118 S5243 IS: Cannabinoid Safety and Regulation Act
U.S. Senate
2024-09-25
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents(a)This Act may be cited as the Cannabinoid Safety and Regulation Act
.(b)The table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—Food and Drug Administration regulation of cannabinoid productsSec. 101. FDA regulation of cannabinoid products.Sec. 102. Amendments to the Federal Food, Drug, and Cosmetic Act.Sec. 103. Regulation of cannabinoid beverages containing tetrahydrocannabinol.TITLE II—Public healthSec. 201. Public health surveillance and data collection.Sec. 202. Awards to prevent underage cannabis use.TITLE III—Cannabis-impaired driving preventionSec. 301. Definitions.Sec. 302. Cannabis-impaired driving research.Sec. 303. DOT cannabis-impaired driving prevention programs.Sec. 304. State cannabis-impaired driving prevention grant program.Sec. 305. National cannabis impairment standard.Sec. 306. Funding.<enum>I</enum><header>Food and Drug Administration regulation of cannabinoid products</header><section id="idC4BC08A2E9F2484095D3544521958D7F"><enum>101.</enum><header>FDA regulation of cannabinoid products</header><subsection id="idF5DE76BD284943B6AAC5EC87B07CC676"><enum>(a)</enum><header>In general</header><text>The Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block id="idC3F764402200484DBCB61DF7C22DD9EF" display-inline="no-display-inline" style="OLC"><chapter id="id170820213a12454288f4771b357668c7"><enum>XI<?LEXA-Enum XI?></enum><header>Cannabinoid products</header><section id="id5207989569f2413c82e222654db77972"><enum>1101.</enum><header>Center for Cannabinoid Products</header><text display-inline="no-display-inline">Not later than 120 days after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, the Secretary shall establish within the Food and Drug Administration the Center for Cannabinoid Products, which shall report to the Commissioner 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.</text></section><section id="id27075fadbe2b46cfa4279228590f1155"><enum>1102.</enum><header>Adulterated cannabinoid products</header><text display-inline="no-display-inline">A cannabinoid product shall be deemed to be adulterated if—</text><paragraph id="id7913c838301b4c9ebfc2c3cbe1a025ee"><enum>(1)</enum><text>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;</text></paragraph><paragraph id="idf9f8905396a14b0d9bc45ba4ae5ad8b5"><enum>(2)</enum><text>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;</text></paragraph><paragraph id="id58d6bff789e84173a03bb8b1314a3677"><enum>(3)</enum><text>it bears or contains any poisonous or deleterious substance that may render it injurious to health;</text></paragraph><paragraph id="idcddcb12414f041468694134b50afd642"><enum>(4)</enum><text>its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health;</text></paragraph><paragraph id="id079b8eb5c44a4d80b2b43f21c60af02c"><enum>(5)</enum><text>it bears or contains an unsafe color additive that is unsafe within the meaning of section 721(a);</text></paragraph><paragraph id="id766b0c01257c44f8afd991c8493ce635"><enum>(6)</enum><text>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); </text></paragraph><paragraph id="id6504d1b0ed36433a8c814f78952d3d84"><enum>(7)</enum><text>it has been manufactured, prepared, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection; or</text></paragraph><paragraph id="idbfc3c37c09f64c9793f9da343d9c53da" commented="no"><enum>(8)</enum><text>it bears or contains, or has been manufactured, prepared, or processed from, artificially or synthetically derived cannabinoids of any kind.</text></paragraph></section><section id="id141c7a8f713b4ec48a94c16525568e2e"><enum>1103.</enum><header>Misbranded cannabinoid products</header><text display-inline="no-display-inline">A cannabinoid product shall be deemed to be misbranded—</text><paragraph id="ida768d37a7d3b4bc19c904f04c7fd88b3"><enum>(1)</enum><text>if its labeling, advertising, or promotion is false or misleading in any particular, except that no cannabinoid product shall be deemed to be misbranded solely because its labeling, advertising, or promotion uses the term <term>cannabis</term>;</text></paragraph><paragraph id="id2cda7581115049d7a6b3c38786f5db6a"><enum>(2)</enum><text>if it is a finished product, unless it bears a label containing—</text><subparagraph id="id53bbffd6263b4904a1981d420de1f5f3"><enum>(A)</enum><text>a prominent statement on the front of the product packaging, and on any internal product insert or packaging, that the product contains cannabinoids;</text></subparagraph><subparagraph id="id4c663fc338bf48468fe6208bc9b2fb4b"><enum>(B)</enum><text>the name, place of business, and contact information (including, as applicable, phone number, email address, and physical address) of its manufacturer, packer, or distributor; </text></subparagraph><subparagraph id="id64738448e4ff4ceaa0828a6d3ce414d9"><enum>(C)</enum><text>an accurate statement of the quantity of its contents in terms of weight, measure, or numerical count;</text></subparagraph><subparagraph id="id876ac4a2aeaf45d39afd9d3b532c8f03"><enum>(D)</enum><text>a statement of its form as specified in regulations promulgated pursuant to section 1105(a);</text></subparagraph><subparagraph id="idda973c6626774a3baf3f0c69e301ddfa"><enum>(E)</enum><text>if it is intended for animal consumption or human consumption and is packaged and labeled in such a way as to suggest more than one serving, dose, or the equivalent, information on how such product may be divisible into, or measured into, a portion equivalent to one serving, dose, or the equivalent;</text></subparagraph><subparagraph id="id640fea364d1f4c8ea885b5a262d108d0"><enum>(F)</enum><text>if it is intended for animal consumption or human consumption and is packaged and labeled in such a way as to suggest more than one serving, dose, or the equivalent, a statement of the amount of total tetrahydrocannabinol, in milligrams, in one serving, dose, or the equivalent; </text></subparagraph><subparagraph id="id446e29e64c6149b3b8f2458b6daf6a64"><enum>(G)</enum><clause commented="no" display-inline="yes-display-inline" id="id970f542aacbf4935b5737378d7b7f6b3"><enum>(i)</enum><text>a statement of the content and amount, in milligrams, of any other cannabinoids in the product, other than naturally occurring cannabinoids present at trace amounts; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id763f1f08774c4c75a0350d8002640f2b" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">if it is packaged and labeled in such a way as to suggest more than one serving, dose, or the equivalent, a statement of the amount of such other cannabinoids in one serving, dose, or the equivalent; </text></clause></subparagraph><subparagraph id="idbecb35df85954ec591f3535641170e99"><enum>(H)</enum><text>adequate directions for use and how to report adverse events, if deemed necessary for the protection of the public health in regulations promulgated pursuant to section 1105(a);</text></subparagraph><subparagraph id="id6d71cd3b5a624f1fb39e8e652e9f93b9"><enum>(I)</enum><text>if it is intended for human consumption, a statement disclosing the presence or the possibility of the presence of any major food allergen or other food allergen which the Secretary may, by order, require to be disclosed; </text></subparagraph><subparagraph id="id974a1052dd1d427f9d0a6c5fe047d800" commented="no"><enum>(J)</enum><text>if it is intended for human use, a statement disclosing any known risks to special populations, including children, individuals who are pregnant or breastfeeding, and individuals taking drugs known to interact with the product, including the following statement: <term>Keep out of reach of children and pets. This product should not be consumed by women who are pregnant or nursing. Consult your health care provider if you have any other medical conditions or are taking any medication(s). This product may be purchased only by persons 21 and older.</term>;</text></subparagraph><subparagraph id="idb2eb62336a92498f97431ba092af4b1e"><enum>(K)</enum><text>a statement disclosing risks posed by consuming or using the specific cannabinoid contained or purported to be contained in the product, including the risk of drug test failure;</text></subparagraph><subparagraph id="id7234273f5ada435c86b586fac7320f8f"><enum>(L)</enum><text>unless it is a dietary supplement that bears the statement required by section 403(r)(6)(C), a statement disclosing that the Food and Drug Administration has not determined the product to be safe or effective for treating any condition, including the following statement: <term>This product has not been evaluated for safety or efficacy by the Food and Drug Administration.</term>; </text></subparagraph><subparagraph id="id549bcbdaca124b7b90beaa6a5a63dee3"><enum>(M)</enum><text>if it is intended for use in animals, a prominently placed, conspicuous—</text><clause id="id5d74730960b6411b89ebe9823b761340"><enum>(i)</enum><text>warning that the product should not be used by humans; and</text></clause><clause id="id84d9cbf3cb174b5b86b17b0dfcb3c689"><enum>(ii)</enum><text>statement that the product is intended for use in animals, including a specification of the intended species;</text></clause></subparagraph><subparagraph id="idcc5a8ce939eb45f7b0763a8591ff2630" commented="no"><enum>(N)</enum><text>the applicable universal symbol described in section 1105(d);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1132b3bfe10f4eefb5d4d69d7d2a0705"><enum>(O)</enum><text display-inline="yes-display-inline">beginning not later than 90 days after issuance of an order or finalization of a rule under section 1105(f)(1), as applicable, information on the safety test results for such product, or information on where to obtain such safety test results; and</text></subparagraph><subparagraph id="id3b00ef7277974f00acc0350507a65f65"><enum>(P)</enum><text>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;</text></subparagraph></paragraph><paragraph id="idabf1ddfd0f7a41339dfd6c7206371679" commented="no"><enum>(3)</enum><text>if it is a dietary supplement or a food and its label or labeling bears a statement describing the role of a cannabis constituent or cannabinoid 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;</text></paragraph><paragraph id="idaa785620bb0440888b07ef4c0f0a1fb5"><enum>(4)</enum><text>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;</text></paragraph><paragraph id="ida0b4e6d327c84a75bf87f127a0f331de"><enum>(5)</enum><text>if it purports to be, or is represented as, a cannabinoid product that is subject to a cannabinoid product standard established under section 1106 unless such cannabinoid product is in all respects in conformity with such standard;</text></paragraph><paragraph id="id9375fbde108c4da6aabaf3b81309fee3"><enum>(6)</enum><text>if its sale, distribution, or label or labeling is not in conformity with applicable requirements under subsections (a) and (b) of section 1105; </text></paragraph><paragraph id="idf2a91b1ab5d946ac95bc932af11f0e5d" commented="no"><enum>(7)</enum><text>if it was manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held in an establishment not duly registered under section 1104, if it was not included in a list required by section 1104, or if it was manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held by or in an establishment for which the registration was suspended under section 1104 and such registration has not been reinstated; </text></paragraph><paragraph id="id6fdca9af6c2f458baa3cb98507f11095"><enum>(8)</enum><text>if it takes such a form as to imitate or replicate a product that is marketed to or is commonly associated with children or minors, imitates a commercially available candy, snack, or beverage packaging or labeling, or is in the shape of real or imagined animals, people, vehicles, or characters, including anthropomorphic non-human animals, vehicles, foods, plants, or other characters, and including cartoon characters; </text></paragraph><paragraph id="id2c7158ca69c84e20b3a049d1dd8ff4c5"><enum>(9)</enum><text>it is a gummy product, unless it is in the shape of a cube, rectangle, sphere, or other geometric shape; or </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0efc0defa10c4d6bb92a34efc36e9de6"><enum>(10)</enum><text display-inline="yes-display-inline">if it purports to be, or is represented as, an eye drop, nasal spray, or injectable.</text></paragraph></section><section id="ida3248ab9c2cb45fc9a60e79c796c92ef"><enum>1104.</enum><header>Registration</header><subsection id="id19e79e09b5e2425c905e0b7f05b25235"><enum>(a)</enum><header>Registration by covered entities</header><paragraph commented="no" display-inline="no-display-inline" id="id13f59499e1494c4fa6f5c75d2bac132f"><enum>(1)</enum><header>Initial registration</header><subparagraph commented="no" display-inline="no-display-inline" id="id9f8bea36ee7b4ada9c2a10f5a5d3c42d"><enum>(A)</enum><header>Existing facilities</header><text display-inline="yes-display-inline">Each covered entity that, on the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, owns or operates a facility that carries out a covered activity shall register each such facility with the Secretary not later than 90 days after such date of enactment, in accordance with subsection (b). </text></subparagraph><subparagraph id="id12f7b5db8dbc41feaa0c8347ac5b957c"><enum>(B)</enum><header>New facilities</header><text>Each covered entity that owns or operates a facility that first carries out, after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, a covered activity shall register with the Secretary not later than 30 days after the date on which a covered entity first engages in such covered activity or 30 days after the deadline for registration under subparagraph (A), whichever is later, in accordance with subsection (b). </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id93d06198d9da45baa72db251fc9ff005"><enum>(2)</enum><header>Renewal of registration</header><text display-inline="yes-display-inline">Each covered entity required to register a facility under this section shall renew such registration with the Secretary on or before December 31 of each even-numbered year. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id22714576802640ea9b5c957aaca64ce7"><enum>(b)</enum><header>Content of registration</header><paragraph commented="no" display-inline="no-display-inline" id="id3de0ec3ca8724652a4d48c618c39fd12"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For each facility at which a covered entity carries out a covered activity, such covered entity shall submit to the Secretary, through the website established under paragraph (2)(A), a registration that includes—</text><subparagraph id="id54d543da07954825ac28fb71b9070711"><enum>(A)</enum><text>information necessary to notify the Secretary of the name (including trade name), address, and telephone number of such facility;</text></subparagraph><subparagraph id="idd2f3498009354dac99b0ef48cc7325f8"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="id80eeacaa5b124265b826b6d21d4406b9"><enum>(i)</enum><text>in the case of a domestic facility, the email address and telephone number for the contact person of such facility; or</text></clause><clause commented="no" display-inline="no-display-inline" id="idd923922be4a74552a10390169a8b623c" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case of a foreign facility, the email address and telephone number for the United States agent for such facility;</text></clause></subparagraph><subparagraph id="id6905529ec83a4b8ea4b04318120d311c"><enum>(C)</enum><text>the general activities conducted at such facility, including the 1 or more categories of cannabinoid products manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held at such facility;</text></subparagraph><subparagraph id="ide76338e90acb4db2a0c8cde7d86c1dfc"><enum>(D)</enum><text>the facility registration number for such facility, if any, previously assigned by the Secretary;</text></subparagraph><subparagraph id="idb5325b162f694b61beb798ebf4447643"><enum>(E)</enum><text>all brand names under which cannabinoid products manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held in such facility are sold, on the condition that the Secretary shall keep such information confidential;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf46fba694217496785b9a9e791e83ecc"><enum>(F)</enum><text display-inline="yes-display-inline">an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act, including section 704; and</text></subparagraph><subparagraph id="idcf17a26faa8a4f18b2644f20bcc62b37"><enum>(G)</enum><text>any other information the Secretary may require.