Sec. 21a-92. (Formerly Sec. 19-212). Definitions.
Sec. 21a-93. (Formerly Sec. 19-213). Prohibited acts.
Sec. 21a-95. (Formerly Sec. 19-215). Penalties.
Sec. 21a-101. (Formerly Sec. 19-221). Adulterated food. Regulations re alcohol-infused confections.
Sec. 21a-104a. Sulfiting agents.
Sec. 21a-106. (Formerly Sec. 19-226). Misbranded drugs and devices.
Sec. 21a-115. (Formerly Sec. 19-234). Regulations and hearings. Exemption.
Sec. 21a-92. (Formerly Sec. 19-212). Definitions. For the purposes of this chapter and sections 21a-65 and 21a-90, the following terms shall have the meanings hereinafter specified:
(1) “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;
(2) (A) “Color additive” means a material that (i) is a dye, pigment or other substance made by a process of synthesis or similar artifice, or extracted, isolated or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral or other source, and (ii) when added or applied to a food, drug or cosmetic, or to the human body or any of its parts, is capable, alone or through reaction with other substance, of imparting color thereto, except that the term “color additive” does not include any material exempted by regulation under the federal act, or that the commissioner, by regulation, determines is used, or intended to be used, solely for a purpose or purposes other than coloring; (B) the term “color” includes black, white and intermediate grays, as well as all other colors; (C) nothing in subparagraph (A) of this subdivision shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical used, or intended to be used, solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil that thereby affects its color, whether before or after harvest;
(3) “Commissioner” means the Commissioner of Consumer Protection;
(4) “Contaminated with filth” applies to any food, drug, device or cosmetic not securely protected from dust or dirt, and as far as may be necessary, by all reasonable means, from all foreign or injurious contaminations;
(5) “Cosmetic” means (A) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any of its parts 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;
(6) “Device”, except when used in subdivision (15) of this section and in subdivision (9) of section 21a-93, subdivision (6) of subsection (a) of section 21a-102, subsection (c) of section 21a-106 and subsection (c) of section 21a-112, means instruments, apparatus and contrivances, including their components, parts and accessories, intended (A) for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals, or (B) to affect the structure or any function of the body of humans or other animals;
(7) “Director” means the director of the agricultural experiment station;
(8) “Drug” means (A) articles recognized in the official United States 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 humans or any other animal; and (D) articles intended for use as a component of any articles specified in this subdivision; but shall not include devices or their components, parts or accessories;
(9) “Federal act” means the federal Food, Drug and Cosmetic Act, as amended, Title 21 USC 301 et seq.: 52 Stat. 1040 et seq.;
(10) “Food” means (A) articles used for food or drink for humans or other animals, (B) chewing gum, (C) infant formula, and (D) articles used for components of any such article;
(11) “Food additive” means any substance the intended use of which results or reasonably may be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food; and including any source of radiation intended for any such use, if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food, to be safe under the conditions of its intended use; except that such term does not include (A) a pesticide chemical in or on a raw agricultural commodity; or (B) a pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity; or (C) a color additive; or (D) any substance used in accordance with a sanction or approval granted prior to June 12, 1963, or the federal Food, Drug and Cosmetic Act, the Poultry Products Inspection Act (21 USC 451 et seq.) or the Meat Inspection Act of March 4, 1907, as amended;
(12) “Immediate container” shall not include package liners;
(13) “Infant formula” means a milk-based or soy-based powder, concentrated liquid or ready-to-feed substitute for human breast milk that is intended for infant consumption and is commercially available;
