Bell Atl. Corp. v. Twombly

Holding that a complaint's allegations should "contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face' "

Lujan v. Defs. of Wildlife

Holding that the elements of standing "must be supported in the same way as any other matter on which the plaintiff bears the burden of proof"

Chevron U.S.A. v. Natural Res. Def. Council

Holding that courts "must give effect to the unambiguously expressed intent of Congress"

Conley v. Gibson

Holding that "a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief"

Warth v. Seldin

Holding that Article III requires plaintiffs "to establish that, in fact, the asserted injury was the consequence of the defendants' actions"

Bennett v. Spear

Holding that a Final Biological Opinion has "legal consequences," even though the action agency is not legally obligated to accept the opinion's recommendations or conclusions, because the opinion "alter the legal regime to which the action agency is subject"

Allen v. Wright

Holding that, even when plaintiffs allege "one of the most serious injuries recognized in our legal system," it's not justiciable where "the chain of causation between the challenged Government conduct and the asserted injury are far too weak for the chain as a whole to sustain respondents' standing"

Hunt v. Washington Apple Advertising Comm'n

Holding that North Carolina's statute banning state grading of apples was discriminatory even though six other states also had no state grading

Citizens to Preserve Overton Park v. Volpe

Holding a decision is committed to agency discretion when there is "no law to apply"

Arlington Heights v. Metropolitan Housing Corp.

Holding that plaintiffs need show only that "a discriminatory purpose has been a motivating factor in the decision," because, after all, "[r]arely can it be said that a legislature or administrative body operating under a broad mandate made a decision motivated solely by a single concern, or even that a particular purpose was the ‘dominant’ or ‘primary’ one."

Section 1331 - Federal question

Finding that in order to invoke federal question jurisdiction, a plaintiff's claims must arise "under the Constitution, laws, or treaties of the United States."

Section 1391 - Venue generally

Finding that venue lies where a "substantial part of the events or omissions giving rise to the claim" occurred

Section 706 - Scope of review

Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

Section 704 - Actions reviewable

Granting judicial review over " final agency action"

Section 355 - New drugs

Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

Section 331 - Prohibited acts

Prohibiting the sale of adulterated foods

Section 352 - Misbranded drugs and devices

Setting labeling requirements for drug products

Section 337 - Proceedings in name of United States; provision as to subpoenas

Restricting FDCA enforcement to suits by the United States

Section 333 - Penalties

Defining civil and criminal penalties for violations of Section 331

Section 516 - Conduct of litigation reserved to Department of Justice

Granting the Attorney General and the Department of Justice exclusive power to direct litigation involving the United States

Section 10.30 - Citizen petition

Describing the requirements for filing a citizens' petition

Section 10.25 - Initiation of administrative proceedings

Including forms under 21 C.F.R. § 314.50 among the forms that constitute a "petition"

Section 330.10 - Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs

Subjecting "[a]ny product which fails to conform to an applicable monograph" to regulatory action

Section 10.45 - Court review of final administrative action; exhaustion of administrative remedies

Providing that " request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25 . . . before any legal action is filed in a court complaining of the action or failure to act"

Section 10.85 - Advisory opinions

Providing that an FDA employee's written statement, which constitutes "an informal communication," "does not necessarily represent the formal position of FDA," a statement that by its terms contemplates that certain employee statements may do so

Section 310.200 - Prescription-exemption procedure