Sec. 501. FDA regulation of cannabis
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/bill/117/s/4591/is/section-501A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) is amended by adding at the end the following: Not later than 90 days after the date of enactment of the , the Secretary shall establish within the Food and Drug Administration the Center for Cannabis Products, which shall report to the Commissioner of Food and Drugs in the same manner as the other agency centers within the Food and Drug Administration. The Center shall be responsible for the implementation of this chapter and related matters assigned by the Commissioner.
Cannabis Administration and Opportunity Act A cannabis product shall be deemed to be adulterated if— it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health; it has been manufactured, prepared, processed, packed, or held in insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; it bears or contains any poisonous or deleterious substance that may render it injurious to health; its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; it bears or contains an unsafe color additive that is unsafe within the meaning of section 721(a); or the methods used in, or the facilities or controls used for, its manufacture, preparing, processing, packing, or storage are not in conformity with applicable requirements under section 1105(c).
Provided that an article that is a food (as defined in section 201(f)) and that is also a cannabis product (as defined in section 201(ss)(2)) otherwise complies with all applicable requirements for food under chapter IV and all applicable requirements for cannabis products under this chapter, such article shall not be deemed— adulterated under section 402(a)(2)(C)(i) solely on account of constituents made or derived from cannabis; or a food to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public for purposes of section 301(ll) solely on account of constituents made or derived from cannabis.
A cannabis product shall be deemed to be misbranded— if its labeling or advertising is false or misleading in any particular; unless it bears a label containing— a prominent statement that the product contains cannabis; the name and place of business of its manufacturer, packer, or distributor; an accurate statement of the quantity of its contents in terms of weight, measure, or numerical count; a statement of its form as specified in regulations promulgated pursuant to section 1105(a); the amount of tetrahydrocannabinol in the product, and if the product is packaged and labeled in such a way as to suggest more than one serving, dose, or the equivalent, the amount of tetrahydrocannabinol in such serving, dose, or the equivalent; adequate directions for use, if deemed necessary for the protection of the public health in regulations promulgated pursuant to section 1105(a); adequate directions against use by children, if deemed necessary for the protection of the public health in regulations promulgated pursuant to section 1105(a); and such other information as the Secretary determines, in regulations promulgated pursuant to section 1105(a), to be necessary for the protection of the public health; if its label or labeling bears a statement describing the role of a cannabis constituent intended to affect the structure or any function of the body of humans or other animals, unless— there is substantiation that such statement is truthful and not misleading; and the statement contains, prominently displayed and in boldface type, the following:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. ; if any word, statement, or other information required by or under authority of this Act 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; if it purports to be, or is represented as, a cannabis product which is subject to a cannabis product standard established under section 1106 unless such cannabis product is in all respects in conformity with such standard; if its sale, distribution, or label or labeling is not in conformity with applicable requirements under subsections
(a)and
(b)of section 1105; if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 1104 or if it was not included in a list required by section 1104; or if it is intended for consumption or application by an individual under 21 years of age. On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a cannabis product shall register with the Secretary the name, places of business, and all such establishments of that person. Every person upon first engaging in the manufacture, preparation, compounding, or processing of a cannabis product in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person’s name, place of business, and such establishment. Every person required to register under subsection
(a)or
(b)shall immediately register with the Secretary any additional establishment which that person owns or operates in the United States and in which that person begins the manufacture, preparation, compounding, or processing of a cannabis product. The Secretary may by regulation prescribe a uniform system for the identification of cannabis products and may require that persons who are required to list such cannabis products under subsection
(g)shall list such cannabis products in accordance with such system. The Secretary shall make available for inspection any registration filed under this section. Any establishment within a foreign country engaged in the manufacture, preparation, compounding, or processing of a cannabis product that is imported or offered for import into the United States, shall register under this section and shall include with the registration the name of the United States agent for the establishment. Every person who registers with the Secretary under subsection (a), (b), or
(c)shall, at the time of registration under such subsection, file with the Secretary— a list of all cannabis products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of cannabis products filed by that person with the Secretary under this paragraph or paragraph
(2)before such time of registration; and such other information as the Secretary, in consultation with the Secretary of the Treasury and the Attorney General, may require, by regulation, to carry out the purposes of the Cannabis Administration and Opportunity Act , including the amendments made by such Act, including chapter 56 of subtitle E of the Internal Revenue Code of 1986. The list under subparagraph (A)(i) shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by a copy of all consumer information and other labeling for such cannabis product, a representative sampling of advertisements for such cannabis product, and, upon request by the Secretary, a copy of all advertisements for a particular cannabis product. Each person who registers with the Secretary under this section shall report to the Secretary as follows: Prior to the introduction into commercial distribution of a cannabis product that has not been included in any list previously filed by the registrant, a list containing such cannabis product. A notice of discontinuance of the manufacture, preparation, compounding, or processing for commercial distribution of a cannabis product included in a list filed under subparagraph
(A)or paragraph (1), and the date of such discontinuance. A notice of resumption of the manufacture, preparation, compounding, or processing for commercial distribution of the cannabis product with respect to which a notice of discontinuance was reported under subparagraph (B). A list of each cannabis product included in a notice filed under subparagraph
