Justice Stevens
delivered the opinion of the Court.
The question presented is whether the incorporation of a federal standard in a state-law private action, when Congress has intended that there not be a federal private action for violations of that federal standard, makes the action one “arising under the Constitution, laws, or treaties of the United States,” 28 U. S. C. § 1331.
I
The Thompson respondents are residents of Canada and the MacTavishes reside in Scotland. They filed virtually identical complaints against petitioner, a corporation, that manufactures and distributes the drug Bendectin. The complaints were filed in the Court of Common Pleas in Hamilton County, Ohio. Each complaint alleged that a child was born with multiple deformities as a result of the mother’s ingestion of Bendectin during pregnancy. In five of the six counts, the recovery of substantial damages was requested on common-law theories of negligence, breach of warranty, strict liability, fraud, and gross negligence. In Count IV, respondents alleged that the drug Bendectin was “misbranded” in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U. S. C. § 301 et seq. (1982 ed. and Supp. Ill), because its labeling did not provide adequate warning that its use was potentially dangerous. Paragraph 26 alleged that the violation of the FDCA “in the promotion” of Bendectin “constitutes a rebuttable presumption of negligence.” Paragraph 27 alleged that the “violation of said federal statutes directly and proximately caused the injuries suffered” by the two infants. App. 22, 32.
Petitioner filed a timely petition for removal from the state court to the Federal District Court alleging that the action was “founded, in part, on an alleged claim arising under the laws of the United States.” After removal, the two cases were consolidated. Respondents filed a motion to remand to the state forum on the ground that the federal court lacked subject-matter jurisdiction. Relying on our decision in Smith v. Kansas City Title & Trust Co., 255 U. S. 180 (1921), the District Court held that Count IV of the complaint alleged a cause of action arising under federal law and denied the motion to remand. It then granted petitioner’s motion to dismiss on forum non conveniens grounds.
The Court of Appeals for the Sixth Circuit reversed. 766 F. 2d 1006 (1985). After quoting one sentence from the concluding paragraph in our recent opinion in Franchise Tax Board v. Construction Laborers Vacation Trust, 463 U. S. 1 (1983), and noting “that the FDCA does not create or imply a private right of action for individuals injured as a result of violations of the Act,” it explained:
“Federal question jurisdiction would, thus, exist only if plaintiffs’ right to relief depended necessarily on a substantial question of federal law. Plaintiffs’ causes of action referred to the FDCA merely as one available criterion for determining whether Merrell Dow was negligent. Because the jury could find negligence on the part of Merrell Dow without finding a violation of the FDCA, the plaintiffs’ causes of action did not depend necessarily upon a question of federal law. Consequently, the causes of action did not arise under federal law and, therefore, were improperly removed to federal court.” 766 F. 2d, at 1006.
We granted certiorari, 474 U. S. 1004 (1985), and we now affirm.
II
Article III of the Constitution gives the federal courts power to hear cases “arising under” federal statutes. That grant of power, however, is not self-executing, and it was not until the Judiciary Act of 1875 that Congress gave the federal courts general federal-question jurisdiction. Although the constitutional meaning of “arising under” may extend to all cases in which a federal question is “an ingredient” of the action, Osborn v. Bank of the United States, 9 Wheat. 738, 823 (1824), we have long construed the statutory grant of federal-question jurisdiction as conferring a more limited power. Verlinden B. V. v. Central Bank of Nigeria, 461 U. S. 480, 494-495 (1983); Romero v. International Terminal Operating Co., 358 U. S. 354, 379 (1959).
Under our longstanding interpretation of the current statutory scheme, the question whether a claim “arises under” federal law must be determined by reference to the “well-pleaded complaint.” Franchise Tax Board, 463 U. S., at 9-10. A defense that raises a federal question is inadequate to confer federal jurisdiction. Louisville & Nashville R. Co. v. Mottley, 211 U. S. 149 (1908). Since a defendant may remove a case only if the claim could have been brought in federal court, 28 U. S. C. § 1441(b), moreover, the question for removal jurisdiction must also be determined by reference to the “well-pleaded complaint.”
