§ 71.05 Adulteration or Misbranding Prohibited; Possession Deemed for Purpose of Sale.
RCNY § 71.05
(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.
(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.
(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.
(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.
(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.
