United States District Court, S.D. West Virginia, Charleston
LARRY W. FAIRCLOTH, Plaintiff,
FOOD AND DRUG ADMINISTRATION, SCOTT GOTTLIEB, M.D., Commissioner of Food and Drugs, and THOMAS PRICE, Secretary of Health and Human Services Defendants.
MEMORANDUM OPINION AND ORDER
T. Copenhaver, Jr. United States District Judge.
is defendants' motion to dismiss, filed on October 28,
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
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
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).
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.
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).
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.
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.
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.
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).
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 “that the jurisdictional
allegations of the ...