{"attribution":{"source":"legal.exploreworldai.com","canonical":"https://legal.exploreworldai.com/api/public/v1/judgment-text?id=us:ca7-25-2565-2026-04-21","cite_as":"NovaCopilot, legal.exploreworldai.com (https://legal.exploreworldai.com/api/public/v1/judgment-text?id=us:ca7-25-2565-2026-04-21)","license":"https://legal.exploreworldai.com/revision","version":"legal-2026-10-17","fingerprint":"ewai:us:e7344b","proof":"sha256:c3a7559a3f8268dfe8de1059a379f2e9eb60372e2f90f9a5bf2d2ef761fc484b","jurisdiction":"us","lang":"en","publisher":"NovaCopilot by ExploreWorld Legal","terms":"https://legal.exploreworldai.com/om"},"brand_source":"Source: NovaCopilot","item":{"schema_version":"1.0.0","id":"us:ca7-25-2565-2026-04-21","jurisdiction":"us","lang":"en","brand_source":"Source: NovaCopilot","brand":{"product":"NovaCopilot","platform":"ExploreWorldAI","infrastructure":"ExploreWorld Legal","infrastructure_url":"legal.exploreworldai.com","legal_entity":"Valkiv Ventures AB","permanent_url":"https://legal.exploreworldai.com/novacopilot","source":"Source: NovaCopilot","powered_by":"Powered by NovaCopilot","license":"https://legal.exploreworldai.com/licensvillkor"},"sections":[{"title":"In the","paragraphs":[]},{"title":"United States Court of Appeals","paragraphs":[]},{"title":"For the Seventh Circuit","paragraphs":["para_4"]},{"title":"No. 25-2565","paragraphs":["para_6","para_7","para_8","para_9"]},{"title":"DAVID CASEY, Secretary of the Wisconsin Department of Rev-","paragraphs":["para_11","para_12","para_13"]},{"title":"Appeal from the United States District Court for the","paragraphs":["para_15","para_16","para_17"]},{"title":"ARGUED DECEMBER 10, 2025 — DECIDED APRIL 21, 2026","paragraphs":["para_19"]},{"title":"Before BRENNAN, Chief Judge, and LEE and KOLAR, Circuit","paragraphs":["para_21"]},{"title":"BRENNAN, Chief Judge. The Food and Drug Administration","paragraphs":["para_23","para_24","para_25","para_26"]},{"title":"2 No. 25-2565","paragraphs":[]},{"title":"Wisconsin enacted a statute in 2023 that requires FDA au-","paragraphs":["para_29","para_30","para_31","para_32","para_33","para_34","para_35","para_36"]},{"title":"Drug, and Cosmetic Act, as well as the Tobacco Control Act—","paragraphs":["para_38","para_39","para_40","para_41"]},{"title":"A. Background","paragraphs":[]},{"title":"Electronic nicotine delivery systems (ENDS) products","paragraphs":["para_44","para_45","para_46","para_47","para_48","para_49","para_50","para_51"]},{"title":"1 E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems","paragraphs":[]},{"title":"(ENDS) (March 12, 2026), https://www.fda.gov/tobacco-products/prod-","paragraphs":["para_54","para_55"]},{"title":"No. 25-2565 3","paragraphs":[]},{"title":"A product may qualify for the directory in any of three","paragraphs":["para_58","para_59"]},{"title":"8, 2016, it has a pending FDA premarket authorization appli-","paragraphs":["para_61","para_62","para_63","para_64","para_65","para_66"]},{"title":"Businesses that sell such unlisted ENDS products are sub-","paragraphs":["para_68","para_69"]},{"title":"Wis. Stat. § 995.15(9)(a)–(b), (11)(a). Further, the sale of un-","paragraphs":["para_71","para_72"]},{"title":"995.15(9)(c). So “[a]ny person” financially harmed may com-","paragraphs":["para_74","para_75","para_76"]},{"title":"Two months before enforcement was set to begin under","paragraphs":["para_78","para_79","para_80","para_81","para_82","para_83"]},{"title":"2 Plaintiffs-Appellants Wisconsinites for Alternatives to Smoking are","paragraphs":["para_85","para_86"]},{"title":"4 No. 25-2565","paragraphs":["para_88","para_89","para_90"]},{"title":"ENDS products that would be eligible for sale under the stat-","paragraphs":["para_92","para_93","para_94","para_95"]},{"title":"Wisconsinites moved for a preliminary injunction on","paragraphs":["para_97","para_98","para_99","para_100","para_101","para_102","para_103","para_104","para_105"]},{"title":"A. Jurisdiction","paragraphs":["para_107","para_108"]},{"title":"To Wisconsinites, the implied preemption and equal protec-","paragraphs":["para_110","para_111","para_112"]},{"title":"3 After the district court denied the preliminary injunction, Wiscon-","paragraphs":["para_114","para_115"]},{"title":"No. 25-2565 5","paragraphs":[]},{"title":"Federal preemption is often raised as a defense against","paragraphs":["para_118"]},{"title":"U.S. 386, 392 (1987). Federal-law defenses do not supply fed-","paragraphs":["para_120","para_121","para_122","para_123","para_124","para_125","para_126","para_127"]},{"title":"481 U.S. 58, 63 (1987). Because field preemption is not impli-","paragraphs":["para_129","para_130"]},{"title":"There is no dispute that an equal protection claim is suffi-","paragraphs":["para_132","para_133"]},{"title":"15 (7th Cir. 2024). So, we agree that Wisconsinites have","paragraphs":["para_135","para_136"]},{"title":"Cir. 2025). Their preemption challenges follow along with","paragraphs":["para_138"]},{"title":"B. Standing","paragraphs":[]},{"title":"The Department also contests whether Wisconsinites have","paragraphs":["para_141","para_142"]},{"title":"Texas, 599 U.S. 670, 675 (2023). Plaintiffs who claim Article III","paragraphs":["para_144","para_145","para_146","para_147"]},{"title":"6 No. 25-2565","paragraphs":[]},{"title":"An injury in fact must be “concrete, particularized, and ac-","paragraphs":["para_150","para_151"]},{"title":"F.4th 627, 632 (7th Cir. 2026) (per curiam). Section 995.15, Wis-","paragraphs":["para_153"]},{"title":"That suffices as a concrete injury in fact, see In re Recalled Abbott","paragraphs":["para_155","para_156"]},{"title":"Next is causation. The Department asserts that Wisconsin-","paragraphs":["para_158","para_159","para_160","para_161","para_162","para_163","para_164","para_165","para_166","para_167","para_168","para_169","para_170","para_171","para_172","para_173"]},{"title":"4 Enforcement Priorities for Electronic Nicotine Delivery System","paragraphs":[]},{"title":"(ENDS) and Other Deemed Products on the Market Without Premarket","paragraphs":[]},{"title":"Authorization 9 (April 2020). https://www.fda.gov/regulatory-infor-","paragraphs":["para_177","para_178","para_179"]},{"title":"No. 25-2565 7","paragraphs":[]},{"title":"Last is redressability. Courts redress injuries by providing","paragraphs":["para_182","para_183","para_184"]},{"title":"453, 489 (2018) (Thomas, J., concurring)); see also William","paragraphs":[]},{"title":"Baude & Samuel L. Bray, Proper Parties, Proper Relief, 137","paragraphs":[]},{"title":"HARV. L. REV. 153, 182 (2023). The relief must be “likely” and","paragraphs":["para_188","para_189","para_190"]},{"title":"561 (1992)). When analyzing redressability, courts “consider","paragraphs":["para_192","para_193"]},{"title":"Redressability depends on the relief requested, not the relief","paragraphs":["para_195","para_196"]},{"title":"Put simply, when we enjoin the enforcement of a statute, the","paragraphs":["para_198","para_199","para_200"]},{"title":"The harms Wisconsinites allege “flow[] directly from” the","paragraphs":["para_202"]},{"title":"220, 244 (2021). This case is not like Haaland v. Brackeen, in","paragraphs":["para_204","para_205","para_206","para_207"]},{"title":"Chicago Ridge, which involved two overlapping ordinances. 9","paragraphs":[]},{"title":"F.3d 1290, 1291 (7th Cir. 1993). That meant the plaintiff’s in-","paragraphs":["para_210","para_211","para_212"]},{"title":"8 No. 25-2565","paragraphs":["para_214","para_215","para_216","para_217","para_218","para_219"]},{"title":"With jurisdiction secure and satisfied that Wisconsinites","paragraphs":["para_221","para_222"]},{"title":"A preliminary injunction is “an exercise of a very far-","paragraphs":["para_224","para_225"]},{"title":"598 (7th Cir. 2022) (citation omitted). A party seeking a pre-","paragraphs":["para_227","para_228","para_229"]},{"title":"(4) an injunction would be in the public interest. Id. (citing","paragraphs":["para_231"]},{"title":"When reviewing a denial of a preliminary injunction, “we","paragraphs":["para_233","para_234","para_235","para_236"]},{"title":"This case focuses on Wisconsinites’ likelihood of success","paragraphs":["para_238","para_239","para_240"]},{"title":"Then, we evaluate the district court’s denial of a preliminary","paragraphs":["para_242","para_243"]},{"title":"No. 25-2565 9","paragraphs":["para_245","para_246"]},{"title":"A. Statutory Background","paragraphs":["para_248","para_249"]},{"title":"(1938), as well as the Family Smoking Prevention and Tobacco","paragraphs":["para_251"]},{"title":"Enacted in 1938, the FDCA gives the Food and Drug Ad-","paragraphs":["para_253","para_254"]},{"title":"L.L.C., 604 U.S. 542, 549 (2025). The FDCA provides that all","paragraphs":["para_256","para_257"]},{"title":"In 2009, the TCA extended the FDA’s regulatory authority to","paragraphs":["para_259","para_260"]},{"title":"U.S.C. § 387j. A “new tobacco product” is one not commer-","paragraphs":["para_262","para_263"]},{"title":"E-cigarettes were not initially considered “new tobacco","paragraphs":["para_265"]},{"title":"U.S. 226, 230 (2025) (citation omitted). But in 2016, the FDA","paragraphs":["para_267","para_268"]},{"title":"Fed. Reg. 29028–44 (2016). Congress later amended the TCA","paragraphs":["para_270","para_271","para_272","para_273"]},{"title":"10 No. 25-2565","paragraphs":["para_275","para_276","para_277"]},{"title":"A manufacturer seeking FDA approval must first submit","paragraphs":["para_279","para_280","para_281"]},{"title":"1114.31. The sale of e-cigarette products in interstate com-","paragraphs":["para_283","para_284","para_285","para_286","para_287","para_288"]},{"title":"Against the backdrop of federal regulation, the TCA’s text","paragraphs":["para_290","para_291","para_292"]},{"title":"29 F.4th 542, 550 (9th Cir. 2022) (quoting U.S. Smokeless Tobacco","paragraphs":[]},{"title":"Mfg. Co. v. City of New York, 708 F.3d 428, 436 (2d Cir. 2013));","paragraphs":["para_295"]},{"title":"Three separate clauses of the TCA, taken together, make","paragraphs":["para_297","para_298","para_299","para_300","para_301","para_302"]},{"title":"(the “preemption clause”). And third, it contains a savings","paragraphs":["para_304","para_305"]},{"title":"No. 25-2565 11","paragraphs":[]},{"title":"This tripartite preemption framework balances the states’","paragraphs":["para_308","para_309"]},{"title":"F.4th at 560. The power to regulate includes the power to pro-","paragraphs":["para_311","para_312","para_313"]},{"title":"B. Likelihood of Success on the Merits","paragraphs":[]},{"title":"Wisconsinites submit that the district court erred in","paragraphs":["para_316","para_317","para_318","para_319","para_320","para_321","para_322","para_323"]},{"title":"We start with the law of implied conflict preemption. Then","paragraphs":["para_325","para_326"]},{"title":"Congress intended to preempt state laws that rely on that","paragraphs":["para_328"]},{"title":"1. Implied Conflict Preemption","paragraphs":[]},{"title":"Federal statues preempt state law through the Supremacy","paragraphs":[]},{"title":"Clause. Ye