Vapor Technology Association v. McKinley Wooten, Jr.

PUBLISHED

UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT

No. 25-1745

VAPOR TECHNOLOGY ASSOCIATION; AMV HOLDINGS, LLC, d/b/a Kure
CBD and Vape; WAGES AND WHITE LION INVESTMENTS, LLC, d/b/a Triton
Distribution; BRIGHT LEAF VENDORS, INC.; REAGAN MURPHY,

Plaintiffs - Appellants,

v.

MCKINLEY WOOTEN, JR., in his official capacity as the North Carolina Secretary
of Revenue; PHILIP E. BERGER, in his official capacity as President Pro Tempore
of the North Carolina Senate; DESTIN HALL, in his official capacity as Speaker of
the North Carolina House of Representatives,

Defendants - Appellees,

------------------------------

STATE OF IOWA; STATE OF ARKANSAS; STATE OF GEORGIA; STATE OF
IDAHO; STATE OF INDIANA; STATE OF KANSAS; STATE OF KENTUCKY;
STATE OF LOUISIANA; STATE OF MAINE; STATE OF MARYLAND; STATE
OF MINNESOTA; STATE OF MONTANA; STATE OF NEBRASKA; STATE OF
NEVADA; STATE OF NEW MEXICO; STATE OF NORTH DAKOTA; STATE
OF OHIO; STATE OF PENNSYLVANIA; STATE OF SOUTH CAROLINA;
STATE OF SOUTH DAKOTA; STATE OF TENNESSEE; STATE OF TEXAS;
STATE OF UTAH; STATE OF VERMONT; STATE OF VIRGINIA; STATE OF
WASHINGTON; STATE OF WISCONSIN; STATE OF WEST VIRGINIA,

Amici Supporting Appellee.

Appeal from the United States District Court for the Eastern District of North Carolina, at
Greenville. Richard E. Myers, II, Chief District Judge. (4:25-cv-00076-M-RJ)

2

Argued: January 29, 2026 Decided: July 30, 2026

Before AGEE, THACKER and QUATTLEBAUM, Circuit Judges.

Affirmed by published opinion. Judge Thacker wrote the opinion in which Judge Agee
joined. Judge Agee wrote a concurring opinion. Judge Quattlebaum wrote a dissenting
opinion.

ARGUED: James Christopher Fraser, THOMPSON HINE LLP, Washington, D.C., for
Appellants. Stephanie A. Brennan, NORTH CAROLINA DEPARTMENT OF JUSTICE,
Raleigh, North Carolina, for Appellee. ON BRIEF: Eric N. Heyer, Anna Stressenger,
THOMPSON HINE LLP, Washington, D.C., for Appellants. Jeff Jackson, Attorney
General, Olga E. Vysotskaya de Brito, Senior Deputy Attorney General, Terence Steed,
Special Deputy Attorney General, Daniel T. Wilkes, Assistant Deputy Attorney General,
NORTH CAROLINA DEPARTMENT OF JUSTICE, Raleigh, North Carolina, for
Appellees. Brenna Bird, Attorney General, Eric Wessan, Solicitor General, Patrick C.
Valencia, Deputy Solicitor General, OFFICE OF THE ATTORNEY GENERAL OF
IOWA, Des Moines, Iowa, for Amicus State of Iowa. Tim Griffin, Attorney General,
OFFICE OF THE ATTORNEY GENERAL OF ARKANSAS, Little Rock, Arkansas, for
Amicus State of Arkansas. Chris Carr, Attorney General, OFFICE OF THE ATTORNEY
GENERAL OF GEORGIA, Atlanta, Georgia, for Amicus State of Georgia. Raúl R.
Labrador, Attorney General, OFFICE OF THE ATTORNEY GENERAL OF IDAHO,
Boise, Idaho, for Amicus State of Idaho. Theodore E. Rokita, Attorney General, OFFICE
OF THE ATTORNEY GENERAL OF INDIANA, Indianapolis, Indiana, for Amicus State
of Indiana. Kris Kobach, Attorney General, OFFICE OF THE ATTORNEY GENERAL
OF KANSAS, Topeka, Kansas, for Amicus State of Kansas. Russell M. Coleman,
Attorney General, OFFICE OF THE ATTORNEY GENERAL OF KENTUCKY,
Frankfort, Kentucky, for Amicus Commonwealth of Kentucky. Liz Murrill, Attorney
General, OFFICE OF THE ATTORNEY GENERAL OF LOUISIANA, Baton Rouge,
Louisiana, for Amicus State of Louisiana. Aaron Frey, Attorney General, OFFICE OF
THE ATTORNEY GENERAL OF MAINE, Augusta, Maine, for Amicus State of Maine.
Anthony G. Brown, Attorney General, OFFICE OF THE ATTORNEY GENERAL OF
MARYLAND, Baltimore, Maryland, for Amicus State of Maryland. Keith Ellison,
Attorney General, OFFICE OF THE ATTORNEY GENERAL OF MINNESOTA, St.
Paul, Minnesota, for Amicus State of Minnesota. Austin Knudsen, Attorney General,
OFFICE OF THE ATTORNEY GENERAL OF MONTANA, Helena, Montana, for
Amicus State of Montana. Michael T. Hilgers, Attorney General, OFFICE OF THE
ATTORNEY GENERAL OF NEBRASKA, Lincoln, Nebraska, for Amicus State of
Nebraska. Aaron D. Ford, Attorney General, OFFICE OF THE ATTORNEY GENERAL

3

OF NEVADA, Carson City, Nevada, for Amicus State of Nevada. Raúl Torrez, Attorney
General, OFFICE OF THE ATTORNEY GENERAL OF NEW MEXICO, Santa Fe, New
Mexico, for Amicus State of New Mexico. Drew Wrigley, Attorney General, OFFICE OF
ATTORNEY GENERAL OF NORTH DAKOTA, Bismarck, North Dakota, for Amicus
State of North Dakota. Dave Yost, Attorney General, OFFICE OF THE ATTORNEY
GENERAL OF OHIO, Columbus, Ohio, for Amicus State of Ohio. Dave Sunday,
Attorney General, OFFICE OF THE ATTORNEY GENERAL OF PENNSYLVANIA,
Harrisburg, Pennsylvania, for Amicus Commonwealth of Pennsylvania. Alan Wilson,
Attorney General, OFFICE OF THE ATTORNEY GENERAL OF SOUTH CAROLINA,
Columbia, South Carolina, for Amicus State of South Carolina. Marty Jackley, Attorney
General, OFFICE OF THE ATTORNEY GENERAL OF SOUTH DAKOTA, Pierre,
South Dakota, for Amicus State of South Dakota. Jonathan Skrmetti, Attorney General,
OFFICE OF THE ATTORNEY GENERAL OF TENNESSEE, Nashville, Tennessee, for
Amicus State of Tennessee. Ken Paxton, Attorney General, OFFICE OF THE
ATTORNEY GENERAL OF TEXAS, Austin, Texas, for Amicus State of Texas. Derek
E. Brown, Attorney General, OFFICE OF THE ATTORNEY GENERAL OF UTAH, Salt
Lake City, Utah, for Amicus State of Utah. Charity R. Clark, Attorney General, OFFICE
OF THE ATTORNEY GENERAL OF VERMONT, Montpelier, Vermont, for Amicus
State of Vermont. Jason S. Miyares, Attorney General, OFFICE OF THE ATTORNEY
GENERAL OF VIRGINIA, Richmond, Virginia, for Amicus Commonwealth of Virginia.
Nicholas W. Brown, Attorney General, OFFICE OF THE ATTORNEY GENERAL OF
WASHINGTON, Olympia, Washington, for Amicus State of Washington. Joshua L. Kaul,
Attorney General, OFFICE OF THE ATTORNEY GENERAL OF WISCONSIN,
Madison, Wisconsin, for Amicus State of Wisconsin. John B. McCuskey, Attorney
General, OFFICE OF THE ATTORNEY GENERAL OF WEST VIRGINIA, Charleston,
West Virginia, for Amicus State of West Virginia.

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THACKER, Circuit Judge:
For almost a decade, the Food and Drug Administration (“FDA”) has said that
electronic nicotine delivery systems, more commonly known as “e-cigarettes” or “vapes,”
are tobacco products that require FDA approval before being sold. But the FDA has been
slow to enforce that requirement. Trying to curb the influx of potentially harmful products
within its borders, the State of North Carolina has recently enacted legislation that sharply
curtails the ability of vape manufacturers and retailers to sell vapes that lack FDA approval
within North Carolina’s borders.
Vapor Technology Association; Wages and White Lion Investments, LLC; Bright
Leaf Vendors, Inc.; AMV Holdings, LLC; and Reagan Murphy (collectively,
“Appellants”) are a coalition consisting of a vape trade group, a vape manufacturer, two
vape retailers, and a vape user. They have filed suit in an attempt to set aside the North
Carolina law. Appellants contend the North Carolina law is preempted by federal law. As
a result, they moved the district court to enjoin the state law. The district court denied the
motion, concluding that Appellants were unlikely to prevail on their preemption theory.
Finding no error, we affirm.
I.
A.
Federal Statutory Background
In 1938, Congress enacted the Food, Drug, and Cosmetic Act (“FDCA”), which
requires covered products to first obtain approval from the FDA before they can be placed
on the market. For 70 years, the FDCA did not cover tobacco products, and tobacco

5

regulation remained a task left largely to the States. R.J. Reynolds Tobacco Co. v. County
of Los Angeles, 29 F.4th 542, 547 (9th Cir. 2022) (“Until just over a decade ago, tobacco
products were regulated almost exclusively by the states and local governments, with little
federal involvement.”).
But, in 2009, Congress amended the FDCA by enacting the Family Smoking
Prevention and Tobacco Control Act (“TCA”). Pub. L. No. 111-31, 123 Stat. 1776 (2009).
The TCA gave the FDA, for the first time, regulatory authority over “new tobacco
products.” Id. The TCA did not, however, classify modern e-cigarettes or vape products
as tobacco products. As a result, vape manufacturers could continue to sell their products
without first obtaining FDA approval. That changed in 2016, when the FDA announced
that vape products dispensing tobacco-derived nicotine were tobacco products subject to
the TCA. And in 2022, Congress amended the TCA to clarify that all vape products --
including those dispensing synthetic nicotine -- were tobacco products covered by the
TCA. Pub. L. No. 117-103, 136 Stat. 789 (2022).
By the time vape products came within the FDA’s regulatory purview, the vape
market in the United States had grown to a considerable size. Recognizing that it would
be disruptive to pull these unapproved tobacco products off the shelves while the
manufacturers sought the newly required FDA approval, the FDA adopted a more lenient
enforcement policy. This policy, beginning in 2017, afforded the FDA a grace period
wherein it deferred enforcement of the FDCA’s pre-market review requirement for vape
products so long as the vape product had been on the market by August 8, 2016, and the

6

FDA approval paperwork had been submitted and was under review. J.A. 21.
1
But, in
2020, the FDA shifted to a “case-by-case” enforcement policy, in which the FDA allows
vape products that lack FDA approval to be placed on the market. J.A. 165. As a result,
the FDA is currently allowing vape products that lack FDA approval to be sold in the
United States and then picking and choosing which vapes it will insist receive FDA
approval.
B.
State Statutory Background
In 2024, the North Carolina General Assembly passed House Bill 900, now known
as Session Law 2024-31 (“S.L. 2024-31”). S.L. 2024-31 creates a regulatory framework
through which the North Carolina Department of Revenue (“the Department” or
“NCDOR”) determines which vape products are eligible for sale in North Carolina.
To be eligible for sale in North Carolina, the manufacturer of a vape product must
certify to the NCDOR Secretary, on an annual basis, that the vape product meets one of the
following three criteria:
1. The vape product has received FDA approval;

2. The vape product was on the market by August 8, 2016, and an application
seeking approval was submitted to the FDA by September 9, 2020;
2
or

1
Citations to the “J.A.” refer to the Joint Appendix filed by the parties in this appeal.
2
This exception applies only to vapes dispensing tobacco derived nicotine. N.C.
Gen. Stat. § 14-313(a)(3c).

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3. The vape product is exempt from the two above listed requirements because it
is only a superficial change to an existing product, such as the name, brand style,
or packaging.

N.C. Gen . Stat. § 143B-245.11(a)(1)–(3). The manufacturer must also submit a $2,000.00
payment with its initial certification, and another $500.00 payment with each annual
renewal. N.C. Gen. S tat. § 143B-245.11(b)(2).
From there, the NCDOR Secretary must assemble a directory listing each vape
product, and its manufacturer, that has been certified eligible for sale in North Carolina.
N.C. Gen. Stat. § 143B-245.12(a). The Secretary must exclude from the directory any vape
product made by a manufacturer the Secretary determines:
1. Failed to provide a complete and accurate certification;

2. Submitted a certification that does not comply with the statutory requirements;

3. Failed to include the required payment with the certification;

4. Previously sold vape products in North Carolina that were required to be certified
eligible for sale and placed on the directory but were not; or

5. Provided in its certification either false information or information that contained
a material misrepresentation or omission.

