2023 Vermont Statutes › Title 18 - Health › Chapter 82 - Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances › § 4051. Definitions

§ 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(2) [Repealed.]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.)