`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FIFTH CIRCUIT
`June 25, 2020
`Lyle W. Cayce
`United States Court of Appeals
`BIG TIME VAPES, INCORPORATED;
`UNITED STATES VAPING ASSOCIATION, INCORPORATED,
`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,
`Appeal from the United States District Court
`for the Southern District of Mississippi
` Case: 19-60921 Document: 00515467200 Page: 2 Date Filed: 06/25/2020
`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 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.
`The facts are not disputed. This appeal turns on a purely legal question:
`Whether section 901’s delegation to the Secretary violates the nondelegation
`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”).
`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.”
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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 products4 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).
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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
`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, 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.
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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.
`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
`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 “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.
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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.
`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).
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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
`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
`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
` Case: 19-60921 Document: 00515467200 Page: 8 Date Filed: 06/25/2020
`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).
`“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 since17 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.”).
`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
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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
`“[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).
`19 Indus. Union Dep’t, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 686–87 (1980)
`(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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`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
`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 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).
` Case: 19-60921 Document: 00515467200 Page: 13 Date Filed: 06/25/2020
`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)).
` Case: 19-60921 Document: 00515467200 Page: 14 Date Filed: 06/25/2020
`Congress’s stated purposes in legislating, undoubtedly identify a “general pol-
`icy” for the Secretary to pursue.
`Likewise, Congress plainly limited the authority that it delegated. Far
`from giving the Secretary carte blanche, the TCA cabined its delegation in two
`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 st