(14) “Intrastate commerce” means any and all commerce within the state of Connecticut and subject to its jurisdiction, and shall include the operation of any business or service establishment;
(15) “Label” means a display of written, printed or graphic matter upon the immediate container of any article, provided a requirement made by or under authority of this chapter that any information or other word or statement appear on the label shall not be considered to be complied with unless such information or other word or statement also appears on the outside container or wrapper, if any, of the retail package of such article, or is easily legible through the outside container or wrapper;
(16) “Labeling” means all labels and other written, printed or graphic matter (A) upon any article or any of its containers or wrappers, or (B) accompanying such article, provided, 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 or sound, or 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, and provided 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 or dusting powder or for such other use as involves prolonged contact with the body;
(17) “Natural food” means food (A) that has not been treated with preservatives, antibiotics, synthetic additives, artificial flavoring or artificial coloring; and (B) that has not been processed in a manner that makes such food significantly less nutritive; and (C) on and after the Commissioner of Consumer Protection recognizes the occurrence of the events described in subdivisions (1) and (2) of subsection (a) of section 21a-92c, that has not been genetically engineered, as defined in section 21a-92b, provided this subparagraph shall apply only to food that is intended for human consumption. Processing of food by extracting, purifying, heating, fermenting, concentrating, dehydrating, cooling or freezing shall not, of itself, prevent the designation of such food as “natural food”;
(18) “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 and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling, or (B) any drug the composition of which is such that such drug, as a result of investigation to determine its safety and effectiveness 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, except that the provisions of this subsection pertaining to “effectiveness” shall not apply to any drug that (i) was commercially sold or used in the United States on October 9, 1962, (ii) was not a new drug as defined by this subsection prior to the enactment of these provisions, and (iii) was not covered by an effective application under section 21a-110 or under Section 355 of the federal act, when such drug is intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on whichever of the above dates is applicable;
(19) “Official compendium” means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them;
(20) “Organically grown” means produced through organic farming methods, which involve a system of ecological soil management and mechanical or biological methods to control insects, weeds, pathogens and other pests and which rely on crop rotation, crop residues, composted animal manures, legumes, green manures, composted organic waste or mineral-bearing rocks;
(21) “Person” includes any individual, partnership, corporation, limited liability company or association;
(22) “Pesticide chemical” means any substance that, alone, in chemical combination or in formulation with one or more other substances is an “economic poison” within the meaning of the federal Insecticide, Fungicide and Rodenticide Act, 7 USC 135-135k, and that is used in the production, storage or transportation of raw agricultural commodities;
(23) “Raw agricultural commodity” means any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled natural form prior to marketing;
(24) The term “safe” has reference to the health of human or animal;
(25) “Sale” means any and every sale and includes (A) manufacture, processing, packing, canning, bottling or any other production, preparation or putting up; (B) exposure, offer or any other proffer; (C) holding, storing or any other possessing; (D) dispensing, giving, delivering, serving or any other supplying; and (E) applying, administering or any other using.
(1949 Rev., S. 3930; 1959, P.A. 412, S. 38, 42; 1963, P.A. 359, S. 1; 1969, P.A. 593, S. 9; P.A. 73-681, S. 24, 29; P.A. 79-379, S. 1; 79-457, S. 1, 4; P.A. 95-79, S. 75, 189; P.A. 98-73, S. 1, 4; June 30 Sp. Sess. P.A. 03-6, S. 146(c); P.A. 04-189, S. 1; P.A. 13-183, S. 1; P.A. 14-17, S. 1; 14-224, S. 6; P.A. 23-52, S. 8.)
