettes and other tobacco products.” They further contended that because of the differences in use, the same health warnings for “mass-market cigars and other tobacco products was not warranted for premium cigars.”

In May 2016, the FDA rejected these arguments, concluding in its final rule that “no evidence put forward during the notice-and-comment period supported exempting premium cigars from regulation.” In turn, the new rule imposed comprehensive warnings requirements for all cigar product packaging and advertisements.

The instant suit was filed in 2016 against the FDA and its commissioner, and U.S. Department of Health and Human Services and its secretary, and others challenging the rule on various grounds as it applied to premium cigars. In May 2018, the District Court for the District of Columbia held that the health warnings requirement neither violated the First Amendment of the U.S. Constitution nor the Administrative Procedure Act. The court entered judgment forthwith to enable the plaintiffs’ appeal, which is presently under review before the D.C. Circuit.

The plaintiff associations put forward a host of other arguments, but lost summary judgment on all but one count in 2019 and 2020. The present appeal seeks review of the two grants of summary judgment in favor of the defendants and one denial of summary judgment against the plaintiffs, which the trial court entered final judgment of and deemed ripe for appeal on August 24.

The plaintiffs are represented by Steptoe & Johnson and Goodwin Procter LLP, and the defendants by the Department of Justice.