N.C. Gen. Stat. § 143B-245.12(b).
The NCDOR Secretary was then charged with publishing the directory by May 1,
2025, and maintaining it moving forward. See N.C. Gen. Stat. § 143B-245.13(a). The
directory publication triggered a 60 day grace period, after which vape products not listed
in the directory are forbidden from being sold in North Carolina. Id.
The NCDOR Secretary is responsible for enforcing S.L. 2024-31. See N.C. Gen.
Stat. § 143B-245.15(a). Should a manufacturer or retailer sell a vape product in North

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Carolina that is not listed on the directory, the Secretary is authorized to impose a variety
of penalties. N.C. Gen. Stat. § 14-313(h). These include monetary fines and seizure of the
unlisted vape product. Id. But North Carolina has also deemed selling vapes not included
in the directory a deceptive trade practice. N.C. Gen. Stat. § 14-313(j). As a result, any
manufacturer or retailer that sells an unlisted vape in North Carolina can be sued for
deceptive trade practices by a competitor. See N.C. Gen. Stat. § 75-16.
C.
The Lawsuit
Appellants filed this lawsuit on April 30, 2025, one day before the directory became
public. They sued three North Carolina officials -- McKinley Wooten Jr., the North
Carolina Secretary of Revenue; Philip E. Berger, the President Pro Tempore of the North
Carolina Senate; and Destin Hall, the Speaker of the North Carolina House of
Representatives (“Appellees”) -- in their official capacities, in an attempt to block
enforcement of S.L. 2024-31.
Appellants bring two claims in support of their suit. First, they allege that S.L.
2024-31 is impliedly preempted by the FDCA and TCA and thus inoperative. Second, they
allege that S.L. 2024-31 violates the Equal Protection Clause of the Fourteenth Amendment
by discriminating against similarly situated vape manufacturers, retailers, and consumers
without a rational basis.
On May 16, 2025, Appellants moved for a preliminary injunction in an attempt to
stop Appellee Wooten, the NCDOR Secretary, from enforcing S.L. 2024-31. In doing so,

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Appellants pressed only their preemption argument. The Equal Protection theory was
never raised in their motion for a preliminary injunction.
In support of their motion, two of the vape retailers -- Appellants AMV Holdings,
LLC and Bright Leaf Vendors, Inc. (the “Commercial Appellants”) -- proffered evidence
that S.L. 2024-31 will irreparably harm them. For example, Sameh Salaymeh, the
President and CEO of Appellant AMV Holdings, LLC, submitted a declaration as to the
financial hardship his stores will suffer.
3
Salaymeh averred that, in 2024, 58% of the gross
revenues for his stores came from vape products that will no longer be eligible for sale in
North Carolina if S.L. 2024-31 is enforced. He thus reasoned that Appellant AMV
Holdings, LLC will stand to lose a little over half of its gross revenue if S.L. 2024-31 is
enforced. That sharp reduction in revenue, he submitted, could force the stores to close
their doors.
Justin Shupe, the manager of Appellant Bright Leaf Vendors, Inc., another vape
retailer, submitted a similar declaration. He averred that Appellant Bright Leaf Vendors,
Inc. operates three vape retail stores in North Carolina -- stores in Greenville, Morehead
City, and Havelock. Shupe explained that the stores in Havelock and Morehead City
generate 71.0% and 67.4% of their revenue, respectively, from vape sales, the majority of
which will no longer be permitted pursuant to S.L. 2024-31. Shupe thus submitted that
these “two stores are certain to close their doors if S.L. 2024-31” takes effect. J.A. 224.

3
Appellant AMV Holdings, LLC has 24 brick and mortar vape shops throughout
North Carolina.

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Appellees opposed the motion on two grounds. First, Appellees argued that
Appellants lacked standing because S.L. 2024-31 only stops them from selling vapes that
lack FDA approval, which is an act that already violates federal law. In other words,
Appellees contended that Appellants’ inability to sell illegal vape products was not an
injury that confers Article III standing. Second, and on the merits, Appellees argued
Appellants could not demonstrate their entitlement to injunctive relief.
The district court denied the motion. The court first held that Appellants had
standing because enforcement of S.L. 2024-31 threatened them with “substantial economic
harm, including the loss of sales revenue and the incursion of civil fines.” J.A. 502. But,
after turning to the merits, the district court held that Appellants were unlikely to prevail
on their preemption claim. This was so, the court reasoned, because the TCA specifically
saved from preemption state laws regulating the sale of tobacco products, such as S.L.
2024-31. The court also found preemption unlikely because Appellants could not establish
that North Carolina was using S.L. 2024-31 to deputize itself to enforce the FDCA’s
premarket authorization requirement, which the FDCA prohibits. The court instead found
that North Carolina was merely using S.L. 2024-31 to regulate which vape products can be
sold within its borders.
This appeal followed.
II.
“Whether a plaintiff has Article III standing is an issue of law that we review de
novo.” Fernandez v. RentGrow, Inc., 116 F.4th 288, 294 (4th Cir. 2024). “We review the
decision to grant or deny a preliminary injunction,” by contrast, “for an abuse of

11

discretion.” Platt v. Mansfield, 162 F.4th 430, 438 (4th Cir. 2025) (quoting Roe v. Dep’t
of Def., 947 F.3d 207, 219 (4th Cir. 2020)). “A district court abuses its discretion when it
applies an incorrect preliminary injunction standard, rests its decision on a clearly
erroneous finding of material fact or misapprehends the law with respect to the underlying
issues in litigation.” N. Va. Hemp & Agric., LLC v. Virginia, 125 F.4th 472, 492 (4th Cir.
2025).
III.
We face two questions here. First, do Appellants have standing? Second, and if so,
should the district court have granted them injunctive relief? We answer these questions
in turn.
A.
Standing
1.
“Article III of the Constitution limits the jurisdiction of the federal courts to ‘Cases’
and ‘Controversies.’” John & Jane Parents 1 v. Montgomery Cnty. Bd. of Educ., 78 F.4th
622, 628 (4th Cir. 2023) (quoting U.S. Const. art. III, § 2). “For there to be a case or
controversy under Article III, the plaintiff must have a ‘personal stake’ in the case—in
other words, standing.” TransUnion LLC v. Ramirez, 594 U.S. 413, 423 (2021) (some
internal quotation marks omitted) (quoting Raines v. Byrd, 521 U.S. 811, 819 (1997)). A
plaintiff has standing to sue when she can “demonstrate (i) that she has suffered or likely
will suffer an injury in fact, (ii) that the injury likely was caused or will be caused by the
defendant, and (iii) that the injury likely would be redressed by the requested judicial

12

relief.” FDA v. All. for Hippocratic Med., 602 U.S. 367, 380 (2024); see also Menders v.
Loudoun Cnty. Sch. Bd., 65 F.4th 157, 162–63 (4th Cir. 2023) (“To establish standing, a
plaintiff must ‘show (i) that he suffered an injury in fact that is concrete, particularized,
and actual or imminent; (ii) that the injury was likely caused by the defendant; and (iii) that
the injury would likely be redressed by judicial relief.’” (quoting TransUnion, 594 U.S. at
423)).
Here, the district court held that the Commercial Appellants satisfy this three part
test and, therefore, have standing. We agree.
4

First, S.L. 2024-31 puts the Commercial Appellants in a Catch-22: either stop
selling their most popular products and lose revenue, or carry on business as usual and face
fines and civil suits from competitors for deceptive trade practices. No matter which path
they take, S.L. 2024-31 threatens the Commercial Appellants with financial harm. That
“pocketbook injury” is the “classic” injury in fact for the purpose of Article III. Tyler v.
Hennepin County, 598 U.S. 631, 636 (2023); United States v. Texas, 599 U.S. 670, 676
(2023) (“Monetary costs are of course an injury.”); TransUnion, 594 U.S. at 425 (“If a
defendant has caused physical or monetary injury to the plaintiff, the plaintiff has suffered
a concrete injury in fact under Article III.”); see also Cottrell v. Alcon Lab’ys, 874 F.3d
154, 163 (3d Cir. 2017) (“[W]here a plaintiff alleges financial harm, standing ‘is often

4
Because we hold that the Commercial Appellants have standing, we need not
decide whether any other Appellant has standing. Biden v. Nebraska, 600 U.S. 477, 489
(2023) (“If at least one plaintiff has standing, the suit may proceed.”).

13

assumed without discussion.’” (quoting Danvers Motor Co. v. Ford Motor Co., 432 F.3d
286, 293 (3d Cir. 2005))).
Second, this threatened financial harm is traceable to Appellee Wooten’s
enforcement of S.L. 2024-31. Appellee Wooten is the NCDOR Secretary. As such, he is
responsible for compiling the registry of approved vapes, publishing the directory, and
enforcing S.L. 2024-31. Appellee Wooten enforces S.L. 2024-31 by fining any store that
sells vapes not included in the registry. Therefore, the Commercial Appellants easily
satisfy the Article III traceability requirement. See Hierholzer v. Guzman, 125 F.4th 104,
116 (4th Cir. 2025) (“To be fairly traceable, there must be a causal connection between the
injury and the conduct complained of.” (internal quotation marks omitted) (quoting Laufer
v. Naranda Hotels, LLC, 60 F.4th 156, 161 (4th Cir. 2023)).
Third, and finally, the Commercial Appellants’ injuries are redressable. If
Appellants prevail here -- and they can prove that S.L. 2024-31 violates federal law -- then
the law will be struck down and thus will be inoperative. If that occurs, the Commercial
Appellants will no longer face fines, nor civil suits from their competitors at least with
regard to S.L. 2024-31. Because a favorable judicial decision in this case will insulate the
Commercial Appellants from the financial harm S.L. 2024-31 threatens, their injury is
redressable. Frank Krasner Enters., Ltd. v. Montgomery County, 401 F.3d 230, 234 (4th
Cir. 2005) (explaining that Article III requires only “a non-speculative likelihood that the
injury would be redressed by a favorable judicial decision”).
Therefore, we hold that the Commercial Appellants have standing to challenge
S.L. 2024-31. In doing so, we join the Seventh Circuit, which recently held that vape

14

retailers that sold non-FDA approved vapes had standing to challenge a Wisconsin
statutory scheme that was functionally identical to S.L. 2024-31. Wisconsinites for Alts. to
Smoking & Tobacco, Inc. v. Casey, 172 F.4th 976, 982–83 (7th Cir. 2026).
2.
Appellees see things differently. In arguing that the Commercial Appellants lack
standing, Appellees begin by pointing to Lujan v. Defenders of Wildlife, in which the
Supreme Court stated that Article III’s injury in fact element requires “an invasion of a
legally protected interest.” 504 U.S. 555, 560 (1992). From there, Appellees note that
federal law already makes it illegal to sell vape products that lack FDA approval. And
because nobody has a right to violate federal law, Appellees conclude that the Commercial
Appellants have no legally protected interest in selling their vape products and, as a result,
will suffer no injury by way of the enforcement of S.L. 2024-31.
But this argument rests on a faulty premise as to whether the Commercial Appellants
have suffered an injury in fact. Lujan did not, as Appellees contend, graft onto Article III
a novel requirement that the plaintiff have a legal right to engage in the regulated conduct.
Instead, Lujan’s statement that there must be “an invasion of a legally protected interest”
was nothing more than a reformulation of the Supreme Court’s longstanding requirement
that the claimed injury be judicially cognizable. See Jud. Watch, Inc. v. U.S. Senate, 432
F.3d 359, 363 (D.C. Cir. 2005) (Williams, J., concurring) (“Lujan itself did not purport to
announce a new rule but rather appeared aimed at restating the Article III standing triad.”).
A number of factors compel this conclusion. To start, Lujan never signaled that it
was tacking a new requirement onto Article III’s injury in fact element; Lujan instead gave

15

every indication that it was summarizing the Court’s existing standing doctrine. See Lujan,
504 U.S. at 560 (“Over the years, our cases have established that the irreducible
constitutional minimum of standing contains three elements.”). And when summarizing
the existing doctrine, Lujan cited three cases to support the notion that Article III standing
requires the “invasion of a legally protected interest” -- and each of those cases explain that
the injured interest must be “cognizable,” not “legally protected.” Allen v. Wright, 468
U.S. 737, 752, 754–56 (1984) (dismissing a claim for lack of Article III standing because
the “injury [wa]s not judicially cognizable”); Warth v. Seldin, 422 U.S. 490, 514 (1975)
(observing that “Congress may create a statutory right or entitlement the alleged
deprivation of which can confer standing to sue even where the plaintiff would have
suffered no judicially cognizable injury in the absence of statute”); Sierra Club v. Morton,
405 U.S. 727, 734–35 (1972) (“[T]he ‘injury in fact’ test requires more than an injury to a
cognizable interest. It requires that the party seeking review be himself among the
injured.”). Perhaps most telling, Lujan used the phrase “legally protected interest” just
once, and that was at the outset when providing an overview of the established standing
doctrine. Lujan, 504 U.S. at 560. When it came time to determine whether the plaintiffs
had suffered an injury that conferred standing, Lujan measured the injury against a familiar
yardstick: whether it was cognizable. Id. at 562–63, 564 (explaining that “the desire to use
or observe an animal species, even for purely esthetic purposes, is undeniably a cognizable
interest for purpose of standing,” but ultimately concluding that the plaintiffs had not
established an imminent injury to that interest because they had only an “inten[t]” to “some
day” travel to the affected area and view the animals).

16

The Supreme Court’s post-Lujan cases confirm that a “legally protected interest” is
just another way of saying a “cognizable interest.” In Bennett v. Spear, for instance, the
Court repeated verbatim Lujan’s articulation of the three elements of standing, save for one
exception: the Court used the phrase “judicially cognizable interest” in place of “legally
protected interest.” 520 U.S. 154, 167 (1997) (“Th[e] irreducible constitutional minimum
of standing requires: (1) that the plaintiff have suffered an injury in fact—an invasion of a
judicially cognizable interest which is (a) concrete and particularized and (b) actual or
imminent, not conjectural or hypothetical; (2) that there be a causal connection between
the injury and the conduct complained of—the injury must be fairly traceable to the
challenged action of the defendant, and not the result of the independent action of some
third party not before the court; and (3) that it be likely, as opposed to merely speculative,
that the injury will be redressed by a favorable decision.” (emphasis supplied) (internal
quotation marks omitted) (citing Lujan, 504 U.S. at 560–61)). And in Raines v. Byrd, the
Court explained that Article III requires “the alleged injury [to] be legally and judicially
cognizable.” 521 U.S. 811, 819 (1997). This, the Court said, requires “that the plaintiff
have suffered an invasion of a legally protected interest which is . . . concrete and
particularized, and that the dispute is traditionally thought to be capable of resolution
through the judicial process.” Id. (internal quotation marks and citations omitted).
We thus reject the notion that Lujan changed Article III’s well established test and
imposed an additional requirement that the plaintiff have a legal right to engage in the
regulated conduct. The injured interest need only be cognizable, and a financial injury is
easily cognizable. Cottrell, 874 F.3d at 164 (“[T]he Supreme Court has repeatedly

17

recognized that financial or economic interests are ‘legally protected interests’ for purposes
of the standing doctrine.” (collecting cases)).
3.
Our dissenting colleague says that our decision in Pender v. Bank of America
Corporation, 788 F.3d 354 (4th Cir. 2015), precludes us from reaching this conclusion. In
the dissent’s view, Pender “already recognized [a plaintiff having a] ‘legally protected
interest’ as an independent requirement [of Article III] and supplied meaning to it.” Post
at 56.
In Pender, we considered whether a pair of plaintiffs had standing to bring a
disgorgement claim pursuant to the Employee Retirement Income Security Act of 1974
(“ERISA”) against their employer. Pender, 788 F.3d at 358. The employer had used the
employees’ retirement contributions to make money in excess of what the plaintiffs
expected to make from their defined benefit retirement accounts, and the employer
pocketed that additional profit. Id. at 358–60. The employer moved to dismiss for lack of
standing, arguing that the employees had not suffered an injury because they had not lost
any money. Id. at 361, 365. We rejected that simplistic analysis. “[I]t goes without
saying,” we began, “that the Supreme Court has never limited the injury-in-fact
requirement to financial losses.” Id. at 366. We explained that, “[i]nstead, an injury refers
to the invasion of some ‘legally protected interest’ arising from constitutional, statutory, or
common law.” Id. (quoting Lujan, 504 U.S. at 578). And because ERISA gives employees
an interest in the profits generated using their contributions, we held that the employees
had standing to bring a disgorgement claim to recoup those profits. Id. at 366–67.

