Petition for Writ of Certiorari — Big Time Vapes, Incorporated, et al., Petitioners v. Food and Drug Administration, et al.

APPENDIX

i

APPENDIX

TABLE OF CONTENTS

Appendix A Opinion in the United States Court of

Appeals for the Fifth Circuit

(June 25, 2020) . . . . . . . . . . . . . . . App. 1

Appendix B Memorandum Opinion and Order

Granting Defendants’ Motion to

Dismiss and Denying Plaintiffs’

Motion for Preliminary Injunction in

the United States District Court for

the Southern District of Mississippi

Southern Division

(December 16, 2019) . . . . . . . . . . App. 24

Appendix C Final Judgment in the United States

District Court for the Southern

District of Mississippi Southern Division

(December 16, 2019) . . . . . . . . . . App. 37

Appendix D Order Denying Petition for Rehearing

in the United States Court of Appeals

for the Fifth Circuit

(August 25, 2020) . . . . . . . . . . . . App. 39

App. 1

APPENDIX A

IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 19-60921

[Filed: June 25, 2020]

_____________________________________________

BIG TIME VAPES, INCORPORATED;

)

UNITED STATES VAPING ASSOCIATION,

)

INCORPORATED,

)

)

Plaintiffs–Appellants,

)

)

versus

)

)

FOOD & DRUG ADMINISTRATION;

)

STEPHEN M. HAHN, Commissioner of Food

)

and Drugs; ALEX M. AZAR, II, Secretary,

)

U.S. Department of Health and Human

)

Services, in his official capacity,

)

)

Defendants–Appellees. )

_____________________________________________)

_____________________

Appeal from the United States District Court

for the Southern District of Mississippi

_____________________

App. 2

Before SMITH, HIGGINSON, and ENGELHARDT,

Circuit Judges.

JERRY E. SMITH, Circuit Judge:

The Family Smoking Prevention and Tobacco

Control Act1 establishes a thorough framework for

regulating tobacco products. Four such products—

cigarettes, cigarette tobacco, roll-your-own tobacco, and

smokeless tobacco—are automatically subject to the

Act. But in section 901 of the TCA, Congress

authorized the Secretary of Health and Human

Services (“the Secretary”) to determine which other

products should be governed by the TCA’s regulatory

scheme. Big Time Vapes, Incorporated, and the United

States Vaping Association sued the Food and Drug

Administration (“FDA”), its Commissioner, and the

Secretary, asserting that Congress’s delegation to the

Secretary was unconstitutional. The district court

dismissed, and we affirm.

I.

The facts are not disputed. This appeal turns on a

purely legal question: Whether section 901’s delegation

to the Secretary violates the nondelegation doctrine.

A.

In 2009, Congress enacted the TCA, thereby

amending the Food, Drug, and Cosmetic Act, 21 U.S.C.

§ 301, et seq. Congress sought to empower the FDA to

1

Pub. L. No. 111–31, 123 Stat. 1776 (2009) (codified at 21 U.S.C.

§ 387, et seq.) (“TCA” or “the Act”).

App. 3

regulate tobacco products,2 whose use Congress found

to be “the foremost preventable cause of premature

death in America.” TCA § 2(13), 123 Stat. at 1777.

“Because past efforts to restrict advertising and

marketing of tobacco products ha[d] failed adequately

to curb tobacco use by adolescents, comprehensive

restrictions on the sale, promotion, and distribution of

such products [we]re needed.” Id. § 2(6). Accordingly,

Congress gave the FDA broad authority to address “the

public health and societal problems caused by the use

of tobacco products.” Id. § 2(7).

To advance its public-health purpose, Congress

established a detailed framework for regulating

tobacco. But that statutory scheme did not apply—at

least not immediately—to all forms of tobacco. Instead,

Congress automatically applied the TCA “to all

cigarettes, cigarette tobacco, roll-your-own tobacco, and

smokeless tobacco.”3 Section 901 provided that the TCA

also would apply “to any other tobacco products4 that

2

In so acting, Congress legislatively abrogated the result of the

watershed decision in FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120, 126 (2000), which held that the FDA lacked the

authority to regulate tobacco as a “drug.”

3

TCA § 901, 123 Stat. at 1786 (codified at 21 U.S.C. § 387a(b)).

Each of those terms is statutorily defined. See 21 U.S.C.

§ 387(3)–(4), (15), (18).

4

Congress defined “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).

App. 4

the Secretary [of Health and Human Services]5 by

regulation deems to be subject to [the Act].” Id.

§ 387a(b).

The TCA imposes several requirements on “tobacco

product manufacturers.”6 They must submit to the FDA

truthful information about their products, including:

(1) “all ingredients, [i.e.,] tobacco, substances,

compounds, and additives”; (2) “[a] description of the

content, delivery, and form of nicotine in each tobacco

product”; and (3) certain information, including

manufacturer-developed documents, related to the

“health, toxicological, behavioral, or physiologic effects

of current or future tobacco products” and their

component parts. Id. § 387d(a). Manufacturers must

file annual registration statements listing all tobacco

products they make, id. § 387e(i)(1), and those lists

must be updated biannually to reflect current offerings,

id. § 387e(i)(3).

