R J Reynolds Tobacco Company v. FDA

Case: 25-40137 Document: 122-1 Page: 1 Date Filed: 08/18/2026 United States Court of Appeals for the Fifth Circuit United States Court of Appeals Fifth Circuit ____________ FILED August 18, 2026 No. 25-40137 Lyle W. Cayce ____________ Clerk R J Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Incorporated; ITG Brands LLC; Liggett Group LLC; Neocom, Incorporated; Rangila Enterprises, Incorporated; Rangila LLC; Sahil Ismail, Incorporated; Is Like You, Incorporated, Plaintiffs—Appellees, versus Food & Drug Administration; United States Department of Health and Human Services; Kyle Diamantas, Acting Commissioner, U.S. Food and Drug Administration; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Defendants—Appellants. ______________________________ Appeal from the United States District Court for the Eastern District of Texas USDC No. 6:20-CV-176 ______________________________ Before Southwick, Willett, and Ho *, Circuit Judges. Don R. Willett, Circuit Judge: _____________________ * Judge Ho joins all but Part III.C.1–2. Case: 25-40137 Document: 122-1 Page: 2 Date Filed: 08/18/2026 No. 25-40137 When Congress legislates in broad strokes, constitutional trouble sometimes follows. This case presents the opposite problem: Congress legislated with precision, and an agency treated that precision as optional. In the Family Smoking Prevention and Tobacco Control Act (TCA), Congress provided a detailed framework with nine prescribed warning statements that must appear on cigarette packages and advertising, while granting the Food and Drug Administration (FDA) only limited, conditional authority to adjust it. The FDA’s rule, however, requires the display of eleven warnings, prompting multiple cigarette manufacturers and retailers (Plaintiffs) to challenge it. At this preliminary stage, the statutory text points one way: the FDA may require the nine warnings Congress prescribed—no more. The district court agreed and temporarily postponed the Rule’s effective date after finding that Plaintiffs had shown a substantial likelihood of success on their claim that the FDA exceeded its statutory authority. Because that interim relief was no abuse of discretion, we AFFIRM. I This appeal sits against an intricate statutory scheme, a long regulatory history, and a parallel case in another circuit. A After decades of federal regulation of cigarette labeling and advertising, 1 Congress enacted the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009. 2 The TCA amended the Federal Cigarette _____________________ 1 See R.J. Reynolds Tobacco Co. v. FDA, 96 F.4th 863, 868–74 (5th Cir. 2024) (detailing the lengthy history of such regulation). 2 Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified as amended in scattered sections of Titles 15 and 21). Tobacco companies quickly challenged the TCA’s 2 Case: 25-40137 Document: 122-1 Page: 3 Date Filed: 08/18/2026 No. 25-40137 Labeling and Advertising Act (FCLAA) 3 and transferred primary regulatory authority over tobacco products to the FDA. 4 Two provisions of the TCA— § 201(a) and § 201(b)—were codified at 15 U.S.C. § 1333(d). To avoid confusion, we adopt the same nomenclature as the parties and the district court: § 1333(d)[1] and § 1333(d)[2]. Relevant here, the TCA made it “unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution” cigarettes if the package “fails to bear . . . one of the following labels[.]” 5 The statute then enumerates nine warning labels addressing specific health risks associated with smoking: • WARNING: Cigarettes are addictive. • WARNING: Tobacco smoke can harm your children. • WARNING: Cigarettes cause fatal lung disease. • WARNING: Cigarettes cause cancer. • WARNING: Cigarettes cause strokes and heart disease. • WARNING: Smoking during pregnancy can harm your baby. • WARNING: Smoking can kill you. • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. _____________________ constitutionality, but the Sixth Circuit upheld it in 2012. See Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 569 (6th Cir. 2012) (controlling opinion by Stranch, J.). 3 15 U.S.C. §§ 1331 et seq. 4 Id. § 1333(d)[1]. 5 Id. § 1333(a)(1). 3 Case: 25-40137 Document: 122-1 Page: 4 Date Filed: 08/18/2026 No. 25-40137 • WARNING: Quitting smoking now greatly reduces serious risks to your health. 