§ 106-121. Definitions and general consideration.
§ 106‑121. Definitions and general consideration.
For the purpose of this Article:
(1) The term "advertisement" means all representationsdisseminated in any manner or by any means, other than by labeling, for thepurposes of inducing, or which are likely to induce, directly or indirectly,the purchase of food, drugs, devices or cosmetics.
(1a) The term "color" includes black, white, andintermediate grays.
(1b) The term "color additive" means a material which:
a. Is a dye, pigment, or other substance made by a process ofsynthesis 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; or
b. When added or applied to a food, drug, or cosmetic, or tothe human body or any part thereof, is capable (alone or through reaction withother substance) of imparting color thereto;
Provided, that such term does not apply to anypesticide chemical, soil or plant nutrient, or other agricultural chemicalsolely because of its effect in aiding, retarding, or otherwise affecting,directly or indirectly, the growth or other natural physiological process ofproduce of the soil and thereby affecting its color, whether before or afterharvest.
(2) The term "Commissioner" means the Commissioner ofAgriculture; the term "Department" means the Department ofAgriculture and Consumer Services, and the term "Board" means theBoard of Agriculture.
(2a) The term "consumer commodity" except as otherwisespecifically provided by this subdivision means any food, drug, device, orcosmetic as those terms are defined by this Article. Such term does notinclude:
a. Any tobacco or tobacco product; or
b. Any commodity subject to packaging or labeling requirementsimposed under the North Carolina Pesticide Law of 1971, Article 52, Chapter143, of the General Statutes of North Carolina, or the provisions of the eighthparagraph under the heading "Bureau of Animal Industry" of the act ofMarch 4, 1913 (37 Stat. 832‑833; 21 U.S.C. 151‑157) commonly knownas the Virus‑Serum Toxin Act; or
c. Any drug subject to the provisions of G.S. 106‑134(13)or 106‑134.1 of this Article or section 503(b)(1) or 506 of the federalact; or
d. Any beverage subject to or complying with packaging or labelingrequirements imposed under the Federal Alcohol Administration Act (27 U.S.C.,et seq.); or
e. Any commodity subject to the provisions of the NorthCarolina Seed Law, Article 31, Chapter 106 of the General Statutes of NorthCarolina.
(3) The term "contaminated with filth" applies to anyfood, drug, device or cosmetic not securely protected from dust, dirt, and asfar as may be necessary by all reasonable means, from all foreign or injuriouscontaminations.
(4) The term "cosmetic" means
a. Articles intended to be rubbed, poured, sprinkled, orsprayed on, introduced into, or otherwise applied to the human body or any partthereof for cleansing, beautifying, promoting attractiveness, or altering theappearance, and
b. Articles intended for use as a component of any sucharticles, except that such terms shall not include soap.
(4a) The term "counterfeit drug" means a drug which, orthe container or labeling of which, without authorization, bears the trademark,trade name or other identifying mark, imprint, or device, or any likenessthereof, of a drug manufacturer, processor, packer or distributor other thanthe person or persons who in fact manufactured, processed, packed ordistributed such drug and which thereby falsely purports or is represented tobe the product of, or to have been packed or distributed by, such other drugmanufacturer, processor, packer or distributor.
(5) The term "device," except when used in subdivision(15) of this section and in G.S. 106‑122, subdivision (10), 106‑130,subdivision (6), 106‑134, subdivision (3) and 106‑137, subdivision(3) means instruments, apparatus and contrivances, including their components,parts and accessories, intended
a. For use in the diagnosis, cure, mitigation, treatment, orprevention of disease in man or other animals; or
b. To affect the structure or any function of the body of manor other animals.
(6) The term "drug" means
a. Articles recognized in the official United StatesPharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or officialNational Formulary, or any supplement to any of them; and
b. Articles intended for use in the diagnosis, cure,mitigation, treatment or prevention of disease in man or other animals; and
c. Articles (other than food) intended to affect the structureor any function of the body of man or other animals; and
d. Articles intended for use as a component of any articlespecified in paragraphs a, b or c; but does not include devices or theircomponents, parts, or accessories.
(7) The term "federal act" means the Federal Food,Drug and Cosmetic Act (Title 21 U.S.C. 301 et seq.; 52 Stat. 1040 et seq.).
(8) The term "food" means
a. Articles used for food or drink for man or other animals,
b. Chewing gum, and
c. Articles used for components of any such article.
(8a) The term "food additive" means any substance, theintended use of which results or may be reasonably expected to result, directlyor indirectly, in its becoming a component or otherwise affecting thecharacteristics of any food (including any substance intended for use inproducing, manufacturing, packing, processing, preparing, treating, packaging,transporting or holding food; and including any source of radiation intendedfor any such use) if such substance is not generally recognized, among expertsqualified by scientific training and experience to evaluate its safety, ashaving been adequately shown through scientific procedures (or, in the case ofa substance used in a food prior to January 1, 1958, through either scientificprocedures or experience based on common use in food) to be safe under theconditions of its intended use; except that such term does not include:
a. A pesticide chemical in or on a raw agricultural commodity;or
b. A pesticide chemical to the extent that it is intended foruse or is used in the production, storage, or transportation of any rawagricultural commodity; or
c. A color additive; or
d. Any substance used in accordance with a sanction or approvalgranted prior to the enactment of the Food Additives Amendment of 1958, pursuantto 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 andextended (21 U.S.C. 71 et seq.).