The TCA likewise prohibits manufacturers from

introducing any “new tobacco product” without

premarket authorization. Id. § 387j(a). A tobacco

product is considered “new” if it “was not commercially

marketed in the United States as of February 15,

5

The Secretary delegated that power to the FDA Commissioner,

who delegated it to several deputy and associate commissioners.

See FDA Staff Manual Guide 1410.21(1)(G)(1).

6

That term “means any person, including any repacker or

relabeler, who–(A) manufactures, fabricates, assembles, processes,

or labels a tobacco product; or (B) imports a finished tobacco

product for sale or distribution in the United States.” 21 U.S.C.

§ 387(20).

App. 5

2007.”7 A manufacturer can obtain premarket

authorization through two primary channels: (1) by

tendering a “premarket tobacco application ” (“PMTA”)

demonstrating that the product “would be appropriate

for the protection of the public health,” id. § 387j(a)(2),

(c)(2)(A); or (2) by submitting a “report” showing that

the product “is substantially equivalent to a tobacco

product commercially marketed” before February 2007,

id. § 387j(a)(2)(A)(i).8 The PMTA process is onerous,

requiring manufacturers to gather significant amounts

of information.9

Finally, the FDA can impose additional rules by

regulation, such as minimum-age restrictions,

7

Id. § 387j(a)(1)(A). The definition also encompasses “any

modification . . . of a tobacco product where the modified product

was commercially marketed in the United States after February

15, 2007.” Id. § 387j(a)(1)(B).

8

Under certain circumstances not relevant here, manufacturers

can also request an exemption from the “substantial equivalence”

requirements. See id. § 387j(a)(2)(A)(ii); see also id. § 387e(j)

(outlining the parameters for products exempt).

9

PMTAs must include (1) report(s) “concerning investigations

which have been made to show the health risks of such tobacco

product and whether such tobacco product presents less risk than

other tobacco products”; (2) a full statement of the product’s

ingredients, components, and principles of operation; (3) a

description of how the product is manufactured and prepared for

sale; (4) references to any applicable statutory standards and

information showing how those standards are met; (5) product

samples; and (6) examples of the proposed labeling for the product.

Id. § 387j(b)(1). According to the plaintiffs, curating the necessary

data to submit a PMTA can cost anywhere from about $180,000 to

more than $2 million.

App. 6

mandatory health warnings, method-of-sale limits, and

advertising constraints. See id. § 387f(d). Failing to

comply with the TCA’s or the FDA’s regulations has

serious consequences. A non-compliant manufacturer’s

product may be designated as “adulterated” or

“misbranded,” see id. §§ 387b, 387c, which could result

in, among other things, civil penalties, see id.

§ 333(f)(8)–(9), or seizure of the offending product, see

id. § 334.

B.

In May 2016, the FDA promulgated a rule that

“deem[ed] all products meeting the statutory definition

of ‘tobacco product,’ except accessories of the newly

deemed tobacco products, to be subject to FDA’s tobacco

product authorities under [the TCA].”10 That swept into

the TCA’s ambit several popular tobacco products,

including Electronic Nicotine Delivery Systems

(“ENDS”).11 The FDA maintained that regulating

10

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 (“Deeming Rule”), 81 Fed. Reg.

28,974 28,976 (May 10, 2016).

11

ENDS include “ecigarettes, e-hookah, e-cigars, vape pens,

advanced refillable personal vaporizers, and electronic pipes.” Id.

Those devices work by heating and aerosolizing a liquid

mixture–called an “e-liquid”–that includes various levels of

nicotine and sometimes flavoring. See Nicopure Labs, LLC v. FDA,

944 F.3d 267, 270 (D.C. Cir. 2019). After the liquid is aerosolized,

it is then inhaled as vapor. See id. Not all e-liquids contain

nicotine, but “[d]ata suggest that experienced ENDS users are able

App. 7

ENDS would benefit public health, because (1) those

products had the potential to effect public harm, and

(2) regulation would permit the FDA to “learn more

about that potential.” Deeming Rule, 81 Fed. Reg. at

28,983. That was especially true given that long-term

studies hadn’t yet been conducted to determine

whether ENDS products were harmful or beneficial to

public health. Id. at 28,984.

As a result of the FDA’s rule, ENDS and e-liquid

producers were “subject to all of the statutory and

regulatory requirements applicable to [tobacco]

manufacturers,” including the TCA’s reporting,

registration, and premarket authorization mandates.

Id. at 29,044. The FDA required compliance with some

TCA provisions as soon as the Deeming Rule became

effective,12 but the FDA indicated that it would not

enforce the premarket-review provisions, for products

already on the market, for several years following the

rule’s effective date.13 For any new products, however,

to achieve clinically significant nicotine levels and levels similar to

those generated by traditional cigarettes.” Deeming Rule 81 Fed.

Reg. at 29,031. Some e-liquids can also contain chemicals that are

known to pose health risks including diacetyl and acetyl propionyl,

formaldehyde, and various other aldehydes. Id. at 29,029-31.