6 Congress further directed the FDA to “issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection (a)(1).” 7 These text-and-graphic pairings must appear on the top 50 percent of the front and rear panels of cigarette packages and at least 20 percent of cigarette advertisements. 8 The warning statements must also comply with detailed placement, rotation, and formatting requirements. 9 Despite the TCA’s intricate specifications, it grants the FDA modest authority to adjust the warnings in two limited ways. First, in § 1333(d)[1], the FDA may visually “adjust the type size, text and format of the label statements . . . so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area.” 10 Second, under § 1333(d)[2], the FDA may “adjust the format, type size, color graphics, and text of any of the label requirements” or “establish the format, type size, and text of any other disclosures required under the Food, Drug, and Cosmetic Act [(FDCA)] . . . if the [FDA] finds that such _____________________ 6 Id. 7 Id. § 1333(d)[1]. 8 Id. § 1333(a)(2), (b)(2). 9 Id. 10 Id. § 1333(d)[1]. The FDA initially acknowledged the modest nature of its authority to “adjust the text” in (d)[1], explaining that it was limited to “changes that go to the visual presentation of cigarette warnings,” such as “placement, typography, clarity, conspicuousness, and legibility.” Tobacco Products; Required Warnings for Cigarette Packages and Advertisements, 85 Fed. Reg. 15,638, 15,642 (Mar. 18, 2020). 4 Case: 25-40137 Document: 122-1 Page: 5 Date Filed: 08/18/2026 No. 25-40137 a change would promote greater public understanding of the risks associated with the use of tobacco products.” 11 The TCA also imposes marketing requirements to ensure that the warning statements are evenly displayed on cigarette packages. Manufacturers must “randomly display[]” “[t]he label statements specified in subsection (a)(1) . . . in as equal a number of times as possible” annually. 12 For advertisements, manufacturers must likewise “rotate[] quarterly in alternating sequence” the specified “label statements.” 13 The TCA amended the FCLAA’s preemption provision, 15 U.S.C. § 1334. Section 1334(a) originally provided that “no statement relating to smoking and health, other than the statement required by section 1333 of this title, shall be required on any cigarette package.” 14 It now opens with the phrase, “[e]xcept to the extent [the FDA] requires additional or different statements on any cigarette package” pursuant to the TCA or certain provisions of the FDCA. 15 B The FDA first tried to implement the TCA’s graphic-warning mandate in 2011. 16 Aiming to “reduc[e] the number of Americans . . . who _____________________ 11 15 U.S.C. § 1333(d)[2]. While the FDA considers this subsection as supplying “broader authority” to make adjustments, its own description of the additional authority notably excludes any mention of increasing the number of warnings. 85 Fed. Reg. at 15,642. 12 15 U.S.C. § 1333(c)(1). 13 Id. § 1333(c)(2). 14 Id. § 1334(a) (2009). 15 Id. § 1334(a) (2026). 16 Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36,628 (June 22, 2011). 5 Case: 25-40137 Document: 122-1 Page: 6 Date Filed: 08/18/2026 No. 25-40137 use cigarettes,” the 2011 rule required cigarette packaging and advertisements to bear one of nine graphic images corresponding to the nine statutory warning statements. 17 The 2011 rule also required a prominent “1-800-QUIT-NOW” message alongside those text-and-image pairings to encourage consumers to contact a smoking-cessation hotline. 18 Before the 2011 rule could take effect, the D.C. Circuit vacated it on First Amendment grounds, holding that the FDA had not demonstrated that the compelled graphics would directly advance its asserted interest in reducing smoking rates. 19 After the 2011 rule was vacated, the FDA began a new rulemaking process. On August 16, 2019—following a delay of seven-and-a-half years— the FDA again issued a proposed graphic-warnings rule. 20 The proposal followed significant testing, including three qualitative studies 21 and two quantitative studies. 22 After receiving extensive public comments, the FDA promulgated the final rule at issue here (Rule). 