En Fuego Tobacco Shop LLC v. United States Food and Drug Administration

CourtDistrict Court, District of Columbia
DecidedJanuary 11, 2019
DocketCivil Action No. 2018-1797
StatusPublished

This text of En Fuego Tobacco Shop LLC v. United States Food and Drug Administration (En Fuego Tobacco Shop LLC 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.

Bluebook
En Fuego Tobacco Shop LLC v. United States Food and Drug Administration, (D.D.C. 2019).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA _________________________________________ ) EN FUEGO TOBACCO SHOP LLC, ) et al. ) ) Plaintiffs, ) ) v. ) Case No. 18-cv-01797 (APM) ) UNITED STATES FOOD AND DRUG ) ADMINISTRATION et al. ) ) Defendants. ) _________________________________________ )

MEMORANDUM OPINION AND ORDER

I. INTRODUCTION

In an order dated July 2, 2018, the District Court for the Eastern District of Texas

transferred this matter to this court under the Fifth Circuit’s first-to-file rule. The court in Texas

found that there is a “likelihood of substantial overlap” between this case and Cigar Association

of America v. FDA, which has been pending before this court since July 2016. Plaintiffs are

Texas-based stakeholders in the premium cigar industry. They now ask the court to retransfer

the case to the Eastern District of Texas, where they originally filed this action. Plaintiffs assert

that retransfer is appropriate because there is not substantial overlap between the two cases, and

further, because the interests of justice and convenience obligate this court to respect Plaintiffs’

choice of forum.

For the reasons that follow, the court declines to retransfer this case. Instead, the court

consolidates this matter with Cigar Association of America v. FDA and directs the parties to meet

and confer and propose a summary judgment briefing schedule. II. BACKGROUND

A. The Deeming Rule

On April 25, 2014, the U.S. Food and Drug Administration (“FDA”) issued a Proposed

Rule that would make, or “deem,” cigars, pipe tobacco, and e-cigarettes subject to the federal Food,

Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. §§ 301, et seq., as amended by the Family

Smoking Prevention and Tobacco Control Act of 2009 (the “TCA”).1 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; Regulations on the Sale and Distribution of

Tobacco Products and Required Warning Statements for Tobacco Products, 79 Fed. Reg. 23,142

(Apr. 25, 2014) (“Proposed Deeming Rule”). In the Proposed Deeming Rule, the FDA announced

for consideration two 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 Option 1, the FDA would deem all products meeting the statutory definition of “tobacco

product”—including cigars and pipe tobacco but excluding accessories—to be subject to the TCA.

Id. Under Option 2, the TCA would cover “only a subset of cigars,” excluding “from the scope of

[the] proposed rule certain cigars that we refer to as ‘premium cigars.’” Id. To effectuate the carve

out for premium cigars, Option 2 proposed to define a “covered cigar” as:

[A]ny cigar as defined in this part, except a cigar that: (1) Is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains primarily long filler tobacco; (4) is made by combining manually the wrapper, filler, and binder; (5) has no filter, tip, or non- tobacco mouthpiece and is capped by hand; (6) has a retail price (after any discounts or coupons) of no less than $10 per cigar (adjusted, as necessary, every 2 years, effective July 1st, to account for any increases in the price of tobacco products since the last price adjustment); (7) does not have a characterizing flavor other than tobacco; and (8) weighs more than 6 pounds per 1000 units.

1 Hereinafter, for ease of reference, the court refers to the FD&C Act, as amended by the TCA, as the “TCA.”

2 Id. at 23,150. As to Option 2, the FDA noted that while “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, based on possible differences in their effects on dual use, youth

initiation[,] and frequency of use by youth and young adults.” Id. at 23,143. The FDA sought

comment on both options.

After receiving and considering comments, on May 10, 2016, the FDA published a final

rule “deeming” all categories of cigars subject to the TCA, including premium cigars, pipe tobacco,

and certain other products (for example, e-cigarettes), as proposed in Option 1 described above.

See Final Rule Deeming 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. 28,974, 29,020 (May 10, 2016) (codified at 21 C.F.R. pts. 1100, 1140, 1143)

(“Deeming Rule”). The final Deeming Rule subjects these newly “deemed” products to

comparable statutory and regulatory requirements already imposed on cigarettes, cigarette

tobacco, roll-your-own tobacco, and smokeless tobacco. See id. In support of its decision to

pursue Option 1, the FDA explained that it “[had] concluded that deeming all cigars, rather than a

subset, more completely protects the public health.” Id. The FDA found that: “(1) All cigars pose

serious negative health risks, (2) the available evidence does not provide a basis for FDA to

conclude that the patterns of premium cigar use sufficiently reduce the health risks to warrant

exclusion, and (3) premium cigars are used by youth and young adults.” Id.

Most significantly for purposes of this litigation, the Deeming Rule mandates that, by

August 10, 2018, packaging and advertisements for all cigar products must display one of six pre-

approved health warnings statements. See Cigar Ass’n of Am. v. U.S. Food & Drug Admin., 315

3 F. Supp. 3d 143, 154 (D.D.C. 2018) (summarizing requirements). The health warnings statements

include the following:

(i) WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.

(ii) WARNING: Cigar smoking can cause lung cancer and heart disease.

(iii) WARNING: Cigars are not a safe alternative to cigarettes.

(iv) WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.

(v) (A) WARNING: Cigar use while pregnant can harm you and your baby.; or

(B) SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight

(vi) WARNING: This product contains nicotine. Nicotine is an addictive chemical.

Id.; 21 C.F.R. § 1143.5(a)(1). These health warnings must be displayed on a rotating basis. See id.

On cigar packages, the statements “must be randomly displayed in each 12–month period, in as

equal number of times as is possible on each brand of cigar sold in product packaging and be

randomly distributed in all areas of the United States in which the product is marketed.” Id.

§ 1143.5(c)(1). On cigar advertisements, the statements “must be rotated quarterly in alternating

sequence in each advertisement for each brand of cigar.” Id. § 1143.5(c)(2). Each cigar company

must submit for FDA approval a plan for rotating warnings twelve months before advertising or

commercially marketing a cigar product. Id. § 1143.5(c)(3).

In addition to the Deeming Rule, the FDA also promulgated in May 2016 a separate rule,

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