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 [806]*806warning 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.”1 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),2 and noting “that the FDCA does not create or imply [807]*807a 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.3 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.4 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. [808]*808Verlinden 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.” [809]*809Franchise Tax Board, 463 U. S., at 9.5 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.6
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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 [806]*806warning 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.”1 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),2 and noting “that the FDCA does not create or imply [807]*807a 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.3 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.4 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. [808]*808Verlinden 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.” [809]*809Franchise Tax Board, 463 U. S., at 9.5 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.6 This case thus poses what Justice Frankfurter called the “litigation-provoking problem,” Textile Workers v. Lincoln Mills, 353 [810]*810U. 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 legis[811]*811lative 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.7 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.8
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 as[812]*812serted 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.9 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.10
[813]*813HH 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. 11 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 [814]*814and 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.12
[815]*815Second, 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 [816]*816not 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.13 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.14
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 [817]*817court 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.15
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.