In 2016 and 2021, the Food and Drug Administration relaxed its regulatory requirements for mifepristone, an abor- González, and Kate Epstein; for Former U. S. Department of Justice Offcials by Alan Schoenfeld, Kimberly A. Parker, Daniel S. Volchok, and Colleen Campbell; for the Freedom From Religion Foundation et al. by Patrick C. Elliott and Geoffrey T. Blackwell; for GenBioPro, Inc., by John P. Elwood, Daphne O'Connor, Robert J. Katerberg, Kolya D. Glick, David C. Frederick, Derek C. Reinbold, Skye L. Perryman, and Carrie Y. Flax- man; for Honeybee Health, Inc., by Stephanie L. Gutwein, A. Scott Chinn, Matthew K. Giffn, Elizabeth A. Charles, and Libby L. Baney; for Legal Voice et al. by Matthew Gordon; for Local Governments et al. by Jonathan B. Miller, Cheran Ivery, Anne L. Morgan, Myriam Zreczny Kasper, Su zanne M. Loose, Mark D. Griffn, Valerie L. Flores, Scott Marcus, Shaun Dabby Jacobs, John P. Markovs, and Lyndsey M. Olson; for Medical Students for Choice by Jayme Jonat; for the NAACP Legal Defense & Educational Fund, Inc., by Janai S. Nelson and Samuel Spital; for the National Council of Jewish Women et al. by Eugene M. Gelernter; for Over 640 State Legislators by Amanda Shafer Berman; for Patient and Provider Advocacy Organizations by Caroline L. Wolverton and Aileen M. Mc Grath; for Pharmaceutical Companies et al. by Eva A. Temkin, Paul Ales sio Mezzina, Joshua N. Mitchell, and Anne M. Voigts; for the Pharmaceutical Research and Manufacturers of America by Peter Safr, David M. Zionts, Daniel G. Randolph, Kendall T. Burchard, James C. Stansel, and Melissa B. Kimmel; for Physicians for Reproductive Health by Janice Mac Avoy; for Public Citizen et al. by Nicolas A. Sansone and Allison M. Zieve; for the Reproductive Freedom Alliance by Jaime A. Santos, An naka Nava, Dorothy Hazan, Jennifer Fisher, and Daryl L. Wiesen; for the Women's Bar Association of the District of Columbia by Candace Beck; for Women Who Have Obtained Medication Abortion Via Telemedicine by Vanessa K. Burrows and Julie F. Kay; for David S. Cohen et al. by David S. Cohen, pro se, and Susan J. Frietsche; for 237 Reproductive Health Organizations et al. by Lindsay C. Harrison; and for 263 Members of Congress by Boris Bershteyn and Jennifer L. Bragg. F. Andrew Hessick, pro se, and Richard A. Simpson fled a brief as amicus curiae urging vacatur in both cases.
Briefs of amici curiae urging affrmance in both cases were fled for the State of Mississippi et al. by Lynn Fitch, Attorney General of Mississippi, Whitney H. Lipscomb, Deputy Attorney General, Scott G. Stewart, Solicitor General, and Justin L. Matheny and Anthony M. Shults, Deputy Solicitors General, and by the Attorneys General for their respective States as Page Proof Pending Publication Page Proof Pending Publication tion 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.
follows: Steve Marshall of Alabama, Treg Taylor of Alaska, Tim Griffn of Arkansas, Ashley Moody of Florida, Christopher M. Carr of Georgia, Theodore E. Rokita of Indiana, Brenna Bird of Iowa, Russell Coleman of Kentucky, Liz Murrill of Louisiana, Austin Knudsen of Montana, Michael T. Hilgers of Nebraska, Drew H. Wrigley of North Dakota, Dave Yost of Ohio, Gentner F. Drummond of Oklahoma, Alan Wilson of South Carolina, Marty J. Jackley of South Dakota, Jonathan Skrmetti of Tennessee, Ken Paxton of Texas, Sean D. Reyes of Utah, Patrick Morrisey of West Virginia, and Bridget Hill of Wyoming; for the American Center for Law and Justice by Jay Alan Sekulow, Jordan A. Sekulow, Stuart J. Roth, Walter M. Weber, Geoffrey R. Surtees, and Laura B. Hernandez; for Americans United for Life by Steven H. Aden and Clarke D. Forsythe; for the Charlotte Lozier Institute by Gene C. Schaerr; for Democrats for Life of America by Rachel N. Morrison and Eric N. Kniffn; for the Elliot Institute et al. by Jay Alan Sekulow, Jordan A. Sekulow, Stuart J. Roth, and Walter M. Weber; for the Family Policy Alliance et al. by Randall L. Wenger, Jeremy L. Samek, and Janice Martino-Gottshall; for the Family Research Council et al. by Christopher E. Mills; for Former U. S. Department of Health and Human Services Offcials et al. by James R. Lawrence III; for Heartbeat International by Thomas Brejcha and B. Tyler Brooks; for Judicial Watch, Inc., by Meredith L. Di Liberto; for the Life Legal Defense Foundation by Catherine Short and Sheila A. Green; for the National Hispanic Leadership Conference et al. by Mathew D. Staver, Anita L. Staver, and Horatio G. Mihet; for Operation Rescue et al. by Jay Alan Sekulow, Jordan A. Sekulow, Stuart J. Roth, and Walter M. Weber; for Priests for Life by Robert Joseph Muise and David Yerushalmi; for the Prolife Center at the University of St. Thomas (MN) by Teresa Stanton Collett; for the Robertson Center for Constitutional Law by Christopher T. Holinger and Bradley J. Lingo; for the Southeastern Legal Foundation et al. by Thomas R. McCarthy, Braden H. Boucek, and Robert Henneke; for Stanton International by Erin Mersino and Robert J. Muise; for Susan B. Anthony Pro-Life America et al. by Heather Gebelin Hacker; for the United States Medical Association by Nathan W. Kellum; for Women and Families Harmed by Mifepristone et al. by Linda Boston Schlueter; for Women Injured by Abortion by Mary J. Browning, Allan E. Parker, R. Clayton Trotter, and Catherine Glenn Foster; for the World Faith Foundation et al. by James L. Hirsen, Tami Fitzgerald, and Deborah J. Dewart; Page Proof Pending Publication 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 diffcult 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 suffce. 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 for Former Secretary David Longly Bernhardt by John C. Sullivan; for Gianina Cazan-London et al. by William Wagner; for Grazie Pozo Christie et al. by Megan M. Wold; for Former U. S. Attorney General Edwin Meese III by David H. Thompson, Brian W. Barnes, and Clark L. Hildabrand; for Calum Miller by Kristine Brown; for Allan Sawyer by Michael S. Overing and Edward C. Wilde; and for 145 Members of Congress by Ste ven H. Aden.
