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Title V — Public health, cannabis administration, and trade practices

S. 4591 · 117th Congress · Jul 21, 2022 · Lineage

V Public health, cannabis administration, and trade practices

A Public health

Sec. 501 FDA regulation of cannabis

(a)
In general— The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by adding at the end the following:

“XI Cannabis products

“1101. Center for Cannabis Products

“Not later than 90 days after the date of enactment of the “Cannabis Administration and Opportunity Act”, the Secretary shall establish within the Food and Drug Administration the Center for Cannabis Products, which shall report to the Commissioner of Food and Drugs in the same manner as the other agency centers within the Food and Drug Administration. The Center shall be responsible for the implementation of this chapter and related matters assigned by the Commissioner.

“1102. Adulterated cannabis products

“(a) In general—A cannabis product shall be deemed to be adulterated if—

“(1) 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;

“(2) 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;

“(3) it bears or contains any poisonous or deleterious substance that may render it injurious to health;

“(4) its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health;

“(5) it bears or contains an unsafe color additive that is unsafe within the meaning of section 721(a); or

“(6) 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).

“(b) Exceptions to certain food requirements for foods containing cannabis—Provided that an article that is a food (as defined in section 201(f)) and that is also a cannabis product (as defined in section 201(ss)(2)) otherwise complies with all applicable requirements for food under chapter IV and all applicable requirements for cannabis products under this chapter, such article shall not be deemed—

“(1) adulterated under section 402(a)(2)(C)(i) solely on account of constituents made or derived from cannabis; or

“(2) a food to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public for purposes of section 301(ll) solely on account of constituents made or derived from cannabis.

“1103. Misbranded cannabis products

“A cannabis product shall be deemed to be misbranded—

“(1) if its labeling or advertising is false or misleading in any particular;

“(2) unless it bears a label containing—

“(A) a prominent statement that the product contains cannabis;

“(B) the name and place of business of its manufacturer, packer, or distributor;

“(C) an accurate statement of the quantity of its contents in terms of weight, measure, or numerical count;

“(D) a statement of its form as specified in regulations promulgated pursuant to section 1105(a);

“(E) the amount of tetrahydrocannabinol in the product, and if the product is packaged and labeled in such a way as to suggest more than one serving, dose, or the equivalent, the amount of tetrahydrocannabinol in such serving, dose, or the equivalent;

“(F) adequate directions for use, if deemed necessary for the protection of the public health in regulations promulgated pursuant to section 1105(a);

“(G) adequate directions against use by children, if deemed necessary for the protection of the public health in regulations promulgated pursuant to section 1105(a); and

“(H) 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;

“(3) if its label or labeling bears a statement describing the role of a cannabis constituent intended to affect the structure or any function of the body of humans or other animals, unless—

“(A) there is substantiation that such statement is truthful and not misleading; and

“(B) the statement contains, prominently displayed and in boldface type, the following: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”;

“(4) 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;

“(5) if it purports to be, or is represented as, a cannabis product which is subject to a cannabis product standard established under section 1106 unless such cannabis product is in all respects in conformity with such standard;

“(6) if its sale, distribution, or label or labeling is not in conformity with applicable requirements under subsections (a) and (b) of section 1105;

“(7) if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 1104 or if it was not included in a list required by section 1104; or

“(8) if it is intended for consumption or application by an individual under 21 years of age.

“1104. Annual registration

“(a) Registration by owners and operators—On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a cannabis product shall register with the Secretary the name, places of business, and all such establishments of that person.

“(b) Registration by new owners and operators—Every person upon first engaging in the manufacture, preparation, compounding, or processing of a cannabis product in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person’s name, place of business, and such establishment.

“(c) Registration of added establishments—Every person required to register under subsection (a) or (b) shall immediately register with the Secretary any additional establishment which that person owns or operates in the United States and in which that person begins the manufacture, preparation, compounding, or processing of a cannabis product.

“(d) Uniform product identification system—The Secretary may by regulation prescribe a uniform system for the identification of cannabis products and may require that persons who are required to list such cannabis products under subsection (g) shall list such cannabis products in accordance with such system.

“(e) Public access to registration information—The Secretary shall make available for inspection any registration filed under this section.

“(f) Registration by foreign establishments—Any establishment within a foreign country engaged in the manufacture, preparation, compounding, or processing of a cannabis product that is imported or offered for import into the United States, shall register under this section and shall include with the registration the name of the United States agent for the establishment.

“(g) Registration information

“(1) Product list

“(A) In general—Every person who registers with the Secretary under subsection (a), (b), or (c) shall, at the time of registration under such subsection, file with the Secretary—

“(i) a list of all cannabis products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which have not been included in any list of cannabis products filed by that person with the Secretary under this paragraph or paragraph (2) before such time of registration; and

“(ii) such other information as the Secretary, in consultation with the Secretary of the Treasury and the Attorney General, may require, by regulation, to carry out the purposes of the Cannabis Administration and Opportunity Act, including the amendments made by such Act, including chapter 56 of subtitle E of the Internal Revenue Code of 1986.

