Big Time Vapes, Incorporated v. FDA ( 2020 )

Case: 19-60921 Document: 00515467200 Page: 1 Date Filed: 06/25/2020
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
United States Court of Appeals
Fifth Circuit
FILED
No. 19-60921 June 25, 2020
Lyle W. Cayce
Clerk
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
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Before SMITH, HIGGINSON, and ENGELHARDT, Circuit Judges.
JERRY E. SMITH, Circuit Judge:
The Family Smoking Prevention and Tobacco Control Act 1 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 Associ-
ation sued the Food and Drug Administration (“FDA”), its Commissioner, and
the Secretary, asserting that Congress’s delegation to the Secretary was uncon-
stitutional. 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 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
1 Pub. L. No. 111–31, 123 Stat. 1776 (2009) (codified at 21 U.S.C. § 387, et seq.) (“TCA”
or “the Act”).
In so acting, Congress legislatively abrogated the result of the watershed decision in
2
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.”
2
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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 auto-
matically 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 products 4 that 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 manufactur-
ers.” 6 They must submit to the FDA truthful information about their products,
including: (1) “all ingredients, [i.e.,] tobacco, substances, compounds, and addi-
tives”; (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 phys-
iologic effects of current or future tobacco products” and their component parts.
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 com-
ponent, part, or accessory of a tobacco product).” 21 U.S.C. § 321(rr)(1).
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) manu-
factures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a fin-
ished tobacco product for sale or distribution in the United States.” 21 U.S.C. § 387(20).
3
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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, 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 equiv-
alent 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, mandatory health warnings, method-of-sale limits,
and advertising constraints. See id. § 387f(d). Failing to comply with the TCA’s
7Id. § 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, com-
ponents, 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.
4
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or the FDA’s regulations has serious consequences. A non-compliant manufac-
turer’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 author-
ities 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 ENDS would benefit public health,
because (1) those products had the potential to effect public harm, and (2) regu-
lation 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
10Deeming 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 “e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable per-
sonal 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 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 alde-
hydes. Id. at 29,029–31.
5
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to all of the statutory and regulatory requirements applicable to [tobacco] man-
ufacturers,” 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, 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,
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
substantial equivalence requirements (24 months). Id. at 29,011. Those compliance dead-
lines 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 manufac-
turer 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 (Apr. 30, 2020) (announcing the guidance).
6
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and the United States Vaping Association, an ENDS industry trade associa-
tion, sued the FDA, contending that the TCA unconstitutionally delegated to
the Secretary the power to deem tobacco products subject to the Act’s man-
dates. 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 injunc-
tion enjoining the FDA “from exercising any authority over any ‘tobacco prod-
ucts’ 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 intelli-
gible principle—specifically, “a desire to protect the public health and to pre-
vent, 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 prod-
ucts as governed by the TCA and presented detailed policies behind its enact-
ment of the TCA.” The court naturally denied a preliminary injunction. The
plaintiffs appeal.
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
7
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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 recog-
nized to be somewhat pliable. 14 “The 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) (ellip-
sis omitted). Delegations are constitutional so long as Congress “lay[s] down
by legislative act an intelligible principle to which the person or body author-
ized [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
14 See Loving, 517 U.S. at 758 (“Th[e] [nondelegation] principle does not mean, how-
ever, 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 Fram-
ers’ design of a workable National Government.”); Mistretta, 488 U.S. at 372 (“[O]ur juris-
prudence has been driven by a practical understanding that in our increasingly complex soci-
ety, replete with ever changing and more technical problems, Congress simply cannot do its
job absent an ability to delegate power under broad general directives.”).
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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 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 since 17 and, instead, has long defended “Congress’[s] ability to
delegate power under broad standards.” 18 In fact, the Court has “almost never
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 intelligible-principle 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 only to find gibberish.” (cleaned up)); Gary Lawson, Delegation and Original
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.”).
16United 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).
17We 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
9
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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, several Justices recently
expressed interest in reexamining the nondelegation doctrine. 20
B.
“[A] nondelegation inquiry always begins (and often almost ends) with
authorize regulation in the “public interest” or to “protect the public health.” See, e.g., Whit-
man 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 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).
Indus. Union Dep’t, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 686–87 (1980)
19
(Rehnquist, J., concurring in the judgment).
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 under-
standing 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.”).
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statutory interpretation,” because we need “to figure out what task [the stat-
ute] 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.
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 param-
eters or guidance whatsoever” to guide the Secretary’s exercise of that discre-
tion. That unbounded delegation of “deeming” authority violates the non-
delegation 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
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 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.”).
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Supreme Court. 22
1.
Congress undeniably delineated its general policy in the TCA. The plain-
tiffs 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 pur-
poses 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 enforcement authority to ensure that there is effective over-
sight of the tobacco industry’s efforts to develop, introduce, and promote less
22 The plaintiffs raise two additional contentions: The district court erred (1) by dis-
missing 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 addi-
tional 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 court abused its discretion
in denying them a preliminary injunction. See Winter v. NRDC, 555 U.S. 7, 20 (2008) (requir-
ing the plaintiffs to establish, among other things, they are they’re “likely to succeed on the
merits”).
23See, 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 pre-
sentment. 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).
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harmful tobacco products.” Id. § 3(4), 123 Stat. at 1782. And still two more
purposes were “to impose appropriate regulatory controls on the tobacco indus-
try” and “to promote cessation to reduce disease risk and the social costs asso-
ciated 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 inher-
ently 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 prod-
ucts”; 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 sweeping” fashion.
Gundy, 139 S. Ct. at 2127 (plurality). Those findings, when coupled with
25 See, e.g., 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
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 experi-
ence 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 Amer-
icans 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 begin using tobacco prod-
ucts. Less restrictive and less comprehensive approaches have not and will not be effective
in reducing the problems addressed by such regulations.” (emphasis added)).
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Congress’s stated purposes in legislating, undoubtedly identify a “general pol-
icy” 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 “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 sub-
mit comprehensive data about their products’ ingredients (including nicotine)
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.
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and health effects. See 21 U.S.C. § 387d(a). The Act also requires manufac-
turers 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 with-
out premarket authorization, and it details the steps manufacturers must take
to obtain approval. See id. § 387j(a). As those 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 (col-
lecting 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 com-
merce” 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 associ-
ations or groups.” NIRA outlined exceedingly broad legislative purposes,
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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]
monopolistic practices,” Schechter, 295 U.S. at 523. But in both cases, Con-
gress 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 stan-
dard than stimulating the economy by assuring ‘fair competition.’” Am. Truck-
ing, 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 delega-
tion to the Attorney General. In enacting SORNA, Congress sought “to combat
sex crimes and crimes against children” by creating “‘more uniform and effec-
tive’ . . . sex-offender registration systems.” Gundy, 139 S. Ct. at 2121 (plur-
ality) (quotation marks omitted). For sex offenders convicted after SORNA,
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 that 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).
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the statute provided a detailed framework outlining their obligations to regis-
ter. 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 appli-
cability of the requirements of this subchapter to sex offenders con-
victed 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 dele-
gation 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
automatically applied to certain classes of persons or products. In both
statutes, Congress delegated to an executive branch official the power to deter-
mine 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.
28Like 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).
29 See Gundy, 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.”).
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* * * * *
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.
18