21 U.S.C. § 321
Definitions; generally
United States · Title 21 — FOOD AND DRUGS · Status: effective
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- 21 U.S.C. § 321, Definitions; generally, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454169
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Full text
For the purposes of this chapter—
The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
The term “new drug” means—
In the case of the use, with respect to food, of a substance described in clause (A) to prevent, destroy, repel, or mitigate microorganisms (including bacteria, viruses, fungi, protozoa, algae, and slime), the following applies for purposes of clause (A):
The definition in such clause for the term “pesticide chemical” does not include the substance if the substance is applied for such use on food, or the substance is included for such use in water that comes into contact with the food, in the preparing, packing, or holding of the food for commercial purposes. The substance is not excluded under this subclause from such definition if the substance is ethylene oxide or propylene oxide, and is applied for such use on food. The substance is not so excluded if the substance is applied for such use on a raw agricultural commodity, or the substance is included for such use in water that comes into contact with the commodity, as follows:
The term “pesticide chemical residue” means a residue in or on raw agricultural commodity or processed food of—
Notwithstanding subparagraphs (1) and (2), the Administrator may by regulation except a substance from the definition of “pesticide chemical” or “pesticide chemical residue” if—
The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—
The term “color additive” means a material which—
The term “new animal drug” means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed,—
The term “informal hearing” means a hearing which is not subject to section 554, 556, or 557 of title 5 and which provides for the following:
The term “abbreviated drug application” means an application submitted under section 355(j) of this title for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and—
The term “knowingly” or “knew” means that a person, with respect to information—
For purposes of section 335a of this title, the term “high managerial agent”—
means—
includes persons having management responsibility for—
The term “dietary supplement”—
means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
means a product that—
does—
not include—
The term “compounded positron emission tomography drug”—
means a drug that—
The term “major food allergen” means any of the following:
A food ingredient that contains protein derived from a food specified in paragraph (1), except the following:
The term “critical food” means a food that is—
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone. The law that originally enacted this section predates the public laws loaded here, so only later amendments are listed.
- Health Research and Health Services Amendments of 1976House: no recorded tallySenate: no recorded tally
- Medical Device Amendments of 1976House: no recorded tallySenate: no recorded tally
- Saccharin Study and Labeling ActHouse: no recorded tallySenate: no recorded tally
- An act to amend the Federal Food, Drug, and Cosmetic Act to strengthen the authority under that Act to assure the safety and nutrition of infant formulas, and for other purposes.House: no recorded tallySenate: no recorded tally
- Generic Animal Drug and Patent Term Restoration ActHouse: no recorded tallySenate: no recorded tally
- Nutrition Labeling and Education Act of 1990House: no recorded tallySenate: no recorded tally
- Safe Medical Devices Act of 1990House: no recorded tallySenate: no recorded tally
- Generic Drug Enforcement Act of 1992House: no recorded tallySenate: no recorded tally
- Medical Device Amendments of 1992House: no recorded tallySenate: no recorded tally
- To amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes.House: no recorded tallySenate: no recorded tally
- Nutrition Labeling and Education Act Amendments of 1993House: no recorded tallySenate: no recorded tally
- Dietary Supplement Health and Education Act of 1994House: no recorded tallySenate: no recorded tally
- Food Quality Protection Act of 1996House: no recorded tallySenate: no recorded tally
- Food and Drug Administration Modernization Act of 1997House: no recorded tallySenate: 98–2
- Antimicrobial Regulation Technical Corrections Act of 1998House: no recorded tallySenate: no recorded tally
- Best Pharmaceuticals for Children ActHouse: no recorded tallySenate: no recorded tally
- Medical Device User Fee and Modernization Act of 2002House: no recorded tallySenate: no recorded tally
- Minor Use and Minor Species Animal Health Act of 2003House: no recorded tallySenate: no recorded tally
- Food and Drug Administration Amendments Act of 2007House: 405–7Senate: no recorded tally
- To protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products, to amend title 5, United States Code, to make certain modifications in the Thrift Savings Plan, the Civil Service Retirement System, and the Federal Employees' Retirement System, and for other purposes.
- 21st Century Cures ActHouse: no recorded tallySenate: no recorded tally
- Safeguarding Therapeutics ActHouse: no recorded tallySenate: no recorded tally
- FASTER Act of 2021House: 415–11Senate: no recorded tally
- Consolidated Appropriations Act, 2022House: no recorded tallySenate: no recorded tally
- Consolidated Appropriations Act, 2023House: 225–201Senate: no recorded tally