18

The dissent posits that Pender’s singular statement that “an injury refers to the
invasion of some ‘legally protected interest’ arising from constitutional, statutory, or
common law” means the plaintiff’s conduct itself must be only “rooted in a recognized
legal source.” Post at 58. Or, put differently, the dissent would insist that a plaintiff
identify some piece of positive law that gives them the specific right to engage in the
regulated activity before a court will hear their challenge to a State regulation of that
activity. C.f. Beck v. McDonald, 848 F.3d 262, 269 (4th Cir. 2017) (holding that “a plaintiff
bears the burden of establishing . . . Article III standing”).
But the dissent misreads Pender at least when viewed in full context. Rather,
Pender instructs courts to focus on the injury that results from the defendant’s conduct.
See Pender, 788 F.3d at 367 (holding that plaintiffs had suffered “an invasion of a legally
protected interest” because they “suffered an individual loss, measured as the spread or
difference between the profit” the employer kept and the money the employees received
(internal quotation marks and citation omitted)). If the plaintiff’s resulting injury has a
basis in “constitutional, statutory, or common law” then it is a cognizable one (although
not the only cognizable one) and suffices for Article III purposes. Id. at 366. And Pender
itself acknowledged that financial losses, such as those the Commercial Appellants claim
here, are cognizable injuries for Article III purposes. Id. Small wonder, then, that no party
to this appeal -- including the 28 State coalition that dedicated their amici brief to arguing
there is no standing -- bothered to cite Pender a single time in the 170 pages of briefing
before us.

19

Our dissenting colleague further criticizes our holding because it allows parties to
file suit and challenge additional government regulation of their already prohibited
conduct. But we discern no issue, in large part because it is a dubious reading of Lujan to
condition a plaintiff’s standing to challenge one law on their compliance with every other
applicable law.
5
And, as we have explained, it is such reasoning on the part of the dissent
that is untethered from the purpose of Article III’s standing requirement: ensuring the
plaintiff is the proper party to bring suit. See, e.g., White Tail Park, Inc. v. Stroube, 413
F.3d 451, 460 (4th Cir. 2005) (“The standing doctrine, of course, depends not upon the
merits, . . . but on whether the plaintiff is the proper party to bring [the] suit.” (internal
quotations marks and citations omitted)).
Article III standing is “a bedrock constitutional requirement” that is “built on a
single basic idea—the idea of separation of powers.” All. for Hippocratic Med., 602 U.S.
at 378 (quoting Texas, 599 U.S. at 675). In our tripartite system of government, the federal
courts do not “operate as an open forum for citizens ‘to press general complaints about the

5
The dissent repeatedly uses the phrase “undisputedly valid federal law” when
explaining that the Commercial Appellants’ conduct violates the FDCA. Post at 53, 62,
63. But what difference should it make whether another unchallenged law that also
prohibits the plaintiff’s conduct was passed by the federal or a state government, or whether
the law is valid beyond dispute or subject to reasonable debate? After all, if the law has
been enacted by a legislative body and signed by the executive, then the law is valid unless
and until it is either struck down or repealed. And if that valid, democratically enacted law
covers and prohibits the plaintiff’s conduct, then, following the dissent’s logic, there is but
one conclusion: the plaintiff has no legally protected interest in that prohibited conduct.
Perhaps the dissent’s conclusion would change if the separate statute that already prohibits
the plaintiff’s conduct was doomed from the start and destined to be struck down. But, as
we understand the dissent’s position, there is no basis to find any cognizable interest in
conduct that a valid, democratically enacted statute prohibits.

20

way in which government goes about its business.’” Id. at 379 (quoting Allen, 468 U.S. at
760). Instead, the federal courts exercise their “proper . . . role in our constitutional
system” by deciding only live disputes between adversaries. Texas, 599 U.S. at 675–76.
Doing so furthers certain commonsense interests, such as “assur[ing] that the legal
questions presented to the court will be resolved, not in the rarefied atmosphere of a
debating society, but in a concrete factual context conducive to a realistic appreciation of
the consequences of judicial action.” Piney Run Pres. Ass’n v. Cnty. Cmm’rs of Carroll
Cnty., 268 F.3d 255, 262 (4th Cir. 2001) (quoting Valley Forge Christian Coll. v. Ams.
United for Separation of Church & State, Inc., 454 U.S. 464, 472 (1982)). But Article III’s
standing requirement serves interests even more fundamental to our system of self
government, such as “prevent[ing] the judicial process from being used to usurp the powers
of the political branches.” Susan B. Anthony List v. Driehaus, 573 U.S. 149, 157 (2014)
(quoting Clapper v. Amnesty Int’l USA, 568 U.S. 398, 408 (2013)).
Thus, to ensure that we remain in our constitutionally prescribed lane, we ask “a
basic question” to every plaintiff that knocks on the courthouse door: “What’s it to you?”
Diamond Alt. Energy, LLC v. EPA, 606 U.S. 100, 110 (2025) (quoting All. for Hippocratic
Med., 602 U.S. at 379). If the plaintiff cannot demonstrate that the defendant’s conduct
affects them in an individualized, personal way, then we must send them away and await a
party that is actually affected by the challenged conduct, a party that will be able to
“properly . . . frame the issues and present them with the necessary adversarial zeal” to
amount to a case or controversy. Md. Shall Issue, Inc. v. Hogan, 971 F.3d 199, 215 (4th
Cir. 2020) (quoting Sec. of State of Md. v. Joseph H. Munson Co., 467 U.S. 947, 956

21

(1984)). If, on the other hand, a prospective plaintiff can demonstrate that a defendant’s
conduct adversely affects them in an individualized way, then they have a sufficient
“personal stake in the case” to unlock the courthouse doors, GenBioPro, Inc. v. Raynes,
144 F.4th 258, 269 (4th Cir. 2025) (internal quotation marks omitted) (quoting Biden, 600
U.S. at 489), and we have a duty to hear them out, Sonda v. W. Va. Oil & Gas Conservation
Comm’n, 92 F.4th 213, 219 (4th Cir. 2024).
That is all Article III’s injury-in-fact requirement is -- a way to “screen[] out
[bystanders] who might have only a general legal, moral, ideological, or policy objection
to a particular government action” from those individuals that are actually living with the
effects of a policy or piece of legislation. All. for Hippocratic Med., 602 U.S. at 381; see
also United States v. Students Challenging Regul. Agency Procs., 412 U.S. 669, 689 n.14
(1973) (explaining that Article III’s injury-in-fact requirement “distinguish[es] a person
with a direct stake in the outcome of a litigation—even though small—from a person with
a mere interest in the problem”); Ansley v. Warren, 861 F.3d 512, 517 (4th Cir. 2017)
(“[C]oncerned bystanders may not marshal the judiciary as a vehicle for the vindication of
value interests—the exercise of judicial power is restricted to litigants who seek to rectify
a personal and discrete harm.” (internal quotation marks omitted) (quoting Hollingsworth
v. Perry, 570 U.S. 693, 707 (2013))).
Thus, a plaintiff need not be in perfect compliance with every applicable law in
order for there to be a case or controversy sufficient to invoke our jurisdiction under Article
III. They need only be adversely affected by the law they challenge. Because the
Commercial Appellants here will suffer adverse financial consequences from Appellee

22

Wooten’s enforcement of S.L. 2024-31, they have demonstrated an injury-in-fact and, with
it, established standing. Therefore, we proceed to the merits.
B.
Merits
Appellants appeal the district court’s denial of their motion for a preliminary
injunction. As they see it, S.L. 2024-31 is preempted by the TCA and the FDCA. To
properly frame the parties’ arguments, we first review our standard for granting a
preliminary injunction, the preemption doctrine, and the pertinent portions of the TCA and
FDCA.
1.
Preliminary Injunction Standard
“A preliminary injunction,” we have said, “is ‘an extraordinary remedy that may
only be awarded upon a clear showing that the plaintiff is entitled to such relief.’”
Mountain Valley Pipeline, LLC v. W. Pocahontas Props. Ltd. P’ship, 918 F.3d 353, 366
(4th Cir. 2019) (quoting Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 22 (2008)). An
injunction “may never be awarded ‘as of right.’” Id. (quoting Winter, 555 U.S. at 24).
To obtain a preliminary injunction, “a plaintiff must establish that [1] they are likely
to succeed on the merits; [2] they are likely to suffer irreparable harm absent preliminary
relief; [3] the balance of the equities favors relief; and [4] the relief is in the public interest.”
Nat’l Ass’n of Diversity Officers in Higher Educ. v. Trump, 167 F.4th 86, 96 (4th Cir. 2026)
(quoting Leaders of a Beautiful Struggle v. Balt. Police Dep’t, 2 F.4th 330, 339 (4th Cir.
2021) (en banc)). Importantly, the party seeking injunctive relief must prove by a clear

23

showing that each factor favors an injunction. Frazier v. Prince George’s County, 86 F.4th
537, 544 (4th Cir. 2023) (“[A] preliminary injunction can be granted only if every [Winter]
factor is met,” “[y]et denying a preliminary injunction only takes the rejection of a single
factor.” (emphasis in original)); see also Henderson ex rel. NLRB v. Bluefield Hosp. Co.,
902 F.3d 432, 439 (4th Cir. 2018) (“Winter made clear that each of these four factors must
be satisfied to obtain preliminary injunctive relief.” (emphasis omitted)).
2.
Preemption Doctrine
“The Supremacy Clause of the Constitution dictates that ‘the Laws of the United
States’ are ‘the supreme Law of the Land.’” Guthrie v. PHH Mortg. Corp., 79 F.4th 328,
336 (4th Cir. 2023) (quoting U.S. Const. art. VI). Put simply, that means “a state law which
conflicts with federal law is preempted” and thus has no effect. Cox v. Shalala, 112 F.3d
151, 154 (4th Cir. 1997).
But preemption raises significant federalism concerns. See Medtronic, Inc. v. Lohr,
518 U.S. 470, 485 (1996); see also Arizona v. United States, 567 U.S. 387, 398 (2012)
(“Federalism, central to the constitutional design, adopts the principle that both the
National and State Governments have elements of sovereignty the other is bound to
respect.”). For that reason, every preemption analysis “begins ‘with the basic assumption
that Congress did not intend to displace state law.’” Guthrie, 79 F.4th at 336 (quoting S.
Blasting Servs., Inc. v. Wilkes County, 288 F.3d 584, 589 (4th Cir. 2002)). This
presumption applies with full force where, as here, federal law ventures into an area
traditionally occupied by the States. Medtronic, Inc., 518 U.S. at 485; see also S. Blasting

24

Servs., Inc., 288 F.3d at 590 (explaining that the presumption against preemption “is
strongest when Congress legislates in a field which the States have traditionally occupied”
(internal quotation marks and citation omitted)).
There are a few ways in which Congress can overcome this presumption when
enacting legislation. Just Puppies, Inc. v. Brown, 123 F.4th 652, 661 (4th Cir. 2024). The
first is through express preemption, which occurs when federal law “explicitly state[s] an
intention to preempt certain state laws.” Guthrie, 79 F.4th at 336. The second method is
through field preemption. Field preemption occurs when “federal law so thoroughly
occupies a legislative field as to make reasonable the inference that Congress left no room
for the States to supplement it.” S. Blasting Servs, Inc., 288 F.3d at 590 (quoting Cipollone
v. Liggett Grp., Inc., 505 U.S. 504, 516 (1992)). Conflict preemption is Congress’ third
option, and it has two subsets. Id. The first subset is known as impossibility preemption,
which, as its name suggests, exists when “compliance with both federal and state
regulations is a physical impossibility.” Hillsborough County v. Automated Med. Lab’ys,
Inc., 471 U.S. 707, 713 (1985) (quoting Fla. Lime & Avocado Growers, Inc. v. Paul, 373
U.S. 132, 142–43 (1963)). The second subset of conflict preemption is known as obstacle
preemption. Obstacle preemption arises “when state law stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of Congress.” S.
Blasting Servs., Inc., 288 F.3d at 590 (quoting Hillsborough, 471 U.S. at 713).

