Source: https://legislature.vermont.gov/statutes/fullchapter/18/082
Timestamp: 2019-09-17 10:15:58
Document Index: 642368621

Matched Legal Cases: ['§ 301', '§ 2', '§ 27', '§ 107', '§ 71', '§ 5', '§ 27', '§ 4056', '§ 7', '§ 27', '§ 16', '§ 4057', '§ 8', '§ 27', '§ 4058', '§ 9', '§ 27', '§ 109', '§ 4060', '§ 11', '§ 27', '§ 73', '§ 4062', '§ 13', '§ 27', '§ 111', '§ 4063', '§ 14', '§ 4064', '§ 15', '§ 27', '§ 112', '§ 4064', '§ 4', '§ 4066', '§ 17', '§ 4067', '§ 18', '§ 27', '§ 19', '§ 27', '§ 4069', '§ 20', '§ 27', '§ 113', '§ 4070', '§ 21', '§ 27', '§ 74', '§ 4071', '§ 22', '§ 27']

Chapter 082: LABELING OF FOODS, DRUGS, COSMETICS, AND HAZARDOUS SUBSTANCES
Subchapter 001: LABELING FOR MARKETING AND SALE
(1) The term "Department" means the Vermont Department of Health.
(2) The term "Board" means the State Board of Health.
(3) The term "person" includes an individual, partnership, corporation, and association.
(4) The term "food" means:
(5) The term "drug" means:
(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 which:
(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 which 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 hundred 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 which 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, which 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 which 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 regulations issued by the Board.
(14) The term "radioactive" shall apply to any substance which 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, which fails to bear a label:
(A) Which 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 which 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 which 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 Board shall, by regulations, provide for minimum information which 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 Board 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 which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual.
(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 which 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 which 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.)
(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 him or her of such false advertisement, unless he or she has refused, on the request of the Board, to furnish the Board the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in the State of Vermont, who causes him or her to disseminate such advertisement. (Added 1959, No. 172, § 5, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961.)
§ 4056. Proceedings
(a) Each State's Attorney to whom the Board 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 his or her views before the Board or its 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.)
§ 4057. Construction
Nothing in this chapter shall require the Board to report for the institution of proceedings under this chapter, minor violations of this chapter, whenever the Board 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.)
§ 4058. Rules; standards
Whenever in the judgment of the Board such action will promote honesty and fair dealing in the interest of consumers, the Board 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 Board shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which 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.)
§ 4060. Misbranded 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.
(5) If in package form, unless it bears a label containing:
(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 Board.
(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:
(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.
(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:
(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 Board. 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 Board.
(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 Board 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 Board.
(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.)
§ 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 Board shall adopt rules limiting the quantity therein or thereon to such extent as the Board 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 Board 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.)
§ 4063. Adulterated drug or device defined
(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 whereby it may have been contaminated with filth, or whereby 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 which 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 therefor 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 United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States 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 United States 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.)
§ 4064. Misbranded drugs or device
A drug or device is misbranded:
(2) If in package form unless it bears a label containing:
(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 Board.
(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, marijuana, 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 Board, 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 Board.
(6) Unless its labeling bears:
(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 Board 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 Board. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States 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 United States Pharmacopoeia.
(8) If it has been found by the Board 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 Board 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;
(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 Board 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.)
§ 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 which 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, Board, 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 United States 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.)
§ 4066. Adulterated cosmetic
(1) If it bears or contains any poisonous or deleterious substance which 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.
(3) If it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby 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 which 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 which has been certified under authority of the federal act. (Added 1959, No. 172, § 17, eff. May 12, 1959.)
§ 4067. Misbranded cosmetic
(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 regulations prescribed by the Board;
(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.)
(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 Board 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 Board shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for the disease, subject to such conditions and restrictions as the Board 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 herein is safe or efficacious. (Added 1959, No. 172, § 19, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961.)
§ 4069. Rules; authority
(a) The authority to adopt rules for the efficient enforcement of this chapter is hereby vested in the Board. The Board may make the rules adopted under this chapter conform, insofar as practicable, with those promulgated under the federal act.
(b) Hearings authorized or required by this chapter shall be conducted by the Board or such officer, agent, or employee as the Board may designate for the purpose.
(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 Board 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 Board, 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 Board, 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.)
§ 4070. Inspection; examination of samples
(a) The Board 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 Board 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.)
§ 4071. Reports
(a) The Board may cause to be published, from time to time, reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof.
(b) The Board may also cause to be disseminated such information regarding food, drugs, devices, and cosmetics as the Board 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 Board from collecting, reporting, and illustrating the results of the investigations of the Board. (Added 1959, No. 172, § 22, eff. May 12, 1959; amended 1959, No. 329 (Adj. Sess.), § 27, eff. March 1, 1961.)
Subchapter 002: MENU LABELING