23 Unlike in 2011, the FDA emphasized that “increased smoking cessation and decreased initiation are _____________________ 17 Id. at 36,628–29. 18 Id. at 36,681. 19 R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205, 1219, 1222 (D.C. Cir. 2012), overruled by Am. Meat Inst. v. USDA, 760 F.3d 18, 21–23 (D.C. Cir. 2014) (en banc) (overruling on the point that Zauderer review applies to “factual and uncontroversial” compelled disclosures that serve government interests other than preventing consumer deception). 20 Required Warnings for Cigarette Packages and Advertisements, 84 Fed. Reg. 42,754 (Aug. 16, 2019). 21 Id. at 42,765–72, 42,777–78; 85 Fed. Reg. at 15,645, 15,648–52. 22 85 Fed. Reg. at 15,651. The FDA, however, stated that it did not rely on qualitative studies. Id. 23 Id. at 15,638. 6 Case: 25-40137 Document: 122-1 Page: 7 Date Filed: 08/18/2026 No. 25-40137 not the purpose[s] of this rule.” 24 Its stated goal, instead, was to “promote greater public understanding of the negative health consequences of cigarette smoking.” 25 The Rule broke from its predecessor in another, more consequential way: it discarded all but two of Congress’s nine statutory warnings and substituted statements of the FDA’s own drafting. 26 As a result, the Rule requires cigarette manufacturers and retailers to display a rotating total of eleven warning statements—rather than the nine enumerated in § 1333(a)(1)—each paired with a graphic image depicting a smoking-related health harm. 27 Those pairings comprise the following graphic labels: _____________________ 24 Id. at 15,650; see also id. at 15,660, 15,665 (providing other purposes). 25 Id. at 15,640. 26 Id. at 15,685, 15,708–09. 27 Id. at 15,709. 7 Case: 25-40137 Document: 122-1 Page: 8 Date Filed: 08/18/2026 No. 25-40137 C Immediately following issuance of the Rule, Plaintiffs filed this action in the Eastern District of Texas. Plaintiffs primarily challenged the Rule under the First Amendment and Administrative Procedure Act (APA). The district court granted summary judgment to Plaintiffs and enjoined enforcement of the Rule based on the First Amendment claim without addressing the APA claims. 28 _____________________ 28 R.J. Reynolds Tobacco Co. v. FDA, No. 6:20-cv-00176, 2022 WL 17489170, at *21 (E.D. Tex. Dec. 7, 2022), rev’d, 96 F.4th 863 (5th Cir. 2024). 8 Case: 25-40137 Document: 122-1 Page: 9 Date Filed: 08/18/2026 No. 25-40137 The FDA appealed, and we reversed, holding that the Rule did not violate the First Amendment and remanding for consideration of Plaintiffs’ APA claims in the first instance. 29 After we denied en banc review 30 and the Supreme Court denied certiorari, 31 Plaintiffs moved for an interim postponement of the Rule’s effective date under § 705 of the APA. The FDA opposed the motion and moved for summary judgment. Following a hearing, the district court granted Plaintiffs’ motion for interim relief. The court concluded that Plaintiffs established a substantial likelihood of success on two of their APA claims: (1) the FDA lacks statutory authority to increase the number of required warnings from nine to eleven, and (2) the FDA lacks statutory authority to substantively rewrite the required warnings. The court also found that irreparable harm would occur absent interim relief, emphasizing substantial compliance costs and the impossibility of recouping those costs if the Rule were later invalidated. Because “the equities strongly tilt in [P]laintiffs’ favor,” the court postponed the Rule’s effective date. The FDA appealed. While this appeal was pending, a separate challenge to the same Rule was filed in the Southern District of Georgia. In Philip Morris USA Inc. v. FDA, a Georgia district court granted summary judgment to different plaintiffs (also tobacco companies) and vacated the Rule in its entirety. 32 The Georgia court held that the FDA violated the APA’s notice-and-comment requirements by failing to disclose key underlying data during the rulemaking _____________________ 29 R.J. Reynolds, 96 F.4th at 887 n.77, 888. 30 R.J. Reynolds Tobacco Co. v. FDA, No. 23-40076, ECF No. 162 (5th Cir. May 21, 2024). 31 R.J. Reynolds Tobacco Co. v. FDA, 145 S. Ct. 592 (2024) (mem.). 32 801 F. Supp. 3d 1353, 1367–68, 1381 (S.D. Ga. 2025). 