2015 Tennessee Code
Title 53 - Food, Drugs And Cosmetics
Chapter 1 - Tennessee Food, Drug and Cosmetic Act
Part 1 - General Provisions
§ 53-1-102 - Chapter definitions.

TN Code § 53-1-102 (2015) What's This?

As used in this chapter, unless the context otherwise requires:

(1) "Advertisement" means all 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, drug, devices or cosmetics;

(2) "Alcohol" means:

(A) Rubbing alcohol compound;

(B) Isopropyl alcohol; or

(C) Any product manufactured with any specially denaturing properties, and represented to be a rubbing alcohol compound, or a rubbing alcohol, or an alcohol made especially for massaging or toilet purposes;

(3) "Antiseptic." The representation of a drug, in its labeling or advertisement, as an "antiseptic" shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or other use that involves prolonged contact with the body;

(4) "Catfish" means any species within the family Ictaluridae or the family Anarchichadidae;

(5) "Catfish product" means any product capable of use as human food that is made wholly or in part from any catfish or portion of catfish, except products that contain catfish only in small proportions or historically have not been, in the judgment of the commissioner, considered by consumers as products of the United States commercial catfish industry and that are exempted from definition as a catfish product by the commissioner under conditions that the commissioner may prescribe to assure that the catfish or portions of catfish contained in the product are not adulterated and that the products are not represented as catfish products;

(6) "Certificate of free sale" means a certificate issued by the department that certifies that the manufacturer of the food, nonprescription drugs, or cosmetics listed in the document is duly authorized to manufacture the products and either that:

(A) The products may be sold freely to the public in the United States, and the manufacturer is in substantial compliance with this chapter as determined by an inspection conducted by the department; or

(B) The manufacturer has provided the department with a complete copy of the report of the most recent inspection conducted by the United States food and drug administration for each Tennessee location where the foods, nonprescription drugs or cosmetic products for which the certificate is being sought are manufactured; and that, based on the inspection report or reports, it is evident that the manufacturer is authorized to sell the products freely in the United States;

(7) (A) (i) "Color additive" means a material that:

(a) Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral or other source; and

(b) When added or applied to a food, drug or cosmetic, or to the human body or any part of the human body, is capable, alone or through reaction with other substances, of imparting color to the food, drug or cosmetic, or to the human body or any part of the human body;

(ii) "Color additive" does not include any material that the commissioner, by regulation, determines is used, or intended to be used, solely for a purpose or purposes other than coloring;

(B) "Color" includes black, white and intermediate grays;

(C) Nothing in this subdivision (7) shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest;

(8) "Commissioner" means the commissioner of agriculture;

(9) "Contaminated with filth" applies to any food, drug, device or cosmetic not securely protected from dust, dirt, and, as far as possible, from all foreign or injurious contamination;

(10) "Cosmetic" means:

(A) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance; and

(B) Articles intended for use as a component of the articles listed in subdivision (10)(A), except that "cosmetic" does not include soap;

(11) "Device," except when used in subdivision (22) and in §§ 53-1-103(a)(7), 53-1-105(6), 53-1-109(a)(3), and 53-1-112(3), 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 any function of the body of humans or other animals;

(12) "Drug" means articles, not including devices or their components, parts or accessories, that are:

(A) Recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them;

(B) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals;

(C) Intended, other than food, to affect the structure or any function of the body of humans or other animals; and

(D) Intended for use as a component of any article specified in subdivisions (12)(A)-(C);

(13) "Federal act" means the federal Food, Drug and Cosmetic Act, compiled at 21 U.S.C. § 301 et seq., as amended;

(14) "Food" means:

(A) Articles used for food or drink for humans or other animals;

(B) Chewing gum; and

(C) Articles used for components of any article listed in subdivisions (14)(A) and (B);

(15) "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 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; except that "food additive" does not include:

(A) A pesticide chemical in or on an agricultural commodity;

(B) A pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity;

(C) A color additive;

(D) Any 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 Food, Drug and Cosmetic Act; or

(E) Any substance used in food prior to January 1, 1958, that has been shown through either scientific procedures or experience based on common use in food to be safe under the conditions of its intended use;

(16) "Immediate container" does not include package liners;

(17) "Imported catfish" means catfish that is produced in a nation other than the United States, either according to the usual and customary techniques of aquaculture or in the freshwater lakes, rivers or streams or the marine or estuarine waters of the foreign nation;

(18) "Imported catfish product" means any product capable of use as human food that is made, wholly or in part, from any imported catfish or portion of catfish;

(19) "Intrastate commerce" means any and all commerce within the state and subject to the jurisdiction of the state, and includes the operation of any business or service establishment;

(20) "Label" means a display of written, printed, or graphic matters upon the immediate container of any article, and a requirement made by or under authority of this chapter, that any word, statement, or other information appearing on the label shall not be considered to be complied with unless the word, statement or other information also appears on the outside container;

(21) "Labeling" means all labels and other written, printed or graphic matter:

(A) Upon any article or any of its containers or wrappers; or

(B) Accompanying the article;

(22) "Misleading." If an article is alleged to be misbranded because the labeling is "misleading," or if an advertisement is alleged to be false because it is "misleading," then in determining whether the labeling or advertisement is "misleading," there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or in any combination of statement, word, design, device, sound, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of the representation or material with respect to consequences that may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement of the article or under conditions of use that are customary or usual;

(23) "New drug" means:

(A) Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended or suggested in the labeling of the drug; or

(B) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under the conditions described in subdivision (23)(A), has become so recognized, but that has not, otherwise than in those investigations, been used to a material extent or for a material time under those conditions;

(24) "Official compendium" means the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, Official National Formulary, or any supplement to any of them;

(25) "Person" includes an individual, partnership, corporation and association;

(26) "Pesticide chemical" means:

(A) Any substance or mixture of substances, including disinfectants, intended for preventing, destroying, repelling or mitigating any insects, rodents, nematodes, fungi, bacteria, weeds or other forms of plant or animal life or viruses, except viruses on or in living humans or other animals, that the commissioner declares to be a pest; and

(B) Any substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant;

(27) "Raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled natural form prior to marketing;

(28) "Salvageable merchandise" means any food, drug, cosmetic, device or other item listed in this chapter or any regulations promulgated under this chapter that can be reconditioned, labeled, relabeled, repackaged, recoopered, sorted, cleaned, culled or by any other means be salvaged to meet the requirements of this chapter or those regulations; and

(29) "Selling." This chapter regarding the "selling" of food, drugs, devices or cosmetics shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession, and holding of those articles for sale, and the supplying or applying of those articles in the conduct of any food, drug or cosmetic establishment. "Selling" does not include infrequent casual sales of honey or the selling or packing of less than one hundred fifty gallons (150 gals.) of honey per year.

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