12

For example, the FDA required newly deemed products

containing nicotine to display the following statement:

“WARNING: This product contains nicotine. Nicotine is an

addictive chemical.” Deeming Rule, 81 Fed. Reg. at 28,979.

13

See id. at 29,011–12. The length of the compliance period varied

by the type of application to be submitted. PMTAs received the

longest compliance period (36 months), followed by substantial

equivalence petitions (30 months) and exemption requests from the

App. 8

tobacco manufacturers had to obtain premarket

authorization before those products could be sold. Id. at

28,978. Because ENDS technology is relatively

young—i.e., there were very few (if any) products on

the market before February 2007—ENDS products and

e-liquids are effectively required to submit PMTAs. See

id. at 28,978–79.

C.

Big Time Vapes, a small-business manufacturer and

retailer of e-liquids, and the United States Vaping

Association, an ENDS industry trade association, sued

the FDA, contending that the TCA unconstitutionally

substantial equivalence requirements (24 months). Id. at 29,011.

Those compliance deadlines have been delayed several times. See,

e.g., FDA, EXTENSION OF CERTAIN TOBACCO PRODUCT COMPLIANCE

DEADLINES RELATED TO THE FINAL DEEMING RULE (REVISED) 9 tbl.2

(2019) (revising 2017 guidance, which extended the compliance

period for certain tobacco products until either August 2021 or

August 2022); see also 82 Fed. Reg. 37,459 (Aug. 10, 2017)

(announcing the 2017 guidance).

The FDA’s current guidance, which was issued in January

2020 and revised in April 2020, prioritizes enforcement against

(1) “[a]ny flavored, cartridge-based ENDS product,” (2) “[a]ll other

ENDS products for which the manufacturer has failed to take (or

is failing to take) adequate measures to prevent minors’ access,”

(3) “[a]ny ENDS product that is targeted to minors or whose

marketing is likely to promote use of ENDS by minors,” and

(4) “any ENDS product that is offered for sale after September 9,

2020, and for which the manufacturer has not submitted a

premarket application . . . .” FDA, ENFORCEMENT PRIORITIES FOR

ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) AND OTHER

DEEMED PRODUCTS ON THE MARKET WITHOUT PREMARKET

AUTHORIZATION (REVISED) 3 (2020); see also 85 Fed. Reg. 23,973

(April 30, 2020) (announcing the guidance).

App. 9

delegated to the Secretary the power to deem tobacco

products subject to the Act’s mandates. The plaintiffs

requested, inter alia, (1) a declaration that section 901

violates the nondelegation doctrine and (2) an

injunction preventing the FDA from enforcing the TCA

against them.

Shortly after filing suit—and in response to a

forthcoming change in federal enforcement

strategy—the plaintiffs moved for a preliminary

injunction enjoining the FDA “from exercising any

authority over any ‘tobacco products’ deemed to be

subject to the TCA . . . .” The FDA opposed the

plaintiffs’ motion and separately moved to dismiss

under Rule 12(b)(6). The plaintiffs countered the FDA’s

motion by asserting that they were entitled to

reasonable discovery.

The district court found no nondelegation violation

and dismissed the suit. The court determined that

Congress had articulated a sufficiently intelligible

principle—specifically, “a desire to protect the public

health and to prevent, to the extent possible,

underaged persons from having access to tobacco

products”—for the delegation to pass constitutional

muster. Moreover, the court concluded that the FDA’s

power was adequately constrained, because

(1) “Congress . . . restricted the FDA’s discretion with

a controlling definition of ‘tobacco product,’” and

(2) “Congress, itself, designated certain tobacco

products as governed by the TCA and presented

detailed policies behind its enactment of the TCA.” The

court naturally denied a preliminary injunction. The

plaintiffs appeal.

App. 10

II.

We review Rule 12(b)(6) dismissals de novo. In re

IntraMTA Switched Access Charges Litig., No.

18-10768, 2020 U.S. App. LEXIS 16844, at *58 (5th

Cir. May 27, 2020). Whether a statute violates the

nondelegation doctrine is a legal question we review de

novo. See United States v. Johnson, 632 F.3d 912, 917

(5th Cir. 2011).

A.

“All legislative Powers herein granted shall be

vested in a Congress of the United States.” U.S. CONST.

art. I, § 1. “Accompanying that assignment of power to

Congress is a bar on its further delegation.” Gundy v.

United States, 139 S. Ct. 2116, 2123 (2019) (plurality).

“Th[at] nondelegation doctrine is rooted in the principle

of separation of powers that underlies our tripartite

system of Government.” Mistretta v. United States, 488

U.S. 361, 371 (1989). “[T]he lawmaking function

belongs to Congress,” Loving v. United States, 517 U.S.

748, 758 (1996), and Congress “may not

constitutionally delegate [that] power to another”

constitutional principal, Touby v. United States, 500

U.S. 160, 165 (1991).