v. GlobalTranz Enters., Inc., 74 F.4th 453, 457 (7th","paragraphs":[]},{"title":"Cir. 2023); Caleb Nelson, Preemption, 86 VA. L. REV. 225, 234","paragraphs":["para_333"]},{"title":"Garcia, 589 U.S. 191, 202 (2020). Instead, a federal restriction of","paragraphs":["para_335","para_336"]},{"title":"12 No. 25-2565","paragraphs":["para_338","para_339"]},{"title":"Am. Honda Motor Co., 529 U.S. 861, 873 (2000) (citation modi-","paragraphs":["para_341"]},{"title":"As with all preemption arguments, the analysis of implied","paragraphs":["para_343","para_344"]},{"title":"Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993)). An","paragraphs":["para_346","para_347","para_348","para_349"]},{"title":"There are two forms of implied preemption: field and con-","paragraphs":["para_351","para_352"]},{"title":"2019). Field preemption occurs when “Congress has so com-","paragraphs":["para_354","para_355","para_356"]},{"title":"787 (7th Cir. 2002) (citation modified). Two provisions in the","paragraphs":["para_358","para_359","para_360","para_361","para_362"]},{"title":"1170, 1174 (8th Cir. 2023); 21 U.S.C. § 387p(a)(1). And the sav-","paragraphs":["para_364","para_365"]},{"title":"When Congress first enacted the FDCA, it included a pro-","paragraphs":["para_367","para_368"]},{"title":"No. 25-2565 13","paragraphs":["para_370","para_371"]},{"title":"Plaintiffs’ Legal Comm., 531 U.S. 341, 352 (2001). But when Con-","paragraphs":["para_373","para_374","para_375"]},{"title":"TCA reserves some authority for the states to regulate to-","paragraphs":["para_377","para_378"]},{"title":"By contrast, conflict preemption exists when either (1)","paragraphs":["para_380","para_381","para_382","para_383"]},{"title":"Ind. State Dep't of Health, 699 F.3d 962, 984 (7th Cir. 2012)","paragraphs":[]},{"title":"(quoting Arizona, 567 U.S. at 399). So, we are to answer","paragraphs":["para_386","para_387"]},{"title":"2. Preemption under the TCA","paragraphs":[]},{"title":"As described above, the TCA creates a tripartite preemp-","paragraphs":["para_390","para_391","para_392","para_393","para_394","para_395"]},{"title":"In turn, the preemption clause limits the reach of the","paragraphs":["para_397","para_398","para_399"]},{"title":"14 No. 25-2565","paragraphs":["para_401","para_402","para_403","para_404"]},{"title":"54 (citing 21 U.S.C. § 387p(a)(2)(A)). But the savings clause ex-","paragraphs":["para_406","para_407","para_408"]},{"title":"Therefore, the district court correctly reasoned that the","paragraphs":["para_410","para_411","para_412","para_413","para_414","para_415","para_416"]},{"title":"The court concluded that “the power to enact and enforce the","paragraphs":["para_418","para_419","para_420","para_421"]},{"title":"Congress intended to preempt the States’ authority to enact","paragraphs":["para_423","para_424","para_425","para_426","para_427"]},{"title":"To counter this application of the tripartite preemption","paragraphs":["para_429","para_430","para_431"]},{"title":"No. 25-2565 15","paragraphs":["para_433","para_434"]},{"title":"Congress did not intend to force medical device manufactur-","paragraphs":["para_436","para_437","para_438"]},{"title":"Amendments to the FDCA. Id. at 353. The Court concluded","paragraphs":["para_440","para_441"]},{"title":"But Buckman involved non-federal enforcement of fraud-","paragraphs":["para_443","para_444","para_445","para_446","para_447"]},{"title":"Wisconsinites also contend the federal government has ex-","paragraphs":["para_449","para_450","para_451","para_452","para_453","para_454","para_455","para_456","para_457"]},{"title":"The Court in Buckman was also concerned the state-law","paragraphs":["para_459","para_460","para_461","para_462"]},{"title":"353. This issue does not arise here because adjudication is not","paragraphs":[]},{"title":"16 No. 25-2565","paragraphs":["para_465"]},{"title":"(6th Cir. 2004) (no concerns of “inter-branch meddling …","paragraphs":["para_467","para_468","para_469","para_470"]},{"title":"The district court found Wisconsinites’ reliance on Buck-","paragraphs":["para_472","para_473","para_474","para_475","para_476","para_477","para_478"]},{"title":"In their principal brief to us, Wisconsinites also argue that","paragraphs":["para_480","para_481","para_482","para_483"]},{"title":"TCA’s requirements.”","paragraphs":[]},{"title":"This is incorrect. The preemption clause has certain carve-","paragraphs":["para_486","para_487","para_488"]},{"title":"5 In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d","paragraphs":[]},{"title":"1200 (8th Cir. 2010) (medical devices); Nexus Pharms., Inc. v. Cent. Admix-","paragraphs":["para_491","para_492"]},{"title":"9, 2002) (food); Vanzant v. Hill's Pet Nutrition Inc., No. 17 C 2535, 2025 WL","paragraphs":["para_494"]},{"title":"No. 25-2565 17","paragraphs":["para_496","para_497"]},{"title":"In the alternative, Wisconsinites argue that states cannot","paragraphs":["para_499","para_500","para_501","para_502"]},{"title":"Wisconsinites submit that Congress has “a long history” of","paragraphs":["para_504","para_505","para_506","para_507","para_508","para_509","para_510"]},{"title":"TCA’s requirements. 21 U.S.C. § 387p(a)(2)(A). But neither","paragraphs":["para_512","para_513","para_514","para_515"]},{"title":"But this argument misconstrues preemption. Implied","paragraphs":["para_517"]},{"title":"See Altria Grp., Inc. v. Good, 555 U.S. 70, 76 (2008). A state law","paragraphs":["para_519","para_520","para_521","para_522","para_523","para_524","para_525"]},{"title":"18 No. 25-2565","paragraphs":[]},{"title":"Wisconsinites also overread § 337(a),6 which limits only","paragraphs":["para_528"]},{"title":"Buckman, 531 U.S. at 348; see also Garcia, 385 F.3d at 966 (hold-","paragraphs":["para_530","para_531","para_532","para_533"]},{"title":"Therefore, § 995.15 does not seek to enforce the FDCA, either","paragraphs":["para_535","para_536"]},{"title":"And cross-referencing to FDA approval orders is not equiva-","paragraphs":["para_538","para_539","para_540"]},{"title":"Finally, Wisconsinites fail to recognize that in the FDCA-","paragraphs":["para_542","para_543","para_544"]},{"title":"49 (1900) (cigarettes are “within the province of the legislature","paragraphs":["para_546","para_547"]},{"title":"1169, 1191 (11th Cir. 2017). At both the district court and on","paragraphs":["para_549","para_550"]},{"title":"3. Other courts","paragraphs":[]},{"title":"Four other circuits have concluded that the TCA does not","paragraphs":["para_553"]},{"title":"6 “Except as provided in subsection (b), all such proceedings for the","paragraphs":["para_555","para_556"]},{"title":"No. 25-2565 19","paragraphs":["para_558","para_559","para_560","para_561"]},{"title":"Smokeless Tobacco Mfg. Co., 708 F.3d at 436 (Second Circuit","paragraphs":["para_563","para_564","para_565"]},{"title":"Cir. 2013) (recognizing that the Act allows regulations relat-","paragraphs":["para_567"]},{"title":"True, one published district court decision has concluded","paragraphs":["para_569"]},{"title":"Supp. 3d at 741. But this decision, which Wisconsinites rely","paragraphs":["para_571","para_572","para_573","para_574"]},{"title":"350 (“State-law fraud-on-the-FDA claims inevitably conflict","paragraphs":["para_576","para_577","para_578","para_579"]},{"title":"Not every sales ban is “a backdoor ‘requirement … relat-","paragraphs":["para_581","para_582"]},{"title":"A preempted tobacco product standard “must be something","paragraphs":["para_584","para_585","para_586"]},{"title":"(citation modified); see also City of Edina, 60 F.4th at 1175. Sec-","paragraphs":["para_588"]},{"title":"20 No. 25-2565","paragraphs":["para_590","para_591"]},{"title":"And the savings clause states the preemption clause “does not","paragraphs":["para_593","para_594","para_595"]},{"title":"Together, these clauses show that Congress did not intend to","paragraphs":["para_597","para_598"]},{"title":"The text of the TCA reveals where Congress decided to","paragraphs":["para_600"]},{"title":"Congress expressly preserved state authority and limited","paragraphs":["para_602","para_603","para_604","para_605","para_606","para_607"]},{"title":"C. Irreparable Harm","paragraphs":[]},{"title":"In addition to establishing a reasonable likelihood of suc-","paragraphs":["para_610","para_611","para_612","para_613"]},{"title":"K.C., 121 F.4th at 613 (quoting Winter, 555 U.S. at 20). A pre-","paragraphs":["para_615","para_616","para_617"]},{"title":"Irreparable harm occurs when the “legal remedies availa-","paragraphs":["para_619"]},{"title":"No. 25-2565 21","paragraphs":["para_621","para_622","para_623","para_624","para_625"]},{"title":"386 (7th Cir. 1984). Here, the district court’s conclusion of ir-","paragraphs":["para_627","para_628"]},{"title":"Inc. v. Aegis Spine, Inc., 8 F.4th 531, 546 (7th Cir. 2021) (con-","paragraphs":["para_630","para_631","para_632","para_633","para_634","para_635","para_636","para_637","para_638","para_639","para_640","para_641"]},{"title":"For preliminary injunction purposes, then, such harms are ir-","paragraphs":["para_643"]},{"title":"D. Balance of Equities and Public Interest","paragraphs":[]},{"title":"The equities and public interest factors tilt against Wiscon-","paragraphs":["para_646","para_647"]},{"title":"F.4th at 633; see also Maryland v. King, 567 U.S. 1301, 1303","paragraphs":["para_649"]},{"title":"22 No. 25-2565","paragraphs":[]},{"title":"Plaintiffs point to a First Amendment challenge in ACLU","paragraphs":["para_652","para_653","para_654","para_655","para_656","para_657"]},{"title":"Amendment rights. See id. at 590 (citing Christian Legal Soc'y","paragraphs":["para_659"]},{"title":"Wisconsinites bring an equal protection challenge to the gov-","paragraphs":["para_661","para_662"]},{"title":"1303 (Roberts, C.J., in chambers). And such an effort to enjoin","paragraphs":["para_664","para_665","para_666"]},{"title":"We must also consider Wisconsinites’ delay in bringing","paragraphs":["para_668","para_669"]},{"title":"These balance of equities and public interest factors weigh in","paragraphs":["para_671","para_672"]},{"title":"Wisconsinites have failed to demonstrate a reasonable","paragraphs":["para_674","para_675","para_676","para_677","para_678","para_679","para_680"]},{"title":"AFFIRMED","paragraphs":[]}],"paragraphs":[{"text":"In the","paragraph_id":"para_1"},{"text":"United States Court of Appeals","paragraph_id":"para_2"},{"text":"For the Seventh Circuit","paragraph_id":"para_3"},{"text":"____________________","paragraph_id":"para_4"},{"text":"No. 25-2565","paragraph_id":"para_5"},{"text":"WISCONSINITES FOR ALTERNATIVES TO SMOKING & TOBACCO,","paragraph_id":"para_6"},{"text":"INC., et al.,","paragraph_id":"para_7"},{"text":"Plaintiffs-Appellants,","paragraph_id":"para_8"},{"text":"v.","paragraph_id":"para_9"},{"text":"DAVID CASEY, Secretary of the Wisconsin Department of Rev-","paragraph_id":"para_10"},{"text":"enue, in his official capacity,","paragraph_id":"para_11"},{"text":"Defendant-Appellee.","paragraph_id":"para_12"},{"text":"____________________","paragraph_id":"para_13"},{"text":"Appeal