Wisconsinites for Alternatives To Smoking & Tobacco, Inc. v. DAVID CASEY, Secretary of the Wisconsin Department of Rev- enue

In the
United States Court of Appeals
For the Seventh Circuit
____________________
No. 25-2565
WISCONSINITES FOR A LTERNATIVES TO SMOKING & T OBACCO,
INC., et al.,
Plaintiffs-Appellants,
v.
D AVID C ASEY, Secretary of the Wisconsin Department of Rev-
enue, in his official capacity,
Defendant-Appellee.
____________________
Appeal from the United States District Court for the
Western District of Wisconsin.
No. 3:25-cv-00552 — William M. Conley, Judge.
____________________
A RGUED D ECEMBER 10, 2025 — D ECIDED A PRIL 21, 2026
____________________
Before BRENNAN, Chief Judge, and LEE and KOLAR , Circuit
Judges.
BRENNAN, Chief Judge. The Food and Drug Administration
regulates electronic products that deliver nicotine to the user,
like electronic vaping devices and e-cigarettes. That authority
includes review and approval of those products before they
are marketed and sold. See 21 U.S.C. § 387j.

-- 1 of 22 --

2 No. 25-2565
Wisconsin enacted a statute in 2023 that requires FDA au-
thorization before electronic nicotine delivery systems may be
sold. Wis. Stat. § 995.15. Manufacturers, distributors, retailers,
and users of vapes and e-cigarettes sued to enjoin
enforcement of that statute. In their view, the federal statutes
granting the FDA exclusive authority over premarket author-
ization preempt the Wisconsin statute. The district court dis-
agreed and denied a preliminary injunction.
The text of the applicable federal laws—the Federal Food,
Drug, and Cosmetic Act, as well as the Tobacco Control Act—
does not preempt the states’ authority to regulate the sale and
marketing of tobacco and tobacco-related products, so we af-
firm.
I.
A. Background
Electronic nicotine delivery systems (ENDS) products
include “[v]apes, vaporizers, vape pens, hookah pens, elec-
tronic cigarettes (e-cigarettes or e-cigs), e-cigars, and e —
pipes.”1 These products typically use a liquid containing
tobacco-derived nicotine “heated to create an aerosol that is
inhaled” by the user. Id. Wisconsin Statute § 995.15 requires
the state’s Department of Revenue to create a directory of
ENDS products that may lawfully be sold in the state. Wis.
Stat. § 995.15(6).
1 E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems
(ENDS) (March 12, 2026), https://www.fda.gov/tobacco-products/prod-
ucts-ingredients-components/e-cigarettes-vapes-and-other-electronic-
nicotine-delivery-systems-ends.

-- 2 of 22 --

No. 25-2565 3
A product may qualify for the directory in any of three
ways: (1) its manufacturer has received an FDA premarket au-
thorization order; (2) it was marketed in the U.S. as of August
8, 2016, it has a pending FDA premarket authorization appli-
cation submitted by September 9, 2020, and that application
remains under review or the final decision has not taken ef-
fect; or (3) it contains hemp but not nicotine. Wis. Stat.
§ 995.15(2). As of September 1, 2025, retailers and manufac-
turers are prohibited from selling any ENDS products not
listed in the directory. Wis. Stat. § 995.15(9)(a)–(b).
Businesses that sell such unlisted ENDS products are sub-
ject to forfeiture penalties of $1,000 per day per product and
the seizure of the unauthorized products as “contraband.”
Wis. Stat. § 995.15(9)(a)–(b), (11)(a). Further, the sale of un-
listed vaping products constitutes “an unfair and deceptive
trade practice in violation of” Wis. Stat. § 100.20. Id. at
995.15(9)(c). So “[a]ny person” financially harmed may com-
mence a civil suit to recover twice that “pecuniary loss, to-
gether with costs, including a reasonable attorney fee.” Wis.
Stat. § 100.20(5).
Two months before enforcement was set to begin under
§ 995.15, Wisconsinites2 sued the Department, arguing that
federal statutes preempted the state statute. They also con-
tended that § 995.15 violates the Equal Protection Clause of
the Fourteenth Amendment. Seeking preliminary and perma-
nent injunctions against enforcement of the statute, Wiscon-
sinites claimed § 995.15 would require them “to either run the
2 Plaintiffs-Appellants Wisconsinites for Alternatives to Smoking are
a Wisconsin non-profit corporation and its members, who are manufac-
turers, distributors, wholesalers, retailers, and users of ENDS products.