</text></subparagraph></paragraph><paragraph id="id98c435942ad64cbcaaf2634687c1eb86"><enum>(2)</enum><header>Procedure</header><subparagraph commented="no" display-inline="no-display-inline" id="id8e3fca00b7a64f72ae10b6bf65eed522"><enum>(A)</enum><header display-inline="yes-display-inline">Website</header><clause commented="no" display-inline="no-display-inline" id="id85bab594194d4c11a1b26e52b91ad345"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than the applicable date described in clause (ii), the Secretary shall establish a website for submission of registration under this subsection.</text></clause><clause commented="no" display-inline="no-display-inline" id="id7a403b63db9a44f5a201f423f7fae502"><enum>(ii)</enum><header>Applicable date described</header><text>The applicable date described in this clause is—</text><subclause commented="no" display-inline="no-display-inline" id="idfdd0438aa4224341b4a10222d678800b"><enum>(I)</enum><text display-inline="yes-display-inline">180 days after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>; or</text></subclause><subclause id="ide12a3dfd8b1741edb8846113d7212408"><enum>(II)</enum><text>if December 31 is less than 180 days after such date of enactment, 240 days after such date of enactment. </text></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6766e48c83854a89b1b46f9e3dd35401"><enum>(B)</enum><header>Notification of receipt; registration numbers</header><text display-inline="yes-display-inline">Not later than 30 days after the date on which the Secretary receives a completed registration submitted under this subsection, the Secretary shall—</text><clause commented="no" display-inline="no-display-inline" id="id803da35395ac4297a080ce0294b44dc9"><enum>(i)</enum><text display-inline="yes-display-inline">notify the applicable covered entity of the receipt of such registration; and </text></clause><clause commented="no" display-inline="no-display-inline" id="idf934f39b932b4caa8648c3c99a8465d4"><enum>(ii)</enum><text display-inline="yes-display-inline">assign such covered entity a registration number.</text></clause></subparagraph><subparagraph id="id13a72a3b1608403cbe663307843a5c95" commented="no"><enum>(C)</enum><header>Owners, operators, and agents in charge</header><text>A registration under this subsection shall—</text><clause id="idcfd2a8ebc0c649d99915e1f66d97ec86" commented="no"><enum>(i)</enum><text>in the case of a domestic facility, be submitted by the owner or operator of such facility; and</text></clause><clause id="id8e99d0c809bb4c069f2adc198c40f86e" commented="no"><enum>(ii)</enum><text>in the case of a foreign facility, be submitted by the owner or operator of such facility.</text></clause></subparagraph></paragraph></subsection><subsection id="id8a73ba6446324ac8b688371017c1a8ef"><enum>(c)</enum><header>Uniform product identification system</header><text>The Secretary may—</text><paragraph commented="no" display-inline="no-display-inline" id="id34cfbc6fa6a241c3a4e540d1d2f2f2e0"><enum>(1)</enum><text display-inline="yes-display-inline">by regulation prescribe a uniform system for the identification of cannabinoid products; and </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id29aac3a8491f457c9069503cea89b7cd"><enum>(2)</enum><text display-inline="yes-display-inline">require persons who are required to list such cannabinoid products under subsection (f)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id2020b7cc87ec4cc7a1a9847e2bf38efe"><enum>(A)</enum><text display-inline="yes-display-inline">to list such cannabinoid products in accordance with such system; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1bae4e0ed7ba48d6bf4180ee31e0222b"><enum>(B)</enum><text display-inline="yes-display-inline">to include the identification number for such cannabinoid products on the labels for such cannabinoid products.</text></subparagraph></paragraph></subsection><subsection id="idb26371fbcb35445887cd016dd8079e7c"><enum>(d)</enum><header>Registration information</header><text display-inline="yes-display-inline">The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section.</text></subsection><subsection id="id6f5b10ffacb9452ba92547862185d62a" commented="no"><enum>(e)</enum><header>Fee for registration</header><paragraph commented="no" display-inline="no-display-inline" id="idd0158d2aa68e4bd09e2975cac35a7d38"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may charge a fee for registration under this section, which shall be due upon submission of such registration. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc7cb6d10706b4118a27058e34b83efe7"><enum>(2)</enum><header>Electronic payment</header><text display-inline="yes-display-inline">Payment of the fee under paragraph (1) may be made electronically pursuant to an online method of payment provided by the Secretary. </text></paragraph><paragraph id="id4db4586c9d274e519ea33c78e274c01b" commented="no"><enum>(3)</enum><header>Amount of fee; inflation adjustments</header><subparagraph commented="no" display-inline="no-display-inline" id="id1dd8619a72914ea795d3ca278554a29c"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">If the Secretary charges a fee under paragraph (1), the Secretary shall establish the amount of the fee as follows:</text><clause commented="no" display-inline="no-display-inline" id="id5e7244569bdd436586290b215ec4e870"><enum>(i)</enum><text display-inline="yes-display-inline">For fiscal year 2024, an amount not to exceed $500. </text></clause><clause commented="no" display-inline="no-display-inline" id="idcb4c4dcc87554b8ebb14afbbb7645bb9"><enum>(ii)</enum><text display-inline="yes-display-inline">For fiscal year 2025 and each fiscal year thereafter, an amount equal to the product obtained by multiplying—</text><subclause commented="no" display-inline="no-display-inline" id="id0002ad45be3a49cf95d31781d01304bd"><enum>(I)</enum><text display-inline="yes-display-inline">the dollar amount of the fee established under clause (i); and </text></subclause><subclause commented="no" display-inline="no-display-inline" id="idad4fb47d6a484357a8e278a0edb53d19"><enum>(II)</enum><text display-inline="yes-display-inline">the percentage (if any) by which the Consumer Price Index for All Urban Consumers, as published by the Bureau of Labor Statistics of the Department of Labor, increased during the most recent 12-month period.</text></subclause></clause></subparagraph><subparagraph id="ide5d231ed54e5442ebb6b059f223f02cd" commented="no"><enum>(B)</enum><header>Effect</header><text>Nothing in this paragraph prevents the Secretary from decreasing the amount of the registration fee under paragraph (1). </text></subparagraph></paragraph><paragraph id="id8bc5172e3c6b4a8290932394cac81d06" commented="no"><enum>(4)</enum><header>Registration refused or withdrawn</header><text>The Secretary shall refund 75 percent of the fee paid under paragraph (1) for any registration that is denied, refused, or withdrawn.</text></paragraph></subsection><subsection id="idf53f515e8e564ca787867a6297a1ca13"><enum>(f)</enum><header>Registration information</header><paragraph id="id65aac4d0b47f4ddc90c7967e52641891"><enum>(1)</enum><header>Product list</header><subparagraph id="id36A58C04A29643CCA648CC5F5D5D3608"><enum>(A)</enum><header>In general</header><text>Each covered entity that registers with the Secretary under this section shall, at the time of such registration, file with the Secretary—</text><clause id="idD9BEF819A0E342BF83AB2380D35A453D"><enum>(i)</enum><text>a list of all cannabinoid products which are being manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held by such covered entity for commercial distribution and which have not been included in any list of cannabinoid products filed by such covered entity with the Secretary under this paragraph or paragraph (2) before such time of registration; and </text></clause><clause id="idAB8FA456E01144F18ECB8F0AF66C62A0"><enum>(ii)</enum><text>such other information as the Secretary may require, by regulation, to carry out the purposes of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, including the amendments made by such Act.</text></clause></subparagraph><subparagraph id="id8987F40D60824E5CB4E0B860AE1239AB"><enum>(B)</enum><header>Form and manner of list</header><text>The list under subparagraph (A)(i) shall include—</text><clause id="id637852684f804e66b3f2d8c31fd13b64"><enum>(i)</enum><text>the facility registration number of each facility where the cannabinoid product is manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held; </text></clause><clause id="idad98bde92978468087d1b5bf7591a4a2"><enum>(ii)</enum><text>the name and contact number of the responsible person and the name for the cannabinoid product, as such name appears on the label;</text></clause><clause id="idb5c86d5170bb40129a2892e93e069ba0"><enum>(iii)</enum><text>the name and contact number of the person submitting the listing; and</text></clause><clause id="idbb53cd0a23164787834829ea7fbfd65c"><enum>(iv)</enum><text>an electronic copy of the label, and an electronic copy of the package insert, if any.</text></clause></subparagraph></paragraph><paragraph id="id62baabcf1de4490eb9f5b037b21eac3f"><enum>(2)</enum><header>Report of any change in product list</header><text>Each covered entity that registers with the Secretary under this section shall report to the Secretary as follows:</text><subparagraph id="id47b75ef935dc436188ee73ee6eeafab4"><enum>(A)</enum><text>Prior to the introduction into commercial distribution of a cannabinoid product that has not been included in any list previously filed by the registrant, a list containing such cannabinoid product. </text></subparagraph><subparagraph id="idf834b2ddd5514b78b8d80cb875935e31"><enum>(B)</enum><text>A notice of discontinuance of the manufacturing, preparing, propagating, compounding, processing, packaging, packing, importing, labeling, or holding for commercial distribution of a cannabinoid product included in a list filed under subparagraph (A) or paragraph (1), and the date of such discontinuance.</text></subparagraph><subparagraph id="id6377bde60cab44d2824a05cf43b68b82"><enum>(C)</enum><text>A notice of resumption of the manufacturing, preparing, propagating, compounding, processing, packaging, packing, importing, labeling, or holding for commercial distribution of the cannabinoid product with respect to which a notice of discontinuance was reported under subparagraph (B).</text></subparagraph><subparagraph id="id1d9c68dffaf7428e833dea9f5dce3e45"><enum>(D)</enum><text>A list of each cannabinoid product included in a notice filed under subparagraph (C) prior to the resumption of the introduction into commercial distribution of such cannabinoid product.</text></subparagraph></paragraph></subsection><subsection id="idb0acb5f764f041e58af3c878e389120d"><enum>(g)</enum><header>Suspensions</header><paragraph id="id5ce9700a5e7c4efbb1fea811ffec3f48"><enum>(1)</enum><header>Suspension of registration of a facility</header><text display-inline="yes-display-inline">The Secretary may suspend the registration of a facility if the Secretary—</text><subparagraph commented="no" display-inline="no-display-inline" id="idf254234cf5d546039ad0c7086aa87988"><enum>(A)</enum><text display-inline="yes-display-inline">determines that a cannabinoid product manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held by such registered facility and distributed in the United States has a reasonable probability of causing a serious adverse effect in humans or other animals; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id31505a90438748dabef1f89c705ace53"><enum>(B)</enum><text display-inline="yes-display-inline">has a reasonable belief that other cannabinoid products manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held by such registered facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held in such registered facility.</text></subparagraph></paragraph><paragraph id="ida4b56f8bd0f94f698ae82fb0638b52ad"><enum>(2)</enum><header>Notice of suspension</header><text>Before suspending the registration of a facility under this subsection, the Secretary shall provide—</text><subparagraph id="idfabf6a640539474e83e03693cec92eac"><enum>(A)</enum><text>notice to the applicable covered entity of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and</text></subparagraph><subparagraph id="idbb5801525624415aa2f5d6afb7deba3b"><enum>(B)</enum><text>an opportunity, within 5 business days of the notice provided under subparagraph (A), for such covered entity to provide a corrective action plan to demonstrate how such covered entity plans to correct the violations found by the Secretary.</text></subparagraph></paragraph><paragraph id="ide9f17ad9246a4c7d8ccf3807b5b16443"><enum>(3)</enum><header>Hearing</header><subparagraph commented="no" display-inline="no-display-inline" id="idfbb71784bb864549bfa65b63af7a2601"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall provide a covered entity the facility registration of which is suspended under this subsection with an opportunity for an informal hearing, to be held as soon as practicable, but in any case not later than 5 business days after such registration is suspended, or such other time period as is agreed upon by the Secretary and the covered entity, on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida0c67e84792544c7826b62f712b8413f"><enum>(B)</enum><header>Post-hearing reinstatement</header><text display-inline="yes-display-inline">If a covered entity requests a hearing under subparagraph (A), and the Secretary determines, based on evidence presented at such hearing, that adequate grounds do not exist to continue the suspension of such registration, the Secretary shall reinstate such registration.</text></subparagraph><subparagraph id="idf66c644dac134e2f8ec0e2f5f754d5db"><enum>(C)</enum><header>Post-hearing corrective action plan</header><clause commented="no" display-inline="no-display-inline" id="ide1d9bf6f8cd64c7f88b7405bd1481513"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">If a covered entity requests a hearing under subparagraph (A), and the Secretary determines, based on evidence presented at such hearing, that the suspension of registration remains necessary, the Secretary shall require the applicable covered entity to submit to the Secretary a corrective action plan described in paragraph (2)(B), if not already submitted. </text></clause><clause commented="no" display-inline="no-display-inline" id="idd9ec08ec09be43aabd5f3ab282649f78"><enum>(ii)</enum><header>Review</header><text display-inline="yes-display-inline">The Secretary shall review, and approve or deny, a plan submitted under paragraph (2)(B) or clause (i), as applicable, not later than 14 business days after such submission or such other time period as is determined by the Secretary, in consultation with the applicable covered entity.</text></clause></subparagraph><subparagraph id="id783d5f207d5a4ee69763709e7ca5a898"><enum>(D)</enum><header>Vacating of order; reinstatement</header><text>Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension of a registration of a facility under this subsection, the Secretary shall promptly vacate such suspension and reinstate such registration. </text></subparagraph></paragraph><paragraph id="idbd0755a071094c5f97be118792b16591"><enum>(4)</enum><header>Effect of suspension</header><text>If the registration of a facility is suspended under this subsection, no person shall carry out a covered activity at such facility. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9bee442171054959ac4de1bfc26627b2"><enum>(h)</enum><header>Disclosure</header><paragraph commented="no" display-inline="no-display-inline" id="id0347e2d19e6441f18b3b0955da510ccc"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The list described in subsection (d), any information submitted by a covered entity pursuant to this section, and any information derived from such list or information, shall be exempt from disclosure under section 552 of title 5, United States Code, to the extent that such list or information discloses the identity or location of a registered facility, unless such information was previously lawfully disclosed to the public. </text></paragraph><paragraph id="id79EF59D80CCB41909E7A7F2F8EA43F1D"><enum>(2)</enum><header>Applicability</header><text>For purposes of paragraph (1), this section shall be considered a statute described in section 552(b)(3)(B) of title 5, United States Code. </text></paragraph></subsection><subsection id="id51361170bda545e687f034814eb237e7" commented="no"><enum>(i)</enum><header>Regulations</header><text>The Secretary may promulgate such regulations as may be necessary to carry out this section. </text></subsection><subsection commented="no" display-inline="no-display-inline" id="idf03d123334264a2bb96b1ff818111c30"><enum>(j)</enum><header>Definitions</header><text>In this section:</text><paragraph commented="no" display-inline="no-display-inline" id="id46998d29e5c84faa861d494b992d73db"><enum>(1)</enum><header>Covered activity</header><text>The term <term>covered activity</term> means—</text><subparagraph commented="no" display-inline="no-display-inline" id="id50f59e1086f1496f935f185fcc5cd5a6"><enum>(A)</enum><text display-inline="yes-display-inline">in the case of a domestic facility, the manufacturing, preparing, propagating, compounding, processing, packaging, packing, importing, labeling, or holding of a cannabinoid product for commercial distribution in the United States; or </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7f557bdd8a0542cfbd5c85c4760e11ad"><enum>(B)</enum><text>in the case of a foreign facility, the manufacturing, preparing, propagating, compounding, processing, packaging, packing, labeling, or holding of a cannabinoid product that is imported or offered for import into the United States.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id31a4783b477f4473816cb1cfe40fc927"><enum>(2)</enum><header>Covered entity</header><text display-inline="yes-display-inline">The term <term>covered entity</term> means any person who owns or operates a domestic facility or foreign facility that is engaged in a covered activity.</text></paragraph><paragraph id="IDBF220EBEAE9142D0A16D77CE6905DCDD" commented="no"><enum>(3)</enum><header>Domestic facility</header><text>The term <term>domestic facility</term> means a facility located in any State.</text></paragraph><paragraph id="IDD3907BC32CD541A49E0F99904F76DA5B" commented="no"><enum>(4)</enum><header>Foreign facility</header><text>The term <term>foreign facility</term> means a facility that manufactures, prepares, propagates, compounds, processes, packages, packs, labels, or holds a cannabinoid product that is imported or offered for import into the United States. </text></paragraph></subsection></section><section id="idde4445d4ff864af5add90d6403cb2e23"><enum>1105.</enum><header>General provisions for control of cannabinoid products</header><subsection id="id9a0318fd252042cf8be4a6b97be69afc"><enum>(a)</enum><header>Restrictions on sale and distribution</header><paragraph id="id7f9f25e6a54a4cbab76cf274dd201b8e"><enum>(1)</enum><header>Remote sales</header><text>Not later than 2 years after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, 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 cannabinoid products intended for human consumption and that contain detectable levels of any tetrahydrocannabinol 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 cannabinoid products to individuals who have not attained the age of 21, including requirements for age verification. Such regulations shall require age to be verified at the time of purchase or prior to shipment, either through use of a reliable online age verification service or by obtaining and examining a copy of a valid, non-expired government-issued identification, including identification issued by an Indian Tribe (as defined in section 1110).</text></paragraph><paragraph id="id6f39e7c72d3349549f92ab01c605bfc0"><enum>(2)</enum><header>Preventing use of cannabinoid products in minors</header><text>The Secretary shall, by regulation, impose such restrictions on sales of cannabinoid products as the Secretary determines necessary and appropriate to prevent the consumption or application of cannabinoid products intended for human consumption by individuals under 21 years of age. Such regulations shall prohibit sales of cannabinoid 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 cannabinoid products in such individuals. </text></paragraph><paragraph id="id4F9A1EFC4BB64F388D287A5B402131F4"><enum>(3)</enum><header>Good faith consultation with Indian Tribes</header><text>In issuing regulations under paragraphs (1) and (2), the Secretary shall conduct good faith, meaningful, and timely consultations with Indian Tribes (as defined in section 1110).</text></paragraph></subsection><subsection id="id0b5483b724e44b01a3ba0cb7eade5f2b"><enum>(b)</enum><header>Labeling statements</header><text>The label and labeling of a cannabinoid product shall bear such appropriate statements of the restrictions required by a regulation under subsection (a) as the Secretary may in such regulation prescribe.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="id8d553201d4e84ec19720f8b60849a981"><enum>(c)</enum><header>Standardized information panel for ingestible cannabinoid products</header><text>The Secretary may prescribe by order a standardized format or label for labeling information required under this chapter for cannabinoid products intended for human consumption.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="id0d7681a2cc024c269c1652306204b47e"><enum>(d)</enum><header>Universal symbol</header><paragraph commented="no" display-inline="no-display-inline" id="idb1651069dd8945178f787fe2307f420b"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The universal symbol referred to in section 1103(2)(N) is, as applicable—</text><subparagraph commented="no" display-inline="no-display-inline" id="id0af9ca1e463a409388386008efa74233"><enum>(A)</enum><text display-inline="yes-display-inline">the most recent international symbol established by ASTM International indicating that a product contains intoxicating cannabinoids; or</text></subparagraph><subparagraph id="id51cbdc568f394ccc9d681e3eed049c86"><enum>(B)</enum><text>the most recent international symbol established by ASTM International indicating that a product contains nonintoxicating cannabinoids.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7f63beaaac2f47ff94003d537c99fad8"><enum>(2)</enum><header>State authority</header><subparagraph commented="no" display-inline="no-display-inline" id="idb25eb716494e4347a5157218158df0d9"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The State in which a cannabinoid product is offered for sale may determine which of the universal symbols described in subparagraphs (A) and (B) of paragraph (1) shall be required to be included on the label for such cannabinoid product for purposes of section 1103(2)(N).</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5d62ab98599140b28d6d8c1b1695f024"><enum>(B)</enum><header>State labels</header><text>Before the date on which an international symbol described in paragraph (1)(B) is established, the State in which a cannabinoid product is offered for sale may establish, for purposes of section 1103(2)(N), a symbol that indicates that a product contains either intoxicating cannabinoids or nonintoxicating cannabinoids.</text></subparagraph></paragraph></subsection><subsection id="id20eb5e22a235401097492cefa822be57"><enum>(e)</enum><header>Tamper-Evident and child safety packaging</header><paragraph commented="no" display-inline="no-display-inline" id="id2101f46be74847d3bc856634ea911e09"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may establish by order requirements for tamper-evident and child safety packaging for cannabinoid products intended for human consumption and that contain more than 1 serving and are packaged in a container that exceeds 4 ounces.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8101069100744f6db333b97ed25ae4aa"><enum>(2)</enum><header>Effect</header><text display-inline="yes-display-inline">Nothing in this subsection shall authorize the Secretary to prescribe by order or rulemaking specific packaging designs, product content, package quantity, or, with the exception of authority granted in section 1103, labeling and packaging.</text></paragraph></subsection><subsection id="idb0aa6019ccd3461faa26104b300024e3"><enum>(f)</enum><header>Good manufacturing practice requirements</header><paragraph commented="no" display-inline="no-display-inline" id="idc8ca7fab7d4048e1a3168a4f1fa150bb"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 9 months after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, the Secretary shall promulgate regulations to require that the methods used in, and the facilities and controls used for, the manufacture, preparing, processing, packing, and holding of a cannabinoid product conform to current good manufacturing practice, including testing of cannabinoid products. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida271a40cae5545beaac768dd8e5adbb4"><enum>(2)</enum><header>Certification</header><text display-inline="yes-display-inline">The Secretary may require each covered entity with a registered facility under section 1104 to certify with respect to such registered facility compliance with the good manufacturing practice regulations described in paragraph (1).</text></paragraph></subsection><subsection id="id1fee416407ce4bd78487bdf2e843f5aa"><enum>(g)</enum><header>Good testing practice requirements</header><paragraph commented="no" display-inline="no-display-inline" id="idfc895c4c65134f90ac6533cf548b52ac"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, the Secretary shall promulgate regulations or issue an order to require a cannabinoid product to be tested for safety in a laboratory certified, accredited, licensed, or otherwise formally recognized for the testing of cannabinoid products in the State in which the cannabinoid product is produced. Such regulations may include requirements for laboratory accreditation standards, such as ISO 17025 of the International Organization for Standardization (or a successor standard).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4e6b196be8754c339632bd86697573d3"><enum>(2)</enum><header>Requirements for entities conducting testing</header><text display-inline="yes-display-inline">The regulations or order under paragraph (1) shall require that an entity conducting a test of a cannabinoid product described in such paragraph—</text><subparagraph commented="no" display-inline="no-display-inline" id="id7551325fdb164da293bbdcd7e0531e00"><enum>(A)</enum><text display-inline="yes-display-inline">be registered and accredited for the testing of cannabinoid products or cannabis products in the applicable State; or </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbd3bf5195b6349bb862fc737a45e78dc"><enum>(B)</enum><text display-inline="yes-display-inline">be registered and in good standing with the Drug Enforcement Agency as a Hemp Analytical Testing Laboratory. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id50bb7a17e68d4a70ac3fdb7f009b1dac"><enum>(3)</enum><header>Requirements for testing</header><text display-inline="yes-display-inline">The regulations or order under paragraph (1) shall require that a test of a cannabinoid product described in such paragraph—</text><subparagraph commented="no" display-inline="no-display-inline" id="id69d524da30734f03beedbe26dc932a7f"><enum>(A)</enum><text display-inline="yes-display-inline">shall be completed using—</text><clause commented="no" display-inline="no-display-inline" id="id95a3e89dd2834b0d96f5c66a51df0f29"><enum>(i)</enum><text display-inline="yes-display-inline">statistically valid sampling of the cannabinoid product; and </text></clause><clause commented="no" display-inline="no-display-inline" id="ideee6460e64404a3e87bd6fcbf5fc4b6a"><enum>(ii)</enum><text display-inline="yes-display-inline">analytical testing methodologies that are—</text><subclause commented="no" display-inline="no-display-inline" id="id8cadfd178f9d468abf654996db76a645"><enum>(I)</enum><text display-inline="yes-display-inline">based on published, peer-reviewed methods validated for cannabis testing by an independent third party; or </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id3eabd56c2ffd4243bec07a2c560ce3ef"><enum>(II)</enum><text display-inline="yes-display-inline">verified by the testing entity for compliance with the Official Methods of Analysis of AOAC International, 22nd edition (or any successor edition); </text></subclause></clause></subparagraph><subparagraph id="id1ce20c4059e143e68679ef45f9d80b8a"><enum>(B)</enum><text>shall include—</text><clause commented="no" display-inline="no-display-inline" id="idad213ad4c45a406abaa4eeeff3f9eb68"><enum>(i)</enum><text display-inline="yes-display-inline">testing for—</text><subclause id="id8aeb15550d0a4ff388ce0d3a85cad440"><enum>(I)</enum><text>pesticides and other chemical residues or residual solvents, regardless of whether a tolerance for such pesticides or other chemical residues or residual solvents has been established;</text></subclause><subclause id="ida4664b8a31c04594823474a9b0c54b91"><enum>(II)</enum><text>synthetic inputs used to produce semi-synthetic cannabinoid products, including hydrochloric acid and sulphuric acid; </text></subclause><subclause id="idd3fe2bfc94d74c52ab2138ea2d9304a2"><enum>(III)</enum><text>heavy metals, including arsenic, cadmium, lead, and copper, regardless of whether a tolerance for such heavy metals has been established; and</text></subclause><subclause id="id76217b8042f94886be1fe392d3490b74"><enum>(IV)</enum><text>foreign matter, including mildew, organic materials foreign to the product, and inorganic materials; and</text></subclause></clause><clause id="id4e7289796bba453fae5778aef0e7a1ae"><enum>(ii)</enum><text>a potency analysis, which may not be adulterated or manipulated by any means, including by the addition of trichromes or other matter incidentally removed while manipulating the product for testing, including measurements of—</text><subclause commented="no" display-inline="no-display-inline" id="id008910299c1a4dbeb85e2f4a3c80da60"><enum>(I)</enum><text display-inline="yes-display-inline">the total tetrahydrocannabinol content of the finished product; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id25839c78fd354b2a8a00ba2b217e84f7"><enum>(II)</enum><text display-inline="yes-display-inline">the total cannabinoid content of the finished product; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id86495090e2b9478c92d43800e86274a0"><enum>(III)</enum><text display-inline="yes-display-inline">the concentration of tetrahydrocannabinol; and </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id8e71d9dfcc804ed9aa38585a0511b314"><enum>(IV)</enum><text display-inline="yes-display-inline">the concentration of cannabinoids;</text></subclause></clause></subparagraph><subparagraph id="idcaaa073dac794d62a5baad8b838d652b"><enum>(C)</enum><text>shall be conducted subject to quality assurance protocols to ensure the validity and reliability of test results;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd29c6a337f0040659f67f4dbedb96b31"><enum>(D)</enum><text display-inline="yes-display-inline">shall use analytical method selection, validation, and verification that ensure that the testing method used is appropriate for the product type and method of consumption by the end user, including post-decarboxylation, if applicable;</text></subparagraph><subparagraph id="id52219c50f4fa41b9bef088cc11c418a4"><enum>(E)</enum><text>shall ensure that analytical tests are sufficiently sensitive for the purposes of the detectability requirements of required testing; and</text></subparagraph><subparagraph id="id3bd7b752fe1c4ccb9c3d44244faf982f"><enum>(F)</enum><text>shall use testing protocols that include an effective disposal procedure for non-compliant samples that do not meet the requirements of this section.