23-235 N7ip

(Slip Opinion) OCTOBER TERM, 2023 1
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is

being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
Syllabus
FOOD AND DRUG ADMINISTRATION ET AL. v.

ALLIANCE FOR HIPPOCRATIC MEDICINE ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR

THE FIFTH CIRCUIT
No. 23–235. Argued March 26, 2024—Decided June 13, 2024*

In 2000, the Food and Drug Administration approved a new drug
application for mifepristone tablets marketed under the brand name
Mifeprex for use in terminating pregnancies up to seven weeks. To
help ensure that Mifeprex would be used safely and effectively, FDA
placed additional restrictions on the drug’s use and distribution, for
example requiring doctors to prescribe or to supervise prescription of
Mifeprex, and requiring patients to have three in-person visits with
the doctor to receive the drug. In 2016, FDA relaxed some of these
restrictions: deeming Mifeprex safe to terminate pregnancies up to 10
weeks; allowing healthcare providers, such as nurse practitioners, to
prescribe Mifeprex; and approving a dosing regimen that required just
one in-person visit to receive the drug. In 2019, FDA approved an
application for generic mifepristone. In 2021, FDA announced that it
would no longer enforce the initial in-person visit requirement. Four
pro-life medical associations and several individual doctors moved for
a preliminary injunction that would require FDA either to rescind
approval of mifepristone or to rescind FDA’s 2016 and 2021 regulatory
actions. Danco Laboratories, which sponsors Mifeprex, intervened to
defend FDA’s actions.
The District Court agreed with the plaintiffs and in effect enjoined
FDA’s approval of mifepristone, thereby ordering mifepristone off the
market. FDA and Danco appealed and moved to stay the District
Court’s order pending appeal. As relevant here, this Court ultimately
——————
*Together with No. 23–236, Danco Laboratories, L.L.C. v. Alliance for
Hippocratic Medicine, also on certiorari to the United States Court of
Appeals for the Fifth Circuit.
2 FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE
Syllabus
stayed the District Court’s order pending the disposition of

proceedings in the Fifth Circuit and this Court. On the merits, the
Fifth Circuit held that plaintiffs had standing. It concluded that
plaintiffs were unlikely to succeed on their challenge to FDA’s 2000
and 2019 drug approvals, but were likely to succeed in showing that
FDA’s 2016 and 2021 actions were unlawful. This Court granted
certiorari with respect to the 2016 and 2021 FDA actions.
Held: Plaintiffs lack Article III standing to challenge FDA’s actions
regarding the regulation of mifepristone. Pp. 5–25.
(a) Article III standing is a “bedrock constitutional requirement that
this Court has applied to all manner of important disputes.” United
States v. Texas, 599 U. S. 670, 675. Standing is “built on a single basic
idea—the idea of separation of powers.” Ibid. Article III confines the
jurisdiction of federal courts to “Cases” and “Controversies.” Federal
courts do not operate as an open forum for citizens “to press general
complaints about the way in which government goes about its
business.” Allen v. Wright, 468 U. S. 737, 760. To obtain a judicial
determination of what the governing law is, a plaintiff must have a
“personal stake” in the dispute. TransUnion LLC v. Ramirez, 594
U. S. 413, 423.
To establish standing, a plaintiff must 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 relief. See
Summers v. Earth Island Institute, 555 U. S. 488, 493. The two key
questions in most standing disputes are injury in fact and causation.
By requiring the plaintiff to show an injury in fact, Article III standing
screens out plaintiffs who might have only a general legal, moral,
ideological, or policy objection to a particular government action.
Causation requires the plaintiff to establish that the plaintiff ’s injury
likely was caused or likely will be caused by the defendant’s conduct.
Causation is “ordinarily substantially more difficult to establish” when
(as here) a plaintiff challenges the government’s “unlawful regulation
(or lack of regulation) of someone else.” Lujan v. Defenders of Wildlife,
504 U. S. 555, 560–561. That is because unregulated parties often may
have more difficulty linking their asserted injuries to the government’s
regulation (or lack of regulation) of someone else. Pp. 5–12.
(b) Plaintiffs are pro-life, oppose elective abortion, and have sincere
legal, moral, ideological, and policy objections to mifepristone being
prescribed and used by others. Because plaintiffs do not prescribe or
use mifepristone, plaintiffs are unregulated parties who seek to
challenge FDA’s regulation of others. Plaintiffs advance several
complicated causation theories to connect FDA’s actions to the
plaintiffs’ alleged injuries in fact. None of these theories suffices to
Cite as: 602 U. S. ____ (2024) 3
Syllabus
establish Article III standing. Pp. 13–24.

(1) Plaintiffs first contend that FDA’s relaxed regulation of
mifepristone may cause downstream conscience injuries to the
individual doctors. Even assuming that FDA’s 2016 and 2021 changes
to mifepristone’s conditions of use cause more pregnant women to
require emergency abortions and that some women would likely seek
treatment from these plaintiff doctors, the plaintiff doctors have not
shown that they could be forced to participate in an abortion or provide
abortion-related medical treatment over their conscience objections.
Federal conscience laws definitively protect doctors from being
required to perform abortions or to provide other treatment that
violates their consciences. Federal law protects doctors from
repercussions when they have “refused” to participate in an abortion.
§300a–7(c)(1). The plaintiffs have not identified any instances where
a doctor was required, notwithstanding conscience objections, to
perform an abortion or to provide other abortion-related treatment
that violated the doctor’s conscience since mifepristone’s 2000
approval. Further, the Emergency Medical Treatment and Labor Act
(or EMTALA) neither overrides federal conscience laws nor requires
individual emergency room doctors to participate in emergency
abortions. Thus, there is a break in any chain of causation between
FDA’s relaxed regulation of mifepristone and any asserted conscience
injuries to the doctors. Pp. 14–17.
(2) Plaintiffs next assert they have standing because FDA’s
relaxed regulation of mifepristone may cause downstream economic
injuries to the doctors. The doctors cite various monetary and related
injuries that they will allegedly suffer as a result of FDA’s actions—in
particular, diverting resources and time from other patients to treat
patients with mifepristone complications; increasing risk of liability
suits from treating those patients; and potentially increasing
insurance costs. But the causal link between FDA’s regulatory actions
in 2016 and 2021 and those alleged injuries is too speculative, lacks
support in the record, and is otherwise too attenuated to establish
standing. Moreover, the law has never permitted doctors to challenge
the government’s loosening of general public safety requirements
simply because more individuals might then show up at emergency
rooms or in doctors’ offices with follow-on injuries. Citizens and
doctors who object to what the law allows others to do may always take
their concerns to the Executive and Legislative Branches and seek
greater regulatory or legislative restrictions. Pp. 18–21.
(3) Plaintiff medical associations assert their own organizational
standing. Under the Court’s precedents, organizations may have
standing “to sue on their own behalf for injuries they have sustained,”
Havens Realty Corp. v. Coleman, 455 U. S. 363, 379, n. 19, but
Syllabus
organizations must satisfy the usual standards for injury in fact,

causation, and redressability that apply to individuals, id., at 378–379.
According to the medical associations, FDA has “impaired” their
“ability to provide services and achieve their organizational missions.”
Brief for Respondents 43. That argument does not work to
demonstrate standing. Like an individual, an organization may not
establish standing simply based on the “intensity of the litigant’s
interest” or because of strong opposition to the government’s conduct,
Valley Forge Christian College v. Americans United for Separation of
Church and State, Inc., 454 U. S. 464, 486. The plaintiff associations
therefore cannot establish standing simply because they object to
FDA’s actions. The medical associations claim to have standing based
on their incurring costs to oppose FDA’s actions. They say that FDA
has “caused” the associations to conduct their own studies on
mifepristone so that the associations can better inform their members
and the public about mifepristone’s risks. Brief for Respondents 43.
They contend that FDA has “forced” the associations to “expend
considerable time, energy, and resources” drafting citizen petitions to
FDA, as well as engaging in public advocacy and public education, all
to the detriment of other spending priorities. Id., at 44. But an
organization that has not suffered a concrete injury caused by a
defendant’s action cannot spend its way into standing simply by
expending money to gather information and advocate against the
defendant’s action. Contrary to what the medical associations
contend, the Court’s decision in Havens Realty Corp. v. Coleman does
not stand for the expansive theory that standing exists when an
organization diverts its resources in response to a defendant’s actions.
Havens was an unusual case, and this Court has been careful not to
extend the Havens holding beyond its context. So too here.
Finally, it was suggested that plaintiffs must have standing because
otherwise it may be that no one would have standing to challenge
FDA’s 2016 and 2021 actions. That suggestion fails because the Court
has long rejected that kind of argument as a basis for standing. The
“assumption” that if these plaintiffs lack “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. Rather, some
issues may be left to the political and democratic processes. Pp. 21–
24.
78 F. 4th 210, reversed and remanded.
KAVANAUGH, J., delivered the opinion for a unanimous Court. THOMAS,

J., filed a concurring opinion.
Cite as: 602 U. S. ____ (2024) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the

United States Reports. Readers are requested to notify the Reporter of
Decisions, Supreme Court of the United States, Washington, D. C. 20543,
[email protected], of any typographical or other formal errors.