“(B) Form and manner of list—The list under subparagraph (A)(i) shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by a copy of all consumer information and other labeling for such cannabis product, a representative sampling of advertisements for such cannabis product, and, upon request by the Secretary, a copy of all advertisements for a particular cannabis product.

“(2) Report of any change in product list—Each person who registers with the Secretary under this section shall report to the Secretary as follows:

“(A) Prior to the introduction into commercial distribution of a cannabis product that has not been included in any list previously filed by the registrant, a list containing such cannabis product.

“(B) A notice of discontinuance of the manufacture, preparation, compounding, or processing for commercial distribution of a cannabis product included in a list filed under subparagraph (A) or paragraph (1), and the date of such discontinuance.

“(C) A notice of resumption of the manufacture, preparation, compounding, or processing for commercial distribution of the cannabis product with respect to which a notice of discontinuance was reported under subparagraph (B).

“(D) A list of each cannabis product included in a notice filed under subparagraph (C) prior to the resumption of the introduction into commercial distribution of such cannabis product.

“(3) Publication—The Secretary shall publish on the website of the Food and Drug Administration every registration and list filed pursuant to this section and the information accompanying every list not later than 10 days after the applicable date of filing.

“(4) Department of the Treasury access—The Secretary shall establish a format and procedure for appropriate Department of the Treasury officials to access the information received by the Secretary under this subsection, in a prompt and secure manner.

“1105. General provisions for control of cannabis products

“(a) Restrictions on sale and distribution

“(1) Remote sales—Not later than 2 years after the date of enactment of the “Cannabis Administration and Opportunity 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 cannabis products that occur through means other than a direct, face-to-face exchange between a retailer and a consumer, in order to prevent the sale and distribution of cannabis products to individuals who have not attained the age of 21, including requirements for age verification.

“(2) Preventing use of cannabis products in minors—The Secretary shall, by regulation, impose such restrictions on advertising, promotion, and marketing of cannabis products as the Secretary determines necessary and appropriate to prevent the consumption or application of cannabis products by individuals under 21 years of age. Such regulations shall prohibit the advertising, promotion, and marketing of cannabis products, whether directly or indirectly, to individuals under 21 years of age, and any other action that has the primary purpose of initiating or increasing the use of cannabis products in such individuals.

“(3) Other regulations—In addition to the restrictions under paragraphs (1) and (2), the Secretary may, by regulation, impose other restrictions on the sale and distribution of cannabis products, including restrictions on the access to, and the advertising and promotion of, the cannabis product, if the Secretary determines that such regulation would be appropriate for the protection of the public health.

“(4) Good faith consultation with Indian Tribes—In issuing regulations under paragraphs (1), (2), and (3), the Secretary shall conduct good faith, meaningful, and timely consultations with Indian Tribes (as defined in section 3 of the Cannabis Administration and Opportunity Act).

“(b) Labeling statements—The label and labeling of a cannabis product shall bear such appropriate statements of the restrictions required by a regulation under subsection (a) as the Secretary may in such regulation prescribe.

“(c) Good manufacturing practice requirements—The Secretary shall issue regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preparing, processing, packing, and holding of a cannabis product conform to current good manufacturing practice, including testing for pesticide chemical residues regardless of whether a tolerance for such chemical residues has been established.

“1106. Cannabis product standards

“(a) In general—The Secretary shall, by regulation, adopt cannabis product standards that are appropriate for protection of the public health.

“(b) Content of standards—A cannabis product standard established under this section shall include provisions—

“(1) on the ingredients of the cannabis product, including, where appropriate—

“(A) 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;

“(B) provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the cannabis product, which may consider, as appropriate, the interaction between constituents and components of the cannabis product; and

“(C) provisions for the reduction or elimination of harmful constituents or components of the product, including smoke constituents;

“(2) for the testing of the cannabis product;

“(3) requiring that the results of testing the cannabis product show that the cannabis product is in conformity with applicable standards;

“(4) for the measurement of the characteristics of the cannabis product, where appropriate;

“(5) requiring that the sale and distribution of the cannabis product be restricted but only to the extent that the sale and distribution of a cannabis product may be restricted under a regulation under this Act;

“(6) where appropriate, requiring the use and prescribing the form and content of labeling for the proper use of the cannabis product and any potential adverse effects of the product; and

“(7) requiring cannabis products containing foreign-grown cannabis to meet the same standards applicable to cannabis products containing domestically grown cannabis.

“(c) Periodic reevaluation of standards—The Secretary shall provide for periodic evaluation of cannabis product standards established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data.

