The Vermont Statutes Online

Title 18: Health

Chapter 082: Labeling of Foods, Drugs, Cosmetics, and Hazardous Substances

• Subchapter 001: Labeling for Marketing and Sale

• § 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  (2) [Repealed.]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.)

• § 4052. Manufacture, sale, delivery; prohibitions

  The following acts and the causing thereof within the State of Vermont are hereby prohibited:

  (1) the manufacture, sale, or delivery, holding, or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded;

  (2) the adulteration or misbranding of any food, drug, device, or cosmetic;

  (3) the receipt in commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise;

  (4) the sale, delivery for sale, holding for sale, or offering for sale of any article in violation of section 4061 or 4065 of this title;

  (5) the dissemination of any false advertisement;

  (6) the refusal to permit entry or inspection, or to permit the taking of a sample, as authorized by section 4070 of this title;

  (7) the giving of a guaranty or undertaking which guaranty or undertaking is false, except by a person who relied on a guaranty or undertaking to the same effect signed by and containing the name and address of the person residing in the State of Vermont from whom he or she received in good faith the food, drug, device, or cosmetic;

  (8) the removal or disposal of a detained or embargoed article in violation of section 4055 of this title;

  (9) the alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device, or cosmetic, if such act is done while such article is held for sale and results in such article being adulterated or misbranded;

  (10) forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by rules adopted under the provisions of this chapter;

  (11) the using, on the labeling of any drug or in any advertisement relating to such drug, of any representation or suggestion that any application with respect to such drug is effective under section 4065 of this title, or that such drug complies with the provisions of such section;

  (12) the sale, offering for sale, distribution, or transportation for sale within this State of any misbranded package of a hazardous substance in a package or container intended for general home and household use. (Added 1959, No. 172, § 3, eff. May 12, 1959; amended 2017, No. 113 (Adj. Sess.), § 72; 2023, No. 6, § 138, eff. July 1, 2023.)

• § 4053. Rules and hearings

  (a) The authority to enforce this chapter is vested in the Department. The Department shall from time to time for the efficient enforcement of this chapter adopt rules after public hearing following due notice at least 10 days in advance of the hearings to interested persons.

  (b) In addition to the other remedies provided in this chapter, the Commissioner is hereby authorized through the Attorney General or State’s Attorneys to apply to the Civil or Criminal Division of any Superior Court, and the court shall have jurisdiction upon hearing and for cause shown, to grant a temporary or permanent injunction restraining any person from violating any provision of this chapter, irrespective of whether or not there exists an adequate remedy at law.

  (c)(1) Any hazardous substance that is in a misbranded package when introduced into or while in intrastate commerce within this State for sale within this State shall be liable to be proceeded against on libel of information and condemned in any court within this State having jurisdiction over such an action. Any hazardous substance condemned under this section shall, after entry of the decree, be disposed of by destruction or sale as the court may direct and the proceeds thereof, if sold, less the legal costs and charges, shall be paid to the State Treasurer, but the hazardous substance shall not be sold under the decree contrary to the provisions of this chapter or the laws of the jurisdiction in which sold, provided that, upon the payment of costs of the proceeding and the execution and delivery of a good and sufficient bond conditioned that the hazardous substance shall not be sold or disposed of contrary to the provisions of this chapter, the court may direct that the hazardous substance be delivered to the owner thereof to be destroyed or brought into compliance with the provisions of this chapter by relabeling or reprocessing, as the case may be.

  (2) When a decree of condemnation is entered against the hazardous substance, court costs and fees and storage and other proper expenses shall be awarded against the person, or one intervening as claimant of the hazardous substance.

  (d) Before any violation of this chapter is reported for institution of a criminal proceeding, the person against whom such proceeding is contemplated may be given appropriate notice and an opportunity to present the person’s views to the Commissioner, either orally or in writing, with regard to the contemplated proceeding. Nothing in this chapter shall be construed as requiring the Commissioner to report for prosecution or for the institution of libel proceedings minor violations of the chapter whenever the Commissioner believes that the public interest will be best served by a suitable notice of warning in writing. (Added 1959, No. 172, § 4, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 1965, No. 194, § 10, eff. July 1, 1965, operative Feb. 1, 1967; 1973, No. 193 (Adj. Sess.), § 3, eff. April 9, 1974; 2009, No. 128 (Adj. Sess.), § 38a; 2009, No. 154 (Adj. Sess.), § 145; 2015, No. 23, § 108; 2023, No. 53, § 84, eff. June 8, 2023.)