9 Case: 25-40137 Document: 122-1 Page: 10 Date Filed: 08/18/2026 No. 25-40137 process, thereby depriving the public of a meaningful opportunity to participate. 33 The court justified its vacatur of the Rule because it was promulgated “without observance of procedure required by law.” 34 Notably, however, that court rejected all other challenges to the FDA’s authority and decisionmaking. 35 This decision is now pending before the Eleventh Circuit. 36 As matters stand, two orders affect the Rule: the Texas district court’s postponement of its effective date and the Georgia district court’s vacatur. The two rest on independent grounds—ours on the statute’s numerical limit, the Georgia court’s on a procedural defect in the rulemaking—so neither leans on the other’s reasoning to stand. II The APA requires courts to “hold unlawful and set aside agency action” found to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 37 While a court evaluates the lawfulness of agency action, it “may issue all necessary and appropriate process to postpone the effective date of an agency action.” 38 “Motions to stay [or postpone] agency action pursuant to [section 705] are reviewed under the same standards used to evaluate requests for _____________________ 33 Id. at 1375–80. 34 Id. at 1381; see also id. at 1380–81 (rejecting remand without vacatur). 35 Id. at 1365–75. 36 Notice of Appeal, Philip Morris USA Inc. v. FDA, No. 25-13863 (11th Cir. Oct. 27, 2025). 37 5 U.S.C. § 706(2)(c). 38 Id. § 705. 10 Case: 25-40137 Document: 122-1 Page: 11 Date Filed: 08/18/2026 No. 25-40137 interim injunctive relief.” 39 A movant must show (1) a likelihood of success on the merits; (2) a substantial threat of irreparable harm; (3) that the balance of hardships weighs in the movant’s favor; and (4) that the interim relief will not disserve the public interest. 40 The last two factors merge when the government is a party. 41 We review the grant of interim relief for abuse of discretion. 42 In doing so, we review the district court’s legal conclusions de novo and factual findings for clear error. 43 III We affirm for three related reasons. First, the district court did not abuse its discretion in concluding that Plaintiffs are substantially likely to succeed on their claim that § 1333(a)(1) establishes a closed set of nine warning statements. Second, the remaining equitable factors favor preserving the status quo while the district court resolves the merits. Third, the district court did not exceed its remedial authority in postponing the Rule’s effective date. A The question before us is narrow. It is not whether Plaintiffs have won on the merits, but whether the district court abused its discretion in concluding that Plaintiffs were substantially likely to win on their claim that _____________________ 39 Affinity Healthcare Servs. v. Sebelius, 720 F. Supp. 2d 12, 15 n.4 (D.D.C. 2010); see also Texas v. EPA, 829 F.3d 405, 435 (5th Cir. 2016) (applying the preliminary injunction factors). 40 Rest. L. Ctr. v. U.S. Dep’t of Lab., 66 F.4th 593, 597 (5th Cir. 2023). 41 Nken v. Holder, 556 U.S. 418, 435 (2009). 42 Texas v. United States, 809 F.3d 134, 150 (5th Cir. 2015). 43 Speaks v. Kruse, 445 F.3d 396, 399 (5th Cir. 2006); Anibowei v. Morgan, 70 F.4th 898, 902 (5th Cir. 2023). 11 Case: 25-40137 Document: 122-1 Page: 12 Date Filed: 08/18/2026 No. 25-40137 the FDA overstepped its statutory authority. The TCA supplies a carefully calibrated framework with nine prescribed warning statements that must appear on cigarette packages and advertising, while granting the FDA only limited and conditional authority to adjust that regime. The Rule departs from this framework by requiring eleven warnings instead of nine. 44 Because Plaintiffs made the requisite showing that the FDA likely lacks authority to increase the number of warning statements, the district court did not abuse its discretion in finding the first interim-relief factor satisfied. 45 1 As always, we begin with the statutory text 46—“the alpha and the omega of the interpretive process.” 47 The operative provision here, § 1333(a)(1), makes it unlawful to sell or distribute cigarettes whose package “fails to bear, in accordance with the requirements of this section, one of the following labels.” 