Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of section 342(a) of this title. In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.
Notes of Decisions
Young v. Cmty. Nutrition Inst., 476 U.S. 974 (1986).
· cites it 6× “We granted certiorari in this case to determine whether the Court of Appeals for the District of Columbia Circuit correctly concluded that the Food and Drug Administration's longstanding interpretation of 21 U. S. C. § 346 was in conflict with the plain language of that…”
Robert W Szymczak, II v. Laura M Kane, 585 S.E.2d 349 (Va. Ct. App. 2003).
· cites it 2× “§ 3509 (court's decision to grant a continuance in a case involving child victims and witnesses); 21 U.S.C. § 346 (a) (final agency decisions regarding pesticide chemical residues under the Food, Drug and Cosmetic Act); 28 U.”
United States v. Blue Ribbon Smoked Fish, Inc., 179 F. Supp. 2d 30 (E.D.N.Y 2001).
· cites it 3× “monocytogenes is an “added substance,” the FDA’s failure to set a “tolerance level” pursuant to 21 U.S.C. § 346 is a violation of the FDCA.”
Alaska Wilderness League v. Sally Jewell, 788 F.3d 1212 (9th Cir. 2015).
· cites it 2× “at 977 (quoting 21 U.S.C. § 346 ). The FDA interpreted this provision to “give it the discretion to decide whether to promulgate” a quantity limit, while the plaintiffs interpreted the statute to require the agency to set a limit whenever a poisonous substance was present.”
Officemax, Inc. v. United States, 428 F.3d 583 (6th Cir. 2005).
“’ ” In another case involving a long-standing agency interpretation asserted to be contrary to plain statutory meaning, the Supreme Court rejected a comparable argument.”
Cmty. Nutrition Inst. v. Frank Young, Comm'r, Food & Drug Admin., 757 F.2d 354 (D.C. Cir. 1985).
· cites it 3× “21 U.S.C. § 346 (emphasis added). Not only is it undisputed that aflatoxin is “poisonous or deleterious” and that it is an “added” substance, but the Secretary also admits facts, see Appellee’s Brief at 4, sufficient to conclude that the presence of aflatoxin in food may render…”
Cont'l Chemiste Corp. v. William D. Ruckelshaus, Adm'r, & Env't Prot. Agency, 461 F.2d 331 (7th Cir. 1972).
· cites it 4× “” 13 He did not disagree with the Examiner's finding that the amount of residue was not toxicologically significant, but held that since the Food and Drug Administrator had not established a tolerance for lindane residues on food for human consumption pursuant to § 406 or § 409…”
United States v. John Peter McGoff, 831 F.2d 1071 (D.C. Cir. 1987).
“21 U.S.C. § 346 (1982) (emphasis added). The Court began its analysis by noting that “the English language does not always force a writer to specify which of two possible objects is the one to which a modifying phrase relates.”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.