• § 4054. Penalties

  (a) A person who violates any of the provisions of section 4052 of this title shall be imprisoned for not more than one year or fined not more than $1,000.00, or both; but if the violation is committed after a conviction of the person under this section has become final, the person shall be imprisoned for not more than one year or fined not more than $2,500.00, or both.

  (b) A person shall not be subject to the penalties of subsection (a) of this section for having violated subdivision 4052(1) or (3) of this title if he or she establishes a guaranty or undertaking signed by and containing the name and address of the person residing in the State of Vermont from whom he or she received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of this chapter, designating this chapter.

  (c) No publisher, radio broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination by the person of such false advertisement, unless the person has refused, on the request of the Commissioner, to furnish the Commissioner the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in the State of Vermont, who causes the person to disseminate such advertisement. (Added 1959, No. 172, § 5, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 85, eff. June 8, 2023.)

• § 4055. Marking; notice

  (a) Whenever a duly authorized agent of the Commissioner finds or has probable cause to believe that any food, drug, device, or cosmetic is adulterated, or so misbranded as to be dangerous or fraudulent, within the meaning of this chapter, the agent shall affix to such article a tag or other appropriate marking, giving notice that the article is, or is suspected of being, adulterated or misbranded and has been detained or embargoed, and warning all persons not to remove or dispose of the article by sale or otherwise until permission for removal or disposal is given by the agent or the court. It shall be unlawful for any person to remove or dispose of the detained or embargoed article by sale or otherwise without that permission.

  (b) When an article detained or embargoed under subsection (a) of this section has been found by the agent to be adulterated or misbranded, he or she shall petition the Civil or Criminal Division of the Superior Court in the unit where the article is detained or embargoed for a libel for condemnation of the article. When the agent has found that an article so detained or embargoed is not adulterated or misbranded, he or she shall remove the tag or other marking.

  (c) If the court finds that a detained or embargoed article is adulterated or misbranded, the article shall, after entry of the decree, be destroyed at the expense of the claimant thereof, under the supervision of the agent, and all court costs and fees, and storage and other proper expenses, shall be taxed against the claimant of the article or the claimant’s agent, provided that when the adulteration or misbranding can be corrected by proper labeling or processing of the article, the court, after entry of the decree and after the costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that the article shall be so labeled or processed, has been executed, may by order direct that the article be delivered to the claimant thereof for such labeling or processing under the supervision of an agent of the Commissioner. The expense of the supervision shall be paid by the claimant. The bond shall be returned to the claimant of the article on representation to the court by the Commissioner that the article is no longer in violation of this chapter and that the expenses of supervision have been paid.

  (d) Whenever the Commissioner or the Commissioner’s authorized agent finds in any room, building, vehicle of transportation, or other structure any meat, seafood, poultry, vegetable, fruit, or other perishable articles that are unsound, or contain any filthy, decomposed, or putrid substance, or that may be poisonous or deleterious to health or otherwise unsafe, those articles and substances being hereby declared to be a nuisance, the Commissioner, or the Commissioner’s authorized agent, shall immediately condemn destroy or, in any other manner, render those articles and substances unsalable as human food. (Added 1959, No. 172, § 6, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 1965, No. 194, § 10, eff. July 1, 1965, operative Feb. 1, 1967; 1973, No. 193 (Adj. Sess.), § 3, eff. April 8, 1974; 2009, No. 128 (Adj. Sess.), § 38a; 2009, No. 154 (Adj. Sess.), § 146; 2023 No. 53, § 86, eff. June 8, 2023; 2023, No. 6, § 139, eff. July 1, 2023.)

• § 4056. Proceedings

  (a) Each State’s Attorney to whom the Commissioner reports any violation of this chapter shall cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.

  (b) Before any violation of this chapter is reported to any such attorney for the institution of a criminal proceeding, the person against whom the proceeding is contemplated shall be given appropriate notice and an opportunity to present the person’s views before the Commissioner or the Commissioner’s designated agent, either orally or in writing, in person, or by attorney, with regard to the contemplated proceedings. (Added 1959, No. 172, § 7, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 93 (Adj. Sess.), § 16; 2023, No. 53, § 87, eff. June 8, 2023.)

