Cigar Ass'n of Am. v. U. S. Food & Drug Admin.
| Decision Date | 05 July 2022 |
| Docket Number | 16-cv-01460 (APM) |
| Parties | CIGAR ASSOCIATION OF AMERICA et al., Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION et al., Defendants. |
| Court | U.S. District Court — District of Columbia |
Once more, the court takes up a challenge to the U.S. Food and Drug Administration's (“FDA”) regulation of a category of tobacco product known as “premium cigars.” In 2016, as part of a rulemaking referred to as the “Final Deeming Rule,” the FDA “deemed” premium cigars subject to the Family Smoking Prevention and Tobacco Control Act of 2009. See Deeming Tobacco Products to Be Subject to the FDCA, 81 Fed.Reg. 28,974, 29,020 (May 10, 2016) (codified at 21 C.F.R. pts. 1100, 1140, 1143). Premium cigar interest groups thereafter brought various challenges to the Final Deeming Rule and largely succeeded. This court has struck down as arbitrary and capricious the Rule's requirement that premium cigar packaging and advertising carry specified health warnings. See Cigar Ass'n of Am. v. FDA (Cigar II), 436 F.Supp.3d 70 (D.D.C. 2020); see also Cigar Ass'n of Am. v. FDA, 964 F.3d 56 (D.C Cir. 2020) (). And it has enjoined the FDA from enforcing the statutory premarket-review scheme against premium cigars because the agency failed to consider an abbreviated, less burdensome process for premium cigars. See Cigar Ass 'n of Am. v. FDA (Cigar III), 480 F.Supp.3d 256, 261 (D.D.C. 2020).
These earlier challenges focused on particular regulatory consequences of the FDA's decision to deem premium cigars. Plaintiffs[1] now contest the deeming itself. They advance two claims. First, they assert that the FDA's decision not to exempt premium cigars altogether from regulation under the Final Deeming Rule was arbitrary and capricious (Count V of the Fourth Amended Complaint). Fourth Am. Compl., ECF No. 236, ¶¶ 166-194. Second, they maintain that the agency failed to reasonably consider the costs and benefits of subjecting small businesses within the premium cigar industry to regulation, as required by the Regulatory Flexibility Act (Count IV of the Fourth Amended Complaint). Id. ¶¶ 141-165.
The court agrees with the first of these contentions but not the second. Accordingly, the parties' cross-motions for summary judgment are granted in part and denied in part. The court will invite additional briefing from the parties before selecting an appropriate remedy.
The background relevant to the claims at issue is as follows.[2] The Family Smoking Prevention and Tobacco Control Act of 2009 (“TCA”) authorizes the FDA to regulate the manufacture, distribution, and marketing of tobacco products. See 21 U.S.C. § 387a. The legislation subjected only certain tobacco products to immediate regulation-namely, “all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.” Id. § 387a(b). Regulation of other tobacco products would be at the FDA's discretion: Congress authorized the agency to “deem[]” other products subject to the TCA. Id.
In 2014, the FDA exercised its deeming authority. It announced a rulemaking that, among other things, would subject cigar products to regulation under the TCA. See Proposed Rule Deeming Tobacco Products To Be Subject to the FDCA, 79 Fed.Reg. 23,142 (Apr. 25, 2014). The agency recognized, however, that a certain category of cigar products known as “premium cigars” might merit different treatment. It wrote that, “although all cigars are harmful and potentially addictive, it has been suggested that different kinds of cigars . . . may have the potential for varying effects on public health.” Id. at 23,150. The FDA thus proposed options that “would provide two alternatives for the scope of the deeming provisions and, consequently, the application of the additional specific provisions.” Id. at 23,143. Under what it called “Option 1,” the FDA would “deem all products meeting the [TCA] statutory definition of ‘tobacco product,'” with some exceptions not relevant here. Id. Option 1, if selected, would subject premium cigars to the TCA's requirements. Conversely, “Option 2” would exclude premium cigars from the scope of the Final Deeming Rule. Id. at 23,145. The agency sought “comment on these options to determine whether all cigars should be subject to deeming and what provisions of the proposed ruled may be appropriate or not appropriate for different kinds of cigars.” Id. at 23,143.
