U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VII— GENERAL AUTHORITY › Part Part F— National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics

21 U.S.C. § 379r

National uniformity for nonprescription drugs

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(a) In generalExcept as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement—(1) that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).(b) Exemption(1) In generalUpon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that—(A) protects an important public interest that would otherwise be unprotected, including the health and safety of children;(B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and(C) would not unduly burden interstate commerce.(2) Timely action

The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1).

(c) Scope(1) In generalThis section shall not apply to—(A) any State or political subdivision requirement that relates to the practice of pharmacy; or(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.(2) Safety or effectiveness

For purposes of subsection (a), a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.

(d) Exceptions(1) In generalIn the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 355 of this title or section 357 of this title (as in effect on the day before November 21, 1997) or a final order under section 355h of this title by the Secretary establishing conditions under which the drug is generally recognized as safe and effective, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with—(A) a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997.(2) State initiatives

This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

(e) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(f) State enforcement authority

Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this chapter.

(June 25, 1938, ch. 675, § 751, as added Pub. L. 105–115, title IV, § 412(a), Nov. 21, 1997, 111 Stat. 2373; amended Pub. L. 116–136, div. A, title III, § 3851(c), Mar. 27, 2020, 134 Stat. 454.)Editorial NotesReferences in Text

The Poison Prevention Packaging Act of 1970, referred to in subsec. (a)(2), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§ 1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§ 1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

Amendments

2020—Subsec. (d)(1). Pub. L. 116–136, § 3851(c)(1), in introductory provisions, substituted “final order under section 355h of this title” for “final regulation promulgated” and struck out “and not misbranded” after “safe and effective”.

Subsec. (d)(1)(A). Pub. L. 116–136, § 3851(c)(2), substituted “regulation or order in effect” for “regulation in effect”.