</text></subparagraph></paragraph><paragraph id="id52c2e2b0bc7b43f4bba70fcce5d1483d"><enum>(4)</enum><header>Product safety thresholds</header><text display-inline="yes-display-inline">The regulations or order under paragraph (1) shall establish thresholds for cannabinoid product safety with respect to residual solvent levels, heavy metals, foreign matter, mycotoxin levels, and byproducts of semi-synthetic manufacturing processes.</text></paragraph></subsection><subsection id="id8a5882ee394641f5bab8f9fcd3944b85" commented="no"><enum>(h)</enum><header>Foods containing cannabinoids</header><paragraph commented="no" display-inline="no-display-inline" id="id613a50c5e1d745f8a800dae9a383c0e5"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">A food may also be a cannabinoid product, or contain a cannabinoid product, if it otherwise complies with all applicable requirements for food under chapter IV and all applicable requirements for cannabinoid products under this chapter.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfd3c182e8167487c9177331e1e57448c"><enum>(2)</enum><header>Effect</header><text display-inline="yes-display-inline">A food that is also a cannabinoid product, or that contains a cannabinoid product, shall not be deemed— </text><subparagraph id="idf098bcd96c074bdb87b7c827c6a5f623" commented="no"><enum>(A)</enum><text>adulterated under section 402(a)(2)(C)(i) solely on account of constituents made or derived from cannabinoids; or</text></subparagraph><subparagraph id="id3e196a67e0f64e8488329d20965522f0" commented="no"><enum>(B)</enum><text>a food to which has been added a drug approved under section 505 or 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.</text></subparagraph></paragraph></subsection><subsection id="id18888b10a5fc4b86b60675e1e3c54017"><enum>(i)</enum><header>Dietary supplements containing cannabinoids</header><paragraph id="id2063826baffa450ca8c773002af90196"><enum>(1)</enum><header>In general</header><text>A dietary supplement may also be a cannabinoid product, or contain a cannabinoid product, if it otherwise complies with all applicable requirements for dietary supplements and food under chapter IV and all applicable requirements for cannabinoid products under this chapter.</text></paragraph><paragraph id="idc7215cce97f64da79a6821b5f917fb86"><enum>(2)</enum><header>Effect</header><text>A dietary supplement that is also a cannabinoid product, or that contains a cannabinoid product, shall not be—</text><subparagraph id="idb0291e6edb4d453fa0ab5b84098a00bb"><enum>(A)</enum><text>deemed adulterated under section 402(f) solely on account of constituents made or derived from cannabinoids; or</text></subparagraph><subparagraph id="id42b55b0c4f8e42e3989958b30fa74db7"><enum>(B)</enum><text>excluded from the definition of dietary supplement under section 201(ff)(3) solely on account of constituents made or derived from cannabis. </text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idd9c011e55d0c46f4b9eabb2a2114be88"><enum>(j)</enum><header>Manufacturing, processing, and production of cannabinoids and semi-Synthetic cannabinoids</header><paragraph commented="no" display-inline="no-display-inline" id="idb6b1baefa4b44a72a2d6da0a4919efe1"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may promulgate regulations regarding the manufacturing, processing, or production of artificially or synthetically derived cannabinoids and semi-synthetic cannabinoids in order to protect the public health. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfd30aa80b79b487691bf2de94e929265"><enum>(2)</enum><header>Safety; removal of dangerous cannabinoids</header><text display-inline="yes-display-inline">If promulgated, the regulations under paragraph (1)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id61c0bd7c5bf44eda875199d888b3b501"><enum>(A)</enum><text display-inline="yes-display-inline">shall determine the safety of artificially or synthetically derived cannabinoids and semi-synthetic cannabinoids across various methods of administration; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id31c0916322354dc589983fdc2e5d65c3"><enum>(B)</enum><text display-inline="yes-display-inline">may establish a process for the removal from the market of—</text><clause commented="no" display-inline="no-display-inline" id="id8a97f4d5e96c4803a53f3f1db7586cd0"><enum>(i)</enum><text display-inline="yes-display-inline">dangerous artificially or synthetically derived cannabinoids or semi-synthetic cannabinoids; or </text></clause><clause commented="no" display-inline="no-display-inline" id="id62bf167eb0e1496c92aa84f0b1927c07"><enum>(ii)</enum><text display-inline="yes-display-inline">artificially or synthetically derived cannabinoids or semi-synthetic cannabinoids that cause a serious adverse effect (as defined in section 201(tt)(5)). </text></clause></subparagraph></paragraph></subsection></section><section commented="no" id="id91f7dd13d33c418cb7a771235896c53d"><enum>1106.</enum><header>Cannabinoid product standards</header><subsection commented="no" id="id0e5ce04a9a354d97834d07b8d95296d1"><enum>(a)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, the Secretary shall, by regulation, adopt cannabinoid product standards that are appropriate for protection of the public health and that distinguish different cannabinoid product types. </text></subsection><subsection commented="no" id="id18961b367c6b4b449dbbd2d3624cdefa"><enum>(b)</enum><header>Content of standards</header><text>A cannabinoid product standard established under this section shall include provisions—</text><paragraph commented="no" id="id644fca931683474199eb80a210e9a5f5"><enum>(1)</enum><text>on the ingredients of the cannabinoid product, including, where appropriate—</text><subparagraph commented="no" id="idB60DF7C94BC844DABCF74F7320EDEB3C"><enum>(A)</enum><text>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; </text></subparagraph><subparagraph commented="no" id="idD25E6F3933DB46329124335B5226F29C"><enum>(B)</enum><text>provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the cannabinoid product, which may consider, as appropriate, the interaction between constituents and components of the cannabinoid product; and</text></subparagraph><subparagraph commented="no" id="id53DA0A7478A24F1C8334F40F62919B47"><enum>(C)</enum><text>provisions for the reduction or elimination of harmful constituents or components of the product, including smoke constituents; </text></subparagraph></paragraph><paragraph commented="no" id="id6969c7ef49034d7b95570e7414d6d3b0"><enum>(2)</enum><text>for the testing of the cannabinoid product, including requiring that the testing of the cannabinoid product be done by a person licensed, certified, or otherwise authorized to perform such testing in the State where such testing occurs; </text></paragraph><paragraph id="id507dc82e353e493284bed58498bae05c"><enum>(3)</enum><text>requiring that the results of testing the cannabinoid product show that the cannabinoid product is in conformity with applicable standards, including with respect to the level of heavy metals, chemical byproducts, or pesticide residues;</text></paragraph><paragraph commented="no" id="idCB23DE01AE054AFABECD96A6ED2136E7"><enum>(4)</enum><text>for the measurement of the characteristics of the cannabinoid product, where appropriate, including total product weight, size, color, appearance, and other distinguishing features;</text></paragraph><paragraph commented="no" id="idD9A5F3C0F696447BB222D51853EA55BC"><enum>(5)</enum><text>requiring that the sale and distribution of the cannabinoid product be restricted but only to the extent that the sale and distribution of a cannabinoid product may be restricted under a regulation under this Act; </text></paragraph><paragraph commented="no" id="id2D7EE924B77E4DFBBD3205A6E4316187"><enum>(6)</enum><text>where appropriate, requiring the use and prescribing the form and content of labeling for the proper use of the cannabinoid product and any potential serious adverse effects of the product; and </text></paragraph><paragraph commented="no" id="idD82F7762EC6E4B31A8D58F5C3042F17D"><enum>(7)</enum><text>requiring cannabinoid products containing foreign-grown hemp or cannabinoids to meet the same standards applicable to cannabinoid products containing domestically grown cannabis. </text></paragraph></subsection><subsection commented="no" id="id290E70F4062E4424A89F9F058E825C87"><enum>(c)</enum><header>Periodic reevaluation of standards</header><text>The Secretary shall provide for periodic evaluation of cannabinoid product standards established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. </text></subsection></section><section commented="no" id="id971c942361924a0cabfc10214fedb47c"><enum>1107.</enum><header>Recall authority</header><subsection commented="no" id="id869535d0cd2f4674afe25b0222e9c335"><enum>(a)</enum><header>In general</header><text>If the Secretary finds that there is a reasonable probability that a cannabinoid product would cause a serious adverse effect, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the cannabinoid product) to immediately cease distribution of such cannabinoid 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 cannabinoid 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.</text></subsection><subsection commented="no" id="idbdf3e65483654b319969b5175243c34a"><enum>(b)</enum><header>Amendment of order To require recall</header><paragraph commented="no" id="idd26fa5892fc04797ac89e5ddb1773fb9"><enum>(1)</enum><header>In general</header><text>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 cannabinoid 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 cannabinoid product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.</text></paragraph><paragraph commented="no" id="id20636d28b4724ca2b02764302f63671c"><enum>(2)</enum><header>Notice</header><text>An amended order under paragraph (1)—</text><subparagraph commented="no" id="idDAE3D3CF2CAD43AF92570D4937141640"><enum>(A)</enum><text>shall not include recall of a cannabinoid product from individuals; and</text></subparagraph><subparagraph commented="no" id="id507B45C1C8F1439F9E8CA1A8CAD761E0"><enum>(B)</enum><text>shall provide for notice to persons subject to the risks associated with the use of such cannabinoid product. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4862af1855be4de08a6139592600f97a"><enum>(3)</enum><header>Use of retailers</header><text display-inline="yes-display-inline">In providing the notice required by paragraph (2)(B), the Secretary may use the assistance of retailers and other persons who distributed such cannabinoid product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons pursuant to section 705(b).</text></paragraph></subsection></section><section commented="no" id="idb974d5f7d58c4631a3c52f7d2d82d20d"><enum>1108.</enum><header>Records and reports on cannabinoid products</header><subsection id="idf225445f76ea402ab7a05fc20404c00f"><enum>(a)</enum><header>In general</header><text>Each person who is a cannabinoid product manufacturer or importer of a cannabinoid 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 cannabinoid product is not adulterated or misbranded and to otherwise protect public health.</text></subsection><subsection id="idcbcc9eaa7b8e4bf9b0f53c3437578143"><enum>(b)</enum><header>Reports of removals and corrections</header><paragraph id="id947408b2dd374ccb90227e890db9aebc"><enum>(1)</enum><header>Requirement</header><subparagraph commented="no" display-inline="no-display-inline" id="id00a4af1b0397433a9bbd12b7ddc3f86f"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (2), the Secretary shall by regulation require a cannabinoid product manufacturer or importer of a cannabinoid product to report promptly to the Secretary any corrective action taken or removal from the market of a cannabinoid product undertaken by such manufacturer or importer if the removal or correction was undertaken—</text><clause id="id639755662bc149f8bf425ef633636477"><enum>(i)</enum><text>to reduce a risk to health posed by the cannabinoid product; or</text></clause><clause id="idc5a001091b8f46c8afde9df611fd12f9"><enum>(ii)</enum><text>to remedy a violation of this chapter caused by the cannabinoid product which may present a risk to health.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide649eac21ae04b6a87c24e434f2a68d8"><enum>(B)</enum><header>Records</header><text display-inline="yes-display-inline">A cannabinoid product manufacturer or importer of a cannabinoid product who undertakes a corrective action or removal from the market of a cannabinoid product that is not required to be reported under this subsection shall keep a record of such correction or removal.</text></subparagraph></paragraph><paragraph id="idf7f778c266d247f48cb80ce4af637bda"><enum>(2)</enum><header>Exception</header><text>No report of the corrective action or removal of a cannabinoid product may be required under paragraph (1)(A) if a report of the corrective action or removal is required and has been submitted under subsection (a). </text></paragraph></subsection></section><section id="ide2c479bda8214e01889c1d3dc9586e79"><enum>1109.</enum><header>Prohibition on flavored electronic cannabinoid product delivery system</header><subsection id="id7e140cdd958b455ba95d0d924c2bded5"><enum>(a)</enum><header>In general</header><text>Except as provided in subsection (b), any electronic cannabinoid product delivery system shall not contain an added artificial or natural flavor, including mint, mango, strawberry, grape, peach, orange, berry or mixed berry, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, watermelon, lemon, lime or lemon-lime, coffee, any combination thereof, or any other flavor that the Secretary may determine by order.</text></subsection><subsection id="id945e45328f584123959956671ebf188f" commented="no"><enum>(b)</enum><header>Application to terpenes</header><text>An electronic cannabinoid product delivery system may contain added or naturally occurring terpenes, including naturally occurring non-cannabis terpenes, on the conditions that—</text><paragraph id="id77fb733e28c44d168e95ade62289987a"><enum>(1)</enum><text>if the cannabinoid product delivered by the electronic cannabinoid product delivery system contains added terpenes but not naturally occurring terpenes, not greater than 5 percent of the total weight of such cannabinoid product shall be added terpenes;</text></paragraph><paragraph id="id632efae07b0b4c33bdd8814dd721ead8" commented="no"><enum>(2)</enum><text>if the cannabinoid product delivered by the electronic cannabinoid product delivery system contains naturally occurring terpenes but not added terpenes, not greater than 6 percent of the total weight of such cannabinoid product shall be naturally occurring terpenes; and</text></paragraph><paragraph id="idb9a507ab2cdc4f13a02999b6f3bc1be5" commented="no"><enum>(3)</enum><text>if the cannabinoid product delivered by the electronic cannabinoid product delivery system contains both added terpenes and naturally occurring terpenes, not greater than 6 percent of the total weight of the cannabinoid product shall be such naturally occurring terpenes and added terpenes.</text></paragraph></subsection><subsection id="id06c6b35365be47c3a6a45ffbd8175329"><enum>(c)</enum><header>Definition</header><text>In this section, the term <term>electronic cannabinoid product delivery system</term> means an electronic device that delivers a cannabinoid product via an aerosolized or vaporized solution to the user inhaling from the device, and any component, liquid, part, or accessory of such a device, whether or not sold separately.</text></subsection></section><section id="idc9515e90c1474097b6017b9991cb1fbb"><enum>1110.