On July 5, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like cigarettes was “arbitrary and capricious.” In reaching this conclusion, Judge Amit Mehta relied heavily on industry comments regarding the relative public health risks and negligible youth use of premium cigars, as well as related studies — which the court said FDA either ignored or glossed over. The opinion underscores the importance of the role of public comments in agency rulemaking.

At issue in the case was the agency’s decision to subject premium cigars to FDA tobacco regulations. The Family Smoking Prevention and Tobacco Control Act of 2009 (TCA) authorized FDA to regulate the manufacture, distribution, and marketing of tobacco products, but the law initially only subjected cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to oversight. 21 U.S.C. § 387a(b). Congress gave FDA the authority to “deem” other tobacco products subject to the TCA through regulation.

In 2014, FDA did just that. The agency proposed a rule deeming cigars subject to the TCA. The agency, however, recognized that different kinds of cigars might have different effects on public health and therefore invited public comments on whether “premium cigars” should be excluded from the final rule.

In finding FDA’s final rule “arbitrary and capricious,” Judge Amit Mehta relied heavily on those comments. For example, Judge Mehta faulted the agency for asserting repeatedly that FDA received no data indicating that different usage patterns for premium cigars might lead to lower health risks. On the contrary, he pointed to comments from Cigar Rights of America, an advocacy group for premium cigar consumers, retailers, and manufacturers, and a plaintiff in the matter who cited a study conducted by an FDA scientist that showed only a small fraction of premium cigar smokers smoked on a daily basis (3.3%) and another study that found no statistically significant difference in the “all-cause” mortality rate between “neversmokers” and those who smoked no more than two cigars per day.

In the litigation, FDA offered reasons for why the agency might not have found the studies persuasive, but, as the court pointed out, an agency is not allowed to justify its actions after-the-fact in litigation when it did not make those points in the rulemaking itself. On this point, Judge Mehta criticized the agency:

In the end, instead of addressing the relevant data before it, the agency resorted to a common refrain to obscure the issue: “[T]here were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.” … That statement was not accurate then, and despite litigation counsel’s efforts, it is not accurate now. Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it.

What happens next remains to be determined. Judge Mehta has asked the parties for additional briefing on the appropriate remedy, including whether to vacate the rule for premium cigars or remand the matter to FDA for further consideration of evidence that FDA failed to adequately consider.

What is clear is that the importance of public comments on proposed agency rulemaking should not be overlooked. The key to the successful litigation challenge was Cigar Rights of America’s comments and evidence addressing the relative public health impacts of premium cigars. Our team regularly assists clients in preparing comments on agency rules. Should you need assistance, please contact us.

The case is Cigar Association of America v. U.S. Food and Drug Administration, No. 16-cv-01460, 2022 U.S. Dist. LEXIS 117364 (D.D.C. July 5, 2022).