21 C.F.R. § 7.1
Scope
This part governs the practices and procedures applicable to regulatory enforcement actions initiated by the Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other laws that it administers. This part also provides guidance for manufacturers and distributors to follow with respect to their voluntary removal or correction of marketed violative products. This part is promulgated to clarify and explain the regulatory practices and procedures of the Food and Drug Administration, enhance public understanding, improve consumer protection, and assure uniform and consistent application of practices and procedures throughout the agency.
Notes of Decisions
Cited in 29
cases (21 in the last 5 years), 1981–2023 · leading case: Parks v. Alpharma, Inc., 25 A.3d 200 (Md. 2011).
Parks v. Alpharma, Inc., 25 A.3d 200 (Md. 2011). “21 C.F.R. §§ 7.1 et seq. The regulation at issue provides the FDA's standard for what details must be included on a prescription drug label if there is "reasonable evidence" that a particular drug has a "clinically significant hazard.”
Viggiano v. Hansen Nat. Corp., 944 F. Supp. 2d 877 (C.D. Cal. 2013). “See 21 C.F.R. § 7.1 et seq. The FDCA deems a food “misbranded” if its labeling “is false or misleading in any particular.”
Grand Labs., Inc. v. Patricia Harris, Sec'y of Health, Educ., & Welfare, 660 F.2d 1288 (8th Cir. 1981). “For example, 21 C.F.R. § 7.1 (f) (1980) defines products to include “an article subject to the jurisdiction of the Food and Drug Administration, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, * * (Emphasis…”
Grand Labs., Inc. v. Patricia Harris, Sec'y of Health, Educ. & Welfare, 644 F.2d 729 (8th Cir. 1981). “1 (f) (1980) defines products to include “an article subject to the jurisdiction of the Food and Drug Administration, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, * *.”
Hughes v. Ester C Co., 99 F. Supp. 3d 278 (E.D.N.Y 2015). “§ 393 (b)(2)(A); (b) promulgate regulations pursuant to this authority; and (c) enforce its regulations through administrative proceedings[,] [s ]ee 21 C.F.R. § 7.1 et seq.” Jovel v. i-Health, Inc.”
United States v. Superpharm Corp., 530 F. Supp. 408 (E.D.N.Y 1981). “See generally 21 CFR § 7.1 , et seq. The authorized vehicle for FDA removal of goods from the marketplace is the seizure remedy.”
Hawkins v. Kellogg Co., 224 F. Supp. 3d 1002 (S.D. Cal. 2016). “§§ 371 , 393(b)(2)(A); 21 C.F.R. § 7.1 et seq. The FDCA also prohibits “[t]he introduction or delivery for introduction into interstate commerce of any food .”
Moore v. Beech-Nut Nutrition Co. (N.D.N.Y. 2023). “§ 371 , 393(b)(2)(A); 21 C.F.R. §§ 7.1 et. seq., and it has authorized the FDA to regulate the false or misleading labeling of food under 21 U.”
Peek v. Beech-Nut Nutrition Co. (N.D.N.Y. 2023). “§ 371 , 393(b)(2)(A); 21 C.F.R. §§ 7.1 et. seq., and it has authorized the FDA to regulate the false or misleading labeling of food under 21 U.”
Loggins v. Beech-Nut Nutrition Co. (N.D.N.Y. 2023). “§ 371 , 393(b)(2)(A); 21 C.F.R. §§ 7.1 et. seq., and it has authorized the FDA to regulate the false or misleading labeling of food under 21 U.”
Henry v. Beech-Nut Nutrition Co. (N.D.N.Y. 2023). “§ 371 , 393(b)(2)(A); 21 C.F.R. §§ 7.1 et. seq., and it has authorized the FDA to regulate the false or misleading labeling of food under 21 U.”
Henry v. Beech-Nut Nutrition Co. (N.D.N.Y. 2023). “§ 371 , 393(b)(2)(A); 21 C.F.R. §§ 7.1 et. seq., and it has authorized the FDA to regulate the false or misleading labeling of food under 21 U.”
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