Statutory Notes and Related SubsidiariesEffective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Notes of Decisions
Cited in 93 cases (44 in the last 5 years), 2001–2026 · leading case: Trejo v. Johnson, 220 Cal. Rptr. 3d 127 (Cal. Ct. App. 5th 2017).
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Trejo v. Johnson, 220 Cal. Rptr. 3d 127 (Cal. Ct. App. 5th 2017). · cites it 11× “) The court explained that, "by its terms, the § 379r(e) savings clause frames its exemption from preemption with a reference to § 379r itself and, as a result, must be read in the context of § 379r as a whole and specifically the express preemption provision set out in §…”
Wyeth v. Levine, 555 U.S. 555 (2009). · cites it 2× “See 21 U.S.C. §§ 379r(e), 379s(d) ("Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State").”
Mills v. Warner Lambert Co., 157 S.W.3d 424 (Tex. 2005). · cites it 5× “at 493 (quoting 21 U.S.C. § 379r). The court also noted that “[ajppellees do not contest the fact that the products in question do indeed comply with the FDA-approved formula for nonprescription [head-lice remedies], and that the products were marketed in compliance with the…”
Mills v. Warner-Lambert Co., 581 F. Supp. 2d 772 (E.D. Tex. 2008). · cites it 8× “21 U.S.C. § 379r. 6 It provides that any State requirement relating *778 to drug regulation that is not identical to a federal requirement under the FDCA is expressly preempted.”
Warner-Lambert Co. v. Mills, 117 S.W.3d 488 (Tex. App. 2003). · cites it 8× “See 21 U.S.C.A. § 379r. A state law action may impose a "requirement" under state law, and therefore be preempted when the state law requirement conflicts with a requirement imposed by federal law.”
Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013). · cites it 2× “* * * This case arises out of tragic circumstances.”
Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015). · cites it 4× “25 The additional subsections of 21 U.S.C. § 379r (2012) are not relevant to this discussion.”
Crozier v. Johnson & Johnson Consum. Companies, Inc., 901 F. Supp. 2d 494 (D.N.J. 2012). · cites it 4× “) And J & J further argues that, with 21 U.S.C. § 379r, “Congress unambiguously stated its intent to preempt any state law which purports to impose additional or different requirements relating to the labeling of active ingredients on OTC medications.”
Delarosa v. Boiron, Inc., 818 F. Supp. 2d 1177 (C.D. Cal. 2011). · cites it 9× “” 21 U.S.C. § 379r(a). In adding this provision to the FDCA, 4 “Congress pre-empted certain state requirements concerning over-the-counter medications and cosmetics,” and did so expressly.”
Batoh v. McNeil-PPC, Inc., 167 F. Supp. 3d 296 (D. Conn. 2016). · cites it 3× “) But as Defendants point out, the statute at issue, which states that "[njothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State,” 21 U.S.C. § 379r(e) (emphasis added), does…”
Eckler v. Neutrogena Corp. CA2/7, 238 Cal. App. 4th 433 (Cal. Ct. App. 2015). · cites it 6× “The court concluded that their claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 379r) and implementing FDA regulations.”
Carter v. Novartis Consum. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008). · cites it 6× “” 21 U.S.C. § 379r. The touchstone of preemption under § 379r is the effect that a finding of liability on a particular claim would have on the Defendants, and not the particular common law or state law theory upon which that claim was brought.”
Show all 93 citing cases →
— 21 U.S.C. § 379r(a) — 39 cases
Goldemberg v. Johnson & Johnson Consum. Companies, Inc., 8 F. Supp. 3d 467 (S.D.N.Y. 2014).
Mills v. Warner-Lambert Co., 581 F. Supp. 2d 772 (E.D. Tex. 2008). “21 U.S.C. § 379r. 6 It provides that any State requirement relating *778 to drug regulation that is not identical to a federal requirement under the FDCA is expressly preempted.”
Dowhal v. Smithkline Beecham Consum. Healthcare, 88 P.3d 1 (Cal. 2004).
Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015). “25 The additional subsections of 21 U.S.C. § 379r (2012) are not relevant to this discussion.”
Crozier v. Johnson & Johnson Consum. Companies, Inc., 901 F. Supp. 2d 494 (D.N.J. 2012). “) And J & J further argues that, with 21 U.S.C. § 379r, “Congress unambiguously stated its intent to preempt any state law which purports to impose additional or different requirements relating to the labeling of active ingredients on OTC medications.”
— 21 U.S.C. § 379r(a)(2) — 18 cases
Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371 (S.D.N.Y. 2014).