25

3.
TCA Overview
Regulating tobacco has historically been a task left largely to the States. R.J.
Reynolds Tobacco Co. v. County of Los Angeles, 29 F.4th 542, 548–49 (9th Cir. 2022).
Indeed, it was not until 2009 that Congress enacted the TCA and gave the federal
government, via the FDA, significant regulatory authority over tobacco products. Pub. L.
No. 111-31, 123 Stat. 1778 (2009).
One of the stated goals of the TCA was to “authorize the [FDA] to set national
standards controlling the manufacture of tobacco products and the identity, public
disclosure, and amount of ingredients used in such products.” Pub. L. No. 111-31, 123
Stat. 1778 (2009). Because setting national uniformity standards required taking some
regulatory authority away from the States, Congress realized that it needed to delineate
what territory it claimed as exclusively federal and what territory it intended to share with
the States. County of Los Angeles, 29 F.4th at 550 (explaining that the “TCA balances state
and federal power over tobacco regulation”). Congress marked these boundaries using a
three part preemption provision. See 21 U.S.C. § 387p.
First is the “Preservation Clause.” It reads:
Except as provided in [the Preemption Clause (discussed
below)], nothing in [the TCA], shall be construed to limit the
authority of . . . a State or political subdivision of a State . . . to
enact, adopt, promulgate, and enforce any law, rule, regulation,
or other measure with respect to tobacco products that is in
addition to, or more stringent than, requirements established
under this subchapter, including a law, rule, regulation, or other
measure relating to or prohibiting the sale, distribution,
possession, exposure to, access to, advertising and promotion

26

of, or use of tobacco products by individuals of any age,
information reporting to the State, or measures relating to fire
safety standards for tobacco products. No provision of this
subchapter shall limit or otherwise affect any State, tribal, or
local taxation of tobacco products.

21 U.S.C. § 387p(a)(1). The effect of the Preservation Clause is straightforward: Congress
merely disclaimed any intent to preempt the tobacco field. R.J. Reynolds Tobacco Co. v.
City of Edina, 60 F.4th 1170, 1174 (8th Cir. 2023) (per curiam) (“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 tobacco use.”).
The second clause in this preemption provision is the “Preemption Clause.” That
clause provides:
No State or political subdivision of a State may establish or
continue in effect with respect to a tobacco product any
requirement which is different from, or in addition to, any
requirement under the provisions of this subchapter relating to
tobacco product standards, premarket review, adulteration,
misbranding, labeling, registration, good manufacturing
standards, or modified risk tobacco products.

21 U.S.C. § 387p(a)(2)(A) (emphasis supplied). Thus, although Congress disclaimed any
intent to preempt the field, Congress used the Preemption Clause to remove a few areas of
the tobacco industry from State regulation. City of Edina, 60 F.4th at 1174 (“So if the
Preservation Clause is a general rule that [States] can regulate beyond the TCA, the
Preemption Clause carves out a few areas where they cannot regulate beyond the TCA.”).
The third and final clause in this tripartite preemption provision is the “Savings
Clause.” It provides:

27

[The Preemption Clause] does not apply to requirements
relating to the sale, distribution, possession, information
reporting to the State, exposure to, access to, the advertising
and promotion of, or use of, tobacco products by individuals of
any age, or relating to fire safety standards for tobacco
products.

21 U.S.C. § 387p(a)(2)(B). The Savings Clause, therefore, removes some matters from the
Preemption Clause’s scope, and it makes clear that States can continue regulating those
matters. County of Los Angeles, 29 F.4th at 549–50 (recognizing that “Congress [did not
intend to] broadly jettison[] the longstanding tradition of states and localities’ role in the
regulation of sales of tobacco products when it enacted the TCA in 2009”).
To recap: in the TCA, Congress disclaimed any intent to occupy the field, but it did
reserve a few areas -- tobacco product standards, pre-market review, adulteration,
misbranding, labeling, registration, good manufacturing standards, and modified risk
tobacco products -- where States cannot legislate. But Congress also made clear that States
maintain the ability to regulate the sale of tobacco products.
Having worked through the TCA’s unique preemption provision, we now have a
second preemption provision to discuss. As explained above, when Congress enacted the
TCA, it placed the TCA within the FDCA. See Pub. L. No. 111-31, 123 Stat. 1778 (2009).
And the FDCA has its own unique preemption provision. Pursuant to 21 U.S.C. § 337(a),
the FDA has exclusive enforcement authority when it comes to FDCA violations:
“all . . . proceedings for the enforcement, or to restrain violations, of th[e] [FDCA] shall be
by and in the name of the United States.” This includes the requirement that tobacco

28

products -- including vape products -- first receive FDA approval before being placed on
the market. See 21 C.F.R. § 1114.5.
4.
North Carolina S.L. 2024-31
Having worked through the necessary table setting, we now return to the case at
hand. At the outset, we note that S.L. 2024-31 appears to fit comfortably in the Savings
Clause as a sales regulation. In enacting S.L. 2024-31, North Carolina has passed
legislation that sets certain criteria that vape products must meet before they can be legally
sold in the State. In other words, S.L. 2024-31 acts as a sales restriction that conditions
market access on a manufacturer certifying the vape product meets certain discrete criteria.
Despite this, Appellants argue that S.L. 2024-31 is impliedly preempted by the
FDCA and TCA. Appellants make two arguments in support of this proposition. First,
they argue that S.L. 2024-31 is preempted by § 337(a) because, in enforcing S.L. 2024-31,
the State is, in effect, enforcing the FDCA premarket approval requirement, which § 337(a)
forbids. Second, and in the alternative, Appellants contend that S.L. 2024-31 will greatly
reduce the amount of vape products on the market, which will stand as an obstacle to the
TCA’s objective of helping tobacco users quit traditional cigarettes.
6
We address each
argument in turn.

6
Appellants also argue that S.L. 2024-31 is expressly preempted by the TCA. But
because Appellants did not raise that theory of preemption below (or even include it in
their complaint), we deem the argument waived. Mountain Valley Pipeline, LLC v. 8.37
Acres of Land by Terry, 101 F.4th 350, 360 (4th Cir. 2024) (“Absent exceptional
(Continued)

29

a.
North Carolina Is Not Enforcing Federal Law
Appellants’ first argument is straightforward. They argue that, because S.L. 2024-
31 requires new vape products to have FDA approval before they can be placed on the
directory and sold in the State, North Carolina is, in effect, using S.L. 2024-31 to enforce
the FDCA’s pre-market approval requirement. That State enforcement, Appellants
contend, runs afoul of § 337(a). See 21 U.S.C. § 337(a) (“[A]ll such proceedings for the
enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the
United States.”).
To resolve this issue, we must determine what it means to “enforce” the FDCA. The
Supreme Court has addressed the matter only once, in Buckman Co. v. Plaintiffs’ Legal
Committee, 531 U.S. 341 (2001). There, a medical device company had difficulty
obtaining FDA approval for surgical screws it made. After a failed attempt, the company
hired a consulting company, which helped the medical device company navigate the
regulatory framework and get the screws approved. But those screws later proved
defective, and they injured several patients. The patients filed a class action against the
screw manufacturer and consulting company. The class brought state law fraud claims,
alleging that the two defendants had made false representations to the FDA in order to get
the screws approved, which led to their injuries.

circumstances, parties may not raise new arguments on appeal that were not first presented
to the district court.”).

30

The Supreme Court held that these common law claims were preempted. In doing
so, the Court first explained that regulating fraud against the FDA is anything but a
traditional state function, which meant the presumption against preemption did not apply.
Buckman, 531 U.S. at 347 (“Policing fraud against federal agencies is hardly a field which
the States have traditionally occupied, such as to warrant a presumption against finding
federal pre-emption of a state-law cause of action.” (internal citation and quotation marks
omitted)). The Court then observed that Congress had given the FDA “a variety of
enforcement options . . . that allow it to make a measured response to suspected fraud,”
ranging from fines and injunctions to criminal prosecution. Id. at 348–49. Allowing
private plaintiffs to also police fraud against the FDA via state law fraud claims, the Court
reasoned, would “would exert an extraneous pull on the scheme established by Congress,”
id. at 353, and “inevitably conflict with the FDA’s responsibility to police fraud
consistently with the [FDA’s] judgment and objectives,” id. at 350.
Trying to avoid this conclusion, the class members argued that the Court had already
established in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), that state law “claims arising
from violations of FDCA requirements” were not preempted by the FDCA. Buckman, 531
U.S. at 352. The Court disagreed. The Court explained that Medtronic involved a state
law claim predicated on “the manufacturer’s alleged failure to use reasonable care in the
production of the product,” as opposed to a “violation of FDCA requirements,” which
meant the plaintiff there was not enforcing the FDCA. Id. at 352. The Buckman class, by
contrast, had brought “fraud claims [that] exist[ed] solely by virtue of the FDCA disclosure
requirements,” which meant the class members would have to prove “a[] violation of the

31

FDCA” in order to make out their claims. Id. at 353. Because “the existence of the[]
[FDCA] [wa]s a critical element [of] their case,” the Court held that the class members’
fraud claims were attempts to enforce the FDCA and thus preempted by § 337(a). Id. at
349 n.4, 353.
Here, Appellants latch onto the “critical element” language from Buckman. As
Appellants read it, Buckman stands for the proposition that a state law claim enforces
federal law, and is therefore preempted, if it incorporates a portion of the FDCA and would
not exist but for the FDCA. In support, Appellants cite Scanlon v. Medtronic Sofamor
Danek USA Inc., 61 F. Supp. 3d 403 (D. Del. 2014), an out of circuit district court case.
But Scanlon is of no moment here. Not only is it of no precedential value to us, it
is wholly irrelevant. As Appellants concede, Scanlon dealt with a different preemption
clause (21 U.S.C. § 360k) and discussed the tightrope that plaintiffs must walk to escape
that preemption clause’s unique requirements. Scanlon, 61 F. Supp. 3d at 411; see also
Appellants’ Opening Br. at 32 (discussing how “state law claim[s] survive[] preemption
under section 360k”). Buckman, by contrast, dealt with § 337(a) alone and specifically
avoided discussing § 360k’s peculiar preemption requirements. Buckman, 531 U.S. at 348
n.2 (“[W]e express no view on whether these claims are subject to express pre-emption
under 21 U.S.C. § 360k.”).
Scanlon aside, Appellants read Buckman too broadly. Buckman does not, as
Appellants suggest, mean a state law claim is preempted if the state law claim would not
exist but for the FDCA’s existence. Instead, Buckman instructs that a state law claim is

32

preempted if, but only if, the plaintiff needs to establish an FDCA violation to prevail on
the claim.
The Ninth Circuit’s decision in Nexus Pharmaceuticals, Inc. v. Central Admixture
Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022), illustrates this point. There, the
FDCA prohibited compounding
7
pharmacies from selling drugs that were “essentially a
copy” of FDA-approved drugs. Id. at 1043. In other words, compounding pharmacies
lacked FDA approval to sell generic versions of trademarked drugs; they could only sell
compounded or altered versions of trademarked drugs. Nevertheless, a compounding
pharmacy sold what was “essentially a copy” or an unapproved generic of a drug
manufacturer’s trademarked, FDA-approved drug. Id. The manufacturer sued the
compounding pharmacy, alleging that these sales violated various States’ laws that
“prohibit[ed] the sale of drugs not approved by the FDA.” Id. at 1044.
The Ninth Circuit held that these claims were preempted. In doing so, the court
explained that the pharmacy was not bringing a traditional state tort suit premised on a
violation of a common law duty that existed independent of the FDCA. Nexus, 48 F.4th at
1047–48. Instead, the court found that “a necessary element of [the plaintiff’s] claim [was
proving] the alleged violation of the FDCA.” Id. at 1048 (emphasis supplied). That meant
the plaintiff’s claim “would require litigation of the alleged underlying FDCA violation in

7
Compounding is the process by which pharmacies “alter[] ingredients in medicines
to tailor them to individual patients.” Nexus, 48 F.4th at 1042. This is done for any number
of reasons. Sometimes, the patient is allergic to a mass produced, FDA approved version
and they need an altered medication free of the allergen. Id. Other times, a prescription
drug may be compounded to make the taste more palatable for children. Id.

33

a circumstance where the FDA has not itself concluded that there was a violation.” Id.
(quoting PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924, 930–31 (9th Cir. 2010)). In effect,
that would result in the plaintiff “assum[ing] enforcement power [of the FDCA and] require
the finder of fact to make a decision that the FDA itself did not make.” Id. at 1049 (quoting
PhotoMedex, Inc., 601 F.3d at 930). Because § 337(a) forbids private plaintiffs from doing
exactly that, the court held that the claims were preempted.
This case is worlds apart from Buckman and Nexus. Unlike those cases, enforcing
S.L. 2024-31 does not require North Carolina to establish an underlying violation of the
FDCA -- much less a violation that the FDA has yet to adjudicate. Instead, to enforce S.L.
2024-31, North Carolina officials need only show that a vape product was sold in the State,
despite it not being listed on North Carolina’s registry. That showing does not require State
officials to establish a violation of the FDCA.
Indeed, a manufacturer may disagree with the decision of the NCDOR Secretary to
remove them from the registry for any number of reasons, such as non-payment of the
annual fee or for having made a material misstatement in the certification process, and
continue to sell their FDA approved vape in North Carolina notwithstanding the
Se cretary’s action. In either circumstance, the manufacturer will have complied with
federal law but violated S.L. 2024-31. Because North Carolina can enforce S.L. 2024-31
without establishing an FDCA violation, S.L. 2024-31 does not run afoul of § 337(a).
Appellants argue in the alternative that S.L. 2024-31 is a backdoor means of
enforcing the FDCA. This is so, Appellants contend, because S.L. 2024-31 “compels at
least partial compliance with the FDCA’s premarket review requirements” (presumably

34

because any new vape that has entered the market after August 8, 2016, can be sold in
North Carolina only if it has FDA approval). Appellants’ Opening Br. at 24.
This argument is irreconcilable with § 337(a)’s text and Buckman’s holding.
Section 337(a), for its part, preempts only those “proceedings for the enforcement, or to
restrain violations, of” the FDCA. 21 U.S.C. § 337(a). And Buckman made clear that a
State proceeding “enforces” the FDCA if, but only if, the State must establish a “violation
of [the] FDCA[’s] requirements” to make its case. Buckman, 531 U.S. at 352–53. Section
337(a) does not prohibit a State, like North Carolina, from setting certain criteria that
prospective sellers must meet before they can sell their tobacco products in the State. That
is a valid exercise of a State’s traditional police powers specifically reserved to the States
by the TCA’s Saving Clause.
8