As was true in Franchise Tax Board, supra, the propriety of the removal in this case thus turns on whether the case falls within the original “federal question” jurisdiction of the federal courts. There is no “single, precise definition” of that concept; rather, “the phrase ‘arising under’ masks a welter of issues regarding the interrelation of federal and state authority and the proper management of the federal judicial system.” Id., at 8.
This much, however, is clear. The “vast majority” of cases that come within this grant of jurisdiction are covered by Justice Holmes’ statement that a “ ‘suit arises under the law that creates the cause of action.’” Id., at 8-9, quoting American Well Works Co. v. Layne & Bowler Co., 241 U. S. 257, 260 (1916). Thus, the vast majority of cases brought under the general federal-question jurisdiction of the federal courts are those in which federal law creates the cause of action.
We have, however, also noted that a case may arise under federal law “where the vindication of a right under state law necessarily turned on some construction of federal law.” Franchise Tax Board, 463 U. S., at 9. Our actual holding in Franchise Tax Board demonstrates that this statement must be read with caution; the central issue presented in that case turned on the meaning of the Employee Retirement Income Security Act of 1974, 29 U. S. C. § 1001 et seq. (1982 ed. and Supp. III), but we nevertheless concluded that federal jurisdiction was lacking.
This case does not pose a federal question of the first kind; respondents do not allege that federal law creates any of the causes of action that they have asserted. This case thus poses what Justice Frankfurter called the “litigation-provoking problem,” Textile Workers v. Lincoln Mills, 353 U. S. 448, 470 (1957) (dissenting opinion) — the presence of a federal issue in a state-created cause of action.
In undertaking this inquiry into whether jurisdiction may lie for the presence of a federal issue in a nonfederal cause of action, it is, of course, appropriate to begin by referring to our understanding of the statute conferring federal-question jurisdiction. We have consistently emphasized that, in exploring the outer reaches of § 1331, determinations about federal jurisdiction require sensitive judgments about congressional intent, judicial power, and the federal system. “If the history of the interpretation of judiciary legislation teaches us anything, it teaches the duty to reject treating such statutes as a wooden set of self-sufficient words. . . . The Act of 1875 is broadly phrased, but it has been continuously construed and limited in the light of the history that produced it, the demands of reason and coherence, and the dictates of sound judicial policy which have emerged from the Act’s function as a provision in the mosaic of federal judiciary legislation.” Romero v. International Terminal Operating Co., 358 U. S., at 379. In Franchise Tax Board, we forcefully reiterated this need for prudence and restraint in the jurisdictional inquiry: “We have always interpreted what Skelly Oil [Co. v. Phillips Petroleum Co., 339 U. S. 667, 673 (1950)] called ‘the current of jurisdictional legislation since the Act of March 3, 1875’. . . with an eye to practicality and necessity.” 463 U. S., at 20.
In this case, both parties agree with the Court of Appeals’ conclusion that there is no federal cause of action for FDCA violations. For purposes of our decision, we assume that this is a correct interpretation of the FDCA. Thus, as the case comes to us, it is appropriate to assume that, under the settled framework for evaluating whether a federal cause of action lies, some combination of the following factors is present: (1) the plaintiffs are not part of the class for whose special benefit the statute was passed; (2) the indicia of legislative intent reveal no congressional purpose to provide a private cause of action; (3) a federal cause of action would not further the underlying purposes of the legislative scheme; and (4) the respondents’ cause of action is a subject traditionally relegated to state law. In short, Congress did not intend a private federal remedy for violations of the statute that it enacted.
This is the first case in which we have reviewed this type of jurisdictional claim in light of these factors. That this is so is not surprising. The development of our framework for determining whether a private cause of action exists has proceeded only in the last 11 years, and its inception represented a significant change in our approach to congressional silence on the provision of federal remedies.
The recent character of that development does not, however, diminish its importance. Indeed, the very reasons for the development of the modern implied remedy doctrine— the “increased complexity of federal legislation and the increased volume of federal litigation,” as well as “the desirability of a more careful scrutiny of legislative intent,” Merrill Lynch, Pierce, Fenner & Smith, Inc. v. Curran, 456 U. S. 353, 377 (1982) (footnote omitted) — are precisely the kind of considerations that should inform the concern for “practicality and necessity” that Franchise Tax Board advised for the construction of § 1331 when jurisdiction is asserted because of the presence of a federal issue in a state cause of action.