_________________
Nos. 23–235 and 23–236

_________________
FOOD AND DRUG ADMINISTRATION, ET AL.,

PETITIONERS
23–235 v.
ALLIANCE FOR HIPPOCRATIC MEDICINE, ET AL.
DANCO LABORATORIES, L.L.C., PETITIONER

23–236 v.
ON WRITS OF CERTIORARI TO THE UNITED STATES COURT OF
APPEALS FOR THE FIFTH CIRCUIT
[June 13, 2024]
JUSTICE KAVANAUGH delivered the opinion of the Court.

In 2016 and 2021, the Food and Drug Administration
relaxed its regulatory requirements for mifepristone, an
abortion drug. Those changes made it easier for doctors to
prescribe and pregnant women to obtain mifepristone.
Several pro-life doctors and associations sued FDA, arguing
that FDA’s actions violated the Administrative Procedure
Act. But the plaintiffs do not prescribe or use mifepristone.
And FDA is not requiring them to do or refrain from doing
anything. Rather, the plaintiffs want FDA to make
mifepristone more difficult for other doctors to prescribe
and for pregnant women to obtain. Under Article III of the
Constitution, a plaintiff ’s desire to make a drug less
available for others does not establish standing to sue. Nor
do the plaintiffs’ other standing theories suffice. Therefore,
the plaintiffs lack standing to challenge FDA’s actions.
I
A
Under federal law, the U. S. Food and Drug
Administration, an agency within the Executive Branch,
ensures that drugs on the market are safe and effective.
For FDA to approve a new drug, the drug sponsor (usually
the drug’s manufacturer or potential marketer) must
submit an application demonstrating that the drug is safe
and effective when used as directed. 21 U. S. C. §355(d).
The sponsor’s application must generally include proposed
labeling that specifies the drug’s dosage, how to take the
drug, and the specific conditions that the drug may treat.
21 CFR §§201.5, 314.50 (2022).
If FDA determines that additional safety requirements
are necessary, FDA may impose extra requirements on
prescription and use of the drug. 21 U. S. C. §355–1(f )(3).
For example, FDA may require that prescribers undergo
specialized training; mandate that the drug be dispensed
only in certain settings like hospitals; or direct that doctors
monitor patients taking the drug. Ibid.
In 2000, FDA approved a new drug application for
mifepristone tablets marketed under the brand name
Mifeprex. FDA approved Mifeprex for use to terminate
pregnancies, but only up to seven weeks of pregnancy. To
help ensure that Mifeprex would be used safely and
effectively, FDA placed further restrictions on the drug’s
use and distribution. For example, only doctors could
prescribe or supervise prescription of Mifeprex. Doctors
and patients also had to follow a strict regimen requiring
the patient to appear for three in-person visits with the
doctor. And FDA directed prescribing doctors to report
incidents of hospitalizations, blood transfusions, or other
serious adverse events to the drug sponsor (who, in turn,
was required to report the events to FDA).
In 2015, Mifeprex’s distributor Danco Laboratories
submitted a supplemental new drug application seeking to
Cite as: 602 U. S. ____ (2024) 3
amend Mifeprex’s labeling and to relax some of the

restrictions that FDA had imposed. In 2016, FDA approved
the proposed changes. FDA deemed Mifeprex safe to
terminate pregnancies up to 10 weeks rather than 7 weeks.
FDA allowed healthcare providers such as nurse
practitioners to prescribe Mifeprex. And FDA approved a
dosing regimen that reduced the number of required in-
person visits from three to one—a single visit to receive
Mifeprex. In addition, FDA changed prescribers’ adverse
event reporting obligations to require prescribers to report
only fatalities—a reporting requirement that was still more
stringent than the requirements for most other drugs.
In 2019, FDA approved an application for generic
mifepristone. FDA established the same conditions of use
for generic mifepristone as for Mifeprex.
In 2021, FDA again relaxed the requirements for
Mifeprex and generic mifepristone. Relying on experience
gained during the COVID–19 pandemic about pregnant
women using mifepristone without an in-person visit to a
healthcare provider, FDA announced that it would no
longer enforce the initial in-person visit requirement.
B
Because mifepristone is used to terminate pregnancies,
FDA’s approval and regulation of mifepristone have
generated substantial controversy from the start. In 2002,
three pro-life associations submitted a joint citizen petition
asking FDA to rescind its approval of Mifeprex. FDA
denied their petition.
In 2019, two pro-life medical associations filed another
petition, this time asking FDA to withdraw its 2016
modifications to mifepristone’s conditions of use. FDA
denied that petition as well.
This case began in 2022. Four pro-life medical
associations, as well as several individual doctors, sued
FDA in the U. S. District Court for the Northern District of
Texas. Plaintiffs brought claims under the Administrative

Procedure Act. They challenged the lawfulness of FDA’s
2000 approval of Mifeprex; FDA’s 2019 approval of generic
mifepristone; and FDA’s 2016 and 2021 actions modifying
mifepristone’s conditions of use. Danco Laboratories, which
sponsors Mifeprex, intervened to defend FDA’s actions.
The plaintiffs moved for a preliminary injunction that
would require FDA to rescind approval of mifepristone or,
at the very least, to rescind FDA’s 2016 and 2021 actions.
The District Court agreed with the plaintiffs and in effect
enjoined FDA’s approval of mifepristone, thereby ordering
mifepristone off the market. 668 F. Supp. 3d 507 (ND Tex.
2023). The court first held that the plaintiffs possessed
Article III standing. It then determined that the plaintiffs
were likely to succeed on the merits of each of their claims.
Finally, the court concluded that the plaintiffs would suffer
irreparable harm from FDA’s continued approval of
mifepristone and that an injunction would serve the public
interest.
FDA and Danco promptly appealed and moved to stay the
District Court’s order pending appeal. The U. S. Court of
Appeals for the Fifth Circuit granted the stay motion in
part and temporarily reinstated FDA’s approval of
Mifeprex. 2023 WL 2913725, *21 (Apr. 12, 2023). But the
Court of Appeals declined to stay the rest of the District
Court’s order. The Court of Appeals’ partial stay would
have left Mifeprex (though not generic mifepristone) on the
market, but only under the more stringent requirements
imposed when FDA first approved Mifeprex in 2000—
available only up to seven weeks of pregnancy, only when
prescribed by doctors, and only with three in-person visits,
among other requirements.
FDA and Danco then sought a full stay in this Court.
This Court stayed the District Court’s order in its entirety
pending the disposition of FDA’s and Danco’s appeals in the
Court of Appeals and ultimate resolution by this Court. 598
Cite as: 602 U. S. ____ (2024) 5
U. S. ___ (2023). As a result of this Court’s stay, Mifeprex

and generic mifepristone have remained available as
allowed by FDA’s relaxed 2016 and 2021 requirements.
A few months later, the Court of Appeals issued its
decision on the merits of the District Court’s order,
affirming in part and vacating in part. 78 F. 4th 210, 222–
223 (CA5 2023). The Court of Appeals first concluded that
the individual doctors and the pro-life medical associations
had standing. The Court of Appeals next concluded that
plaintiffs were not likely to succeed on their challenge to
FDA’s 2000 approval of Mifeprex and 2019 approval of
generic mifepristone. So the Court of Appeals vacated the
District Court’s order as to those agency actions. But the
Court of Appeals agreed with the District Court that
plaintiffs were likely to succeed in showing that FDA’s 2016
and 2021 actions were unlawful.
The Court of Appeals’ merits decision did not alter this
Court’s stay of the District Court’s order pending this
Court’s review. This Court then granted certiorari with
respect to the 2016 and 2021 FDA actions held unlawful by
the Court of Appeals. 601 U. S. ___ (2023).
II
The threshold question is whether the plaintiffs have
standing to sue under Article III of the Constitution.
Article III standing is a “bedrock constitutional
requirement that this Court has applied to all manner of
important disputes.” United States v. Texas, 599 U. S. 670,
675 (2023). Standing is “built on a single basic idea—the
idea of separation of powers.” Ibid. (quotation marks
omitted). Importantly, separation of powers “was not
simply an abstract generalization in the minds of the
Framers: it was woven into the document that they drafted
in Philadelphia in the summer of 1787.” TransUnion LLC
v. Ramirez, 594 U. S. 413, 422–423 (2021) (quotation marks
omitted). Therefore, we begin as always with the precise
text of the Constitution.

