UNITED STATES DISTRICT COURT FOR THE …

1 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA _____ ) CIGAR ASSOCIATION OF AMERICA, et al., ) ) Plaintiffs, ) ) v. ) Case No. 1:16-cv-1460 (APM) ) FOOD AND DRUG ) ADMINISTRATION, et al., ) ) Defendants. ) _____ ) MEMORANDUM OPINION I. INTRODUCTION Six public health organizations (the Proposed Intervenors ) seek to intervene in this case to defend regulat ions issued by the Food and Drug Administration that subject cigars, pipe tobacco, and other tobacco products to the Federal Food, Drug, and Cosmetic Act, 21 301 et seq., as amended by the Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111 31, 123 Stat. 1777 (2009) ( Tobacco Control Act ). Plaintiffs, associations that represent cigar manufacturers, retailers, and importers, challenge the FDA s (1) adoption of warning label requirements for cigar and pipe tobacco products; (2) imposition of user fees on cigar and pipe tobacco products but not e-cigarettes; (3) treatment of retailers who blend pipe tobacco as tobacco product manufacturers ; and (4) classification of pipes as components of tobacco products.

2 Of those challenges, Proposed Intervenors motion to intervene is predicated primarily on Plaintiffs first challenge the new warning requirements for cigar and pipe tobacco products. Proposed Intervenors contend that, if Plaintiffs are successful, then they will be forced to spend resources educating the public about the risks of tobacco use that otherwise would be conveyed by the Case 1:16-cv-01460-APM Document 68 Filed 10/16/17 Page 1 of 222 warnings themselves. That additional expenditure of resources, they believe, establishes the injury-in-fact necessary to demonstrate Article III standing and constitutes the legal interest required to intervene as of right under Rule 24(a) of the Federal Rules of Civil Procedure. Upon careful consideration of the briefs and the record, the COURT concludes that Proposed Intervenors have not established that they would suffer a legally sufficient injury-in-fact if Plaintiffs were to prevail in this litigation.

3 Therefore, they lack standing to intervene as of right, and the COURT declines to allow Proposed Intervenors to intervene permissively. Accordingly, the COURT denies Proposed Intervenors Motion to Intervene. II. BACKGROUND A. Plaintiffs Challenge to the Rule In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act ( Tobacco Control Act ), which granted the Food and Drug Administration the authority to regulate cigarettes and other tobacco products. See 21 387a. Congress immediately applied the Act to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco ( Originally Regulated Products ). Id. 387a(b). Congress left it to the FDA to decide whether to apply the Act to other types of tobacco products. Specifically, it vested in the FDA the authority to deem[ ] any other tobacco product[ ] subject to the Act.

4 Id. In May 2016, the FDA exercised its deeming muscle. It published a Final Rule ( Rule ) designating cigars, pipe tobacco, and certain other tobacco products ( , e-cigarettes) as other tobacco products subject to the Tobacco Control Act. See 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 Fed. Reg. 28,973 (May 10, Case 1:16-cv-01460-APM Document 68 Filed 10/16/17 Page 2 of 223 2016) (to be codified at 21 pts. 1100, 1140, 1143).1 The FDA s action made cigars and pipe tobacco subject to requirements currently in place for Originally Regulated Products, such as pre-market review, a prohibition on the sale of products with descriptors such as light and mild, and ingredient reporting.

5 Id. And, critically, for present purposes, the Rule included comprehensive warning requirements for cigar and pipe tobacco packaging and advertising. 81 Fed. Reg. at 28,974. That provision mandates that cigar manufacturers, distributors, importers, and retailers include one of six health warnings on cigar and pipe tobacco packages and in cigar and pipe tobacco advertisements, as well as rotate those six warnings in a manner that ensures consumers see all six. 81 Fed. Reg. at 29,060 29,062. The provision also sets font size, location, and other requirements for displaying the warnings and mandates the submission of warning plans. Id. Plaintiffs three associations that represent cigar manufacturers, importers, distributors, retail shops, suppliers, and consumers filed suit in July 2016 to challenge the Rule in multiple respects as unlawful under the Tobacco Control Act, the Administrative Procedure Act (the APA ), and the First and Fifth Amendments to the UNITED STATES Constitution.