But that seemingly inflexible constitutional text has

long been recognized to be somewhat pliable.14 “The

14

See Loving, 517 U.S. at 758 (“Th[e] [nondelegation] principle

does not mean, however, that only Congress can make a rule of

prospective force. To burden Congress with all federal rulemaking

would divert that branch from more pressing issues, and defeat the

Framers’ design of a workable National Government.”); Mistretta,

488 U.S. at 372 (“[O]ur jurisprudence has been driven by a

App. 11

Constitution has never been regarded as denying to the

Congress the necessary resources of flexibility and

practicality to perform its function.” Yakus v. United

States, 321 U.S. 414, 425 (1944) (ellipsis omitted).

Delegations are constitutional so long as Congress

“lay[s] down by legislative act an intelligible principle

to which the person or body authorized [to exercise the

authority] is directed to conform.” J.W. Hampton, Jr.,

& Co. v. United States, 276 U.S. 394, 409 (1928). It is

“constitutionally sufficient if Congress clearly

delineates the general policy, the public agency which

is to apply it, and the boundaries of th[e] delegated

authority.” Am. Power & Light Co. v. SEC, 329 U.S. 90,

105 (1946).

“Those standards . . . are not demanding.”15 Even

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.”).

15

Gundy, 139 S. Ct. at 2129 (plurality). Some have suggested that

the Court’s intelligible-principle standard is really no hurdle at all.

See, e.g., id. at 2140 (Gorsuch, J., dissenting) (“[The intelligibleprinciple standard] has been abused to permit delegations of

legislative power that on any other conceivable account should be

held unconstitutional. Indeed, where some have claimed to see

‘intelligible principles’ many less discerning readers have been able

to only find gibberish.” (cleaned up)); Gary Lawson, Delegation and

Orginial Meaning, 88 VA. L. REV. 327, 329 (2002) (“[I]n

Mistretta . . . the Court aptly summarized more than half a century

of case law by unanimously declaring the nondelegation doctrine

to be effectively a dead letter.”); David Schoenbrod, The Delegation

Doctrine: Could the Court Give It Substance?, 83 MICH. L. REV.

1223, 1231 (1985) (“The [intelligible-principle] test has become so

ephemeral and elastic as to lose its meaning.”).

App. 12

though Congress has delegated power to the President

“[f]rom the beginning of the government,”16 the Court

did not find a delegation of legislative power to be

unlawful until 1935, when the Court declared two to be

unconstitutional. See Pan. Ref. Co. v. Ryan, 293 U.S.

388, 433 (1935); A.L.A. Schechter Poultry Corp. v.

United States, 295 U.S. 495, 542 (1935). But the Court

has not done so in the nearly nine decades since17 and,

instead, has long defended “Congress’[s] ability to

delegate power under broad standards.”18 In fact, the

16

United States v. Grimaud, 220 U.S. 506, 517 (1911); see also

Wayman v. Southard, 23 U.S. (10 Wheat.) 1, 41–47 (1825)

(upholding a provision of the Process and Compensation Act of

1792 that permitted federal courts to make rules altering the

“forms and modes of proceeding” that Congress had adopted);

Cargo of the Brig Aurora v. United States, 11 U.S. (7 Cranch) 382,

383 (1813) (observing that the Non-Intercourse Act of 1809

authorized the president, by proclamation, to revoke or modify

portions of the Act if he found certain facts).

17

We also have uniformly upheld Congress’s delegations. See,

e.g., United States v. Jones, 132 F.3d 232, 239 (5th Cir. 1998)

(upholding delegation of authority to the DOJ to “define

nonstatutory aggravating factors” to determine which offenders

were “death-eligible” under the Federal Death Penalty Act); United

States v. Mirza, 454 F. App’x 249 256 (5th Cir. 2011) (per curiam)

(upholding International Emergency Economic Powers Act’s

delegation, which authorizes the President to declare a national

emergency and limit certain types of economic activity related to

that threat).

18

Mistretta, 488 U.S. at 373. For example, the Court has blessed

delegations that authorize regulation in the “public interest” or to

“protect the public health.” See, e.g., Whitman v. Am. Trucking

Ass’ns, Inc., 531 U.S. 457, 472 (2001) (upholding delegation to EPA

to regulate “ambient air quality standards the attainment and

maintenance of which in the judgment of the Administrator . . . are

App. 13

Court has “almost never felt qualified to second-guess

Congress regarding the permissible degree of policy

judgment that can be left to those executing or

applying the law.” Am. Trucking, 531 U.S. at 474–75.

That does not mean, however, that we must

rubber-stamp all delegations of legislative power.

Indeed, “[w]e ought not to shy away from our judicial

duty to invalidate unconstitutional delegations”; “[i]f

we are ever to reshoulder the burden of ensuring that

Congress itself make the critical policy decisions, these

are surely the cases in which to do it.”19 In that spirit,

requisite to protect the public health”); Nat’l Broad. Co. v. United

States, 319 U.S. 190, 225-26 (1943) (upholding delegation to FCC

to regulate broadcast licensing in the “public interest”); N.Y. Cent.