-- 3 of 22 --

4 No. 25-2565
risk of incurring substantial fines and forfeitures for sales of
[unlisted] ENDS products … or shut down because they can-
not maintain a profitable business with the limited range of
ENDS products that would be eligible for sale under the stat-
ute.” They also asserted that the law would deprive consum-
ers, including plaintiffs Kurt Wylie and Germaine Carmody,
“of the ability to purchase and consume their preferred ENDS
products because those products will not be eligible for sale.”
Wisconsinites moved for a preliminary injunction on
preemption grounds. Four days after § 995.15 went into effect,
the district court denied Wisconsinites’ motion. The court
concluded that the Wisconsin statute was not preempted by
the Federal Food, Drug, and Cosmetic Act, and therefore Wis-
consinites had not shown a reasonable likelihood of success
on the merits. They also failed to establish that the equities
weighed in favor of enjoining the statute’s enforcement. Wis-
consinites timely appeal.3
II.
A. Jurisdiction
Before addressing the denial of the preliminary injunction,
the parties debate the grounds for subject-matter jurisdiction.
To Wisconsinites, the implied preemption and equal protec-
tion claims raise federal questions on which jurisdiction can
rest. 28 U.S.C. § 1331. The Department contends that jurisdic-
tion exists only through the equal protection claim.
3 After the district court denied the preliminary injunction, Wiscon-
sinites moved for an injunction pending appeal, which was denied on sim-
ilar grounds.

-- 4 of 22 --

No. 25-2565 5
Federal preemption is often raised as a defense against
claims in a plaintiff’s complaint. Caterpillar Inc. v. Williams, 482
U.S. 386, 392 (1987). Federal-law defenses do not supply fed-
eral question jurisdiction, “even if the defense is anticipated
in the plaintiff’s complaint, and even if both parties concede
that the federal defense is the only question truly at issue.” Id.
at 393. Field, or complete, preemption does confer federal
question jurisdiction, but conflict preemption “is merely a de-
fense to the merits of a claim,” and thus does not confer juris-
diction under 28 U.S.C. § 1331. Vorhees v. Naper Aero Club, Inc.,
272 F.3d 398, 403 (7th Cir. 2001); Metro. Life Ins. Co. v. Taylor,
481 U.S. 58, 63 (1987). Because field preemption is not impli-
cated here, see infra III.B.1., Wisconsinites must advance a non-
preemption basis to assert federal question jurisdiction.
There is no dispute that an equal protection claim is suffi-
cient to supply federal-question jurisdiction. See K.C. v. Indi-
vidual Members of Med. Licensing Bd. of Ind., 121 F.4th 604, 614–
15 (7th Cir. 2024). So, we agree that Wisconsinites have
properly alleged a cause of action sufficient “to open the fed-
eral courthouse doors.” Braid v. Stilley, 142 F.4th 956, 962 (7th
Cir. 2025). Their preemption challenges follow along with
their constitutional claim.
B. Standing
The Department also contests whether Wisconsinites have
standing. “Article III of the Constitution confines the federal
judicial power to ‘Cases’ and ‘Controversies.’” United States v.
Texas, 599 U.S. 670, 675 (2023). Plaintiffs who claim Article III
standing must establish they (1) “suffered an injury in fact,”
that (2) was “likely caused by the defendant,” and (3) is
“likely [to] be redressed by judicial relief.” TransUnion LLC v.
Ramirez, 594 U.S. 413, 423 (2021).

-- 5 of 22 --

6 No. 25-2565
An injury in fact must be “concrete, particularized, and ac-
tual or imminent.” Id. Concrete injuries include tangible inju-
ries such as monetary harms. Wisconsin Voter All. v. Millis, 166
F.4th 627, 632 (7th Cir. 2026) (per curiam). Section 995.15, Wis-
consinites allege, will cause them to lose sales and business.
That suffices as a concrete injury in fact, see In re Recalled Abbott
Infant Formula Prods. Liab. Litig., 97 F.4th 525, 529 (7th Cir.
2024), which the district court correctly found.
Next is causation. The Department asserts that Wisconsin-
ites lack standing because their conduct would be illegal, re-
gardless of this case’s outcome. But this case is not similar to
decisions the Department cites involving drivers running red
lights or traffickers of illegal narcotics. Rather, as the district
court found, Wisconsinites have a legitimate basis to believe
they are engaged in legal economic activities. If the FDA had
been taking enforcement action against unapproved tobacco
products, Wisconsinites could not sell those products regard-
less of any state enforcement. But the FDA has opted for
limited case-by-case enforcement.4 Neither the actual nor re-
alized threat of federal enforcement prevents Wisconsinites
from selling their e-cigarettes. So, the state enforcement of
§ 995.15 would cause financial harm to Wisconsinites. They
have thus shown causation for purposes of this standing anal-
ysis. See FDA v. All. for Hippocratic Med., 602 U.S. 367, 385
(2024).
4 Enforcement Priorities for Electronic Nicotine Delivery System
(ENDS) and Other Deemed Products on the Market Without Premarket
Authorization 9 (April 2020). https://www.fda.gov/regulatory-infor-
mation/search-fda-guidance-documents/enforcement-priorities-elec-
tronic-nicotine-delivery-system-ends-and-other-deemed-products-mar-
ket.

