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

United States District Court, District of Columbia

January 11, 2019

EN FUEGO TOBACCO SHOP LLC, et al. Plaintiffs,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION et al. Defendants.

          MEMORANDUM OPINION AND ORDER

          AMIT P. MEHTA UNITED STATES DISTRICT JUDGE

         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.

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 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 ...

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