Appendix D
Congressionally Defined Product Categories
That the U.S. Food and Drug
Administration Regulates
Cosmetic | 21 U.S.C. § 321(i)—The term “cosmetic” means: |
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap. | |
Food | 21 U.S.C. § 321(f)—The term “food” means: |
Articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article. | |
Food Additive | 21 U.S.C. §321(s)—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), 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 . . . to be safe under the conditions of its intended use; except that such term does not include [pesticide chemicals and residues, color additives, new animal drugs, or dietary supplements]. |
Major Food Allergen | 21 U.S.C. § 321(qq)—The term “major food allergen” means any of the following: |
Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. A food ingredient that contains protein derived from a food specified in paragraph 1, except for [specified exceptions]. | |
Dietary Supplement | 21 U.S.C. 321(ff)—The term “dietary supplement” means: |
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Except for purposes of paragraph g [defining drugs] and section 350f [defining reportable foods for which there is a reasonable probability that use or exposure will cause serious adverse health consequences or death to humans or animals], a dietary supplement shall be deemed to be a food. | |
Medical Foods | 21 U.S.C. § 360ee(b)(3) |
The U.S. Food and Drug Administration (FDA) originally created this category administratively by interpreting powers elsewhere provided in its statutes (Hutt et al., 2014), but the Orphan Drug Act Amendments of 1988 later defined it as “a food that is formulated to be consumed or administered enterically under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on scientific principles, are established by medical evaluation.” |
Color Additive | 21 U.S.C. § 321(t)(1)—The term “color additive” means a material which: |
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Infant Formula | 21 U.S.C. § 321(z)—The term “infant formula” means: |
A food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. | |
New Animal Drug | 21 U.S.C. § 321(v)—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 | |
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Provided that any drug intended for minor use or use in a minor species that is not the subject of a final regulation published by the Secretary through notice and comment rulemaking finding that the criteria of paragraphs 1 and 2 have not been met (or that the exception to the criterion in paragraph 1 has been met) is a new animal drug. | |
Animal Food | 21 U.S.C. § 321(f)—See term “food” on p. 209. |
Tobacco Product | 21 U.S.C. § 321(rr)—The term “tobacco product” means: |
Any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). |
Drug (relevant insofar as it sets boundaries on other product definitions) | 21 U.S.C. § 321(g)(1)—The term “drug” means: |
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A food or dietary supplement [that makes nutritional or health related claims that comply with FDA’s regulations at 21 U.S.C. § 353(r)] is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with [21 U.S.C. § 353(r)(6), which requires manufacturers of dietary supplements to substantiate claims and provide certain disclosures to customers] is not a drug. | |
Device (relevant insofar as it sets boundaries on other product categories) | 21 U.S.C. § 321(h)—The term “device” 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 | |
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REFERENCE
Hutt, P.B., R.A. Merrill, and L.A. Grossman. 2014. Food and Drug Law: Cases and Materials, 4th Ed. St. Paul, MN: Foundation Press.