Article III of the Constitution confines the jurisdiction of
federal courts to “Cases” and “Controversies.” The case or
controversy requirement limits the role of the Federal
Judiciary in our system of separated powers. As this Court
explained to President George Washington in 1793 in
response to his request for a legal opinion, federal courts do
not issue advisory opinions about the law—even when
requested by the President. 13 Papers of George
Washington: Presidential Series 392 (C. Patrick ed. 2007).
Nor do federal courts operate as an open forum for citizens
“to press general complaints about the way in which
government goes about its business.” Allen v. Wright, 468
U. S. 737, 760 (1984) (quotation marks omitted); see
California v. Texas, 593 U. S. 659, 673 (2021); Valley Forge
Christian College v. Americans United for Separation of
Church and State, Inc., 454 U. S. 464, 487 (1982); United
States v. Richardson, 418 U. S. 166, 175 (1974); Ex parte
Levitt, 302 U. S. 633, 634 (1937) (per curiam);
Massachusetts v. Mellon, 262 U. S. 447, 487–488 (1923);
Fairchild v. Hughes, 258 U. S. 126, 129–130 (1922).
As Justice Scalia memorably said, Article III requires a
plaintiff to first answer a basic question: “ ‘What’s it to
you?’ ” A. Scalia, The Doctrine of Standing as an Essential
Element of the Separation of Powers, 17 Suffolk U. L. Rev.
881, 882 (1983). For a plaintiff to get in the federal
courthouse door and obtain a judicial determination of what
the governing law is, the plaintiff cannot be a mere
bystander, but instead must have a “personal stake” in the
dispute. TransUnion, 594 U. S., at 423. The requirement
that the plaintiff possess a personal stake helps ensure that
courts decide litigants’ legal rights in specific cases, as
Article III requires, and that courts do not opine on legal
issues in response to citizens who might “roam the country
in search of governmental wrongdoing.” Valley Forge, 454
U. S., at 487; see, e.g., Schlesinger v. Reservists Comm. to
Cite as: 602 U. S. ____ (2024) 7
Stop the War, 418 U. S. 208, 227 (1974); Richardson, 418

U. S., at 175; Tyler v. Judges of Court of Registration, 179
U. S. 405, 406 (1900). Standing also “tends to assure that
the legal questions presented to the court will be resolved,
not in the rarified atmosphere of a debating society, but in
a concrete factual context conducive to a realistic
appreciation of the consequences of judicial action.” Valley
Forge, 454 U. S., at 472. Moreover, the standing doctrine
serves to protect the “autonomy” of those who are most
directly affected so that they can decide whether and how
to challenge the defendant’s action. Id., at 473.
By limiting who can sue, the standing requirement
implements “the Framers’ concept of the proper—and
properly limited—role of the courts in a democratic society.”
J. Roberts, Article III Limits on Statutory Standing, 42
Duke L. J. 1219, 1220 (1993) (quotation marks omitted). In
particular, the standing requirement means that the
federal courts decide some contested legal questions later
rather than sooner, thereby allowing issues to percolate and
potentially be resolved by the political branches in the
democratic process. See Raines v. Byrd, 521 U. S. 811, 829–
830 (1997); cf. Clapper v. Amnesty Int’l USA, 568 U. S. 398,
420–422 (2013). And the standing requirement means that
the federal courts may never need to decide some contested
legal questions: “Our system of government leaves many
crucial decisions to the political processes,” where
democratic debate can occur and a wide variety of interests
and views can be weighed. Schlesinger, 418 U. S., at 227;
see Campbell v. Clinton, 203 F. 3d 19, 23 (CADC 2000).
A
The fundamentals of standing are well-known and firmly
rooted in American constitutional law. To establish
standing, as this Court has often stated, a plaintiff must
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 relief. See
Summers v. Earth Island Institute, 555 U. S. 488, 493
(2009); Lujan v. Defenders of Wildlife, 504 U. S. 555, 560–
561 (1992). Those specific standing requirements
constitute “an essential and unchanging part of the case-or-
controversy requirement of Article III.” Id., at 560.
The second and third standing requirements—causation
and redressability—are often “flip sides of the same coin.”
Sprint Communications Co. v. APCC Services, Inc., 554
U. S. 269, 288 (2008). If a defendant’s action causes an
injury, enjoining the action or awarding damages for the
action will typically redress that injury. So the two key
questions in most standing disputes are injury in fact and
causation.1
First is injury in fact. An injury in fact must be
“concrete,” meaning that it must be real and not abstract.
See TransUnion, 594 U. S., at 424. The injury also must be
particularized; the injury must affect “the plaintiff in a
personal and individual way” and not be a generalized
grievance. Lujan, 504 U. S., at 560, n. 1. An 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. Moreover, the injury
must be actual or imminent, not speculative—meaning that
the injury must have already occurred or be likely to occur
soon. Clapper, 568 U. S., at 409. And when a plaintiff seeks
prospective relief such as an injunction, the plaintiff must
establish a sufficient likelihood of future injury. Id., at 401.
By requiring the plaintiff to show an injury in fact, Article
——————
1 Redressability can still pose an independent bar in some cases. For
example, a plaintiff who suffers injuries caused by the government still

may not be able to sue because the case may not be of the kind
“traditionally redressable in federal court.” United States v. Texas, 599
U. S. 670, 676 (2023); cf. California v. Texas, 593 U. S. 659, 671–672
(2021).
Cite as: 602 U. S. ____ (2024) 9
III standing screens out plaintiffs who might have only a

general legal, moral, ideological, or policy objection to a
particular government action. For example, a citizen does
not have standing to challenge a government regulation
simply because the plaintiff believes that the government
is acting illegally. See Valley Forge, 454 U. S., at 473, 487.
A citizen may not sue based only on an “asserted right to
have the Government act in accordance with law.” Allen,
468 U. S., at 754; Schlesinger, 418 U. S., at 225–227. Nor
may citizens sue merely because their legal objection is
accompanied by a strong moral, ideological, or policy
objection to a government action. See Valley Forge, 454
U. S., at 473.
The injury in fact requirement prevents the federal
courts from becoming a “vehicle for the vindication of the
value interests of concerned bystanders.” Allen, 468 U. S.,
at 756 (quotation marks omitted). An Article III court is
not a legislative assembly, a town square, or a faculty
lounge. Article III does not contemplate a system where
330 million citizens can come to federal court whenever
they believe that the government is acting contrary to the
Constitution or other federal law. See id., at 754.
Vindicating “the public interest (including the public
interest in Government observance of the Constitution and
laws) is the function of Congress and the Chief Executive.”
Lujan, 504 U. S., at 576.
In sum, to sue in federal court, a plaintiff must show that
he or she has suffered or likely will suffer an injury in fact.
Second is causation. The plaintiff must also establish
that the plaintiff ’s injury likely was caused or likely will be
caused by the defendant’s conduct.
Government regulations that require or forbid some
action by the plaintiff almost invariably satisfy both the
injury in fact and causation requirements. So in those
cases, standing is usually easy to establish. See Lujan, 504
U. S., at 561–562; see, e.g., Susan B. Anthony List v.
Driehaus, 573 U. S. 149, 162–163 (2014).

