2023 Montana Code Annotated › Title 50. Health and Safety › Chapter 31. Montana Food, Drug, and Cosmetic Act › Part 1. General Provisions › 50-31-103. Definitions

50-31-103. Definitions.
Unless the context requires otherwise, in this chapter, the following definitions apply:
(1) "Advertisement" means representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.
(2) "Beef patty mix" means "hamburger" or "ground beef" to which have been added binders or extenders as those terms are understood by general custom and usage in the food industry.
(3) "Bottled water" means water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients, except that bottled water may optionally contain safe and suitable antimicrobial agents.
(4) "Cell-cultured edible product" means the concept of meat, including but not limited to muscle cells, fat cells, connective tissue, blood, and other components produced via cell culture, rather than from a whole slaughtered animal. A cell-cultured edible product derived from meat muscle cells, fat cells, connective tissue, blood, or other meat components must contain labeling indicating it is derived from those cells, tissues, blood, or components.
(5) "Color" includes black, white, and intermediate grays.
(6) (a) "Color additive" means a material that:
(i) is a dye, pigment, or other substance made by a process of synthesis or similar artifice or that is extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source; or
(ii) when added or applied to a food, drug, or cosmetic or to the human body is capable (alone or through reaction with another substance) of imparting color to the human body.
(b) The term does not include material that has been or is exempted under the federal act.
(7) (a) "Consumer commodity", except as otherwise specifically provided by this subsection, means any food, drug, device, or cosmetic as those terms are defined by this chapter or by the federal act and regulations pursuant to the federal act.
(b) The term does not include:
(i) any tobacco or tobacco product;
(ii) a commodity subject to packaging or labeling requirements imposed under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136, et seq.) or the provisions of the eighth paragraph under the heading "Bureau of Animal Industry" of the act of March 4, 1913 (37 Stat. 832-833; 21 U.S.C. 151 through 157), commonly known as the Virus-Serum-Toxin Act;
(iii) a drug subject to 50-31-306(1)(m) or 50-31-307(2)(c) or section 503(b)(1) or 506 of the federal act (21 U.S.C. 353(b)(1) and 356);
(iv) a beverage subject to or complying with packaging or labeling requirements imposed under the Federal Alcohol Administration Act (27 U.S.C. 201, et seq.); or
(v) a commodity subject to the Federal Seed Act (7 U.S.C. 1551 through 1610).
(8) "Contaminated with filth" applies to a food, drug, device, or cosmetic not securely protected from dust, dirt, and, as far as may be necessary by all reasonable means, foreign, or injurious contaminations.
(9) (a) "Cosmetic" means:
(i) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance; and
(ii) articles intended for use as a component of these articles.
(b) The term does not include soap.
(10) "Counterfeit drug" means a drug, drug container, or drug label that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device or any likeness of an identifying mark, imprint, or device of a drug manufacturer, processor, packer, or distributor other than the person who in fact manufactured, processed, packed, or distributed the drug and that falsely purports or is represented to be the product of or to have been packed or distributed by the other drug manufacturer, processor, packer, or distributor.
(11) "Department" means the department of public health and human services provided for in 2-15-2201.
(12) "Device" (except when used in 50-31-107(2), 50-31-203(6), 50-31-306(1)(c) and (1)(q), 50-31-402(3), and 50-31-501(10)) means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended:
(a) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or
(b) to affect the structure or function of the body of humans or other animals.
(13) "Dietary supplement" means a product, other than a tobacco product, that is intended to supplement the diet and that:
(a) is advertised only as a food supplement;
(b) bears or contains one or more of the following ingredients:
(i) a vitamin;
(ii) a mineral;
(iii) an herb or other botanical substance;
(iv) an amino acid;
(v) a dietary substance used to supplement the diet by increasing the total dietary intake or a concentrate, metabolite, constituent, extract, or combination of any ingredients described in subsections (13)(b)(i) through (13)(b)(iv);
(c) conforms to any additional provisions for the definition of dietary supplement under 21 U.S.C. 321.
(14) "Drug" means:
(a) articles recognized in the official United States Pharmacopoeia, official National Formulary, or a supplement to either of these;
(b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;
(c) articles (other than food) intended to affect the structure or function of the body of humans or other animals;
(d) articles intended for use as components of any article specified in subsection (14)(a), (14)(b), or (14)(c) but does not include devices or their components, parts, or accessories.
(15) "Federal act" means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301, et seq.).
(16) "Food" means:
(a) articles used for food or drink for humans or other animals;
(b) chewing gum;
(c) articles used for components of these articles; and
(d) dietary supplements.
(17) (a) "Food additive" means a substance, the intended use of which results or may be reasonably expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of food. The term includes a substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food and a source of radiation intended for this use if the 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. Alternatively, for a substance used in a food prior to January 1, 1958, the determination of safety under the conditions of the substance's intended use may be through either scientific procedures or experience based on common use in food.