The significance of the necessary assumption that there is no federal private cause of action thus cannot be overstated. For the ultimate import of such a conclusion, as we have repeatedly emphasized, is that it would flout congressional intent to provide a private federal remedy for the violation of the federal statute. We think it would similarly flout, or at least undermine, congressional intent to conclude that the federal courts might nevertheless exercise federal-question jurisdiction and provide remedies for violations of that federal statute solely because the violation of the federal statute is said to be a “rebuttable presumption” or a “proximate cause” under state law, rather than a federal action under federal law.
HH HH HH
Petitioner advances three arguments to support its position that, even in the face of this congressional preclusion of a federal cause of action for a violation of the federal statute, federal-question jurisdiction may lie for the violation of the federal statute as an element of a state cause of action.
First, petitioner contends that the case represents a straightforward application of the statement in Franchise Tax Board that federal-question jurisdiction is appropriate when “it appears that some substantial, disputed question of federal law is a necessary element of one of the well-pleaded state claims.” 463 U. S., at 13. Franchise Tax Board, however, did not purport to disturb the long-settled understanding that the mere presence of a federal issue in a state cause of action does not automatically confer federal-question jurisdiction. Indeed, in determining that federal-question jurisdiction was not appropriate in the case before us, we stressed Justice Cardozo’s emphasis on principled, pragmatic distinctions: “‘What is needed is something of that common-sense accommodation of judgment to kaleidoscopic situations which characterizes the law in its treatment of causation... a selective process which picks the substantial causes out of the web and lays the other ones aside.Id., at 20-21 (quoting Gully v. First National Bank, 299 U. S. 109, 117-118 (1936)).
Far from creating some kind of automatic test, Franchise Tax Board thus candidly recognized the need for careful judgments about the exercise of federal judicial power in an area of uncertain jurisdiction. Given the significance of the assumed congressional determination to preclude federal private remedies, the presence of the federal issue as an element of the state tort is not the kind of adjudication for which jurisdiction would serve congressional purposes and the federal system. This conclusion is fully consistent with the very sentence relied on so heavily by petitioner. We simply conclude that the congressional determination that there should be no federal remedy for the violation of this federal statute is tantamount to a congressional conclusion that the presence of a claimed violation of the statute as an element of a state cause of action is insufficiently “substantial” to confer federal-question jurisdiction.
Second, petitioner contends that there is a powerful federal interest in seeing that the federal statute is given uniform interpretations, and that federal review is the best way of insuring such uniformity. In addition to the significance of the congressional decision to preclude a federal remedy, we do not agree with petitioner’s characterization of the federal interest and its implications for federal-question jurisdiction. To the extent that petitioner is arguing that state use and interpretation of the FDCA pose a threat to the order and stability of the FDCA regime, petitioner should be arguing, not that federal courts should be able to review and enforce state FDCA-based causes of action as an aspect of federal-question jurisdiction, but that the FDCA pre-empts state-court jurisdiction over the issue in dispute. Petitioner’s concern about the uniformity of interpretation, moreover, is considerably mitigated by the fact that, even if there is no original district court jurisdiction for these kinds of action, this Court retains power to review the decision of a federal issue in a state cause of action.
Finally, petitioner argues that, whatever the general rule, there are special circumstances that justify federal-question jurisdiction in this case. Petitioner emphasizes that it is unclear whether the FDCA applies to sales in Canada and Scotland; there is, therefore, a special reason for having a federal court answer the novel federal question relating to the extraterritorial meaning of the Act. We reject this argument. We do not believe the question whether a particular claim arises under federal law depends on the novelty of the federal issue. Although it is true that federal jurisdiction cannot be based on a frivolous or insubstantial federal question, “the interrelation of federal and state authority and the proper management of the federal judicial system,” Franchise Tax Board, 463 U. S., at 8, would be ill served by a rule that made the existence of federal-question jurisdiction depend on the district court’s case-by-ease appraisal of the novelty of the federal question asserted as an element of the state tort. The novelty of an FDCA issue is not sufficient to give it status as a federal cause of action; nor should it be sufficient to give a state-based FDCA claim status as a jurisdiction-triggering federal question.