History: 1959 act replaced commissioner of food and drugs with commissioner of consumer protection; 1963 act updated Subsec. (h) to refer to act as amended, changed Subsec. (n) to refer to effectiveness of drugs, adding exceptions to this provision and added Subsecs. (r) through (v); 1969 act redefined “commissioner” to include commissioner of health where chapter applies to practitioner, care-giving institution or juvenile training institution; P.A. 73-681 deleted commissioner of health from definition of “commissioner”; P.A. 79-379 changed alphabetic Subdiv. indicators to numeric indicators and numeric Subpara. indicators to alphabetic indicators, inserted definitions of “color additive”, “food additive”, “pesticide chemical”, “safe” and “raw agricultural commodity” in proper alphabetical order, removing them from end of section, defined “natural food” and “organically grown food” and made minor technical changes; P.A. 79-457 made definitions applicable to Sec. 19-66a (transferred to Sec. 19-209a in 1981); Sec. 19-212 transferred to Sec. 21a-92 in 1983; P.A. 95-79 redefined “person” to include a limited liability company, effective May 31, 1995; P.A. 98-73 amended Subdiv. (19) to revise the definition of “organically grown”, effective July 1, 1998; June 30 Sp. Sess. P.A. 03-6 replaced Commissioner of Consumer Protection with Commissioner of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; P.A. 13-183 added reference to Secs. 21a-92b, 21a-92c and 21a-102, redefined “food” by adding new Subpara. (C) re infant formula in Subdiv. (10), added new Subdiv. (13) defining “infant formula”, redesignated existing Subdivs. (13) to (24) as Subdivs. (14) to (25), redefined “natural food” by adding Subpara. (C) re genetically-engineered food in redesignated Subdiv. (17), replaced “man” with “humans” throughout, and made technical changes; P.A. 14-17 amended Subdiv. (17) by redefining “natural food”, effective May 12, 2014; P.A. 14-224 added reference to Sec. 21a-90 and made technical changes, effective July 1, 2014; P.A. 23-52 made a conforming change in Subdiv. (6), effective June 13, 2023.
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Sec. 21a-93. (Formerly Sec. 19-213). Prohibited acts. The following acts and the causing thereof shall be prohibited: (1) The sale in intrastate commerce of any food, drug, device or cosmetic that is adulterated or misbranded; (2) the adulteration or misbranding of any food, drug, device or cosmetic in intrastate commerce; (3) the receipt in intrastate commerce of any food, drug, device or cosmetic that is adulterated or misbranded, and the sale thereof in such commerce for pay or otherwise; (4) the introduction or delivery for introduction into intrastate commerce of (A) any food in violation of section 21a-103 or (B) any new drug in violation of section 21a-110; (5) the dissemination within this state, in any manner or by any means or through any medium, of any false advertisement; (6) the refusal to permit (A) entry and the taking of a sample or specimen or the making of an investigation as authorized by section 21a-116, or (B) access to or copying of any record as authorized by section 21a-117; (7) the refusal to permit entry or inspection as authorized by section 21a-118; (8) the giving of a guaranty or undertaking in intrastate commerce, referred to in subsection (c) of section 21a-95, that is false; (9) the forging, counterfeiting, simulating or falsely representing, or, without proper authority, using, any mark, stamp, tag, label or other identification device authorized or required by regulations promulgated under the provisions of this chapter or of the federal act; (10) the alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of a food, drug, device or cosmetic, or the doing of any other act with respect to a food, drug, device or cosmetic, or the labeling or advertisement thereof, which results in a violation of this chapter; (11) the using in interstate commerce, in the labeling or advertisement of any drug, of any representation or suggestion that an application with respect to such drug is effective under Section 355 of the federal act or under section 21a-110, or that such drug complies with the provisions of either such section; (12) the violation of any provision of section 21a-108; (13) in the case of a prescription drug distributed or offered for sale in this state, the failure of the manufacturer, packer or distributor thereof to maintain for transmittal, or to transmit, to any practitioner licensed by applicable state law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved by the commissioner or under the federal act. Nothing in this subdivision shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this chapter unless specifically exempted under the federal act, as effective on April 26, 1974; (14) the using by any person to his own advantage, or revealing, other than to the commissioner or his duly authorized agents or to the courts when relevant in any judicial proceeding under this chapter, of any information acquired under authority of this chapter concerning any method, process, substance or any other subject which as a trade secret is entitled to protection; (15) (A) placing or causing to be placed upon any drug or device or upon the container of any drug or device, with intent to defraud, the trademark, trade name or other identifying mark, imprint or device of another or any likeness thereof; or (B) selling, dispensing, disposing of or causing to be sold, dispensed or disposed of or concealing or keeping in possession, control or custody, with intent to sell, dispense or dispose of, any drug, device or any container thereof transported, received or held for transportation in commerce, with knowledge that the trademark, trade name or other identifying mark, imprint or device of another or any likeness thereof has been placed thereon in a manner prohibited by subparagraph (A) of this subdivision; or (C) making, selling, disposing of or causing to be made, sold or disposed of or keeping in possession, control or custody, or concealing, with intent to defraud, any punch, die, plate, stone or other thing designed to print, imprint or reproduce the trademark, trade name or other identifying mark, imprint or device of another or any likeness thereof upon any drug, device or container thereof; (16) failing to demonstrate adherence to applicable provisions of United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time, concerning compounding or preparation of sterile drugs; or (17) failing to demonstrate adherence to applicable provisions of United States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – Nonsterile Preparations, as amended from time to time, concerning compounding or preparation of nonsterile drugs.