• § 4057. Construction

  Nothing in this chapter shall require the Commissioner to report for the institution of proceedings under this chapter minor violations of this chapter whenever the Commissioner believes that the public interest will be adequately served in the circumstances by a suitable written notice of warning. (1959, No. 172, § 8, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 88, eff. June 8, 2023.)

• § 4058. Rules; standards

  Whenever in the judgment of the Commissioner such action will promote honesty and fair dealing in the interest of consumers, the Department shall adopt rules fixing and establishing for any food or class of food a reasonable definition and standard of identity, or reasonable standard of quality or fill of container. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Department shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients that shall be named on the label. The definitions and standard so adopted shall conform so far as practicable to the definitions and standards promulgated under authority of the federal act. (Added 1959, No. 172, § 9, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 109; 2023, No. 53, § 89, eff. June 8, 2023.)

• § 4059. Adulterated food defined

  A food shall be deemed to be adulterated:

  (1)(A) If it bears or contains any poisonous or deleterious substance that may render it injurious to health; but in case the substance is not an added substance, the food shall not be considered adulterated under this clause if the quantity of the substance in the food does not ordinarily render it injurious to health;

  (B) if it bears or contains any added poisonous or added deleterious substance that is unsafe within the meaning of section 4062 of this title;

  (C) if it consists in whole or in part of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;

  (D) if it has been produced, prepared, packed, or held under unsanitary conditions in which it may have become contaminated with filth or in which it may have been rendered diseased, unwholesome, or injurious to health;

  (E) if it is the product of a diseased animal or an animal that has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse; or

  (F) if its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.

  (2)(A) If any valuable constituent has been in whole or in part omitted or abstracted therefrom;

  (B) if any substance has been substituted wholly or in part therefor;

  (C) if damage or inferiority has been concealed in any manner; or

  (D) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength or make it appear better or of greater value than it is.

  (3) If it is confectionery and it bears or contains any alcohol or nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one percent, harmless natural wax not in excess of four-tenths of one percent, harmless natural gum and pectin; provided that this subdivision shall not apply to any confectionery by reason of its containing less than one-half of one percent by volume of alcohol derived solely from the use of flavoring, extracts, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances.

  (4) If it bears or contains a coal tar color other than one from a batch that has been certified under authority of the federal act. (Added 1959, No. 172, § 10, eff. May 12, 1959; amended 2023, No. 6, § 140, eff. July 1, 2023.)

• § 4060. Misbranded food

  A food shall be deemed to be misbranded:

  (1) If its labeling is false or misleading in any particular.

  (2) If it is offered for sale under the name of another food.

  (3) If it is an imitation of another food for which a definition and standard of identity have been prescribed by rules adopted pursuant to section 4058 of this title or if it is an imitation of another food that is not subject to subdivision (7) of this section, unless its label bears in type of uniform size and prominence the word imitation and, immediately thereafter, the name of the food imitated.

  (4) If its container is so made, formed, or filled as to be misleading.

  (5) If in package form, unless it bears a label containing:

  (A) the name and place of business of the manufacturer, packer, or distributor; and

  (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that under this subdivision reasonable variations shall be permitted, and exemptions as to small packages shall be established by rules prescribed by the Department.

  (6) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

  (7) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by rules adopted pursuant to section 4058 of this title, unless:

  (A) it conforms to that definition and standard; and

  (B) its label bears the name of the food specified in the definition and standard and, insofar as may be required by the rules, the common names of optional ingredients (other than spices, flavoring, and coloring) present in the food.

  (8) If it purports to be or is represented as:

  (A) a food for which a standard of quality has been prescribed by rules adopted pursuant to section 4058 of this title, and its quality falls below the standard unless its label bears, in such manner and form as the rules specify, a statement that it falls below those standards; or

  (B) a food for which a standard or standards of fill of container have been prescribed by rules adopted pursuant to section 4058 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as the rules specify, a statement that it falls below the standard.