</enum><header>Effect</header><subsection commented="no" display-inline="no-display-inline" id="idc41e2872b9d348eb8f63ce18531f8dd6"><enum>(a)</enum><header display-inline="yes-display-inline">Preservation of Federal, State, Tribal, and local authority</header><paragraph id="id2503ff42f8774537a0d7aecaf66df825"><enum>(1)</enum><header>Effect</header><subparagraph commented="no" display-inline="no-display-inline" id="idad65a89ee0ec40458e165a58901c8e36"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>Except as provided in subparagraph (B), 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 to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to cannabinoid 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 cannabinoid products by individuals of any age, information reporting to the State or Indian Tribe, or measures relating to fire safety or environmental standards for cannabinoid products. No provision of this chapter shall limit or otherwise affect any State, Tribal, or local taxation of cannabinoid products. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb4865c5fc1194e60911911c968b4cc6d"><enum>(B)</enum><header>Restriction</header><text display-inline="yes-display-inline">No State or political subdivision of a State may enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure for the labeling of cannabinoid products that is not identical to the requirements for the packaging or labeling of a cannabinoid product required by section 1103 (including regulations).</text></subparagraph><subparagraph id="id1ff2634cc24948ca85438ce3353cd8a8"><enum>(C)</enum><header>Transportation of cannabinoid products</header><text>No State or Indian Tribe may prohibit the transportation or shipment of cannabinoid products produced in accordance with this chapter (including regulations) through the State or land under the jurisdiction of the Indian Tribe. </text></subparagraph></paragraph><paragraph id="id09032d695e694534983d6fc7981ad05b" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header>Rule of construction regarding product liability</header><text>No provision of this chapter relating to a cannabinoid 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.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6f19b580c7834cc488fbabcc47bf62ba"><enum>(3)</enum><header>Definition of Indian Tribe</header><text display-inline="yes-display-inline">In this subsection, the term <term>Indian Tribe</term> means the governing body of any individually identified and federally recognized Indian or Alaska Native tribe, band, nation, pueblo, village, community, affiliated Tribal group, or component reservation included on the list published most recently as of the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title> pursuant to section 104(a) of the Federally Recognized Indian Tribe List Act of 1994.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id870a7fe67b97495ab9ab56b43dc618c7"><enum>(b)</enum><header>Authority of USDA</header><text display-inline="yes-display-inline">Nothing in this chapter affects the jurisdiction of the Secretary of Agriculture over the planting, cultivation, growing, and harvesting of hemp (as defined in section 297A of the Agricultural Marketing Act of 1946).</text></subsection></section></chapter><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="id4bc52eef46cc41c796a3fbcae8e1e9b0"><enum>102.</enum><header>Amendments to the Federal Food, Drug, and Cosmetic Act</header><subsection id="idb347a96c07cd407bb5586c25d6e0e197"><enum>(a)</enum><header>Definitions</header><text>Section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>) is amended—</text><paragraph commented="no" id="id163f73f4ca6b461583ba2d3f3edbaefc"><enum>(1)</enum><text>in paragraph (g)(1)(C), by striking <quote>(other than food)</quote> and inserting <quote>(other than food or cannabinoid products)</quote>;</text></paragraph><paragraph id="id7d279fd985e042a49a76432544193155"><enum>(2)</enum><text>in paragraph (ff)(1), by striking <quote>(other than tobacco)</quote> and inserting <quote>(other than a tobacco product or a cannabinoid product)</quote>;</text></paragraph><paragraph id="id30c8e74d541149a4a702c9f0322cafd6"><enum>(3)</enum><text>in paragraph (rr)(4), by inserting <quote>cannabinoid product,</quote> after <quote>medical device</quote>; and</text></paragraph><paragraph id="id2dcf20a568ca4794a0f2a72dd27d52cc"><enum>(4)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ida845b5814ebe49ef96bb90094986106d"><subsection commented="no" id="id4b87c52f5212491d8c72df5a80253db8"><enum>(tt)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id3AB0006C78B34B479C5349F4D44E8BCB"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id849E0E9CAD4246F5B22339537F2FB0FA"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>cannabis</term> means— </text><clause commented="no" id="id210BEC07ACDF47B9B04B6C4A1EFF03C2" indent="up2"><enum>(i)</enum><text display-inline="yes-display-inline">all parts of the plant Cannabis sativa L., whether growing or not; </text></clause><clause commented="no" indent="up2" id="idD73E0229BF8346968DC180D711B20043"><enum>(ii)</enum><text display-inline="yes-display-inline">the seeds of such plant;</text></clause><clause commented="no" indent="up2" id="idB9ED4EDBD8C54AAAB755D4DE0DBC236C"><enum>(iii)</enum><text display-inline="yes-display-inline">the resin extracted from any part of such plant; and </text></clause><clause commented="no" indent="up2" id="id66116EA25C494A8CB74F700F71ADD677"><enum>(iv)</enum><text display-inline="yes-display-inline">every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin, or other constituent element derived from such plant. </text></clause></subparagraph><subparagraph commented="no" indent="up2" id="id9B01BD9FCB48406189135D1C5ED73273"><enum>(B)</enum><text display-inline="yes-display-inline">The term <term>cannabis</term> does not include—</text><clause commented="no" display-inline="no-display-inline" id="idb75656b7784044278e8dbf3b6878f050"><enum>(i)</enum><text display-inline="yes-display-inline">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;</text></clause><clause id="id85fc6c9307c947729db5e033893dea48"><enum>(ii)</enum><text>a cannabinoid product; or</text></clause><clause id="id1cdd2806b46249ed8a4b7f63d5c36efd"><enum>(iii)</enum><text>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.</text></clause></subparagraph></paragraph><paragraph id="id04fc9d5195224ea488122a7a6b89cbbd" commented="no" indent="up1"><enum>(2)</enum><text>The term <term>cannabinoid</term> means any of the following:</text><subparagraph commented="no" display-inline="no-display-inline" id="id61ba6bb3b7424953809cfa3fd9161638"><enum>(A)</enum><text>Any chemical in any plant of the genus Cannabis that is unique in nature to such plant, including any of the following chemicals:</text><clause commented="no" display-inline="no-display-inline" id="id682a6934def74d16867fabd4f6250bbd"><enum>(i)</enum><text>Tetrahydrocannabinol.</text></clause><clause id="id39EC35FADF984472B4128533773DFF8F" commented="no"><enum>(ii)</enum><text>Cannabinol.</text></clause><clause id="idD0CE47DA3BB946C7862D706A578B4DEF" commented="no"><enum>(iii)</enum><text>Cannabidiol.</text></clause><clause id="id5D1EA90E648641B9AF18D5A019CCE990" commented="no"><enum>(iv)</enum><text>Cannabigerol.</text></clause><clause id="id9DA888AD7650465AAB427B6062BDCA62" commented="no"><enum>(v)</enum><text>Cannabichromene.</text></clause><clause id="id55F7D84769364CCF9BDDC2121CB7DD6F" commented="no"><enum>(vi)</enum><text>Tetrahydrocannabivarin.</text></clause><clause id="id68FDE97F3B4E4ED4A9516F26EA642E5B" commented="no"><enum>(vii)</enum><text>Cannabivarin.</text></clause><clause id="id91F22CBC594C44FABD226CB2F9165C59" commented="no"><enum>(viii)</enum><text>Cannabidivarin.</text></clause><clause id="id391FB36C41F44F88AB87775BA00A5B92" commented="no"><enum>(ix)</enum><text>Cannabielsion.</text></clause><clause id="id28136E1D80E5446FA502F8B06D2AA22F" commented="no"><enum>(x)</enum><text>Cannabicyclol.</text></clause><clause id="id5B617DC42D04474EABF06659B7100041" commented="no"><enum>(xi)</enum><text>Cannabitriol. </text></clause><clause id="idad40c3af33f3444da858e9f9ed98fc1a"><enum>(xii)</enum><text>Cannabicitran. </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idacdd547001bf4b7db45ea802142b563b"><enum>(B)</enum><text>Any isomer of a chemical described in clause (A), and any acids, acetates, salts, esters, ethers, and derivatives thereof.</text></subparagraph><subparagraph id="ida5adfc29ecc54c659a77259c6db0e3a1"><enum>(C)</enum><text>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).</text></subparagraph><subparagraph id="id2f2bf72c3b2d43c881fe4035286bb19f"><enum>(D)</enum><text>Any chemical derived from a plant of the genus Cannabis that is a CB–1 or CB–2 receptor agonist or partial agonist. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idaa99ab5a8aec42c3a16731e1052ba064"><enum>(E)</enum><text>Any chemical that the Secretary has, by order, deemed to be a cannabinoid.</text></subparagraph></paragraph><paragraph id="id2ca31d0c17d34d85931440b8f732a067" indent="up1"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id86e5f4db5c624eb1a7ada84037e18ede"><enum>(A)</enum><text>The term <term>cannabinoid product</term> means any article or product, including its components or parts, that—</text><clause indent="up1" commented="no" display-inline="no-display-inline" id="id9108815236744d2997632a2fc5f31de5"><enum>(i)</enum><text display-inline="yes-display-inline">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</text></clause><clause indent="up1" commented="no" display-inline="no-display-inline" id="id9f663de7ff5c4a57b732e046f579e250"><enum>(ii)</enum><text display-inline="yes-display-inline">is intended for use in, through any route of administration, or to be applied to, the body of humans or other animals.</text></clause></subparagraph><subparagraph indent="up1" commented="no" display-inline="no-display-inline" id="idaf850116e04745d3a5a90e5b528f3786"><enum>(B)</enum><text display-inline="yes-display-inline">The term <term>cannabinoid product</term> does not include—</text><clause commented="no" display-inline="no-display-inline" id="idf83917135fdb4a11b020bbaa26174109"><enum>(i)</enum><text>a drug that is subject to the requirements of chapter V or section 351 of the Public Health Service Act;</text></clause><clause commented="no" id="id0E890CEA04CA49E5B5E23E369A2B3B0F"><enum>(ii)</enum><text>a device that is subject to the requirements of chapter V;</text></clause><clause commented="no" id="id4FD0140E96D041879ED841A60A09C368"><enum>(iii)</enum><text>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</text></clause><clause commented="no" display-inline="no-display-inline" id="id0bbe3a8c42e44720b64d4e84102c81f2"><enum>(iv)</enum><text display-inline="yes-display-inline">a virus, serum, toxin, or analogous product subject to the requirements of the eighth paragraph of the matter under the heading <quote><header-in-text level="section" style="traditional">BUREAU OF ANIMAL INDUSTRY</header-in-text></quote> in the Act of March 4, 1913 (commonly known as the <quote>Virus-Serum-Toxin Act</quote>).</text></clause></subparagraph></paragraph><paragraph id="id415806cb772546ee89dc3529546072b4" indent="up1"><enum>(4)</enum><text>With respect to cannabis or a cannabinoid product, the term <term>manufacture</term> does not include the planting, cultivation, growing, or harvesting of cannabis.</text></paragraph><paragraph indent="up1" commented="no" display-inline="no-display-inline" id="id457b86653fe94dcdab84b3d8dd44e167"><enum>(5)</enum><text display-inline="yes-display-inline">With respect to a cannabinoid product, the term <term>serious adverse effect</term> means that use of the product—</text><subparagraph commented="no" display-inline="no-display-inline" id="id72d64a4ab5684741ac4a211841d23579"><enum>(A)</enum><text display-inline="yes-display-inline">results in—</text><clause commented="no" display-inline="no-display-inline" id="idb1b51d189ae04d20bbc45533b7295778"><enum>(i)</enum><text display-inline="yes-display-inline">death; </text></clause><clause commented="no" display-inline="no-display-inline" id="id5ad5013db02c44ae9a99645636e6d4d6"><enum>(ii)</enum><text display-inline="yes-display-inline">a life-threatening adverse experience; </text></clause><clause commented="no" display-inline="no-display-inline" id="idb7d2e1c9c39544b2b23c405678bd3a0a"><enum>(iii)</enum><text display-inline="yes-display-inline">inpatient hospitalization or prolongation of existing hospitalization; </text></clause><clause commented="no" display-inline="no-display-inline" id="id991890822c8e4f6cb864553fd52fbe03"><enum>(iv)</enum><text display-inline="yes-display-inline">a persistent or significant disability or incapacity; </text></clause><clause commented="no" display-inline="no-display-inline" id="id37ef1bbce2c6477a81ecbfb8adb267df"><enum>(v)</enum><text display-inline="yes-display-inline">a congenital anomaly or birth defect; or </text></clause><clause commented="no" display-inline="no-display-inline" id="idb36163f1e94044c69e66f9c391f2cf78"><enum>(vi)</enum><text display-inline="yes-display-inline">other serious medical event; or </text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id712507a6ce2e4798a5a258aa666933a4"><enum>(B)</enum><text display-inline="yes-display-inline">requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in clause (A).</text></subparagraph></paragraph></subsection><subsection id="idd8bcf3dfc40142718db03fe9955929d1"><enum>(uu)</enum><text>The term <term>intended for human consumption</term>, with respect to a cannabinoid product, means a cannabinoid product intended for ingestion or inhalation by a human. </text></subsection><subsection id="id4c63b017cce040f6af832037d8cfa52b"><enum>(vv)</enum><text display-inline="yes-display-inline">The term <term>tetrahydrocannabinol</term> means—</text><paragraph id="id468507812541494db46838513b1bdc90"><enum>(1)</enum><text>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;</text></paragraph><paragraph id="id3ecb5bf3265343719dfdfe6def57b46e"><enum>(2)</enum><text>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;</text></paragraph><paragraph id="idc189c63f789a4c1592f8d696370501cc"><enum>(3)</enum><text>tetrahydrocannabivarins, including delta-8 tetrahydrocannabivarin, and exo-tetrahydrocannabinol;</text></paragraph><paragraph id="id45b0534270934423800b3e1cc477d142"><enum>(4)</enum><text>hydrogenated forms of tetrahydrocannabinol including hexahydrocannabinol, hexahydrocannabiphorol, and hexahydrocannabihexol;</text></paragraph><paragraph id="id23d38d79de354746aa6fb36e519232ce"><enum>(5)</enum><text>analogues of tetrahydrocannabinols with an alkyl chain of four or more carbon atoms, including tetrahydrocannabiphorols, tetrahydrocannabiocytls, tetrahydrocannabihexols, or tetrahydrocannabutols; and</text></paragraph><paragraph id="idd2390a60b5a649fc8286508f084cfef7"><enum>(6)</enum><text>any combination of the chemical substances described in subparagraphs (1) through (5) whether naturally or artificially derived or synthetically or semi-synthetically produced. </text></paragraph></subsection><subsection id="ida003ac1d5dc941179fd4470973f1e6c5"><enum>(ww)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id08ff4de079af4f2e9e86df7efe23ff32"><enum>(1)</enum><text>The term <term>artificially or synthetically derived cannabinoid</term> 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. </text></paragraph><paragraph indent="up1" commented="no" display-inline="no-display-inline" id="idd185582b0a624813b8356de544f5bc4e"><enum>(2)</enum><text>The term <term>artificially or synthetically derived cannabinoid</term> does not include—</text><subparagraph commented="no" display-inline="no-display-inline" id="id8a7723f09efb487db21ec92e79927cef"><enum>(A)</enum><text display-inline="yes-display-inline">a cannabinoid or a cannabinoid-like compound produced through the decarboxylation of naturally occurring cannabinoids from their acidic forms;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida9fbf6aad3454ad69a343c63805354ba"><enum>(B)</enum><text display-inline="yes-display-inline">a cannabinoid product or input that undergoes the removal of solvents, catalysts, or other unwanted materials from the cannabinoid product or input; or </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id60d0e6bfb6ab408e85b138d22eb642dd"><enum>(C)</enum><text display-inline="yes-display-inline">a semi-synthetic cannabinoid.