8
Appellants also posit that construing the Savings Clause to permit the sort of sales
regulation here will render the Preemption Clause a “nullity.” Appellants’ Opening Br. at
34. This is so, Appellants argue, because States could begin legislating on matters
preempted by § 387p(a)(2)(A) so long as they couch the preempted laws as sales
restrictions. We have yet to address whether a sales restriction can have the effect of
regulating matters preempted by § 387p(a)(2)(A)’s Preemption Clause, and our sister
circuits have expressed some disagreement on the matter. Compare U.S. Smokeless
Tobacco Mfg. Co. v. City of New York, 708 F.3d 428, 434 (2d Cir. 2013) (“Certainly, any
purported sales ban that in fact functions as a command to tobacco manufacturers to
structure their operations in accordance with locally prescribed standards would not escape
preemption simply because the City ‘fram[ed] it as a ban on the sale of [tobacco] produced
in whatever way [it] disapproved.’” (citation and some internal quotation marks omitted)),
with Nat’l Ass’n of Tobacco Outlets, Inc. v. City of Providence, 731 F.3d 71, 83 n.11 (1st
Cir. 2013) (disagreeing with U.S. Smokeless’ “reasoning to the extent it suggests that, under
some circumstances, a sales regulation may be an effective regulation on manufacturing”
because “[g]iven Congress’ decision to exempt sales regulations from preemption, whether
those regulations have an impact on manufacturing is irrelevant”). We need not enter that
fray today because, even if Appellants are correct and some sales restrictions may
(Continued)

35

b.
North Carolina S.L. 2024-31 Does Not Frustrate Federal Objectives
We now turn to Appellants’ second preemption argument, in which they argue that
S.L. 2024-31 stands as an obstacle to the TCA and is therefore preempted. In support,
Appellants first note that Congress enacted the TCA to give the FDA “flexible enforcement
authority” over “less harmful tobacco products.” Appellants’ Opening Br. at 40. This was
done, Appellants say, because Congress wanted the FDA to use the TCA to “reduc[e]
serious tobacco-related disease and death, which is primarily caused by” traditional
cigarettes. Id. From there, Appellants argue that the FDA has adopted its selective
enforcement policy on vapes in order to carry out that command, recognizing that vapes,
even if unapproved, are a safer option than traditional cigarettes. But Appellants contend
that S.L. 2024-31 will limit consumers’ options of vape products, including the most
popular ones. And, Appellants posit, if vape users are left without their preferred products,
they will revert to traditional cigarettes and risk contracting the tobacco related diseases
Congress enacted the TCA to curtail. Appellants thus ask us to hold that S.L. 2024-31
stands as an obstacle to the TCA. We decline to do so.
As explained above, a state statute is obstacle preempted if it “stands as an obstacle
to the accomplishment and execution of the full purposes and objectives of Congress.”
Columbia Venture, LLC v. Dewberry & Davis, LLC, 604 F.3d 824, 829–30 (4th Cir. 2010)

impermissibly intrude into matters immune from state regulation, the sales restrictions
under review here do no such thing. So, we leave that issue for another day.

36

(quoting Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)). Making that
determination “is a two-step process.” Guthrie, 79 F.4th at 338 (quoting Va. Uranium, Inc.
v. Warren, 848 F.3d 590, 599 (4th Cir. 2017)). We must first “determine Congress’s
‘significant objectives’ in passing the federal law.” Id. (quoting Va. Uranium, Inc., 848
F.3d at 599). “We then turn to whether the state law stands ‘as an obstacle to the
accomplishment of a significant federal regulatory objective.’” Id. (quoting Va. Uranium,
Inc., 848 F.3d at 599).
Congress enacted the TCA to give the FDA “authority . . . to regulate tobacco
products under [the FDCA], by recognizing [the FDA] as the primary [f]ederal regulatory
authority with respect to the manufacture, marketing, and distribution of tobacco
products.” Pub. L. No. 111-31, 123 Stat. 1778 (2009) (emphasis supplied). In other words,
Congress enacted the TCA to “authorize the [FDA] to set national standards controlling
the manufacture of tobacco products and the identity, public disclosure, and amount of
ingredients used in such products.” Id.
These congressional pronouncements make clear that Congress intended the FDA
to be the primary player in regulating the manufacture, marketing, and distribution of
tobacco products. And Congress made that intention a reality when it preempted States --
via the TCA’s Preemption Clause -- from regulating those specific areas of the tobacco
industry.
But Congress never said that it intended the TCA to strip States of their traditional
police power to regulate the sale of tobacco products within their borders. More to the
point, we have no indication that Congress intended the TCA to force States to allow every

37

available tobacco product -- even those that lack FDA approval -- to be sold in their
borders, simply because the FDA has yet to crack down on those tobacco products.
Yet Appellants ask us to find that Congress intended just that when it enacted the
TCA. In making that argument, however, Appellants misconstrue the stated congressional
purpose on which they purport to rely. In the TCA, Congress also declared that it was
enacting the statute “to provide new and flexible enforcement authority to ensure that there
is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote
less harmful tobacco products.” Pub. L. No. 111-31, 123 Stat. 1778 (2009) (emphasis
supplied). That meant only that Congress intended the FDA to have some flexibility to
work with tobacco companies as they developed new products and got them on the market.
That stated purpose did not, as Appellants believe, demonstrate any “[c]ongress[ional]
objective . . . to give tobacco companies an unqualified right to sell each and every tobacco
product” to which the FDA turns a blind eye. City of Edina, 60 F.4th at 1178. To the
contrary, Congress disclaimed that intent when it enacted the TCA’s Savings Clause, which
explicitly states the TCA does not preempt any state laws that “relat[e] to the sale [of]
tobacco products.” 21 U.S.C. § 387p(a)(2)(B).
This understanding matches Congress’ intended operation of the TCA. The TCA
gives the FDA exclusive regulatory authority when it comes to the manufacture and
development of tobacco products. As a result, the FDA alone decides which tobacco
products can go on the market. But the TCA also allows the States to use their longstanding
police powers to pick and choose what available tobacco products can be sold within their
borders. States remain free to follow the lead of the FDA and allow the sale of every

38

available tobacco product. But States also remain free to ban the sale of any tobacco
product they choose -- or even entire classes of tobacco products, if they so desire. County
of Los Angeles, 29 F.4th at 560 (“Congress intended to allow the federal government the
sole authority to set tobacco product standards, while retaining for states and localities their
longstanding authority to say: ‘not here.’”); see also Austin v. Tennessee, 179 U.S. 343,
348–49 (1900) (upholding state law that bans cigarette sales, stating, “we think it within
the province of the legislature to say how far [cigarettes] may be sold, or to prohibit their
sale entirely [because] there [can] be no reason to doubt that the act in question is designed
for the protection of the public health”).
We do not see how S.L. 2024-31 stands as an obstacle to this two-tiered statutory
scheme. The FDA is allowing unapproved vape products to enter the market -- that is the
FDA’s prerogative. But North Carolina remains free to prohibit the sale of those products
within its borders. That is a valid exercise of North Carolina’s police powers, and it is
entirely consistent with the Savings Clause found in the TCA. Therefore, S.L. 2024-31
does not impede any congressional purpose enshrined in the TCA.
Appellants also point out, and we recognize, that S.L. 2024-31 may conflict with
the FDA’s case-by-case enforcement method for vapes that lack FDA approval. But that
is immaterial to the obstacle preemption analysis. As the Supreme Court has made clear,
“the possibility that federal enforcement priorities might be upset [by a State’s co-
regulation of that same activity] is not enough to provide a basis for preemption.” Kansas
v. Garcia, 589 U.S. 191, 212 (2020). And that makes good sense: obstacle preemption
inquires into Congress’ objectives, not the Executive’s. City of Edina, 60 F.4th at 1178

39

(“[C]onflict preemption requires the state law to stand in the way of the objectives of
Congress, not the FDA.”).
* * *
In sum, there is no indication that S.L. 2024-31 is preempted by federal law.
Appellants have thus failed to demonstrate that they are likely to succeed on the merits,
and the district court properly denied their motion for a preliminary injunction on that basis.
IV.
For the foregoing reasons, we affirm the district court’s denial of Appellants’ motion
for a preliminary injunction.
AFFIRMED

40

AGEE, Circuit Judge, concurring:
This case is about whether the Federal Food, Drug, and Cosmetic Act (“FDCA”)
preempts North Carolina’s statutory scheme regulating electronic nicotine delivery system
(“ENDS”) products, SL 2024-31. Judge Thacker’s opinion explains why it does not, and
why, as a threshold matter, Plaintiffs—North Carolina retailers of ENDS products—have
standing to bring this challenge. I am pleased to join it in full.
I write separately to respond to my good friend in dissent to discuss more directly
the application of standing principles in this case.
1
In Judge Quattlebaum’s view, Plaintiffs
haven’t suffered an Article III injury in fact because the FDCA, an unchallenged federal
statute, also prohibits the sale of the products they wish to sell. In my view, the dissent
reads too much into Lujan’s
2
lone reference to a “legally protected interest” for standing
purposes. That said, the Supreme Court’s stray language in Lujan has led to a degree of
uncertainty that it ought to clarify.
* * *
Standing is a foundational constitutional principle. Under Article III, if a party
doesn’t have standing then it has no right to access a federal courthouse to present its claim.
Just as important, without standing, the court is without authority to act on a claim.
As my colleagues have recounted, the oft-repeated elements of standing that a
plaintiff must establish to come through the courthouse door are (1) injury in fact, (2)

1
I use “Plaintiffs” to refer to what Judge Thacker has defined to be the “Commercial
Appellants.” See Maj. Op. at 9.
2
Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992).

41

traceability (causation), and (3) redressability. Food & Drug Admin. v. All. for Hippocratic
Med., 602 U.S. 367, 380 (2024).
It’s important to keep in mind that, in this case, we are primarily concerned with the
first element: have Plaintiffs suffered a cognizable injury for Article III purposes? If not,
then the remaining elements, traceability (causation) and redressability, are moot. That
said, even if there is a cognizable injury, Plaintiffs still lack standing if their injury is not
traceable to the defendant (i.e., the defendant wasn’t the likely cause) or the court cannot
provide a remedy for the injury.
3

What qualifies as an injury in fact? At the most basic level, the injury requirement
seeks “to distinguish a person with a direct stake in the outcome of a litigation—even
though small—from a person with a mere interest in the problem.” United States v.
Students Challenging Regul. Agency Procs. (SCRAP), 412 U.S. 669, 689 n.14 (1973); see
also Friends of the Earth, Inc. v. Gaston Copper Recycling Corp., 204 F.3d 149, 156 (4th
Cir. 2000) (en banc) (“The injury in fact requirement precludes those with merely
generalized grievances from bringing suit to vindicate an interest common to the entire
public.”).
Putting those purposes into focus, the injury in fact requirement requires a plaintiff
to plead “an injury in fact that is concrete, particularized, and actual or imminent[.]” Thole
v. U.S. Bank N.A., 590 U.S. 538, 540 (2020). As Justice Kavanaugh recently put it: “An

3
As discussed later, in a case with different facts, some of the concerns raised by
Judge Quattlebaum could be resolved if a plaintiff cannot meet its burden to establish the
traceability or redressability prongs of standing.

42

injury in fact can be a physical injury, a monetary injury, an injury to one’s property, or an
injury to one’s constitutional rights, to take just a few common examples.” All. for
Hippocratic Med., 602 U.S. at 381.
I agree with Judge Thacker that Plaintiffs clear the injury in fact bar in this case.
They allege that North Carolina’s enforcement of SL 2024-31 will prevent them from
selling ENDS products in the State and force them to close their stores, which will lead to
lost profits. See, e.g., J.A. 28 ¶ 79. Those alleged economic harms are the interests at issue
and are a paradigmatic judicially cognizable injury in fact: “classic pocketbook injury.”
Maj. Op. at 12; see also Air Evac EMS, Inc. v. Cheatham, 910 F.3d 751, 760 (4th Cir. 2018)
(holding that “financial harm is a classic and paradigmatic form of injury in fact”).
Enforcement of SL 2024-31 will, as alleged, “affect the plaintiff[s] in a personal and
individual way.” Spokeo, Inc. v. Robins, 578 U.S. 330, 339 (2016). And North Carolina
has made clear it intends to enforce SL 2024-31, so the injury is sufficiently imminent. All
this suffices, at this stage of the litigation, to adequately demonstrate Plaintiffs have alleged
a sufficient injury in fact.
Concluding otherwise, the dissent focuses on the “legally protected interest”
language from Lujan to conclude that Plaintiffs don’t have an injury in fact. In support, the
dissent zeros in on one line in Pender v. Bank of America Corp., where we said that a
“‘legally protected interest’ aris[es] from constitutional, statutory, or common law.” 788
F.3d 354, 366 (4th Cir. 2015) (quoting Lujan, 504 U.S. at 578). From that singular dictum,
the dissent asserts that we’ve already “recognized the importance” of, and “supplied
meaning to” Lujan’s use of “legally protected interest” in the standing context. Diss. Op.

43

at 56. And because “neither the Constitution nor any statute nor the common law gives the
plaintiffs a legally protected interest in conduct that violates unchallenged federal law,” the
dissent proffers that Plaintiffs have not alleged an injury in fact and thus do not have
standing. Id. at 59.
Respectfully, I disagree. In my view, the dissent’s analysis fails for at least two
reasons. First, properly understood, Lujan requires only an injury to a judicially cognizable
interest. The weight of authority demonstrates that, when the Supreme Court referred to a
“legally protected interest,” it meant only a judicially cognizable one. See, e.g., Sierra Club
v. Jewell, 764 F.3d 1, 6 (D.C. Cir. 2014) (“When the Lujan Court used the phrase ‘legally
protected interest’ as an element of injury-in-fact, it was referring only to a cognizable
interest.” (cleaned up)). And, as explained below, an interest is judicially cognizable if it’s
“traditionally thought to be capable of resolution through the judicial process.” Flast v.
Cohen, 392 U.S. 83, 97 (1968). The Supreme Court, in Lujan or elsewhere, has never
circumscribed a judicially cognizable interest, even by implication, to be limited to an
interest solely derived from constitutional, statutory, or common law.
Second, the dissent’s construction of “legally protected interest” unnecessarily
conflates standing with the merits and confuses concerns ordinarily raised in assessing
traceability and redressability with whether there’s been an injury in fact.
Admittedly our discussion here is a bit academic. After all, it’s hard to conceive of
a valid injury that doesn’t flow from a constitutional, statutory or common-law claim. But
for standing purposes, the query is as whether the injury is initially “cognizable,” that is, a
recognized injury as alleged that gets you through the courthouse door to plead your case.