(1949 Rev., S. 3931; 1955, S. 2091d; 1963, P.A. 359, S. 2; 1969, P.A. 593, S. 10; P.A. 74-72, S. 1, 3; P.A. 23-52, S. 9.)
History: 1963 act added provision in Subsec. (i) for regulations promulgated under the federal act and added Subsecs. (m) through (o); 1969 act replaced “officers or employees of the department of consumer protection” with “his duly authorized agents” in Subsec. (n); P.A. 74-72 clarified construction of Subsec. (m) re exemption from labeling requirements to allow exemptions if “specifically exempted under the federal act, as effective on April 26, 1974”; Sec. 19-213 transferred to Sec. 21a-93 in 1983; P.A. 23-52 redesignated Subsecs. (a) to (d) as Subdivs. (1) to (4), Subsecs. (d)(1) and (2) as Subdiv. (4)(A) and (B), Subsecs. (e) and (f) as Subdivs. (5) and (6), Subsec. (f)(1) and (2) as Subdiv. (6)(A) and (B), Subsecs. (g) to (o) as Subdivs. (7) to (15) and Subsecs. (o)(1) to (3) as Subdivs. (15)(A) to (C), added Subdivs. (16) and (17) re failure to demonstrate adherence to United States Pharmacopeia Chs. 797 and 795, respectively, and made technical and conforming changes throughout, effective June 13, 2023.
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Sec. 21a-95. (Formerly Sec. 19-215). Penalties. (a) Any person who violates any provision of section 21a-93 shall, on conviction thereof, be imprisoned not more than six months or fined not more than five hundred dollars or both; but, if the violation is committed after a conviction of such person under this subsection has become final, such person shall be imprisoned not more than one year or fined not more than one thousand dollars or both.
(b) Notwithstanding the provisions of subsection (a) of this section, any person who violates any provision of section 21a-93, with intent to defraud or mislead, shall be imprisoned not more than one year or fined not more than one thousand dollars or both.
(c) No person shall be subject to the penalties of subsection (a) of this section for having violated subdivision (1) or (3) of section 21a-93 if he establishes a guaranty or undertaking signed by and containing the name and address of the person residing in this state from whom he received the article in good faith, to the effect that such article is not adulterated or misbranded within the meaning of this chapter. In such guaranty this chapter shall be designated by title.
(d) No publisher, radiobroadcast licensee, advertising agency or agency or medium for the dissemination of advertising, except the manufacturer, packer, distributor or seller of the article to which the advertisement relates, shall be subject to the penalties of subsection (a) of this section by reason of his dissemination of any false advertisement, unless he has refused, on the request of the commissioner, to furnish the name and address of the manufacturer, packer, distributor, seller or advertising agency in the United States, who caused him to disseminate such false advertisement.
(1949 Rev., S. 3933; P.A. 23-52, S. 10.)
History: Sec. 19-215 transferred to Sec. 21a-95 in 1983; P.A. 23-52 amended Subsec. (c) by making conforming changes, effective June 13, 2023.
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Sec. 21a-97. (Formerly Sec. 19-217). Prosecution for violation. Hearing before report of criminal violation. (a) Each state's attorney or assistant state's attorney of the Superior Court to whom the commissioner reports any violation of this chapter shall cause appropriate proceedings to be instituted without delay, and to be prosecuted as prescribed by law.