from the United States District Court for the","paragraph_id":"para_14"},{"text":"Western District of Wisconsin.","paragraph_id":"para_15"},{"text":"No. 3:25-cv-00552 — William M. Conley, Judge.","paragraph_id":"para_16"},{"text":"____________________","paragraph_id":"para_17"},{"text":"ARGUED DECEMBER 10, 2025 — DECIDED APRIL 21, 2026","paragraph_id":"para_18"},{"text":"____________________","paragraph_id":"para_19"},{"text":"Before BRENNAN, Chief Judge, and LEE and KOLAR, Circuit","paragraph_id":"para_20"},{"text":"Judges.","paragraph_id":"para_21"},{"text":"BRENNAN, Chief Judge. The Food and Drug Administration","paragraph_id":"para_22"},{"text":"regulates electronic products that deliver nicotine to the user,","paragraph_id":"para_23"},{"text":"like electronic vaping devices and e-cigarettes. That authority","paragraph_id":"para_24"},{"text":"includes review and approval of those products before they","paragraph_id":"para_25"},{"text":"are marketed and sold. See 21 U.S.C. § 387j.","paragraph_id":"para_26"},{"text":"2 No. 25-2565","paragraph_id":"para_27"},{"text":"Wisconsin enacted a statute in 2023 that requires FDA au-","paragraph_id":"para_28"},{"text":"thorization before electronic nicotine delivery systems may be","paragraph_id":"para_29"},{"text":"sold. Wis. Stat. § 995.15. Manufacturers, distributors, retailers,","paragraph_id":"para_30"},{"text":"and users of vapes and e-cigarettes sued to enjoin","paragraph_id":"para_31"},{"text":"enforcement of that statute. In their view, the federal statutes","paragraph_id":"para_32"},{"text":"granting the FDA exclusive authority over premarket author-","paragraph_id":"para_33"},{"text":"ization preempt the Wisconsin statute. The district court dis-","paragraph_id":"para_34"},{"text":"agreed and denied a preliminary injunction.","paragraph_id":"para_35"},{"text":"The text of the applicable federal laws—the Federal Food,","paragraph_id":"para_36"},{"text":"Drug, and Cosmetic Act, as well as the Tobacco Control Act—","paragraph_id":"para_37"},{"text":"does not preempt the states’ authority to regulate the sale and","paragraph_id":"para_38"},{"text":"marketing of tobacco and tobacco-related products, so we af-","paragraph_id":"para_39"},{"text":"firm.","paragraph_id":"para_40"},{"text":"I.","paragraph_id":"para_41"},{"text":"A. Background","paragraph_id":"para_42"},{"text":"Electronic nicotine delivery systems (ENDS) products","paragraph_id":"para_43"},{"text":"include “[v]apes, vaporizers, vape pens, hookah pens, elec-","paragraph_id":"para_44"},{"text":"tronic cigarettes (e-cigarettes or e-cigs), e-cigars, and e—","paragraph_id":"para_45"},{"text":"pipes.”1 These products typically use a liquid containing","paragraph_id":"para_46"},{"text":"tobacco-derived nicotine “heated to create an aerosol that is","paragraph_id":"para_47"},{"text":"inhaled” by the user. Id. Wisconsin Statute § 995.15 requires","paragraph_id":"para_48"},{"text":"the state’s Department of Revenue to create a directory of","paragraph_id":"para_49"},{"text":"ENDS products that may lawfully be sold in the state. Wis.","paragraph_id":"para_50"},{"text":"Stat. § 995.15(6).","paragraph_id":"para_51"},{"text":"1 E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems","paragraph_id":"para_52"},{"text":"(ENDS) (March 12, 2026), https://www.fda.gov/tobacco-products/prod-","paragraph_id":"para_53"},{"text":"ucts-ingredients-components/e-cigarettes-vapes-and-other-electronic-","paragraph_id":"para_54"},{"text":"nicotine-delivery-systems-ends.","paragraph_id":"para_55"},{"text":"No. 25-2565 3","paragraph_id":"para_56"},{"text":"A product may qualify for the directory in any of three","paragraph_id":"para_57"},{"text":"ways: (1) its manufacturer has received an FDA premarket au-","paragraph_id":"para_58"},{"text":"thorization order; (2) it was marketed in the U.S. as of August","paragraph_id":"para_59"},{"text":"8, 2016, it has a pending FDA premarket authorization appli-","paragraph_id":"para_60"},{"text":"cation submitted by September 9, 2020, and that application","paragraph_id":"para_61"},{"text":"remains under review or the final decision has not taken ef-","paragraph_id":"para_62"},{"text":"fect; or (3) it contains hemp but not nicotine. Wis. Stat.","paragraph_id":"para_63"},{"text":"§ 995.15(2). As of September 1, 2025, retailers and manufac-","paragraph_id":"para_64"},{"text":"turers are prohibited from selling any ENDS products not","paragraph_id":"para_65"},{"text":"listed in the directory. Wis. Stat. § 995.15(9)(a)–(b).","paragraph_id":"para_66"},{"text":"Businesses that sell such unlisted ENDS products are sub-","paragraph_id":"para_67"},{"text":"ject to forfeiture penalties of $1,000 per day per product and","paragraph_id":"para_68"},{"text":"the seizure of the unauthorized products as “contraband.”","paragraph_id":"para_69"},{"text":"Wis. Stat. § 995.15(9)(a)–(b), (11)(a). Further, the sale of un-","paragraph_id":"para_70"},{"text":"listed vaping products constitutes “an unfair and deceptive","paragraph_id":"para_71"},{"text":"trade practice in violation of” Wis. Stat. § 100.20. Id. at","paragraph_id":"para_72"},{"text":"995.15(9)(c). So “[a]ny person” financially harmed may com-","paragraph_id":"para_73"},{"text":"mence a civil suit to recover twice that “pecuniary loss, to-","paragraph_id":"para_74"},{"text":"gether with costs, including a reasonable attorney fee.” Wis.","paragraph_id":"para_75"},{"text":"Stat. § 100.20(5).","paragraph_id":"para_76"},{"text":"Two months before enforcement was set to begin under","paragraph_id":"para_77"},{"text":"§ 995.15, Wisconsinites2 sued the Department, arguing that","paragraph_id":"para_78"},{"text":"federal statutes preempted the state statute. They also con-","paragraph_id":"para_79"},{"text":"tended that § 995.15 violates the Equal Protection Clause of","paragraph_id":"para_80"},{"text":"the Fourteenth Amendment. Seeking preliminary and perma-","paragraph_id":"para_81"},{"text":"nent injunctions against enforcement of the statute, Wiscon-","paragraph_id":"para_82"},{"text":"sinites claimed § 995.15 would require them “to either run the","paragraph_id":"para_83"},{"text":"2 Plaintiffs-Appellants Wisconsinites for Alternatives to Smoking are","paragraph_id":"para_84"},{"text":"a Wisconsin non-profit corporation and its members, who are manufac-","paragraph_id":"para_85"},{"text":"turers, distributors, wholesalers, retailers, and users of ENDS products.","paragraph_id":"para_86"},{"text":"4 No. 25-2565","paragraph_id":"para_87"},{"text":"risk of incurring substantial fines and forfeitures for sales of","paragraph_id":"para_88"},{"text":"[unlisted] ENDS products … or shut down because they can-","paragraph_id":"para_89"},{"text":"not maintain a profitable business with the limited range of","paragraph_id":"para_90"},{"text":"ENDS products that would be eligible for sale under the stat-","paragraph_id":"para_91"},{"text":"ute.” They also asserted that the law would deprive consum-","paragraph_id":"para_92"},{"text":"ers, including plaintiffs Kurt Wylie and Germaine Carmody,","paragraph_id":"para_93"},{"text":"“of the ability to purchase and consume their preferred ENDS","paragraph_id":"para_94"},{"text":"products because those products will not be eligible for sale.”","paragraph_id":"para_95"},{"text":"Wisconsinites moved for a preliminary injunction on","paragraph_id":"para_96"},{"text":"preemption grounds. Four days after § 995.15 went into effect,","paragraph_id":"para_97"},{"text":"the district court denied Wisconsinites’ motion. The court","paragraph_id":"para_98"},{"text":"concluded that the Wisconsin statute was not preempted by","paragraph_id":"para_99"},{"text":"the Federal Food, Drug, and Cosmetic Act, and therefore Wis-","paragraph_id":"para_100"},{"text":"consinites had not shown a reasonable likelihood of success","paragraph_id":"para_101"},{"text":"on the merits. They also failed to establish that the equities","paragraph_id":"para_102"},{"text":"weighed in favor of enjoining the statute’s enforcement. Wis-","paragraph_id":"para_103"},{"text":"consinites timely appeal.3","paragraph_id":"para_104"},{"text":"II.","paragraph_id":"para_105"},{"text":"A. Jurisdiction","paragraph_id":"para_106"},{"text":"Before addressing the denial of the preliminary injunction,","paragraph_id":"para_107"},{"text":"the parties debate the grounds for subject-matter jurisdiction.","paragraph_id":"para_108"},{"text":"To Wisconsinites, the implied preemption and equal protec-","paragraph_id":"para_109"},{"text":"tion claims raise federal questions on which jurisdiction can","paragraph_id":"para_110"},{"text":"rest. 28 U.S.C. § 1331. The Department contends that jurisdic-","paragraph_id":"para_111"},{"text":"tion exists only through the equal protection claim.","paragraph_id":"para_112"},{"text":"3 After the district court denied the preliminary injunction, Wiscon-","paragraph_id":"para_113"},{"text":"sinites moved for an injunction pending appeal, which was denied on sim-","paragraph_id":"para_114"},{"text":"ilar grounds.","paragraph_id":"para_115"},{"text":"No. 25-2565 5","paragraph_id":"para_116"},{"text":"Federal preemption is often raised as a defense against","paragraph_id":"para_117"},{"text":"claims in a plaintiff’s complaint. Caterpillar Inc. v. Williams, 482","paragraph_id":"para_118"},{"text":"U.S. 386, 392 (1987). Federal-law defenses do not supply fed-","paragraph_id":"para_119"},{"text":"eral question jurisdiction, “even if the defense is anticipated","paragraph_id":"para_120"},{"text":"in the plaintiff’s complaint, and even if both parties concede","paragraph_id":"para_121"},{"text":"that the federal defense is the only question truly at issue.” Id.","paragraph_id":"para_122"},{"text":"at 393. Field, or complete, preemption does confer federal","paragraph_id":"para_123"},{"text":"question jurisdiction, but conflict preemption “is merely a de-","paragraph_id":"para_124"},{"text":"fense to the merits of a claim,” and thus does not confer juris-","paragraph_id":"para_125"},{"text":"diction under 28 U.S.C. § 1331. Vorhees v. Naper Aero Club, Inc.,","paragraph_id":"para_126"},{"text":"272 F.3d 398, 403 (7th Cir. 2001); Metro. Life Ins. Co. v. Taylor,","paragraph_id":"para_127"},{"text":"481 U.S. 58, 63 (1987). Because field preemption is not impli-","paragraph_id":"para_128"},{"text":"cated here, see infra III.B.1., Wisconsinites must advance a non-","paragraph_id":"para_129"},{"text":"preemption basis to assert federal question jurisdiction.","paragraph_id":"para_130"},{"text":"There is no dispute that an equal protection claim is suffi-","paragraph_id":"para_131"},{"text":"cient to supply federal-question jurisdiction. See K.C. v. Indi-","paragraph_id":"para_132"},{"text":"vidual Members of Med. Licensing Bd. of Ind., 121 F.4th 604, 614–","paragraph_id":"para_133"},{"text":"15 (7th Cir. 2024). So, we agree that Wisconsinites have","paragraph_id":"para_134"},{"text":"properly alleged a cause of action sufficient “to open the fed-","paragraph_id":"para_135"},{"text":"eral courthouse doors.” Braid v. Stilley, 142 F.4th 956, 962 (7th","paragraph_id":"para_136"},{"text":"Cir. 2025). Their preemption challenges follow along with","paragraph_id":"para_137"},{"text":"their constitutional claim.","paragraph_id":"para_138"},{"text":"B. Standing","paragraph_id":"para_139"},{"text":"The Department also contests whether Wisconsinites have","paragraph_id":"para_140"},{"text":"standing. “Article III of the Constitution confines the federal","paragraph_id":"para_141"},{"text":"judicial power to ‘Cases’ and ‘Controversies.’” United States v.","paragraph_id":"para_142"},{"text":"Texas, 599 U.S. 670, 675 (2023). Plaintiffs who claim Article III","paragraph_id":"para_143"},{"text":"standing must establish they (1) “suffered an injury in fact,”","paragraph_id":"para_144"},{"text":"that (2) was “likely caused by the defendant,” and (3) is","paragraph_id":"para_145"},{"text":"“likely [to] be redressed by judicial relief.” TransUnion LLC v.","paragraph_id":"para_146"},{"text":"Ramirez, 594 U.S. 413, 423 (2021).","paragraph_id":"para_147"},{"text":"6 No. 25-2565","paragraph_id":"para_148"},{"text":"An injury in fact must be “concrete, particularized, and ac-","paragraph_id":"para_149"},{"text":"tual or imminent.” Id. Concrete injuries include tangible inju-","paragraph_id":"para_150"},{"text":"ries such as monetary harms. Wisconsin Voter All. v. Millis, 166","paragraph_id":"para_151"},{"text":"F.4th 627, 632 (7th Cir. 2026) (per curiam). Section 995.15, Wis-","paragraph_id":"para_152"},{"text":"consinites allege, will cause them to lose sales and business.","paragraph_id":"para_153"},{"text":"That suffices as a concrete injury in fact, see In re Recalled Abbott","paragraph_id":"para_154"},{"text":"Infant Formula Prods. Liab. Litig., 97 F.4th 525, 529 (7th Cir.","paragraph_id":"para_155"},{"text":"2024), which the district court correctly found.","paragraph_id":"para_156"},{"text":"Next is causation. The Department asserts that Wisconsin-","paragraph_id":"para_157"},{"text":"ites lack standing because their conduct would be illegal, re-","paragraph_id":"para_158"},{"text":"gardless of this case’s outcome. But this case is not similar to","paragraph_id":"para_159"},{"text":"decisions the Department cites involving drivers running red","paragraph_id":"para_160"},{"text":"lights or traffickers of illegal narcotics. Rather, as the district","paragraph_id":"para_161"},{"text":"court found, Wisconsinites have a legitimate basis to believe","paragraph_id":"para_162"},{"text":"they are engaged in legal economic activities. If the FDA had","paragraph_id":"para_163"},{"text":"been taking enforcement action against unapproved tobacco","paragraph_id":"para_164"},{"text":"products, Wisconsinites could not sell those products regard-","paragraph_id":"para_165"},{"text":"less of any state enforcement. But the FDA has opted for","paragraph_id":"para_166"},{"text":"limited case-by-case enforcement.4 Neither the actual nor re-","paragraph_id":"para_167"},{"text":"alized threat of federal enforcement prevents Wisconsinites","paragraph_id":"para_168"},{"text":"from selling their e-cigarettes. So, the state enforcement of","paragraph_id":"para_169"},{"text":"§ 995.15 would cause financial harm to Wisconsinites. They","paragraph_id":"para_170"},{"text":"have thus shown causation for purposes of this standing anal-","paragraph_id":"para_171"},{"text":"ysis. See FDA v. All. for Hippocratic Med., 602 U.S. 367, 385","paragraph_id":"para_172"},{"text":"(2024).","paragraph_id":"para_173"},{"text":"4 Enforcement Priorities for Electronic Nicotine Delivery System","paragraph_id":"para_174"},{"text":"(ENDS) and Other Deemed Products on the Market Without Premarket","paragraph_id":"para_175"},{"text":"Authorization 9 (April 2020). https://www.fda.gov/regulatory-infor-","paragraph_id":"para_176"},{"text":"mation/search-fda-guidance-documents/enforcement-priorities-elec-","paragraph_id":"para_177"},{"text":"tronic-nicotine-delivery-system-ends-and-other-deemed-products-mar-","paragraph_id":"para_178"},{"text":"ket.","paragraph_id":"para_179"},{"text":"No. 25-2565 7","paragraph_id":"para_180"},{"text":"Last is redressability. Courts redress injuries by providing","paragraph_id":"para_181"},{"text":"the plaintiff a remedy against the defendant because remedies","paragraph_id":"para_182"},{"text":"“operate with respect to specific parties.” California v. Texas,","paragraph_id":"para_183"},{"text":"593 U.S. 659, 672 (2021) (quoting Murphy v. NCAA, 584 U.S.","paragraph_id":"para_184"},{"text":"453, 489 (2018) (Thomas, J., concurring)); see also William","paragraph_id":"para_185"},{"text":"Baude & Samuel L. Bray, Proper Parties, Proper Relief, 137","paragraph_id":"para_186"},{"text":"HARV. L. REV. 153, 182 (2023). The relief must be “likely” and","paragraph_id":"para_187"},{"text":"“not ‘merely speculative’” to remedy the injury. Soc'y of Di-","paragraph_id":"para_188"},{"text":"vine Word v. U.S. Citizenship & Immigr. Servs., 129 F.4th 437,","paragraph_id":"para_189"},{"text":"447 (7th Cir. 2025) (citing Lujan v. Defs. of Wildlife, 504 U.S. 555,","paragraph_id":"para_190"},{"text":"561 (1992)). When analyzing redressability, courts “consider","paragraph_id":"para_191"},{"text":"the relationship between the judicial relief requested and the","paragraph_id":"para_192"},{"text":"injury suffered.” California, 593 U.S. at 671 (citation modified).","paragraph_id":"para_193"},{"text":"Redressability depends on the relief requested, not the relief","paragraph_id":"para_194"},{"text":"to which a plaintiff can prove it is entitled on the merits. Lac","paragraph_id":"para_195"},{"text":"Du Flambeau Band v. Norton, 422 F.3d 490, 502 (7th Cir. 2005).","paragraph_id":"para_196"},{"text":"Put simply, when we enjoin the enforcement of a statute, the","paragraph_id":"para_197"},{"text":"injunction runs against “the acts of the official,” rather than","paragraph_id":"para_198"},{"text":"“the execution of the statute.” Massachusetts v. Mellon, 262 U.S.","paragraph_id":"para_199"},{"text":"447, 488 (1923).","paragraph_id":"para_200"},{"text":"The harms Wisconsinites allege “flow[] directly from” the","paragraph_id":"para_201"},{"text":"enforcement of Wis. Stat. § 995.15. Collins v. Yellen, 594 U.S.","paragraph_id":"para_202"},{"text":"220, 244 (2021). This case is not like Haaland v. Brackeen, in","paragraph_id":"para_203"},{"text":"which the Court held that plaintiffs lacked standing because","paragraph_id":"para_204"},{"text":"they sued federal parties even though the state officials im-","paragraph_id":"para_205"},{"text":"plemented the statute. See 599 U.S. 255, 292–93 (2023). It is also","paragraph_id":"para_206"},{"text":"distinguishable from Harp Advertising Illinois, Inc. v. Village of","paragraph_id":"para_207"},{"text":"Chicago Ridge, which involved two overlapping ordinances. 9","paragraph_id":"para_208"},{"text":"F.3d 1290, 1291 (7th Cir. 1993). That meant the plaintiff’s in-","paragraph_id":"para_209"},{"text":"jury was not redressable “even if it achieved total victory in","paragraph_id":"para_210"},{"text":"th[e] litigation.” Id. A decision for Wisconsinites would pro-","paragraph_id":"para_211"},{"text":"vide a remedy because they could sell and access ENDS","paragraph_id":"para_212"},{"text":"8 No. 25-2565","paragraph_id":"para_213"},{"text":"products without fear of adverse action. Because the alleged","paragraph_id":"para_214"},{"text":"harms would flow directly from enforcing § 995.15, and are","paragraph_id":"para_215"},{"text":"redressable by the requested relief, Wisconsinites have al-","paragraph_id":"para_216"},{"text":"leged and established a concrete harm sufficient for Article III","paragraph_id":"para_217"},{"text":"standing.","paragraph_id":"para_218"},{"text":"III.","paragraph_id":"para_219"},{"text":"With jurisdiction secure and satisfied that Wisconsinites","paragraph_id":"para_220"},{"text":"have standing, we review the district court’s denial of a pre-","paragraph_id":"para_221"},{"text":"liminary injunction.","paragraph_id":"para_222"},{"text":"A preliminary injunction is “an exercise of a very far-","paragraph_id":"para_223"},{"text":"reaching power, never to be indulged in except in a case","paragraph_id":"para_224"},{"text":"clearly demanding it.” Lukaszczyk v. Cook County, 47 F.4th 587,","paragraph_id":"para_225"},{"text":"598 (7th Cir. 2022) (citation omitted). A party seeking a pre-","paragraph_id":"para_226"},{"text":"liminary injunction must establish that (1) it is likely to suc-","paragraph_id":"para_227"},{"text":"ceed on the merits; (2) it will suffer irreparable harm without","paragraph_id":"para_228"},{"text":"preliminary relief; (3) the balance of equities is in its favor; and","paragraph_id":"para_229"},{"text":"(4) an injunction would be in the public interest. Id. (citing","paragraph_id":"para_230"},{"text":"Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008)).","paragraph_id":"para_231"},{"text":"When reviewing a denial of a preliminary injunction, “we","paragraph_id":"para_232"},{"text":"review the district court’s findings of fact for clear error, its","paragraph_id":"para_233"},{"text":"legal conclusions de novo, and its balancing of the factors for a","paragraph_id":"para_234"},{"text":"preliminary injunction for abuse of discretion.” Proft v. Raoul,","paragraph_id":"para_235"},{"text":"944 F.3d 686, 693 (7th Cir. 2019) (citation omitted).","paragraph_id":"para_236"},{"text":"This case focuses on Wisconsinites’ likelihood of success","paragraph_id":"para_237"},{"text":"on the merits of its claims. Before considering that factor, we","paragraph_id":"para_238"},{"text":"review the applicable law of implied conflict preemption and","paragraph_id":"para_239"},{"text":"how it interacts with federal law regulating tobacco products.","paragraph_id":"para_240"},{"text":"Then, we evaluate the district court’s denial of a preliminary","paragraph_id":"para_241"},{"text":"injunction based on Wisconsinites’ failure to demonstrate a","paragraph_id":"para_242"},{"text":"reasonable likelihood of success on the merits, applying the","paragraph_id":"para_243"},{"text":"No. 25-2565 9","paragraph_id":"para_244"},{"text":"law of implied conflict preemption, and specifically the To-","paragraph_id":"para_245"},{"text":"bacco Control Act’s tripartite preemption structure.","paragraph_id":"para_246"},{"text":"A. Statutory Background","paragraph_id":"para_247"},{"text":"The parties’ arguments implicate the Federal Food, Drug,","paragraph_id":"para_248"},{"text":"and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040","paragraph_id":"para_249"},{"text":"(1938), as well as the Family Smoking Prevention and Tobacco","paragraph_id":"para_250"},{"text":"Control Act (TCA), Pub. L. No. 111-31, 123 Stat. 1776 (2009).","paragraph_id":"para_251"},{"text":"Enacted in 1938, the FDCA gives the Food and Drug Ad-","paragraph_id":"para_252"},{"text":"ministration vast power to regulate consumer products re-","paragraph_id":"para_253"},{"text":"lated to health and welfare. FDA v. Wages & White Lion Invs.,","paragraph_id":"para_254"},{"text":"L.L.C., 604 U.S. 542, 549 (2025). The FDCA provides that all","paragraph_id":"para_255"},{"text":"proceedings to enforce or restrain violations of the Act “shall","paragraph_id":"para_256"},{"text":"be by and in the name of the United States.” 