Sec. 102. Amendments to the Federal Food, Drug, and Cosmetic Act
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Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) is amended— in paragraph (g)(1)(C), by striking (other than food) and inserting (other than food or cannabinoid products) ; in paragraph (ff)(1), by striking (other than tobacco) and inserting (other than a tobacco product or a cannabinoid product) ; in paragraph (rr)(4), by inserting cannabinoid product, after medical device ; and by adding at the end the following: The term cannabis means— all parts of the plant Cannabis sativa L., whether growing or not; the seeds of such plant; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin, or other constituent element derived from such plant.
The term cannabis does not include— any cannabis plant actively under cultivation that is being cultivated in accordance with the requirements of subtitle G of the Agricultural Marketing Act of 1946; a cannabinoid product; or the mature stalks of the plant Cannabis sativa L., fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, cake, or the sterilized seed of such plant that is incapable of germination.
The term cannabinoid means any of the following: Any chemical in any plant of the genus Cannabis that is unique in nature to such plant, including any of the following chemicals: Tetrahydrocannabinol. Cannabinol. Cannabidiol. Cannabigerol. Cannabichromene. Tetrahydrocannabivarin. Cannabivarin. Cannabidivarin. Cannabielsion. Cannabicyclol. Cannabitriol. Cannabicitran. Any isomer of a chemical described in clause (A), and any acids, acetates, salts, esters, ethers, and derivatives thereof.
Any chemical, regardless of origin or method of production, that is equivalent in chemical structure to a chemical referred to in clause (A), or has both a similar terpenophenolic chemical structure and pharmacological effect to a chemical referred to in clause (A). Any chemical derived from a plant of the genus Cannabis that is a CB–1 or CB–2 receptor agonist or partial agonist. Any chemical that the Secretary has, by order, deemed to be a cannabinoid. The term cannabinoid product means any article or product, including its components or parts, that— contains or purports to contain any quantity of 1 or more cannabinoids that are derived from hemp (as defined in section 297A of the Agricultural Marketing Act of 1946); and is intended for use in, through any route of administration, or to be applied to, the body of humans or other animals.
The term cannabinoid product does not include— a drug that is subject to the requirements of chapter V or section 351 of the Public Health Service Act; a device that is subject to the requirements of chapter V; any cannabis plant actively under cultivation that is being cultivated in accordance with the requirements of subtitle G of the Agricultural Marketing Act of 1946; or a virus, serum, toxin, or analogous product subject to the requirements of the eighth paragraph of the matter under the heading in the Act of March 4, 1913 (commonly known as the BUREAU OF ANIMAL INDUSTRY Virus-Serum-Toxin Act ).
With respect to cannabis or a cannabinoid product, the term manufacture does not include the planting, cultivation, growing, or harvesting of cannabis. With respect to a cannabinoid product, the term serious adverse effect means that use of the product— results in— death; a life-threatening adverse experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; or other serious medical event; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in clause (A).
The term intended for human consumption , with respect to a cannabinoid product, means a cannabinoid product intended for ingestion or inhalation by a human. The term tetrahydrocannabinol means— the chemical substance found in the Cannabis sativa L. plant, including the delta-6a, delta-7, delta-8, delta-9, delta-10a, and delta-10 forms, whether naturally occurring in the Cannabis sativa L. plant or synthetically or semi-synthetically derived; all isomers of tetrahydrocannabinol, and any acids, acetates, metabolites (including 11-hydroxy-THC, 3-hydroxy-THC, and 7-hydroxy-THC and their isomers), salts, esters, ethers, and derivatives thereof, including its precursor form, tetrahydrocannabinolic acid; tetrahydrocannabivarins, including delta-8 tetrahydrocannabivarin, and exo-tetrahydrocannabinol; hydrogenated forms of tetrahydrocannabinol including hexahydrocannabinol, hexahydrocannabiphorol, and hexahydrocannabihexol; analogues of tetrahydrocannabinols with an alkyl chain of four or more carbon atoms, including tetrahydrocannabiphorols, tetrahydrocannabiocytls, tetrahydrocannabihexols, or tetrahydrocannabutols; and any combination of the chemical substances described in subparagraphs
(1)through
(5)whether naturally or artificially derived or synthetically or semi-synthetically produced. The term artificially or synthetically derived cannabinoid means a cannabinoid or a cannabinoid-like compound that is produced using chemical synthesis, chemical modification, or chemical conversion, including by using in-vitro biosynthesis or other bioconversion. The term artificially or synthetically derived cannabinoid does not include— a cannabinoid or a cannabinoid-like compound produced through the decarboxylation of naturally occurring cannabinoids from their acidic forms; a cannabinoid product or input that undergoes the removal of solvents, catalysts, or other unwanted materials from the cannabinoid product or input; or a semi-synthetic cannabinoid. For purposes of subparagraph (2)(C), the term semi-synthetic cannabinoid means a substance that is created by a single chemical reaction that converts one cannabinoid extracted from a cannabis plant directly into a different cannabinoid that is found in more than trace amounts in a cannabis plant. For purposes of subparagraph (2)(C), the term semi-synthetic cannabinoid includes a cannabinoid that is produced by the conversion of cannabidiol, including cannabinol and delta-8 tetrahydrocannabinol. For purposes of subparagraph (2)(C), the term semi-synthetic cannabinoid does not include a cannabinoid that is produced through the decarboxylation of naturally occurring acidic forms of cannabinoids into the corresponding neutral cannabinoid through the use of heat or light, without the use of chemical reagents or catalysts, and that results in no other chemical change. . Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended— by inserting cannabinoid product, after tobacco product, each place it appears in paragraphs