Sec. Corp. v. United States, 287 U.S. 12, 24-25 (1932) (upholding

delegation of authority to Interstate Commerce Commission to

approve railroad consolidations that are in the “public interest”).

Moreover, the Court has also approved of delegations that spoke

in terms of fairness and equity. See, e.g., Am. Power, 329 U.S. at

104 (upholding delegation to SEC to ensure that holding

companies didn’t “unduly or unnecessarily complicate” corporate

structures or “unfairly or inequitably distribute voting power

among security holders”); Yakus, 321 U.S. at 426-27 (upholding

delegation to agency to set commodity prices that are “fair and

equitable” and that “tend to promote the purposes of the Act”); cf.

Lichter v. United States, 334 U.S. 742, 785-86 (1948) (upholding

delegation of to Secretary of War to recover “excessive profits” from

private businesses in times of crisis).

19

Indus. Union Dep’t, AFL-CIO v. Am. Petroleum Inst., 448 U.S.

607, 686-87 (1980) (Rehnquist, J., concurring in the judgment).

App. 14

several Justices recently expressed interest in

reexamining the nondelegation doctrine.20

B.

“[A] nondelegation inquiry always begins (and often

almost ends) with statutory interpretation,” because we

need “to figure out what task [the statute] delegates

and what instructions it provides.” Gundy, 139 S. Ct. at

2123 (plurality). Our task should not be limited to the

text alone—when evaluating whether Congress laid

down a sufficiently intelligible principle, we’re meant

also to consider “the purpose of the [TCA], its factual

background[,] and the statutory context.”21 “That

non-blinkered brand of interpretation” generally bodes

well for delegations. Id. at 2126.

20

See Gundy, 139 S. Ct. at 2131 (Alito, J., concurring in the

judgment) (“If a majority of this Court were willing to reconsider

the approach we have taken for the past 84 years, I would support

that effort.”); id. (Gorsuch, J., dissenting) (indicating that the court

shouldn’t wait to reconsider the nondelegation doctrine, whose

abandonment is premised on “an understanding of the

Constitution at war with its text and history”); Paul v. United

States, 140 S. Ct. 342 (2019) (Kavanaugh, J., respecting the denial

of certiorari) (“Justice GORSUCH’s scholarly analysis of the

Constitution’s nondelegation doctrine in his Gundy dissent may

warrant further consideration in future cases.”).

21

Am. Power, 329 U.S. at 104; accord United States v. Womack,

654 F.2d 1034, 1037 (5th Cir. Unit B Aug. 1981) (“The standards

of the statute are not to 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.”).

App. 15

In the TCA, Congress delegated to the Secretary the

power to “deem” which tobacco products should be

subject to the Act’s mandates. See 21 U.S.C. § 387a(b).

But the plaintiffs assert that Congress didn’t provide

“any parameters or guidance whatsoever” to guide the

Secretary’s exercise of that discretion. That unbounded

delegation of “deeming” authority violates the nondelegation doctrine, the plaintiffs maintain, as did the

limitless delegation in Panama Refining. And because

the TCA laid down no principle— notwithstanding the

Secretary’s authority’s being limited to “tobacco

products” or the statutory framework established for

enumerated tobacco products—the broad delegations

that the Court has approved in the past are inapposite.

We disagree. Recall that it is“constitutionally

sufficient if Congress [(1)] clearly delineates [its]

general policy, [(2)] the public agency which is to apply

it, and [(3)] the boundaries of th[at] delegated

authority.” Mistretta, 488 U.S. at 372–73 (quoting Am.

Power, 329 U.S. at 105). The second factor isn’t at

issue; the TCA’s text facially designates the Secretary.

And on the other two, the TCA’s delegation, despite the

plaintiffs’ suggestions to the contrary, falls comfortably

within the outer boundaries demarcated by the

Supreme Court.22

22

The plaintiffs raise two additional contentions: The district court

erred (1) by dismissing their complaint before reasonable discovery

and (2) by denying them a preliminary injunction. Neither is

meritorious. The plaintiffs identify no authority that even

suggests, much less requires, that the district court had to afford

them discovery, especially when additional facts wouldn’t have

helped them overcome a distinctly legal barrier. And, because the

plaintiffs haven’t stated a claim, they cannot show that the district

App. 16

1.

Congress undeniably delineated its general policy in

the TCA. The plaintiffs improperly discount other

materials that we must consider, namely the TCA’s

purpose and the relevant factual background.23 Both

factors support upholding section 901’s delegation.

Start with statutory purpose. The plaintiffs suggest

that the TCA’s purposes are “various and diverse,” so

much so that they “are in actual tension with one

another.” To come to that conclusion, the plaintiffs

essentially ignore Section 3 of the TCA, which is aptly

labeled “PURPOSE.”24

In that section, Congress stated that the TCA was

meant “to ensure that the [FDA] 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.” TCA, § 3(2), 123 Stat. at

1781. Another purpose was “to provide new and flexible

court abused its discretion in denying them a preliminary

injunction. See Winter v. NRDC, 555 U.S. 7, 20 (2008) (requiring

the plaintiffs to establish, among other things, they are they’re

“likely to succeed on the merits”).

