C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 109—UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL › Subpart A—General Provisions

21 C.F.R. § 109.3

Definitions and interpretations

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(a) Act means the Federal Food, Drug, and Cosmetic Act.

(b) The definitions of terms contained in section 201 of the act are applicable to such terms when used in this part unless modified in this section.

(c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental, agricultural, industrial, or other contamination.

(d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase.

(e) Food includes human food and substances migrating to food from food-contact articles.

Notes of Decisions
Cited in 6 cases, 1978–2009 · leading case: People Ex Rel. Brown v. Tri-Union Seafoods, LLC, 171 Cal. App. 4th 1549 (Cal. Ct. App. 2009).
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People Ex Rel. Brown v. Tri-Union Seafoods, LLC, 171 Cal. App. 4th 1549 (Cal. Ct. App. 2009). “” ( 21 C.F.R. § 109.3 (c) (2008).) An added poisonous or deleterious substance is one that is not naturally occurring.”
United States v. Blue Ribbon Smoked Fish, Inc., 179 F. Supp. 2d 30 (E.D.N.Y 2001). · cites it 2× “21 C.F.R. § 109.3 (c) & (d) (italics in original).”
United States v. Anderson Seafoods, Inc., Anderson Seafoods, Inc. v. Patricia Roberts Harris, Sec'y of Health & Human Servs., 622 F.2d 157 (5th Cir. 1980). · cites it 2× “21 C.F.R. §§ 109.3 (c), (d) (1977). Under this theory, all the mercury in swordfish is an added substance, because it results not from the creature’s bodily processes but from mercury in the environment, whether natural or introduced by man.”
Cont'l Seafoods, Inc. v. Richard S. Schweiker, Sec'y of Health & Human Servs., 674 F.2d 38 (D.C. Cir. 1982). “21 C.F.R. § 109.3 (1977). The FDA states that under its “ ‘inherent’ test, a substance is ‘added’ to a food if its presence therein is attributable to man or, if the substance is not an inherent, natural constitutent of the food.”
United States v. Union Cheese Co., 902 F. Supp. 778 (N.D. Ohio 1995). “A definition can be extrapolated, however, from 21 C.F.R. section 109.3(c) and (d): (c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental,…”
United States v. Anderson Seafoods, Inc., 447 F. Supp. 1151 (N.D. Fla. 1978). “52819 (1977) (to be codified at 21 C.F.R. § 109.3 (c), (d)). Even the greatest of deference, however, would not require or permit a court to accept an interpretation contrary both to the legislative history and the language of the Supreme Court.”
— 21 C.F.R. § 109.3(c) — 1 case
United States v. Union Cheese Co., 902 F. Supp. 778 (N.D. Ohio 1995). “A definition can be extrapolated, however, from 21 C.F.R. section 109.3(c) and (d): (c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and is not the result of environmental,…”
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