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LLC v. United States Food and Drug Administration

United States District Court, M.D. Alabama, Northern Division

March 22, 2018

CYCLOPS VAPORS 2, LLC, et al., Plaintiffs,




         On July 8, 2016, the plaintiffs filed this declaratory judgment action against the United States Food and Drug Administration (“FDA”), Robert Califf and Sylvia Burwell (“collectively the government defendants”) challenging the defendants' implementation of a final rule related to e-cigarette devices and e-liquids. The plaintiffs distribute e-cigarette devices and e-liquids, and challenge the FDA's “Deeming Rule” which places these products under the FDA's authority to regulate pursuant to the Tobacco Control Act, 21 U.S.C. § 387a(b).[1] According to the plaintiffs, the defendants' Deeming Rule will subject their products to “the premarket approval, reporting, recordkeeping, inspection, labeling, manufacturing, testing and other requirements” of tobacco products, and will “severely and unnecessarily burden” their businesses. (Doc. # 1 at 7, ¶ 30-31). The plaintiffs ask the court to declare the Deeming Rule “an arbitrary and capricious regulatory system” and vacate the rule. (Id. at 16.) The court has jurisdiction of this action pursuant to the Administrative Procedures Act, 5 U.S.C. § 500 et seq., the Administrative Procedure Act Regulatory Flexibility Act, 5 U.S.C. § 601 et seq., the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02, and the court's federal question jurisdiction, 28 U.S.C. § 1331.

         On December 13, 2016, the parties filed a joint motion for entry of a briefing schedule asserting that because this case is governed by the Administrative Procedures Act, “it will be resolved on the basis of the administrative record complied by the agency.” (Doc. # 15 at 1, ¶ 2. On December 19, 2016, the court granted the parties' motion and entered a scheduling order setting forth deadlines for filing dispositive motions, cross motions and responses. (Doc. # 20). On February 1, 2017, the plaintiffs filed a motion for summary judgment. (Doc. # 21). On February 10, 2017, the Campaign for Tobacco-Free Kids filed a motion for leave to file an amicus brief (doc. # 25) which the court granted (doc. # 28).

         On March 1, 2017, the defendants filed a consent motion for an extension of time to respond to the plaintiffs' motion for summary judgment (doc. # 29) which the court granted. (Doc. # 30). On May 1, 2017, the parties filed another joint motion to amend the scheduling order (doc. # 31) which the court also granted. (Doc. # 32).

         On July 24, 2017, 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 (collectively “the Public Health Intervenors”) filed a motion to intervene pursuant to Fed.R.Civ.P. 24. (Doc. # 33). The Public Health Intervenors seek to intervene as a matter of right under Fed.R.Civ.P. 24(a)(2) or alteratively, permissibly under Fed.R.Civ.P. 24(b)(1). The plaintiffs oppose the motion to intervene (doc. # 67) arguing that the motion is premature and untimely. The plaintiffs also argue that the Public Health Intervenors have not demonstrated that the government defendants would not adequately defend their rights. The government defendants have filed a response in which they reserve the right to oppose intervention but suggest that the motion to intervene is premature. (Doc. # 65).

         Also pending before the court is the parties' joint motion to stay the case and vacate the briefing schedule (doc. # 54) pending the outcome of the appeal of Nicopure Labs LLC v. FDA, 266 F.Supp.3d 360 (D.C. 2017) appeal docketed No. 17-5196 (D.C. Cir. Aug. 31, 2017) which addresses the very issues raised in this case.

         Pursuant to 28 U.S.C. § 636, this case is referred to the undersigned for consideration and disposition or recommendation of all pretrial matters. (Doc. # 19). The court heard oral argument on the motion to intervene on August 10, 2017. After careful consideration of the motion to intervene, and the briefs filed in support of and in opposition to the motion, the court concludes the motion to intervene (doc. # 33) is due to be granted. The court further concludes that the joint motion to stay the case (doc. # 54) is due to be granted and the motion to vacate the briefing schedule is due to be denied as moot.


         A. Motion to Intervene

         The crux of this litigation involves the “Deeming Rule” created by the FDA which determined that e-cigarettes, e-liquids, and other related products were deemed tobacco products and subject to FDA regulation. According to the Public Health Intervenors the “Deeming Rule” is necessary to permit the FDA to regulate flavored e-cigarettes and products as well as marketing strategies aimed at young people. The Public Health Intervenors assert that “[s]etting aside the Deeming Rule, as Plaintiffs request, would have a direct adverse effect on public health, particularly among youth.” (Doc.# 33 at 7[2]). In opposition to the motion to intervene, the plaintiffs assert that intervention by the Public Health Intervenors at this juncture would “unnecessarily encumber the litigation of the issues raised in this lawsuit.” (Doc. # 67 at 6). The court disagrees.

         “Intervention under Rule 24 can be either as of right or permissive.” Salvors, Inc. v.Unidentified Wrecked & Abandoned Vessel, 861 F.3d 1278, 1293 (11th Cir. 2017). Fed.R.Civ.P. 24(a) allows a third party to intervene as a matter of right if four requirements are met:

(1) [the] application to intervene is timely; (2) [the applicant] has an interest relating to the property or transaction which is the subject of the action; (3) [the applicant] is so situated that disposition of the action, as a practical matter, may impede or impair his ability to protect that interest; and (4) [the ...

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