-- 6 of 22 --

No. 25-2565 7
Last is redressability. Courts redress injuries by providing
the plaintiff a remedy against the defendant because remedies
“operate with respect to specific parties.” California v. Texas,
593 U.S. 659, 672 (2021) (quoting Murphy v. NCAA, 584 U.S.
453, 489 (2018) (Thomas, J., concurring)); see also William
Baude & Samuel L. Bray, Proper Parties, Proper Relief, 137
HARV. L. REV. 153, 182 (2023). The relief must be “likely” and
“not ‘merely speculative’” to remedy the injury. Soc'y of Di-
vine Word v. U.S. Citizenship & Immigr. Servs., 129 F.4th 437,
447 (7th Cir. 2025) (citing Lujan v. Defs. of Wildlife, 504 U.S. 555,
561 (1992)). When analyzing redressability, courts “consider
the relationship between the judicial relief requested and the
injury suffered.” California, 593 U.S. at 671 (citation modified).
Redressability depends on the relief requested, not the relief
to which a plaintiff can prove it is entitled on the merits. Lac
Du Flambeau Band v. Norton, 422 F.3d 490, 502 (7th Cir. 2005).
Put simply, when we enjoin the enforcement of a statute, the
injunction runs against “the acts of the official,” rather than
“the execution of the statute.” Massachusetts v. Mellon, 262 U.S.
447, 488 (1923).
The harms Wisconsinites allege “flow[] directly from” the
enforcement of Wis. Stat. § 995.15. Collins v. Yellen, 594 U.S.
220, 244 (2021). This case is not like Haaland v. Brackeen, in
which the Court held that plaintiffs lacked standing because
they sued federal parties even though the state officials im-
plemented the statute. See 599 U.S. 255, 292–93 (2023). It is also
distinguishable from Harp Advertising Illinois, Inc. v. Village of
Chicago Ridge, which involved two overlapping ordinances. 9
F.3d 1290, 1291 (7th Cir. 1993). That meant the plaintiff’s in-
jury was not redressable “even if it achieved total victory in
th[e] litigation.” Id. A decision for Wisconsinites would pro-
vide a remedy because they could sell and access ENDS

-- 7 of 22 --

8 No. 25-2565
products without fear of adverse action. Because the alleged
harms would flow directly from enforcing § 995.15, and are
redressable by the requested relief, Wisconsinites have al-
leged and established a concrete harm sufficient for Article III
standing.
III.
With jurisdiction secure and satisfied that Wisconsinites
have standing, we review the district court’s denial of a pre-
liminary injunction.
A preliminary injunction is “an exercise of a very far-
reaching power, never to be indulged in except in a case
clearly demanding it.” Lukaszczyk v. Cook County, 47 F.4th 587,
598 (7th Cir. 2022) (citation omitted). A party seeking a pre-
liminary injunction must establish that (1) it is likely to suc-
ceed on the merits; (2) it will suffer irreparable harm without
preliminary relief; (3) the balance of equities is in its favor; and
(4) an injunction would be in the public interest. Id. (citing
Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20 (2008)).
When reviewing a denial of a preliminary injunction, “we
review the district court’s findings of fact for clear error, its
legal conclusions de novo, and its balancing of the factors for a
preliminary injunction for abuse of discretion.” Proft v. Raoul,
944 F.3d 686, 693 (7th Cir. 2019) (citation omitted).
This case focuses on Wisconsinites’ likelihood of success
on the merits of its claims. Before considering that factor, we
review the applicable law of implied conflict preemption and
how it interacts with federal law regulating tobacco products.
Then, we evaluate the district court’s denial of a preliminary
injunction based on Wisconsinites’ failure to demonstrate a
reasonable likelihood of success on the merits, applying the

-- 8 of 22 --

No. 25-2565 9
law of implied conflict preemption, and specifically the To-
bacco Control Act’s tripartite preemption structure.
A. Statutory Background
The parties’ arguments implicate the Federal Food, Drug,
and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040
(1938), as well as the Family Smoking Prevention and Tobacco
Control Act (TCA), Pub. L. No. 111-31, 123 Stat. 1776 (2009).
Enacted in 1938, the FDCA gives the Food and Drug Ad-
ministration vast power to regulate consumer products re-
lated to health and welfare. FDA v. Wages & White Lion Invs.,
L.L.C., 604 U.S. 542, 549 (2025). The FDCA provides that all
proceedings to enforce or restrain violations of the Act “shall
be by and in the name of the United States.” 21 U.S.C. § 337(a).
In 2009, the TCA extended the FDA’s regulatory authority to
“new tobacco product[s],” requiring manufacturers to receive
approval from the FDA before marketing those products. 21
U.S.C. § 387j. A “new tobacco product” is one not commer-
cially marketed in the United States as of February 15, 2007,
or modified after that date. 21 U.S.C. § 387j(a)(1).
E-cigarettes were not initially considered “new tobacco
products” under the TCA. FDA v. R. J. Reynolds Vapor Co., 606
U.S. 226, 230 (2025) (citation omitted). But in 2016, the FDA
changed course and determined e-cigarettes were “tobacco
products,” requiring FDA premarket authorization. Id.; 81
Fed. Reg. 29028–44 (2016). Congress later amended the TCA
to define “tobacco product[s]” as those containing nicotine
“from any source,” such as synthetic (non-tobacco-derived)
nicotine. 21 U.S.C. § 321(rr)(1). To mitigate any disruption to
the market, the FDA deferred TCA enforcement against e-