48 It then immediately prescribes the labels to use. 49 Rarely is statutory text this crisp. The command requires a package to bear “one of the following labels,” and then lists nine of them—yet the FDA would read nine as eleven. Nine is not a placeholder for eleven. _____________________ 44 Although Plaintiffs raised additional APA claims, we need not address them to uphold the district court’s postponement of the Rule. See Mock v. Garland, 75 F.4th 563, 578 (5th Cir. 2023) (concluding that plaintiffs established a substantial likelihood of success on one claim while declining to address the other claims). We express no view on their merits. 45 See Kruse, 445 F.3d at 399. 46 Duncan v. Walker, 533 U.S. 167, 172 (2001) (“We begin, as always, with the language of the statute.”). 47 United States v. Maturino, 887 F.3d 716, 723 (5th Cir. 2018). 48 15 U.S.C. § 1333(a)(1) (emphasis added). 49 Id. 12 Case: 25-40137 Document: 122-1 Page: 13 Date Filed: 08/18/2026 No. 25-40137 “One of the following labels,” trailed by nine specific labels, reads as exclusive—a closed set of exactly those nine. 50 No phrase like “including” or “such as” signals an open list; nothing marks the nine as illustrative or default; and nothing hints that the FDA may add to them. The better reading is the plain one: Congress specified nine warnings—and only nine—that the FDA may require. Consider a familiar analogy: If a restaurant menu says a customer may choose “one of the following sides” followed by a list of nine choices, no ordinary diner reads that as license to order an unlisted tenth. Trendy eateries may keep a secret menu; the United States Code does not. Congress supplied a list of nine labels and required sellers and manufacturers to use one of them on rotation. But the Rule departs from that command. It instead requires packages and advertisements to rotate among eleven warnings—two more than Congress listed. A package bearing one of the extra labels is thus not bearing “one of the following labels” Congress enumerated. That straightforward reading suffices here. Even if the ordinary meaning were unclear, the surrounding statutory structure reinforces our interpretation. The statute repeatedly refers back to the label statements specified in subsection (a)(1). For instance, subsections (a)(2) and (b)(2) impose detailed typographical, placement, and formatting requirements for “each label statement required by paragraph (1).” 51 Subsection (b)(1) similarly requires advertisements to display “one of the labels specified in subsection (a).” 52 Throughout these provisions, Congress _____________________ 50 See Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of Legal Texts 132 (2012) (discussing the presumption of nonexclusive “include”). 51 15 U.S.C. § 1333(a)(2), (b)(2). 52 Id. § 1333(b)(1). 13 Case: 25-40137 Document: 122-1 Page: 14 Date Filed: 08/18/2026 No. 25-40137 cross-references the warnings already “specified” in subsection (a)(1), confirming that the nine statements anchor the entire labeling regime. The TCA’s rotation-and-display requirements point in the same direction. Section 1333(c) requires manufacturers to randomly display and rotate “[t]he label statements specified in subsection (a)(1)” and to ensure that “all of the labels required under this section” are displayed at the same time across different products and locations. 53 These provisions assume a fixed and finite set of warnings. Reading them to permit a “default” set of warnings, as the FDA urges, would disrupt the coherence of the rotation scheme Congress enacted. Despite this fixed set of nine, the Rule compels the rotating use of one of “11 required warnings.” 54 The FDA contends that adding two extra labels is permissible because the statute nowhere says “exactly nine.” But Congress need not use the word “exactly” to prescribe a finite set; it may do so through semantic devices and negative implication. 55 When (a)(1) directs a regulated entity to choose “one of the following” and then provides an enumerated list with no textual indicators that the list is merely exemplary or suggestive, the phrase should be read as exhaustive. 56 That reading is reinforced by the statute’s command that it is “unlawful” for a package or _____________________ 53 Id. § 1333(c)(1), (c)(3)(B). 