(g)and (h); in paragraph (j), by striking or 920(b) and inserting 920(b), or 1103 ; in paragraph (p)— by striking 510 or 905 and inserting 510, 905, or 1103 ; by striking or 905(j) and inserting 905(j), or 1103(g) ; and by striking or 905(i)(3) and inserting , 905(i)(3), or 1103(g)(2) ; in paragraph (q)(2) by inserting , cannabinoid product, after device ; in paragraph (r), by inserting cannabinoid product, after device, each place it appears; and by adding at the end the following: The sale or distribution of a cannabinoid product intended for human consumption and that contains detectable levels of any tetrahydrocannabinol to any person younger than 21 years of age. The sale or distribution of an article that is a cannabinoid product and that contains alcohol, tobacco, nicotine, or another substance with effects that could interact with cannabinoids or enhance or alter the effects of cannabinoids, as determined by the Secretary through rulemaking. The failure of a manufacturer or distributor to notify the Attorney General of its knowledge of cannabinoid products used in illicit trade. The introduction or delivery for introduction into commerce of any cannabinoid product that is adulterated or misbranded. The introduction or delivery for introduction into interstate commerce of an article intended for ingestion in tablet, capsule, powder, softgel, gelcap, liquid, or other form, which is not represented as a conventional food and not represented for use as a sole item of a meal or of the diet if it— contains any synthetic ingredient with a molecular structure that does not occur in nature; and does not meet the definition of a dietary supplement in section 201(ff), except that this subsection does not apply to any article introduced or delivered for introduction into interstate commerce in compliance with chapter V, VI, or IX or with section 351 of the Public Health Service Act. The adulteration or misbranding of any cannabinoid product in commerce. The receipt in commerce of any cannabinoid product that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise. The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a cannabinoid product, if such act is done while such article is held for sale (whether or not the first sale) after shipment in commerce and results in such article being adulterated or misbranded. The sale or distribution of a cannabinoid product intended for human consumption that contains multiple servings, unless the contents of such cannabinoid product are readily divisible into portions equivalent to one serving. The sale or distribution of a cannabinoid product intended for human consumption that is in liquid form, unless such cannabinoid product— contains not more than one serving; or if the serving size is less than 1 fluid ounce, includes a convenient device for measuring servings, such as a dropper or measuring cup, unless it is a food. . Section 303(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(f) ) is amended— in paragraph (5)— in subparagraph (A)— in the first sentence, by striking or
(9)and inserting (9), or
(11); and by inserting or no-cannabinoid-product-sale order after no-tobacco-sale order each place it appears; in subparagraph (B)— by inserting or no-cannabinoid-product-sale order after no-tobacco-sale order each place it appears; and in the second sentence, by inserting or cannabinoid products, as applicable, after tobacco products ; in subparagraph (C), in the first sentence, by striking or
(9)and inserting (9), or
(11); and in subparagraph
(D)by inserting or no-cannabinoid-product-sale order after no-tobacco-sale order ; in paragraph (6), by inserting or no-cannabinoid- product-sale order after no-tobacco-sale order each place it appears; and by adding at the end the following: Any person who violates a requirement of this Act that relates to cannabinoid products shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $15,000,000 for all such violations adjudicated in a single proceeding. Any person who knowingly violates a requirement of this Act that relates to cannabinoid products shall be subject to a civil monetary penalty of— not to exceed $250,000 per violation, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding; or in the case of a violation that continues after the Secretary provides written notice of the violation to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $10,000,000 for any 30-day period, and not to exceed $20,000,000 for all such violations adjudicated in a single proceeding. If the Secretary finds that a person has committed repeated violations of a requirement of this Act that relates to cannabinoid products at a particular retail or online outlet, or association of retail or online outlets, then the Secretary may impose a no-cannabinoid-product-sale order on that person prohibiting the sale of cannabinoid products in that outlet. A no-cannabinoid-product-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-cannabinoid-product-sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, including, at a retailer’s request, a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available. . Section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 ) is amended— in subsection (a)— in paragraph (1), by inserting cannabinoid product, after drug, ; and in paragraph (2)— by striking and
(H)Any punch and inserting
(H)Any punch ; and by inserting before the period at the end the following: , and
(I)Any adulterated or misbranded cannabinoid product ; in subsection (d)(1), by inserting cannabinoid product, after tobacco product, ; and in subsection (g), by striking or tobacco product each place it appears in paragraphs
(1)and (2)(A) and inserting , tobacco product, or cannabinoid product . Section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ) is amended— in subsection (a)— by inserting cannabinoid products, after tobacco products, each place it appears; by striking or tobacco products each place it appears and inserting tobacco products, or cannabinoid products ; and by striking and tobacco products and inserting tobacco products, and cannabinoid products ; and in subsection (b)(1), by inserting cannabinoid product, after tobacco product, . Section 705(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 375(b) ) is amended by inserting cannabinoid products, after tobacco products, . Section 709 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379a ) is amended by inserting cannabinoid product, after tobacco product, . Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended— in subsection (a)— by inserting cannabinoid products, after tobacco products, ; by striking or tobacco products each place it appears and inserting , tobacco products, or cannabinoid products ; and by striking or section 905(h) and inserting , 905(h), or 1103 ; and in subsection (e), by striking tobacco product or and inserting tobacco product, cannabinoid product, or .
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Sec. 102
Amendments to the Federal Food, Drug, and Cosmetic Act
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