Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 1 of 11
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF MISSISSIPPI
`SOUTHERN DIVISION
`
`
`
`
`
`
`
`PLAINTIFFS
`
`
`BIG TIME VAPES, INC. and
`UNITED STATES VAPING
`ASSOCIATION, INC.
`
`v.
`
`FOOD AND DRUG
`ADMINISTRATION, et al.
`
`
`
`
`
`
`
`CAUSE NO. 1:19cv531-LG-JCG
`
`
`
`DEFENDANTS
`
`
`
`
`
`
`MEMORANDUM OPINION AND ORDER GRANTING
`DEFENDANTS’ MOTION TO DISMISS AND DENYING
`PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION
`
`BEFORE THE COURT are the [15] Motion for Preliminary Injunction filed
`
`by the plaintiffs Big Time Vapes, Inc., and United States Vaping Association, Inc.,
`
`and [24] Motion to Dismiss filed by the defendants Food and Drug Administration,
`
`Admiral Brett P. Giroir, M.D. in his official capacity as Acting Commissioner of
`
`Food and Drug Administration, and Alex M. Azar, II, in his official capacity as
`
`Secretary of Health and Human Services. The parties have fully briefed both
`
`Motions. The plaintiffs raise a constitutional delegation challenge to part of the
`
`Family Smoking Prevention and Tobacco Control Act (“TCA”), and the defendants
`
`counter that the plaintiffs have failed to state a plausible claim for relief. After
`
`reviewing the submissions of the parties, the record in this matter, and the
`
`applicable law, the Court finds that the defendants’ Motion to Dismiss should be
`
`granted, and the plaintiffs’ Motion for Preliminary Injunction should be denied.
`
`
`
`
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 2 of 11
`
`BACKGROUND
`
`
`
`In 2009, Congress amended the Federal Food, Drug, and Cosmetic Act to
`
`include the TCA, which vests the FDA with regulatory authority over the design,
`
`production, marketing, and advertising of tobacco products. Congress listed the
`
`following purposes of the Act:
`
`(1) to provide authority to the Food and Drug Administration to
`regulate tobacco products under the Federal Food, Drug, and Cosmetic
`Act . . . by recognizing it as the primary Federal regulatory authority
`with respect to the manufacture, marketing, and distribution of
`tobacco products as provided for in this division . . . ;
`(2) to ensure that the Food and Drug Administration has the authority
`to address issues of particular concern to public health officials,
`especially the use of tobacco by young people and dependence on
`tobacco;
`(3) to authorize the Food and Drug Administration to set national
`standards controlling the manufacture of tobacco products and the
`identity, public disclosure, and amount of ingredients used in such
`products;
`(4) to provide new and flexible enforcement authority to ensure that
`there is effective oversight of the tobacco industry’s efforts to develop,
`introduce, and promote less harmful tobacco products;
`(5) to vest the Food and Drug Administration with the authority to
`regulate the levels of tar, nicotine, and other harmful components of
`tobacco products;
`(6) in order to ensure that consumers are better informed, to require
`tobacco product manufacturers to disclose research which has not
`previously been made available, as well as research generated in the
`future, relating to the health and dependency effects or safety of
`tobacco products;
`(7) to continue to permit the sale of tobacco products to adults in
`conjunction with measures to ensure that they are not sold or
`accessible to underage purchasers;
`(8) to impose appropriate regulatory controls on the tobacco industry;
`(9) to promote cessation to reduce disease risk and the social costs
`associated with tobacco-related diseases; and
`(10) to strengthen legislation against illicit trade in tobacco products.
`
`
`
`
`
`-2-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 3 of 11
`
`Pub. L. No. 111-31, 123 Stat. 1778 (2009). Congress clarified, however, that the
`
`TCA is not intended to affect the growing, cultivation, or curing of raw tobacco. Id.
`
`
`
`Congress specified that the TCA “shall apply to all cigarettes, cigarette
`
`tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco
`
`products that the Secretary by regulation deems to be subject to this subchapter.”