54 85 Fed. Reg. at 15,670 (emphasis added). 55 See Scalia & Garner, supra, at 107–11 (negative-implication canon); id. at 233 (discussing ways statutory language excludes the negative-implication canon); see also id. at 132–33, 210, 227 (explaining that “to include” introduces examples rather than an exhaustive list). 56 See Henson v. Santander Consumer USA Inc., 582 U.S. 79, 83–84 (2017) (recognizing that courts interpret statutory phrases based on ordinary meaning). 14 Case: 25-40137 Document: 122-1 Page: 15 Date Filed: 08/18/2026 No. 25-40137 advertisement not to use one of the specifically enumerated labels. 57 By imposing additional warnings beyond the list of nine, some cigarette packages and advertisements will necessarily be unlawful by failing to carry one of the required nine. The district court thus acted well within its discretion in refusing to treat Congress’s nine warnings as a mere starting point. 2 Because the FDA cannot identify any provision that expressly authorizes more than nine warning statements, it then relies on § 1333(d)[2], which permits the Secretary to “adjust the format, type size, color graphics, and text of any of the label requirements” upon making a specified finding about improved public understanding. 58 According to the FDA, because § 1333(d)[2] authorizes it to “adjust the . . . text,” this authority implicitly includes the power to add new warnings or eliminate old ones. But that reading loads more onto “adjust” than the word can carry, and it ignores the context around it. To adjust is to modify something that already exists—not to conjure something new. 59 It does not naturally encompass the broad power to create additional items—such as new warning statements—or to increase the number Congress selected. Had Congress intended to authorize the FDA to expand the warning set, it could have said so directly or otherwise indicated that the list was not exhaustive. 60 Congress did neither. At a _____________________ 57 15 U.S.C. § 1333(a)(1). 58 Id. § 1333(d)[2]. 59 Adjust, Collins English Dictionary (7th ed. 2005); see also Adjust, The New Oxford American Dictionary (2d ed. 2005) (“[A]lter or move (something) slightly in order to achieve the desired fit, appearance, or result”); Adjust, Cambridge Dictionary of American English (2d ed. 2008) (“[T]o change something slightly to make it fit, work better, or be more suitable”). 60 See Scalia & Garner, supra, at 132–33, 210, 227. 15 Case: 25-40137 Document: 122-1 Page: 16 Date Filed: 08/18/2026 No. 25-40137 minimum, the district court did not abuse its discretion in concluding that “adjust” is too modest a verb to bear the weight the FDA places on it. Situating § 1333(d)[2] within the broader statutory framework is further instructive. Section 1333(d)[2] presupposes the existence of the prescribed “label requirements” and permits the FDA to adjust specified attributes—format, type size, color graphics, and text. Nothing in that language suggests Congress broadly empowered the FDA to increase the number of warning statements beyond those listed in § 1333(a)(1). Indeed, the word “number” (or a synonym) does not even appear in the provisions discussing the FDA’s adjustment authority. If Congress intended to confer such authority, it could have done so expressly, as it has in other regulatory schemes. 61 Because Congress did not do so here, the district court did not abuse its discretion when it concluded that expanding the number of warnings demonstrates that the FDA exceeded its authority. 3 The district court rested on § 1333 alone. The FDA counters that a different provision—the FCLAA’s preemption clause, § 1334—hands it broad power to change the warnings’ number and content. That argument fares no better. Section 1334(a) is a preemption provision designed to prohibit state and local governments from imposing additional smoking-and-health statements beyond those required by federal law. 62 It is not an independent _____________________ 61 See U.S. ex rel. Polansky v. Exec. Health Res. Inc., 599 U.S. 419, 436 (2023) (explaining that courts do not infer sweeping authority from silence); Nat’l Ass’n of Home Builders v. Defs. of Wildlife, 551 U.S. 644, 668–69 (2007) (same); Hartford Underwriters Ins. Co. v. Union Planters Bank, N.A., 530 U.S. 1, 6 (2000) (Scalia, J.) (“Congress says in a statute what it means and means in a statute what it says there.”). 