Sec. 101. FDA regulation of cannabinoid products
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/bill/119/s/3474/is/section-101A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) is amended by adding at the end the following: A cannabinoid product shall be deemed to be adulterated if— it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health; it has been manufactured, prepared, processed, packed, or held in insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; it bears or contains any poisonous or deleterious substance that may render it injurious to health; its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health; it bears or contains an unsafe color additive that is unsafe within the meaning of section 721(a); 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 1104(c); 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; it bears or contains, or has been manufactured, prepared, or processed from, artificially or synthetically derived cannabinoids of any kind; or it bears or contains an amount or level of tetrahydrocannabinol that is in excess of the allowable amount or level prescribed by the State in which the cannabinoid product is sold; or if the State in which the cannabinoid product is sold does not have in effect laws governing the sale of, and the allowable amount or level of tetrahydrocannabinol in, cannabinoid products, if it is in violation of section 1105(c)(2).
A cannabinoid product shall be deemed to be misbranded— 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 cannabis ; if it is a finished product, unless it bears a label containing— a prominent statement on the front of the product packaging, and on any internal product insert or packaging, that the product contains cannabinoids; the name, place of business, and contact information (including, as applicable, phone number, email address, and physical address) of its manufacturer, packer, or distributor; an accurate statement of the quantity of its contents in terms of weight, measure, or numerical count; a statement of its form as specified in regulations promulgated pursuant to section 1104(a); 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; 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; 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 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; 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 1104(a); 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; 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:
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. ; 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; 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:
This product has not been evaluated for safety or efficacy by the Food and Drug Administration. ; if it is intended for use in animals, a prominently placed, conspicuous— warning that the product should not be used by humans; and statement that the product is intended for use in animals, including a specification of the intended species; the applicable universal symbol described in section 1104(d); beginning not later than 90 days after issuance of an order or finalization of a rule under section 1104(f)(1), as applicable, information on the safety test results for such product, or information on where to obtain such safety test results; and such other information as the Secretary determines, in regulations promulgated pursuant to section 1104(a), to be necessary for the protection of the public health; 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; if any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; if it purports to be, or is represented as, a cannabinoid product that is subject to a cannabinoid product standard established under section 1105 unless such cannabinoid product is in all respects in conformity with such standard; if its sale, distribution, or label or labeling is not in conformity with applicable requirements under subsections
(a)and
(b)of section 1104; if it was manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held in an establishment not duly registered under section 1103, if it was not included in a list required by section 1103, 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 1103 and such registration has not been reinstated; 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; it is a gummy product, unless it is in the shape of a cube, rectangle, sphere, or other geometric shape; or if it purports to be, or is represented as, an eye drop, nasal spray, or injectable. Each covered entity that, on the date of enactment of the Cannabinoid Safety and Regulation Act , 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). Each covered entity that owns or operates a facility that first carries out, after the date of enactment of the Cannabinoid Safety and Regulation Act , 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). 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. 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— information necessary to notify the Secretary of the name (including trade name), address, and telephone number of such facility; in the case of a domestic facility, the email address and telephone number for the contact person of such facility; or in the case of a foreign facility, the email address and telephone number for the United States agent for such facility; 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; the facility registration number for such facility, if any, previously assigned by the Secretary; 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; 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 any other information the Secretary may require. Not later than the applicable date described in clause (ii), the Secretary shall establish a website for submission of registration under this subsection. The applicable date described in this clause is— 180 days after the date of enactment of the Cannabinoid Safety and Regulation Act ; or if December 31 is less than 180 days after such date of enactment, 240 days after such date of enactment. Not later than 30 days after the date on which the Secretary receives a completed registration submitted under this subsection, the Secretary shall— notify the applicable covered entity of the receipt of such registration; and assign such covered entity a registration number. A registration under this subsection shall— in the case of a domestic facility, be submitted by the owner or operator of such facility; and in the case of a foreign facility, be submitted by the owner or operator of such facility. The Secretary may— by regulation prescribe a uniform system for the identification of cannabinoid products; and require persons who are required to list such cannabinoid products under subsection (f)— to list such cannabinoid products in accordance with such system; and to include the identification number for such cannabinoid products on the labels for such cannabinoid products. The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. The Secretary may charge a fee for registration under this section, which shall be due upon submission of such registration. Payment of the fee under paragraph
(1)may be made electronically pursuant to an online method of payment provided by the Secretary. If the Secretary charges a fee under paragraph (1), the Secretary shall establish the amount of the fee as follows: For fiscal year 2026, an amount not to exceed $500. For fiscal year 2027 and each fiscal year thereafter, an amount equal to the product obtained by multiplying— the dollar amount of the fee established under clause (i); and 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. Nothing in this paragraph prevents the Secretary from decreasing the amount of the registration fee under paragraph (1). The Secretary shall refund 75 percent of the fee paid under paragraph