By contrast, when (as here) a plaintiff challenges the
government’s “unlawful regulation (or lack of regulation) of
someone else,” “standing is not precluded, but it is ordinarily
substantially more difficult to establish.” Lujan, 504 U. S.,
at 562 (quotation marks omitted); see Summers, 555 U. S.,
at 493. That is often because unregulated parties may have
more difficulty establishing causation—that is, linking
their asserted injuries to the government’s regulation (or
lack of regulation) of someone else. See Clapper, 568 U. S.,
at 413–414; Lujan, 504 U. S., at 562; Duke Power Co. v.
Carolina Environmental Study Group, Inc., 438 U. S. 59, 74
(1978); Simon v. Eastern Ky. Welfare Rights Organization,
426 U. S. 26, 41–46 (1976); Warth v. Seldin, 422 U. S. 490,
504–508 (1975).
When the plaintiff is an unregulated party, causation
“ordinarily hinge[s] on the response of the regulated (or
regulable) third party to the government action or
inaction—and perhaps on the response of others as well.”
Lujan, 504 U. S., at 562. Yet the Court has said that
plaintiffs attempting to show causation generally cannot
“rely on speculation about the unfettered choices made by
independent actors not before the courts.” Clapper, 568
U. S., at 415, n. 5 (quotation marks omitted); see also
Bennett v. Spear, 520 U. S. 154, 168–169 (1997). Therefore,
to thread the causation needle in those circumstances, the
plaintiff must show that the “ ‘third parties will likely react
in predictable ways’ ” that in turn will likely injure the
plaintiffs. California, 593 U. S., at 675 (quoting
Department of Commerce v. New York, 588 U. S. 752, 768
(2019)).
As this Court has explained, the “line of causation
between the illegal conduct and injury”—the “links in the
chain of causation,” Allen, 468 U. S., at 752, 759—must not
be too speculative or too attenuated, Clapper, 568 U. S., at
410–411. The causation requirement precludes speculative
Cite as: 602 U. S. ____ (2024) 11
links—that is, where it is not sufficiently predictable how

third parties would react to government action or cause
downstream injury to plaintiffs. See Allen, 468 U. S., at
757–759; Simon, 426 U. S., at 41–46. The causation
requirement also rules out attenuated links—that is, where
the government action is so far removed from its distant
(even if predictable) ripple effects that the plaintiffs cannot
establish Article III standing. See Allen, 468 U. S., at 757–
759; cf. Department of Commerce, 588 U. S., at 768.
The causation requirement is central to Article III
standing. Like the injury in fact requirement, the causation
requirement screens out plaintiffs who were not injured by
the defendant’s action. Without the causation requirement,
courts would be “virtually continuing monitors of the
wisdom and soundness” of government action. Allen, 468
U. S., at 760 (quotation marks omitted).
Determining causation in cases involving suits by
unregulated parties against the government is admittedly
not a “mechanical exercise.” Id., at 751. That is because
the causation inquiry can be heavily fact-dependent and a
“question of degree,” as private petitioner’s counsel aptly
described it here. Tr. of Oral Arg. 50. Unfortunately,
applying the law of standing cannot be made easy, and that
is particularly true for causation. Just as causation in tort
law can pose line-drawing difficulties, so too can causation
in standing law when determining whether an unregulated
party has standing.
That said, the “absence of precise definitions” has not left
courts entirely “at sea in applying the law of standing.”
Allen, 468 U. S., at 751. Like “most legal notions, the
standing concepts have gained considerable definition from
developing case law.” Ibid. As the Court has explained, in
“many cases the standing question can be answered chiefly
by comparing the allegations of the particular complaint to
those made in prior standing cases.” Id., at 751–752.
Stated otherwise, assessing standing “in a particular case
may be facilitated by clarifying principles or even clear

rules developed in prior cases.” Id., at 752.
Consistent with that understanding of how standing
principles can develop and solidify, the Court has identified
a variety of familiar circumstances where government
regulation of a third-party individual or business may be
likely to cause injury in fact to an unregulated plaintiff. For
example, when the government regulates (or under-
regulates) a business, the regulation (or lack thereof ) may
cause downstream or upstream economic injuries to others
in the chain, such as certain manufacturers, retailers,
suppliers, competitors, or customers. E.g., National Credit
Union Admin. v. First Nat. Bank & Trust Co., 522 U. S. 479,
488, n. 4 (1998); General Motors Corp. v. Tracy, 519 U. S.
278, 286–287 (1997); Barlow v. Collins, 397 U. S. 159, 162–
164 (1970); Association of Data Processing Service
Organizations, Inc. v. Camp, 397 U. S. 150, 152 (1970).
When the government regulates parks, national forests, or
bodies of water, for example, the regulation may cause
harm to individual users. E.g., Summers, 555 U. S., at 494.
When the government regulates one property, it may
reduce the value of adjacent property. The list goes on. See,
e.g., Department of Commerce, 588 U. S., at 766–768.
As those cases illustrate, to establish causation, the
plaintiff must show a predictable chain of events leading
from the government action to the asserted injury—in other
words, that the government action has caused or likely will
cause injury in fact to the plaintiff.2
——————
2 In cases of alleged future injuries to unregulated parties from
government regulation, the causation requirement and the imminence

element of the injury in fact requirement can overlap. Both target the
same issue: Is it likely that the government’s regulation or lack of
regulation of someone else will cause a concrete and particularized injury
in fact to the unregulated plaintiff?
Cite as: 602 U. S. ____ (2024) 13
B
Here, the plaintiff doctors and medical associations are
unregulated parties who seek to challenge FDA’s regulation
of others. Specifically, FDA’s regulations apply to doctors
prescribing mifepristone and to pregnant women taking
mifepristone. But the plaintiff doctors and medical
associations do not prescribe or use mifepristone. And FDA
has not required the plaintiffs to do anything or to refrain
from doing anything.
The plaintiffs do not allege the kinds of injuries described
above that unregulated parties sometimes can assert to
demonstrate causation. Because the plaintiffs do not
prescribe, manufacture, sell, or advertise mifepristone or
sponsor a competing drug, the plaintiffs suffer no direct
monetary injuries from FDA’s actions relaxing regulation of
mifepristone. Nor do they suffer injuries to their property,
or to the value of their property, from FDA’s actions.
Because the plaintiffs do not use mifepristone, they
obviously can suffer no physical injuries from FDA’s actions
relaxing regulation of mifepristone.
Rather, the plaintiffs say that they are pro-life, oppose
elective abortion, and have sincere legal, moral, ideological,
and policy objections to mifepristone being prescribed and
used by others. The plaintiffs appear to recognize that those
general legal, moral, ideological, and policy concerns do not
suffice on their own to confer Article III standing to sue in
federal court. So to try to establish standing, the plaintiffs
advance several complicated causation theories to connect
FDA’s actions to the plaintiffs’ alleged injuries in fact.
The first set of causation theories contends that FDA’s
relaxed regulation of mifepristone may cause downstream
conscience injuries to the individual doctor plaintiffs and
the specified members of the plaintiff medical associations,
who are also doctors. (We will refer to them collectively as
“the doctors.”) The second set of causation theories asserts
that FDA’s relaxed regulation of mifepristone may cause
downstream economic injuries to the doctors. The third set

of causation theories maintains that FDA’s relaxed
regulation of mifepristone causes injuries to the medical
associations themselves, who assert their own
organizational standing. As we will explain, none of the
theories suffices to establish Article III standing.
1
We first address the plaintiffs’ claim that FDA’s relaxed
regulation of mifepristone causes conscience injuries to the
doctors.
The doctors contend that FDA’s 2016 and 2021 actions
will cause more pregnant women to suffer complications
from mifepristone, and those women in turn will need more
emergency abortions by doctors. The plaintiff doctors say
that they therefore may be required—against their
consciences—to render emergency treatment completing
the abortions or providing other abortion-related
treatment.
The Government correctly acknowledges that a
conscience injury of that kind constitutes a concrete injury
in fact for purposes of Article III. See Tr. of Oral Arg. 11–
12; TransUnion, 594 U. S., at 425; see, e.g., Holt v. Hobbs,
574 U. S. 352 (2015). So doctors would have standing to
challenge a government action that likely would cause them
to provide medical treatment against their consciences.
But in this case—even assuming for the sake of argument
that FDA’s 2016 and 2021 changes to mifepristone’s
conditions of use cause more pregnant women to require
emergency abortions and that some women would likely
seek treatment from these plaintiff doctors—the plaintiff
doctors have not shown that they could be forced to
participate in an abortion or provide abortion-related
medical treatment over their conscience objections.
That is because, as the Government explains, federal
conscience laws definitively protect doctors from being
Cite as: 602 U. S. ____ (2024) 15
required to perform abortions or to provide other treatment