23

See, e.g., Thomas v. Union Carbide Agric. Prod. Co., 473 U.S.

568, 593 (1985); Am. Power, 329 U.S. at 104; Womack, 654 F.2d at

1037.

24

Section 3 is part of the positive law that ran the gauntlet of

bicameralism and presentment. See TCA, § 3, 123 Stat. at

1781–82. That’s a far cry from “the sort of unenacted legislative

history that often is neither truly legislative . . . nor truly

historical . . . .” BNSF Ry. v. Loos, 139 S. Ct. 893, 906 (2019)

(Gorsuch, J., dissenting).

App. 17

enforcement authority to ensure that there is effective

over-sight of the tobacco industry’s efforts to develop,

introduce, and promote less harmful tobacco products.”

Id. § 3(4), 123 Stat. at 1782. And still two more

purposes were “to impose appropriate regulatory

controls on the tobacco industry” and “to promote

cessation to reduce disease risk and the social costs

associated with tobacco-related diseases.” Id. § 3(8)–

(9). Obviously, the TCA’s purpose sounds in

(1) protecting public health and (2) preventing young

people from accessing (and becoming addicted to)

tobacco products.

That purpose was informed by Congress’s extensive

fact-finding. See id. § 2, 123 Stat. at 1776–81. Congress

concluded that, for several reasons, tobacco products

posed a significant risk to children: (1) “[T]obacco

products are inherently dangerous and cause cancer,

heart disease, and other serious adverse health effects”;

(2) “[n]icotine is an addictive drug”; (3) “[v]irtually all

new users of tobacco products are under the minimum

legal age to purchase such products”; and (4) “[t]obacco

advertising and marketing contribute significantly to

the use of nicotine-containing tobacco products by

adolescents.” Id. § 2(1)–(5), 123 Stat. at 1777. And

Congress meant for the FDA to attack those problems

comprehensively,25 that is, in an “all-encompassing or

25

See, eg., TCA, § 2(6), 123 Stat. at 1777 (“Because past efforts to

restrict advertising and marketing of tobacco products have failed

adequately to curb tobacco use by adolescents, comprehensive

restrictions on the sale, promotion, and distribution of such

products are needed.” (emphasis added)); id. § 2(7) (“Federal and

State governments have lacked the legal and regulatory authority

and resources they need to address comprehensively the public

App. 18

sweeping” fashion. Gundy, 139 S. Ct. at 2127

(plurality). Those findings when coupled with

Congress’s stated purposes in legislating, undoubtedly

identify a “general policy” for the Secretary to pursue.

2.

Likewise, Congress plainly limited the authority

that it delegated. Far from giving the Secretary carte

blanche, the TCA cabined its delegation in two

important ways.

First, and critically, Congress enacted a controlling

definition of “tobacco product,” which necessarily

restricts the Secretary’s power to only products

meeting that definition. See 21 U.S.C. § 321(rr)(1).

Congress also identified four products—“cigarettes,

cigarette tobacco, roll-your-own tobacco, and smokeless

tobacco”—that were immediately subject to the TCA’s

mandates. Id. § 387a(b). Together, those features

health and societal problems caused by the use of tobacco

products.” (emphasis added)); id. § 2(25), 123 Stat. at 1778

(“Comprehensive advertising restrictions will have a positive effect

on the smoking rates of young people.” (emphasis added)); id.

§ 2(27) (“International experience shows that advertising

regulations that are stringent and comprehensive have a greater

impact on overall tobacco use and young people’s use than weaker

or less comprehensive ones.” (emphasis added)); id. § 2(31), 123

Stat. at 1779 (“An overwhelming majority of Americans who use

tobacco products begin using such products while they are minors

and become addicted to the nicotine in those products before

reaching the age of 18. Tobacco advertising and promotion play a

crucial role in the decision of these minors to being using tobacco

products. Less restrictive and less comprehensive approaches have

not and will not be effective in reducing the problems addressed by

such regulations.” (emphasis added)).

App. 19

“ha[ve] the effect of constricting the [Secretary’s]

discretion to a narrow and defined category.” United

States v. Ambert, 561 F.3d 1202, 1214 (11th Cir. 2009)

(cited favorably by United States v. Whaley, 577 F.3d

254, 264 (5th Cir. 2009)). We recognized as much in the

context of a federal statute criminalizing the

production of “explosives.”26

And second, Congress restricted the Secretary’s

discretion by making many of the key regulatory

decisions itself. See Ambert, 561 F.3d at 1214. Among

myriad other things, the TCA requires tobacco

manufacturers to submit comprehensive data about

their products’ ingredients (including nicotine) and

health effects. See 21 U.S.C. § 387d(a). The Act also

requires manufacturers to file annual registration

statements listing their products and to update those

lists biannually. See id. § 387e(i)(1); id. § 387e(i)(3).