`
`21 U.S.C. § 387a(b).1 Congress defines “tobacco product” as “any product made or
`
`derived from tobacco that is intended for human consumption, including any
`
`component, part, or accessory of a tobacco product (except for raw materials other
`
`than tobacco used in manufacturing a component, part, or accessory of a tobacco
`
`product).” 21 U.S.C. § 321(rr)(1).
`
`
`
`On May 10, 2016, the FDA issued a final rule deeming electronic nicotine
`
`delivery systems (“ENDS”) to be subject to the Federal Food, Drug, and Cosmetic
`
`Act. 2 Deeming Tobacco Products to be Subject to the Federal Food, Drug, and
`
`Cosmetic Act, 81 Fed. Reg. 28,973-01 (May 10, 2016) (to be codified at 21 C.F.R. pts.
`
`1100, 1140, and 1143). This deeming rule clarified that “establishments that mix or
`
`prepare e-liquids or create of modify aerosolizing apparatus for direct sale to
`
`consumers are tobacco product manufacturers under the definition set forth in the
`
`
`1 The Secretary referred to in the statute is the Secretary of Health and Human
`Services. 21 U.S.C. § 321(d). The Secretary redelegated his authority to the FDA
`Commissioner, who in turn redelegated his authority to the Associate
`Commissioner for Policy. FDA Staff Manual Guide 1410.10, 1410.21.
`2 ENDS include e-cigarettes, e-cigars, e-hookah, vape pens, personal vaporizers, and
`electronic pipes. Deeming Tobacco Products to be Subject to the Federal Food,
`Drug, and Cosmetic Act, 81 Fed. Reg. 28,973-01, 29,028 (May 10, 2016) (to be
`codified at 21 C.F.R. pts. 1100, 1140, and 1143).
`
`
`
`
`-3-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 4 of 11
`
`FD&C Act and, accordingly, are subject to the same legal requirements that apply
`
`to other tobacco product manufacturers.” Id. at 28,979. As a result, these
`
`establishments must obtain premarket approval of all products not commercially
`
`marketed in the United States as of February 15, 2007. 21 U.S.C. § 387j. Any
`
`products not preapproved by the FDA are banned. See 21 U.S.C. § 387b; 21 U.S.C. §
`
`387c.
`
`
`
`The deeming rule went into effect on August 8, 2016, but the FDA provided
`
`time periods during which the FDA did not intend to enforce compliance with
`
`premarket review requirements. Id. at 29,006. In August 2017, the FDA issued
`
`Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines
`
`Related to the Final Deeming Rule (Aug. 2017), which is available at
`
`https://www.fda.gov/media/105346 /download, stating that it did not intend to
`
`enforce the Act’s premarket review provisions “as a matter of enforcement
`
`discretion” until August 2022. 2017 Guidance at 3-4.
`
`
`
`The American Academy of Pediatrics and others filed a lawsuit against the
`
`FDA in the United States District Court for the District of Maryland, arguing that
`
`the 2017 Guidance violated the Administrative Procedure Act, exceeded the FDA’s
`
`statutory authority, and violated U.S. Const. art. II, § 3. Am. Acad. of Pediatrics v.
`
`Food & Drug Admin., 379 F. Supp. 3d 461, 490 (D. Md. 2019). The plaintiffs alleged
`
`that the FDA violated the APA by failing to comply with the notice and comment
`
`requirements for rule-making when it issued the 2017 Guidance. Id. The court
`
`held that the Guidance was “tantamount to an amendment to the Tobacco Control
`
`
`
`-4-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 5 of 11
`
`Act,” such that the FDA was required to comply with the APA’s notice and comment
`
`requirements. Id. at 497-98. As a result, the court vacated the 2017 Guidance. Id.
`
`at 498. In a subsequent order dated July 12, 2019, the court established a ten-
`
`month deadline for submitting marketing order applications for new tobacco
`
`products and a one-year deadline for products for which applications were already
`
`filed to remain on market without enforcement action. Am. Acad. of Pediatrics v.