IV
We conclude that a complaint alleging a violation of a federal statute as an element of a state cause of action, when Congress has determined that there should be no private, federal cause of action for the violation, does not state a claim “arising under the Constitution, laws, or treaties of the United States.” 28 U. S. C. § 1331.
The judgment of the Court of Appeals is affirmed.
It is so ordered.
App. 36-37. The petition also alleged that the action “is between citizens of a State and citizens or subjects of a foreign state.” Id,., at 36. Because petitioner is a corporation -with its principal place of business in Ohio, however, the removal was not proper unless the action was founded on a claim arising under federal law. Title 28 U. S. C. § 1441(b) provides:
“(b) Any civil action of which the district courts have original jurisdiction founded on a claim or right arising under the Constitution, treaties or laws of the United States shall be removable without regard to the citizenship or residence of the parties. Any other such action shall be removable only if none of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.”
“ ‘Under our interpretations, Congress has given the lower courts jurisdiction to hear, originally or by removal from a state court, only those eases in which a well-pleaded complaint establishes either that federal law creates the cause of action or that the plaintiff’s right to relief necessarily depends on resolution of a substantial question of federal law.’” 766 F. 2d, at 1006 (quoting Franchise Tax Board, 463 U. S., at 28).
See Art. III, § 2 (“The judicial Power shall extend to all Cases, in Law and Equity, arising under this Constitution, the Laws of the United States, and Treaties made, or which shall be made, under their Authority . . .”).
Act of Mar. 3, 1875, § 1, 18 Stat. 470. As currently codified, the statute provides: “The district courts shall have original jurisdiction of all civil actions arising under the Constitution, laws or treaties of the United States.” 28 U. S. C. § 1331.
The case most frequently cited for that proposition is Smith v. Kansas City Title & Trust Co., 255 U. S. 180 (1921). In that case the Court upheld federal jurisdiction of a shareholder’s bill to enjoin the corporation from purchasing bonds issued by the federal land banks under the authority of the Federal Farm Loan Act on the ground that the federal statute that authorized the issuance of the bonds was unconstitutional. The Court stated:
“The general rule is that where it appears from the bill or statement of the plaintiff that the right to relief depends upon the construction or application of the Constitution or laws of the United States, and that such federal claim is not merely colorable, and rests upon a reasonable foundation, the District Court has jurisdiction under this provision.” Id., at 199.
The effect of this view, expressed over Justice Holmes’ vigorous dissent, on his American Well Works formulation has been often noted. See, e. g., Franchise Tax Board, 463 U. S., at 9 (“[I]t is well settled that Justice Holmes’ test is more useful for describing the vast majority of cases that come within the district courts’ original jurisdiction than it is for describing which cases are beyond district court jurisdiction”); T. B. Harms Co. v. Eliscu, 339 F. 2d 823, 827 (CA2 1964) (Friendly, J.) (“It has come to be realized that Mr. Justice Holmes’ formula is more useful for inclusion than for the exclusion for which it was intended”).
Jurisdiction may not be sustained on a theory that the plaintiff has not advanced. See Healy v. Sea Gull Specialty Co., 237 U. S. 479, 480 (1915) (“[T]he plaintiff is absolute master of what jurisdiction he will appeal to”); The Fair v. Kohler Die & Specialty Co., 228 U. S. 22, 25 (1913) (“[T]he party who brings a suit is master to decide what law he will rely upon”). See also United States v. Mottaz, 476 U. S. 834, 850 (1986).
See California v. Sierra Club, 451 U. S. 287, 293 (1981); Cannon v. University of Chicago, 441 U. S. 677, 689-709 (1979); Cort v. Ash, 422 U. S. 66, 78 (1975).
See Merrill Lynch, Pierce, Fenner & Smith, Inc. v. Curran, 456 U. S. 353, 377 (1982) (“In 1975 the Court unanimously decided to modify its approach to the question whether a federal statute includes a private right of action”). Cf. Middlesex County Sewerage Authority v. National Sea Clammers Assn., 453 U. S. 1, 25 (1981) (Stevens, J., concurring in judgment in part and dissenting in part) (“In 1975, in Cort v. Ash, 422 U. S. 66, the Court cut back on the simple common-law presumption by fashioning a four-factor formula that led to the denial of relief in that case”).