And finally, the TCA prohibits manufacturers from

introducing new tobacco products without premarket

authorization, and it details the steps manufacturers

must take to obtain approval. See id. § 387j(a). As those

26

See Womack, 654 F.2d at 1038 (rejecting assertion that federal

statute regulating explosives lacked “adequate standards,” given

that the statute “carefully define[d] the term ‘explosives’ . . . and

an illustrative list of subject explosives [wa]s provided”). The

plaintiffs spill a lot of ink to distinguish Womack’s facts, likely

because the district court found Womack to be analogous to this

case. The plaintiffs assert that the statute in Womack essentially

conferred no discretion; it required the Treasury Secretary to list

all “explosives” that met the statutory definition. We needn’t

determine whether those factual differences are of any moment.

Even assuming that Womack is factually distinct and therefore

does not control, it doesn’t follow that the delegation at issue here

must be unconstitutional.

App. 20

substantive provisions show, Congress painted much of

the regulatory canvas, leaving the finishing touches to

the FDA. The Court has held, time after time, that

that’s enough to clear the Constitution’s low hurdles.

See, e.g., Mistretta, 488 U.S. at 372–74 (collecting

cases).

3.

The relevant caselaw drives those conclusions home.

It bears repeating: The Court has found only two

delegations to be unconstitutional. Ever. And none in

more than eighty years. See Pan. Ref., 293 U.S. at 433;

Schechter, 295 U.S. at 542. Considering those decisions,

it’s evident that we confront nothing similar here.

Instead, the TCA’s commission to the Secretary mirrors

the delegation to the Attorney General of the Sex

Offender Registration and Notification Act (“SORNA”),

which the Court approved just last year. See Gundy,

139 S. Ct. at 2121 (plurality). In Panama Refining and

Schechter, the Court invalidated two of the National

Industrial Recovery Act’s delegations to the President.

In Panama Refining, 293 U.S. at 406, the Court

considered Section 9(c), which authorized the President

“to prohibit the transportation in interstate and foreign

commerce” of certain petroleum products. And

Schechter, 295 U.S. at 521–22, evaluated Section 3,

which empowered “the President to approve ‘codes of

fair competition’” that were submitted by “one or more

trade or industrial associations or groups.” NIRA

outlined exceedingly broad legislative purposes,

including (1) “remov[ing] obstructions to the free flow

of interstate and foreign commerce,” Pan. Ref., 293 U.S.

at 418, and (2) disfavoring “monopolies [and]

App. 21

monopolistic practices,” Schechter, 295 U.S. at 523. But

in both cases, Congress erected no guide rails to limit

how the President should exercise his authority.27

The Court found both delegations to be

unconstitutional. See Pan. Ref., 293 U.S. at 433;

Schechter, 295 U.S. at 542. That’s not surprising, given

that NIRA placed almost no limits on how the

President—and in Schechter’s case, private

groups—could wield their delegated authority. Section

9(c) “provided literally no guidance for the exercise of

discretion,” and Section 3 “conferred authority to

regulate the entire economy on the basis of no more

precise a standard than stimulating the economy by

assuring ‘fair competition.’” Am. Trucking, 531 U.S. at

474.

By contrast, the TCA’s delegation to the Secretary

is circumscribed, and Congress provided far more

signposts to direct the exercise of the authority it

delegated. The TCA’s targeted statements of

purpose and voluminous fact-finding make that

incontrovertible.

Instead, the TCA’s deputizing of the Secretary

mirrors SORNA’s delegation to the Attorney General.

27

See Pan. Ref., 293 U.S. at 417!418 (observing that Congress

“la[id] down no policy of limitation” in Section 9(c), and its general

policy statement “contain[ed] nothing as to the circumstances or

conditions in which transportation of petroleum or petroleum

products should be prohibited”); Schechter, 295 U.S. at 541 (noting

that the Section 3 was “without precedent,” because it “sets up no

standards” to guide the President’s exercise of his authority

outside of NIRA’s “general aims of rehabilitation, correction, and

expansion” of the economy).

App. 22

In enacting SORNA, Congress sought “to combat sex

crimes and crimes against children” by creating “‘more

uniform and effective’ . . . sex-offender registration

systems.” Gundy, 139 S. Ct. at 2121 (plurality)

(quotation marks omitted). For sex offenders convicted

after SORNA, the statute provided a detailed

framework outlining their obligations to register. Id.

at 2122. SORNA didn’t specify, however, how it would

apply to pre-Act offenders, leaving that decision up to

the Attorney General:

The Attorney General shall have the authority

to specify the applicability of the requirements of

this subchapter to sex offenders convicted before

the enactment of this chapter . . . and to

prescribe rules for the registration of any such

sex offenders . . . .

34 U.S.C. § 20913(d). But beyond the text of that

provision, the plurality observed that SORNA’s

purposes,28 statutory context, and legislative history all

pointed in one direction: Congress meant for SORNA to

apply to pre-Act offenders as soon as feasible. Gundy,

139 S. Ct. at 2126–29 (plurality). Given that backdrop,

the plurality had little trouble determining that

SORNA’s delegation was constitutionally permissible.

See id. at 2129–30.