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" indent="up1" id="id376a933a69184843bda69adbc27f8329"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id44b696d2af5a4b2894906eb27dbab7b4"><enum>(A)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (2)(C), the term <term>semi-synthetic cannabinoid</term> 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. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" indent="up1" id="id35cb6001f48246498c7a66cf55f81fdb"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (2)(C), the term <term>semi-synthetic cannabinoid</term> includes a cannabinoid that is produced by the conversion of cannabidiol, including cannabinol and delta–8 tetrahydrocannabinol.</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" indent="up1" id="id954f42bc575d4c9b9410448b85a69a9b"><enum>(C)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (2)(C), the term <term>semi-synthetic cannabinoid</term> 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.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="ida101563e921b4037a3ceb9a8f53dd5d4"><enum>(b)</enum><header>Prohibited Acts</header><text>Section 301 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended—</text><paragraph id="id32a6e396488d4e99aaeec54bd81d86a8"><enum>(1)</enum><text>by inserting <quote>cannabinoid product,</quote> after <quote>tobacco product,</quote> each place it appears in paragraphs (g) and (h);</text></paragraph><paragraph commented="no" id="idBFCD832BC0244853940741636AD0D40D"><enum>(2)</enum><text>in paragraph (j), by striking <quote>or 920(b)</quote> and inserting <quote>920(b), or 1104</quote>;</text></paragraph><paragraph commented="no" id="idC8C5EFDCACD34D30A5FD4922A1486349"><enum>(3)</enum><text>in paragraph (p)—</text><subparagraph commented="no" id="id292EDC4C9E254472B3AB2EA33B9DFC23"><enum>(A)</enum><text>by striking <quote>510 or 905</quote> and inserting <quote>510, 905, or 1104</quote>;</text></subparagraph><subparagraph commented="no" id="idC4B02686019F4FFCBBFE25B815276F8B"><enum>(B)</enum><text>by striking <quote>or 905(j)</quote> and inserting <quote>905(j), or 1104(g)</quote>; and</text></subparagraph><subparagraph commented="no" id="idAC694F09A1084EAFA89B771935C746B4"><enum>(C)</enum><text>by striking <quote>or 905(i)(3)</quote> and inserting <quote>, 905(i)(3), or 1104(g)(2)</quote>;</text></subparagraph></paragraph><paragraph id="idf51629979063452eb7b47c7975055ee9"><enum>(4)</enum><text>in paragraph (q)(2) by inserting <quote>, cannabinoid product,</quote> after <quote>device</quote>; </text></paragraph><paragraph id="id7C587350B850492EB5E0D28B98C37016"><enum>(5)</enum><text>in paragraph (r), by inserting <quote>cannabinoid product,</quote> after <quote>device,</quote> each place it appears; and</text></paragraph><paragraph id="id8c8979ddcf1f46a4892e33ad2d9024c2"><enum>(6)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idC18A8F62972745899D28BFE18127B1BE"><subsection commented="no" id="ide98142c2cf354fd58185bd133709ebc2"><enum>(jjj)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id74ADB37800BE403B981713AB60FBCDD3"><enum>(1)</enum><text>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.</text></paragraph><paragraph indent="up1" commented="no" display-inline="no-display-inline" id="id406d44f1592343fb9e5c27518f7370d7"><enum>(2)</enum><text>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.</text></paragraph><paragraph commented="no" indent="up1" id="idAD2AC99BD41D4D65AFAA95A843C188C0"><enum>(3)</enum><text>The failure of a manufacturer or distributor to notify the Attorney General of its knowledge of cannabinoid products used in illicit trade.</text></paragraph></subsection><subsection commented="no" id="id53015C84269541038AD329AE21CEA9E0"><enum>(kkk)</enum><paragraph commented="no" display-inline="yes-display-inline" id="idA576AA68342B429087E3938472ED4E48"><enum>(1)</enum><text>The introduction or delivery for introduction into commerce of any cannabinoid product that is adulterated or misbranded.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idac1596e5c47740d3abe19d92b85445e8" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">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— </text><subparagraph commented="no" display-inline="no-display-inline" id="id5321a8f1e9bf4066807e86907f3eb785"><enum>(A)</enum><text display-inline="yes-display-inline">contains any synthetic ingredient with a molecular structure that does not occur in nature; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide5560b0e216a472c9d79c06e063a6ec3"><enum>(B)</enum><text display-inline="yes-display-inline">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. </text></subparagraph></paragraph><paragraph commented="no" id="id8744BD199E294F5EA5B47F38F94C47BD" indent="up1"><enum>(3)</enum><text>The adulteration or misbranding of any cannabinoid product in commerce. </text></paragraph><paragraph commented="no" indent="up1" id="id05646FC4D8D54395B4E338A403216B35"><enum>(4)</enum><text>The receipt in commerce of any cannabinoid product that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.</text></paragraph><paragraph commented="no" indent="up1" id="idCB37EF2E68CA4D9CA2EA85F52D44CA3F"><enum>(5)</enum><text>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. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id65007822c17e4ef1a6a5ee611e5da839"><enum>(lll)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id7796474777d541e9a3dfec356290b56d"><enum>(1)</enum><text display-inline="yes-display-inline">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. </text></paragraph><paragraph commented="no" display-inline="no-display-inline" indent="up1" id="idd1efb7bc48d24b998748cbb2020c3aac"><enum>(2)</enum><text display-inline="yes-display-inline">The sale or distribution of a cannabinoid product intended for human consumption that is in liquid form, unless such cannabinoid product—</text><subparagraph commented="no" display-inline="no-display-inline" id="id9e583cd587194b8e9cfb368e1577bf14"><enum>(A)</enum><text display-inline="yes-display-inline">contains not more than one serving; or </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcbf18233033b441db8108ad1f5e41a8d"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="idf984fb92477244fbb01aa2bfb5bd886d"><enum>(c)</enum><header>Penalties</header><text>Section 303(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)</external-xref>) is amended—</text><paragraph id="idd2ccae7e95984765a113696fe343000d"><enum>(1)</enum><text>in paragraph (5)—</text><subparagraph id="id3606d988cf6347e4ba83278eb4fd557a"><enum>(A)</enum><text>in subparagraph (A)—</text><clause id="id616f5c745f034efcb70ffa70b5b86470"><enum>(i)</enum><text>in the first sentence, by striking <quote>or (9)</quote> and inserting <quote>(9), or (11)</quote>; and</text></clause><clause id="idd81ed5c4df084b298c2c8dd0cced3ca9"><enum>(ii)</enum><text>by inserting <quote>or no-cannabinoid-product-sale order</quote> after <quote>no-tobacco-sale order</quote> each place it appears;</text></clause></subparagraph><subparagraph id="id6dca1c796de7400e84cc0b35a9b1b66f"><enum>(B)</enum><text>in subparagraph (B)—</text><clause id="idcbe09b75f9004d5585dede5ec0400774"><enum>(i)</enum><text>by inserting <quote>or no-cannabinoid-product-sale order</quote> after <quote>no-tobacco-sale order</quote> each place it appears; and</text></clause><clause id="id8e049b944eac4640a528c4e9e157ca94"><enum>(ii)</enum><text>in the second sentence, by inserting <quote>or cannabinoid products, as applicable,</quote> after <quote>tobacco products</quote>;</text></clause></subparagraph><subparagraph id="id48e9016c332748b687be5841f3017961"><enum>(C)</enum><text>in subparagraph (C), in the first sentence, by striking <quote>or (9)</quote> and inserting <quote>(9), or (11)</quote>; and</text></subparagraph><subparagraph id="id39ade938ef804ca2a6eac0b3efa98ac3"><enum>(D)</enum><text>in subparagraph (D) by inserting <quote>or no-cannabinoid-product-sale order</quote> after <quote>no-tobacco-sale order</quote>;</text></subparagraph></paragraph><paragraph id="ida8a623630236466f9e84844d34bdc93d"><enum>(2)</enum><text>in paragraph (6), by inserting <quote>or no-cannabinoid- product-sale order</quote> after <quote>no-tobacco-sale order</quote> each place it appears; and</text></paragraph><paragraph id="ide10b1e41c6814840a9028376891c45b5"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idA409FABDC8AC44FDA46A16BBA1BC0297"><paragraph id="id08b3cb84373b4148a6568480bbc4ae0e"><enum>(10)</enum><header>Civil monetary penalties for violation of cannabinoid product requirements</header><subparagraph id="ida20f473f64584b3797925dc6176c6cf9"><enum>(A)</enum><header>In general</header><text>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.</text></subparagraph><subparagraph id="id01d9853402904a97a5fe3d4054da3d7f"><enum>(B)</enum><header>Enhanced civil penalties</header><text>Any person who knowingly violates a requirement of this Act that relates to cannabinoid products shall be subject to a civil monetary penalty of—</text><clause id="ide385a0bb27ee45deb6e054f7d528d303"><enum>(i)</enum><text>not to exceed $250,000 per violation, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding; or</text></clause><clause id="id65ed40662a8d4a87ba4378f553772616"><enum>(ii)</enum><text>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.</text></clause></subparagraph></paragraph><paragraph id="id395636ee573f42caa87ab2a9d1ab014a" commented="no"><enum>(11)</enum><header>Repeated violations relating to cannabinoid products</header><subparagraph commented="no" display-inline="no-display-inline" id="idcf618c03ee6244f1b718486f05539dcc"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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).</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb55cc992516e44aa85a79d151f40137a"><enum>(B)</enum><header>Hearing</header><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="id18d727fd98e04d9f9e412c9f6dfa3b0f"><enum>(d)</enum><header>Seizure authorities</header><text display-inline="yes-display-inline">Section 304 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/334">21 U.S.C. 334</external-xref>) is amended—</text><paragraph id="idF4743303D92741FC80DE29A6F2F2FC84"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph id="idF9696C8347EE4B98A187A8E5FFE9293B"><enum>(A)</enum><text>in paragraph (1), by inserting <quote>cannabinoid product,</quote> after <quote>drug,</quote>; and</text></subparagraph><subparagraph id="id855092DC636542CBAA8DB2422C239129" commented="no"><enum>(B)</enum><text>in paragraph (2)—</text><clause commented="no" display-inline="no-display-inline" id="id282d4e3c9c0543e58644f1743c281804"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>and (H) Any punch</quote> and inserting <quote>(H) Any punch</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="ida6f0750c9e7e49c3ad97018622d5ac5b"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting before the period at the end the following: <quote>, and (I) Any adulterated or misbranded cannabinoid product</quote>;</text></clause></subparagraph></paragraph><paragraph id="id726F4CA1F3994D0083050E4AF2EF6CAD"><enum>(2)</enum><text>in subsection (d)(1), by inserting <quote>cannabinoid product,</quote> after <quote>tobacco product,</quote>; and</text></paragraph><paragraph id="id05BEEEDDBDC841FFAAD229AF39E5CE63"><enum>(3)</enum><text>in subsection (g), by striking <quote>or tobacco product</quote> each place it appears in paragraphs (1) and (2)(A) and inserting <quote>, tobacco product, or cannabinoid product</quote>.</text></paragraph></subsection><subsection id="id5BE641F43D2B42ADA52B7BAFD3F007EE"><enum>(e)</enum><header>Factory inspection</header><text display-inline="yes-display-inline">Section 704 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>) is amended—</text><paragraph id="id96a49bb55dca41a3bd8b4cf571a3e6b4"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph id="id366c9cfae9324878b4eac9bc4512ff1e"><enum>(A)</enum><text>by inserting <quote>cannabinoid products,</quote> after <quote>tobacco products,</quote> each place it appears;</text></subparagraph><subparagraph id="id2e35071b1c1a48dd9aa760f6a5bc0817"><enum>(B)</enum><text>by striking <quote>or tobacco products</quote> each place it appears and inserting <quote>tobacco products, or cannabinoid products</quote>; and</text></subparagraph><subparagraph id="id87eadb7c51904f398e30741eda6f509a"><enum>(C)</enum><text>by striking <quote>and tobacco products</quote> and inserting <quote>tobacco products, and cannabinoid products</quote>; and</text></subparagraph></paragraph><paragraph id="id0ad872d0af594566a9d795a0fc8ba1aa"><enum>(2)</enum><text>in subsection (b)(1), by inserting <quote>cannabinoid product,</quote> after <quote>tobacco product,</quote>. </text></paragraph></subsection><subsection id="id1F93CDD3F74840F2B521411CBA43C6A8"><enum>(f)</enum><header>Publicity</header><text display-inline="yes-display-inline">Section 705(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/375">21 U.S.C. 375(b)</external-xref>) is amended by inserting <quote>cannabinoid products,</quote> after <quote>tobacco products,</quote>.</text></subsection><subsection id="id3836975760164b15bbbc5c1b321400ac"><enum>(g)</enum><header>Presumption</header><text display-inline="yes-display-inline">Section 709 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379a">21 U.S.C. 379a</external-xref>) is amended by inserting <quote>cannabinoid product,</quote> after <quote>tobacco product,</quote>.</text></subsection><subsection id="id0b4956a6d20d4624bf57aac1353e85df"><enum>(h)</enum><header>Imports and exports</header><text display-inline="yes-display-inline">Section 801 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381</external-xref>) is amended—</text><paragraph id="idc9f49d3f01b846ce8805e70a675357c1"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph id="idb44319279c2448e5b21e77f45b736810"><enum>(A)</enum><text>by inserting <quote>cannabinoid products,</quote> after <quote>tobacco products,</quote>;</text></subparagraph><subparagraph id="idf387b123821d4ef6ab8cdaa28e933dbd"><enum>(B)</enum><text>by striking <quote>or tobacco products</quote> each place it appears and inserting <quote>, tobacco products, or cannabinoid products</quote>; and</text></subparagraph><subparagraph id="id5ce7097772ac4f67a615e075309fe626"><enum>(C)</enum><text>by striking <quote>or section 905(h)</quote> and inserting <quote>, 905(h), or 1104</quote>; and</text></subparagraph></paragraph><paragraph id="id03b5589b252a4611a655953dee5e3d88" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>in subsection (e), by striking <quote>tobacco product or</quote> and inserting <quote>tobacco product, cannabinoid product, or</quote>. </text></paragraph></subsection></section><section id="idf0a7e9cce1054028b8acfa67b9d0eb3a" commented="no"><enum>103.</enum><header>Regulation of cannabinoid beverages containing tetrahydrocannabinol</header><text display-inline="no-display-inline">Not later than 60 days after the date of enactment of this Act, the Secretary of Agriculture, the Commissioner of Food and Drugs, the Attorney General, and the Director of the Alcohol and Tobacco Tax and Trade Bureau, acting jointly, shall publish a report that includes recommendations for a Federal regulatory framework for cannabinoid beverages that contain tetrahydrocannabinol (as defined in paragraph (vv) of section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>)) that—</text><paragraph id="id931d3a2ce73344969225728150ef9370" commented="no"><enum>(1)</enum><text>is modeled on the Federal regulatory framework for alcohol; and</text></paragraph><paragraph id="id5674ca47322f49d4ab960fb87fa9f3f0" commented="no"><enum>(2)</enum><text>delineates responsibilities among the Department of Agriculture, the Food and Drug Administration, the Department of Justice, and the Alcohol and Tobacco Tax and Trade Bureau, for labeling, taxation, manufacturing, and adulteration standards of cannabinoid beverages that contain tetrahydrocannabinol.</text></paragraph></section><enum>II</enum><header>Public health</header><section id="idc5c0916ed1e3435783dbc535ccb9fa82"><enum>201.