44

It’s not whether your claim is ultimately valid from its inception as a matter of
constitutional, statutory, or common law. If that were true, then every standing decision
would be resolved at the first step on the merits, and the courthouse door would be closed
before the plaintiff could enter.
Let’s begin with Lujan. There is no indication in that decision that the Supreme
Court altered the standing doctrine when it referred to an injury in fact as the “invasion of
a legally protected interest.” If it did introduce a new requirement for standing—“a bedrock
constitutional requirement that [the Supreme Court] has applied to all manner of important
disputes,” All. for Hippocratic Med., 602 U.S. at 378 (cleaned up)—one would expect the
Court to have said so and explained how it operates. It did neither. Lujan did not define the
phrase, nor did it independently analyze it when applying the alleged test it had just
articulated. Further, the Supreme Court has rarely mentioned the phrase since.
To the contrary, Lujan cited cases establishing the “irreducible constitutional
minimum of standing” that had developed “[o]ver the years.” 504 U.S. at 560. Those
decisions asked only whether the asserted injury was judicially cognizable, not whether it
was barred by constitutional, statutory, or common law ab initio. See Allen v. Wright, 468
U.S. 737, 763 (1984) (“The interest acquired was judicially cognizable because it was a
personal interest, created by law, in having the State refrain from taking specific actions.”);
Warth v. Seldin, 422 U.S. 490, 514 (1975) (“Congress may create a statutory right or
entitlement the alleged deprivation of which can confer standing to sue even where the
plaintiff would have suffered no judicially cognizable injury in the absence of statute.”);
Sierra Club v. Morton, 405 U.S. 727, 740 (1972).

45

Indeed, Lujan itself described “the desire to use or observe an animal species, even
for purely esthetic purposes” as “undeniably a cognizable interest for purpose of standing.”
504 U.S. at 562–63 (emphasis added) (citing Morton, 405 U.S. at 734). The plaintiffs’
injury did not turn on whether that interest was “legally protected,” but whether the
plaintiffs were “among the injured,” and “directly affected” by the challenged actions. Id.
at 563 (cleaned up).
Lujan says nothing about the particular source of a plaintiff’s alleged injury, nor did
it establish a new requirement, since unmentioned, that every injury trace back to a
circumscribed “legally protected interest.” So, when Pender cited Lujan, there would have
been no precedential basis by which to establish that only interests conclusively established
“from constitutional, statutory, or common law” would be valid for standing purposes. See
788 F.3d at 366 (citing Lujan, 504 U.S. at 578). Pender merely identified a subset of
injuries that are judicially cognizable. The critical requirement remains that the injury
“affect ‘the plaintiff in a personal and individual way’” rather than amount to a mere
“generalized grievance.” All. for Hippocratic Med., 602 U.S. at 381 (quoting Lujan, 504
U.S. at 560 n.1); cf. Cantrell v. City of Long Beach, 241 F.3d 674, 681 (9th Cir. 2001)
(“That the litigant’s interest must be greater than that of the public at large does not imply
that the interest must be a substantive right sounding in property or contract.”).
Nor am I persuaded by the dissent’s reliance on our prior isolated use of the phrase
“legally protected interest.” See Diss. Op. at 54. Consider White Tail Park, Inc. v. Stroube,
413 F.3d 451 (4th Cir. 2005), which provides no reason to think that a “legally protected

46

interest” differs from a judicially cognizable one.
4
There, we observed that “[a] regulation
that reduces the size of a speaker’s audience [could] constitute an invasion of a legally
protected interest” because the speaker had a First Amendment interest in maintaining its
audience size. Id. at 461. The point wasn’t that the plaintiff had identified a freestanding
source of positive law protecting audience size. It was that the asserted injury was the sort
traditionally regarded as capable of judicial resolution.
That understanding accords with the consistent reading of Lujan. As the D.C. Circuit
recently explained, the phrase “‘legally protected interest’ in Lujan is best understood as
referring to a cognizable interest rather than imposing a new requirement that the invaded
interest be affirmatively protected by positive law.” Tanner-Brown v. Haaland, 105 F.4th
437, 446 (D.C. Cir. 2024) (citing Jud. Watch, Inc. v. U.S. Senate, 432 F.3d 359, 363 (D.C.
Cir. 2005) (Williams, J., concurring)); see also Maj. Op. at 14 (“Lujan did not . . . graft
onto Article III a novel requirement that the plaintiff have a legal right to engage in the
regulated conduct.”); ABF Freight Sys., Inc. v. Int’l Bhd. of Teamsters, 645 F.3d 954, 959
(8th Cir. 2011) (“A ‘legally protected interest’ requires only a ‘judicially cognizable
interest.’”).

4
The same is true of the out-of-circuit cases that Judge Quattlebaum indicates
“agree” that “legally protected interest” does independent work in the standing analysis.
See Diss. Op. at 55. For example, in Ruiz v. Bally Total Fitness Holding Corp., the First
Circuit found that if a contract “violate[s] the plaintiff’s rights under” Massachusetts law,
“that violation would necessarily constitute an invasion of a legally protected interest.” 496
F.3d 1, 6 (1st Cir. 2007). But Ruiz never undertook to limit a “legally protected interest” to
the exclusive box of constitutional, statutory, or common law. One can simply swap
“legally protected interest” with “judicially cognizable interest”—and I conclude the two
are interchangeable—and get to the same place.

47

In my view, Lujan only requires a plaintiff to allege an injury to a judicially
cognizable interest that is (1) concrete and particularized and (2) actual or imminent. And
an interest is judicially cognizable when it is “traditionally thought to be capable of
resolution through the judicial process.” Flast, 392 U.S. at 97; see also Friends of the
Earth, Inc., 204 F.3d at 154 (“Is the injury too abstract, or otherwise not appropriate, to be
considered judicially cognizable?”). The question, for standing purposes, is whether the
asserted injury is the sort courts can recognize, not whether the plaintiff can identify a
constitutional provision, statute, or common-law rule that affirmatively and conclusively
protects the precise conduct at issue ab initio.
The dissent acknowledges Plaintiffs’ alleged injury from the challenged provision
but concludes that this injury is insufficient to demonstrate an injury in fact. Put differently,
the dissent would accept that SL 2024-31 forces Plaintiffs to either not sell ENDS products
and lose profits or be subject to the statute’s extensive enforcement scheme. Diss. Op. at
62. Despite acknowledging this economic injury—a “classic and paradigmatic form of
injury in fact,” Air Evac EMS, Inc., 910 F.3d at 760—the dissent concludes that no injury
in fact exists because “neither the Constitution nor any statute nor the common law gives
the plaintiffs a legally protected interest in conduct that violates unchallenged federal law,”
Diss. Op. at 59.
But that conclusion answers a query ancillary to the determination of whether a
plaintiff has an injury for standing purposes. Instead, standing asks whether the challenged
action injures the plaintiff. See, e.g., White Tail Park, Inc., 413 F.3d at 461 (“A regulation
that reduces the size of a speaker’s audience can constitute an invasion of a legally

48

protected interest.”). In that regard, Plaintiffs challenge North Carolina’s enforcement of
SL 2024-31, which they allege prevents them from selling ENDS products and causes them
to lose profits. Those allegations describe a concrete and particularized injury. Yet under
the dissent’s approach, none of that matters and whether their injury is to a legally protected
interest turns on whether Plaintiffs also separately challenge the FDCA.
The Supreme Court has repeatedly instructed that “standing in no way depends on
the merits of the plaintiff’s contention that particular conduct is illegal.” Warth, 422 U.S.
at 500. Accordingly, courts assessing standing must initially assume the validity of the
plaintiff’s legal theory rather than resolve it at a nascent stage. See Laufer v. Naranda
Hotels, LLC, 60 F.4th 156, 161 (4th Cir. 2023). For the same reason, we “may not dismiss
for lack of standing on the theory that the underlying interest is not legally protected.”
Cooksey v. Futrell, 721 F.3d 226, 239 (4th Cir. 2013). Yet that’s effectively what the
dissent’s analysis requires. To determine whether Plaintiffs have suffered an injury to a
legally protected interest, the dissent would first determine whether they have a lawful
entitlement to engage in the regulated conduct. Under that approach, the standing inquiry
becomes dependent on the very legal question a plaintiff would seek to litigate.
Whether Plaintiffs have suffered an injury in fact can’t depend on the addition of
another claim to the complaint. If it did, standing would turn not on the injury alleged but
on the legal theories pleaded. Article III demands something different. Simply put, whether
Plaintiffs also challenge the FDCA is beside the point. The injury they allege does not
vanish simply because they seek relief from one source of the alleged harm—the inability

49

to sell ENDS products in North Carolina and the lost profits therefrom—rather than
another.
5

To be sure, courts—including our own—have repeatedly confronted the problem
posed by an unchallenged law that may independently prohibit the conduct that a plaintiff
has alleged is infringed. But they’ve addressed that potential problem through traceability
and redressability—not injury in fact. See, e.g., Doe v. Va. Dept. of State Police, 713 F.3d
745, 756 (4th Cir. 2013) (“A plaintiff faces a related obstacle to establishing traceability
and redressability when there exists an unchallenged, independent rule, policy, or decision
that would prevent relief even if the court were to render a favorable decision.”); WBY, Inc.
v. City of Chamblee, Ga., 155 F.4th 1242, 1259 (11th Cir. 2025).
The Sixth Circuit’s decision in White v. United States illustrates the point. 601 F.3d
545 (6th Cir. 2010). There, gamefowl breeders and sellers challenged provisions of the
federal Animal Welfare Act restricting cockfighting activities, and the court determined

5
The dissent relies on a handful of out-of-circuit cases that have “found no
standing,” Diss. Op. at 60, but those offer nothing more than dicta. See, e.g., E. Bay
Sanctuary Covenant v. Trump, 932 F.3d 742, 764 (9th Cir. 2018) (mentioning in assessing
third-party standing that the plaintiff-organizations’ “clients, of course, would not have
standing to assert a right to cross the border illegally, to seek asylum or otherwise” when
no party sought to protect such a “right” (citing Initiative & Referendum Inst. v. Walker,
450 F.3d 1082, 1093 (10th Cir. 2006) (en banc))); Citizen Ctr. v. Gessler, 770 F.3d 900,
910 (10th Cir. 2014) (mentioning that “a plaintiff lacks standing to complain about his
inability to commit crimes because no one has a right to commit a crime” even though none
of the plaintiffs sought to protect an interest in committing crimes (citing Walker, 450 F.3d
at 1903)); Levine v. Kling, 123 F.3d 580, 582 (7th Cir. 1997) (holding, with no discussion
of standing, that a criminal defendant doesn’t have a legal malpractice tort cause of action
if the plaintiff can’t establish “that he was innocent of the crime with which he was
charged” because, among other things, “[t]ort law provides damages only for harms to the
plaintiff’s legally protected interests, and the liberty of a guilty criminal is not one of them”
(citation omitted)).

50

they lacked standing to do so based on the existence of unchallenged laws that restricted
the identical conduct. But as the court acknowledged, the plaintiffs’ alleged “economic
injuries may constitute an injury-in-fact.” Id. at 552. The problem thus wasn’t the plaintiffs’
lack of injury; it was an inability to show traceability and redressability. Because
cockfighting was already prohibited “to a greater or lesser degree in all fifty states and the
District of Columbia,” the plaintiffs couldn’t show that their alleged injuries were traceable
to the federal statute or that invalidating it would redress them. Id. Their alleged lost profits
remained economic injuries; they simply could not establish the remaining elements of
standing.
The Ninth Circuit’s decision in San Diego County Gun Rights Committee v. Reno
points in the same direction. 98 F.3d 1121 (9th Cir. 1996), abrogated in part on other
grounds by District of Columbia v. Heller, 554 U.S. 570 (2008). Reno involved a challenge
to the Violent Crime Control and Law Enforcement Act provisions that prohibited the
manufacture, transfer, or possession of new semiautomatic weapons. Id. at 1124. The
plaintiffs pleaded an economic injury: “the Crime Control Act has caused the price of
banned devices and grandfathered arms to increase ‘from 40% to 100%,’ thus hindering
their ability to exercise their constitutional rights.” Id. at 1130. As the court recognized,
“[e]conomic injury is clearly a sufficient basis for standing[,]” but the “plaintiffs’ asserted
financial injury here fails the second prong of the Lujan test; plaintiffs fail to demonstrate
that their alleged economic injury is fairly traceable to the Crime Control Act.” Id. That
was so because California also banned the same activity, so “any finding that the Crime

51

Control Act had a significant impact on the increase in prices of weapons would be
tantamount to sheer speculation.” Id.
The lesson of these cases is straightforward. When an independent, unchallenged
law would prevent the plaintiff from achieving the desired result, the obstacle ordinarily
arises at the traceability and redressability stages of the standing inquiry. Put differently,
another law may defeat standing because it establishes lack of causation or prevents
redress. But it doesn’t erase an otherwise concrete and particularized injury in fact.
6

6
Considering the issues raised by the dissent in their proper framework, I conclude
that Plaintiffs’ alleged injury here is traceable and redressable. Traceability is established
if it is “likely that the injury was caused by the conduct complained of and not by the
independent action of some third party not before the court.” Doe, 713 F.3d at 755
(emphasis added). An injury is redressable if it is “likely, as opposed to merely speculative,
that the injury will be redressed by a favorable decision.” Id. Traceability and redressability
“are often flip sides of the same coin.” All. for Hippocratic Med., 602 U.S. at 380 (cleaned
up). Here, Plaintiffs’ theory is that only the FDA may enforce the FDCA and that, as a
matter of enforcement discretion, the FDA has chosen not to require the immediate removal
of the ENDS products at issue from the market. Accepting those allegations as true,
plaintiffs have alleged that their inability to sell those products in North Carolina is
traceable to SL 2024-31 rather than a separate federal barrier. And for the same reason,
they have plausibly alleged that an injunction against SL 2024-31 would redress their
injury.
To be sure, the FDA has emphasized that its enforcement guidance “does not in any
way alter the fact that it is illegal to market any new tobacco product without premarket
authorization.” J.A. 137. But the question for standing purposes is not whether plaintiffs’
conduct is ultimately lawful under federal law. The question is whether plaintiffs have
plausibly alleged that North Carolina’s law, rather than possible federal enforcement, is
preventing them from selling the products at issue. They have. Indeed, Plaintiffs allege that
the FDA has deliberately exercised enforcement discretion in this area to avoid forcing
certain ENDS products off the market while “it strike[s] a balance between the serious risk
[those products] pose to youth [against] their potential benefit in helping adult smokers
transition completely away from or significantly reduce smoking combustible cigarettes.”
J.A. 20 ¶ 56. At this stage, those allegations are sufficient to establish traceability and
redressability so that Plaintiffs have standing to challenge SL 2024-31.

