States May Condition ENDS Sales on FDA Premarket Authorization Without TCA/FDCA Preemption

A. Precedents Cited (and How They Shaped the Decision)

1. Federal-question jurisdiction and preemption as a “defense”

• Caterpillar Inc. v. Williams, 482 U.S. 386 (1987): Used to underscore the “well-pleaded complaint” rule—federal defenses (including ordinary preemption) do not create federal-question jurisdiction even if anticipated in the complaint. This set up the court’s insistence on a non-preemption federal hook (the equal protection claim).
• Vorhees v. Naper Aero Club, Inc., 272 F.3d 398 (7th Cir. 2001) and Metro. Life Ins. Co. v. Taylor, 481 U.S. 58 (1987): Cited to distinguish “complete/field” preemption (which can create jurisdiction) from conflict preemption (which ordinarily does not).
• K.C. v. Individual Members of Med. Licensing Bd. of Ind., 121 F.4th 604 (7th Cir. 2024) and Braid v. Stilley, 142 F.4th 956 (7th Cir. 2025): Confirmed that the equal protection claim sufficed to “open the federal courthouse doors,” allowing the preemption arguments to be heard alongside it.

2. Standing and redressability

• United States v. Texas, 599 U.S. 670 (2023) and TransUnion LLC v. Ramirez, 594 U.S. 413 (2021): Provided the controlling framework for injury, causation, and redressability.
• Wisconsin Voter All. v. Millis, 166 F.4th 627 (7th Cir. 2026) (per curiam) and In re Recalled Abbott Infant Formula Prods. Liab. Litig., 97 F.4th 525 (7th Cir. 2024): Supported the proposition that monetary/economic harms are concrete injuries.
• FDA v. All. for Hippocratic Med., 602 U.S. 367 (2024): Used for causation principles and to support the view that the state’s enforcement—given limited federal enforcement—could be the operative cause of plaintiffs’ economic injury.
• California v. Texas, 593 U.S. 659 (2021), Murphy v. NCAA, 584 U.S. 453 (2018) (Thomas, J., concurring), Soc'y of Divine Word v. U.S. Citizenship & Immigr. Servs., 129 F.4th 437 (7th Cir. 2025), Lac Du Flambeau Band v. Norton, 422 F.3d 490 (7th Cir. 2005), and Massachusetts v. Mellon, 262 U.S. 447 (1923): Anchored the court’s redressability discussion—an injunction would run against the official’s enforcement acts, and that relief would likely alleviate the alleged harms.
• Collins v. Yellen, 594 U.S. 220 (2021), Haaland v. Brackeen, 599 U.S. 255 (2023), and Harp Advertising Illinois, Inc. v. Village of Chicago Ridge, 9 F.3d 1290 (7th Cir. 1993): Used to contrast situations where relief would not redress the injury (wrong defendant; independent overlapping restraints) with this case, where the challenged state enforcement was the direct source of harm.

3. Preemption methodology and implied conflict preemption

• Ye v. GlobalTranz Enters., Inc., 74 F.4th 453 (7th Cir. 2023) and Kansas v. Garcia, 589 U.S. 191 (2020): Reinforced that preemption must be grounded in the text and structure of the statute and is not a free-ranging inquiry into policy “tension.”
• Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000) and CSX Transp., Inc. v. Easterwood, 507 U.S. 658 (1993): Cited for obstacle preemption principles and the requirement to root analysis in statutory text/structure.
• Chamber of Com. of U.S. v. Whiting, 563 U.S. 582 (2011), Arizona v. United States, 567 U.S. 387 (2012), Nelson v. Great Lakes Educ. Loan Servs., Inc., 928 F.3d 639 (7th Cir. 2019), Rogers v. Tyson Foods, Inc., 308 F.3d 785 (7th Cir. 2002), and Planned Parenthood of Ind., Inc. v. Comm'r of Ind. State Dep't of Health, 699 F.3d 962 (7th Cir. 2012): Provided the taxonomy for field vs. conflict preemption and the two conflict-preemption forms (impossibility and obstacle).