  (9) If it is not subject to the provisions of subdivision (7) of this section, unless it bears labeling clearly giving:

  (A) the common or usual name of the food, if any there be; and

  (B) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings, without naming each, provided that, to the extent that compliance with the requirements of this subdivision is impractical or results in deception or unfair competition, exemptions shall be established by rules adopted by the Department. And provided further that the requirements of this subdivision shall not apply to food products that are packaged at the direction of purchasers at retail at the time of sale, the ingredients of which are disclosed to the purchasers by other means in accordance with rules adopted by the Department.

  (10) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Department determines to be, and by rules adopted, as necessary in order to inform purchasers fully as to its value for such uses.

  (11) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact, provided that to the extent that compliance with the requirements of this subsection is impracticable, exemptions shall be established by rules adopted by the Department.

  (12) If it is a product intended as an ingredient of another food and when used according to the directions of the purveyor will result in the final food product being adulterated or misbranded. (Added 1959, No. 172, § 11, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 113 (Adj. Sess.), § 73; 2023, No. 53, § 90, eff. June 8, 2023.)

• § 4061. Rules regarding permits; investigation

  (a) Whenever the Department finds after investigation that the distribution in Vermont of any class of food may, by reason of contamination with microorganisms during manufacture, processing, or packing thereof in any locality, be injurious to health, and that the injurious nature cannot be adequately determined after the articles have entered commerce, it then, and in that case only, shall adopt rules providing for the issuance to manufacturers, processors, or packers of that class of food in that locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of that class of food and for such temporary period of time, as may be necessary to protect the public health, and after the effective date of the rules and during the temporary period, no person shall introduce or deliver for introduction into commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless the manufacturer, processor, or packer holds a permit issued by the Department as provided by the rules.

  (b) The Department is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of the permit and the Department shall, immediately after prompt hearing and inspection of the establishment, reinstate the permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued, or as amended.

  (c) Any officer or employee duly designated by the Department shall have access to any factory or establishment, the operator of which holds a permit from the Department, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for the inspection shall be grounds for suspension of the permit until the access is freely given by the operator. (Added 1959, No. 172, § 12, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 110; 2023, No. 6, § 141, eff. July 1, 2023; 2023, No. 53, § 91, eff. June 8, 2023.)

• § 4062. Substances added to food; rules

  Any poisonous or deleterious substance added to any food except where the substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of subdivision 4059(1)(B) of this title, but when the substance is so required or cannot be so avoided, the Department shall adopt rules limiting the quantity therein or thereon to such extent as the Department finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of subdivision 4059(1)(B) of this title. While such a rule is in effect limiting the quantity of any such substance in the case of any food, the food shall not, by reason of bearing or containing any added amount of the substance, be considered to be adulterated within the meaning of subdivision 4059(1)(A) of this title. In determining the quantity of the added substance to be tolerated in or on different articles of food, the Department shall take into account the extent to which the use of the substance is required or cannot be avoided in the production of each such article and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances. (Added 1959, No. 172, § 13, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 111; 2023, No. 53, § 92, eff. June 8, 2023.)

• § 4063. Adulterated drug or device defined

  A drug or device shall be deemed to be adulterated:

  (1)(A) If it consists in whole or in part of any filthy, putrid, or decomposed substance;

  (B) if it has been produced, prepared, packed, or held under unsanitary conditions in which it may have been contaminated with filth or in which it may have been rendered injurious to health;

  (C) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; or

  (D) if it is a drug and it bears or contains, for purposes of coloring only, a coal tar color other than one from a batch certified under the authority of the federal act.

  (2) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium. The determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of the tests or methods of assay, those prescribed under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this subdivision because it differs from the standard of strength, quality, or purity set forth in the compendium, if its difference in strength, quality, or purity from the standard is plainly stated on its label. Whenever a drug is recognized in both the U.S. Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the U.S. Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the U.S. Pharmacopoeia.

  (3) If it is not subject to the provisions of subdivision (2) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

  (4) If it is a drug and any substance has been:

  (A) mixed or packed therewith so as to reduce its quality or strength; or

  (B) substituted wholly or in part therefor. (Added 1959, No. 172, § 14, eff. May 12, 1959; amended 2023, No. 6, § 142, eff. July 1, 2023.)

• § 4064. Misbranded drugs or device

  A drug or device is misbranded:

  (1) If its labeling is false or misleading in any particular.