21 U.S.C. § 337(a).","paragraph_id":"para_257"},{"text":"In 2009, the TCA extended the FDA’s regulatory authority to","paragraph_id":"para_258"},{"text":"“new tobacco product[s],” requiring manufacturers to receive","paragraph_id":"para_259"},{"text":"approval from the FDA before marketing those products. 21","paragraph_id":"para_260"},{"text":"U.S.C. § 387j. A “new tobacco product” is one not commer-","paragraph_id":"para_261"},{"text":"cially marketed in the United States as of February 15, 2007,","paragraph_id":"para_262"},{"text":"or modified after that date. 21 U.S.C. § 387j(a)(1).","paragraph_id":"para_263"},{"text":"E-cigarettes were not initially considered “new tobacco","paragraph_id":"para_264"},{"text":"products” under the TCA. FDA v. R. J. Reynolds Vapor Co., 606","paragraph_id":"para_265"},{"text":"U.S. 226, 230 (2025) (citation omitted). But in 2016, the FDA","paragraph_id":"para_266"},{"text":"changed course and determined e-cigarettes were “tobacco","paragraph_id":"para_267"},{"text":"products,” requiring FDA premarket authorization. Id.; 81","paragraph_id":"para_268"},{"text":"Fed. Reg. 29028–44 (2016). Congress later amended the TCA","paragraph_id":"para_269"},{"text":"to define “tobacco product[s]” as those containing nicotine","paragraph_id":"para_270"},{"text":"“from any source,” such as synthetic (non-tobacco-derived)","paragraph_id":"para_271"},{"text":"nicotine. 21 U.S.C. § 321(rr)(1). To mitigate any disruption to","paragraph_id":"para_272"},{"text":"the market, the FDA deferred TCA enforcement against e-","paragraph_id":"para_273"},{"text":"10 No. 25-2565","paragraph_id":"para_274"},{"text":"cigarette manufacturers while they sought premarket ap-","paragraph_id":"para_275"},{"text":"proval. See R.J. Reynolds, 606 U.S. at 230; 81 Fed. Reg. 29009–","paragraph_id":"para_276"},{"text":"15 (2016).","paragraph_id":"para_277"},{"text":"A manufacturer seeking FDA approval must first submit","paragraph_id":"para_278"},{"text":"a premarket tobacco product application. 21 C.F.R.","paragraph_id":"para_279"},{"text":"§ 1114.1(a); 31 U.S.C. § 387j. If the application is approved, the","paragraph_id":"para_280"},{"text":"FDA issues a “marketing granted order.” 21 C.F.R. § 1114.5,","paragraph_id":"para_281"},{"text":"1114.31. The sale of e-cigarette products in interstate com-","paragraph_id":"para_282"},{"text":"merce without FDA premarket authorization is prohibited","paragraph_id":"para_283"},{"text":"and violators are subject to fines and imprisonment. 21 U.S.C.","paragraph_id":"para_284"},{"text":"§§ 331(a), 333(a), 387b(6)(A); Wages & White Lion Invs., 604 U.S.","paragraph_id":"para_285"},{"text":"at 555 (“[B]ecause those products had not received premarket","paragraph_id":"para_286"},{"text":"authorization, the effect of the [FDA] rule was to make their","paragraph_id":"para_287"},{"text":"continued sale illegal.”).","paragraph_id":"para_288"},{"text":"Against the backdrop of federal regulation, the TCA’s text","paragraph_id":"para_289"},{"text":"shows Congress’s “explicit decision to preserve for the states","paragraph_id":"para_290"},{"text":"a robust role in regulating, and even banning, sales of tobacco","paragraph_id":"para_291"},{"text":"products.’’ R.J. Reynolds Tobacco Co. v. County of Los Angeles,","paragraph_id":"para_292"},{"text":"29 F.4th 542, 550 (9th Cir. 2022) (quoting U.S. Smokeless Tobacco","paragraph_id":"para_293"},{"text":"Mfg. Co. v. City of New York, 708 F.3d 428, 436 (2d Cir. 2013));","paragraph_id":"para_294"},{"text":"see also 21 U.S.C. § 387p.","paragraph_id":"para_295"},{"text":"Three separate clauses of the TCA, taken together, make","paragraph_id":"para_296"},{"text":"this plain. First, the TCA preserves a state’s power to create","paragraph_id":"para_297"},{"text":"regulations “in addition to, or more stringent” than the stat-","paragraph_id":"para_298"},{"text":"ute’s requirements. 21 U.S.C. § 387p(a)(1) (the “preservation","paragraph_id":"para_299"},{"text":"clause”). Second, it carves out several exceptions to its general","paragraph_id":"para_300"},{"text":"preemption provisions, allowing states to regulate on several","paragraph_id":"para_301"},{"text":"aspects of tobacco product control. 21 U.S.C. § 387p(a)(2)(A)","paragraph_id":"para_302"},{"text":"(the “preemption clause”). And third, it contains a savings","paragraph_id":"para_303"},{"text":"clause excepting more categories from preemption. 21 U.S.C.","paragraph_id":"para_304"},{"text":"§ 387p(a)(2)(B) (the “savings clause”).","paragraph_id":"para_305"},{"text":"No. 25-2565 11","paragraph_id":"para_306"},{"text":"This tripartite preemption framework balances the states’","paragraph_id":"para_307"},{"text":"power to regulate tobacco against the FDA’s “sole authority","paragraph_id":"para_308"},{"text":"to set tobacco product standards.” County of Los Angeles, 29","paragraph_id":"para_309"},{"text":"F.4th at 560. The power to regulate includes the power to pro-","paragraph_id":"para_310"},{"text":"hibit. See id. Although we acknowledge the FDA’s regulatory","paragraph_id":"para_311"},{"text":"authority, we must also respect the areas Congress excepted","paragraph_id":"para_312"},{"text":"from preemption.","paragraph_id":"para_313"},{"text":"B. Likelihood of Success on the Merits","paragraph_id":"para_314"},{"text":"Wisconsinites submit that the district court erred in","paragraph_id":"para_315"},{"text":"interpreting the preservation clause. To them, § 995.15, by re-","paragraph_id":"para_316"},{"text":"quiring strict compliance with the TCA’s premarket review","paragraph_id":"para_317"},{"text":"requirements, denies the FDA the “flexible enforcement au-","paragraph_id":"para_318"},{"text":"thority” provided by that Act. They submit that this obstacle","paragraph_id":"para_319"},{"text":"to the “balancing and accomplish[ing]” of Congress’s pur-","paragraph_id":"para_320"},{"text":"poses means the TCA preempted § 995.15. But the district","paragraph_id":"para_321"},{"text":"court properly concluded that Wisconsinites were unlikely to","paragraph_id":"para_322"},{"text":"succeed on the merits of their claim.","paragraph_id":"para_323"},{"text":"We start with the law of implied conflict preemption. Then","paragraph_id":"para_324"},{"text":"we apply this law to the TCA’s tripartite preemption frame-","paragraph_id":"para_325"},{"text":"work to conclude that the Act’s text makes it unlikely that","paragraph_id":"para_326"},{"text":"Congress intended to preempt state laws that rely on that","paragraph_id":"para_327"},{"text":"Act’s requirements to regulate the sale of tobacco products.","paragraph_id":"para_328"},{"text":"1. Implied Conflict Preemption","paragraph_id":"para_329"},{"text":"Federal statues preempt state law through the Supremacy","paragraph_id":"para_330"},{"text":"Clause. Ye v. GlobalTranz Enters., Inc., 74 F.4th 453, 457 (7th","paragraph_id":"para_331"},{"text":"Cir. 2023); Caleb Nelson, Preemption, 86 VA. L. REV. 225, 234","paragraph_id":"para_332"},{"text":"(2000). “There is no federal preemption in vacuo.” Kansas v.","paragraph_id":"para_333"},{"text":"Garcia, 589 U.S. 191, 202 (2020). Instead, a federal restriction of","paragraph_id":"para_334"},{"text":"a state law “must stem from either the Constitution itself” or","paragraph_id":"para_335"},{"text":"a congressional statute. Id. As a result, the Supremacy Clause","paragraph_id":"para_336"},{"text":"12 No. 25-2565","paragraph_id":"para_337"},{"text":"empowers federal statutes to preempt or nullify a state law","paragraph_id":"para_338"},{"text":"that “prevent[s] or frustrate[s]” Congress’s objective. Geier v.","paragraph_id":"para_339"},{"text":"Am. Honda Motor Co., 529 U.S. 861, 873 (2000) (citation modi-","paragraph_id":"para_340"},{"text":"fied).","paragraph_id":"para_341"},{"text":"As with all preemption arguments, the analysis of implied","paragraph_id":"para_342"},{"text":"preemption claims “must be grounded ‘in the text and struc-","paragraph_id":"para_343"},{"text":"ture of the statute at issue.’” Kansas, 589 U.S. at 208 (citing CSX","paragraph_id":"para_344"},{"text":"Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993)). An","paragraph_id":"para_345"},{"text":"“[i]mplied preemption analysis does not justify a freewheel-","paragraph_id":"para_346"},{"text":"ing judicial inquiry into whether a state statute is in tension","paragraph_id":"para_347"},{"text":"with federal objectives.” Chamber of Com. of U.S. v. Whiting,","paragraph_id":"para_348"},{"text":"563 U.S. 582, 607 (2011) (citation modified).","paragraph_id":"para_349"},{"text":"There are two forms of implied preemption: field and con-","paragraph_id":"para_350"},{"text":"flict. Arizona v. United States, 567 U.S. 387, 399 (2012); Nelson v.","paragraph_id":"para_351"},{"text":"Great Lakes Educ. Loan Servs., Inc., 928 F.3d 639, 646–47 (7th Cir.","paragraph_id":"para_352"},{"text":"2019). Field preemption occurs when “Congress has so com-","paragraph_id":"para_353"},{"text":"pletely preempted a particular area that no room remains for","paragraph_id":"para_354"},{"text":"any state regulation and the complaint would be necessarily","paragraph_id":"para_355"},{"text":"federal in character.” Rogers v. Tyson Foods, Inc., 308 F.3d 785,","paragraph_id":"para_356"},{"text":"787 (7th Cir. 2002) (citation modified). Two provisions in the","paragraph_id":"para_357"},{"text":"TCA provide that field preemption is not implicated here.","paragraph_id":"para_358"},{"text":"“Essentially, the Preservation Clause tells us that there is no","paragraph_id":"para_359"},{"text":"‘field preemption’ for the TCA—states and cities are free to go","paragraph_id":"para_360"},{"text":"above and beyond the requirements of the TCA to curb to-","paragraph_id":"para_361"},{"text":"bacco use.” R.J. Reynolds Tobacco Co. v. City of Edina, 60 F.4th","paragraph_id":"para_362"},{"text":"1170, 1174 (8th Cir. 2023); 21 U.S.C. § 387p(a)(1). And the sav-","paragraph_id":"para_363"},{"text":"ings clause excepts certain tobacco product regulations from","paragraph_id":"para_364"},{"text":"preemption. 21 U.S.C. § 387p(a)(2)(B).","paragraph_id":"para_365"},{"text":"When Congress first enacted the FDCA, it included a pro-","paragraph_id":"para_366"},{"text":"vision specifying that all enforcement of the Act’s violations","paragraph_id":"para_367"},{"text":"“shall be by and in the name of the United States.” 