52

* * *
“Standing has been called one of the most amorphous (concepts) in the entire
domain of public law[,]” Flast, 392 U.S. at 99 (citation omitted), and this case is obviously
no exception. Indeed, Judge Quattlebaum is not alone in his construction of injury in fact
for standing purposes.
7

In short, this difference of opinion all flows from the Supreme Court’s peculiar use
of the phrase “legally protected interest” in Lujan. See Jud. Watch, Inc., 432 F.3d at 363
(Williams, J., concurring) (expressing “puzzlement over the meaning of . . . ‘legally
protected interest’” (quoting Lujan, 504 U.S. at 560)). The resulting confusion, as
witnessed by the multiple opinions in this case, can and should be resolved once and for
all by the Supreme Court upon its next occasion to address standing.

7
See, e.g., Vapor Tech. Ass’n v. Graham, No. 1:25cv336, 2025 WL 3731013, at *4
(S.D. Miss. Dec. 15, 2025); Vapor Tech. Ass’n v. Taylor, No. 3:24cv74, 2025 WL 348684,
at *2–3 (E.D. Ky. Jan. 30, 2025); cf. Jud. Watch, Inc., 432 F.3d at 363–66 (Williams, J.,
concurring).

53

QUATTLEBAUM, Circuit Judge, dissenting:

Is lost revenue from illegal activity an “injury in fact” for purposes of Article III
standing? Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992). The plaintiffs say yes, and
the majority agrees. According to them, North Carolina’s regulatory scheme for electronic
nicotine delivery system (ENDS) products—which makes it illegal to sell certain products
in North Carolina—has cost the plaintiffs revenue. But selling these products is illegal
under the Federal Food, Drug, and Cosmetic Act (FDCA), too. And the plaintiffs don’t
challenge the FDCA. In fact, they say it preempts the North Carolina scheme. In my view,
the plaintiffs don’t have standing to challenge a state law that prohibits what is already
prohibited under an undisputedly valid federal law. So, while I agree with the majority that
the FDCA doesn’t preempt the North Carolina scheme, before we even get there, I’d
remand this case with instructions to dismiss for lack of standing.
I.
I begin with standing. Our precedent seems to require that we apply Lujan’s “legally
protected interest” language. Doing so, I conclude that it cannot encompass lost revenue
from undeniably illegal activity. Then, I explain why the plaintiffs’ backup arguments,
which don’t rely on there being a legally protected interest in undisputedly illegal conduct,
should fail.
A.
A plaintiff must satisfy three elements to establish standing—injury in fact,
traceability and redressability. Lujan, 504 U.S. at 560–61. This appeal involves the injury
requirement. Lujan defined “injury in fact” as “an invasion of a legally protected interest

54

which is (a) concrete and particularized; and (b) actual or imminent, not conjectural or
hypothetical.” Id. at 560 (citation modified). But Lujan didn’t define “legally protected
interest.” While subsequent Supreme Court cases have elaborated on the other Lujan
requirements, see, e.g., Gill v. Whitford, 585 U.S. 48, 65–69 (2018) (particularity);
TransUnion LLC v. Ramirez, 594 U.S. 413, 424 (2021) (concreteness), “[t]he Supreme
Court has not defined the term ‘legally protected interest’ as it pertains to Article III
standing, nor has it clarified whether the term does any independent work in the standing
analysis,” Cottrell v. Alcon Lab’ys, 874 F.3d 154, 163 (3d Cir. 2017).
Our circuit has cited the Lujan standard on many occasions. See, e.g., Opiotennione
v. Bozzuto Mgmt. Co., 130 F.4th 149, 153 (4th Cir. 2025); Hierholzer v. Guzman, 125 F.4th
104, 113 (4th Cir. 2025); Laufer v. Naranda Hotels, LLC, 60 F.4th 156, 161 (4th Cir. 2023).
More than that, we have said that a “‘legally protected interest’ aris[es] from constitutional,
statutory, or common law.” Pender v. Bank of Am. Corp., 788 F.3d 354, 366 (4th Cir. 2015)
(quoting Lujan, 504 U.S. at 578); see White Tail Park, Inc. v. Stroube, 413 F.3d 451, 461
(4th Cir. 2005) (finding that “[a] regulation that reduces the size of a speaker’s audience
[could] constitute an invasion of a legally protected interest” because the speaker had a
First Amendment interest in maintaining its audience size); Wikimedia Found. v. Nat’l Sec.
Agency, 857 F.3d 193, 209 (4th Cir. 2017) (“The allegation that the NSA is intercepting
and copying communications suffices to show an invasion of a legally protected interest—
the ‘Fourth Amendment right to be free from unreasonable searches and seizures.’”
(quoting Schuchardt v. President of the U.S., 839 F.3d 336, 353 (3d Cir. 2016))).

55

Some of our sister circuits agree. See, e.g., Ruiz v. Bally Total Fitness Holding
Corp., 496 F.3d 1, 6 (1st Cir. 2007) (finding that if a contract “violate[s] the plaintiff’s
rights under” Massachusetts law, “that violation would necessarily constitute an invasion
of a legally protected interest”); Donoghue v. Bulldog Invs. Gen. P’ship, 696 F.3d 170, 176
(2d Cir. 2012) (finding that a section of the Securities Exchange Act provided the plaintiff
with a legally protected interest); E.T. v. Paxton, 41 F.4th 709, 717 (5th Cir. 2022)
(determining that “[n]either the ADA nor [the Rehabilitation Act] creates a legally
protected interest in equality simpliciter”); Aurora Loan Servs., Inc. v. Craddieth, 442 F.3d
1018, 1023–24 (7th Cir. 2006) (noting that a legally protected interest “must be . . . the sort
of interest that the law protects when it is wrongfully invaded” and deeming a plaintiff’s
foreclosure-sale certificate to confer a “solid legally protected interest” under Illinois law);
Shulman v. Kaplan, 58 F.4th 404, 408 (9th Cir. 2023) (observing that a legally protected
interest “may be ‘one of property, one arising out of contract, one protected against tortious
invasion, or one founded on a statute which confers a privilege’” (quoting Tenn. Elec.
Power Co. v. Tenn. Valley Auth., 306 U.S. 118, 137 (1939), overruled in part on other
grounds, Bond v. United States, 564 U.S. 211, 216 (2011))).
Others do not. See, e.g., Jud. Watch, Inc. v. U.S. Senate, 432 F.3d 359, 363 (D.C.
Cir. 2005) (Williams, J., concurring) (expressing “puzzlement over” Lujan’s inclusion of
a “legally protected interest” requirement and suggesting that the Court simply meant “that
the interest affected be a cognizable one” (emphasis in original)); see Parker v. District of
Columbia, 478 F.3d 370, 377 (D.C. Cir. 2007) (citing Judge Williams’ concurrence
approvingly); ABF Freight Sys., Inc. v. Int’l Bhd. of Teamsters, 645 F.3d 954, 959 (8th Cir.

56

2011) (citing Parker approvingly). Indeed, 20 years before Lujan, the Court rejected a
“legal interest” test as “go[ing] to the merits” rather than to standing. Ass’n of Data
Processing Servs. v. Camp, 397 U.S. 150, 153 (1970); see Jud. Watch, 432 F.3d at 364
(Williams, J., concurring) (“[I]t would seem strange to bring in through the backdoor what
Data Processing threw out by the front.”).
In a thoughtful order, the district court sided with the latter camp. And by affirming
that decision, the majority does the same. It adopts Judge Williams’ reasoning in Judicial
Watch, declaring that even after Lujan, “[t]he injured interest need only be cognizable, and
a financial injury is easily cognizable.” Maj. Op. at 16. And like the district court’s order,
the majority and concurring opinions raise some good points. It’s true, for example, that
the Court “used the phrase ‘legally protected interest’ just once” in Lujan and that it hasn’t
always used that phrase in its post-Lujan injury-in-fact rule statements. See id. at 15–16;
Conc. Op. at 44.
But it seems to me that in Pender, our circuit already recognized the importance of
Lujan’s “legally protected interest” language and supplied meaning to it. See Pender, 788
F.3d at 366. There, we said that a “‘legally protected interest’ aris[es] from constitutional,
statutory, or common law.” Id. (quoting Lujan, 504 U.S. at 578). In my view, we must
apply that precedent. See McMellon v. United States, 387 F.3d 329, 332 (4th Cir. 2004) (en
banc) (“[O]ne panel cannot overrule a decision issued by another panel.”).
1

1
Judge Agee regards Pender’s discussion of “legally protected interest” as
“dictum.” Conc. Op. at 42. I disagree. After saying that legally protected interests arise
from constitutional, statutory or common law, we “examine[d] the principles that
(Continued)

57

B.
How, then, does the requirement that the plaintiffs’ injury arise from constitutional,
statutory
2
or common law apply in this case? Let’s begin with how not to apply it. Courts
that are skeptical of taking “legally protected interest” seriously worry that doing so would
conflate standing and the merits. See, e.g., Jud. Watch, 432 F.3d at 364 (Williams, J.,
concurring) (“[T]he use of the phrase ‘legally protected’ to require showing of a substantive
right would thwart a major function of standing doctrine—to avoid premature judicial
involvement in resolution of issues on the merits.”). The district court made the same point,
observing that “[t]he standing doctrine does not presume upon the merits [of] a party’s
claim.” J.A. 501 (citing White Tail Park, 413 F.3d at 460).
That’s fair. It can’t be that “every unsuccessful plaintiff [on the merits] . . . lack[s]
standing in the first place.” White Tail Park, 413 F.3d at 461 (quoting Claybrook v. Slater,
111 F.3d 904, 907 (D.C. Cir. 1997)). And on a different standing requirement, I have
expressed a similar concern. Lowy v. Daniel Def., LLC, 167 F.4th 175, 213 (4th Cir. 2026)
(Quattlebaum, J., dissenting) (discussing the overlap between traceability and tort

underl[ay] [the plaintiffs’] claim . . . to discern whether there exist[ed] a legally protected
interest.” Pender, 788 F.3d at 366. Looking to the common law of restitution and trusts, as
well as the “overall tenor of ERISA,” we found that there was one. Id. at 366–67. So, our
analysis of the term “legally protected interest” was necessary to our holding that the
plaintiffs had standing.
2
Identifying a statute as a source of an interest does not mean that a statutory
violation automatically creates an injury in fact. TransUnion, 594 U.S. at 426. A plaintiff
must still show that he has suffered a concrete harm, assessed by whether he has “identified
a close historical or common-law analogue for [his] asserted injury.” Id. at 424.

58

causation). So, I agree we should be careful not to interpret “legally protected interest” in
a way that conflates standing and the merits.
But the fact that a legally protected interest must arise from constitutional, statutory
or common law doesn’t mean that the plaintiffs’ claim must be valid under those sources
of law.
3
A plaintiff may have a lousy claim on the merits but still allege an injury rooted in
constitutional, statutory or common law. See, e.g., White Tail Park, 413 F.3d at 461
(finding that the plaintiff had demonstrated a legally protected interest arising from the
First Amendment “[a]lthough the First Amendment challenge . . . may ultimately prove
unsuccessful” on the merits). If so, that plaintiff has standing to pursue that claim in federal
court.
Rather than requiring ultimate success on the merits, asking whether an injury arises
from constitutional, statutory or common law merely requires that a plaintiff’s interest be
rooted in a recognized legal source. Analyzed that way, the plaintiffs’ alleged interest falls
short. Two laws prohibit the plaintiffs from selling unauthorized ENDS products—the
North Carolina scheme and the FDCA. The plaintiffs have only challenged the North
Carolina scheme. So, even if the plaintiffs are right that the North Carolina scheme is

3
Nor does it mean, as the majority says, that a plaintiff must “identify some piece
of positive law” protecting his conduct. Maj. Op. at 18. Take a robber who slips and falls
during a heist and sues the homeowner. The robber’s conduct certainly isn’t legally
protected. But as the majority says, the operative question is whether the robber’s injury is
to a legally protected interest. So, if the robber’s alleged injury is that he broke his leg and
incurred hospital bills, he probably has standing, since his injury isn’t the inability to
engage in illegal conduct. On the other hand, if his alleged injury is that he wasn’t able to
finish the profitable string of robberies he had planned for the evening, I think he lacks
standing.