(b) Before any violation of this chapter, except for any violation of subdivision (12) of section 21a-93, is reported by the commissioner to any such attorney for the institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views to the commissioner, either orally or in writing, with regard to such contemplated proceeding.
(1949 Rev., S. 3935; 1961, P.A. 517, S. 58; P.A. 74-183, S. 228, 291; P.A. 76-436, S. 197, 681; P.A. 80-291; P.A. 23-52, S. 11.)
History: 1961 act substituted prosecuting attorney of circuit court for town or city prosecuting attorney; P.A. 74-183 replaced circuit court with court of common pleas in Subsec. (a), effective December 31, 1974; P.A. 76-436 replaced prosecuting attorney with assistant state's attorney and court of common pleas with superior court and deleted “in the proper courts” referring to institution of proceedings in Subsec. (a), effective July 1, 1978; P.A. 80-291 added exception re violations of Sec. 19-213(l) in Subsec. (b); Sec. 19-217 transferred to Sec. 21a-97 in 1983; P.A. 23-52 made a conforming change in Subsec. (b), effective June 13, 2023.
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Sec. 21a-101. (Formerly Sec. 19-221). Adulterated food. Regulations re alcohol-infused confections. (a) A food shall be deemed to be adulterated:
(1) (A) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but, if the substance is not an added substance, such food shall not be considered adulterated under this clause if the quantity of such substance in such food would not ordinarily render it injurious to health; (B) if it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of section 21a-104; (C) if it consists in whole or in part of any 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 insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered diseased, unwholesome or injurious to health; (E) if it is in whole or in part the product of a diseased animal or of an animal which has died otherwise than by slaughter or which has been fed on the uncooked offal from a slaughterhouse; or (F) if its container is composed in whole or in part of any poisonous or deleterious substance which 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 bears or contains a color additive which is unsafe within the meaning of section 21a-104;
(4) 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 per cent, harmless natural gum or pectin; provided this subdivision shall not apply to any confectionery by reason of its containing less than one-half of one per cent 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, or any alcohol-infused confection subject to regulations adopted under subsection (b) of this section; and
(5) If such food is to be offered for sale at retail as a food product and a retail or wholesale establishment has added to such food any sulfiting agent, including sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite or potassium metabisulfite, separately or in combination, unless such sulfiting agent is an incidental additive, as defined in section 21a-104a.
(b) The commissioner shall approve the sale of alcohol-infused confections containing not more than one-half of one per cent of alcohol by weight and shall adopt regulations, in accordance with the provisions of chapter 54, regarding the manufacture, sale and distribution of such confections.
(1949 Rev., S. 3939; 1963, P.A. 359, S. 3; P.A. 86-322, S. 2; P.A. 21-50, S. 1; P.A. 23-99, S. 22.)
History: 1963 act deleted provision in subsection (c) re adulteration when product contains a coal tar color which is not suitable for use in food according to regulations promulgated under section 346(b) of the federal act, substituting reference to color additive unsafe within meaning of Sec. 19-224; Sec. 19-221 transferred to Sec. 21a-101 in 1983; P.A. 86-322 added Subsec. (e) which provided that food offered at retail which contains a sulfiting agent added by a wholesaler or retail is considered adulterated; P.A. 21-50 amended Subsec. (a) to redesignate existing Subdivs.(1) to (6) as Subparas. (A) to (F) in Subdiv. (1), redesignated existing Subsecs. (b)(1) to (4) as Subparas. (A) to (D) in Subsec. (a)(2), redesignated existing Subsecs. (c) to (e) as Subsecs. (a)(3) to (a)(5), added new Subsec. (b) re approval and regulations re alcohol-infused confections and made technical changes, effective July 1, 2021; P.A. 23-99 amended Subsec. (a)(5) by adding provision re sulfiting agent and making a technical change, effective June 29, 2023.
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Sec. 21a-104a. Sulfiting agents. (a) For the purposes of this section:
(1) “Incidental additive” has the same meaning as provided in 21 CFR 101.100, as amended from time to time;
(2) “Manufacturer” means any person, firm or corporation which (A) produces or grows food, and (B) packages such food for resale or distribution;
(3) “Person” means any individual, partnership, firm, association, limited liability company or corporation; and
(4) “Sulfiting agent” means any sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite or potassium metabisulfite.