that violates their consciences. See 42 U. S. C. §300a–
7(c)(1); see also H. R. 4366, 118th Cong., 2d Sess., Div. C,
Title II, §203 (2024). The Church Amendments, for
instance, speak clearly. They allow doctors and other
healthcare personnel to “refus[e] to perform or assist” an
abortion without punishment or discrimination from their
employers. 42 U. S. C. §300a–7(c)(1). And the Church
Amendments more broadly provide that doctors shall not be
required to provide treatment or assistance that would
violate the doctors’ religious beliefs or moral convictions.
§300a–7(d). Most if not all States have conscience laws to
the same effect. See N. Sawicki, Protections From Civil
Liability in State Abortion Conscience Laws, 322 JAMA
1918 (2019); see, e.g., Tex. Occ. Code Ann. §103.001 (West
2022).
Moreover, as the Government notes, federal conscience
protections encompass “the doctor’s beliefs rather than
particular procedures,” meaning that doctors cannot be
required to treat mifepristone complications in any way
that would violate the doctors’ consciences. Tr. of Oral Arg.
37; see §300a–7(c)(1). As the Government points out, that
strong protection for conscience remains true even in a so-
called healthcare desert, where other doctors are not
readily available. Tr. of Oral Arg. 18.
Not only as a matter of law but also as a matter of fact,
the federal conscience laws have protected pro-life doctors
ever since FDA approved mifepristone in 2000. The
plaintiffs have not identified any instances where a doctor
was required, notwithstanding conscience objections, to
perform an abortion or to provide other abortion-related
treatment that violated the doctor’s conscience. Nor is
there any evidence in the record here of hospitals overriding
or failing to accommodate doctors’ conscience objections.
In other words, none of the doctors’ declarations says
anything like the following: “Here is the treatment I
provided, here is how it violated my conscience, and here is

why the conscience protections were unavailable to me.” Cf.
App. 153–154 (Dr. Francis saw a patient suffering
complications from an abortion drug obtained from India;
no allegation that Dr. Francis helped perform an abortion);
id., at 154 (Dr. Francis witnessed another doctor perform
an abortion; no allegation that the other doctor raised
conscience objections or tried not to participate); id., at 163–
164 (doctor’s hospital treated women suffering
complications from abortion drugs; no allegation that the
doctors treating the patients had or raised conscience
objections to the treatment they provided); id., at 173–174
(doctor treated a patient suffering from mifepristone
complications; no description of what that treatment
involved and no statement that the doctor raised a
conscience objection to providing that treatment).
In response to all of that, the doctors still express fear
that another federal law, the Emergency Medical
Treatment and Labor Act or EMTALA, might be
interpreted to override those federal conscience laws and to
require individual emergency room doctors to participate in
emergency abortions in some circumstances. See 42
U. S. C. §1395dd. But the Government has disclaimed that
reading of EMTALA. And we agree with the Government’s
view of EMTALA on that point. EMTALA does not require
doctors to perform abortions or provide abortion-related
medical treatment over their conscience objections because
EMTALA does not impose obligations on individual doctors.
See Brief for United States 23, n. 3. As the Solicitor
General succinctly and correctly stated, EMTALA does not
“override an individual doctor’s conscience objections.” Tr.
of Oral Arg. 18; see also Tr. of Oral Arg. in Moyle v. United
States, O. T. 2023, No. 23–726 etc., pp. 88–91 (Moyle Tr.).
We agree with the Solicitor General’s representation that
federal conscience protections provide “broad coverage” and
will “shield a doctor who doesn’t want to provide care in
Cite as: 602 U. S. ____ (2024) 17
violation of those protections.” Tr. of Oral Arg. 18, 36.

The doctors say, however, that emergency room doctors
summoned to provide emergency treatment may not have
time to invoke federal conscience protections. But as the
Government correctly explained, doctors need not follow a
time-intensive procedure to invoke federal conscience
protections. Reply Brief for United States 5. A doctor may
simply refuse; federal law protects doctors from
repercussions when they have “refused” to participate in an
abortion. §300a–7(c)(1); Reply Brief for United States 5.
And as the Government states, “[h]ospitals must
accommodate doctors in emergency rooms no less than in
other contexts.” Ibid. For that reason, hospitals and
doctors typically try to plan ahead for how to deal with a
doctor’s absence due to conscience objections. Tr. of Oral
Arg. 18; Moyle Tr. 89–90. And again, nothing in the record
since 2000 supports plaintiffs’ speculation that doctors will
be unable to successfully invoke federal conscience
protections in emergency circumstances.
In short, given the broad and comprehensive conscience
protections guaranteed by federal law, the plaintiffs have
not shown—and cannot show—that FDA’s actions will
cause them to suffer any conscience injury. Federal law
fully protects doctors against being required to provide
abortions or other medical treatment against their
consciences—and therefore breaks any chain of causation
between FDA’s relaxed regulation of mifepristone and any
asserted conscience injuries to the doctors.3
——————
3 The doctors also suggest that they are distressed by others’ use of
mifepristone and by emergency abortions. It is not clear that this alleged

injury is distinct from the alleged conscience injury. But even if it is, this
Court has long made clear that distress at or disagreement with the
activities of others is not a basis under Article III for a plaintiff to bring
a federal lawsuit challenging the legality of a government regulation
allowing those activities. See, e.g., Valley Forge Christian College v.
Americans United for Separation of Church and State, Inc., 454 U. S.
464, 473, 485–486 (1982); United States v. Richardson, 418 U. S. 166,
2
In addition to alleging conscience injuries, the doctors cite
various monetary and related injuries that they allegedly
will suffer as a result of FDA’s actions—in particular,
diverting resources and time from other patients to treat
patients with mifepristone complications; increasing risk of
liability suits from treating those patients; and potentially
increasing insurance costs.
Those standing allegations suffer from the same
problem—a lack of causation. The causal link between
FDA’s regulatory actions and those alleged injuries is too
speculative or otherwise too attenuated to establish
standing.
To begin with, the claim that the doctors will incur those
injuries as a result of FDA’s 2016 and 2021 relaxed
regulations lacks record support and is highly speculative.
The doctors have not offered evidence tending to suggest
that FDA’s deregulatory actions have both caused an
increase in the number of pregnant women seeking
treatment from the plaintiff doctors and caused a resulting
diversion of the doctors’ time and resources from other
patients. Moreover, the doctors have not identified any
instances in the past where they have been sued or required
to pay higher insurance costs because they have treated
pregnant women suffering mifepristone complications. Nor
have the plaintiffs offered any persuasive evidence or
reason to believe that the future will be different.
In any event, and perhaps more to the point, the law has
never permitted doctors to challenge the government’s
loosening of general public safety requirements simply
because more individuals might then show up at emergency
rooms or in doctors’ offices with follow-on injuries. Stated
otherwise, there is no Article III doctrine of “doctor
standing” that allows doctors to challenge general
——————
175 (1974); Sierra Club v. Morton, 405 U. S. 727, 739 (1972).
Cite as: 602 U. S. ____ (2024) 19
government safety regulations. Nor will this Court now

create such a novel standing doctrine out of whole cloth.
Consider some examples. EPA rolls back emissions
standards for power plants—does a doctor have standing to
sue because she may need to spend more time treating
asthma patients? A local school district starts a middle
school football league—does a pediatrician have standing to
challenge its constitutionality because she might need to
spend more time treating concussions? A federal agency
increases a speed limit from 65 to 80 miles per hour—does
an emergency room doctor have standing to sue because he
may have to treat more car accident victims? The
government repeals certain restrictions on guns—does a
surgeon have standing to sue because he might have to
operate on more gunshot victims?
The answer is no: The chain of causation is simply too
attenuated. Allowing doctors or other healthcare providers
to challenge general safety regulations as unlawfully lax
would be an unprecedented and limitless approach and
would allow doctors to sue in federal court to challenge
almost any policy affecting public health.4
And in the FDA drug-approval context, virtually all drugs
come with complications, risks, and side effects. Some
drugs increase the risk of heart attack, some may cause
cancer, some may cause birth defects, and some heighten
the possibility of stroke. Approval of a new drug may
therefore yield more visits to doctors to treat complications
or side effects. So the plaintiffs’ loose approach to causation
would also essentially allow any doctor or healthcare
provider to challenge any FDA decision approving a new
drug. But doctors have never had standing to challenge
FDA’s drug approvals simply on the theory that use of the
——————
4 A safety law regulating hospitals or the doctors’ medical practices
obviously would present a different issue—either such a law would

directly regulate doctors, or the causal link at least would be
substantially less attenuated.
drugs by others may cause more visits to doctors.