62 15 U.S.C. § 1334 (titled “Preemption”); id. § 1334(a) (“[N]o statement relating to smoking and health, other than the statement required by section 1333 of this title, shall 16 Case: 25-40137 Document: 122-1 Page: 17 Date Filed: 08/18/2026 No. 25-40137 grant of regulatory authority. Its opening clause—permitting “additional or different statements” to the extent the Secretary requires them pursuant to federal law 63—presupposes valid authority conferred elsewhere; it does not create that authority itself. Reading § 1334(a) as an independent grant of power would invert the statute’s structure and render § 1333(d)[2]’s limitations largely superfluous. 64 Properly read, § 1334(a) does not expand the FDA’s authority to change the number of warnings. It merely clarifies that, when the FDA lawfully acts under another provision, such as § 1333, its actions are not preempted. That narrower reading preserves the statute’s structure: § 1333 supplies the substantive authority and its limits; § 1334 ensures that otherwise authorized federal warnings are not preempted. The text confirms as much at every turn. Section 1334 is titled “Preemption,” and it addresses which additional warning statements may be required, and by whom. 65 Subsection (a) is framed in prohibitory terms: “no statement relating to smoking and health . . . shall be required.” 66 It is also subject to express exceptions: “to the extent the Secretary requires” such statements and “pursuant to” the TCA and the related FDCA provisions. 67 _____________________ be required on any cigarette package.”); id. § 1334(b) (prohibiting state-law prohibitions or requirements). 63 Id. § 1334(a). 64 See Scalia & Garner, supra, at 174–79 (canon against surplusage). 65 15 U.S.C. § 1334; see also Scalia & Garner, supra, at 222 (title-and-headings canon). 66 15 U.S.C. § 1334(a). 67 Section 1334(a) expressly creates a preemption exception only for “additional or different statements” required “by a regulation, by an order, by a standard, by an authorization to market a product, or by a condition of marketing a product, pursuant to [the TCA]” or “as required under section 387c(a)(2) . . . or section 387t(a) of [the 17 Case: 25-40137 Document: 122-1 Page: 18 Date Filed: 08/18/2026 No. 25-40137 In other words, § 1334’s title, structure, and prohibitory phrasing all point the same way. The provision begins from a baseline of no additional state- ments and then carves out statements otherwise authorized by federal law. Section 1334’s language must also be harmonized with § 1333’s oper- ative scheme. The “except to the extent” clause does not supply an inde- pendent font of authority to impose any warning regime the FDA chooses. Rather, it clarifies the preemptive effect of federal law when the FDA acts pursuant to the delegations contained in the TCA (including § 1333(d)[2]). On that reading, the FDA’s authority to require “additional or different statements” remains bounded by § 1333(d)[2]’s conditions and by the struc- ture and text of § 1333(a). This construction preserves coherence across the TCA’s integrated amendments to §§ 1333 and 1334 without converting a preemption clause into a backdoor delegation that nullifies the statute’s care- fully drawn limits. The “pursuant to” phrase is likewise informative. Congress did not write an open-ended authorization that the agency “may require” any addi- tional statements. To the contrary, it wrote a preemption provision recogniz- ing that additional statements may be required when the agency acts under the substantive authority conferred elsewhere in federal law. Along with the “except to the extent” phrase, this language presupposes a valid FDA action elsewhere. The amendment’s most natural function, then, is to ensure that the FCLAA’s preemption rule does not bar the agency from requiring _____________________ FDCA]”—a different federal statute. Id. Section 387c(a)(2) of the FDCA concerns statements about modified-risk claims or other marketing terms that the FDA can require. 