U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER III— PROHIBITED ACTS AND PENALTIES

21 U.S.C. § 337

Proceedings in name of United States; provision as to subpoenas

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(a) Except as provided in subsection (b), all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States. Subpoenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any proceeding under this section.(b)(1) A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if the food that is the subject of the proceedings is located in the State.(2) No proceeding may be commenced by a State under paragraph (1)—(A) before 30 days after the State has given notice to the Secretary that the State intends to bring such proceeding,(B) before 90 days after the State has given notice to the Secretary of such intent if the Secretary has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding, or(C) if the Secretary is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food.In any court proceeding described in subparagraph (C), a State may intervene as a matter of right.(June 25, 1938, ch. 675, § 310, formerly § 307, 52 Stat. 1046; Sept. 3, 1954, ch. 1263, § 37, 68 Stat. 1239; Pub. L. 101–535, § 4, Nov. 8, 1990, 104 Stat. 2362; renumbered § 310, Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150.)Editorial NotesAmendments

1990—Pub. L. 101–535 substituted “(a) Except as provided in subsection (b), all” for “All” and “any proceeding under this section” for “any such proceeding” and added subsec. (b).

1954—Act Sept. 3, 1954, struck out reference to section 654 of title 28.

Statutory Notes and Related SubsidiariesEffective Date of 1990 Amendment

Amendment by Pub. L. 101–535 effective 24 months after Nov. 8, 1990, except that such amendment effective Dec. 31, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances, see section 10(a)(1)(C) of Pub. L. 101–535, set out as a note under section 343 of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

Notes of Decisions
Cited in 452 cases (142 in the last 5 years), 1947–2026 · leading case: Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001).
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Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). · cites it 4× “21 U. S. C. § 337 (a). Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision in the MDA.”
Alton Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012). · cites it 6× “For the reasons that follow, we AFFIRM the dismissal of Bass’s strict liability, design defect, negligence, and Texas Deceptive Trade Practices Act (“DTPA”) claims to the extent they are premised on a failure to warn or a marketing defect; AFFIRM as to Bass’s breach of express…”
Brooks v. Mentor Worldwide, 985 F.3d 1272 (10th Cir. 2021). · cites it 3× “21 U.S.C. § 337 . Interpreting and applying this requirement is easier than the first.”
James Kroessler v. Cvs Health Corp., 977 F.3d 803 (9th Cir. 2020). · cites it 3× “” 21 U.S.C. § 337 (a). Private plaintiffs may not bring actions to enforce violations of the FDCA.”
Joseph Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017). · cites it 3× “§ 360k(a), the “express preemption” provision, and 21 U.S.C. § 337 (a), the “implied preemption” provision.”
Rita McDaniel v. Upsher-Smith Labs., Inc., 893 F.3d 941 (6th Cir. 2018). · cites it 4× “” 21 U.S.C. § 337 (a). “The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance .”
Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016). · cites it 4× “61, at 63 (quoting Cales, 2014 WL 6600018 )). In enacting the FDCA, Congress not only declined to create a private cause of action, but also affirmatively required that any action to enforce the FDCA “shall' be by and in the name of the United States” ( 21 U.”
Gillian Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024). · cites it 5× “It is therefore helpful to review the relevant statutory and regulatory provisions: • 21 U.S.C. § 337 (a) (FDCA § 310(a)) - This provision dictates that the FDCA shall only be enforced by the United States, except as described in § 337(b).”
Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844 (W.D. Tenn. 2015). · cites it 7× “§ 360k(a); (2) Plaintiffs’ claims for violations of FDA regulations are impliedly preempted and barred by 21 U.S.C. § 337 (a); and (3) Plaintiffs’ claims each have independent grounds for dismissal.”
In Re Medtronic, Inc., Sprint Fidelis Leads, 623 F.3d 1200 (8th Cir. 2010). · cites it 2× “The MDA also provides that all actions to enforce FDA requirements "shall be by and in the name of the United States," 21 U.S.C. § 337 (a). In Buckman Co. v. Plaintiffs' Legal Comm.”
Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296 (11th Cir. 2011). · cites it 2× “Ill Because the Gableses’ claims are preempted, we do not address Arrow’s assertion that private actions brought for violations of the FDA regulations are barred pursuant to 21 U.S.C. § 337 (a). Under 21 U.S.C. § 337 (a), “[e]xcept as provided in subsection (b) [regarding…”
Theresa Huck v. Wyeth, Inc. D/B/A Wyeth Schwarz Pharma, Inc. & Pliva, Inc., 850 N.W.2d 353 (Iowa 2014). · cites it 3× “PLIVA argues Huck’s claims are merely attempts to enforce the FDCA, which 21 U.S.C. § 337 (a) disallows. The court of appeals and district court agreed.”
Show all 452 citing cases →
— 21 U.S.C. § 337(a) — 9 cases
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). “21 U. S. C. § 337 (a). Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision in the MDA.”
Minnesota Mining & Mfg. Co. & Riker Labs., Inc., & Alphapharm Pty. Ltd. v. Barr Labs., Inc., 289 F.3d 775 (Fed. Cir. 2002).
Lewkut v. Stryker Corp., 724 F. Supp. 2d 648 (S.D. Tex. 2010).
Mylan Pharm., Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir. 2001).
Luckey (E.D. Ky. 2026).
— 21 U.S.C. § 337(b)(1) — 1 case
Bowlin v. Bd. of Directors, Judah Christian Sch. (C.D. Ill. 2023).
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