Premium cigar interest groups accepted the FDA's invitation and urged the agency to select Option 2. One commenter's submission is illustrative. Plaintiff Cigar Rights of America (“CRA”), an advocacy group for premium cigar consumers, cited multiple reasons for selecting Option 2. It asserted that, because the “vast majority of premium cigar consumers are only occasional users (one cigar per day or less),” premium cigars do not pose the same type of public health concerns as other tobacco products. J.A., ECF No. 259 [hereinafter A.R.], J.A. - Vol. II, ECF No. 259-1 [hereinafter A.R. Vol. II], at 130340. It also posited that most premium cigar smokers “do not inhale at all,” “which also substantially lowers disease risk.” Id. at 130341.
CRA also addressed youth consumption. It wrote that smokers of premium cigars tended to be more mature adults, typically above the age of 40, and that “[t]here is still no evidence that minors use premium cigars in significant quantities.” Id. at 130337-38.
Notwithstanding such comments, the FDA decided to deem premium cigars and selected Option 1. 81 Fed.Reg. at 28,976. The agency stated that, “despite our explicit requests,” commenters “did not include data indicating that premium cigar smokers are not subject to disease risk and addiction.” Id. at 29,024. It added that “there 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.” Id. at 29,020. With regard to youth consumption, the FDA observed that “studies indicate that [youth and young adults] are also using premium cigars.” Id. at 29,022. Ultimately, the agency “concluded that deeming all cigars, rather than a subset, more completely protects the public health.” Id. at 29,020.
The agency performed a Regulatory Flexibility Act analysis as part of the Final Deeming Rule. In so doing, the FDA did not undertake a specific cost-benefit analysis with regard to the selection of Option 1 over Option 2. Id. at 29,074-76.
Plaintiffs advance three primary arguments as to why the FDA's decision to deem premium cigars was arbitrary and capricious. First, they contend that the FDA erroneously based its decision on the belief that there was no evidence in the administrative record of different usage patterns for premium cigars that might lead to different health outcomes, when in fact there was such evidence. Pls.' Mot. for Summ. J. & for a Permanent Inj., ECF No. 247 , Pls.' Mem. in Supp. of Pls.' Mot., ECF No. 247-1 , at 21-28. Second, they claim that the FDA's finding as to youth usage of premium cigars was premised on a flawed reading of a particular study. Id. at 28-32. And finally, Plaintiffs argue that the FDA's action was fatally flawed because the agency failed to adequately explain how regulating premium cigars would promote public health. Id. at 33-40. The court discusses the first two of these contentions below but need not reach the third.[3]
When the FDA proposed two options for regulating cigar products, it did so because of the suggestion, made by some, that “different kinds of cigars . . . may have the potential for varying effects on public health, if there are differences in their effects on youth initiation, the frequency of their use by youth and young adults, and other factors.” 79 Fed.Reg. at 23,150. The FDA did not concede that there were in fact such varying effects, but it acknowledged that “[s]ome have contended that usage patterns of . . . premium cigars[] can vary dramatically from usage patterns of other cigars.” Id. at 23,151. And it admitted that “differences in patterns of use” could produce “differences in disease risks.” Id. As a result, the FDA sought comment to ensure that the exclusion from regulation would apply, if at all, “only to those cigars that, because of how they are used, may have less of a public health impact than other types of cigars.” Id. at 23,150. The agency thus signaled that evidence of different usage patterns and their public health impacts would be a central consideration in deciding whether to exclude premium cigars from the scope of the final rule.
Despite this ask for evidence, the FDA said it received none. According to the agency, “despite [its] explicit requests in the [Notice of Proposed Rulemaking], the comments did not include data indicating that premium cigar smokers are not subject to disease risk and addiction.” 81 Fed.Reg. at 29,024. It made similar “no data” statements elsewhere in the Final Deeming Rule. The FDA said that “there 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.” Id. at 29,020. Similarly, it declared that “there are no data indicating that premium cigar users are not susceptible to health risks.” Id. And, it reiterated once more, the “FDA specifically sought comment on how the potential different patterns of use for premium cigars might result in different or decreased health impacts, but no such evidence was submitted.” Id. at 29,022.
Plaintiffs assert that these “no data” declarations-and the resulting decision to deem premium cigars-were arbitrary and...
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