In all material respects the TCA’s statutory scheme

parallels SORNA’s. Both SORNA and the TCA

established detailed regulatory frameworks that

28

Like the TCA’s, SORNA’s purposes were enacted as part of the

positive law. See Pub. L. No. 109-248, § 102, 120 Stat. 587, 590-91

(2006) (codified at 34 U.S.C. § 20901).

App. 23

automatically applied to certain classes of persons or

products. In both statutes, Congress delegated to an

executive branch official the power to determine

whether those requirements applied to other

non-covered classes. And in both instances, Congress

outlined specific purposes to inform the executive

officer’s exercise of the discretion so afforded. Although

a less-than-full-strength Court fractured in Gundy, five

Justices elected to affirm SORNA’s delegation.29 Those

votes compel our affirmance here.

* * * * *

The Court might well decide—perhaps soon—to

reexamine or revive the nondelegation doctrine. But

“[w]e are not supposed to . . . read tea leaves to predict

where it might end up.” United States v. Mecham, 950

F.3d 257, 265 (5th Cir. 2020), cert. denied, 2020 WL

3405899 (U.S. June 22, 2020) (No. 19-7865). The

judgment of dismissal is therefore AFFIRMED.

29

See Grundy, 139 S. Ct. at 2121 (plurality); see also id. at 2131

(Alito, j., concurring in the judgment) (“Because I cannot say that

the statute lacks a . . . standard that is adequate under the

approach this Court has taken for many years, I vote to affirm.”).

App. 24

APPENDIX B

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF

MISSISSIPPI

SOUTHERN DIVISION

CAUSE NO. 1:19cv531-LG-JCG

[Filed: December 16, 2019]

_____________________________________________

BIG TIME VAPES, INC. and

)

UNITED STATES VAPING

)

ASSOCIATION, INC.

)

)

PLAINTIFFS

)

)

v.

)

)

FOOD AND DRUG

)

ADMINISTRATION, et al.

)

)

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,

App. 25

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.

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

App. 26

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

App. 27

(10) to strengthen legislation against illicit trade

in tobacco products.

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

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).

App. 28

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 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,

App. 29

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 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 tenmonth 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

App. 30

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 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).

DISCUSSION

I. DEFENDANTS’ MOTION TO DISMISS

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

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.)

App. 31

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).

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

4

The plaintiffs ask the Court to permit them to conduct discovery

prior to ruling on the defendants’ Motion to Dismiss, because the

App. 32

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

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

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.

App. 33

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 (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

App. 34

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 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.

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).

App. 35

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 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

App. 36

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

App. 37

APPENDIX C

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF

MISSISSIPPI

SOUTHERN DIVISION

CAUSE NO. 1:19cv531-LG-JCG

[Filed: December 16, 2019]

_____________________________________________

BIG TIME VAPES, INC. and

)

UNITED STATES VAPING

)

ASSOCIATION, INC.

)

)

PLAINTIFFS

)

)

v.

)

)

FOOD AND DRUG

)

ADMINISTRATION, et al.

)

)

DEFENDANTS

)

_____________________________________________)

FINAL JUDGMENT

In accordance with the Memorandum Opinion and

Order entered herewith, this Court finds that this

lawsuit should be dismissed pursuant to Fed. R. Civ. P.

12(b)(6).

App. 38

IT IS, THEREFORE, ORDERED AND

ADJUDGED that this lawsuit is hereby DISMISSED

WITH PREJUDICE.

SO ORDERED AND ADJUDGED this the 16th

day of December, 2019.

s/ Louis Guirola, Jr.

LOUIS GUIROLA, JR.

UNITED STATES DISTRICT JUDGE

App. 39

APPENDIX D

United States Court of Appeals

for the Fifth Circuit

No. 19-60921

[Filed: August 25, 2020]

_____________________________________________

BIG TIME VAPES, INCORPORATED;

)

UNITED STATES VAPING ASSOCIATION,

)

INCORPORATED,

)

)

Plaintiffs – Appellants, )

)

versus

)

)

FOOD & DRUG ADMINISTRATION,

)

STEPHEN M. HAHN, COMMISSIONER OF FOOD

)

AND DRUGS; ALEX M. AZAR, II, SECRETARY,

)

U.S. DEPARTMENT OF HEALTH AND HUMAN

)

SERVICES, IN HIS OFFICIAL CAPACITY,

)

)

Defendant – Appellees.

)

_____________________________________________)

Appeal from the United States District Court

for the Southern District of Mississippi

USDC No. 1:19-CV-531

ON PETITION FOR REHEARING EN BANC

(Opinion June 25, 2020, 963 F.3d 436)

App. 40

Before SMITH, HIGGINSON, and ENGELHARDT, Circuit

Judges.

PER CURIAM:

Treating the petition for rehearing en banc as a

petition for panel rehearing, the petition for panel

rehearing is DENIED. No judge in regular active

service having requested that the court be polled on

rehearing en banc (FEDERAL RULE OF APPELLATE

PROCEDURE 35 and 5TH CIRCUIT RULE 35), the petition

for rehearing en banc is DENIED.

ENTERED FOR THE COURT

___/s/ Jerry E. Smith

United States Circuit Judge