</enum><header>Public health surveillance and data collection</header><subsection id="id810f057973c9449b92a7925ce4c0bcc3"><enum>(a)</enum><header>In general</header><text>Section 392A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1">42 U.S.C. 280b–1</external-xref>) is amended—</text><paragraph id="id0d71b4d279994125b34ca16f5b339bd3"><enum>(1)</enum><text>in the section heading, by inserting <quote><header-in-text style="OLC" level="section">and adverse health effects of cannabis use</header-in-text></quote> after <quote><header-in-text style="OLC" level="section">substances</header-in-text></quote>;</text></paragraph><paragraph id="ida7efe0fea8ff4d2e8b4de5f378ab1c62"><enum>(2)</enum><text>in subsection (a)—</text><subparagraph id="idE9A3007EFDFF4B17805624EB0B89C185"><enum>(A)</enum><text>in paragraph (2)—</text><clause id="id1CF8C017483143729364137DAD6038EA"><enum>(i)</enum><text>in subparagraph (C) by inserting <quote>and adverse health effects of cannabis use</quote> before the period; and</text></clause><clause id="id7A187D865F5D4292B990C9132F37A225"><enum>(ii)</enum><text>in subparagraph (D) by inserting <quote>, cannabis, and polysubstance use</quote> before the period; and</text></clause></subparagraph><subparagraph id="idb069b595346d4c489d06f5542a83547f"><enum>(B)</enum><text>in paragraph (4), by inserting <quote>and collect data to better understand the use and health effects of cannabis, stimulants, and polysubstances, and</quote> after <quote>conduct studies and evaluations</quote>; </text></subparagraph></paragraph><paragraph id="id39d156fcfcef47f8bc41e14de14aecc8"><enum>(3)</enum><text>in subsection (e), by striking <quote>$496,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$596,000,000 for each of fiscal years 2024 through 2028</quote>; and</text></paragraph><paragraph id="idA2E1676EFB1A4504B4CC505922949DC4"><enum>(4)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idB4DC8FCEF7004E279B3C29B5975796DE"><subsection id="idDAE1E463DE9D44EBAE39D80CEEBC9D7A"><enum>(f)</enum><header>Additional funding</header><text>In addition to amounts otherwise available, there is appropriated, out of any funds in the Treasury not otherwise appropriated, $100,000,000 for each of fiscal years 2024 through 2028 to carry out this section.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section commented="no" id="idD95274F8DC6D4097AB273273A39E55B8"><enum>202.</enum><header>Awards to prevent underage cannabis use</header><text display-inline="no-display-inline">Part D of title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290dd">42 U.S.C. 290dd et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block id="idAC77D94219BB442DB5FB02A3C1224BD2" display-inline="no-display-inline" style="OLC"><section id="id21919C6907354A048966A89BCB8545FB"><enum>553.</enum><header>Awards to prevent underage cannabis use</header><subsection commented="no" id="id03F622320DCF4B7B8F637402129C20C9"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Assistant Secretary, shall award grants, contracts, and cooperative agreements to eligible entities to prevent and reduce underage use of cannabis. </text></subsection><subsection id="idcc2be02d2160431f9f9216e181e32914"><enum>(b)</enum><header>Eligible entities</header><text>To receive an award under this section, an entity shall be a State, a political subdivision of a State, an Indian Tribe or Tribal organization, an urban Indian organization, a nonprofit community-based organization, or any other nonprofit entity the Secretary determines appropriate.</text></subsection><subsection id="id1bc104d1dde14c4ea402b7249d3b9bcb"><enum>(c)</enum><header>Use of funds</header><text>An eligible entity receiving an award under this subsection shall use funds from such award to—</text><paragraph id="id9ef96b87d01d44e1a3b821d1e97d7b06"><enum>(1)</enum><text>establish, enhance, and support culturally- and linguistically-appropriate programs, including community-based, school-based, and higher-education based programs, and programs that target youth within the juvenile justice and child welfare systems, that offer screening, prevention, early intervention, diagnosis, treatment, referral, and recovery support services related to underage cannabis use;</text></paragraph><paragraph id="id0ad366b423de439d823a304a70406d88"><enum>(2)</enum><text>design, test, evaluate, and disseminate evidence-based and evidence-informed strategies to maximize the effectiveness of community-wide approaches to preventing and reducing underage cannabis use;</text></paragraph><paragraph id="id9ce565810476429389ff6c2a04904057"><enum>(3)</enum><text>educate children, adolescents, youth, parents, health care providers, and communities about the dangers of underage cannabis use, including impaired driving due to cannabis use;</text></paragraph><paragraph id="id8a29cdfa62014037b1faefdf15b354d8"><enum>(4)</enum><text>collect data on underage cannabis use to identify and address needs, service gaps, and trends;</text></paragraph><paragraph id="ide19af0e104514f60a4717c001c717e3c"><enum>(5)</enum><text>strengthen collaboration among communities, the Federal Government, and State, local, and Tribal governments to prevent underage cannabis use;</text></paragraph><paragraph id="idecd1edebe0eb4ddbb38df7054114033d"><enum>(6)</enum><text>address community norms regarding underage cannabis use, reduce opportunities for underage cannabis use, and reduce the prevalence of negative consequences associated with underage cannabis use; and</text></paragraph><paragraph id="id44bde9e808bb411ab8f49e915faa5f44"><enum>(7)</enum><text>support other evidence-based and evidence-informed practices to reduce underage cannabis use, as determined by the Secretary.</text></paragraph></subsection><subsection id="id067458188743454cb01b8659879f4076"><enum>(d)</enum><header>Supplement not supplant</header><text>Funds awarded under this section shall supplement, and not supplant, existing State, Federal, local, and Tribal funds to prevent and reduce underage cannabis use.</text></subsection><subsection id="id65deb7ae2e7140e4b5f04d915796fe54"><enum>(e)</enum><header>Priority consideration</header><text>In making awards under this section, the Secretary shall give priority to eligible entities that serve medically underserved communities, communities with high rates of underage cannabis use, and communities that have historically experienced disproportionate arrest and conviction rates related to the sale, possession, use, manufacture, or cultivation of cannabis (but not counting convictions involving distribution of cannabis to a minor).</text></subsection><subsection id="idebe03188ae754999a7cdc55c716ce6cc"><enum>(f)</enum><header>Funding</header><text>In addition to amounts otherwise available, there is appropriated, out of any funds in the Treasury not otherwise appropriated, $25,000,000 for each of fiscal years 2024 through 2028 to carry out this section.</text></subsection><subsection id="idbee43cd55efc4937b3256c5ed98ff1d3" commented="no"><enum>(g)</enum><header>Definitions</header><text>In this section:</text><paragraph id="id267ada6495b44754a5853f022e574165"><enum>(1)</enum><header>Cannabis</header><text>The term <term>cannabis</term> means cannabis or a cannabinoid product (as such terms are defined in section 201(tt) of the Federal Food, Drug, and Cosmetic Act).</text></paragraph><paragraph id="id19DE43C778B44C87996B93F73E6511F3" commented="no" display-inline="no-display-inline"><enum>(2)</enum><header display-inline="yes-display-inline">Indian Tribe</header><text display-inline="yes-display-inline">the term <term>Indian Tribe</term> means the governing body of any individually identified and federally recognized Indian or Alaska Native tribe, band, nation, pueblo, village, community, affiliated Tribal group, or component reservation included on the list published most recently as of the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title> pursuant to section 104(a) of the Federally Recognized Indian Tribe List Act of 1994. </text></paragraph><paragraph id="idebd91f99ed28443b8a18659ec143bc33" commented="no"><enum>(3)</enum><header>Tribal organization</header><text>The term <term>Tribal organization</term> means the governing body of an Indian Tribe.</text></paragraph><paragraph id="id6daf07b35e1d4f3bbe513c805297e9f9" commented="no" display-inline="no-display-inline"><enum>(4)</enum><header>Urban Indian organization</header><text>The term <term>urban Indian organization</term> has the meaning given such term in section 4 of the Indian Health Care Improvement Act.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><enum>III</enum><header>Cannabis-impaired driving prevention</header><section id="id1cfae99340cf4a59aef207372b40d8c6"><enum>301.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text><paragraph id="idDC018CB5FE03479E92596E08AF611665"><enum>(1)</enum><header>Administrator</header><text>The term <term>Administrator</term> means the Administrator of the National Highway Traffic Safety Administration.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idba975fc3d54d4191b8847fba88adee8e"><enum>(2)</enum><header>Cannabis</header><text>The term <term>cannabis</term> means—</text><subparagraph commented="no" display-inline="no-display-inline" id="idfa12baece12e4fa49efa38f770ce086b"><enum>(A)</enum><text display-inline="yes-display-inline">cannabis (as defined in paragraph (tt) of section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>)); and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id04b1b31cbd6546ea9fe8fd1b3f870ab5"><enum>(B)</enum><text display-inline="yes-display-inline">a cannabinoid product (as so defined).</text></subparagraph></paragraph><paragraph id="idCE4F58588D5447AAB9B9B1E091239534"><enum>(3)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Transportation.</text></paragraph><paragraph id="idA063BFBEBD6A4334BB51CD8A583F3DB7"><enum>(4)</enum><header>THC</header><text>The term <term>THC</term> means tetrahydrocannabinol (as defined in paragraph (vv) of section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>)).</text></paragraph></section><section id="id61E66EBC63194A4EA8FF44F3CA992EBF"><enum>302.</enum><header>Cannabis-impaired driving research</header><subsection id="idcea5249cb8304439b86c0d8e9b84bd6c"><enum>(a)</enum><header>Cannabis-Impaired driving data</header><paragraph id="id490AAF49CCC54D6B911EFD2E722EBC34"><enum>(1)</enum><header>In general</header><text>The Secretary shall collect and, as appropriate, share with the Secretary of Health and Human Services, data relating to cannabis-impaired driving, or a combination of cannabis and another substance, including through the collection of crash data specific to crashes involving drivers with—</text><subparagraph id="idD02E247368F045F3A2AA85ACE88EDFB0"><enum>(A)</enum><text>THC in their system; or </text></subparagraph><subparagraph id="id9E34ECB590754155AEBAA494156E7C86"><enum>(B)</enum><text>a combination of THC and another substance in their system.</text></subparagraph></paragraph><paragraph id="idb39b9487cde449b8b5a87e1212f6e153"><enum>(2)</enum><header>National roadside survey</header><subparagraph id="id5AFBC8F3C2B842CE91B6F0BACBD16855"><enum>(A)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of this Act, the Administrator shall initiate a National Roadside Survey to collect data on drivers with THC in their system.</text></subparagraph><subparagraph id="id1380c131f745417cb029fe49da40703c"><enum>(B)</enum><header>Report</header><text>Not later than 3 years after the date of enactment of this Act, the Secretary shall submit to the Committees on Commerce, Science, and Transportation, Environment and Public Works, and Health, Education, Labor, and Pensions of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report summarizing the data acquired, and conclusions drawn, from the National Roadside Survey required under subparagraph (A).</text></subparagraph></paragraph></subsection><subsection id="idc4dec164a9d74e379db0b1ba4aa15404"><enum>(b)</enum><header>Research on risks of cannabis-Impaired driving</header><paragraph id="idB3E7A1622D0B4DEC8E9A83A000041FE0"><enum>(1)</enum><header>Study required</header><subparagraph id="id9024C8A45965448F8E29258963B8EF0C"><enum>(A)</enum><header>In general</header><text>Not later than 3 years after the date of enactment of this Act, the Secretary shall carry out a study to evaluate and quantify the risks of cannabis-impaired driving.</text></subparagraph><subparagraph id="idB6683ABD0C544232A33292F13AFFEE1C"><enum>(B)</enum><header>Requirements</header><text>The study required under subparagraph (A) shall analyze—</text><clause id="id5240aa7561c5447d892f11a99eb5e054"><enum>(i)</enum><text>whether there is an increased likelihood of crashing a motor vehicle after recent cannabis use;</text></clause><clause id="id7842c9d54b8945c39be823c642788b33"><enum>(ii)</enum><text>the effect of cannabis on driving behavior;</text></clause><clause id="id1882db43faa74f91abc36a54994e3a51"><enum>(iii)</enum><text>whether there is a correlation between THC level (as tested in oral fluids or through any other test designated by the Secretary in consultation with the Secretary of Health and Human Services) and level of impairment;</text></clause><clause id="ida3b96d6020564acd8b2f1cb23ffb10c9"><enum>(iv)</enum><text>whether the current Standard Field Sobriety Test developed by the National Highway Traffic Safety Administration accurately identifies cannabis impairment and impairment due to cannabis and other substance use;</text></clause><clause commented="no" display-inline="no-display-inline" id="idc6efbbb83c70413e8fe17102d9448862"><enum>(v)</enum><text>whether driving behavior changes depending on frequency of cannabis use;</text></clause><clause commented="no" display-inline="no-display-inline" id="idbf1f3f15bc2a4e1483f4c3ce77e71402"><enum>(vi)</enum><text>whether there are any measurable increased risks associated with using cannabis together with another substance;</text></clause><clause commented="no" display-inline="no-display-inline" id="id5c0ea650a1d34b848a75d9d89c43ea62"><enum>(vii)</enum><text>whether there is a measurable effect of cannabis use by drivers on pedestrian safety; and</text></clause><clause id="id083b4cc2037e4594b621d0cbb5bf2f43"><enum>(viii)</enum><text>any other data necessary to improve safe driving outcomes, as determined by the Secretary.</text></clause></subparagraph></paragraph><paragraph id="iddb103a519cb6417f9cdc68077d686b32"><enum>(2)</enum><header>Report</header><text>Not later than 3 years after the date of enactment of this Act, and annually thereafter until the date on which the study required under paragraph (1) is complete, the Secretary shall submit to the Committees on Commerce, Science, and Transportation, Environment and Public Works, and Health, Education, Labor, and Pensions of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report summarizing the data acquired, and conclusions drawn, from the study required under paragraph (1).</text></paragraph></subsection></section><section id="ida5c2eb2408284770b907243255b00109"><enum>303.</enum><header>DOT cannabis-impaired driving prevention programs</header><subsection id="id156aea8674034344a6bd612be16821d4"><enum>(a)</enum><header>In general</header><text>The Secretary shall research and implement data-driven strategies to educate the public about the dangers of cannabis-impaired driving, which shall include the following:</text><paragraph id="id11af5029ff784c778dac05eca458db55"><enum>(1)</enum><header>Cannabis-impaired driving use prevention best practices</header><subparagraph id="idAF0E4C092F984AA6A06714D879C2C03F"><enum>(A)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of this Act, the Secretary shall develop and issue best practices for States and communities to prevent cannabis-impaired driving, including impaired driving involving the use of cannabis and another substance and practices targeting drivers under the age of 21, in consultation with the Director of the Centers for Disease Control and Prevention, the Secretary of Health and Human Services, and the heads of other Federal agencies as appropriate.