  (2) If in package form unless it bears a label containing:

  (A) the name and place of business of the manufacturer, packer, or distributor; and

  (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that under this subdivision (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established by rules adopted by the Department.

  (3) If any word, statement, or other information required by or under authority of this chapter to appear on the labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

  (4) If it is for use by humans and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, morphine, opium, paraldehyde, peyote, sulphonmethane, or other recognized narcotic or hypnotic substances or any chemical derivative of those substances, which derivative has been by the Department, after investigation, found to be, and by rules under this chapter, designated as habit forming, unless its label bears the name and quantity or proportion of the substance or derivative and in juxtaposition therewith the statement “warning—may be habit forming.”

  (5) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears:

  (A) the common or usual name of the drug, if such there be; and

  (B) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including whether active or not the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or other synthetic compounds, or any derivative or preparation of any of those substances, contained therein, provided that to the extent that compliance with the requirements of this subdivision (B) is impracticable, exemptions shall be established by rules adopted by the Department.

  (6) Unless its labeling bears:

  (A) adequate directions for use; and

  (B) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, provided that where any requirement of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Department shall adopt rules exempting the drug or device from the requirements.

  (7) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein, provided that the method of packing may be modified with consent of the Commissioner. Whenever a drug is recognized in both the U.S. Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the U.S. Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the U.S. Pharmacopoeia.

  (8) If it has been found by the Department to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Department shall by rule require as necessary for the protection of public health. No such rule shall be established for any drug recognized in an official compendium until the Board informs the appropriate body charged with the revision of the compendium of the need for the packaging or labeling requirements and that body fails within a reasonable time to prescribe the requirements.

  (9)(A) If it is a drug and its container is so made, formed, or filled as to be misleading;

  (B) if it is an imitation of another drug; or

  (C) if it is offered for sale under the name of another drug.

  (10) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

  (11) If it is a drug sold at retail and contains any quantity of aminopyrine, barbituric acid, cinchophen, pituitary, thyroid, or their derivatives; or it is a drug or device sold at retail and its label, as originally packed, directs that it is to be dispensed or sold only on prescription, unless it is dispensed or sold on a written prescription signed by a practitioner who is licensed by law to administer the drug or device and its label, as dispensed, bears the name and place of business of the dispenser or seller, the serial number and date of the prescription, and the name of the licensed practitioner. Those prescriptions shall not be refilled except on the specific authorization of the prescribing practitioner, provided that where any requirement of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Department shall adopt rules exempting the drug or device from the requirement.

  (12) A drug sold on a written prescription signed by a member of the medical, dental, or veterinary profession (except a drug sold in the course of the conduct of a business of selling drugs pursuant to diagnosis by mail) shall be exempt from the requirement of this section if:

  (A) the member of the medical, dental, or veterinary profession is licensed by law to administer the drug or recognized synthetic compounds; and

  (B) the drug bears a label containing the name and place of business of the seller, the serial number and date of the prescription, and the name of the member of the medical, dental, or veterinary profession. (Added 1959, No. 172, § 15, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 112; 2023, No. 6, § 143, eff. July 1, 2023; 2023, No. 53, § 93, eff. June 8, 2023.)

• § 4064a. Misbranded drugs or devices sold by prescription

  (a) Except as provided in subsections (b), (c), and (d) of this section, a drug or device that is sold or offered for sale by prescription, including those transported or mailed into this State for use in this State although purchased elsewhere, is misbranded:

  (1) if its labeling is false or misleading in any particular; or

  (2) unless it is labeled with the following:

  (A) the name of the patient or if the patient is an animal the name of its owner and the species of the animal;

  (B) the expiration date of the drug where the date is required by law or has been determined by the manufacturer, Department, or any agency of the State or U.S. government, if this date is less than one year from date of dispensing;

  (C) the name or place of business of the dispenser;

  (D) the serial number and the date the prescription was filled;

  (E) directions for use as may be stated in the prescription and the name of the medical, dental, osteopathic, or veterinary professional prescribing the drug or device;

  (F) the name and strength of the drug or its generic equivalent, if any, according to the latest official U.S. Pharmacopoeia, latest official Homeopathic Pharmacopoeia of the United States, or latest official national formulary, or any supplement to any of them;

  (G) the name of the drug shall be the same as written by the prescriber, unless the prescription has been filled with a generic equivalent approved by the prescriber and the purchaser has been informed of the change.