-- 9 of 22 --

10 No. 25-2565
cigarette manufacturers while they sought premarket ap-
proval. See R.J. Reynolds, 606 U.S. at 230; 81 Fed. Reg. 29009–
15 (2016).
A manufacturer seeking FDA approval must first submit
a premarket tobacco product application. 21 C.F.R.
§ 1114.1(a); 31 U.S.C. § 387j. If the application is approved, the
FDA issues a “marketing granted order.” 21 C.F.R. § 1114.5,
1114.31. The sale of e-cigarette products in interstate com-
merce without FDA premarket authorization is prohibited
and violators are subject to fines and imprisonment. 21 U.S.C.
§§ 331(a), 333(a), 387b(6)(A); Wages & White Lion Invs., 604 U.S.
at 555 (“[B]ecause those products had not received premarket
authorization, the effect of the [FDA] rule was to make their
continued sale illegal.”).
Against the backdrop of federal regulation, the TCA’s text
shows Congress’s “explicit decision to preserve for the states
a robust role in regulating, and even banning, sales of tobacco
products.’’ R.J. Reynolds Tobacco Co. v. County of Los Angeles,
29 F.4th 542, 550 (9th Cir. 2022) (quoting U.S. Smokeless Tobacco
Mfg. Co. v. City of New York, 708 F.3d 428, 436 (2d Cir. 2013));
see also 21 U.S.C. § 387p.
Three separate clauses of the TCA, taken together, make
this plain. First, the TCA preserves a state’s power to create
regulations “in addition to, or more stringent” than the stat-
ute’s requirements. 21 U.S.C. § 387p(a)(1) (the “preservation
clause”). Second, it carves out several exceptions to its general
preemption provisions, allowing states to regulate on several
aspects of tobacco product control. 21 U.S.C. § 387p(a)(2)(A)
(the “preemption clause”). And third, it contains a savings
clause excepting more categories from preemption. 21 U.S.C.
§ 387p(a)(2)(B) (the “savings clause”).

-- 10 of 22 --

No. 25-2565 11
This tripartite preemption framework balances the states’
power to regulate tobacco against the FDA’s “sole authority
to set tobacco product standards.” County of Los Angeles, 29
F.4th at 560. The power to regulate includes the power to pro-
hibit. See id. Although we acknowledge the FDA’s regulatory
authority, we must also respect the areas Congress excepted
from preemption.
B. Likelihood of Success on the Merits
Wisconsinites submit that the district court erred in
interpreting the preservation clause. To them, § 995.15, by re-
quiring strict compliance with the TCA’s premarket review
requirements, denies the FDA the “flexible enforcement au-
thority” provided by that Act. They submit that this obstacle
to the “balancing and accomplish[ing]” of Congress’s pur-
poses means the TCA preempted § 995.15. But the district
court properly concluded that Wisconsinites were unlikely to
succeed on the merits of their claim.
We start with the law of implied conflict preemption. Then
we apply this law to the TCA’s tripartite preemption frame-
work to conclude that the Act’s text makes it unlikely that
Congress intended to preempt state laws that rely on that
Act’s requirements to regulate the sale of tobacco products.
1. Implied Conflict Preemption
Federal statues preempt state law through the Supremacy
Clause. Ye v. GlobalTranz Enters., Inc., 74 F.4th 453, 457 (7th
Cir. 2023); Caleb Nelson, Preemption, 86 VA . L. R EV. 225, 234
(2000). “There is no federal preemption in vacuo.” Kansas v.
Garcia, 589 U.S. 191, 202 (2020). Instead, a federal restriction of
a state law “must stem from either the Constitution itself” or
a congressional statute. Id. As a result, the Supremacy Clause