See, e. g., Daily Income Fund, Inc. v. Fox, 464 U. S. 523, 535-536 (1984) (“In evaluating such a claim, our focus must be on the intent of Congress when it enacted the statute in question”); Middlesex County Sewerage Authority v. National Sea Clammers Assn., 453 U. S., at 13 (“The key to the inquiry is the intent of the Legislature”); Texas Industries, Inc. v. Radcliff Materials, Inc., 451 U. S. 630, 639 (1981) (“Our focus, as it is in any case involving the implication of a right of action, is on the intent of Congress”); California v. Sierra Club, 451 U. S., at 293 (“[T]he ultimate issue is whether Congress intended to create a private right of action”); Northwest Airlines, Inc. v. Transport Workers, 451 U. S. 77, 91 (1981) (“The ultimate question in cases such as this is whether Congress intended to create the private remedy”); Transamerica Mortgage Advisors, Inc. v. Lewis, 444 U. S. 11, 15 (1979) (“The question whether a statute creates a cause of action, either expressly or by implication, is basically a matter of statutory construction”); Touche Ross & Co. v. Redington, 442 U. S. 560, 568 (1979) (“The question of the existence of a statutory cause of action is, of course, one of statutory construction”).
When we conclude that Congress has decided not to provide a particular federal remedy, we are not free to “supplement” that decision in a way that makes it “meaningless.” Cf. Mobil Oil Corp. v. Higginbotham, 436 U. S. 618, 625 (1978) (When Congress “does speak directly to a question, the courts are not free to ‘supplement’ Congress’ answer so thoroughly that the Act becomes meaningless”). See also California v. Sierra Club, 451 U. S., at 297 (“The federal judiciary will not engraft a remedy on a statute, no matter how salutary, that Congress did not intend to provide”).
See, e. g., Textile Workers v. Lincoln Mills, 353 U. S. 448, 470 (1957) (Frankfurter, J., dissenting) (defining inquiry as “the degree to which federal law must be in the forefront of the case and not collateral, peripheral or remote”); Gully v. First National Bank, 299 U. S. 109, 115 (1936) (“Not every question of federal law emerging in a suit is proof that a federal law is the basis of the suit”); id,., at 118 (“If we follow the ascent far enough, countless claims of right can be discovered to have their source or their operative limits in the provisions of a federal statute or in the Constitution itself with its circumambient restrictions upon legislative power. To set bounds to the pursuit, the courts have formulated the distinction between controversies that are basic and those that are collateral, between disputes that are necessary and those that are merely possible. We shall be lost in a maze if we put that compass by”).
Several commentators have suggested that our §1331 decisions can best be understood as an evaluation of the nature of the federal interest at stake. See, e. g., Shapiro, Jurisdiction and Discretion, 60 N. Y. U. L. Rev. 543, 568 (1985); C. Wright, Federal Courts 96 (4th ed. 1983); Cohen, The Broken Compass: The Requirement That a Case Arise “Directly” Under Federal Law, 115 U. Pa. L. Rev. 890, 916 (1967). Cf. Kravitz v. Homeowners Warranty Corp., 542 F. Supp. 317, 320 (ED Pa. 1982) (Pollak, J.) (“I cannot identify any compelling reasons of federal judicial policy for embracing a case of this kind as a federal question case. The essential Pennsylvania elements of plaintiffs’ suit for rescission would be more appropriately dealt with by a Court of Common Pleas than by this court; and, with respect to the lesser-included issue of federal law, Pennsylvania’s courts are fully competent to interpret the Magnuson-Moss Warranty Act and the relevant F. T. C. regulations, subject to review by the United States Supreme Court”).