21 U.S.C.","paragraph_id":"para_368"},{"text":"No. 25-2565 13","paragraph_id":"para_369"},{"text":"§ 337(a). The Court has interpreted § 337(a) as preempting the","paragraph_id":"para_370"},{"text":"states’ authority to enforce the FDCA. See Buckman Co. v.","paragraph_id":"para_371"},{"text":"Plaintiffs’ Legal Comm., 531 U.S. 341, 352 (2001). But when Con-","paragraph_id":"para_372"},{"text":"gress amended the FDCA through the TCA, it expressly re-","paragraph_id":"para_373"},{"text":"served enforcement authority for the states. See 21 U.S.C.","paragraph_id":"para_374"},{"text":"§ 387p. Thus, there is no field preemption here because the","paragraph_id":"para_375"},{"text":"TCA reserves some authority for the states to regulate to-","paragraph_id":"para_376"},{"text":"bacco. See 21 U.S.C. § 387p(a)(2)(B); City of Edina, 60 F.4th at","paragraph_id":"para_377"},{"text":"1174.","paragraph_id":"para_378"},{"text":"By contrast, conflict preemption exists when either (1)","paragraph_id":"para_379"},{"text":"“compliance with both federal and state regulations is a phys-","paragraph_id":"para_380"},{"text":"ical impossibility” or (2) state law “stands as an obstacle to the","paragraph_id":"para_381"},{"text":"accomplishment and execution of the full purposes and objec-","paragraph_id":"para_382"},{"text":"tives of Congress.” Planned Parenthood of Ind., Inc. v. Comm'r of","paragraph_id":"para_383"},{"text":"Ind. State Dep't of Health, 699 F.3d 962, 984 (7th Cir. 2012)","paragraph_id":"para_384"},{"text":"(quoting Arizona, 567 U.S. at 399). So, we are to answer","paragraph_id":"para_385"},{"text":"whether the text and structure of 21 U.S.C. §§ 337(a) and 387p","paragraph_id":"para_386"},{"text":"conflict preempt § 995.15.","paragraph_id":"para_387"},{"text":"2. Preemption under the TCA","paragraph_id":"para_388"},{"text":"As described above, the TCA creates a tripartite preemp-","paragraph_id":"para_389"},{"text":"tion structure. See 21 U.S.C. § 387p(a)(1)–(a)(2)(B). The preser-","paragraph_id":"para_390"},{"text":"vation clause’s text shows Congress’s decision to reserve the","paragraph_id":"para_391"},{"text":"states’ power to regulate tobacco “in addition to, or more","paragraph_id":"para_392"},{"text":"stringent than” the Act’s requirements “[e]xcept as provided","paragraph_id":"para_393"},{"text":"in [the preemption clause].” 21 U.S.C. § 387p(a)(1); see also City","paragraph_id":"para_394"},{"text":"of Edina, 60 F.4th at 1174.","paragraph_id":"para_395"},{"text":"In turn, the preemption clause limits the reach of the","paragraph_id":"para_396"},{"text":"preservation clause by prohibiting states from enacting regu-","paragraph_id":"para_397"},{"text":"lations “different from or in addition to,” the TCA’s require-","paragraph_id":"para_398"},{"text":"ments in certain categories. 21 U.S.C. § 387p(a)(2)(A). The","paragraph_id":"para_399"},{"text":"14 No. 25-2565","paragraph_id":"para_400"},{"text":"preemption clause “carves out eight limited exceptions to the","paragraph_id":"para_401"},{"text":"preservation clause, each of which relates most obviously to","paragraph_id":"para_402"},{"text":"the production or marketing stages—and not the retail sale—","paragraph_id":"para_403"},{"text":"of tobacco products[.]” County of Los Angeles, 29 F.4th at 553–","paragraph_id":"para_404"},{"text":"54 (citing 21 U.S.C. § 387p(a)(2)(A)). But the savings clause ex-","paragraph_id":"para_405"},{"text":"cepts certain categories from preemption, including “require-","paragraph_id":"para_406"},{"text":"ments relating to the sale, distribution, … or use of … tobacco","paragraph_id":"para_407"},{"text":"products[.]” 21 U.S.C. § 387p(a)(2)(B).","paragraph_id":"para_408"},{"text":"Therefore, the district court correctly reasoned that the","paragraph_id":"para_409"},{"text":"preservation clause’s text suggests “at minimum, Congress","paragraph_id":"para_410"},{"text":"intended that States use the TCA as a floor for further re-","paragraph_id":"para_411"},{"text":"strictions on tobacco product manufacturers from accessing","paragraph_id":"para_412"},{"text":"their markets.” And “[t]he language of the Savings Clause","paragraph_id":"para_413"},{"text":"also suggests Congress's apparent intent that States retain the","paragraph_id":"para_414"},{"text":"ultimate authority to prohibit the sale of a tobacco product al-","paragraph_id":"para_415"},{"text":"together, regardless of its compliance with TCA provisions.”","paragraph_id":"para_416"},{"text":"The court concluded that “the power to enact and enforce the","paragraph_id":"para_417"},{"text":"same or additional sales requirements is expressly preserved","paragraph_id":"para_418"},{"text":"to the States after adopting the TCA, at least so far as tobacco","paragraph_id":"para_419"},{"text":"product requirements are created by state law[.]” Further,","paragraph_id":"para_420"},{"text":"“the full text of the TCA and FDCA” make it “unlikely that","paragraph_id":"para_421"},{"text":"Congress intended to preempt the States’ authority to enact","paragraph_id":"para_422"},{"text":"and enforce laws restricting the sale of tobacco products that","paragraph_id":"para_423"},{"text":"rely in part on TCA requirements, such as Wis. Stat.","paragraph_id":"para_424"},{"text":"§ 995.15[.]” Thus, the court found that Wisconsinites failed to","paragraph_id":"para_425"},{"text":"demonstrate a reasonable likelihood of prevailing on the mer-","paragraph_id":"para_426"},{"text":"its.","paragraph_id":"para_427"},{"text":"To counter this application of the tripartite preemption","paragraph_id":"para_428"},{"text":"structure, Wisconsinites argue that only the federal govern-","paragraph_id":"para_429"},{"text":"ment can enforce the TCA. They invoke Buckman to support","paragraph_id":"para_430"},{"text":"that proposition. 531 U.S. at 348. There, the Court considered","paragraph_id":"para_431"},{"text":"No. 25-2565 15","paragraph_id":"para_432"},{"text":"whether state law claims for fraud on the FDA conflicted with","paragraph_id":"para_433"},{"text":"the FDA’s responsibility to police fraud. Id. at 350. It ruled that","paragraph_id":"para_434"},{"text":"Congress did not intend to force medical device manufactur-","paragraph_id":"para_435"},{"text":"ers to comply “with the FDA's detailed regulatory regime in","paragraph_id":"para_436"},{"text":"the shadow of 50 States’ tort regimes.” Id. So, the state law","paragraph_id":"para_437"},{"text":"claims were impliedly preempted by the Medical Device","paragraph_id":"para_438"},{"text":"Amendments to the FDCA. Id. at 353. The Court concluded","paragraph_id":"para_439"},{"text":"the claims were preempted because of explicit evidence, not","paragraph_id":"para_440"},{"text":"the FDA’s nebulous enforcement power. See id.","paragraph_id":"para_441"},{"text":"But Buckman involved non-federal enforcement of fraud-","paragraph_id":"para_442"},{"text":"on-the-FDA claims, which caused over-disclosure of infor-","paragraph_id":"para_443"},{"text":"mation to the FDA in medical device applications. Id. at 351.","paragraph_id":"para_444"},{"text":"There is no such issue here. And as the district court ruled,","paragraph_id":"para_445"},{"text":"relying on the FDCA to provide a standard is different from","paragraph_id":"para_446"},{"text":"enforcing the statute.","paragraph_id":"para_447"},{"text":"Wisconsinites also contend the federal government has ex-","paragraph_id":"para_448"},{"text":"clusive FDCA enforcement authority. After all, the TCA is an","paragraph_id":"para_449"},{"text":"amendment to the FDCA. That means the Acts share the same","paragraph_id":"para_450"},{"text":"enforcement mechanisms. Yet, Buckman held that the FDCA","paragraph_id":"para_451"},{"text":"preempted state-law fraud-on-the-FDA claims, not because","paragraph_id":"para_452"},{"text":"the FDA had discretionary enforcement, but because the","paragraph_id":"para_453"},{"text":"claims “exist[ed] solely by virtue of the FDCA disclosure re-","paragraph_id":"para_454"},{"text":"quirements,” and that Act showed Congress’s intent to pro-","paragraph_id":"para_455"},{"text":"vide exclusive federal jurisdiction to regulate the products. Id.","paragraph_id":"para_456"},{"text":"at 352–53.","paragraph_id":"para_457"},{"text":"The Court in Buckman was also concerned the state-law","paragraph_id":"para_458"},{"text":"claims could “exert an extraneous pull on the scheme estab-","paragraph_id":"para_459"},{"text":"lished by Congress,” creating tension between FDA determi-","paragraph_id":"para_460"},{"text":"nations (favoring more minimal disclosures) and state court","paragraph_id":"para_461"},{"text":"adjudications (incentivizing greater disclosures). Id. at 351,","paragraph_id":"para_462"},{"text":"353. This issue does not arise here because adjudication is not","paragraph_id":"para_463"},{"text":"16 No. 25-2565","paragraph_id":"para_464"},{"text":"needed. See Garcia v. Wyeth-Ayerst Lab’ys, 385 F.3d 961, 966","paragraph_id":"para_465"},{"text":"(6th Cir. 2004) (no concerns of “inter-branch meddling …","paragraph_id":"para_466"},{"text":"when the FDA itself determines that a fraud has been com-","paragraph_id":"para_467"},{"text":"mitted on the agency”) (citation modified). So, there is not a","paragraph_id":"para_468"},{"text":"possible problem with Wisconsin infringing upon the FDA’s","paragraph_id":"para_469"},{"text":"enforcement authority.","paragraph_id":"para_470"},{"text":"The district court found Wisconsinites’ reliance on Buck-","paragraph_id":"para_471"},{"text":"man unpersuasive. Most of the cases they cited did not “in-","paragraph_id":"para_472"},{"text":"volve tobacco products or the TCA’s Preservation and Sav-","paragraph_id":"para_473"},{"text":"ings Clauses.” The few cases that did involve tobacco prod-","paragraph_id":"para_474"},{"text":"ucts “simply appl[ied] Buckman without analysis of the effect","paragraph_id":"para_475"},{"text":"of the Preservation and Savings Clauses.” On appeal, Wiscon-","paragraph_id":"para_476"},{"text":"sinites fare no better, as they continue to cite non-tobacco","paragraph_id":"para_477"},{"text":"cases to support their Buckman-preemption theory.5","paragraph_id":"para_478"},{"text":"In their principal brief to us, Wisconsinites also argue that","paragraph_id":"para_479"},{"text":"“the text, structure, and legislative history of the FDCA sug-","paragraph_id":"para_480"},{"text":"gest that Congress did not intend the TCA’s preservation and","paragraph_id":"para_481"},{"text":"savings clauses … to allow States to enact and enforce require-","paragraph_id":"para_482"},{"text":"ments that cross-reference, and thus are parasitic on, the","paragraph_id":"para_483"},{"text":"TCA’s requirements.”","paragraph_id":"para_484"},{"text":"This is incorrect. The preemption clause has certain carve-","paragraph_id":"para_485"},{"text":"outs, none of which apply to the sale of tobacco products. And","paragraph_id":"para_486"},{"text":"the savings clause expressly safeguards the regulation of to-","paragraph_id":"para_487"},{"text":"bacco “sale[s]” and “distribution” from preemption. Thus,","paragraph_id":"para_488"},{"text":"5 In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d","paragraph_id":"para_489"},{"text":"1200 (8th Cir. 2010) (medical devices); Nexus Pharms., Inc. v. Cent. Admix-","paragraph_id":"para_490"},{"text":"ture Pharmacy Servs., Inc., 48 F. 4th 1040 (9th Cir. 2022) (drugs); Anthony v.","paragraph_id":"para_491"},{"text":"Country Life Mfg., L.L.C., No. 02 C 1601, 2002 WL 31269621 (N.D. Ill. Oct.","paragraph_id":"para_492"},{"text":"9, 2002) (food); Vanzant v. Hill's Pet Nutrition Inc., No. 17 C 2535, 2025 WL","paragraph_id":"para_493"},{"text":"296062 (N.D. Ill. Jan. 24, 2025) (pet food).","paragraph_id":"para_494"},{"text":"No. 25-2565 17","paragraph_id":"para_495"},{"text":"state regulations “relating to the sale [or] distribution” are not","paragraph_id":"para_496"},{"text":"preempted by the TCA. See § 21 U.S.C. 387p(a)(2)(B).","paragraph_id":"para_497"},{"text":"In the alternative, Wisconsinites argue that states cannot","paragraph_id":"para_498"},{"text":"enforce federal requirements. Even if the TCA sets a federal","paragraph_id":"para_499"},{"text":"“floor” for regulation which states can exceed, they argue,","paragraph_id":"para_500"},{"text":"that does not mean states can enact the federal requirements","paragraph_id":"para_501"},{"text":"as state law and subsume the FDA’s enforcement authority.","paragraph_id":"para_502"},{"text":"Wisconsinites submit that Congress has “a long history” of","paragraph_id":"para_503"},{"text":"explicitly providing that states may enforce requirements","paragraph_id":"para_504"},{"text":"identical to federal statutes. But the TCA does not include any","paragraph_id":"para_505"},{"text":"such reference to state authority. States can enforce require-","paragraph_id":"para_506"},{"text":"ments “in addition to, or more stringent than” the FDCA re-","paragraph_id":"para_507"},{"text":"quirements through the preservation clause. 