  (b) The labeling requirements of subdivisions (a)(2)(F) and (G) of this section shall not apply to a drug or device if the prescribing physician explicitly requests for medical reasons that such information shall be omitted.

  (c) The labeling requirements of subsection (a) of this section shall not apply to a drug or device administered under the supervision of a licensed physician to patients within a hospital or nursing home.

  (d) Nothing in this section shall be construed to limit the ability of a licensed physician to give, administer, or dispense any drug or device to a patient under his or her care. (Added 1971, No. 182 (Adj. Sess.), eff. July 1, 1972; amended 2007, No. 163 (Adj. Sess.), § 4; 2023, No. 6, § 144, eff. July 1, 2023; 2023, No. 53, § 94, eff. June 8, 2023.)

• § 4065. New drugs; sale regulations

  (a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless:

  (1) an application with respect thereto has become effective under section 505 of the federal act; or

  (2) when not subject to the federal act, unless the drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof and before selling or offering the drug for sale, there has been filed with the Department an application setting forth:

  (i) full reports of investigations that have been made to show whether or not the drug is safe for use;

  (ii) a full list of the articles used as components of the drug;

  (iii) a full statement of the composition of the drug;

  (iv) a full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of the drug;

  (v) such samples of the drug and of the articles used as components thereof as the Department may require; and

  (vi) specimens of the labeling proposed to be used for the drug.

  (b) An application provided for in subdivision (a)(2) of this section shall become effective on the 60th day after the filing thereof, except that if the Commissioner finds, after giving the applicant due notice and an opportunity for a hearing, that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Commissioner shall, before the effective date of the application, issue an order refusing to permit the application to become effective.

  (c) This section shall not apply:

  (1) to a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs, provided the drug is plainly labeled “for investigational use only”;

  (2) to a drug sold in this State at any time before the enactment of this chapter or introduced into interstate commerce at any time before the enactment of the federal act; or

  (3) to any drug that is licensed under the Virus, Serum and Toxin Act of July 1, 1902 (U.S.C. 1934 ed. title 42, chap. 4).

  (d) An order refusing to permit an application under this section to become effective may be revoked by the Commissioner. (Added 1959, No. 172, § 16, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 95, eff. June 8, 2023.)

• § 4066. Adulterated cosmetic

  A cosmetic shall be deemed to be adulterated:

  (1) If it bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual. Provided, that this provision shall not apply to coal tar hair dye the label of which bears the following legend conspicuously displayed thereon: “caution—this product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows, to do so may cause blindness,” and the labeling of which bears adequate directions for the preliminary testing. For the purpose of this subdivision and subdivision (5) of this section, the term “hair dye” shall not include eyelash dyes or eyebrow dyes.

  (2) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

  (3) If it has been produced, prepared, packed, or held under unsanitary conditions in which it may have become contaminated with filth, or in which it may have been rendered injurious to health.

  (4) If its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.

  (5) If it is not a hair dye and it bears or contains a coal tar color other than one from a batch that has been certified under authority of the federal act. (Added 1959, No. 172, § 17, eff. May 12, 1959; amended 2023, No. 6, § 145, eff. July 1, 2023.)

• § 4067. Misbranded cosmetic

  A cosmetic shall be deemed to be misbranded:

  (1) if its labeling is false or misleading in any particular;

  (2) if in package form unless it bears a label containing:

  (A) the name and place of business of the manufacturer, packer, or distributor; and

  (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that under this subdivision (B) reasonable variations shall be permitted and exemptions as to small packages shall be established by rules adopted by the Department;

  (3) if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

  (4) if its container is so made, formed, or filled as to be misleading. (Added 1959, No. 172, § 18, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 6, § 146, eff. July 1, 2023; 2023, No. 53, § 96, eff. June 8, 2023.)

• § 4068. Advertising Rules

  (a) An advertisement of a food, drug, device, or cosmetic shall be deemed to be false if it is false or misleading in any particular.

