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Faircloth v. Food And Drug Administration

United States District Court, S.D. West Virginia, Charleston

September 28, 2017

FOOD AND DRUG ADMINISTRATION, SCOTT GOTTLIEB, M.D., Commissioner of Food and Drugs, and THOMAS PRICE, Secretary of Health and Human Services Defendants.


          John T. Copenhaver, Jr. United States District Judge.

         Pending is defendants' motion to dismiss, filed on October 28, 2016.

         I. Introduction

         On June 10, 2016, Larry W. Faircloth, a resident of West Virginia, instituted this action against the United States Food and Drug Administration (“FDA”), Dr. Scott Gottlieb in his capacity as Commissioner of Food and Drugs, and Thomas Price in his capacity as Secretary of Health and Human Services.[1]

         The complaint challenges the legality of the FDA's final rule, “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” (“Rule” or “Deeming Rule”), which regulates “vaping devices, ” also known as “e-cigarettes, ” and “e-liquids.” See Compl. at 1-2; Mem. in Supp. of Mot. to Dismiss at 4. Mr. Faircloth filed this action in this court, invoking jurisdiction under 28 U.S.C. §§ 1331, 2201-02 and 5 U.S.C. § 701 providing for judicial review of final agency actions.

         On May 10, 2016, under the authority conferred upon it by Congress in 21 U.S.C. § 387a(b), the FDA issued the final Rule deeming several new products, including vaping devices, as “tobacco products” subject to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”), as amended by the Family Smoking Prevention & Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1777 (2009) (“TCA”). See Deeming Rule 81 FR 28974 (May 10, 2016) (to be codified at 21 C.F.R. pts. 1100, 1140, and 1143) (deeming electronic nicotine delivery systems, including “e-cigarettes, ” “e-liquids, ” “vape pens, ” and “advanced refillable personal vaporizers” as included in “tobacco products” under the TCA). “Tobacco products” include “any product made or derived from tobacco including any component, part or accessory.” 21 U.S.C. § 321(rr)(1).

         Vaping devices “use a heat source to convert e-liquid into vapor.” Compl. at ¶ 2. E-liquids typically contain propylene glycol, glycerol, flavors, and various concentrations of nicotine, though some e-liquids contain zero nicotine. See Compl. at ¶ 3-4. In 2010, the D.C. Circuit ruled that the FDA had properly categorized vaping devices and e-liquids as “tobacco products” because the nicotine contained in e-liquids is derived from tobacco. Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891, 897-99.

         In deeming vaping devices to be “tobacco products, ” the FDA subjects manufacturers, retailers, importers, and distributors of “tobacco products” to manufacturing, sale, and marketing requirements designed to protect public health. See, e.g., 21 U.S.C. §§ 387d(a), 387a-1(a)(2)(G); Mem. in Supp. of Mot. to Dismiss at 6; Compl. at ¶ 26. These requirements include, inter alia: (1) providing accurate information about ingredients and additives to the FDA, 21 U.S.C § d(a)(1)-(2); (2) labeling products with ingredients, Id. at 387c; (3) including necessary warnings, 15 U.S.C. § 4402(a)(1); (4) undergoing premarket review of products claiming “modified risks” when compared with traditional cigarettes, 21 U.S.C. § 387k; (5) registering as manufacturers with the FDA, Id. at § 387e(b); (6) adhering to manufacturing requirements set by the FDA, Id. at § 387f(e); (7) abiding by regulations limiting the concentration of ingredients, Id. at § 387g(a)(3); (8) undergoing premarket review of new “tobacco products” entering the market after February 15, 2007, Id. at § 387j; and (9) discontinuing the distribution of products as free samples, 21 C.F.R. § 1140.16(d).

         Mr. Faircloth is a consumer and user of vaping devices and e-liquids. See Compl. at ¶¶ 6, 9, 29. As a former user of tobacco cigarettes, he smoked approximately two packs per day. Id. at ¶¶ 29-30. He used vaping devices and e-liquids to quit using traditional tobacco cigarettes. Id. at ¶ 29. Mr. Faircloth asserts that if he could no longer use vaping devices and e-liquids, he would likely return to using traditional tobacco cigarettes. See Id. at ¶¶ 29-30.

         Mr. Faircloth raises five claims for relief. Count I asserts that the FDA lacks the statutory authority to deem vaping devices as “tobacco products” under the FDA. Compl. at ¶¶ 37-8. Count II claims the Rule is arbitrary and capricious because the premarket approval process required for new “tobacco products” imposes an “extraordinary burden” on manufacturers, treats vaping devices the same as traditional tobacco cigarettes in the face of “compelling safety data, ” and imposes a de facto moratorium on the introduction of new vaping devices pending their premarket approval. Id. at ¶¶ 39-41, 43-45. Count III alleges the FDA's cost-benefit analysis “erroneously concludes the Rule's benefits outweigh its costs” and fails to recognize the “severe regulatory burdens” placed on manufacturers. Id. at ¶¶ 49, 51. Count IV asserts that the Rule violates Mr. Faircloth's First Amendment rights by restricting his ability to receive free samples, and “truthful and non-misleading statements” about vaping devices from manufacturers. Id. at ¶¶ 55-56. Finally, Count V alleges that the Rule violates the Tenth Amendment by “co-opting [West Virginia]'s ability to control its Medicaid budget” by compelling the state “to expend money . . . on tobacco related healthcare costs.” Id. at 58.

         Defendants move to dismiss the entire action for lack of jurisdiction pursuant to Fed.R.Civ.P. 12(b)(1), alleging that Mr. Faircloth lacks standing to challenge the Deeming Rule as a consumer of vaping devices, and that his challenge is unripe.

         II. Governing Standard

         Federal district courts are courts of limited subject matter jurisdiction, possessing “only the jurisdiction authorized them by the United States Constitution and by federal statute.” United States ex. rel. Vuyyuru v. Jadhav, 555 F.3d 337, 347 (4th Cir. 2008). As such, “there is no presumption that the court has jurisdiction.” Pinkley, Inc. v. City of Frederick, 191 F.3d 394, 399 (4th Cir. 1999) (citing 160 U.S. 327, 327 (1895)). Indeed, when the existence of subject matter jurisdiction is challenged under Rule 12(b)(1), “[t]he plaintiff has the burden of proving that subject matter jurisdiction exists.” 166 F.3d 642, 647 (4th Cir. 1999); see also Richmond, Fredericksburg, & Potomac R .R. Co. v. United States, 945 F.2d 765, 768 (4th Cir. 1991). If subject matter jurisdiction is lacking, the claim must be dismissed. See Arbaugh v. Y & H Corp., 546 U.S. 500, 506 (2006).

         Subject matter jurisdiction may be attacked by a defendant with either a facial or a factual challenge. Kerns v. United States,585 F.3d 188, 192 (4th Cir. 2009). In a facial challenge, the defendant is asserting that the allegations contained in the complaint fail to sufficiently establish the existence of subject matter jurisdiction. Id. In a facial attack, the plaintiff is “afforded the same procedural protection as she would receive under a Rule 12(b)(6) consideration, ” so that “facts alleged in the complaint are taken as true, ” and the defendant's motion “must be denied if the complaint alleges sufficient facts to invoke subject matter jurisdiction.” Id. In a factual challenge, a defendant may argue ‚Äúthat the jurisdictional allegations of the ...

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