59

invalid, the FDCA renders lost revenue from unauthorized ENDS products—the asserted
injury in fact—illegal. And neither the Constitution nor any statute nor the common law
gives the plaintiffs a legally protected interest in revenue from conduct that violates
unchallenged federal law.
Judge Thacker and Judge Agee read Pender differently. They say Pender merely
provided a few examples of sources of legally protected interests. See Maj. Op. at 18 (“If
the plaintiff’s resulting injury has a basis in ‘constitutional, statutory, or common law’ then
it is a cognizable one (although not the only cognizable one) and suffices for Article III
purposes.” (quoting Pender, 788 F.3d at 366)); Conc. Op. at 45 (“Pender merely identified
a subset of injuries that are judicially cognizable.”). But Pender didn’t say that. It said,
“[A]n injury refers to the invasion of some ‘legally protected interest’ arising from
constitutional, statutory, or common law.” Pender, 788 F.3d at 366 (quoting Lujan, 504
U.S. at 578). Nothing about that language suggests that constitutional, statutory and
common law interests are a subset of some larger set.
In fact, my colleagues do not identify sources of judicially cognizable injuries other
than constitutional, statutory and common law. See Conc. Op. at 43 (“[I]t’s hard to
conceive of a valid injury that doesn’t flow from a constitutional, statutory or common-law
claim.”). If the Constitution, statutes and common law are a subset of a larger group of
sources, you’d think we’d know at least one of the other items from the larger set.
Judge Agee also points out that Lujan didn’t provide a “precedential basis by which
to establish that only interests conclusively established ‘from constitutional, statutory, or
common law’ would be valid for standing purposes.” Conc. Op. at 45 (quoting Pender, 788

60

F.3d at 366). I agree. But Lujan likewise didn’t describe legally protected interest in a way
that precludes that understanding. That’s why we must rely on Pender.
It’s true that our circuit hasn’t addressed standing in a fact pattern similar to this
one. But when our sister circuits have, they’ve largely found no standing. See E. Bay
Sanctuary Covenant v. Trump, 932 F.3d 742, 764 (9th Cir. 2018) (noting that foreign
nationals “would not have standing to assert a right to cross the border illegally, to seek
asylum or otherwise”); Initiative & Referendum Inst. v. Walker, 450 F.3d 1082, 1093 (10th
Cir. 2006) (“[A] person complaining that government action will make his criminal activity
more difficult lacks standing because his interest is not ‘legally protected.’”); Citizen Ctr.
v. Gessler, 770 F.3d 900, 910 (10th Cir. 2014) (“Though we do not consider the merits in
connection with standing, we do consider whether the plaintiffs have a legal right to do
what is allegedly being impeded. For example, a plaintiff lacks standing to complain about
his inability to commit crimes because no one has a right to commit a crime.”); Hotel &
Rest. Emps. Union, Loc. 25 v. Smith, 846 F.2d 1499, 1518 (D.C. Cir. 1988) (en banc)
(Silberman, J., separate opinion) (“Surely it cannot be argued that an [undocumented
immigrant] who has violated American law by securing illegal entry has a legally protected
interest in remaining undetected.”); see also Levine v. Kling, 123 F.3d 580, 582 (7th Cir.
1997) (“Tort law provides damages only for harms to the plaintiff’s legally protected
interests, and the liberty of a guilty criminal is not one of them.” (citation modified)); 13A
Wright & Miller’s Federal Practice and Procedure § 3531.4 (3d ed. 2026) (“If customs
officials were to institute a new and rigorous policy for inspecting packages brought in
from other countries . . . [s]tanding would not be recognized for a smuggler who asserted

61

that his drug traffic was disrupted. Although the smuggler had been injured in fact, and the
inspection procedures might indeed be unlawful, the asserted interest is not one the courts
will protect. Thus the test of injury in fact leaves it necessary to identify what interests
deserve protection against injury.” (footnote omitted)).
To be sure, the majority points out that in Wisconsinites for Alternatives to Smoking
& Tobacco, Inc. v. Casey, 172 F.4th 976 (7th Cir. 2026), the Seventh Circuit found standing
in a similar circumstance. There, the court held similarly situated plaintiffs had standing to
challenge a Wisconsin scheme almost identical to North Carolina’s. Id. at 982–83. It noted
that injuries in fact must be concrete and that “[c]oncrete injuries include tangible injuries
such as monetary harms,” found that the plaintiffs would “lose sales and business” and
ended its injury-in-fact analysis there. Id. at 982. But the issue here is not whether the
plaintiffs have suffered a concrete harm; it’s whether they have suffered an invasion of a
legally protected interest.
4
Wisconsinites for Alternatives didn’t grapple with that question.
The closest it got was in its causation analysis, where it said that the plaintiffs had “a
legitimate basis to believe they [were] engaged in legal economic activities.” Id. That
would be news to the FDA, which has told companies that “[m]anufacturers cannot have
settled expectations to market unlawful products, especially in the face of evolving public
health concerns,” J.A. 161, and said that its industry guidance on its enforcement priorities
“does not in any way alter the fact that it is illegal to market any new tobacco product

4
These are separate requirements. See Biden v. Nebraska, 600 U.S. 477, 489 (2023)
(defining “injury in fact” as “a concrete and imminent harm to a legally protected interest”).

62

without premarket authorization,” J.A. 137. The executive branch doesn’t render illegal
conduct legal simply by policing it leniently.
Considering these decisions from our sister circuits, I’m not convinced that North
Carolina’s regulatory scheme, as the majority concludes, causes the plaintiffs a “classic”
“pocketbook injury.” Maj. Op. at 12 (quoting Tyler v. Hennepin Cnty., 598 U.S. 631, 636
(2023)). While I agree that the North Carolina scheme causes these plaintiffs to “either stop
selling their most popular products and lose revenue, or carry on business as usual and face
fines and civil suits from competitors for deceptive trade practices,” id., they still haven’t
suffered an injury in fact. Why? Because those same sales are prohibited by an
undisputedly valid federal law. A party has no legally protected interest in lost revenue that
it concedes it could not legally obtain. And without the invasion of a legally protected
interest, there is no injury in fact.
C.
The plaintiffs make two other arguments claiming they have shown injury in fact.
But neither engages with the weight of authority I’ve just described. In fact, both are policy
arguments.
1.
First, the plaintiffs contend that they must have standing because if they don’t, states
will be immunized from preemption challenges. See NOVA Distro, Inc. v. Miyares, No.
3:25-cv-857 (DJN), 2025 WL 3680321, at *5 (E.D. Va. Dec. 18, 2025) (“If standing turned
on a plaintiff’s perfect adherence to the federal requirements, states could sidestep
preemption review simply by pointing to an alleged violation of the very federal standards

63

they may be forbidden to enforce.” (citing Iowans for Alts. to Smoking & Tobacco, Inc. v.
Iowa Dep’t of Revenue, 781 F. Supp. 3d 724, 734 (S.D. Iowa 2025))). I disagree. We must
follow the law wherever it takes us, whether we like the consequences or not. For that
reason, “[t]he assumption that if [the plaintiffs] have no standing to sue, no one would have
standing, is not a reason to find standing.” Schlesinger v. Reservists Comm. to Stop the
War, 418 U.S. 208, 227 (1974).
Besides, that premise—if these plaintiffs don’t have standing, then nobody does—
seems wrong here. A plaintiff who undisputedly violates an undisputedly valid federal law
lacks standing to challenge the state’s enforcement of that law. But a plaintiff challenging
a state’s erroneous enforcement of an undisputedly valid federal law would seem to have
standing because, unlike this case, his suit isn’t premised on a violation of federal law. So
would a plaintiff whose conduct violates federal and state law and who disputes the legality
of the federal law and challenges the state law on preemption grounds.
What’s more, if we’re judging theories of standing by their consequences, the
plaintiffs’ theory has negative consequences of its own. Consider these hypotheticals:
• An agency promulgates a customs regulation. The smuggler described in Wright &
Miller doesn’t challenge the separate federal law prohibiting smuggling. But he
challenges the customs regulation, asserting an injury in fact traceable to the
regulation and redressable by its invalidation—lost revenue because the regulation
has made it harder for him to smuggle.

• A city enacts a curfew on minors. A bar owner doesn’t challenge the separate
municipal law prohibiting alcohol sales to minors. But he challenges the curfew,
asserting an injury in fact traceable to the curfew and redressable by its
invalidation—lost revenue because he can’t sell as much alcohol to minors as he did
before.

64

• Congress imposes import tariffs on raw materials used in the production of ballistic
missiles. An arms dealer doesn’t challenge the separate federal prohibition against
providing material support to designated terrorist organizations. But he challenges
the tariffs, asserting an injury in fact traceable to the tariffs and redressable by their
invalidation—lost revenue from decreased sales of ballistic missiles to designated
terrorist organizations.

The smuggler, the bar owner and the arms dealer claim the kind of injury the
majority finds today—lost revenue from conduct that’s already prohibited by a separate
law of unquestioned validity. That means that after today’s decision, all three of these
hypothetical plaintiffs have an injury in fact in our circuit.
2.
Second, the plaintiffs argue that the North Carolina scheme “will force [the
plaintiffs] to close their doors, causing them to suffer lost revenue and profits from sales
of other products that they sell,” including products that are “legal to sell under federal
law.” Reply Br. at 8. But that’s just a downstream effect of being unable to sell ENDS
products in violation of federal law. See J.A. 92 (declaration from AMV Holdings, LLC
noting that “at least 98.7%” of revenue from sales of ENDS products in North Carolina
stores came from products “not eligible for inclusion on the North Carolina directory”);
J.A. 223 (declaration from Bright Leaf Vendors, Inc. that while they “currently carry
several lines of bottled e-liquids found on the [North Carolina] directory, these e-liquids
only accounted for 4.3%” of a North Carolina location’s revenue). A company that earns a
lot of illegal revenue and a little legal revenue doesn’t have a legally protected interest in
maintaining its illegal revenue just because that revenue keeps the whole operation—illegal
and legal revenue streams alike—afloat.

65

Thus, to wrap up, because I don’t think lost illegal revenue is an injury in fact, I
conclude that the plaintiffs lack Article III standing.
5
II.
Since the majority finds the plaintiffs have standing, it addresses the likelihood that
the plaintiffs would succeed on their preemption claim. Despite my view on standing, I
agree that the FDCA doesn’t preempt the North Carolina scheme. And while I agree with
much of the majority’s reasoning, I write separately to identify a few other points
supporting that conclusion.
First, the plain text of 21 U.S.C. § 337(a) doesn’t seem to pose any conflict with the
North Carolina scheme. That provision provides that, with an exception not relevant here,
“all such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be
by and in the name of the United States.” 21 U.S.C. § 337(a). The majority correctly points
out that it’s possible to violate the North Carolina scheme without also violating the FDCA.
See Maj. Op. at 33. But even if North Carolina prosecutes an ENDS retailer for selling a
product that the FDA didn’t approve in advance, and thus wasn’t included on the North
Carolina directory, that doesn’t violate the text of § 337(a). Section 337(a) prohibits a state
attorney general from bringing an FDCA claim. But North Carolina is not doing that. It is

5
If the plaintiffs who retail ENDS products lack standing, so do the remaining
plaintiffs. On appeal, the plaintiffs don’t argue that the Vapor Technology Association has
any better claim to standing than the retailer plaintiffs. They do argue that the individual
plaintiff, Reagan Murphy, has standing since “the FDCA does not prohibit the mere
possession (or use) of unauthorized ENDS.” Reply Br. at 9. But I’m unconvinced that a
consumer has a legally protected interest in buying a product whose sale an unchallenged
federal law prohibits.

66

enforcing its own law, and that law partially measures compliance against the FDCA. What
if North Carolina had simply copied and pasted requirements listed in the FDCA into its
own scheme instead of explicitly referencing the FDCA? The plaintiffs conceded at oral
argument that this wouldn’t have created a preemption problem under § 337(a). If that’s
right, I don’t see how referencing an FDCA provision does either.
Second, the plaintiffs rely too heavily on Buckman Co. v. Plaintiffs’ Legal
Committee, 531 U.S. 341 (2001), in arguing that the North Carolina scheme is impliedly
preempted by § 337(a). The North Carolina scheme is a health-and-safety regulation,
meaning that we start our analysis with a presumption against preemption. See Medtronic,
Inc. v. Lohr, 518 U.S. 470, 486 (1996) (describing a presumption against preemption as
“consistent with both federalism concerns and the historic primacy of state regulation of
matters of health and safety”). That presumption did not apply in Buckman because the
state action in that case addressed an “inherently federal” issue—“the relationship between
a federal agency and the entity it regulates.” 531 U.S. at 347. So, here, unlike in Buckman,
we start with a thumb on the scale in favor of the state scheme.
Also, in Buckman, the Supreme Court expressed concern that state and federal
authorities would interpret FDA regulations differently from one another. See id. at 351
(observing that regulated entities might “fear that their disclosures to the FDA, although
deemed appropriate by the [FDA], will later be judged insufficient in state court”); accord
Nexus Pharms., Inc. v. Cent. Admixture Pharmacy Servs., Inc., 48 F.4th 1040, 1048 (9th
Cir. 2022) (finding implied preemption where a state claim “would require litigation of the
alleged underlying FDCA violation in a circumstance where the FDA has not itself

67

concluded that there was a violation” (quoting PhotoMedex, Inc. v. Irwin, 601 F.3d 919,
924 (9th Cir. 2010))). There’s no such concern here. To sell an ENDS product in North
Carolina, a distributor or retailer simply needs to make sure the product is on North
Carolina’s directory. To the extent North Carolina uses the FDA’s list of pre-approved
products to determine what products are on its directory, there is no state interpretation of
a federal rule or standard. So, there is no risk of inconsistent and conflicting interpretations
of federal law.
In my view, these points bolster the majority’s conclusion that the plaintiffs are
unlikely to succeed on the merits of their preemption claim.
III.
I agree with the majority that the plaintiffs are unlikely to succeed on the merits of
their preemption claim. But as a matter of law, the plaintiffs lack Article III standing to
assert that claim.
6
So, rather than affirming the district court’s denial of a preliminary
injunction, I would remand with instructions to dismiss. See Elec. Priv. Info. Ctr. v. U.S.
Dep’t of Com., 928 F.3d 95, 104 (D.C. Cir. 2019) (“[I]f, in reviewing the denial of a
preliminary injunction, we determine that a litigant cannot establish standing as a matter
of law, the proper course is to remand the case for dismissal.” (emphasis in original));

6
For the same reasons, the plaintiffs lack standing to pursue their Equal Protection
Clause claim. See J.A. 31 (plaintiffs’ complaint describing the harm from the alleged equal
protection violation as “forcing [the plaintiffs] to stop selling [their] unauthorized ENDS
products containing non-tobacco-derived nicotine”).

68

Delmarva Fisheries Ass’n v. Atl. States Marine Fisheries Comm’n, 127 F.4th 509, 515 (4th
Cir. 2025) (citing Elec. Priv. Info. Ctr., 928 F.3d at 104).