21 U.S.C. § 336
Report of minor violations
Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning.
Notes of Decisions
Cited in 27
cases, 1954–2019 · leading case: Heckler v. Chaney, 470 U.S. 821 (1985).
Heckler v. Chaney, 470 U.S. 821 (1985). “" 21 U. S. C. § 336 . Respondents seek to draw from this section the negative implication that the Secretary is required to report for prosecution all "major" violations of the Act, however those might be defined, and that it therefore supplies the needed indication of an intent…”
United States v. Park, 421 U.S. 658 (1975). “[13] See 21 U. S. C. § 336 . Cf. United States v. Sullivan, 332 U.”
United States v. Gen. Foods Corp., 446 F. Supp. 740 (N.D.N.Y. 1978). “under section 306 of the Act, 21 U.S.C. § 336 . The failure of the F.D.”
Healthpoint, Ltd. v. Stratus Pharm., Inc., 273 F. Supp. 2d 769 (W.D. Tex. 2001). “To the extent such an argument may have been presented, Stratus has not established a likelihood of succeeding on the merits of showing that there is a causal connection between the alleged mislabeling and any loss of sales or good will, a necessary element of a Lanham Act false…”
United States v. 449 Cases, Containing Tomato Paste, 212 F.2d 567 (2d Cir. 1954). “” 21 U.S.C. § 336 . Obviously the Congress considered such administrative control a wiser course than the hedging of power by various theoretical restrictions, the negativ *573 ing of which might be difficult of proof, in a particular case.”
Cmty. Nutrition Inst., Laura A. Rogers v. Frank Young, Comm'r, Food & Drug Admin., 818 F.2d 943 (D.C. Cir. 1987). “” Rather, the Act makes clear that these enforcement decisions are vested, as they traditionally are, with the agency. Section 336, for example, expressly recognizes that FDA need not “report for prosecution, or for the institution of libel or injunction proceedings, minor…”
Med. Ctr. Pharmacy v. Mukasey, 536 F.3d 383 (5th Cir. 2008). “” 21 U.S.C. § 336 , and this court has affirmed such discretion in an analogous context, observing, “Although the [FDCA] makes illegal any amount of substance which ‘may render (food) injurious to health’ the FDA is not required to seek to enjoin, prosecute or otherwise litigate…”
Cmty. Nutrition Inst. v. Frank Young, Comm'r, Food & Drug Admin., 757 F.2d 354 (D.C. Cir. 1985). “The Commissioner, on the other hand, maintains that this provision merely authorizes FDA to issue tolerances but that the agency may, alternatively, elect to proceed by means of informal action levels indicating the levels of contamination below which the FDA will exercise its…”
Healthpoint, Ltd. v. Ethex Corp., 273 F. Supp. 2d 817 (W.D. Tex. 2001). “21 U.S.C. § 336 ; Heckler v. Chaney, 470 U.”
United States v. Boston Farm Ctr., Inc., a Corp., & James R. Gordon, an Individual, 590 F.2d 149 (5th Cir. 1979). “21 U.S.C. § 336 . To guide its prosecutorial discretion in the bringing of non-rule enforcements of the Act the FDA may establish certain in-house guidelines called action levels.”
Nat'l Ass'n of Pharm. Mfrs. v. Dep't of Health & Human Servs., 586 F. Supp. 740 (S.D.N.Y. 1984). “Section 306 of the Act, 21 U.S.C. § 336 , gives the Secretary authority to issue a warning rather than initiate a prosecution as to minor violations of the Act.”
United States v. Thriftimart, Inc., a Corp., Dba Smart & Final Iris Co., Gil P. Stewart, Wm. Todd, Sr., & Robert D. Jensen, Individuals, 429 F.2d 1006 (9th Cir. 1970). “21 U.S.C. § 336 giving the FDA discretion whether to proceed criminally or civilly is constitutional; the FDA is not required to prosecute every violation,.”
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