-- 11 of 22 --

12 No. 25-2565
empowers federal statutes to preempt or nullify a state law
that “prevent[s] or frustrate[s]” Congress’s objective. Geier v.
Am. Honda Motor Co., 529 U.S. 861, 873 (2000) (citation modi-
fied).
As with all preemption arguments, the analysis of implied
preemption claims “must be grounded ‘in the text and struc-
ture of the statute at issue.’” Kansas, 589 U.S. at 208 (citing CSX
Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993)). An
“[i]mplied preemption analysis does not justify a freewheel-
ing judicial inquiry into whether a state statute is in tension
with federal objectives.” Chamber of Com. of U.S. v. Whiting,
563 U.S. 582, 607 (2011) (citation modified).
There are two forms of implied preemption: field and con-
flict. Arizona v. United States, 567 U.S. 387, 399 (2012); Nelson v.
Great Lakes Educ. Loan Servs., Inc., 928 F.3d 639, 646–47 (7th Cir.
2019). Field preemption occurs when “Congress has so com-
pletely preempted a particular area that no room remains for
any state regulation and the complaint would be necessarily
federal in character.” Rogers v. Tyson Foods, Inc., 308 F.3d 785,
787 (7th Cir. 2002) (citation modified). Two provisions in the
TCA provide that field preemption is not implicated here.
“Essentially, the Preservation Clause tells us that there is no
‘field preemption’ for the TCA—states and cities are free to go
above and beyond the requirements of the TCA to curb to-
bacco use.” R.J. Reynolds Tobacco Co. v. City of Edina, 60 F.4th
1170, 1174 (8th Cir. 2023); 21 U.S.C. § 387p(a)(1). And the sav-
ings clause excepts certain tobacco product regulations from
preemption. 21 U.S.C. § 387p(a)(2)(B).
When Congress first enacted the FDCA, it included a pro-
vision specifying that all enforcement of the Act’s violations
“shall be by and in the name of the United States.” 21 U.S.C.

-- 12 of 22 --

No. 25-2565 13
§ 337(a). The Court has interpreted § 337(a) as preempting the
states’ authority to enforce the FDCA. See Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 352 (2001). But when Con-
gress amended the FDCA through the TCA, it expressly re-
served enforcement authority for the states. See 21 U.S.C.
§ 387p. Thus, there is no field preemption here because the
TCA reserves some authority for the states to regulate to-
bacco. See 21 U.S.C. § 387p(a)(2)(B); City of Edina, 60 F.4th at
1174.
By contrast, conflict preemption exists when either (1)
“compliance with both federal and state regulations is a phys-
ical impossibility” or (2) state law “stands as an obstacle to the
accomplishment and execution of the full purposes and objec-
tives of Congress.” Planned Parenthood of Ind., Inc. v. Comm'r of
Ind. State Dep't of Health, 699 F.3d 962, 984 (7th Cir. 2012)
(quoting Arizona, 567 U.S. at 399). So, we are to answer
whether the text and structure of 21 U.S.C. §§ 337(a) and 387p
conflict preempt § 995.15.
2. Preemption under the TCA
As described above, the TCA creates a tripartite preemp-
tion structure. See 21 U.S.C. § 387p(a)(1)–(a)(2)(B). The preser-
vation clause’s text shows Congress’s decision to reserve the
states’ power to regulate tobacco “in addition to, or more
stringent than” the Act’s requirements “[e]xcept as provided
in [the preemption clause].” 21 U.S.C. § 387p(a)(1); see also City
of Edina, 60 F.4th at 1174.
In turn, the preemption clause limits the reach of the
preservation clause by prohibiting states from enacting regu-
lations “different from or in addition to,” the TCA’s require-
ments in certain categories. 21 U.S.C. § 387p(a)(2)(A). The

-- 13 of 22 --

14 No. 25-2565
preemption clause “carves out eight limited exceptions to the
preservation clause, each of which relates most obviously to
the production or marketing stages—and not the retail sale—
of tobacco products[.]” County of Los Angeles, 29 F.4th at 553–
54 (citing 21 U.S.C. § 387p(a)(2)(A)). But the savings clause ex-
cepts certain categories from preemption, including “require-
ments relating to the sale, distribution, … or use of … tobacco
products[.]” 21 U.S.C. § 387p(a)(2)(B).
Therefore, the district court correctly reasoned that the
preservation clause’s text suggests “at minimum, Congress
intended that States use the TCA as a floor for further re-
strictions on tobacco product manufacturers from accessing
their markets.” And “[t]he language of the Savings Clause
also suggests Congress's apparent intent that States retain the
ultimate authority to prohibit the sale of a tobacco product al-
together, regardless of its compliance with TCA provisions.”
The court concluded that “the power to enact and enforce the
same or additional sales requirements is expressly preserved
to the States after adopting the TCA, at least so far as tobacco
product requirements are created by state law[.]” Further,
“the full text of the TCA and FDCA” make it “unlikely that
Congress intended to preempt the States’ authority to enact
and enforce laws restricting the sale of tobacco products that
rely in part on TCA requirements, such as Wis. Stat.
§ 995.15[.]” Thus, the court found that Wisconsinites failed to
demonstrate a reasonable likelihood of prevailing on the mer-
its.
To counter this application of the tripartite preemption
structure, Wisconsinites argue that only the federal govern-
ment can enforce the TCA. They invoke Buckman to support
that proposition. 531 U.S. at 348. There, the Court considered