(b) The term does not include:
(i) a pesticide chemical in or on a raw agricultural commodity;
(ii) a pesticide chemical to the extent that the pesticide chemical is intended for use or is used in the production, storage, or transportation of a raw agricultural commodity;
(iii) a color additive;
(iv) a substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the federal act, the Poultry Products Inspection Act (21 U.S.C. 451, et seq.), or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. 603, et seq.).
(18) "Food service establishment" means a retail food establishment defined in 50-50-102 and any facility operated by a governmental entity where food is served.
(19) "Hamburger" or "ground beef" means ground fresh or frozen beef or a combination of both fresh and frozen beef, with or without the addition of suet, to which no water, binders, or extenders are added. The term includes only products entirely derived from the edible flesh of livestock or a livestock product, as meat is defined in 81-9-217. The term does not include cell-cultured edible products. There are four grades of hamburger or ground beef:
(a) "regular hamburger" or "regular ground beef" may have:
(i) a fat content no greater than the federal standard set forth in 9 CFR 319.15; and
(ii) a lean content of no less than 70%;
(b) "lean hamburger" or "lean ground beef" may have:
(i) a fat content no greater than 22%; and
(ii) a lean content of no less than 78%;
(c) "extra lean hamburger" or "extra lean ground beef" may have:
(i) a fat content no greater than 16%; and
(ii) a lean content of no less than 84%; and
(d) "super lean hamburger" or "super lean ground beef" may have:
(i) a fat content no greater than 12%; and
(ii) a lean content of no less than 88%.
(20) "Honey" means the nectar and saccharine plant exudations, gathered, modified, and stored in the comb by honey bees, that are levorotatory and that contain not more than 25% of water, not more than 0.25% of ash, and not more than 8% sucrose.
(21) "Label" means a display of written, printed, or graphic matter on the immediate container of an article. "Immediate container" does not include package liners.
(22) "Labeling" means labels and other written, printed, or graphic matter:
(a) on an article or its containers or wrappers;
(b) accompanying the article.
(23) "Menu" means a list presented to the patron that states the food items for sale in a food service establishment.
(24) "New drug" means a drug, the composition of which:
(a) is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs as safe and effective for use under the conditions prescribed, recommended, or suggested in the new drug's labeling; or
(b) has become recognized as a result of investigations to determine the new drug's safety and effectiveness for use under the conditions prescribed but has not, other than in the investigations, been used to a material extent or for a material time under the conditions prescribed.
(25) "Official compendium" means the official United States Pharmacopoeia, official National Formulary, or a supplement to either of these.
(26) (a) "Package" means a container or wrapping in which a consumer commodity is enclosed for use in the delivery or display of that consumer commodity to retail purchasers.
(b) The term does not include:
(i) shipping containers or wrappings used solely for the transportation of a consumer commodity in bulk or in quantity to manufacturers, packers, or processors or to wholesale or retail distributors;
(ii) shipping containers or outer wrappings used by retailers to ship or deliver a commodity to retail customers if the containers and wrappings bear no printed matter pertaining to a particular commodity.
(27) "Person" includes an individual, partnership, corporation, and association.
(28) "Pesticide chemical" means a substance that alone, in chemical combination, or in formulation with one or more other substances is an "economic poison" under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136, et seq.), as amended, and that is used in the production, storage, or transportation of raw agricultural commodities.
(29) "Placard" means a nonpermanent sign used to display or describe food items for sale in a food service establishment or retail meat establishment.
(30) "Principal display panel" means that part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.
(31) "Processing" means cooking, baking, heating, drying, mixing, grinding, churning, separating, extracting, cutting, freezing, or otherwise manufacturing a food or changing the physical characteristics of a food and the enclosure of the food in a package.
(32) "Raw agricultural commodity" has the meaning as provided in 50-50-102.
(33) "Retail meat establishment" means a commercial establishment at which meat or meat products are displayed for sale or provision to the public, with or without charge.
(34) "Synthetically compounded" means a product formulated by a process that chemically changes a material or substance extracted from naturally occurring plant, animal, or mineral sources, except for microbiological processes.
History: En. Sec. 2, Ch. 307, L. 1967; amd. Sec. 1, Ch. 171, L. 1971; amd. Sec. 1, Ch. 114, L. 1974; amd. Sec. 3, Ch. 349, L. 1974; R.C.M. 1947, 27-702(part); amd. Sec. 8, Ch. 37, L. 1979; amd. Sec. 1, Ch. 456, L. 1979; amd. Sec. 1, Ch. 361, L. 1981; amd. Sec. 1, Ch. 605, L. 1985; amd. Sec. 1, Ch. 169, L. 1989; amd. Sec. 4, Ch. 472, L. 1989; amd. Sec. 1, Ch. 133, L. 1991; amd. Sec. 129, Ch. 418, L. 1995; amd. Sec. 307, Ch. 546, L. 1995; amd. Sec. 210, Ch. 42, L. 1997; amd. Sec. 3, Ch. 172, L. 1999; amd. Sec. 1, Ch. 373, L. 2003; amd. Sec. 6, Ch. 239, L. 2015; amd. Sec. 1, Ch. 186, L. 2019.