(9) The term "immediate container" does not includepackage liners.
(10) The term "label" means a display of written,printed or graphic matter upon the immediate container of any article; and arequirement made by or under authority of this Article that any word,statement, or other information appearing on the label shall not be consideredto be complied with unless such word, statement, or other information alsoappears on the outside container or wrapper, if any there be, of the retailpackage of such article, or is easily legible through the outside container orwrapper.
(11) The term "labeling" means all labels and otherwritten, printed, or graphic matter
a. Upon an article or any of its containers or wrappers, or
b. Accompanying such article.
(11a) Repealed by Session Laws 1989, c. 226, s. 1.
(12) The term "new drug" means
a. Any drug the composition of which is such that such drug isnot generally recognized, among experts qualified by scientific training andexperience to evaluate the safety and effectiveness of drugs, as safe andeffective for use under the conditions prescribed, recommended, or suggested inthe labeling thereof; or
b. Any drug the composition of which is such that such drug, asa result of investigations to determine its safety and effectiveness for useunder such conditions, has become so recognized, but which has not, otherwisethan in such investigation, been used to a material extent or for a materialtime under such conditions.
(12a) Repealed by Session Laws 1989, c. 226, s. 1.
(13) The term "official compendium" means the officialUnited States Pharmacopoeia, official Homeopathic Pharmacopoeia of the UnitedStates, official National Formulary, or any supplement to any of them.
(13a) The term "package" means any container or wrappingin which any consumer commodity is enclosed for use in the delivery or displayof that consumer commodity to retail purchasers, but does not include:
a. Shipping containers or wrappings used solely for thetransportation of any consumer commodity in bulk or in quantity tomanufacturers, packers, or processors, or to wholesale or retail distributorsthereof; or
b. Shipping containers or outer wrappings used by retailers toship or deliver any commodity to retail customers if such containers andwrappings bear no printed matter pertaining to any particular commodity.
(14) The term "person" includes individual, partnership,corporation, and association.
(14a) The term "pesticide chemical" means any substancewhich, alone, in chemical combination, or in formulation with one or more othersubstances is a "pesticide" within the meaning of the North CarolinaPesticide Law of 1971, Article 52, Chapter 143, of the General Statutes ofNorth Carolina, or the Federal Insecticide, Fungicide and Rodenticide Act (7U.S.C. 135 et seq.), and which is used in the production, storage, ortransportation of raw agricultural commodities.
(14b) The term "practitioner" means a physician, dentist,veterinarian or other person licensed, registered or otherwise permitted todistribute, dispense, conduct research with respect to or to administer a drugso long as such activity is within the normal course of professional practiceor research.
(14c) The term "principal display panel" means that partof a label that is most likely to be displayed, presented, shown, or examinedunder normal and customary conditions of display for retail sale.
(14d) The term "raw agricultural commodity" means any foodin its raw or natural state, including all fruits that are washed, colored, orotherwise treated in their unpeeled natural form prior to marketing.
(14e), (14f) Repealed by Session Laws 1989, c. 226, s. 1.
(15) If an article is alleged to be misbranded because thelabeling is misleading, or if an advertisement is alleged to be false becauseit is misleading, then in determining whether the labeling or advertisement ismisleading, there shall be taken into account (among other things) not onlyrepresentations made or suggested by statement, word, design, device, sound, orany combination thereof, but also the extent to which labeling or advertisementfails to reveal facts material in the light of such representations or materialwith respect to consequences which may result from the use of the article towhich the labeling or advertisement relates under the conditions of useprescribed in the labeling or advertisement thereof or under such conditions ofuse as are customary or usual.
(16) The representation of a drug, in its labeling oradvertisement, as an antiseptic shall be considered to be a representation thatit is a germicide, except in the case of a drug purporting to be, orrepresented as, an antiseptic for inhibitory use as a wet dressing, ointment,dusting powder, or such other use as involves prolonged contact with the body.
(17) The provisions of this Article regarding the selling of food,drugs, devices, or cosmetics, shall be considered to include the manufacture,production, processing, packing, exposure, offer, possession, and holding ofany such article for sale; and the sale, dispensing, and giving of any sucharticle; and the supplying or applying of any such article in the conduct ofany food, drug or cosmetic establishment. (1939, c. 320, s. 2; 1975, c. 614, ss. 1, 2; 1987, c. 737, s. 1; 1989,c. 226, s. 1; 1997‑261, s. 32.)