6 Compl., ECF No. 1 [hereinafter Compl.], 4 5. Though filed more than a year ago, this suit has barely gotten off the ground. Following Defendants 2 answering of the Complaint and Plaintiffs filing of an initial motion for summary judgment, the change in presidential administrations caused the parties to seek multiple extensions of the briefing schedule to allow new leadership personnel at the 1 Plaintiffs also challenge the User Fee Rule, under which the FDA plans to collect fees from domestic manufacturers and importers of cigars and pipe tobacco. Under the Federal Food, Drug, and Cosmetic Act, FDA has the authority to assess and collect fees from domestic manufacturers and importers of tobacco products in order to fund its regulation of tobacco products. Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco, 81 Fed.

7 Reg. 28,707, 28,707 (May 10, 2016). Proposed Intervenors do not take a position on that issue. Mot. to Intervene, ECF No. 36, at 6 2 Plaintiffs named as defendants the FDA, the Department of Health and Human Services, Sylvia Mathews Burwell, in her official capacity as Secretary of Health and Human Services, and Robert Califf, in his official capacity as Commissioner of Food and Drugs. The COURT refers to them collectively as Defendants. Case 1:16-cv-01460-APM Document 68 Filed 10/16/17 Page 3 of 224 Department of Health and Human Services to more fully consider the issues raised in this case and determine how best to proceed. Joint Mot. to Amend Scheduling Order, ECF No. 27; Joint Mot. to Amend Scheduling Order, ECF No. 34. The parties hoped that the extensions of time would enable them to resolve the pending disputes or, at least, narrow the issues. The additional time proved to be partially successful from Plaintiffs perspective.

8 On July 28, 2017, the FDA announced a new comprehensive plan for regulating tobacco products that delayed implementation of the Rule in several important respects. Pls. Opp n to Mot. to Intervene, ECF No. 44 [hereinafter Pls. Opp n], Ex. A, ECF No. 44-1 [hereinafter Pls. Opp n, Ex. A]. The FDA extended to August 8, 2021, the deadline for tobacco manufacturers to submit applications for newly regulated products, including cigars and pipe tobacco, that were on the market as of August 8, 2016, and provided that manufacturers could continue to market those products while the applications were pending. Pls. Opp n, Ex. A at 2; Joint Status Report, ECF No. 51, 3. The FDA also announced that it would seek public comment on (1) the role that flavors in tobacco products play in attracting youth and (2) the patterns of use and resulting public health impacts of premium cigars, thereby suggesting that future rulemaking may result in the Rule s amendment.

9 Joint Status Report, ECF No. 51, 3. The FDA otherwise left the Rule intact, including its comprehensive warning requirements for cigars and pipe tobacco. In response to the new comprehensive plan, Plaintiffs limited the number of claims presented. Plaintiffs identified six claims as the ones they wished to pursue at this Id. 5. On October 3, 2017, Plaintiffs moved for summary judgment as to those claims and sought order enjoining the warning requirements. Pls. Mot. for Prelim. Inj., ECF No. 61; Pls. Mot. for Partial 3 The remaining three claims are held in abeyance pending the outcome of the FDA s review described above. Case 1:16-cv-01460-APM Document 68 Filed 10/16/17 Page 4 of 225 Summ. J., ECF No. 62 [hereinafter Pls. Mot. for Partial Summ. J.], at 2 4. Defendants opposition brief is due on October 24, 2017.

10 See Order, Sept. 19, 2017, ECF No. 57. B. The Proposed Intervention The Proposed Intervenors the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative are six public health organizations that seek to defend the Rule against Plaintiffs challenges. The COURT granted the Proposed Intervenors initial request to participate in this matter as amici. Order, Apr. 3, 2017, ECF No. 30. On July 24, 2017, however, the Proposed Intervenors sought to upgrade their status to that of parties and filed a Motion to Intervene as defendants (the Motion ), citing recent indications that Defendants may not aggressively defend the [Rule], or may seek to alter or rescind the Rule. Mot. to Intervene, ECF No. 36 [hereinafter Mot.]