</text></subparagraph><subparagraph id="idB902B6FA8CCB4942B36FB4E8C523F78C"><enum>(B)</enum><header>Updates</header><text>Not less frequently than biannually, the Secretary shall update and reissue the best practices required under subparagraph (A) as new research and data becomes available.</text></subparagraph></paragraph><paragraph id="id4a3108f41a5a4f5d9511fbd7c3767aaa"><enum>(2)</enum><header>Cannabis-impaired driving use prevention campaigns</header><text>Not later than 2 years after the date of enactment of this Act, the Secretary shall establish and carry out national campaigns to prevent cannabis-impaired driving, including—</text><subparagraph id="idF03C62509550439CAAFC709C45BEEEAA"><enum>(A)</enum><text>cannabis-impaired driving involving the use of cannabis and another substance; and </text></subparagraph><subparagraph id="id537AF4EE4CC3423A89B273A735132FE7"><enum>(B)</enum><text>cannabis-impaired driving among drivers under the age of 21.</text></subparagraph></paragraph></subsection><subsection id="id47439acf0ce74763880bec622afdd0e9"><enum>(b)</enum><header>Campaign evaluation</header><text>Not less frequently than once every 3 years, the Secretary shall evaluate the effectiveness of the campaigns required under subsection (a)(2) and the activities carried out by States using a grant awarded under section 409 of title 23, United States Code, by using a variety of factors, including—</text><paragraph id="ide01c9f984b944f35b59d19839614ab46"><enum>(1)</enum><text>collecting data, including behavioral data, and comparing that data from before and after the campaigns;</text></paragraph><paragraph id="idefbabbb982e84c56ae3e947f3a66f501"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idF25241FFE913426A90DE9FD5BFD9DD9C"><enum>(A)</enum><text>engaging with stakeholders that were involved in the campaigns; and </text></subparagraph><subparagraph id="idBF2C9EF76AEB45519B444FB8E5C6526D" indent="up1"><enum>(B)</enum><text>analyzing feedback from those stakeholders on what the stakeholders saw as strengths and weaknesses of the campaigns;</text></subparagraph></paragraph><paragraph id="idcbc51c7ad8834a34be82df03cc2a33ea"><enum>(3)</enum><text>determining whether the campaigns accomplished the objectives the Secretary set out to accomplish through analysis of data relating to the campaigns; and</text></paragraph><paragraph id="id7fd14dd70d4d4d5aac83b7351665988c"><enum>(4)</enum><text>any other factors the Secretary determines appropriate included in the document of the National Highway Traffic Safety Administration entitled <quote>The Art of Appropriate Evaluation: A Guide for Highway Safety Program Managers</quote> and dated December 2008 (or a successor document).</text></paragraph></subsection><subsection id="id9cb3b31ebbcd4b51830405f689a85562"><enum>(c)</enum><header>Report</header><text>Not later than 6 months after the date on which the Secretary completes an evaluation conducted under subsection (b), the Secretary shall submit to the Committees on Commerce, Science, and Transportation, Environment and Public Works, and Health, Education, Labor, and Pensions of the Senate and the Committee on Transportation and Infrastructure of the House of Representatives a report that—</text><paragraph id="id34515EB5E0B74BC58080880ECE62DAAD"><enum>(1)</enum><text>summarizes the data collected and provides the analysis of the data from an evaluation conducted under subsection (b);</text></paragraph><paragraph id="id7D416342E6764CDDB6DB5DBA7E521339"><enum>(2)</enum><text>includes recommendations for future impaired driving campaigns; and </text></paragraph><paragraph id="id468318D75CD94371B951A22665DACCE0"><enum>(3)</enum><text>includes any determinations that a national campaign or an activity carried out by a State using a grant awarded under section 409 of title 23, United States Code, is ineffective at preventing cannabis-impaired driving.</text></paragraph></subsection></section><section id="id15a645a2db56406a9479382550a9e8e3"><enum>304.</enum><header>State cannabis-impaired driving prevention grant program</header><subsection id="id7237B6B7DC8D47F1AF20249B8D5DA6D9"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/23/4">Chapter 4</external-xref> of title 23, United States Code, is amended by inserting after <external-xref legal-doc="usc" parsable-cite="usc/23/408">section 408</external-xref> the following:</text><quoted-block style="USC" display-inline="no-display-inline" id="id8EFD806511214ACDB59EA289686F2E2C"><section id="idE48E936B5F5241E0B427A0B7C8EF7114"><enum>409.</enum><header>State cannabis-impaired driving prevention grant program</header><subsection id="idD47316DE1F4D430396365D7DBFBA4AD0"><enum>(a)</enum><header>Definitions</header><text>In this section:</text><paragraph id="id994142D19D17474395C4B0F3D492F792" commented="no"><enum>(1)</enum><header>Cannabis</header><text>The term <term>cannabis</term> has the meaning given the term in paragraph (tt) of section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text></paragraph><paragraph id="id96FA57535EBD4E1D936997B6ADE6DF4A"><enum>(2)</enum><header>Grant program</header><text>The term <term>grant program</term> means the grant program established under subsection (b).</text></paragraph><paragraph id="id451AC5717E75402CB1A7886D62E98F74" commented="no"><enum>(3)</enum><header>THC</header><text>The term <term>THC</term> means tetrahydrocannabinol (as defined in paragraph (vv) of section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>)).</text></paragraph></subsection><subsection id="idAAC4A936C14A4C74ACBF006074CF5DE9"><enum>(b)</enum><header>Establishment</header><text>Not later than 1 year after the date of enactment of the <short-title>Cannabinoid Safety and Regulation Act</short-title>, the Secretary, acting through the Administrator of the National Highway Traffic Safety Administration, shall establish a program to provide grants to States, in accordance with subsection (c), to implement programs to prevent impaired driving due to cannabis use.</text></subsection><subsection id="idc6ff69a1a02c440f94e5073708c77c2b"><enum>(c)</enum><header>Eligibility</header><text>The Secretary may provide a grant under this section to any State that—</text><paragraph id="id003a48f38963492faa759035de8942ce"><enum>(1)</enum><text>describes how the State will use the grant funds in accordance with a highway safety program under section 402, including how the State will implement the best practices developed by the Secretary under section 303(a)(1) of the <short-title>Cannabinoid Safety and Regulation Act</short-title>; and</text></paragraph><paragraph id="id306559e9e5b84f7c866222e12b245070"><enum>(2)</enum><text>agrees to provide data and information, as determined by the Secretary, to assist with the evaluation of the effectiveness of the eligible activities described in subsection (d).</text></paragraph></subsection><subsection id="id8c9e24b5a7e9457492c11895ce783afe"><enum>(d)</enum><header>Use of funds</header><text>A State may use a grant awarded under this section for the following activities:</text><paragraph id="id593b4c400b3b427ca945f020c1ac70b9"><enum>(1)</enum><text>Enforcement activities, including—</text><subparagraph id="idaf8782ae347f49d8b6cbb97e0395b422"><enum>(A)</enum><text>to train public safety personnel to detect impaired driving due to the use of cannabis or a combination of cannabis and another substance;</text></subparagraph><subparagraph id="id53fff9f3cd134f59bfb3706010d4d645"><enum>(B)</enum><text>to increase the capacity of impaired driving toxicology testing laboratories in the State to support impaired driving investigations, including to purchase equipment, hire staff, provide training, and improve procedures, including to improve toxicology testing standards to be consistent with the standards contained in the document of the National Safety Council entitled <quote>Recommendations for Toxicological Investigation of Drug-Impaired Driving and Motor Vehicle Fatalities–2021 Update</quote> (or a successor document);</text></subparagraph><subparagraph id="ide8aaee64089141a1b364a12421811052"><enum>(C)</enum><text>to train for and implement impaired driving assessment programs or other tools designed to increase the probability of identifying the recidivism risk of an individual convicted of driving under the influence of cannabis, or a combination of cannabis and another substance, and to determine the most effective mental health or substance abuse treatment or sanction that will reduce that risk;</text></subparagraph><subparagraph id="idfadba07d5ba44cd1b41abfa101fb3533"><enum>(D)</enum><text>to develop and implement high-visibility enforcement efforts relating to cannabis-impaired driving; and</text></subparagraph><subparagraph id="id8fce4ac2dc304ef2bc0ad656359990d1"><enum>(E)</enum><text>for court support of high-visibility enforcement efforts, to train and educate criminal justice professionals (including law enforcement personnel, prosecutors, judges, and probation officers) to assist those professionals in—</text><clause id="idD03D63B05B684FEFA0D26B3C246F08FB"><enum>(i)</enum><text>handling cannabis-impaired driving cases;</text></clause><clause id="id85FAFA793E6B4177852B72ED94A3DDEA"><enum>(ii)</enum><text>hiring traffic safety resource prosecutors;</text></clause><clause id="idC62FFE0BD46B4373BAE3F777BDE18F15"><enum>(iii)</enum><text>hiring judicial outreach liaisons; and </text></clause><clause id="idB5625E757FFC4943876BF4DE98388348"><enum>(iv)</enum><text>establishing driving while intoxicated courts.</text></clause></subparagraph></paragraph><paragraph id="id6ebdc7f299634dc895032e4e054f7c37"><enum>(2)</enum><text>Data collection activities, including—</text><subparagraph id="id262fd469ee7a4a78bd3012b24b09f454"><enum>(A)</enum><text>to collect data relating to the use of cannabis, drugs, or multiple substances by drivers, including the prevalence of the use of those substances among drivers arrested for impaired driving; and</text></subparagraph><subparagraph id="ida9f4da43c31645baa4a9b58464600fec"><enum>(B)</enum><text>to increase drug testing and reporting for all fatal crashes and serious injuries to better understand the scope of cannabis-impaired driving, or a combination of cannabis and another substance.</text></subparagraph></paragraph><paragraph id="idfdd249f5ffc6459cba75763c340cf640"><enum>(3)</enum><text>Education activities, including—</text><subparagraph id="idc1a2c10f384d4ba2a18af770cad20a24"><enum>(A)</enum><text>to develop and carry out educational campaigns to better educate the public about the harms associated with cannabis-impaired driving, including impaired driving associated with the use of cannabis and another substance; and</text></subparagraph><subparagraph id="id76036abd39824f36a2776486f1326ba8"><enum>(B)</enum><text>to participate in national campaigns organized by the Secretary under section 303(a)(2) of the <short-title>Cannabinoid Safety and Regulation Act</short-title>.</text></subparagraph></paragraph></subsection><subsection id="idc90129873420425c8dc994aa4d161b12"><enum>(e)</enum><header>Prohibition</header><text>The Secretary may prohibit the use of grant funds for an activity described in subsection (d) if the Secretary determines that the activity is ineffective at preventing cannabis-impaired driving after conducting an evaluation required under section 303(b) of the <short-title>Cannabinoid Safety and Regulation Act</short-title>.</text></subsection><subsection id="ide64c3d4e2ab34e35b207116aef266744"><enum>(f)</enum><header>Grant amounts</header><paragraph id="idB904C243AA7C499B8181EEF0B615EF71"><enum>(1)</enum><header>In general</header><text>The allocation of grant funds to a State under this section for a fiscal year shall be in proportion to the apportionment of funds a State receives under section 402(c)(2).</text></paragraph><paragraph id="idBEC78EAB14324BA1A813550DB8EFEC16"><enum>(2)</enum><header>Requirement</header><text>Not less than 10 percent of the funds allocated to a State under this section shall be used to carry out activities described in subsection (d)(1)(B).</text></paragraph></subsection><subsection id="idec699ee81b2540f28409c06764035717"><enum>(g)</enum><header>Federal share</header><paragraph id="idA557F41773F6493AA46D6E5E208C7BEE"><enum>(1)</enum><header>In general</header><text>For the first 3 fiscal years after the date on which the grant program is established under subsection (b), and each fiscal year thereafter for a State that meets the condition described in paragraph (2)(B) during that fiscal year, the Federal share of the costs of activities carried out with a grant awarded under the grant program shall be 80 percent in any fiscal year in which the State is awarded a grant.</text></paragraph><paragraph id="id6E0205FCC5A842CC9AAEEA0E7CDB73DD"><enum>(2)</enum><header>Decreased Federal share</header><subparagraph id="idF3C5D3ED1A5742159D53CA6EB35A3714"><enum>(A)</enum><header>In general</header><text>For any State that does not meet the condition described in subparagraph (B), the Federal share of the costs of activities carried out with a grant awarded under the grant program shall be—</text><clause id="id2FC2F08ECD354FEDB3B98F393B81EF4D"><enum>(i)</enum><text>70 percent in the fourth fiscal year after the date on which the grant program is established under subsection (b);</text></clause><clause id="id1B4F245E074A493AA0EAEA4FC47844B5"><enum>(ii)</enum><text>60 percent in the fifth fiscal year after that date; and</text></clause><clause id="id16A07DA4BECE4DA99B73F6922D1F3B2F"><enum>(iii)</enum><text>50 percent in the sixth fiscal year after that date and each fiscal year thereafter.</text></clause></subparagraph><subparagraph id="id7F906F0ECA6549178FBC3B573C31B4B0"><enum>(B)</enum><header>Condition</header><text>The condition referred to in paragraph (1) and subparagraph (A) is that the State shall implement an open container law relating to cannabis products.</text></subparagraph></paragraph></subsection><subsection id="id4197D019B60C49F8B9FDA22200459451"><enum>(h)</enum><header>Funding</header><text>In addition to amounts otherwise available, there is appropriated, out of any money in the Treasury not otherwise appropriated, $40,000,000 for each of fiscal years 2024 through 2028 to carry out this section.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="id59AD60267CC6453EB8E548906904CEFA"><enum>(b)</enum><header>Clerical amendment</header><text>The analysis for <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/23/4">chapter 4</external-xref> of title 23, United States Code, is amended by inserting after the item relating to <external-xref legal-doc="usc" parsable-cite="usc/23/408">section 408</external-xref> the following: </text><quoted-block style="OLC" display-inline="no-display-inline" id="idD3F8DE51517F44D3BFD819FBAC567C7D"><toc><toc-entry level="section" bold="off">409. State cannabis-impaired driving prevention grant program.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="id29f020440a1244e1be83897c285862c9"><enum>305.</enum><header>National cannabis impairment standard</header><subsection id="id15e6fbb346db492a9f14423b49284bf4"><enum>(a)</enum><header>In general</header><text>Not later than 3 years after the date of enactment of this Act, and once every 2 years thereafter, the Secretary shall make a determination as to whether or not it is feasible to establish a national standard for determining impairment for cannabis-impaired driving. </text></subsection><subsection id="idB03B05D58C1D440BB61B2FCC20422A46"><enum>(b)</enum><header>Rulemaking required</header><text>If the Secretary determines that establishing a national standard relating to cannabis-impaired driving under subsection (a) is feasible, the Secretary shall, not later than 1 year after that determination, promulgate regulations establishing a model cannabis impairment standard for States.</text></subsection></section><section id="id9C4C96A1EC3046F7AC554D193658DC95" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>306.</enum><header>Funding</header><text display-inline="no-display-inline">In addition to amounts otherwise available, there is appropriated, out of any money in the Treasury not otherwise appropriated, $30,000,000 for each of fiscal years 2024 through 2029 to carry out sections 302 and 303.</text></section>