Since it became effective in 2016, the cigar industry has mounted several challenges to the U.S. Food and Drug Administration’s (“FDA”) “Deeming Rule,” which extended the Agency’s tobacco product authority beyond cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco, to all products that meet the “tobacco product” definition in the Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act.^[1]

In 2020, the United States District Court for the District of Columbia (the “Court”) issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5, and remanding the final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency.^[2] On August 19, 2020, the Court issued a ruling, in part, to prohibit FDA enforcement of the Tobacco Control Act’s premarket authorization requirement for premium cigars until after the Agency considers developing a streamlined substantial equivalence process specifically for premium cigars.

Now, the Court has addressed the central issue of whether FDA should have ever deemed premium cigars to be subject to the Tobacco Control Act in the first place – ruling that doing so was arbitrary and capricious in violation of the Administrative Procedure Act (“APA”). The ruling does not apply to little cigars or cigarillos.^[3]

By way of background, in 2014, the FDA promulgated the notice of proposed rulemaking (“NPRM”) for the long-awaited Deeming Rule. In the NPRM, FDA proposed two options defining the scope of the rule. Under “Option 1,” FDA would deem all products meeting the statutory definition of “tobacco product,” including premium cigars, to be subject to its regulatory authority, while under “Option 2,” FDA would exclude premium cigars from its regulatory authority.^[4] FDA sought comments on these options, to “determine whether all cigars should be subject to deeming and what provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.”^[5]

Of note, the Cigar Rights of America (“CRA”) in conjunction with the Cigar Association of America and the Premium Cigar Association, submitted comments to the NPRM regarding the usage patterns of premium cigar consumers, asserting the majority of premium cigar consumers are adults over 40 years old and only occasionally smoke the products, indicating that premium cigars do not pose the same type of public health concerns, including youth usage, as other tobacco products. The groups noted that the vast majority of premium cigar smokers are adults who rarely use premium cigars (71.2%), that only3.3% reported ‘every day’ use, and 25.6% reported ‘someday’ use.

Notwithstanding such comments, FDA issued the final Deeming Rule, which became effective on August 8, 2016, and immediately deemed all products meeting the statutory definition of “tobacco product,” including premium cigars, to be subject to its regulatory authority (i.e., Option 1).^[6] Specifically, FDA concluded 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.”^[7]

Following the publication of the final rule, the Cigar Association of America, the Premium Cigar Association, and the CRA (the “Plaintiffs”) collectively challenged the final rule, arguing that FDA’s decision to deem premium cigars and thereby subject them to the Tobacco Control Act requirements, including premarket authorization for new products, was arbitrary and capricious. The groups asserted:

• FDA erroneously decided to deem premium cigars, based on an alleged lack of evidence in the administrative record of different usage patterns for premium cigar consumers, when in fact there was such evidence submitted by the CRA;

• FDA erroneously concluded that there was significant youth usage of premium cigars further justifying regulation, based on a misinterpretation of one particular study; and

• FDA failed to adequately conduct a cost-benefit analysis under the Regulatory Flexibility Act (RFA) of how regulating premium cigars would promote public health.^[8]

In a Memorandum Opinion and Order issued on July 5, 2022, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia ruled that FDA’s decision to deem premium cigars was indeed arbitrary and capricious.^[9] Specifically, the Court found that there was pertinent record evidence on premium cigar usage, but that FDA failed to adequately consider the submitted comments and data, despite signaling during rulemaking (i.e., the presentation of the two options) that evidence of different usage patterns and public health impacts would be a central consideration in deciding whether to exclude premium cigars from the scope of the final rule.^[10] In short, Judge Mehta found FDA ignored relevant data about the population health risks of premium cigar use.

Before issuing a final ruling vacating the Deeming Rule for premium cigars, or remanding the rule back to FDA for further consideration, for example, the court has asked the parties to submit briefs proposing potential remedies by July 26, 2022. We will continue to monitor this case, so stay tuned for updates.

ENDNOTES

[1] See Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 79 Federal Register 23,141 (Apr. 25, 2014).

[2] See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020).

[3] One issue for the Court to confirm in a final decision is how to define “premium cigar.” For the purposes of the August 2020 decision on premarket authorization requirements, for example, a premium cigar was defined as a cigar that meets all of the following eight criteria: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units.

[4] Id. at 23,143–23,145.

[5] Id. at 23,143.

[6] See final rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Federal Register 28,973 (May 10, 2016) (codified at 21 C.F.R. §§ 1100, 1140, 1143).

[7] Id. at 29,020.

[8] See Cigar Association of America et al. v. United States Food and Drug Administration et al., Case No. 1:16-cv-01460-APM (D.D.C.) (July 5, 2022), 4–5.

[9] Id. at 1.

[10] Id. at 5–6, 14–15.

[11] Id. at 15–16.

[12] Id. at 18.