As used in this part 4, 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 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) (a) Color additive means a material which:
(I) 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
(II) 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
is exempted under the federal act.
(b) Nothing in this subsection (3) 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 process or produce of the soil and thereby affecting
its color, whether before or after harvest.
(4) Consumer commodity, except as otherwise specifically provided in this
subsection (4), means any food, drug, cosmetic, or device. Such term does not
include:
(a) Any tobacco or tobacco product;
(b) Any commodity subject to packaging or labeling requirements imposed
under article 9 of title 35, C.R.S., being known as the Pesticide Act, or imposed by
the secretary of agriculture under the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended (7 U.S.C. sec. 136 et seq.), or under the federal
Animal Virus, Serum, Toxin, Antitoxin Act (21 U.S.C. secs. 151-158);
(c) Any drug subject to the provisions of section 25-5-415 (1)(m) or of 21
U.S.C. sec. 353 (b)(1) or 356;
(d) Any beverage subject to or complying with packaging or labeling
requirements imposed under the Federal Alcohol Administration Act (27 U.S.C.
secs. 201-211); or
(e) Any commodity subject to the provisions of article 27 of title 35, C.R.S.,
concerning seeds.
(5) Contaminated with filth applies to any food, drug, cosmetic, or device
not securely protected from dust, dirt, and, as far as may be necessary by all
reasonable means, from all foreign or injurious contaminations.
(6) Cosmetic means 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 articles intended for use as a component of any such articles; except
that such term does not include soap.
(7) Department means the department of public health and environment.
(8) Device, except when used in subsection (23) of this section and in
sections 25-5-403 (1)(j), 25-5-411 (1)(g), 25-5-415 (1)(d), and 25-5-417 (1)(d), means
instruments, apparatus, and contrivances, including their components, parts, and
accessories, intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals or to affect the structure or any
function of the body of man or other animals.
(9) Drug means:
(a) Articles 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) 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;
(d) Articles intended for use as a component of any article specified in
paragraph (a), (b), or (c) of this subsection (9) but does not include devices or their
components, parts, or accessories.
(10) Federal act means the Federal Food, Drug, and Cosmetic Act (21
U.S.C. sec. 301 et seq., 52 Stat. 1040).
(11) Food means articles used for food or drink for man or other animals,
chewing gum, and articles used for components of any such article.
(12) 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. The 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 amendment to the federal act known as the Food
Additives Amendment of 1958, the Poultry Products Inspection Act (21 U.S.C.
secs. 451-470), or the Federal Meat Inspection Act, as amended and extended (21
U.S.C. secs. 603-623).
(13) Immediate container does not include package liners.
(14) Label means a display of written, printed, or graphic matter upon the
immediate container of any article; and by or under the authority of this part 4 a
requirement that any word, statement, or other information appear on the label
shall not be considered to be complied with unless such word, statement, or other
information also appears on the outside container or wrapper, if any, of the retail
package of such article or is easily legible through the outside container or
wrapper.
(15) Labeling means all labels and other written, printed, or graphic matter
upon an article or any of its containers or wrappers, or accompanying such article.
(16) 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.
(17) Package means any container or wrapping in which any consumer
commodity is enclosed for use in the delivery or display of that consumer
commodity to retail purchasers. The term does not include:
(a) Shipping containers or wrappings used solely for the transportation of
any consumer commodity in bulk or in quantity to manufacturers, packers, or
processors, or to wholesale or retail distributors thereof; or
(b) Shipping containers or outer wrappings used by retailers to ship or
deliver any commodity to retail customers if such containers or wrappers bear no
printed matter pertaining to any particular commodity.
(18) Person includes an individual, partnership, corporation, 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 section 35-9-102 (21), C.R.S., and which is used in the
production, storage, or transportation of raw agricultural commodities.
(20) 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.
(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.
(22) Safe, as used in subsection (12) of this section, has reference to the
health of man or animal.
(23) 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 all representations made or suggested by statement,
work, design, device, sound, or any combination thereof, and 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.
(24) 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 being, an antiseptic for
inhibitory use which involves prolonged contact with the body.
(25) The provisions of this part 4 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 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.