21 U.S.C. § 301
Short title
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
Notes of Decisions
Cited in 1,640
cases (236 in the last 5 years), 1942–2026 · leading case: Riegel v. Medtronic, Inc.
Riegel v. Medtronic, Inc. (2008)
“1040 , as amended, 21 U.S.C. § 301 et seq., has long required FDA approval for the introduction of new drugs into the market.”
Merrell Dow Pharmaceuticals Inc. v. Thompson Ex Rel. Thompson (1986)
“1040 , as amended, 21 U. S. C. § 301 et seq. (1982 ed. and Supp.”
Holly Vanzant v. Hill's Pet Nutrition, Incorpo (2019)
“Under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. , pet food intended to treat or prevent disease and marketed as such is considered a drug and requires approval of a new animal drug application.”
Wyeth v. Levine (2009)
“1040 , as amended, 21 U.S.C. § 301 et seq. The Act's most substantial innovation was its provision for premarket approval of new drugs.”
Buckman Co. v. Plaintiffs' Legal Committee (2001)
“539 , 21 U. S. C. § 301 (1994 ed. and Supp. V).”
Riegel v. Medtronic, Inc. (2006)
“______________ KATZMANN , Circuit Judge: This case calls upon us to determine, inter alia, the scope of the preemption provision set forth in Section 360k(a) of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et. seq. Specifically, we…”
Sarah Speed v. Wyeth Pharmaceuticals, Inc. (2013)
“The makers of the generic metoclopramide moved to dismiss the claims against them, arguing that all of the plaintiffs’ claims are preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 -399f, under the Supreme Court decision in PLIVA, Inc.”
Haudrich v. Howmedica, Inc. (1996)
“The appellate court rejected this contention, holding instead that the United States Congress did not intend to preempt common law tort actions by passing the Medical Device Amendments.”
Heckler v. Chaney (1985)
“1040 , as amended, 21 U. S. C. § 301 et seq. (FDCA), and requesting that the FDA take various enforcement actions to prevent these violations.”
Food & Drug Administration v. Brown & Williamson Tobacco Corp. (2000)
“1040 , as amended, 21 U. S. C. § 301 et seq., and that cigarettes and smokeless tobacco are "combination products" that deliver nicotine to the body.”
Jones v. Rath Packing Co. (1977)
“1040 , as amended, *533 21 U. S. C. § 301 et seq., and the Fair Packaging and Labeling Act (FPLA), 80 Stat.”
Dumont v. Reily Foods Co. (2019)
“The defendants propose one additional alternative ground for affirming the dismissal of Dumont's complaint: Even if the complaint alleges a claim under chapter 93A, they argue, that claim is impliedly preempted by the Federal Food, Drug, and Cosmetic Act [FDCA], 21 U.S.C. § 301…”
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