For the purpose of this chapter:
1. "Advertisement" means all representations disseminated in any manner or by any
means, other than by labeling, for the purpose of inducing, or which are likely to
induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.
2. "Color" includes black, white, and intermediate grays.
3. "Color additive" means a material which:
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; or
b. When added or applied to a food, drug, or cosmetic, or to the human body or any
part thereof, is capable, alone or through reaction with other substance, of
imparting color thereto, except that such term does not include any material
which has been or hereafter is exempted under the Federal Act.
4. "Contaminated with filth" applies to any food, drug, device, or cosmetic not securely
protected from dust, dirt, and as far as may be necessary by all reasonable means,
from all foreign or injurious contaminations.
5. "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 thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance; or
b. Articles intended for use as a component of any such articles, except that such
term does not include soap.
6. "Department" means the department of health and human services.
7. "Device", except when used in the first paragraph following subsection 21 of this
section and in subsection 10 of section 19-02.1-02, subsection 6 of section
19-02.1-10, subsections 3 and 16 of section 19-02.1-14, and subsection 3 of section
19-02.1-18, 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
man or other animals; or
b. To affect the structure or any function of the body of man or other animals.
8. "Drug" means:
a. Articles recognized in the official United States pharmacopoeia, official
homeopathic pharmacopoeia of the United States, or official national formulary, or
any supplement to any of them;
b. Articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals;
c. Articles, other than food, intended to affect the structure or any function of the
body of man or other animals; or
d. Articles intended for use as a component of any article specified in subdivision a,
b, or c, but does not include devices or their components, parts, or accessories.
Provided, however, that "drug", for the purpose of this chapter, and as defined by
this subsection, does not include those controlled substances or drugs regulated
by or under the authority of the Uniform Controlled Substances Act, with respect
to such drugs, the Uniform Controlled Substances Act takes precedence over and
supplants the provisions of this chapter only so far as its authority and control is
synonymous with the provisions of this chapter.
9. "Federal Act" means the Federal Food, Drug, and Cosmetic Act, as amended
[21 U.S.C. 301 et seq.].
10. "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.
11. "Food additive" means any 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 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 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, or, in the case of a substance
used in a food prior to January 1, 1958, through either scientific procedures or
experience based on common use in food, to be safe under the conditions of its
intended use, except that such term does not include:
a. A pesticide chemical in or on a raw 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; or
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
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. 71 et seq.].
12. "Immediate container" does not include package liners.
13. "Label" means a display of written, printed, or graphic matter 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 may not be
considered to be complied with unless such word, statement, or other information also
appears on the outside container or wrapper, if any there be, of the retail package of
such article, or is easily legible through the outside container or wrapper.
14. "Labeling" means all labels and other written, printed, or graphic matter:
a. Upon an article or any of its containers or wrappers; or
b. Accompanying such article.
15. "Manufacture, compound, or process" includes repackaging or otherwise changing the
container, wrapper, or labeling of any drug package in the furtherance of the
distribution of the drug from the original place of manufacture to the person who
makes final delivery or sale to the ultimate consumer, and the term "manufacturers,
compounders, and processors" must be deemed to refer to persons engaged in such
defined activities.
16. "New drug" means:
a. Any drug the composition of which is such that such drug 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 labeling
thereof; or
b. Any drug the composition of which is such that such drug, as a result of
investigations to determine its safety and effectiveness for use under such
conditions, has become so recognized, but which has not, otherwise than in such
investigations, been used to a material extent or for a material time under such
conditions.
17. "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.
18. "Person" includes individual, partnership, corporation, limited liability company, and
association.
19. "Pesticide chemical" means any substance which, alone, in chemical combination, or
in formulation with one or more other substances is a pesticide within the meaning of
chapter 4.1-34, and which is used in the production, storage, or transportation of raw
agricultural commodities.
20. "Practitioner" means an individual licensed, registered, or otherwise authorized by the
jurisdiction in which the individual is practicing to prescribe drugs in the course of
professional practice which are subject to this chapter.
21. "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.
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 must be taken into account, among other things,
not only representations made or suggested by statement, word, design, device, sound, or in
any combination thereof, but also the extent to which the labeling or advertisement fails to
reveal facts material in the light of such representations or material with respect to
consequences which 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
thereof or under such conditions of use as are customary or usual.
The representation of a drug, in its labeling or advertisement, as an antiseptic must 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 such other use as involves prolonged contact with the body.
The provisions of this chapter regarding the selling of food, drugs, devices, or cosmetics
must be considered to include the manufacture, production, processing, packing, exposure,
offer, possession, and holding of any such article for sale; and the sale, dispensing, and giving
of any such article and the supplying or applying of any such articles in the conduct of any food,
drug, or cosmetic establishment.
Nothing in subsection 21 may 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 process of
produce of the soil and thereby affecting its color, whether before or after harvest.