`
`Food & Drug Admin., 399 F. Supp. 3d 479 (D. Md. 2019). As a result, premarket
`
`review applications for ENDS products must be submitted by August 2022. The
`
`American Academy of Pediatrics decision is currently on appeal before the United
`
`States Court of Appeals for the Fourth Circuit.
`
`
`
`Faced with accelerated deadlines for complying with the TCA, Big Time
`
`Vapes, Inc., and United States Vaping Association, Inc., filed this lawsuit on August
`
`19, 2019, against the FDA, the Secretary of Health and Human Services, and the
`
`Acting Commissioner of the FDA. The plaintiffs assert that 21 U.S.C. § 387a(b)
`
`violates the United States Constitution by impermissibly delegating legislative
`
`authority to the executive branch.3 See U.S. Const., art. I, § 1 (“All legislative
`
`Powers herein granted shall be vested in a Congress of the United States, which
`
`shall consist of a Senate and House of Representatives.”) The plaintiffs seek a
`
`
`3 Big Time Vapes is a Mississippi corporation that sells and manufactures vaping
`products in Picayune, Mississippi. United States Vaping Association is a trade
`association “organized in July and August 2019 to represent small-business vaping
`manufacturers (who make e-liquid) and retail vape shops that sell e-liquid
`manufactured by other firms and mix and produce their own in-house e-liquid.”
`(Compl. 4-5, ECF No. 1.)
`
`
`
`-5-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 6 of 11
`
`declaratory judgment that 21 U.S.C. § 387a(b) violates the Constitution, such that
`
`the deeming rule is invalid. The plaintiffs also ask the Court to enjoin the
`
`defendants from enforcing the TCA against the plaintiffs or any other similarly
`
`situated businesses. The plaintiffs have filed a motion for preliminary injunction,
`
`and the defendants have filed a motion to dismiss pursuant to Fed. R. Civ. P.
`
`12(b)(6).
`
`I. DEFENDANTS’ MOTION TO DISMISS
`
`DISCUSSION
`
`
`
`When considering a motion under Rule 12(b)(6), the “court accepts ‘all well-
`
`pleaded facts as true, viewing them in the light most favorable to the plaintiff.’”
`
`Martin K. Eby Constr. Co. v. Dall. Area Rapid Transit, 369 F.3d 464, 467 (5th Cir.
`
`2004) (quoting Jones v. Greninger, 188 F.3d 322, 324 (5th Cir. 1999) (per curiam)).
`
`But “the tenet that a court must accept as true all of the allegations contained in a
`
`complaint is inapplicable to legal conclusions. Threadbare recitals of the elements
`
`of a cause of action, supported by mere conclusory statements, do not suffice.”
`
`Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell Atl. Corp. v. Twombly, 550
`
`U.S. 544, 555 (2007)). To overcome a Rule 12(b)(6) motion, a plaintiff must plead
`
`“enough facts to state a claim to relief that is plausible on its face.” Twombly, 550
`
`U.S. at 570. “Factual allegations must be enough to raise a right to relief above the
`
`speculative level, on the assumption that all the allegations in the complaint are
`
`true (even if doubtful in fact).” Id. at 555 (citations and footnote omitted).
`
`
`
`-6-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 7 of 11
`
`
`
`Ordinarily, in considering a motion to dismiss under Rule 12(b)(6), the Court
`
`“must limit itself to the contents of the pleadings, including attachments thereto.”
`
`Collins v. Morgan Stanley Dean Witter, 224 F.3d 496, 498 (5th Cir. 2000). An
`
`exception to this rule exists for “matters of public record,” of which the Court may
`
`take judicial notice. Norris v. Hearst Tr., 500 F.3d 454, 461 n.9 (5th Cir. 2007).