  (b) For the purpose of this chapter, the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright’s disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or venereal disease shall also be deemed to be false, except that no advertisement, not in violation of subsection (a) of this section, shall be deemed to be false under this subsection if it is disseminated only to members of the medical, dental, or veterinary professions, or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of the drugs or devices, provided that whenever the Department determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named in this subsection, the Department shall by rule authorize the advertisement of drugs having curative or therapeutic effect for the disease, subject to such conditions and restrictions as the Department may deem necessary in the interests of public health, provided that this subsection shall not be construed as indicating that self-medication for diseases other than those named in this section is safe or efficacious. (Added 1959, No. 172, § 19, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 6, § 147, eff. July 1, 2023; 2023, No. 53, § 97, eff. June 8, 2023.)

• § 4069. Rules; authority

  (a) The authority to adopt rules for the efficient enforcement of this chapter is hereby vested in the Department. The Department may make the rules adopted under this chapter conform, insofar as practicable, with those promulgated under the federal act.

  (b) [Repealed.]

  (c) Before adopting any rules contemplated by section 4058; subdivision 4060(10); section 4061; subdivisions 4064(4), (6), (7), (8), and (11); or subsection 4068(b) of this title, the Department shall give appropriate notice of the proposal and of the time and place for a hearing. The rule so adopted shall take effect on a date fixed by the Department, which date shall not be earlier than 60 days after its adoption. The rule may be amended or repealed in the same manner as is provided for its adoption, except that in the case of a rule amending or repealing any such rule, the Department, to such extent as it deems necessary in order to prevent undue hardship, may disregard the foregoing provisions regarding notice, hearing, or effective date. (Added 1959, No. 172, § 20, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2015, No. 23, § 113; 2023, No. 53, § 98, eff. June 8, 2023.)

• § 4070. Inspection; examination of samples

  (a) The Department or its duly authorized agent shall have free access at all reasonable hours to any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into commerce, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in commerce, for the purpose:

  (1) of inspecting the factory, warehouse, establishment, or vehicle to determine if any of the provisions of this chapter are being violated; and

  (2) to secure samples or specimens of any food, drug, device, or cosmetic after paying or offering to pay for the sample.

  (b) It shall be the duty of the Department to make or cause to be made examinations of samples secured under the provisions of this section to determine whether any provision of this chapter is being violated. (Added 1959, No. 172, § 21, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2017, No. 113 (Adj. Sess.), § 74; 2023, No. 53, § 99, eff. June 8, 2023.)

• § 4071. Reports

  (a) The Commissioner may cause to be published, from time to time, reports summarizing all judgments, decrees, and court orders that have been rendered under this chapter, including the nature of the charge and the disposition thereof.

  (b) The Commissioner may also cause to be disseminated such information regarding food, drugs, devices, and cosmetics as the Commissioner deems necessary in the interest of public health and the protection of the consumer against fraud. Nothing in this section shall be construed to prohibit the Department from collecting, reporting, and illustrating the results of the investigations of the Department. (Added 1959, No. 172, § 22, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961; 2023, No. 53, § 100, eff. June 8, 2023.)

• Subchapter 002: Menu Labeling

• § 4086. Menus and menu boards

  (a) Restaurants and similar food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items shall disclose on the menu and on the menu board:

  (1) adjacent to the name of each standard menu item the number of calories contained in the item; and

  (2) a succinct statement concerning suggested daily caloric intake.

  (b) This section shall not apply to alcoholic beverages or to grocery stores except for separately owned food facilities to which this section otherwise applies that are located in a grocery store. For purposes of this section, grocery stores include convenience stores.

  (c) If at any time subsection (a) or (b) of this section, or both, are preempted by federal law, then restaurants and similar food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items shall comply with the menu labeling provisions of the applicable federal statutes and regulations.

  (d) A violation of this section shall be deemed a violation of the Consumer Protection Act, 9 V.S.A. chapter 63, provided that no private right of action shall arise from the provisions of this section. The Attorney General has the same authority to make rules, conduct civil investigations, enter into assurances of discontinuance, and bring civil actions as provided under 9 V.S.A. chapter 63, subchapter 1. (Added 2009, No. 128 (Adj. Sess.), § 38b, eff. Jan. 1, 2011; amended 2011, No. 109 (Adj. Sess.), § 3, eff. May 8, 2012; 2011, No. 136 (Adj. Sess.), § 1b, eff. May 18, 2012.)