Dowhal v. Smithkline Beecham Consum. Healthcare, 88 P.3d 1 (Cal. 2004).
Langan v. Johnson & Johnson Consum. Companies, 95 F. Supp. 3d 284 (D. Conn. 2015).
Delarosa v. Boiron, Inc., 818 F. Supp. 2d 1177 (C.D. Cal. 2011). “” 21 U.S.C. § 379r(a). In adding this provision to the FDCA, 4 “Congress pre-empted certain state requirements concerning over-the-counter medications and cosmetics,” and did so expressly.”
Green v. Bdi Pharm., 803 So. 2d 68 (La. Ct. App. 2001).
— 21 U.S.C. § 379r(a)(l) — 1 case
Sciortino v. Pepsico, Inc., 108 F. Supp. 3d 780 (N.D. Cal. 2015).
— 21 U.S.C. § 379r(b) — 4 cases
Carter v. Novartis Consum. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008). “” 21 U.S.C. § 379r. The touchstone of preemption under § 379r is the effect that a finding of liability on a particular claim would have on the Defendants, and not the particular common law or state law theory upon which that claim was brought.”
Delarosa v. Boiron, Inc., 818 F. Supp. 2d 1177 (C.D. Cal. 2011). “” 21 U.S.C. § 379r(a). In adding this provision to the FDCA, 4 “Congress pre-empted certain state requirements concerning over-the-counter medications and cosmetics,” and did so expressly.”
Valdes v. Optimist Club of Suniland, Inc., 27 So. 3d 689 (Fla. 3d DCA 2009).
Goldstein v. Walmart, Inc. (S.D.N.Y. 2022).
— 21 U.S.C. § 379r(b)(1)(B) — 1 case
Dowhal v. Smithkline Beecham Consum., 122 Cal. Rptr. 2d 246 (Cal. Ct. App. 2002).
— 21 U.S.C. § 379r(c)(2) — 3 cases
Eckler v. Neutrogena Corp. CA2/7, 238 Cal. App. 4th 433 (Cal. Ct. App. 2015). “The court concluded that their claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 379r) and implementing FDA regulations.”
Carter v. Novartis Consum. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008). “” 21 U.S.C. § 379r. The touchstone of preemption under § 379r is the effect that a finding of liability on a particular claim would have on the Defendants, and not the particular common law or state law theory upon which that claim was brought.”
Collaza v. Johnson & Johnson Consum. Inc. (2d Cir. 2025).
— 21 U.S.C. § 379r(d) — 1 case
Delarosa v. Boiron, Inc., 818 F. Supp. 2d 1177 (C.D. Cal. 2011). “” 21 U.S.C. § 379r(a). In adding this provision to the FDCA, 4 “Congress pre-empted certain state requirements concerning over-the-counter medications and cosmetics,” and did so expressly.”
— 21 U.S.C. § 379r(d)(2) — 7 cases
Dowhal v. Smithkline Beecham Consum. Healthcare, 88 P.3d 1 (Cal. 2004).
Sciortino v. Pepsico, Inc., 108 F. Supp. 3d 780 (N.D. Cal. 2015).
Dowhal v. Smithkline Beecham Consum., 122 Cal. Rptr. 2d 246 (Cal. Ct. App. 2002).
Post Foods, LLC v. Superior Court (Cal. Ct. App. 2018).
Post Foods, LLC v. Superior Court (Cal. Ct. App. 2018).
— 21 U.S.C. § 379r(d)(l) — 2 cases
Delarosa v. Boiron, Inc., 818 F. Supp. 2d 1177 (C.D. Cal. 2011). “” 21 U.S.C. § 379r(a). In adding this provision to the FDCA, 4 “Congress pre-empted certain state requirements concerning over-the-counter medications and cosmetics,” and did so expressly.”
Delarosa v. Boiron, Inc., 275 F.R.D. 582 (C.D. Cal. 2011).
— 21 U.S.C. § 379r(d)(l)(A)(B) — 1 case
Delarosa v. Boiron, Inc., 818 F. Supp. 2d 1177 (C.D. Cal. 2011). “” 21 U.S.C. § 379r(a). In adding this provision to the FDCA, 4 “Congress pre-empted certain state requirements concerning over-the-counter medications and cosmetics,” and did so expressly.”
— 21 U.S.C. § 379r(e) — 28 cases
Trejo v. Johnson, 220 Cal. Rptr. 3d 127 (Cal. Ct. App. 5th 2017). “) The court explained that, "by its terms, the § 379r(e) savings clause frames its exemption from preemption with a reference to § 379r itself and, as a result, must be read in the context of § 379r as a whole and specifically the express preemption provision set out in §…”
Wyeth v. Levine, 555 U.S. 555 (2009). “See 21 U.S.C. §§ 379r(e), 379s(d) ("Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State").”
Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013). “* * * This case arises out of tragic circumstances.”
Batoh v. McNeil-PPC, Inc., 167 F. Supp. 3d 296 (D. Conn. 2016). “) But as Defendants point out, the statute at issue, which states that "[njothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State,” 21 U.S.C. § 379r(e) (emphasis added), does…”
Sarah Speed v. Wyeth Pharm., Inc., 737 F.3d 378 (6th Cir. 2013).
— 21 U.S.C. § 379r(f) — 2 cases
Oregon ex rel. Kroger v. Johnson & Johnson, 832 F. Supp. 2d 1250 (D. Or. 2011).
Leboeuf v. Edgewell Pers. Care Co. (N.D.N.Y. 2023).
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