-- 14 of 22 --

No. 25-2565 15
whether state law claims for fraud on the FDA conflicted with
the FDA’s responsibility to police fraud. Id. at 350. It ruled that
Congress did not intend to force medical device manufactur-
ers to comply “with the FDA's detailed regulatory regime in
the shadow of 50 States’ tort regimes.” Id. So, the state law
claims were impliedly preempted by the Medical Device
Amendments to the FDCA. Id. at 353. The Court concluded
the claims were preempted because of explicit evidence, not
the FDA’s nebulous enforcement power. See id.
But Buckman involved non-federal enforcement of fraud-
on-the-FDA claims, which caused over-disclosure of infor-
mation to the FDA in medical device applications. Id. at 351.
There is no such issue here. And as the district court ruled,
relying on the FDCA to provide a standard is different from
enforcing the statute.
Wisconsinites also contend the federal government has ex-
clusive FDCA enforcement authority. After all, the TCA is an
amendment to the FDCA. That means the Acts share the same
enforcement mechanisms. Yet, Buckman held that the FDCA
preempted state-law fraud-on-the-FDA claims, not because
the FDA had discretionary enforcement, but because the
claims “exist[ed] solely by virtue of the FDCA disclosure re-
quirements,” and that Act showed Congress’s intent to pro-
vide exclusive federal jurisdiction to regulate the products. Id.
at 352–53.
The Court in Buckman was also concerned the state-law
claims could “exert an extraneous pull on the scheme estab-
lished by Congress,” creating tension between FDA determi-
nations (favoring more minimal disclosures) and state court
adjudications (incentivizing greater disclosures). Id. at 351,
353. This issue does not arise here because adjudication is not

-- 15 of 22 --

16 No. 25-2565
needed. See Garcia v. Wyeth-Ayerst Lab’ys, 385 F.3d 961, 966
(6th Cir. 2004) (no concerns of “inter-branch meddling …
when the FDA itself determines that a fraud has been com-
mitted on the agency”) (citation modified). So, there is not a
possible problem with Wisconsin infringing upon the FDA’s
enforcement authority.
The district court found Wisconsinites’ reliance on Buck-
man unpersuasive. Most of the cases they cited did not “in-
volve tobacco products or the TCA’s Preservation and Sav-
ings Clauses.” The few cases that did involve tobacco prod-
ucts “simply appl[ied] Buckman without analysis of the effect
of the Preservation and Savings Clauses.” On appeal, Wiscon-
sinites fare no better, as they continue to cite non-tobacco
cases to support their Buckman-preemption theory.5
In their principal brief to us, Wisconsinites also argue that
“the text, structure, and legislative history of the FDCA sug-
gest that Congress did not intend the TCA’s preservation and
savings clauses … to allow States to enact and enforce require-
ments that cross-reference, and thus are parasitic on, the
TCA’s requirements.”
This is incorrect. The preemption clause has certain carve-
outs, none of which apply to the sale of tobacco products. And
the savings clause expressly safeguards the regulation of to-
bacco “sale[s]” and “distribution” from preemption. Thus,
5 In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d
1200 (8th Cir. 2010) (medical devices); Nexus Pharms., Inc. v. Cent. Admix-
ture Pharmacy Servs., Inc., 48 F. 4th 1040 (9th Cir. 2022) (drugs); Anthony v.
Country Life Mfg., L.L.C., No. 02 C 1601, 2002 WL 31269621 (N.D. Ill. Oct.
9, 2002) (food); Vanzant v. Hill's Pet Nutrition Inc., No. 17 C 2535, 2025 WL
296062 (N.D. Ill. Jan. 24, 2025) (pet food).

-- 16 of 22 --

No. 25-2565 17
state regulations “relating to the sale [or] distribution” are not
preempted by the TCA. See § 21 U.S.C. 387p(a)(2)(B).
In the alternative, Wisconsinites argue that states cannot
enforce federal requirements. Even if the TCA sets a federal
“floor” for regulation which states can exceed, they argue,
that does not mean states can enact the federal requirements
as state law and subsume the FDA’s enforcement authority.
Wisconsinites submit that Congress has “a long history” of
explicitly providing that states may enforce requirements
identical to federal statutes. But the TCA does not include any
such reference to state authority. States can enforce require-
ments “in addition to, or more stringent than” the FDCA re-
quirements through the preservation clause. 21 U.S.C.
§ 387p(a)(1). And the preemption clause prohibits states from
enacting regulations “different from or in addition to,” the
TCA’s requirements. 21 U.S.C. § 387p(a)(2)(A). But neither
clause references requirements identical to FDCA require-
ments. Thus, Wisconsinites claim, Congress only intended to
allow state tobacco regulations that differed from federal reg-
ulations.
But this argument misconstrues preemption. Implied
preemption asks whether state law conflicts with federal law.
See Altria Grp., Inc. v. Good, 555 U.S. 70, 76 (2008). A state law
that mirrors a federal standard does not create a conflict; ra-
ther, they impose the same standards. Id. at 76–77. There is no
implied conflict preemption if there is no conflict. See Wyeth
v. Levine, 555 U.S. 555, 581 (2009). Accordingly, the TCA per-
mits identical regulations as well regulations “in addition to,
or more stringent than” the FDA’s requirements. See 21 U.S.C.
§ 387p(a)(1).