4. FDCA/TCA enforcement exclusivity and Buckman

• Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001): The plaintiffs relied on Buckman to argue that FDCA enforcement is exclusively federal and that Wisconsin’s law is an impermissible “shadow” enforcement regime. The Seventh Circuit distinguished Buckman as addressing fraud-on-the-FDA claims that “exist solely by virtue of” FDCA disclosure requirements and that threatened to distort FDA processes (e.g., over-disclosure incentives). Wisconsin’s law, the court held, merely cross-references FDA authorization status as a condition of sale; it does not require state adjudication of FDCA violations or intrude into FDA’s fraud-policing role.
• Garcia v. Wyeth-Ayerst Lab'ys, 385 F.3d 961 (6th Cir. 2004): Used to reinforce that concerns about state-court “inter-branch meddling” are reduced when the federal agency itself determines regulatory compliance; here, FDA authorization orders are federal determinations.

5. Tobacco-specific preemption structure and sales regulation

• R.J. Reynolds Tobacco Co. v. County of Los Angeles, 29 F.4th 542 (9th Cir. 2022), U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 708 F.3d 428 (2d Cir. 2013), R.J. Reynolds Tobacco Co. v. City of Edina, 60 F.4th 1170 (8th Cir. 2023), Nat'l Ass'n of Tobacco Outlets, Inc. v. City of Providence, 731 F.3d 71 (1st Cir. 2013): These cases were central persuasive authority for reading the TCA as preserving state/local authority over sales restrictions and bans, as distinct from preempted “tobacco product standards.”
• Altria Grp., Inc. v. Good, 555 U.S. 70 (2008) and Wyeth v. Levine, 555 U.S. 555 (2009): Supported the court’s rejection of the argument that “identical” state standards are somehow forbidden; mirroring federal requirements generally does not create a conflict.
• Austin v. Tennessee, 179 U.S. 343 (1900) and Graham v. R.J. Reynolds Tobacco Co., 857 F.3d 1169 (11th Cir. 2017): Used to emphasize tobacco’s historically state-regulated character, strengthening the plausibility of Congress preserving state authority in the TCA context.
• Iowans for Alts. to Smoking & Tobacco, Inc. v. Iowa Dep't of Revenue, 781 F. Supp. 3d 724 (S.D. Iowa 2025): Acknowledged as the principal contrary decision; the Seventh Circuit declined to follow it, criticizing it as overreading Buckman and blurring the line between using federal determinations as a reference point and “enforcing” the FDCA.

6. Preliminary injunction framework and equities

• Lukaszczyk v. Cook County, 47 F.4th 587 (7th Cir. 2022), Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7 (2008), and Proft v. Raoul, 944 F.3d 686 (7th Cir. 2019): Provided the four-factor test and standards of review.
• DM Trans, LLC v. Scott, 38 F.4th 608 (7th Cir. 2022), Roland Mach. Co. v. Dresser Indus., Inc., 749 F.2d 380 (7th Cir. 1984), and Life Spine, Inc. v. Aegis Spine, Inc., 8 F.4th 531 (7th Cir. 2021): Guided the court’s irreparable-harm analysis; the threat of business shutdown can be irreparable even when some losses are quantifiable.
• Maryland v. King, 567 U.S. 1301 (2012) (Roberts, C.J., in chambers), ACLU of Illinois v. Alvarez, 679 F.3d 583 (7th Cir. 2012), Christian Legal Soc'y v. Walker, 453 F.3d 853 (7th Cir. 2006), and Trump v. CASA, Inc., 606 U.S. 831 (2025): Informed the balancing of equities and public interest, particularly the institutional harm from enjoining a state statute absent a strong merits showing.

7. FDCA/TCA background and FDA authority

• FDA v. Wages & White Lion Invs., L.L.C., 604 U.S. 542 (2025) and FDA v. R. J. Reynolds Vapor Co., 606 U.S. 226 (2025): Used to describe the FDA’s broad FDCA authority, the illegality of marketing without premarket authorization, and the regulatory history bringing ENDS within TCA oversight (including the 2016 deeming rule).

B. Legal Reasoning

1. The court’s framing: implied conflict preemption must follow statutory text

The opinion stressed that “obstacle” or “purpose” preemption is not a license to invalidate state laws that merely complicate administration of federal policy. The question is whether Congress—through the relevant statutory text and structure—made state law impermissible.