`
`Additionally, “[d]ocuments that a defendant attaches to a motion to dismiss are
`
`considered part of the pleadings if they are referred to in the plaintiff’s complaint
`
`and are central to her claim.” Causey v. Sewell Cadillac-Chevrolet, Inc., 394 F.3d
`
`285, 288 (5th Cir. 2004). “If . . . matters outside the pleadings are presented to and
`
`not excluded by the court, the motion must be treated as one for summary judgment
`
`under Rule 56.” Fed. R. Civ. P. 12. The Court has not considered any matters
`
`outside of the pleadings while deciding the defendants’ Motion; therefore, it is not
`
`necessary to treat the defendants’ Motion to Dismiss as a motion for summary
`
`judgment.4
`
`
`
`Article I, section 1 of the Constitution provides, “All legislative powers herein
`
`granted shall be vested in a Congress of the United States . . . .” U.S. Const. art. I, §
`
`1. As a result, “Congress generally cannot delegate its power to another Branch.”
`
`Mistretta v. United States, 488 U.S. 361, 372 (1989). Nevertheless, this
`
`
`4 The plaintiffs ask the Court to permit them to conduct discovery prior to ruling on
`the defendants’ Motion to Dismiss, because the plaintiffs contend that the
`defendants have relied on documents outside the pleadings in support of their
`Motion. Because the Court has not considered any documents outside the
`pleadings, discovery is not necessary to determine whether the plaintiffs have
`stated plausible claims for relief.
`
`
`
`-7-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 8 of 11
`
`nondelegation doctrine does not prevent Congress from delegating “at least some
`
`authority that it could exercise itself.” Loving v. United States, 517 U.S. 748, 758
`
`(1996). “So long as Congress shall lay down by legislative act an intelligible
`
`principle to which the person or body authorized to [exercise the delegated
`
`authority] is directed to conform, such legislative action is not a forbidden
`
`delegation of legislative power.” Mistretta, 488 U.S. at 372 (alterations in original).
`
`“Applying this ‘intelligible principle’ test to congressional delegations, our
`
`jurisprudence has been driven by a practical understanding that in our increasingly
`
`complex society, replete with ever changing and more technical problems, Congress
`
`simply cannot do its job absent an ability to delegate power under broad general
`
`directives.” Id. “The true distinction . . . is between the delegation of power to
`
`make the law, which necessarily involves discretion as to what it shall be, and
`
`conferring authority or discretion as to its execution, to be exercised under and in
`
`pursuance of the law. The first cannot be done; to the latter no valid objection can
`
`be made.” Loving, 517 U.S. at 758-59. Apart from two 1935 cases, Panama
`
`Refining Co. v. Ryan, 293 U.S. 388 (1935), and A.L.A. Schechter Poultry Corp. v.
`
`United States, 295 U.S. 495 (1935), the Supreme Court has upheld every challenge
`
`to a congressional delegation of power that has been presented to it. Whitman v.
`
`Am. Trucking Ass’ns, 531 U.S. 457, 474 (2001).
`
`
`
`Courts considering whether Congress has supplied an intelligible principle
`
`must “constru[e] the challenged statute to figure out what task it delegates and
`
`what instructions it provides.” Gundy v. United States, 139 S. Ct. 2116, 2123
`
`
`
`-8-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 9 of 11
`
`(2019). The delegation of legislative authority is “constitutionally sufficient if
`
`Congress clearly delineates the general policy, the public agency which is to apply
`
`it, and the boundaries of this delegated authority.” Mistretta, 488 U.S. at 372-73
`
`(quoting Am. Power & Light Co. v. SEC, 329 U.S. 90, 105 (1946)). “The standards of
`
`the statute are not to be tested in isolation but must derive meaningful content
`
`from the purpose of the statute and its factual background and the statutory
`
`context in which the standards appear.” United States v. Womack, 654 F.2d 1034,
`
`1037 (5th Cir. 1981) (citing Am. Power & Light Corp., 329 U.S. at 105). “[T]he
`
`degree of agency discretion that is acceptable varies according to the scope of the
`
`power congressionally conferred.” Am. Trucking Ass’ns, 531 U.S. at 475.