And if we were now to invent a new doctrine of doctor
standing, there would be no principled way to cabin such a
sweeping doctrinal change to doctors or other healthcare
providers. Firefighters could sue to object to relaxed
building codes that increase fire risks. Police officers could
sue to challenge a government decision to legalize certain
activities that are associated with increased crime.
Teachers in border states could sue to challenge allegedly
lax immigration policies that lead to overcrowded
classrooms.
We decline to start the Federal Judiciary down that
uncharted path. That path would seemingly not end until
virtually every citizen had standing to challenge virtually
every government action that they do not like—an approach
to standing that this Court has consistently rejected as
flatly inconsistent with Article III.
We recognize that many citizens, including the plaintiff
doctors here, have sincere concerns about and objections to
others using mifepristone and obtaining abortions. But
citizens and doctors do not have standing to sue simply
because others are allowed to engage in certain activities—
at least without the plaintiffs demonstrating how they
would be injured by the government’s alleged under-
regulation of others. See Coalition for Mercury-Free Drugs
v. Sebelius, 671 F. 3d 1275, 1277 (CADC 2012). Citizens
and doctors who object to what the law allows others to do
may always take their concerns to the Executive and
Legislative Branches and seek greater regulatory or
legislative restrictions on certain activities.
In sum, the doctors in this case have failed to establish
Article III standing. The doctors have not shown that
FDA’s actions likely will cause them any injury in fact. The
asserted causal link is simply too speculative or too
Cite as: 602 U. S. ____ (2024) 21
attenuated to support Article III standing.5

3
That leaves the medical associations’ argument that the
associations themselves have organizational standing.
Under this Court’s precedents, organizations may have
standing “to sue on their own behalf for injuries they have
sustained.” Havens Realty Corp. v. Coleman, 455 U. S. 363,
379, n. 19 (1982). In doing so, however, organizations must
satisfy the usual standards for injury in fact, causation, and
redressability that apply to individuals. Id., at 378–379.
According to the medical associations, FDA has
“impaired” their “ability to provide services and achieve
their organizational missions.” Brief for Respondents 43.
That argument does not work to demonstrate standing.
Like an individual, an organization may not establish
standing simply based on the “intensity of the litigant’s
interest” or because of strong opposition to the
government’s conduct, Valley Forge, 454 U. S., at 486, “no
matter how longstanding the interest and no matter how
qualified the organization,” Sierra Club v. Morton, 405
U. S. 727, 739 (1972). A plaintiff must show “far more than
simply a setback to the organization’s abstract social
interests.” Havens, 455 U. S., at 379. The plaintiff
——————
5 The doctors also suggest that they can sue in a representative
capacity to vindicate their patients’ injuries or potential future injuries,

even if the doctors have not suffered and would not suffer an injury
themselves. This Court has repeatedly rejected such arguments. Under
this Court’s precedents, third-party standing, as some have called it,
allows a narrow class of litigants to assert the legal rights of others. See
Hollingsworth v. Perry, 570 U. S. 693, 708 (2013). But “even when we
have allowed litigants to assert the interests of others, the litigants
themselves still must have suffered an injury in fact, thus giving them a
sufficiently concrete interest in the outcome of the issue in dispute.” Ibid.
(quotation marks and alterations omitted). The third-party standing
doctrine does not allow doctors to shoehorn themselves into Article III
standing simply by showing that their patients have suffered injuries or
may suffer future injuries.
associations therefore cannot assert standing simply

because they object to FDA’s actions.
The medical associations say that they have
demonstrated something more here. They claim to have
standing not based on their mere disagreement with FDA’s
policies, but based on their incurring costs to oppose FDA’s
actions. They say that FDA has “caused” the associations
to conduct their own studies on mifepristone so that the
associations can better inform their members and the
public about mifepristone’s risks. Brief for Respondents 43.
They contend that FDA has “forced” the associations to
“expend considerable time, energy, and resources” drafting
citizen petitions to FDA, as well as engaging in public
advocacy and public education. Id., at 44 (quotation marks
omitted). And all of that has caused the associations to
spend “considerable resources” to the detriment of other
spending priorities. Ibid.
But an organization that has not suffered a concrete
injury caused by a defendant’s action cannot spend its way
into standing simply by expending money to gather
information and advocate against the defendant’s action.
An organization cannot manufacture its own standing in
that way.
The medical associations respond that under Havens
Realty Corp. v. Coleman, standing exists when an
organization diverts its resources in response to a
defendant’s actions. 455 U. S. 363. That is incorrect.
Indeed, that theory would mean that all the organizations
in America would have standing to challenge almost every
federal policy that they dislike, provided they spend a single
dollar opposing those policies. Havens does not support
such an expansive theory of standing.
The relevant question in Havens was whether a housing
counseling organization, HOME, had standing to bring a
claim under the Fair Housing Act against Havens Realty,
which owned and operated apartment complexes. Id., at
Cite as: 602 U. S. ____ (2024) 23
368, 378. Havens had provided HOME’s black employees

false information about apartment availability—a practice
known as racial steering. Id., at 366, and n. 1, 368.
Critically, HOME not only was an issue-advocacy
organization, but also operated a housing counseling
service. Id., at 368. And when Havens gave HOME’s
employees false information about apartment availability,
HOME sued Havens because Havens “perceptibly impaired
HOME’s ability to provide counseling and referral services
for low- and moderate-income homeseekers.” Id., at 379. In
other words, Havens’s actions directly affected and
interfered with HOME’s core business activities—not
dissimilar to a retailer who sues a manufacturer for selling
defective goods to the retailer.
That is not the kind of injury that the medical
associations have alleged here. FDA’s actions relaxing
regulation of mifepristone have not imposed any similar
impediment to the medical associations’ advocacy
businesses.
At most, the medical associations suggest that FDA is not
properly collecting and disseminating information about
mifepristone, which the associations say in turn makes it
more difficult for them to inform the public about safety
risks. But the associations have not claimed an
informational injury, and in any event the associations
have not suggested that federal law requires FDA to
disseminate such information upon request by members of
the public. Cf. Federal Election Comm’n v. Akins, 524 U. S.
11 (1998).
Havens was an unusual case, and this Court has been
careful not to extend the Havens holding beyond its context.
So too here.
Finally, it has been suggested that the plaintiffs here
must have standing because if these plaintiffs do not have
standing, then it may be that no one would have standing
to challenge FDA’s 2016 and 2021 actions. For starters, it
is not clear that no one else would have standing to

challenge FDA’s relaxed regulation of mifepristone. But
even if no one would have standing, this Court has long
rejected that kind of “if not us, who?” argument as a basis
for standing. See Clapper, 568 U. S., at 420–421; Valley
Forge, 454 U. S., at 489; Richardson, 418 U. S., at 179–180.
The “assumption” that if these plaintiffs lack “standing to
sue, no one would have standing, is not a reason to find
standing.” Schlesinger, 418 U. S., at 227. Rather, some
issues may be left to the political and democratic processes:
The Framers of the Constitution did not “set up something
in the nature of an Athenian democracy or a New England
town meeting to oversee the conduct of the National
Government by means of lawsuits in federal courts.”
Richardson, 418 U. S., at 179; see Texas, 599 U. S., at 685.
* * *
The plaintiffs have sincere legal, moral, ideological, and
policy objections to elective abortion and to FDA’s relaxed
regulation of mifepristone. But under Article III of the
Constitution, those kinds of objections alone do not
establish a justiciable case or controversy in federal court.
Here, the plaintiffs have failed to demonstrate that FDA’s
relaxed regulatory requirements likely would cause them to
suffer an injury in fact. For that reason, the federal courts
are the wrong forum for addressing the plaintiffs’ concerns
about FDA’s actions. The plaintiffs may present their
concerns and objections to the President and FDA in the
regulatory process, or to Congress and the President in the
legislative process. And they may also express their views
about abortion and mifepristone to fellow citizens,
including in the political and electoral processes.
“No principle is more fundamental to the judiciary’s
proper role in our system of government than the
constitutional limitation of federal-court jurisdiction to
actual cases or controversies.” Simon, 426 U. S., at 37. We
reverse the judgment of the U. S. Court of Appeals for the
Cite as: 602 U. S. ____ (2024) 25
Fifth Circuit and remand the case for further proceedings

consistent with this opinion.
It is so ordered.
Cite as: 602 U. S. ____ (2024) 1
THOMAS, J., concurring

_________________
Nos. 23–235 and 23–236

_________________
FOOD AND DRUG ADMINISTRATION, ET AL.,

PETITIONER
23–235 v.
DANCO LABORATORIES, L.L.C., PETITIONER

23–236 v.
ON WRITS OF CERTIORARI TO THE UNITED STATES COURT OF
APPEALS FOR THE FIFTH CIRCUIT
[June 13, 2024]
JUSTICE THOMAS, concurring.

