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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(2) [Repealed.]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; and
(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; 2023, No. 85 (Adj. Sess.), § 48, eff. July 1, 2024.)
§ 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. 6, § 139, eff. July 1, 2023; 2023, No. 53, § 86, eff. June 8, 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.)