§321 Definitions; generally

Summary

Defines many words used in this chapter. It explains what each key term means in simple ways. State — any U.S. State or Territory, the District of Columbia, and Puerto Rico. Territory — a U.S. territory or possession; this includes the District of Columbia but excludes Puerto Rico and the Canal Zone. Interstate commerce — trade between a State or Territory and places outside it, and trade inside D.C. or other territories without a legislature. Department — the Department of Health and Human Services. Secretary — the Secretary of Health and Human Services. Person — an individual, partnership, corporation, or association. Food — things people or animals eat or drink, chewing gum, and ingredients of those items. Drug — items listed in the official drug books, products used to diagnose, treat, prevent, or cure disease in people or animals, nonfood items that change the body’s structure or function, and components of those items; certain food or supplement label claims do not by themselves make something a drug. Counterfeit drug — a drug or its package that falsely uses another maker’s marks to pretend it came from them. Device — instruments or similar articles used to diagnose, treat, prevent disease, or affect body structure or function, and their parts. Counterfeit device — a device or its package that falsely uses another maker’s marks. Cosmetic — things applied to the body to clean, beautify, or change appearance, and their components, but not soap. Official compendium — the main official drug books. Label — writing or pictures on an item’s immediate container; required label information must also appear on the outside retail package or be clearly visible. Immediate container — does not include package liners. Labeling — all written or graphic material on a product, its containers, or that comes with it. Misleading labeling or advertising — judged by what is shown and by what important facts are left out about how the product is used or its results. Antiseptic claim — calling a drug an antiseptic is read as saying it kills germs, except for antiseptics meant for long contact uses like ointments or dressings. New drug — a drug not generally accepted by qualified experts as safe and effective for its labeled uses, with a special exception for drugs handled under the Food and Drugs Act before June 25, 1938 and the Act of June 30, 1906. Pesticide chemical — substances that are pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act, including all ingredients; ethylene oxide and propylene oxide count when applied on food; there are specific exclusions for certain uses to control microorganisms on food, for certain food contact uses and packaging, and the EPA Administrator may by rule exclude substances that appear mainly from natural causes or non‑pesticidal human activities after talking with the Secretary. Pesticide chemical residue — pesticide residues or their breakdown products on raw or processed food. Raw agricultural commodity — food in its raw state, including fruits treated but still unpeeled. Food additive — a substance expected to become part of food or change its properties unless experts recognize it as safe; this term does not include pesticide residues or chemicals, color additives, some pre‑September 6, 1958 approvals, new animal drugs, or certain dietary supplement ingredients; a special date for prior common food use is January 1, 1958. Color additive — a dye or pigment that can add color to food, drugs, cosmetics, or the body; “color” covers black, white, and grays. Safe — refers to human or animal health in the food additive and related rules. New animal drug — like “new drug” but for animals, with the same June 25, 1938 exception. Animal feed — food for animals other than humans that provides a substantial part of their nutrients. Informal hearing — a hearing not under formal administrative rules that gives notice, the right to an attorney, chances to present and question evidence, and a written report; transcripts may be required. Saccharin — includes calcium, sodium, and ammonium saccharin. Infant formula — food made or sold as a substitute for human milk for infants. Abbreviated drug application — an application that relies on another approved drug’s data for approval. Knowingly or knew — means actual knowledge or deliberate ignorance or reckless disregard of the truth. High managerial agent — top officers, partners, or employees who manage drug development, production, quality, or research. Drug product — a drug regulated under the main drug approval laws. Commissioner — the Commissioner of Food and Drugs. Dietary supplement — a non‑tobacco product meant to add to the diet that contains things like vitamins, minerals, herbs, amino acids, or similar ingredients; it must be meant to be swallowed, not sold as a regular food or a sole meal, and labeled as a dietary supplement; some drugs or biologics that were marketed as supplements before approval are included unless the Secretary says otherwise. Processed food — any food that is not a raw agricultural commodity, including raw items that have been canned, cooked, frozen, or milled. Administrator — the Administrator of the U.S. Environmental Protection Agency. Compounded positron emission tomography drug — a PET drug made to give certain medical images, compounded by or ordered by a licensed practitioner under state law, and including related nonradioactive items used to prepare it. Antibiotic drug — a human drug made wholly or partly from certain microbe‑produced substances like penicillin or streptomycin that kill or stop microbes. Priority supplement — a drug application given priority under the 1997 FDA Modernization Act. Single‑use device — a device meant for one use or one patient in one procedure. Reprocessed single‑use device — a used single‑use device that has been processed and remanufactured for one more single use; it is treated as reprocessed even if called “recycled.” Original device — a new, unused single‑use device. Critical reprocessed device — a reprocessed single‑use device meant to touch sterile body areas. Semi‑critical reprocessed device — a reprocessed single‑use device meant to touch mucous membranes but not sterile body areas. Major species — cattle, horses, swine, chickens, turkeys, dogs, and cats, though the Secretary can add species. Minor species — animals other than humans that are not major species. Minor use — using a drug in a major species for a condition that happens rarely or in small numbers of animals. Major food allergen — milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, and ingredients that contain protein from those foods, with narrow exceptions for some refined oils and certain exempt ingredients. Tobacco product — any product made or derived from tobacco or containing nicotine meant for people to use, including parts and accessories, but not raw non‑tobacco manufacturing materials; it does not include articles that are drugs, devices, or combination products covered elsewhere, and those drug/device/biologic items fall under other rules; tobacco products cannot be sold combined with other regulated products; a food article with no nicotine or only trace natural nicotine is not a tobacco product. Critical food — an infant formula or a medical food.