I join the Court’s opinion in full because it correctly ap-
plies our precedents to conclude that the Alliance for Hip-
pocratic Medicine and other plaintiffs lack standing. Our
precedents require a plaintiff to demonstrate that the de-
fendant’s challenged actions caused his asserted injuries.
And, the Court aptly explains why plaintiffs have failed to
establish that the Food and Drug Administration’s changes
to the regulation of mifepristone injured them. Ante, at 13–
24.
The Court also rejects the plaintiff doctors’ theory that
they have third-party standing to assert the rights of their
patients. Ante, at 21, n. 5. Our third-party standing prec-
edents allow a plaintiff to assert the rights of another per-
son when the plaintiff has a “close relationship with the
person who possesses the right” and “there is a hindrance
to the possessor’s ability to protect his own interests.” Kow-
alski v. Tesmer, 543 U. S. 125, 130 (2004) (internal quota-

tion marks omitted). Applying these precedents, the Court
explains that the doctors cannot establish third-party
standing to sue for violations of their patients’ rights with-
out showing an injury of their own. Ante, at 21, n. 5. But,
there is a far simpler reason to reject this theory: Our third-
party standing doctrine is mistaken. As I have previously
explained, a plaintiff cannot establish an Article III case or
controversy by asserting another person’s rights.1 See June
Medical Services L. L. C. v. Russo, 591 U. S. 299, 366 (2020)
(THOMAS, J., dissenting); Kowalski, 543 U. S., at 135
(THOMAS, J., concurring). So, just as abortionists lack
standing to assert the rights of their clients, doctors who
oppose abortion cannot vicariously assert the rights of their
patients.
I write separately to highlight what appear to be similar
problems with another theory of standing asserted in this
suit. The Alliance and other plaintiff associations claim
that they have associational standing to sue for their mem-
bers’ injuries.2 Under the Court’s precedents, “an associa-
tion has standing to bring suit on behalf of its members
when: (a) its members would otherwise have standing to
sue in their own right; (b) the interests it seeks to protect
are germane to the organization’s purpose; and (c) neither
the claim asserted nor the relief requested requires the par-
ticipation of individual members in the lawsuit.” Hunt v.
Washington State Apple Advertising Comm’n, 432 U. S.
——————
1 Certain forms of standing that may be representational in a general
sense, such as next friend standing, are “not inconsistent with this
point.” June Medical Services, L. L. C. v. Russo, 591 U. S. 299, 365, n. 2
(2020) (THOMAS, J., dissenting).
2 By “associational standing,” I do not refer to standing premised upon
an association’s own alleged injuries. Instead, I refer to the doctrine that

permits a plaintiff association to assert the rights of its members. See
Warth v. Seldin, 422 U. S. 490, 511 (1975).
Cite as: 602 U. S. ____ (2024) 3
333, 343 (1977). If an association can satisfy these require-

ments, we allow the association to pursue its members’
claims, without joining those members as parties to the
suit.
Associational standing, however, is simply another form
of third-party standing. And, the Court has never ex-
plained or justified either doctrine’s expansion of Article III
standing. In an appropriate case, we should explain just
how the Constitution permits associational standing.
I
Associational standing raises constitutional concerns by
relaxing both the injury and redressability requirements
for Article III standing. It also upsets other legal doctrines.
First, associational standing conflicts with Article III by
permitting an association to assert its members’ injuries in-
stead of its own. The “judicial power” conferred by Article
III “is limited to cases and controversies of the sort tradi-
tionally amenable to, and resolved by, the judicial process.”
See June Medical, 591 U. S., at 364 (opinion of THOMAS, J.)
(internal quotation marks omitted). “[T]o ascertain the
scope of Article III’s case-or-controversy requirement,”
courts therefore “refer directly to the traditional, funda-
mental limitations upon the powers of common-law courts.”
Ibid. (internal quotation marks omitted). Traditionally, a
plaintiff had to show a violation of his own rights to have
his claim considered by a common-law court. See id., at
364–366. So, “private parties could not bring suit to vindi-
cate the constitutional [or other legal] rights of individuals
who are not before the Court.” Id., at 359. “After all, ‘[t]he
province of the court is, solely, to decide on the rights of in-
dividuals,’ ” not to answer legal debates in the abstract.
Acheson Hotels, LLC v. Laufer, 601 U. S. 1, 10 (2023)
(THOMAS, J., concurring in judgment) (quoting Marbury v.
Madison, 1 Cranch 137, 170 (1803)); see also ante, at 5–7.
Associational standing seems to run roughshod over this
traditional understanding of the judicial power. Our doc-

trine permits an association to have standing based purely
upon a member’s injury, not its own. If a single member of
an association has suffered an injury, our doctrine permits
that association to seek relief for its entire membership—
even if the association has tens of millions of other, non-
injured members. See Brief for Professor F. Andrew
Hessick as Amicus Curiae 28 (explaining that, among other
associations, the American Association of Retired People’s
“potential standing is staggering” because our doctrine per-
mits it to “sue to redress” the injury of a single member out
of its “almost thirty-eight million members”). As I have al-
ready explained in the context of third-party standing, Ar-
ticle III does not allow a plaintiff to seek to vindicate some-
one else’s injuries. See June Medical, 591 U. S., at 364–366
(opinion of THOMAS, J.); Kowalski, 543 U. S., at 135 (opin-
ion of THOMAS, J.). It is difficult to see why that logic
should not apply with equal force to an association as to any
other plaintiff. I thus have serious doubts that an associa-
tion can have standing to vicariously assert a member’s in-
jury.
The Alliance’s attempted use of our associational-stand-
ing doctrine illustrates how far we have strayed from the
traditional rule that plaintiffs must assert only their own
injuries. The Alliance is an association whose members are
other associations. See 1 App. 9–10. None of its members
are doctors. Instead, the Alliance seeks to have associa-
tional standing based on injuries to the doctors who are
members of its member associations. Thus, the allegedly
injured parties—the doctors—are two degrees removed
from the party before us pursuing those injuries.
Second, our associational-standing doctrine does not ap-
pear to comport with the requirement that the plaintiff pre-
sent an injury that the court can redress. For a plaintiff to
have standing, a court must be able to “provid[e] a remedy
that can redress the plaintiff ’s injury.” Uzuegbunam v.
Cite as: 602 U. S. ____ (2024) 5
Preczewski, 592 U. S. 279, 291 (2021) (emphasis added).

But, as explained, associational standing creates a mis-
match: Although the association is the plaintiff in the suit,
it has no injury to redress. The party who needs the rem-
edy—the injured member—is not before the court. Without
such members as parties to the suit, it is questionable
whether “relief to these nonparties . . . exceed[s] constitu-
tional bounds.” Association of American Physicians & Sur-
geons v. FDA, 13 F. 4th 531, 540 (CA6 2021); see also De-
partment of Homeland Security v. New York, 589 U. S. ___,
___ (2020) (GORSUCH, J., concurring in grant of stay) (ex-
plaining that remedies “are meant to redress the injuries
sustained by a particular plaintiff in a particular lawsuit”);
Brief for Professor F. Andrew Hessick as Amicus Curiae 18
(“A bedrock principle of the Anglo-American legal system
was that the right to a remedy for an injury was personal”).
Consider the remedial problem when an association
seeks an injunction, as the Alliance did here. See 1 App.
113. “We have long held” that our equity jurisdiction is lim-
ited to “the jurisdiction in equity exercised by the High
Court of Chancery in England at the time of the adoption of
the Constitution.” Grupo Mexicano de Desarrollo, S. A. v.
Alliance Bond Fund, Inc., 527 U. S. 308, 318 (1999). And,
“as a general rule, American courts of equity did not provide
relief beyond the parties to the case.” Trump v. Hawaii, 585
U. S. 667, 717 (2018) (THOMAS, J., concurring). For associ-
ations, that principle would mean that the relief could not
extend beyond the association. But, if a court entered “[a]n
injunction that bars a defendant from enforcing a law or
regulation against the specific party before the court—the
associational plaintiff—[it would] not satisfy Article III be-
cause it w[ould] not redress an injury.” Association of Amer-
ican Physicians & Surgeons, 13 F. 4th, at 540 (internal quo-