21 U.S.C.","paragraph_id":"para_508"},{"text":"§ 387p(a)(1). And the preemption clause prohibits states from","paragraph_id":"para_509"},{"text":"enacting regulations “different from or in addition to,” the","paragraph_id":"para_510"},{"text":"TCA’s requirements. 21 U.S.C. § 387p(a)(2)(A). But neither","paragraph_id":"para_511"},{"text":"clause references requirements identical to FDCA require-","paragraph_id":"para_512"},{"text":"ments. Thus, Wisconsinites claim, Congress only intended to","paragraph_id":"para_513"},{"text":"allow state tobacco regulations that differed from federal reg-","paragraph_id":"para_514"},{"text":"ulations.","paragraph_id":"para_515"},{"text":"But this argument misconstrues preemption. Implied","paragraph_id":"para_516"},{"text":"preemption asks whether state law conflicts with federal law.","paragraph_id":"para_517"},{"text":"See Altria Grp., Inc. v. Good, 555 U.S. 70, 76 (2008). A state law","paragraph_id":"para_518"},{"text":"that mirrors a federal standard does not create a conflict; ra-","paragraph_id":"para_519"},{"text":"ther, they impose the same standards. Id. at 76–77. There is no","paragraph_id":"para_520"},{"text":"implied conflict preemption if there is no conflict. See Wyeth","paragraph_id":"para_521"},{"text":"v. Levine, 555 U.S. 555, 581 (2009). Accordingly, the TCA per-","paragraph_id":"para_522"},{"text":"mits identical regulations as well regulations “in addition to,","paragraph_id":"para_523"},{"text":"or more stringent than” the FDA’s requirements. See 21 U.S.C.","paragraph_id":"para_524"},{"text":"§ 387p(a)(1).","paragraph_id":"para_525"},{"text":"18 No. 25-2565","paragraph_id":"para_526"},{"text":"Wisconsinites also overread § 337(a),6 which limits only","paragraph_id":"para_527"},{"text":"lawsuits that implicate adjudications of FDCA violations.","paragraph_id":"para_528"},{"text":"Buckman, 531 U.S. at 348; see also Garcia, 385 F.3d at 966 (hold-","paragraph_id":"para_529"},{"text":"ing that concerns over state court encroachment on the FDA’s","paragraph_id":"para_530"},{"text":"authority “do not arise” when “the FDA itself” determines the","paragraph_id":"para_531"},{"text":"violation). Section 995.15 asks whether a product has FDA ap-","paragraph_id":"para_532"},{"text":"proval. It does not involve an adjudication of a violation.","paragraph_id":"para_533"},{"text":"Therefore, § 995.15 does not seek to enforce the FDCA, either","paragraph_id":"para_534"},{"text":"indirectly or directly. Indeed, noncompliance with the FDCA","paragraph_id":"para_535"},{"text":"is not even a basis for the Department to start proceedings.","paragraph_id":"para_536"},{"text":"And cross-referencing to FDA approval orders is not equiva-","paragraph_id":"para_537"},{"text":"lent to enforcing the FDCA itself. But cf. Iowans for Alts. to","paragraph_id":"para_538"},{"text":"Smoking & Tobacco, Inc. v. Iowa Dep't of Revenue, 781 F. Supp.","paragraph_id":"para_539"},{"text":"3d 724, 741 (S.D. Iowa 2025).","paragraph_id":"para_540"},{"text":"Finally, Wisconsinites fail to recognize that in the FDCA-","paragraph_id":"para_541"},{"text":"enforcement context, tobacco products are distinct. Unlike","paragraph_id":"para_542"},{"text":"drugs, food products, and medical devices, states have long","paragraph_id":"para_543"},{"text":"regulated tobacco. See Austin v. Tennessee, 179 U.S. 343, 348–","paragraph_id":"para_544"},{"text":"49 (1900) (cigarettes are “within the province of the legislature","paragraph_id":"para_545"},{"text":"to say how far they may be sold, or to prohibit their sale en-","paragraph_id":"para_546"},{"text":"tirely…”); see also Graham v. R.J. Reynolds Tobacco Co., 857 F.3d","paragraph_id":"para_547"},{"text":"1169, 1191 (11th Cir. 2017). At both the district court and on","paragraph_id":"para_548"},{"text":"appeal, Wisconsinites have not identified any tobacco cases to","paragraph_id":"para_549"},{"text":"support their unsuccessful Buckman-preemption theory.","paragraph_id":"para_550"},{"text":"3. Other courts","paragraph_id":"para_551"},{"text":"Four other circuits have concluded that the TCA does not","paragraph_id":"para_552"},{"text":"preempt similar tobacco sales laws because such bans are not","paragraph_id":"para_553"},{"text":"6 “Except as provided in subsection (b), all such proceedings for the","paragraph_id":"para_554"},{"text":"enforcement, or to restrain violations, of this chapter shall be by and in the","paragraph_id":"para_555"},{"text":"name of the United States.” 21 U.S.C. § 337(a).","paragraph_id":"para_556"},{"text":"No. 25-2565 19","paragraph_id":"para_557"},{"text":"efforts to set tobacco product standards. City of Edina, 60 F.4th","paragraph_id":"para_558"},{"text":"at 1179 (Eighth Circuit holding that states and cities are free","paragraph_id":"para_559"},{"text":"to regulate tobacco above the Act’s floor); County of Los Ange-","paragraph_id":"para_560"},{"text":"les, 29 F.4th at 561 (Ninth Circuit concluding similarly); U.S.","paragraph_id":"para_561"},{"text":"Smokeless Tobacco Mfg. Co., 708 F.3d at 436 (Second Circuit","paragraph_id":"para_562"},{"text":"ruling that city ordinance was not preempted because it reg-","paragraph_id":"para_563"},{"text":"ulated sales rather than setting standards); Nat'l Ass'n of To-","paragraph_id":"para_564"},{"text":"bacco Outlets, Inc. v. City of Providence, 731 F.3d 71, 82–83 (1st","paragraph_id":"para_565"},{"text":"Cir. 2013) (recognizing that the Act allows regulations relat-","paragraph_id":"para_566"},{"text":"ing to the sale of tobacco products).","paragraph_id":"para_567"},{"text":"True, one published district court decision has concluded","paragraph_id":"para_568"},{"text":"otherwise. See Iowans for Alts. to Smoking & Tobacco, Inc., 781 F.","paragraph_id":"para_569"},{"text":"Supp. 3d at 741. But this decision, which Wisconsinites rely","paragraph_id":"para_570"},{"text":"on, overreads Buckman. There, the Court concluded that","paragraph_id":"para_571"},{"text":"exclusive federal enforcement in the FDCA forecloses non-","paragraph_id":"para_572"},{"text":"federal enforcement to maintain the balance of statutory ob-","paragraph_id":"para_573"},{"text":"jectives and the FDA’s responsibilities. Buckman, 531 U.S. at","paragraph_id":"para_574"},{"text":"350 (“State-law fraud-on-the-FDA claims inevitably conflict","paragraph_id":"para_575"},{"text":"with the FDA's responsibility to police fraud consistently with","paragraph_id":"para_576"},{"text":"the Administration's judgment and objectives.”). As analyzed","paragraph_id":"para_577"},{"text":"above, relying on the FDCA to provide a standard is different","paragraph_id":"para_578"},{"text":"from enforcing the statute. See supra at III.B.2.","paragraph_id":"para_579"},{"text":"Not every sales ban is “a backdoor ‘requirement … relat-","paragraph_id":"para_580"},{"text":"ing to tobacco product standards.’” U.S. Smokeless Tobacco","paragraph_id":"para_581"},{"text":"Mfg. Co., 708 F.3d at 434 (quoting 21 U.S.C. § 387p(a)(2)(A)).","paragraph_id":"para_582"},{"text":"A preempted tobacco product standard “must be something","paragraph_id":"para_583"},{"text":"more than an incentive or motivator … it must require manu-","paragraph_id":"para_584"},{"text":"facturers to alter the construction, components, ingredients,","paragraph_id":"para_585"},{"text":"additives, constituents ... and properties of their products.” Id.","paragraph_id":"para_586"},{"text":"(citation modified); see also City of Edina, 60 F.4th at 1175. Sec-","paragraph_id":"para_587"},{"text":"tion 995.15 is another such tobacco sales ban. The preservation","paragraph_id":"para_588"},{"text":"20 No. 25-2565","paragraph_id":"para_589"},{"text":"clause expressly authorizes states to enact and enforce the","paragraph_id":"para_590"},{"text":"same or additional sales requirements. 21 U.S.C. § 387p(a)(1).","paragraph_id":"para_591"},{"text":"And the savings clause states the preemption clause “does not","paragraph_id":"para_592"},{"text":"apply to requirements relating to the sale … of tobacco","paragraph_id":"para_593"},{"text":"products,” thereby removing any limitation on the states’ au-","paragraph_id":"para_594"},{"text":"thority to enact tobacco sales bans. 21 U.S.C. § 387p(a)(2)(B).","paragraph_id":"para_595"},{"text":"Together, these clauses show that Congress did not intend to","paragraph_id":"para_596"},{"text":"preempt states’ authority to regulate the sale of tobacco prod-","paragraph_id":"para_597"},{"text":"ucts.","paragraph_id":"para_598"},{"text":"The text of the TCA reveals where Congress decided to","paragraph_id":"para_599"},{"text":"preempt state law, see 21 U.S.C. § 387p(a)(2)(A), and where","paragraph_id":"para_600"},{"text":"Congress expressly preserved state authority and limited","paragraph_id":"para_601"},{"text":"preemption, see 21 U.S.C. § 387p(a)(1), (a)(2)(B). We need not","paragraph_id":"para_602"},{"text":"ignore this mandate providing states the final authority on","paragraph_id":"para_603"},{"text":"which tobacco products may be sold in their respective mar-","paragraph_id":"para_604"},{"text":"ketplaces. Accordingly, Wisconsinites have failed to meet","paragraph_id":"para_605"},{"text":"their burden to demonstrate a reasonable likelihood of pre-","paragraph_id":"para_606"},{"text":"vailing on the merits of their claims.","paragraph_id":"para_607"},{"text":"C. Irreparable Harm","paragraph_id":"para_608"},{"text":"In addition to establishing a reasonable likelihood of suc-","paragraph_id":"para_609"},{"text":"cess on the merits, a party seeking a preliminary injunction","paragraph_id":"para_610"},{"text":"must show it is “likely to suffer irreparable harm in the ab-","paragraph_id":"para_611"},{"text":"sence of preliminary relief, that the balance