(b) No person who sells, offers for sale or distributes food, other than a manufacturer of food, shall add any sulfiting agent, other than an incidental additive, to any food sold, offered for sale or distributed in this state.
(c) Each sulfiting agent that is added to any food or to any ingredient in any food shall comply with the requirements established in 21 CFR 101.100(a)(4), as amended from time to time.
(d) Except as provided in 21 CFR 101.100, as amended from time to time, with respect to incidental additives, any manufacturer who adds a sulfiting agent to any food or to any ingredient in any food, which sulfiting agent is present in the finished food product, shall include such sulfiting agent as an ingredient of the food in the ingredient statement of the label attached to such food product. Such ingredient statement shall indicate the name of the sulfiting agent and the function of such sulfiting agent.
(P.A. 86-322, S. 1; P.A. 95-79, S. 76, 189; P.A. 23-99, S. 23.)
History: P.A. 95-79 amended Subsec. (a) to redefine “person” to include a limited liability company, effective May 31, 1995; P.A. 23-99 amended Subsec. (a) by adding Subdiv. (1) defining “incidental additive”, redesignating existing Subdiv. (3) defining “manufacturer” as Subdiv. (2) and redesignating existing Subdivs. (1) and (2) as Subdivs. (3) and (4), amended Subsec. (b) by adding provision re incidental additive, deleted former Subsec. (c) re bulk display of unpackaged food containing sulfiting agent, added new Subsec. (c) re compliance with 12 CFR 101.100(a)(4), as amended from time to time, amended Subsec. (d) by adding provision re incidental additives, and made technical and conforming changes in Subsecs. (a) and (d), effective June 29, 2023.
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Sec. 21a-106. (Formerly Sec. 19-226). Misbranded drugs and devices. A drug or device shall be deemed to be misbranded:
(a) If its labeling is false or misleading in any particular. Any statement on the label or labeling either directly or indirectly implying that the product is recommended or endorsed by any agency of the federal or state government shall be considered misleading, unless the agency concerned has approved the statement prior to its use, or unless such statement is authorized by Section 357(c) of the federal act;
(b) If in package form, unless it bears a label containing (1) the name and place of business of the manufacturer, packer or distributor, except that the label of a prescription drug packaged after October 1, 1976, shall contain the name and place of business of the manufacturer of the final dosage form of the drug and, if different, the name and place of business of the packer or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count, provided reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations promulgated by the commissioner and director, acting jointly, or by regulations issued under the federal act;
(c) If any information or other word or statement, 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;
(d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote or sulphonmethane, or any chemical derivative of any such substance, which derivative has been designated as habit-forming by regulations promulgated under Section 352(d) of the federal act; unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning–may be habit-forming”;
(e) (1) If it is a drug, unless (A) its label bears, to the exclusion of any other nonproprietary name, except the applicable systematic chemical name or the chemical formula, (i) the established name, as defined in subdivision (2) of this subsection, of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided the requirement for stating the quantity of the active ingredients, other than those specifically named in this paragraph, shall apply only to prescription drugs packaged prior to July 1, 1980, and provided further, the requirement for stating the quantity or proportion of the active ingredients, other than those specifically named in this paragraph, shall apply to all drugs packaged on or after July 1, 1980, except nonprescription drugs which are also cosmetics; and (B) if it is a prescription drug, unless the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient. To the extent that compliance with the requirements of clause (A) (ii) or clause (B) is impracticable, exemptions shall be established by regulations promulgated by the commissioner and director, acting jointly, or by regulations issued under the federal act. (2) As used in this subsection (e), the term, “established name”, with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to Section 358 of the federal act, or (B), if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) applies, then the common or usual name, if any, of such ingredient. Where clause (B) applies to an article recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply;
(f) Unless its labeling bears (1) adequate directions for use and (2) 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, when any requirement of subdivision (1) of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the commissioner and director, acting jointly, shall promulgate regulations exempting such drug or device from such requirement; provided further, articles exempted under regulations issued under Section 352(f) of the federal act shall also be exempt from the requirements of this subsection;