(1)for any registration that is denied, refused, or withdrawn. Each covered entity that registers with the Secretary under this section shall, at the time of such registration, file with the Secretary— 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 such other information as the Secretary may require, by regulation, to carry out the purposes of the Cannabinoid Safety and Regulation Act , including the amendments made by such Act. The list under subparagraph (A)(i) shall include— the facility registration number of each facility where the cannabinoid product is manufactured, prepared, propagated, compounded, processed, packaged, packed, imported, labeled, or held; the name and contact number of the responsible person and the name for the cannabinoid product, as such name appears on the label; the name and contact number of the person submitting the listing; and an electronic copy of the label, and an electronic copy of the package insert, if any. Each covered entity that registers with the Secretary under this section shall report to the Secretary as follows: 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. 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. 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). 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. The Secretary may suspend the registration of a facility if the Secretary— 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 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. Before suspending the registration of a facility under this subsection, the Secretary shall provide— 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 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. 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. 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. 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. 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. 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. If the registration of a facility is suspended under this subsection, no person shall carry out a covered activity at such facility. 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. 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. The Secretary may promulgate such regulations as may be necessary to carry out this section. In this section: The term covered activity means— 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 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. The term covered entity means any person who owns or operates a domestic facility or foreign facility that is engaged in a covered activity. The term domestic facility means a facility located in any State. The term foreign facility 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. Not later than 2 years after the date of enactment of the Cannabinoid Safety and Regulation Act , 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 1109). 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. 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 1109). 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. 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. The universal symbol referred to in section 1102(2)(N) is, as applicable— the most recent international symbol established by ASTM International indicating that a product contains intoxicating cannabinoids; or the most recent international symbol established by ASTM International indicating that a product contains nonintoxicating cannabinoids. 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 1102(2)(N). 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 1102(2)(N), a symbol that indicates that a product contains either intoxicating cannabinoids or nonintoxicating cannabinoids. 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. 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 1102, labeling and packaging. Not later than 9 months after the date of enactment of the Cannabinoid Safety and Regulation Act , 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. The Secretary may require each covered entity with a registered facility under section 1103 to certify with respect to such registered facility compliance with the good manufacturing practice regulations described in paragraph (1). Not later than 18 months after the date of enactment of the Cannabinoid Safety and Regulation Act , 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). The regulations or order under paragraph
(1)shall require that an entity conducting a test of a cannabinoid product described in such paragraph— be registered and accredited for the testing of cannabinoid products or cannabis products in the applicable State; and be registered and in good standing with— the Drug Enforcement Agency as a Hemp Analytical Testing Laboratory; or the applicable Federal agency pursuant to paragraph (5). The regulations or order under paragraph
(1)shall require that a test of a cannabinoid product described in such paragraph— shall be completed using— statistically valid sampling of the cannabinoid product; and analytical testing methodologies that are— based on published, peer-reviewed methods validated for cannabis testing by an independent third party; or verified by the testing entity for compliance with the Official Methods of Analysis of AOAC International, 22nd edition (or any successor edition); shall include— testing for— 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; synthetic inputs used to produce semi-synthetic cannabinoid products, including hydrochloric acid and sulphuric acid; heavy metals, including arsenic, cadmium, lead, and copper, regardless of whether a tolerance for such heavy metals has been established; and foreign matter, including mildew, organic materials foreign to the product, and inorganic materials; and 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— the total tetrahydrocannabinol content of the finished product; the total cannabinoid content of the finished product; the concentration of tetrahydrocannabinol; and the concentration of cannabinoids; shall be conducted subject to quality assurance protocols to ensure the validity and reliability of test results; 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; shall ensure that analytical tests are sufficiently sensitive for the purposes of the detectability requirements of required testing; and shall use testing protocols that include an effective disposal procedure for non-compliant samples that do not meet the requirements of this section. 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. Not later than 90 days after the date of enactment of the Cannabinoid Safety and Regulation Act , the Secretary and the Administrator of the Drug Enforcement Administration shall enter into a memorandum of understanding that establishes the criteria by which a laboratory may be accredited for purposes of the testing of cannabinoid products under this subsection. The criteria established under subparagraph (A)— shall not require that a laboratory be registered with the Attorney General, acting through the Administrator of the Drug Enforcement Administration, to be accredited for the purposes described in subparagraph (A); shall allow laboratories registered with the Department of Agriculture or the Department of Health and Human Services to be considered to be accredited for the purposes described in subparagraph (A); and shall require proof of accreditation, through an accreditation body recognized by the International Laboratory Accreditation Cooperation, to ISO 17025 of the International Organization for Standardization (or a successor standard). 