§ 4051. Definitions
As used in this chapter:
(1) The term “Department” means the Vermont Department of Health.
(2) [Repealed.]
(3) The term “person” includes an individual, partnership, corporation, and association.
(4) The term “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 such article.
(5) The term “drug” means:
(A) articles recognized in the official U.S. 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 humans or other animals;
(C) articles (other than food) intended to affect the structure or any function of the
body of man or other animals; and
(D) articles intended for use as a component of any article specified in subdivision (A),
(B), or (C) of this subdivision (5) but does not include devices or their components,
parts, or accessories.
(6)(A) The term “device” (except when used in subdivision (18) of this section and in subdivisions 4052(10), 4060(6), 4064(3), and 4067(3) of this title) means instruments, apparatus, and contrivances, including their components, parts,
and accessories, intended:
(i) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
humans or other animals; or
(ii) to affect the structure of any function of the body of humans or other animals.
(B) The term “device” shall not mean professional diagnostic instruments.
(7) The term “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; and
(B) articles intended for use as a component of any such articles, except that such term
shall not include soap.
(8) The term “hazardous substance” means any substance or mixture of substances that:
(A) is toxic;
(B) is corrosive;
(C) is an irritant;
(D) is flammable;
(E) is radioactive; or
(F) generates pressure through decomposition, heat, or other means if such substance or
mixture of substances may cause substantial personal injury or illness during any
customary or reasonably anticipated handling.
(9) The term “toxic” shall apply to any substance that has the inherent capacity to produce
bodily injury to humans through ingestion, inhalation, or absorption through the skin.
(10)(A) The term “poison” means any toxic substance that falls within any of the following
categories:
(i) produces death within 48 hours in one-half or more than one-half of a group of 10
or more laboratory white rats each weighing between 200 and 300 grams, at a single
dose of 50 milligrams or less per kilogram of body weight, when orally administered;
or
(ii) produces death within 48 hours in one-half or more than one-half of a group of 10
or more laboratory white rats each weighing between 200 and 300 grams, when inhaled
continuously for a period of one hour or less at an atmospheric concentration of two
milligrams or less per liter of gas, vapor mist, or dust, provided the concentration
is likely to be encountered by man when the substance is used in any reasonably foreseeable
manner; or
(iii) produces death within 48 hours in one-half or more than one-half of a group of 10
or more rabbits tested in a dosage of 200 milligrams or less per kilogram of body
weight, when administered by continuous contact with the bare skin for 24 hours or
less.
(B) If available data on human experience with any substance in the dosages or concentrations
described in subdivision (A) of this subdivision (10) indicate results different from
those obtained on animals, the human data shall take precedence.
(11) The term “corrosive” means any substance that in contact with living tissue will cause
substantial destruction of tissue by chemical action, but shall not refer to action
on inanimate surfaces.
(12) The term “irritant” means any substance, not corrosive within the meaning of subdivision
(11) of this section, that on immediate, prolonged, or repeated contact with normal
living tissue will induce a local inflammatory reaction.
(13) The term “flammable” shall apply to any substance that has a flashpoint of 80 degrees
Fahrenheit, or below, as determined by the Tagliabue open cup tester, except that
the flammability of the contents of self-pressurized containers shall be determined
by methods generally applicable to the containers and established by rules adopted
by the Commissioner.
(14) The term “radioactive” shall apply to any substance that as a result of disintegration
of unstable atomic nuclei, emits energy.
(15) The term “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 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 there be, of the retail package
of the article, or is easily legible through the outside container or wrapper.
(16) The term “immediate container” does not include package liners.
(17) The term “misbranded package” means any retailed package of a hazardous substance,
intended for household use, that fails to bear a label:
(A) That states conspicuously:
(i) the name or identifying trade name or trademark and place of business of the manufacturer,
packer, or distributor;
(ii) the common or usual name, or the chemical name (if there be no common or usual name)
or the recognized generic name (not trade name only) of the hazardous substance or
of each component that contributes substantially to its hazard;
(iii) one of the following signal words: “danger, “warning,” or “caution”; when necessary
an affirmative statement of the principal hazard or hazards such as “flammable,” “vapor
harmful,” “causes burns,” absorbed through skin,” or similar wording descriptive of
the hazard;
(iv) precautionary measures describing the action to be followed or avoided;
(v) instructions, when necessary, for the first aid treatment in case of contact or exposure,
if the substance is hazardous through contact or exposure;
(vi) the word “poison” for any substance that is defined as poisonous by subdivision (10)(A)
of this section;
(vii) instructions for handling or storage; and
(viii) the statement “keep out of the reach of children,” or its practical equivalent; and
(B) On which any statement required under subdivision (A) of this subdivision (17) is
located prominently and is in English in legible type in contrast by typography, layout,
or color with other printed matter on the label, provided that the Commissioner shall,
by rule, provide for minimum information that shall appear on the labels for small
packages, which labels need not include all of the information required by this subsection;
provided further that the Commissioner may provide for less than the foregoing statement
of the hazard or precautionary measures for labels of hazardous substances presenting
only minor hazards; and the term “misbranded package” shall not apply to packages
of economic poisons subject to the federal Insecticide, Fungicide and Rodenticide
Act, to packages of substances subject to the federal Food, Drug and Cosmetic Act
or to packages of substances intended for use in agriculture, horticulture, industrial,
or related uses. Nothing in this chapter shall be construed to be in conflict or interfere
with the administration of 6 V.S.A. chapter 81.
(18) 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 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 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 thereof or under such conditions
of use as are customary or usual.
(19) The term “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, drugs, devices, or cosmetics.
(20) 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 such other use as involves prolonged contact
with the body.
(21) The term “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
of drugs, as safe 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 for use under such conditions, has become so recognized, but
that has not, otherwise than in such investigations, been used to a material extent
or for a material time under such conditions.
(22) The term “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.
(23) The provisions of this chapter regarding the selling of food, drugs, devices, or cosmetics
shall be considered to include the manufacture, production, processing, packing, 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.
(24) The term “federal act” means the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.; 52 Stat. 1040 et seq. (Added 1959, No. 172, § 2, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 107; 2017, No. 113 (Adj. Sess.), § 71; 2019, No. 131 (Adj. Sess.), § 122; 2023, No. 6, § 137, eff. July 1, 2023; 2023, No. 53, § 83, eff. June 8, 2023.)