21 U.S.C. § 387c(a)(2). And § 387t(a) concerns origin-labeling statements, such as “sale only allowed in the United States.” Id. § 387t(a)(1). Both are “additional or different statements” that may appear on cigarette packaging or advertising in addition to the TCA’s nine prescribed warnings. 18 Case: 25-40137 Document: 122-1 Page: 19 Date Filed: 08/18/2026 No. 25-40137 additional or different statements when it acts under the TCA’s newly granted regulatory powers. The FDA’s broadest reading founders on a basic canon: no construc- tion should render a neighboring provision inoperative. 68 Read § 1334(a) as an independent license to require any number of warnings, and § 1333(d)[2]’s carefully drawn predicate—that the FDA may adjust the la- bels only upon finding that a change would “promote greater public under- standing”—collapses into surplusage, a hoop the agency could sidestep at will. Congress does not bury a sweeping delegation in a preemption clause and then erect detailed conditions next door for the agency to vault over. The FDA presses the point all the same, urging that “additional or different statements” in § 1334(a) frees it from § 1333’s limits altogether—and at least one court has agreed. The Southern District of Georgia read the phrase as an “affirmative statutory authorization,” concluding that “changing the num- ber of warnings is authorized by section 1334.” 69 But that reading works only by looking past the surrounding text and draining § 1333(d)[2] of force. Con- gress did not say the agency may require “additional or different statements” whenever it wishes; it tied any adjustment of the label requirements—“for- mat” and “text” included—to a prerequisite finding that the change would “promote greater public understanding.” 70 A construction that lets the agency slip that finding cannot be the better one. In any event, the competing reading does not undermine the district court’s conclusion that Plaintiffs are substantially likely to succeed on their narrower reading of the statute. _____________________ 68 See Scalia & Garner, supra, at 174–79 (canon against surplusage). 69 Philip Morris, 801 F. Supp. 3d at 1367. 70 15 U.S.C. § 1333(d)[2]. 19 Case: 25-40137 Document: 122-1 Page: 20 Date Filed: 08/18/2026 No. 25-40137 Finally, standard interpretive practice disfavors a reading that allows a general clause to swallow a specific one. 71 With this in mind, the more co- herent interpretation is that § 1334(a)’s carveout recognizes that additional or different statements may be required elsewhere, but only “to the extent” the agency does so as required by the two FDCA provisions or pursuant to the TCA’s substantive grants—which include § 1333(d)[2]’s limits and predicates. 72 Under this view, § 1334(a) and § 1333(d)[2] fit together harmo- niously, 73 with § 1333(d)[2] defining when and how the FDA may alter warn- ing content and § 1334(a) ensuring that FCLAA preemption does not forbid otherwise authorized warnings. The same cannot be said for the FDA’s in- terpretation. For these reasons, the far better reading treats § 1334(a) as a narrow preemption carveout tied to valid exercises of authority under § 1333 or else- where in federal law—not as an independent enlargement of the FDA’s au- thority. Treating § 1334(a) as a freestanding delegation of the power to in- crease the number of warnings would let a preemption clause override the detailed limits Congress placed in § 1333’s affirmative delegation. Although the district court did not address § 1334(a), the questions raised by the amended preemption provision do not undermine its conclusion that the _____________________ 71 See RadLAX Gateway Hotel, LLC v. Amalgamated Bank, 566 U.S. 639, 645 (2012) (“[I]t is a commonplace of statutory construction that the specific governs the general.” (quoting Morales v. Trans World Airlines, Inc., 504 U.S. 374, 384 (1992)); HCSC–Laundry v. United States, 450 U.S. 1, 6 (1981) (per curiam) (explaining that the specific governs the general, “particularly when the two are interrelated and closely positioned, both in fact being parts of [the same statutory scheme]”); see also Scalia & Garner, supra, at 183–88 (“If there is a conflict between a general provision and a specific provision, the specific provision prevails.”). 72