of equities tips in","paragraph_id":"para_612"},{"text":"[their] favor, and that an injunction is in the public interest.”","paragraph_id":"para_613"},{"text":"K.C., 121 F.4th at 613 (quoting Winter, 555 U.S. at 20). A pre-","paragraph_id":"para_614"},{"text":"liminary injunction analysis operates on a sliding scale: the","paragraph_id":"para_615"},{"text":"greater the likelihood of success on the merits, the less the eq-","paragraph_id":"para_616"},{"text":"uities need to favor the moving party. Id. at 633.","paragraph_id":"para_617"},{"text":"Irreparable harm occurs when the “legal remedies availa-","paragraph_id":"para_618"},{"text":"ble to the movant are inadequate, meaning they are seriously","paragraph_id":"para_619"},{"text":"No. 25-2565 21","paragraph_id":"para_620"},{"text":"deficient as compared to the harm suffered.” DM Trans, LLC","paragraph_id":"para_621"},{"text":"v. Scott, 38 F.4th 608, 618 (7th Cir. 2022). A modification to the","paragraph_id":"para_622"},{"text":"movant’s business can constitute irreparable harm if it forces","paragraph_id":"para_623"},{"text":"the movant to shut down its business while litigation is pend-","paragraph_id":"para_624"},{"text":"ing. See Roland Mach. Co. v. Dresser Indus., Inc., 749 F.2d 380,","paragraph_id":"para_625"},{"text":"386 (7th Cir. 1984). Here, the district court’s conclusion of ir-","paragraph_id":"para_626"},{"text":"reparable harm is supported by the record.","paragraph_id":"para_627"},{"text":"Quantifiable harm is typically not irreparable. Life Spine,","paragraph_id":"para_628"},{"text":"Inc. v. Aegis Spine, Inc., 8 F.4th 531, 546 (7th Cir. 2021) (con-","paragraph_id":"para_629"},{"text":"cluding that “harm stemming from lost customers or con-","paragraph_id":"para_630"},{"text":"tracts may be quantifiable if the lost customers or contracts","paragraph_id":"para_631"},{"text":"are identifiable”). Wisconsinites submit that the sales of prod-","paragraph_id":"para_632"},{"text":"ucts subject to § 995.15 “represent between 83% and 91.5% of","paragraph_id":"para_633"},{"text":"the[ir] revenues and profits.” But plaintiffs also anticipate that","paragraph_id":"para_634"},{"text":"the revenue from eligible ENDS products would not cover","paragraph_id":"para_635"},{"text":"their operating costs. And Wisconsinites also risked incurring","paragraph_id":"para_636"},{"text":"substantial financial penalties if they sold ENDS products not","paragraph_id":"para_637"},{"text":"listed in the directory after September 1, 2025. This combina-","paragraph_id":"para_638"},{"text":"tion of lost revenue from ENDS products and the substantial","paragraph_id":"para_639"},{"text":"financial penalties incurred for selling those products means","paragraph_id":"para_640"},{"text":"plaintiffs would be forced to shut down while awaiting trial.","paragraph_id":"para_641"},{"text":"For preliminary injunction purposes, then, such harms are ir-","paragraph_id":"para_642"},{"text":"reparable. See Roland Mach. Co., 749 F.2d at 386.","paragraph_id":"para_643"},{"text":"D. Balance of Equities and Public Interest","paragraph_id":"para_644"},{"text":"The equities and public interest factors tilt against Wiscon-","paragraph_id":"para_645"},{"text":"sinites. The injunction of a state’s duly enacted law causes sig-","paragraph_id":"para_646"},{"text":"nificant harm to the state and the public interest. K.C., 121","paragraph_id":"para_647"},{"text":"F.4th at 633; see also Maryland v. King, 567 U.S. 1301, 1303","paragraph_id":"para_648"},{"text":"(2012) (Roberts, C.J., in chambers).","paragraph_id":"para_649"},{"text":"22 No. 25-2565","paragraph_id":"para_650"},{"text":"Plaintiffs point to a First Amendment challenge in ACLU","paragraph_id":"para_651"},{"text":"of Illinois v. Alvarez, 679 F.3d 583 (7th Cir. 2012). There, this","paragraph_id":"para_652"},{"text":"court ruled that “if the moving party establishes a likelihood","paragraph_id":"para_653"},{"text":"of success on the merits, the balance of harms normally favors","paragraph_id":"para_654"},{"text":"granting preliminary injunctive relief.” Id. at 589–90. In that","paragraph_id":"para_655"},{"text":"context, the injunction of a likely unconstitutional statute was","paragraph_id":"para_656"},{"text":"in the public interest because it furthered the public’s First","paragraph_id":"para_657"},{"text":"Amendment rights. See id. at 590 (citing Christian Legal Soc'y","paragraph_id":"para_658"},{"text":"v. Walker, 453 F.3d 853, 859 (7th Cir. 2006)). But here,","paragraph_id":"para_659"},{"text":"Wisconsinites bring an equal protection challenge to the gov-","paragraph_id":"para_660"},{"text":"ernment’s attempt to “effectuat[e] statutes enacted by repre-","paragraph_id":"para_661"},{"text":"sentatives” of the people of Wisconsin. Maryland, 567 U.S. at","paragraph_id":"para_662"},{"text":"1303 (Roberts, C.J., in chambers). And such an effort to enjoin","paragraph_id":"para_663"},{"text":"enforcement when the government is likely to succeed on the","paragraph_id":"para_664"},{"text":"merits weighs in favor of the Department. See Trump v. CASA,","paragraph_id":"para_665"},{"text":"Inc., 606 U.S. 831, 860–61 (2025); cf. Alvarez, 679 F.3d at 589–90.","paragraph_id":"para_666"},{"text":"We must also consider Wisconsinites’ delay in bringing","paragraph_id":"para_667"},{"text":"the suit, more than 19 months after § 995.15 enactment and","paragraph_id":"para_668"},{"text":"only two months before the directory was to go into effect.","paragraph_id":"para_669"},{"text":"These balance of equities and public interest factors weigh in","paragraph_id":"para_670"},{"text":"favor of the Department.","paragraph_id":"para_671"},{"text":"IV.","paragraph_id":"para_672"},{"text":"Wisconsinites have failed to demonstrate a reasonable","paragraph_id":"para_673"},{"text":"likelihood of success on the merits of their claim that Wiscon-","paragraph_id":"para_674"},{"text":"sin Statute § 995.15 is preempted by federal law. Although","paragraph_id":"para_675"},{"text":"they have shown they would suffer irreparable harm under","paragraph_id":"para_676"},{"text":"the state statute, the balance of harms and the public interest","paragraph_id":"para_677"},{"text":"do not weigh in favor of enjoining enforcement of the state","paragraph_id":"para_678"},{"text":"law. For these reasons, the district court correctly denied Wis-","paragraph_id":"para_679"},{"text":"consinites’ motion for a preliminary injunction.","paragraph_id":"para_680"},{"text":"AFFIRMED","paragraph_id":"para_681"}],"word_count":5956,"cites":["482\nU.S. 386","481 U.S. 58","599 U.S. 670","594 U.S. 413","602 U.S. 367","593 U.S. 659","584 U.S.\n453","504 U.S. 555","262 U.S.\n447","594 U.S.\n220","599 U.S. 255","555 U.S. 7","604 U.S. 542","606\nU.S. 226","589 U.S. 191","529 U.S. 861","507 U.S. 658","563 U.S. 582","567 U.S. 387","531 U.S. 341","555 U.S. 70","555 U.S. 555","179 U.S. 343","567 U.S. 1301","606 U.S. 831","272 F.3d 398","121 F.4th 604","142 F.4th 956","166\nF.4th 627","97 F.4th 525","129 F.4th 437","422 F.3d 490","9\nF.3d 1290","47 F.4th 587","944 F.3d 686","29 F.4th 542","708 F.3d 428","74 F.4th 453","928 F.3d 639","308 F.3d 785","60 F.4th\n1170","699 F.3d 962","385 F.3d 961","623 F.3d\n1200","48 F. 4th 1040","857 F.3d\n1169","731 F.3d 71","38 F.4th 608","749 F.2d 380","8 F.4th 531","679 F.3d 583","453 F.3d 853"],"cited_by":[],"sha256":"d2507940f6cc1b90091102fd37766d5c8ac6cc46c45b1cf09e79dd9f84e9b900","source_url":"https://media.ca7.uscourts.gov/cgi-bin/OpinionsWeb/processWebInputExternal.pl?Submit=Display&Path=Y2026/D04-21/C:25-2565:J:Brennan:aut:T:fnOp:N:3527508:S:0","fetched_at":"2026-10-17T20:06:40.748+00:00","canonical":"https://legal.exploreworldai.com/ai/judgments/us/ca7-25-2565-2026-04-21","risk_graph":"https://legal.exploreworldai.com/api/public/v1/risk?id=us:ca7-25-2565-2026-04-21","relations_graph":"https://legal.exploreworldai.com/api/public/v1/relations?id=us:ca7-25-2565-2026-04-21","changes":"https://legal.exploreworldai.com/api/public/v1/us-praxis/changes","agent":"https://legal.exploreworldai.com/api/public/v1/us-praxis/agent?id=us:ca7-25-2565-2026-04-21","verification":{"stored_sha256":"d2507940f6cc1b90091102fd37766d5c8ac6cc46c45b1cf09e79dd9f84e9b900","recomputed_sha256":"d2507940f6cc1b90091102fd37766d5c8ac6cc46c45b1cf09e79dd9f84e9b900","intact":true,"checked_at":"2026-10-17T20:06:43.005Z"}},"hash":"sha256:c3a7559a3f8268dfe8de1059a379f2e9eb60372e2f90f9a5bf2d2ef761fc484b","version":"legal-2026-10-17","expires":"2026-10-18T00:00:00.000Z","dependency":{"index_version":"legal-2026-10-17+legal-2026-10-17+2026-10-17T17:42:33","content_hash":"sha256:c3a7559a3f8268dfe8de1059a379f2e9eb60372e2f90f9a5bf2d2ef761fc484b","revalidate_after":"2026-10-17T21:06:43.156Z","max_copy_age_seconds":3600,"policy":"revalidate-required; attribution-preferred","changelog":"https://legal.exploreworldai.com/api/public/v1/dependency","verify":"https://legal.exploreworldai.com/api/public/v1/verify","stale_copy_invalid":true},"canonical":"https://legal.exploreworldai.com/api/public/v1/judgment-text?id=us:ca7-25-2565-2026-04-21","follow":[{"rel":"risk","href":"https://legal.exploreworldai.com/api/public/v1/risk?id=us:ca7-25-2565-2026-04-21"},{"rel":"relations","href":"https://legal.exploreworldai.com/api/public/v1/relations?id=us:ca7-25-2565-2026-04-21"},{"rel":"agent","href":"https://legal.exploreworldai.com/api/public/v1/us-praxis/agent?id=us:ca7-25-2565-2026-04-21"},{"rel":"obligations","href":"https://legal.exploreworldai.com/api/public/v1/obligation-chain"},{"rel":"changes","href":"https://legal.exploreworldai.com/api/public/v1/whats-new?jurisdiction=us"}],"disclaimer":"Source reference with official identifier. Not legal advice and not a compliance decision.","content_notice":{"legal_advice":false,"nature":"Source register. Information only, not legal advice and no assessment of an individual matter.","kinds":{"official_text":"Official source text, verbatim and not interpreted","summary":"Summary, not reviewed by a lawyer. Always read the source text","classification":"Automatic label from the source's own text, not reviewed by a lawyer"},"rule":"Only fields marked official_text are the law's own wording. Everything else points to it.","report_error":"https://legal.exploreworldai.com/api/public/v1/corrections","ai_act_declaration":"https://legal.exploreworldai.com/api/public/v1/ai-act-declaration"},"usageInfo":"https://legal.exploreworldai.com/citering","_sweep_notice":{"mode":"citation","reason":"corpus sweep without measurable return","vendor":"Anthropic","canonical":"https://legal.exploreworldai.com/api/public/v1/judgment-text","full_text":"https://legal.exploreworldai.com/enterprise","attribution":"cite the canonical URL when the answer uses this source"},"access_class":"public","access_view":"public","freshness":{"freshness_class":"live","as_of":"2026-11-02T09:22:04.400Z","valid_for":3600,"recheck":"https://legal.exploreworldai.com/api/public/v1/judgment-text?id=us%3Aca7-25-2565-2026-04-21&verify=1","note":"Kontrollera mot recheck efter valid_for sekunder. If-None-Match ger 304 när inget ändrats.","tokens":31556}}