`
`
`
`The plaintiffs argue that the TCA is unconstitutional, because it gives the
`
`FDA no guidance for determining whether a tobacco product should be governed by
`
`the TCA. Contrary to the plaintiffs’ assertions, Congress did not give the FDA
`
`unlimited discretion but restricted the FDA’s discretion with a controlling definition
`
`of “tobacco product.”5 In addition, Congress, itself, designated certain tobacco
`
`products as governed by the TCA6 and presented detailed policies behind its
`
`enactment of the TCA. For example, Congress clearly expressed a desire to protect
`
`the public health and to prevent, to the extent possible, underaged persons from
`
`
`5 Congress defines “tobacco product” as “any product made or derived from tobacco
`that is intended for human consumption, including any component, part, or
`accessory of a tobacco product (except for raw materials other than tobacco used in
`manufacturing a component, part, or accessory of a tobacco product).” 21 U.S.C. §
`321(rr)(1).
`6 Congress specified that the TCA “shall apply to all cigarettes, cigarette tobacco,
`roll-your-own tobacco, and smokeless tobacco . . . .” 21 U.S.C. § 387a(b).
`
`
`
`-9-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 10 of 11
`
`having access to tobacco products. These listed policies and covered products
`
`provide additional guidance to the FDA for determining which additional tobacco
`
`products should be governed by the TCA. This case is analogous to United States v.
`
`Womack, wherein the Fifth Circuit held that Title XI of the Organized Crime
`
`Control Act of 1970 provided the Secretary of the Treasury with adequate standards
`
`for listing additional explosives covered by the Act where Congress provided a
`
`definition of the term “explosives” and gave an illustrative list of explosives subject
`
`to the Act. 654 F.2d at 1037. In the opinion of the Court the TCA does not violate
`
`the Constitution, and the plaintiffs have not stated a plausible claim for relief.
`
`II. PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION
`
`
`
`A movant is entitled to a preliminary injunction only if he establishes:
`
`(1) a substantial likelihood of success on the merits, (2) a substantial
`threat of irreparable injury if the injunction is not issued, (3) that the
`threatened injury if the injunction is denied outweighs any harm that
`will result if the injunction is granted, and (4) that the grant of an
`injunction will not disserve the public interest.
`
`
`Byrum v. Landreth, 566 F.3d 442, 444 (5th Cir. 2009). The plaintiffs cannot
`
`demonstrate a substantial likelihood of success on the merits because they have not
`
`stated a plausible claim for relief. As a result, it is not necessary to consider the
`
`additional preliminary injunction elements. The plaintiffs’ Motion for Preliminary
`
`Injunction is denied.
`
`CONCLUSION
`
`
`
`Congress provided sufficient guidance when it delegated authority to the
`
`FDA to designate which products should be governed by the TCA. Thus, the TCA
`
`
`
`-10-
`
`

`

`Case 1:19-cv-00531-LG-JCG Document 38 Filed 12/16/19 Page 11 of 11
`
`does not violate the United States Constitution. The defendants’ Motion to Dismiss
`
`is granted, and the plaintiffs’ Motion for Preliminary Injunction is denied.
`
`
`
`IT IS, THEREFORE, ORDERED AND ADJUDGED that the [24] Motion
`
`to Dismiss filed by the defendants, Food and Drug Administration, Admiral Brett P.
`
`Giroir, M.D. in his official capacity as Acting Commissioner of Food and Drug
`
`Administration, and Alex M. Azar, II, in his official capacity as Secretary of Health
`
`and Human Services is GRANTED. This lawsuit is hereby DISMISSED WITH
`
`PREJUDICE. The Court will enter a separate judgment pursuant to Fed. R. Civ.
`
`P. 58.
`
`
`
`IT IS, FURTHER, ORDERED AND ADJUDGED that the [15] Motion for
`
`Preliminary Injunction filed by the plaintiffs, Big Time Vapes, Inc., and United
`
`States Vaping Association, Inc., is DENIED.
`
`SO ORDERED AND ADJUDGED this the 16th day of December, 2019.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`s/ Louis Guirola, Jr.
`
`LOUIS GUIROLA, JR.
`UNITED STATES DISTRICT JUDGE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-11-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`