Briefs of amici curiae were fled in both cases for the State of Missouri et al. by Andrew Bailey, Attorney General of Missouri, Joshua M. Divine, Solicitor General, and Maria A. Lanahan and Samuel C. Freedlund, Deputy Solicitors General, by Raúl R. Labrador, Attorney General of Idaho, Alan M. Hurst, Solicitor General, Joshua N. Turner, Deputy Solicitor General, and James E. M. Craig, and by Kris W. Kobach, Attorney General of Kansas, Anthony J. Powell, Solicitor General, and Erin B. Gaide, Assistant Attorney General; for Advancing American Freedom et al. by J. Marc Wheat; for Business Leaders by Jonathan R. Whitehead; for the Ethics and Public Policy Center by M. Edward Whelan III, Charles W. Fillmore, and H. Dustin Fillmore III; for the Human Coalition et al. by Elissa M. Graves and Chelsey D. Youman; for the Jewish Coalition for Religious Liberty by Howard Slugh; for the Mountain States Legal Foundation by Jennifer L. Mascott, R. Trent McCotter, and Ivan L. London; for the National Association of Nurse Practitioners in Women's Health et al. by Jon athan K. Youngwood and Simona G. Strauss; for Over 300 Reproductive Health Researchers by Melissa Goodman and Claudia Hammerman; and for Students for Life of America by William Bock III.
Niyati Shah and Noah Baron fled a brief for AANHPI et al. as amici curiae in No. 23–235.
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 specifes the drug's dosage, how to take the drug, and the specifc 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 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 Page Proof Pending Publication 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 fled another petition, this time asking FDA to withdraw its 2016 modifcations 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 Page Proof Pending Publication Page Proof Pending Publication 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 frst 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 frst 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 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, affrming in part and vacating in part. 78 F. 4th 210, 222–223 (CA5 2023). The Court of Appeals frst 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 confnes 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 Page Proof Pending Publication 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 cu riam); 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 frst 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 specifc 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 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 rarifed 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 Page Proof Pending Publication 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. Schle singer, 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 frmly 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 specifc 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 “fip sides of the same coin.” Sprint Communications Co. v. APCC Services, Inc., 554 Page Proof Pending Publication 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 suffcient likelihood of future injury. Id., at 401. 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. 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.
1Redressability 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). Page Proof Pending Publication 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 id., 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 diffcult 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 diffculty 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 Page Proof Pending Publication Page Proof Pending Publication 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 links—that is, where it is not suffciently 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 diffculties, so too can causation in standing law when determining whether an unregulated party has standing.
That said, the “absence of precise defnitions” 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 defnition from developing case law.” Ibid. As the Court has explained, in “many cases the standing question can be answered chiefy 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 identifed 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); Gen Page Proof Pending Publication eral 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., Sum mers, 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
B
Here, the plaintiff doctors and medical associations are unregulated parties who seek to challenge FDA's regulation of others. Specifcally, 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 inju2In 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?
Page Proof Pending Publication ries 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 suffce 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 frst set of causation theories contends that FDA's relaxed regulation of mifepristone may cause downstream conscience injuries to the individual doctor plaintiffs and the specifed 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 suffces to establish Article III standing.
We frst 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 emerPage Proof Pending Publication gency 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; Trans- Union, 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 defnitively protect doctors from being 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).
Page Proof Pending Publication 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 identifed 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. 1 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 Page Proof Pending Publication 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 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.
Page Proof Pending Publication 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 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 3The 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. Ameri cans United for Separation of Church and State, Inc., 454 U. S. 464, 473, 485–486 (1982); United States v. Richardson, 418 U. S. 166, 175 (1974); Sierra Club v. Morton, 405 U. S. 727, 739 (1972).
Page Proof Pending Publication 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 identifed 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' offces with follow-on injuries. Stated otherwise, there is no Article III doctrine of “doctor standing” that allows doctors to challenge general 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 Page Proof Pending Publication Page Proof Pending Publication 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 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. Firefghters could sue to object to relaxed building codes that increase fre risks. Police offcers 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 fatly 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 citi4A 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.
zens 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 attenuated to support Article III standing.5 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 5The 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 suffciently 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.
Page Proof Pending Publication 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 qualifed 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 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.
Page Proof Pending Publication The medical associations respond that under Havens Re alty 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 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 home- seekers.” 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 diffcult 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 Page Proof Pending Publication 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 fnd standing.” Schle singer, 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 Page Proof Pending Publication Page Proof Pending Publication 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 Fifth Circuit and remand the case for further proceedings consistent with this opinion.
It is so ordered.