Focusing on the nature of the federal interest, moreover, suggests that the widely perceived “irreconcilable” conflict between the finding of federal jurisdiction in Smith v. Kansas City Title & Trust Co., 255 U. S. 180 (1921), and the finding of no jurisdiction in Moore v. Chesapeake & Ohio R. Co., 291 U. S. 205 (1934), see, e. g., M. Redish, Federal Jurisdiction: Tensions in the Allocation of Judicial Power 67 (1980), is far from clear. For the difference in results can be seen as manifestations of the differences in the nature of the federal issues at stake. In Smith, as the Court emphasized, the issue was the constitutionality of an important federal statute. See 255 U. S., at 201 (“It is . . . apparent that the controversy concerns the constitutional validity of an act of Congress which is directly drawn in question. The decision depends upon the determination of this issue”). In Moore, in contrast, the Court emphasized that the violation of the federal standard as an element of state tort recovery did not fundamentally change the state tort nature of the action. See 291 U. S., at 216-217 (“ ‘The action fell within the familiar category of cases involving the duty of a master to his servant. This duty is defined by the common law, except as it may be modified by legislation. The federal statute, in the present case, touched the duty of the master at a single point and, save as provided in the statute, the right of the plaintiff to recover was left to be determined by the law of the State’ ”) (quoting Minneapolis, St. P. & S. S. M. R. Co. v. Popplar, 237 U. S. 369, 372 (1915)).
The importance of the nature of the federal issue in federal-question jurisdiction is highlighted by the fact that, despite the usual reliability of the Holmes test as an inclusionary principle, this Court has sometimes found that formally federal causes of action were not properly brought under federal-question jurisdiction because of the overwhelming predominance of state-law issues. See Shulthis v. McDougal, 225 U. S. 561, 569-570 (1912) (“A suit to enforce a right which takes its origin in the laws of the United States is not necessarily, or for that reason alone, one arising under those laws, for a suit does not so arise unless it really and substantially involves a dispute or controversy respecting the validity, construction or effect of such a law, upon the determination of which the result depends. This is especially so of a suit involving rights to land acquired under a law of the United States. If it were not, every suit to establish title to land in the central and western States would so arise, as all titles in those States are traceable back to those laws”); Shoshone Mining Co. v. Rutter, 177 U. S. 505, 507 (1900) (“We pointed out in the former opinion that it was well settled that a suit to enforce a right which takes its origin in the laws of the United States is not necessarily one arising under the Constitution or laws of the United States, within the meaning of the jurisdiction clauses, for if it did every action to establish title to real estate (at least in the newer States) would be such a one, as all titles in those States come from the United States or by virtue of its laws”).
Cf. Longshoremen v. Davis, 476 U. S. 380, 391 (1986) (“[O]ur decisions describing the nature of Garmon pre-emption and defining its boundaries have rested on a determination that in enacting the [National Labor Relations Act] Congress intended for the [National Labor Relations] Board generally to exercise exclusive jurisdiction in this area”).
See Moore v. Chesapeake & Ohio R. Co., 291 U. S., at 214-215 (“Questions arising in actions in state courts to recover for injuries sustained by employees in intrastate commerce and relating to the scope or construction of the Federal Safety Appliance Acts are, of course, federal questions which may appropriately be reviewed in this Court. . . . But it does not follow that a suit brought under the state statute which defines liability to employees who are injured while engaged in intrastate commerce, and brings within the purview of the statute a breach of the duty imposed by the federal statute, should be regarded as a suit arising under the laws of the United States and cognizable in the federal court in the absence of diversity of citizenship”). Cf. Franchise Tax Board, 463 U. S., at 12, n. 12 (“[T]he absence of original jurisdiction does not mean that there is no federal forum in which a pre-emption defense may be heard. If the state courts reject a claim of federal pre-emption, that decision may ultimately be reviewed on appeal by this Court”).
Petitioner also contends that the Court of Appeals opinion rests on a view that federal-question jurisdiction was inappropriate because, whatever the role of the federal issue in the FDCA-related count, the plaintiff could recover on other, strictly state-law claims. See 766 F. 2d, at 1006 (noting that “the jury could find negligence on the part of Merrell Dow without finding a violation of the FDCA”). To the extent that the opinion can be read to express such a view, we agree that it was erroneous. If the FDCA-related count presented a sufficient federal question, its relationship to the other, state-law claims would be determined by the ordinary principles of pendent jurisdiction described in Mine Workers v. Gibbs, 383 U. S. 715 (1966). For the reasons that we have stated, however, there is no federal-question jursidiction even with that possible error corrected.