(g) 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 the method of packing may be modified with the consent of the commissioner and director, acting jointly, and provided 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; provided further, in the event of inconsistency between the requirements of this subsection and those of subsection (e) as to the name by which the drug or its ingredients shall be designated, the requirements of subsection (e) shall prevail;
(h) If it has been found by the commissioner 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 commissioner and director, acting jointly, by regulations, require as necessary for the protection of public health; provided no such regulations shall be established for any drug recognized in an official compendium until the commissioner has informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body has failed within a reasonable time to prescribe such requirements;
(i) (1) If it is a drug and its container is so made, formed or filled as to be misleading or (2) if it is an imitation of another drug or (3) if it is offered for sale under the name of another drug;
(j) 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;
(k) If it is a legend drug, as defined in section 20-571, that is not administered, dispensed, prescribed or otherwise possessed or distributed in accordance with federal and state laws and regulations;
(l) If it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements contained in regulations issued under the federal act;
(m) In the case of any prescription drug distributed or offered for sale in any state, unless the manufacturer, packer or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer or distributor with respect to that drug a true statement of (1) the established name, as defined in subsection (e) (2) of this section, printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under subsection (e) of this section, and (3) such other information in brief summary relating to side effects, contraindications and effectiveness as required in regulations issued under the federal act unless it is a drug which has been exempted from the labeling provisions of the federal act, as effective on April 26, 1974, or is permitted to be sold without a prescription under the federal act, as effective on said date;
(n) If it is a drug and was manufactured, prepared, propagated, compounded or processed in an establishment in this state not duly registered under section 21a-70;
(o) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin or any other antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to Section 357 of the federal act, and (2) such certificate or release is in effect with respect to such drug; provided that this subsection shall not apply to any drug or class of drugs exempted by regulations promulgated under Section 357 (c) or (d) of the federal act. For the purpose of this subsection, “antibiotic drug” means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution, and the chemically synthesized equivalent of any such substance.
(1949 Rev., S. 3944; 1951, S. 2095d; 1953, S. 2096d; 1957, P.A. 104; 1963, P.A. 359, S. 6; P.A. 74-72, S. 2, 3; P.A. 76-129; P.A. 79-116, S. 1; P.A. 91-164, S. 2; P.A. 95-264, S. 55; P.A. 00-182, S. 2; P.A. 21-192, S. 7; P.A. 23-19, S. 11.)
History: 1963 act, in Subsecs. (a) and (b), added references to statement authorized by section 357(c) of federal act; in Subsec. (e), changed technical language, added references to antipyrine and thyroid and proviso in Subdiv. (1)(A)(ii), deleted provision for exemptions to be established by regulations promulgated by commissioner and director and added Subdivs. (1)(B) and (2); in Subsec. (f), added proviso re articles exempt under federal regulations; in Subsec. (g) added that Subsec. (e) shall prevail in case of inconsistency and added Subsecs. (l) through (o); P.A. 74-72 exempted from consideration as misbranded, drugs “exempted from the labeling provisions of the federal act … or permitted to be sold without a prescription under the federal act, as effective on April 26, 1974” in Subsec. (m); P.A. 76-129 added exception re prescription drugs and deleted reference to Subdiv. (2) in Subsec. (b); P.A. 79-116 amended proviso in Subsec. (e)(1) to require statement of active ingredients only for prescription drugs “packaged before July 1, 1980” and to require statement of quantity or proportion of active ingredients for all drugs packaged after that date except for nonprescription drugs which are also cosmetics; Sec. 19-226 transferred to Sec. 21a-106 in 1983; P.A. 91-164 amended Subsec. (k) to include reference to Sec. 20-184d; P.A. 95-264 amended Subsec. (k) to include electronic transmission as a possible means of prescription and deleted provisions re refills of prescriptions for substances covered by the subsection; P.A. 00-182 replaced language in Subsec. (k) re a drug sold at retail containing certain substances with language re a legend drug; P.A. 21-192 amended Subsec. (k) by substituting reference to Sec. 20-571(16) for reference to Sec. 20-571(14), effective July 13, 2021; P.A. 23-19 made a conforming change in Subsec. (k), effective July 1, 2023.