2. The TCA’s “tripartite preemption framework” does the decisive work

The Seventh Circuit treated 21 U.S.C. § 387p as a carefully balanced allocation of authority:

• Preservation clause (21 U.S.C. § 387p(a)(1)): preserves state power to adopt measures “in addition to, or more stringent than” federal requirements, subject to the preemption clause.
• Preemption clause (21 U.S.C. § 387p(a)(2)(A)): preempts certain state requirements “different from, or in addition to” federal requirements in enumerated categories that the court (tracking other circuits) associated primarily with product standards/marketing/production matters.
• Savings clause (21 U.S.C. § 387p(a)(2)(B)): carves back from preemption and protects state “requirements relating to the sale, distribution, … or use of … tobacco products.”

On this reading, Wisconsin’s directory requirement is a “sale” restriction: it conditions lawful sale on FDA authorization (or limited statutory alternatives), but does not dictate how products must be designed or manufactured. The court therefore viewed § 995.15 as fitting comfortably within the sales/distribution sphere that Congress protected from preemption.

3. Cross-referencing FDA authorization is not “enforcing the FDCA”

The plaintiffs’ core theory was that Wisconsin’s law undermines FDA’s purported “flexible enforcement authority” by converting federal premarket authorization into a state-policed sales prerequisite. The court rejected that framing for two related reasons:

• No FDCA adjudication: Wis. Stat. § 995.15 does not require Wisconsin to determine whether the FDCA was violated; it asks whether the FDA has issued an authorization order (a federal determination).
• Buckman is distinguishable: Wisconsin is not inviting state juries/courts to police fraud against the FDA or second-guess FDA’s internal processes. The risk of distortion that drove Buckman—state-law claims “pulling” the federal scheme—was not present in the same way.

The opinion also narrowed the relevance of 21 U.S.C. § 337(a): it limits who may bring “proceedings for the enforcement, or to restrain violations” of the FDCA, but Wisconsin’s regime was characterized as a state sales restriction that uses FDA authorization status as a reference point, not a state “proceeding” to enforce FDCA violations.

4. “Identical” state standards are not inherently preempted

Wisconsinites argued that because the TCA text mentions “in addition to, or more stringent,” it somehow excludes identical mirroring requirements. The Seventh Circuit treated that as a category error: preemption doctrine is about conflict. Mirroring a federal requirement typically creates no impossibility and no obstacle; it is the same rule applied through state law consequences.

5. Preliminary-injunction outcome: merits drive the equities

While accepting irreparable harm (credible threat of business shutdown plus large daily forfeitures), the court held the weak merits showing was decisive, and it emphasized the public and institutional costs of enjoining a state statute. It also noted plaintiffs’ delay (suing roughly 19 months after enactment and two months before enforcement), which weighed against emergency equitable relief.

C. Impact

• Validation of state ENDS “directory” laws keyed to FDA status: The decision strengthens state authority—at least within the Seventh Circuit—to condition lawful retail sale on FDA premarket authorization (and similar FDA-status criteria), framing such laws as protected “sale/distribution” regulations under 21 U.S.C. § 387p(a)(2)(B).
• Constraining “Buckman-style” preemption arguments in the tobacco context: The court’s distinction between (a) state adjudication/enforcement of FDCA violations and (b) state reliance on FDA determinations as predicates for state sales restrictions provides a roadmap for defending analogous statutes from implied-preemption challenges.
• Reinforcement of the national circuit trend: By aligning with the First, Second, Eighth, and Ninth Circuits cited, the Seventh Circuit adds weight to a broad interpretive consensus: the TCA preserves robust state/local power over where, when, and whether tobacco products may be sold, even when such regulation affects market access.
• Practical regulatory consequence: ENDS sellers may face a dual regime—federal authorization requirements plus state market-access rules with state penalties and private-litigation exposure (here, via Wisconsin’s unfair-and-deceptive-practices linkage). The opinion signals that such layered consequences are not, without more, preempted.
• Litigation strategy implications: The court’s jurisdiction discussion underscores that plaintiffs bringing affirmative preemption suits should ensure a valid federal cause of action (e.g., constitutional claim) or another jurisdictional basis, because conflict preemption alone generally will not supply § 1331 jurisdiction.