-- 17 of 22 --

18 No. 25-2565
Wisconsinites also overread § 337(a),6 which limits only
lawsuits that implicate adjudications of FDCA violations.
Buckman, 531 U.S. at 348; see also Garcia, 385 F.3d at 966 (hold-
ing that concerns over state court encroachment on the FDA’s
authority “do not arise” when “the FDA itself” determines the
violation). Section 995.15 asks whether a product has FDA ap-
proval. It does not involve an adjudication of a violation.
Therefore, § 995.15 does not seek to enforce the FDCA, either
indirectly or directly. Indeed, noncompliance with the FDCA
is not even a basis for the Department to start proceedings.
And cross-referencing to FDA approval orders is not equiva-
lent to enforcing the FDCA itself. But cf. Iowans for Alts. to
Smoking & Tobacco, Inc. v. Iowa Dep't of Revenue, 781 F. Supp.
3d 724, 741 (S.D. Iowa 2025).
Finally, Wisconsinites fail to recognize that in the FDCA-
enforcement context, tobacco products are distinct. Unlike
drugs, food products, and medical devices, states have long
regulated tobacco. See Austin v. Tennessee, 179 U.S. 343, 348–
49 (1900) (cigarettes are “within the province of the legislature
to say how far they may be sold, or to prohibit their sale en-
tirely…”); see also Graham v. R.J. Reynolds Tobacco Co., 857 F.3d
1169, 1191 (11th Cir. 2017). At both the district court and on
appeal, Wisconsinites have not identified any tobacco cases to
support their unsuccessful Buckman-preemption theory.
3. Other courts
Four other circuits have concluded that the TCA does not
preempt similar tobacco sales laws because such bans are not
6 “Except as provided in subsection (b), all such proceedings for the
enforcement, or to restrain violations, of this chapter shall be by and in the
name of the United States.” 21 U.S.C. § 337(a).

-- 18 of 22 --

No. 25-2565 19
efforts to set tobacco product standards. City of Edina, 60 F.4th
at 1179 (Eighth Circuit holding that states and cities are free
to regulate tobacco above the Act’s floor); County of Los Ange-
les, 29 F.4th at 561 (Ninth Circuit concluding similarly); U.S.
Smokeless Tobacco Mfg. Co., 708 F.3d at 436 (Second Circuit
ruling that city ordinance was not preempted because it reg-
ulated sales rather than setting standards); Nat'l Ass'n of To-
bacco Outlets, Inc. v. City of Providence, 731 F.3d 71, 82–83 (1st
Cir. 2013) (recognizing that the Act allows regulations relat-
ing to the sale of tobacco products).
True, one published district court decision has concluded
otherwise. See Iowans for Alts. to Smoking & Tobacco, Inc., 781 F.
Supp. 3d at 741. But this decision, which Wisconsinites rely
on, overreads Buckman. There, the Court concluded that
exclusive federal enforcement in the FDCA forecloses non-
federal enforcement to maintain the balance of statutory ob-
jectives and the FDA’s responsibilities. Buckman, 531 U.S. at
350 (“State-law fraud-on-the-FDA claims inevitably conflict
with the FDA's responsibility to police fraud consistently with
the Administration's judgment and objectives.”). As analyzed
above, relying on the FDCA to provide a standard is different
from enforcing the statute. See supra at III.B.2.
Not every sales ban is “a backdoor ‘requirement … relat-
ing to tobacco product standards.’” U.S. Smokeless Tobacco
Mfg. Co., 708 F.3d at 434 (quoting 21 U.S.C. § 387p(a)(2)(A)).
A preempted tobacco product standard “must be something
more than an incentive or motivator … it must require manu-
facturers to alter the construction, components, ingredients,
additives, constituents ... and properties of their products.” Id.
(citation modified); see also City of Edina, 60 F.4th at 1175. Sec-
tion 995.15 is another such tobacco sales ban. The preservation