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. A food that is also a cannabinoid product, or that contains a cannabinoid product, shall not be deemed— adulterated under section 402(a)(2)(C)(i) solely on account of constituents made or derived from cannabinoids; or 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. 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. A dietary supplement that is also a cannabinoid product, or that contains a cannabinoid product, shall not be— deemed adulterated under section 402(f) solely on account of constituents made or derived from cannabinoids; or excluded from the definition of dietary supplement under section 201(ff)(3) solely on account of constituents made or derived from cannabis. 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. If promulgated, the regulations under paragraph (1)— shall determine the safety of artificially or synthetically derived cannabinoids and semi-synthetic cannabinoids across various methods of administration; and may establish a process for the removal from the market of— dangerous artificially or synthetically derived cannabinoids or semi-synthetic cannabinoids; or artificially or synthetically derived cannabinoids or semi-synthetic cannabinoids that cause a serious adverse effect (as defined in section 201(tt)(5)). Not later than 1 year after the date of enactment of the Cannabinoid Safety and Regulation Act , 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. A cannabinoid product standard established under this section shall include provisions— on the ingredients of the cannabinoid product, including, where appropriate— cannabinoid yields of the product, which may consider or address, as appropriate, different types of cannabinoids and the interaction between the constituents of the product; provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the cannabinoid product, which may consider, as appropriate, the interaction between constituents and components of the cannabinoid product; and provisions for the reduction or elimination of harmful constituents or components of the product, including smoke constituents; 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; 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, and pesticide residues; for the measurement of the characteristics of the cannabinoid product, where appropriate, including total product weight, size, color, appearance, and other distinguishing features; 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; 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 requiring cannabinoid products containing foreign-grown hemp or cannabinoids to meet the same standards applicable to cannabinoid products containing domestically grown cannabis. The cannabinoid product standards established under this section shall include provisions for the following cannabinoid product categories: Edible cannabinoid products that are intended for human consumption, take a solid form, and are ingested orally. Inhalable cannabinoid products that are intended for human consumption and are inhaled. Topical cannabinoid products that are intended for human use but not human consumption and are applied externally to the body. Drinkable cannabinoid products that are intended for human consumption, take liquid form, and are ingested orally. The Secretary may include for each cannabinoid product category described in paragraph
(1)the following requirements for serving sizes which shall apply in States that do not have in effect a law governing serving sizes for such product categories: Edible cannabinoid products may not contain, bear, or purport to contain more than 5 milligrams of tetrahydrocannabinol per serving, and may not contain, bear, or purport to contain more than 50 milligrams of tetrahydrocannabinol per container. Inhalable cannabinoid products may not contain, bear, or purport to contain more than 5 milligrams of tetrahydrocannabinol per serving, and may not contain, bear, or purport to contain more than 50 milligrams of tetrahydrocannabinol per container. Topical cannabinoid products may not contain, bear, or purport to contain more than 5 milligrams of tetrahydrocannabinol per serving, and may not contain, bear, or purport to contain more than 50 milligrams of tetrahydrocannabinol per container. Drinkable cannabinoid products may not contain, bear, or purport to contain more than 5 milligrams of tetrahydrocannabinol per serving, and may not contain, bear, or purport to contain more than 10 milligrams of tetrahydrocannabinol per container. In this subsection: The term container means the innermost wrapping, packaging, or vessel in direct contact with a cannabinoid product in which the cannabinoid product is enclosed for retail sale to consumers, such as a jar, bottle, bag, box, packet, can, carton, or cartridge. The term container excludes bulk shipping containers or outer wrappings that are not essential for the final retail delivery or sale to an end consumer for personal or household use. The Secretary shall provide for periodic evaluation of cannabinoid product standards, cannabinoid product categories, and serving size limits established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. If the Secretary finds that there is a reasonable probability that a 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. 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. An amended order under paragraph (1)— shall not include recall of a cannabinoid product from individuals; and shall provide for notice to persons subject to the risks associated with the use of such cannabinoid product. 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). 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. 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— to reduce a risk to health posed by the cannabinoid product; or to remedy a violation of this chapter caused by the cannabinoid product which may present a risk to health. 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. 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). 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. An electronic cannabinoid product delivery system may contain added or naturally occurring terpenes, including naturally occurring non-cannabis terpenes, on the conditions that— 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; 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 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. In this section, the term electronic cannabinoid product delivery system 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. 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. 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 1102 (including regulations). 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. 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. In this subsection, the term Indian Tribe 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 Cannabinoid Safety and Regulation Act pursuant to section 104(a) of the Federally Recognized Indian Tribe List Act of 1994. 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). .
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U.S. Code
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Sec. 101
FDA regulation of cannabinoid products
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