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Sec. 21a-115. (Formerly Sec. 19-234). Regulations and hearings. Exemption. (a) The authority to promulgate regulations for the efficient enforcement of this chapter is vested in the commissioner and director, acting jointly. The provisions of such regulations shall not prohibit the sale of food at a noncommercial function such as an educational, religious, political or charitable organization's bake sale or potluck supper provided the seller maintains such food under the temperature, pH level and water activity level conditions which will inhibit the rapid and progressive growth of infectious or toxigenic microorganisms. For the purposes of this section, a “noncommercial function” means a function where food is sold by a person not regularly engaged in the business of selling such food.
(b) The purpose of this chapter being to promote uniformity of state legislation with the federal act, the commissioner and director, acting jointly, are authorized (1) to adopt, so far as applicable, the regulations from time to time promulgated under the federal act, (2) to make the regulations promulgated under this chapter conform, so far as practicable, with those promulgated under the federal act and (3) to adopt regulations banning the sale or introduction into intrastate commerce of any adulterated food, drug, device or cosmetic, which adversely affects the health or safety of the public.
(c) Hearings authorized or required by this chapter shall be conducted by the commissioner and director, acting jointly, or their authorized representative designated for the purpose.
(d) The commissioner and director, acting jointly, shall hold a public hearing upon a proposal to promulgate any new or amended regulation under this chapter, which requires or prohibits any practice in intrastate commerce; except in the case of a proposal to adopt an applicable regulation promulgated under the federal act. The commissioner shall give appropriate notice of such hearing. The notice shall state the time and place of the hearing to be held not fewer than ten days after the date of such notice, except in the case of an emergency found by the commissioner. No regulation promulgated under this chapter, by order issued after such hearing, shall take effect prior to the thirtieth day after the date of such order, except in the case of an emergency found by the commissioner.
(e) In the promulgation of regulations under the provisions of this section applicable to prescribing practitioners, care-giving institutions, and correctional and juvenile training institutions, as defined in section 20-571, the Commissioner of Consumer Protection shall act in place of the director. Existing regulations shall continue in effect unless superseded by action of said commissioner pursuant to this subsection.
(1949 Rev., S. 3951; 1969, P.A. 593, S. 11; P.A. 73-681, S. 25, 29; P.A. 74-338, S. 20, 94; P.A. 86-322, S. 3; P.A. 95-44, S. 1; 95-264, S. 56; June 30 Sp. Sess. P.A. 03-6, S. 146(c); P.A. 04-189, S. 1; P.A. 21-192, S. 8; P.A. 23-19, S. 12.)
History: 1969 act added Subsec. (e) re regulation power of commissioner of health re practitioners, care-giving institutions and correctional and juvenile training institutions; P.A. 73-681 replaced commissioner of health with commissioner of consumer protection in Subsec. (e); P.A. 74-338 replaced “commissioners” with “commissioner” in Subsec. (e); Sec. 19-234 transferred to Sec. 21a-115 in 1983; P.A. 86-322 added Subsec. (b)(3) authorizing adoption of regulations banning the sale or introduction into intrastate commerce of adulterated foods, drugs, etc.; P.A. 95-44 prohibited the regulations from prohibiting the sale of food at noncommercial functions and defined “noncommercial function” in Subsec. (a); P.A. 95-264 made technical change in Subsec. (e); June 30 Sp. Sess. P.A. 03-6 replaced Commissioner of Consumer Protection with Commissioner of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; P.A. 21-192 amended Subsec. (e) by substituting reference to Sec. 20-571(7) for reference to Sec. 20-571(6), effective July 13, 2021; P.A. 23-19 made a conforming change in Subsec. (e), effective July 1, 2023.
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