(C)prior to the resumption of the introduction into commercial distribution of such cannabis product. The Secretary shall publish on the website of the Food and Drug Administration every registration and list filed pursuant to this section and the information accompanying every list not later than 10 days after the applicable date of filing. The Secretary shall establish a format and procedure for appropriate Department of the Treasury officials to access the information received by the Secretary under this subsection, in a prompt and secure manner. Not later than 2 years after the date of enactment of the the Secretary shall propose, and not later than 3 years after such date of enactment the Secretary shall finalize, regulations regarding the promotion, sale, and distribution of cannabis products that occur through means other than a direct, face-to-face exchange between a retailer and a consumer, in order to prevent the sale and distribution of cannabis products to individuals who have not attained the age of 21, including requirements for age verification. Cannabis Administration and Opportunity Act The Secretary shall, by regulation, impose such restrictions on advertising, promotion, and marketing of cannabis products as the Secretary determines necessary and appropriate to prevent the consumption or application of cannabis products by individuals under 21 years of age. Such regulations shall prohibit the advertising, promotion, and marketing of cannabis products, whether directly or indirectly, to individuals under 21 years of age, and any other action that has the primary purpose of initiating or increasing the use of cannabis products in such individuals. In addition to the restrictions under paragraphs
(1)and (2), the Secretary may, by regulation, impose other restrictions on the sale and distribution of cannabis products, including restrictions on the access to, and the advertising and promotion of, the cannabis product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. In issuing regulations under paragraphs (1), (2), and (3), the Secretary shall conduct good faith, meaningful, and timely consultations with Indian Tribes (as defined in section 3 of the Cannabis Administration and Opportunity Act ). The label and labeling of a cannabis product shall bear such appropriate statements of the restrictions required by a regulation under subsection
(a)as the Secretary may in such regulation prescribe. The Secretary shall issue regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preparing, processing, packing, and holding of a cannabis product conform to current good manufacturing practice, including testing for pesticide chemical residues regardless of whether a tolerance for such chemical residues has been established. The Secretary shall, by regulation, adopt cannabis product standards that are appropriate for protection of the public health. A cannabis product standard established under this section shall include provisions— on the ingredients of the cannabis product, including, where appropriate— cannabinoid yields of the product, which may consider or address, as appropriate, different types of cannabinoids and the interaction between the constituents of the product; provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the cannabis product, which may consider, as appropriate, the interaction between constituents and components of the cannabis product; and provisions for the reduction or elimination of harmful constituents or components of the product, including smoke constituents; for the testing of the cannabis product; requiring that the results of testing the cannabis product show that the cannabis product is in conformity with applicable standards; for the measurement of the characteristics of the cannabis product, where appropriate; requiring that the sale and distribution of the cannabis product be restricted but only to the extent that the sale and distribution of a cannabis product may be restricted under a regulation under this Act; where appropriate, requiring the use and prescribing the form and content of labeling for the proper use of the cannabis product and any potential adverse effects of the product; and requiring cannabis products containing foreign-grown cannabis to meet the same standards applicable to cannabis products containing domestically grown cannabis. The Secretary shall provide for periodic evaluation of cannabis product standards established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. If the Secretary finds that there is a reasonable probability that a cannabis product would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the cannabis product) to immediately cease distribution of such cannabis product. The order shall provide the person subject to the order with an opportunity to appear and introduce testimony, to be held not later than 20 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such cannabis product. If, after providing an opportunity to appear and introduce testimony, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order. If, after providing an opportunity to appear and introduce testimony under subsection (a), the Secretary determines that the order should be amended to include a recall of the cannabis product with respect to which the order was issued, the Secretary shall, except as provided in paragraph (2), amend the order to require a recall. The Secretary shall specify a timetable in which the cannabis product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall. An amended order under paragraph (1)— shall not include recall of a cannabis product from individuals; and shall provide for notice to persons subject to the risks associated with the use of such cannabis product. In providing the notice required by subparagraph (B), the Secretary may use the assistance of retailers and other persons who distributed such cannabis product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons pursuant to section 705(b). Every person who is a cannabis product manufacturer or importer of a cannabis product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such cannabis product is not adulterated or misbranded and to otherwise protect public health. Except as provided in paragraph (2), the Secretary shall by regulation require a cannabis product manufacturer or importer of a cannabis product to report promptly to the Secretary any corrective action taken or removal from the market of a cannabis product undertaken by such manufacturer or importer if the removal or correction was undertaken— to reduce a risk to health posed by the cannabis product; or to remedy a violation of this chapter caused by the cannabis product which may present a risk to health. A cannabis product manufacturer or importer of a cannabis product who undertakes a corrective action or removal from the market of a cannabis product that is not required to be reported under this subsection shall keep a record of such correction or removal. No report of the corrective action or removal of a cannabis product may be required under paragraph
(1)if a report of the corrective action or removal is required and has been submitted under subsection (a). Any electronic cannabis product delivery system shall not contain an artificial or natural flavor (other than cannabis) that is a characterizing flavor, including menthol, mint, mango, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee. For purposes of this section, the term electronic cannabis product delivery system means an electronic device that delivers a cannabis product via an aerosolized solution to the user inhaling from the device, and any component, liquid, part, or accessory of such a device, whether or not sold separately. Nothing in this chapter, or rules promulgated under this chapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or political subdivision of a State, or the government of an Indian Tribe (as defined in section 3 of the Cannabis Administration and Opportunity Act ) to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to cannabis products that is in addition to, or more stringent than, requirements established under this chapter, including a law, rule, regulation, or other measure relating to or prohibiting the manufacture, sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of cannabis products by individuals of any age, information reporting to the State or Indian Tribe (as so defined), or measures relating to fire safety or environmental standards for cannabis products. No provision of this chapter shall limit or otherwise affect any State, Tribal, or local taxation of cannabis products. No provision of this chapter relating to a cannabis product shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State or Indian Tribe (as so defined). .
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Sec. 501
FDA regulation of cannabis
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