(a) No person shall manufacture, produce, pack, possess, sell, offer for sale, deliver or give away any food, drug or cosmetic which is adulterated or misbranded. A food, drug or cosmetic in the possession of, held, kept or offered for sale by any person shall, prima facie, be presumed to be held, kept or offered for sale for human consumption or use.
(b) No person shall adulterate or misbrand a food, drug or cosmetic.
(c) Food deemed adulterated. A food shall be deemed adulterated if the Department has determined the food to be adulterated or as set forth in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342) or the New York State Agriculture and Markets Law (§ 200) under circumstances including, but not limited to, any one or more of the following:
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health.
(2) If it bears or contains any added poisonous or added deleterious substance that is unsafe within the meaning of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 346), or as determined by the Department, unless such added substance is a pesticide chemical residue in or on a raw agricultural commodity, or if it is a processed food, a food additive, or a color additive.
(3) If it is a raw agricultural commodity and bears or contains a pesticide chemical residue, it will be considered adulterated if it is unsafe within the meaning in the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 346a).
(4) If the food is, bears or contains any food additive, it will be considered adulterated if it is unsafe within the meaning of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 348).
(5) If it consists in whole or in part of any diseased, contaminated, filthy, putrid or decomposed substance, or if it is otherwise unfit for consumption as food.
(6) 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 injurious to health.
(7) 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 fed upon uncooked offal.
(8) If its container is composed in whole or in part of any poisonous or deleterious substance that may render the contents injurious to health.
(9) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 348) or the New York State Agriculture and Markets Law (§§ 199-a or 199-b).
(d) Food deemed misbranded. A food shall be deemed misbranded in accordance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 343) or the New York State Agriculture and Markets Law (§ 201) under circumstances including, but not limited to, any of the following:
(1) If its labeling is false or misleading in any particular.
(2) If it is offered for sale under the name of another article.
(3) If it is an imitation of another food, unless its label bears the word "imitation" and immediately thereafter the name of the food imitated in type of uniform size and equal prominence, followed by a statement showing the constituents thereof.
(4) If its container is so made, formed, colored or filled as to be misleading.
(5) If in package form, unless it bears a label containing the name and place of business of the manufacturer, packer, or distributor.
(6) If any word, statement or other information required by or under authority of this Code 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, unless it conforms to such definition and standard, and its label bears the name of the food specified in the definition and standard, and, in so far as may be required, the common names of optional ingredients present in such food.
(8) 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 Commissioner determines to be and prescribes as necessary in order to inform purchasers fully as to its value for such uses.
(9) If a food is not a raw agricultural commodity and it is or it contains an ingredient that bears or contains a major food allergen, unless labeled pursuant to the standards as set forth in the Federal Food, Drug, and Cosmetic Act.
(10) If it is in package form and contains two or more discrete components and does not bear a label containing the contents.
(11) If it purports or is represented to be for special dietary uses, the label of which does not bear such information concerning its vitamin, mineral and other dietary properties as is necessary in order to inform purchasers fully as to its value for such uses.
(12) If it is otherwise mislabeled in a manner that obscures or fails to declare its source, contents, or purpose.
(13) If it is in a package that does not bear a label containing the name and place of business of the manufacturer, packer or distributor.
(e) Drug deemed adulterated. A drug shall be deemed to be adulterated if the Department has determined the drug to be adulterated or as set forth in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 351) or the New York State Education Law (§ 6815) under circumstances including but not limited to, any of the following:
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to users when used in the dosage, or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof or under such conditions of use as are customary or usual.
(2) If it bears or contains any added poisonous or added deleterious substance.
(3) If it consists in whole or in part of any filthy, putrid or decomposed substance.
(4) If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or rendered injurious to health.
(5) 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.
(6) 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 that has been certified pursuant to Article 137 of the New York Education Law or the regulations promulgated thereunder.
(7) 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 such compendium. 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 such compendium if such difference is plainly stated on the label. When 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.
(8) If it is not subject to the provisions of paragraph (5) of this subdivision and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
(9) If it is a drug and any substance has been mixed or packed therewith so as to reduce its quality or strength or substituted wholly or in part therefore.
(10) If it is sold under or by a name not recognized in or according to a formula not given in the United States pharmacopoeia or the national formulary but that is found in some other standard work on pharmacology recognized by the board, and it differs in strength, quality or purity from the strength, quality or purity required, or the formula prescribed in, the standard work.
(f) Drug deemed misbranded. A drug shall be deemed misbranded as set forth in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 352) or the State Education Law (§ 6815) under circumstances including, but not limited to, any of the following:
(1) If its labeling is false or misleading in any particular.
(2) If in package form, unless it bears a label containing the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.
(3) If any word, statement, or other information required by or under authority of this article 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.
(g) Cosmetic deemed adulterated. A cosmetic shall be deemed adulterated if the Department has determined the cosmetic to be adulterated or as set forth in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 361) or State Education Law (§ 6818) under circumstances including, but not limited to, any of the following:
(1) If it bears or contains any poisonous or deleterious substance, including lead, that may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.
(A) Kohl, kajal, al-Kahal, surma, tiro, tozali, and kwalli, and other cosmetic color additives (as defined in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 201(t)) containing lead that have not been approved by the U.S. Food and Drug Administration for sale in the United States are per se adulterated substances.
(B) Litargirio, as defined in Paragraph 2 of Subdivision a of § 17-189 of the Administrative Code, and any powder containing lead intended for sale for personal use, including, but not limited to, use as an antiperspirant, deodorant, foot fungicide or as a treatment for burns and wounds, are per se adulterated substances.
(C) Any cosmetic product that, pursuant to 21 U.S.C. § 740.1, has been authorized by the U.S. Food and Drug Administration to bear a label warning of the hazards associated with use of the product is not considered adulterated for purposes of this Article.
(2) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(3) If it has been prepared, packed, or held under insanitary 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.
(h) Cosmetic deemed misbranded. A cosmetic shall be deemed misbranded as set forth in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 362) or the New York State Education Law (§ 6818) under circumstances including, but not limited to, any of the following:
(1) If its labeling is false or misleading in any particular.
(2) If in package form, unless it bears a label containing the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the or numerical count, reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations.
(3) If any word, statement, or other information required by or under authority of this article 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 or if it bears a copy, counterfeit, or colorable imitation of a trademark, label, or identifying name or design of another cosmetic.
(Amended City Record 6/19/2019, eff. 7/19/2019)