tation marks omitted).3
Our precedents have provided a workaround for this ob-
vious remedial problem through the invention of the so-
called “universal injunction.” Universal injunctions typi-
cally “prohibit the Government from enforcing a policy with
respect to anyone.” Trump, 585 U. S., at 713, n. 1
(THOMAS, J., concurring). By providing relief beyond the
parties to the case, this remedy is “legally and historically
dubious.” Id., at 721; see also Labrador v. Poe, 601 U. S.
___, ___–___ (2024) (slip op., at 4–5) (GORSUCH, J., concur-
ring in grant of stay). It seems no coincidence that associa-
tional standing’s “emergence in the 1960s overlaps with the
emergence of [this] remedial phenomenon” of a similarly
questionable nature. Association of American Physicians &
Surgeons, 13 F. 4th, at 541. Because no party should be
permitted to obtain an injunction in favor of nonparties, I
have difficulty seeing why an association should be permit-
ted to do so for its members. Associational standing thus
seems to distort our traditional understanding of the judi-
cial power.
In addition to these Article III concerns, there is tension
between associational standing and other areas of law.
First, the availability of associational standing subverts the
class-action mechanism. A class action allows a named
plaintiff to represent others with similar injuries, but it is
subject to the many requirements of Federal Rule of Civil
Procedure 23. Associational standing achieves that same
——————
3 This also raises the question of who should pick the remedy. Associ-
ations “may have very different interests from the individuals whose
rights they are raising.” Kowalski v. Tesmer, 543 U. S. 125, 135 (2004)
(THOMAS, J., concurring). For example, an association might prefer an
injunction preventing the enforcement of a law that harms its members,
while an injured member may instead want damages to compensate him
for his injuries. Or perhaps a member would wish to settle the litigation,
whereas an association might want to continue the fight. Our associa-
tional-standing doctrine ignores these obvious concerns.
Cite as: 602 U. S. ____ (2024) 7
end goal: One lawsuit can provide relief to a large group of

people. “As compared to a class action,” however, associa-
tional standing seems to require “show[ing] an injury to
only a single member,” and the association “need not show
that litigation by representation is superior to individual
litigation.” 13A C. Wright, A. Miller, & E. Cooper, Federal
Practice and Procedure §3531.9.5, pp. 879–880 (3d ed.,
Supp. 2023); see also Fed. Rule Civ. Proc. 23(a). Associa-
tional standing thus allows a party to effectively bring a
class action without satisfying any of the ordinary require-
ments. Second, associational standing creates the possibil-
ity of asymmetrical preclusion. The basic idea behind pre-
clusion is that a party gets only one bite at the apple. If a
party litigates and loses an issue or claim, it can be barred
from reasserting that same issue or claim in another suit.
In general, preclusion prevents the relitigation of claims or
issues only by a party to a previous action, and we have
been careful to limit the exceptions to that rule. See Taylor
v. Sturgell, 553 U. S. 880, 892–893 (2008). In the context of
associational standing, the general rule would mean that
preclusion applies only to the association, even though the
purpose of the association’s suit is to assert the injuries of
its members. See id., at 893–896. But, if the association
loses, it is not clear whether the adverse judgment would
bind the members. See Automobile Workers v. Brock, 477
U. S. 274, 290 (1986) (suggesting that, if an association fails
to adequately represent its members, “a judgment won
against it might not preclude subsequent claims by the as-
sociation’s members without offending due process princi-
ples”). Associational standing might allow a member two
bites at the apple—after an association’s claims are re-
jected, the underlying members might be able to assert the
exact same issues or claims in a suit in their own names.
In short, our associational-standing doctrine appears to
create serious problems, both constitutional and otherwise.
II
I am particularly doubtful of associational-standing doc-
trine because the Court has never attempted to reconcile it
with the traditional understanding of the judicial power.
Instead, the Court departed from that traditional under-
standing without explanation, seemingly by accident. To
date, the Court has provided only practical reasons for its
doctrine.
For over a century and a half, the Court did not have a
separate standing doctrine for associations. As far as I can
tell, the Court did not expressly contemplate such a doc-
trine until the late 1950s. In NAACP v. Alabama ex rel.
Patterson, 357 U. S. 449 (1958), the Court permitted an as-
sociation to assert the constitutional rights of its members
to prevent the disclosure of its membership lists. While the
Court allowed the NAACP to raise a challenge on behalf of
its members, it also acknowledged that the NAACP had ar-
guably faced an injury of its own. Id., at 459–460. The
Court, however, soon discarded any notion that an associa-
tion needed to have its own injury, creating our modern as-
sociational-standing doctrine. In National Motor Freight
Traffic Assn., Inc. v. United States, 372 U. S. 246 (1963) (per
curiam), the Court suggested that an uninjured industry
group had standing to challenge a tariff schedule on behalf
of its members. Id., at 247. The Court offered no explana-
tion for how that theory of standing comported with the tra-
ditional understanding of the judicial power. In fact, the
Court’s entire analysis consisted of a one-paragraph order
denying rehearing. Since then, however, the Court has par-
roted that “[e]ven in the absence of injury to itself, an asso-
ciation may have standing solely as the representative of its
members.” Warth v. Seldin, 422 U. S. 490, 511 (1975) (em-
phasis added; citing National Motor Freight Traffic Assn.,
372 U. S. 246); see also, e.g., Automobile Workers, 477 U. S.,
at 281. The Court has gone so far as to hold that a state
Cite as: 602 U. S. ____ (2024) 9
agency—not a membership organization at all—had associ-

ational standing to “asser[t] the claims of the Washington
apple growers and dealers who form its constituency.”
Hunt, 432 U. S., at 344.
Despite its continued reliance on associational standing,
the Court has yet to explain how the doctrine comports with
Article III. When once asked to “reconsider and reject the
principles of associational standing” in favor of the class-
action mechanism, the Court justified the doctrine solely by
reference to its “special features, advantageous both to the
individuals represented and to the judicial system as a
whole.” Automobile Workers, 477 U. S., at 288–289. Those
“special features” included an association’s “pre-existing
reservoir of expertise and capital,” and the fact that people
often join an association “to create an effective vehicle for
vindicating interests that they share with others.” Id., at
289–290. But, considerations of practical judicial policy
cannot overcome the Constitution’s mandates. The lack of
any identifiable justification further suggests that the
Court should reconsider its associational-standing doctrine.
* * *
No party challenges our associational-standing doctrine
today. That is understandable; the Court consistently ap-
plies the doctrine, discussing only the finer points of its op-
eration. See, e.g., Students for Fair Admissions, Inc. v.
President and Fellows of Harvard College, 600 U. S. 181,
199–201 (2023). In this suit, rejecting our associational-
standing doctrine is not necessary to conclude that the
plaintiffs lack standing. In an appropriate case, however,
the Court should address whether associational standing
can be squared with Article III’s requirement that courts
respect the bounds of their judicial power.

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(Slip Opinion) OCTOBER TERM, 2023 1

NOTE: Where it is feasible, a syllabus (headnote) will be released, as is

SUPREME COURT OF THE UNITED STATES

FOOD AND DRUG ADMINISTRATION ET AL. v.

CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR

No. 23–235. Argued March 26, 2024—Decided June 13, 2024*

stayed the District Court’s order pending the disposition of

establish Article III standing. Pp. 13–24.

organizations must satisfy the usual standards for injury in fact,

KAVANAUGH, J., delivered the opinion for a unanimous Court. THOMAS,

Opinion of the Court

NOTICE: This opinion is subject to formal revision before publication in the

SUPREME COURT OF THE UNITED STATES

Nos. 23–235 and 23–236

FOOD AND DRUG ADMINISTRATION, ET AL.,

DANCO LABORATORIES, L.L.C., PETITIONER

JUSTICE KAVANAUGH delivered the opinion of the Court.

Opinion of the Court

Opinion of the Court

amend Mifeprex’s labeling and to relax some of the

Opinion of the Court

Texas. Plaintiffs brought claims under the Administrative

Opinion of the Court

U. S. ___ (2023). As a result of this Court’s stay, Mifeprex

Opinion of the Court

text of the Constitution.

Opinion of the Court

Stop the War, 418 U. S. 208, 227 (1974); Richardson, 418

Opinion of the Court

be caused by the defendant, and (iii) that the injury likely

example, a plaintiff who suffers injuries caused by the government still

Opinion of the Court

III standing screens out plaintiffs who might have only a

Opinion of the Court

Driehaus, 573 U. S. 149, 162–163 (2014).

Opinion of the Court

links—that is, where it is not sufficiently predictable how

Opinion of the Court

may be facilitated by clarifying principles or even clear

government regulation, the causation requirement and the imminence

Opinion of the Court

Opinion of the Court

downstream economic injuries to the doctors. The third set

Opinion of the Court

required to perform abortions or to provide other treatment

Opinion of the Court

provided, here is how it violated my conscience, and here is

Opinion of the Court

violation of those protections.” Tr. of Oral Arg. 18, 36.

mifepristone and by emergency abortions. It is not clear that this alleged

Opinion of the Court

Opinion of the Court

government safety regulations. Nor will this Court now

obviously would present a different issue—either such a law would

Opinion of the Court

drugs by others may cause more visits to doctors.

Opinion of the Court

attenuated to support Article III standing.5

capacity to vindicate their patients’ injuries or potential future injuries,

Opinion of the Court

associations therefore cannot assert standing simply

Opinion of the Court

368, 378. Havens had provided HOME’s black employees