Cigar Association of America v. United States Food and Drug Administration

CourtDistrict Court, District of Columbia
DecidedOctober 16, 2017
DocketCivil Action No. 2016-1460
StatusPublished

This text of Cigar Association of America v. United States Food and Drug Administration (Cigar Association of America v. United States Food and Drug Administration) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Cigar Association of America v. United States Food and Drug Administration, (D.D.C. 2017).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

_________________________________________ ) CIGAR ASSOCIATION OF AMERICA, et al., ) ) Plaintiffs, ) ) v. ) Case No. 1:16-cv-1460 (APM) ) U.S. 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 regulations issued by the U.S. Food and Drug Administration that subject cigars, pipe

tobacco, and other tobacco products to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §

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. 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 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. 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 U.S. Food and Drug Administration the authority to

regulate cigarettes and other tobacco products. See 21 U.S.C. § 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. 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.g., 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,

2 2016) (to be codified at 21 C.F.R. 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. 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. 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. 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 n.6. 2 Plaintiffs named as defendants the FDA, the U.S. 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.

3 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. 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

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