-- 19 of 22 --

20 No. 25-2565
clause expressly authorizes states to enact and enforce the
same or additional sales requirements. 21 U.S.C. § 387p(a)(1).
And the savings clause states the preemption clause “does not
apply to requirements relating to the sale … of tobacco
products,” thereby removing any limitation on the states’ au-
thority to enact tobacco sales bans. 21 U.S.C. § 387p(a)(2)(B).
Together, these clauses show that Congress did not intend to
preempt states’ authority to regulate the sale of tobacco prod-
ucts.
The text of the TCA reveals where Congress decided to
preempt state law, see 21 U.S.C. § 387p(a)(2)(A), and where
Congress expressly preserved state authority and limited
preemption, see 21 U.S.C. § 387p(a)(1), (a)(2)(B). We need not
ignore this mandate providing states the final authority on
which tobacco products may be sold in their respective mar-
ketplaces. Accordingly, Wisconsinites have failed to meet
their burden to demonstrate a reasonable likelihood of pre-
vailing on the merits of their claims.
C. Irreparable Harm
In addition to establishing a reasonable likelihood of suc-
cess on the merits, a party seeking a preliminary injunction
must show it is “likely to suffer irreparable harm in the ab-
sence of preliminary relief, that the balance of equities tips in
[their] favor, and that an injunction is in the public interest.”
K.C., 121 F.4th at 613 (quoting Winter, 555 U.S. at 20). A pre-
liminary injunction analysis operates on a sliding scale: the
greater the likelihood of success on the merits, the less the eq-
uities need to favor the moving party. Id. at 633.
Irreparable harm occurs when the “legal remedies availa-
ble to the movant are inadequate, meaning they are seriously

-- 20 of 22 --

No. 25-2565 21
deficient as compared to the harm suffered.” DM Trans, LLC
v. Scott, 38 F.4th 608, 618 (7th Cir. 2022). A modification to the
movant’s business can constitute irreparable harm if it forces
the movant to shut down its business while litigation is pend-
ing. See Roland Mach. Co. v. Dresser Indus., Inc., 749 F.2d 380,
386 (7th Cir. 1984). Here, the district court’s conclusion of ir-
reparable harm is supported by the record.
Quantifiable harm is typically not irreparable. Life Spine,
Inc. v. Aegis Spine, Inc., 8 F.4th 531, 546 (7th Cir. 2021) (con-
cluding that “harm stemming from lost customers or con-
tracts may be quantifiable if the lost customers or contracts
are identifiable”). Wisconsinites submit that the sales of prod-
ucts subject to § 995.15 “represent between 83% and 91.5% of
the[ir] revenues and profits.” But plaintiffs also anticipate that
the revenue from eligible ENDS products would not cover
their operating costs. And Wisconsinites also risked incurring
substantial financial penalties if they sold ENDS products not
listed in the directory after September 1, 2025. This combina-
tion of lost revenue from ENDS products and the substantial
financial penalties incurred for selling those products means
plaintiffs would be forced to shut down while awaiting trial.
For preliminary injunction purposes, then, such harms are ir-
reparable. See Roland Mach. Co., 749 F.2d at 386.
D. Balance of Equities and Public Interest
The equities and public interest factors tilt against Wiscon-
sinites. The injunction of a state’s duly enacted law causes sig-
nificant harm to the state and the public interest. K.C., 121
F.4th at 633; see also Maryland v. King, 567 U.S. 1301, 1303
(2012) (Roberts, C.J., in chambers).

-- 21 of 22 --

22 No. 25-2565
Plaintiffs point to a First Amendment challenge in ACLU
of Illinois v. Alvarez, 679 F.3d 583 (7th Cir. 2012). There, this
court ruled that “if the moving party establishes a likelihood
of success on the merits, the balance of harms normally favors
granting preliminary injunctive relief.” Id. at 589–90. In that
context, the injunction of a likely unconstitutional statute was
in the public interest because it furthered the public’s First
Amendment rights. See id. at 590 (citing Christian Legal Soc'y
v. Walker, 453 F.3d 853, 859 (7th Cir. 2006)). But here,
Wisconsinites bring an equal protection challenge to the gov-
ernment’s attempt to “effectuat[e] statutes enacted by repre-
sentatives” of the people of Wisconsin. Maryland, 567 U.S. at
1303 (Roberts, C.J., in chambers). And such an effort to enjoin
enforcement when the government is likely to succeed on the
merits weighs in favor of the Department. See Trump v. CASA,
Inc., 606 U.S. 831, 860–61 (2025); cf. Alvarez, 679 F.3d at 589–90.
We must also consider Wisconsinites’ delay in bringing
the suit, more than 19 months after § 995.15 enactment and
only two months before the directory was to go into effect.
These balance of equities and public interest factors weigh in
favor of the Department.
IV.
Wisconsinites have failed to demonstrate a reasonable
likelihood of success on the merits of their claim that Wiscon-
sin Statute § 995.15 is preempted by federal law. Although
they have shown they would suffer irreparable harm under
the state statute, the balance of harms and the public interest
do not weigh in favor of enjoining enforcement of the state
law. For these reasons, the district court correctly denied Wis-
consinites’ motion for a preliminary injunction.
A FFIRMED

-- 22 of 22 --