21 C.F.R. § 341.1
Scope
(a) An over-the-counter cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
Notes of Decisions
Cited in 6
cases (4 in the last 5 years), 2001–2024 · leading case: Carter v. Novartis Consum. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008).
Carter v. Novartis Consum. Health, Inc., 582 F. Supp. 2d 1271 (C.D. Cal. 2008). “” See 21 C.F.R. § 341.1 ; see also 21 U.S.C. § 355 (drugs requiring NDA approval).”
Green v. Bdi Pharm., 803 So. 2d 68 (La. Ct. App. 2001). “See, 21 C.F.R. §§ 341.1 , 341.76, 341.78. No State or political subdivision of a State may establish or continue in effect any requirement that relates to the regulation of a drug that is "different from or in addition to, or that is otherwise not identical with, a requirement…”
Goldstein v. Walmart, Inc. (S.D.N.Y. 2022). “21 C.F.R. § 341.1 (emphasis added); see also id.”
Tobin v. Procter & Gamble Co. (N.D. Cal. 2024). “” 21 C.F.R. § 341.1 . Part 341 provides a non-exclusive list of statements 20 that may be used to describe cough and cold medications.”
Amara v. Publix Supermarkets, Inc. (M.D. Fla. 2022). “§352 (a)(1)) and 21 C.F.R. § 341.1 (a) (over- the-counter cough medicines must meet “each of the general conditions established in § 330.”
Singo v. Ricola USA, Inc. (S.D.N.Y. 2024). “21 C.F.R. § 341.1 (emphasis added); see also id.”
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