“1107. Recall authority

“(a) In general—If the Secretary finds that there is a reasonable probability that a cannabis product would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the cannabis product) to immediately cease distribution of such cannabis product. The order shall provide the person subject to the order with an opportunity to appear and introduce testimony, to be held not later than 20 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such cannabis product. If, after providing an opportunity to appear and introduce testimony, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

“(b) Amendment of order To require recall

“(1) In general—If, after providing an opportunity to appear and introduce testimony under subsection (a), the Secretary determines that the order should be amended to include a recall of the cannabis product with respect to which the order was issued, the Secretary shall, except as provided in paragraph (2), amend the order to require a recall. The Secretary shall specify a timetable in which the cannabis product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.

“(2) Notice—An amended order under paragraph (1)—

“(A) shall not include recall of a cannabis product from individuals; and

“(B) shall provide for notice to persons subject to the risks associated with the use of such cannabis product.

“1108. Records and reports on cannabis products

“(a) In general—Every person who is a cannabis product manufacturer or importer of a cannabis product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such cannabis product is not adulterated or misbranded and to otherwise protect public health.

“(b) Reports of removals and corrections

“(1) In general—Except as provided in paragraph (2), the Secretary shall by regulation require a cannabis product manufacturer or importer of a cannabis product to report promptly to the Secretary any corrective action taken or removal from the market of a cannabis product undertaken by such manufacturer or importer if the removal or correction was undertaken—

“(A) to reduce a risk to health posed by the cannabis product; or

“(B) to remedy a violation of this chapter caused by the cannabis product which may present a risk to health.

“(2) Exception—No report of the corrective action or removal of a cannabis product may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).

“1109. Prohibition on flavored electronic cannabis product delivery system

“(a) In general—Any electronic cannabis product delivery system shall not contain an artificial or natural flavor (other than cannabis) that is a characterizing flavor, including menthol, mint, mango, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee.

“(b) Definition—For purposes of this section, the term electronic cannabis product delivery system means an electronic device that delivers a cannabis product via an aerosolized solution to the user inhaling from the device, and any component, liquid, part, or accessory of such a device, whether or not sold separately.

“1110. Preservation of State, Tribal, and local authority

“(a) In general—Nothing in this chapter, or rules promulgated under this chapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or political subdivision of a State, or the government of an Indian Tribe (as defined in section 3 of the Cannabis Administration and Opportunity Act) to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to cannabis products that is in addition to, or more stringent than, requirements established under this chapter, including a law, rule, regulation, or other measure relating to or prohibiting the manufacture, sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of cannabis products by individuals of any age, information reporting to the State or Indian Tribe (as so defined), or measures relating to fire safety or environmental standards for cannabis products. No provision of this chapter shall limit or otherwise affect any State, Tribal, or local taxation of cannabis products.

“(b) Rule of construction regarding product liability—No provision of this chapter relating to a cannabis product shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State or Indian Tribe (as so defined).”

Sec. 502 Amendments to the Federal Food, Drug, and Cosmetic Act

(a)
Definitions— Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended—
(1)
in paragraph (g)(1)(C), by striking “(other than food)” and inserting “(other than food or cannabis products)”;
(2)
in paragraph (ff)(1), by striking “(other than tobacco)” and inserting “(other than a tobacco product or cannabis product)”;
(3)
in paragraph (rr)(4), by inserting “cannabis product,” after “medical device”; and
(4)
by adding at the end the following:

“(ss)

“(1)

“(A) The term cannabis means—

“(i) all parts of the plant Cannabis sativa L., whether growing or not;

“(ii) the seeds thereof;

“(iii) the resin extracted from any part of such plant; and

“(iv) every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.

“(B) The term cannabis does not include—

“(i) hemp, as defined in section 297A of the Agricultural Marketing Act of 1946; or

“(ii) the mature stalks of such plant, 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, or cake, or the sterilized seed of such plant which is incapable of germination.

“(2)

“(A) The term cannabis product means any product made or derived from cannabis that is intended for consumption or applied to the body of man or other animals, including any component of such product.

“(B) A cannabis product does not mean an article that is a drug within the meaning of paragraph (g)(1).

“(3) With respect to cannabis or a cannabis product, the term manufacture includes the planting, cultivation, growing, and harvesting of cannabis.”

(b)
Prohibited acts— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended—
(1)
by inserting “cannabis product,” after “tobacco product,” each place it appears in paragraphs (g) and (h);
(2)
in paragraph (j), by striking “or 920(b)” and inserting “920(b), or 1104”;
(3)
in paragraph (p)—
(A)
by striking “510 or 905” and inserting “510, 905, or 1104”;
(B)
by striking “or 905(j)” and inserting “905(j), or 1104(g)”; and
(C)
by striking “or 905(i)(3)” and inserting “, 905(i)(3), or 1104(g)(2)”;
(4)
in paragraph (q)(2) by inserting “, cannabis product,” after “device”;
(5)
in paragraph (r), by inserting “cannabis product,” after “device,” each place it appears; and
(6)
by adding at the end the following:

“(fff)

“(1) The sale or distribution of a cannabis product to any person younger than 21 years of age.

“(2) The sale or distribution, in any retail single transaction, of more than 10 ounces of any cannabis product.

“(3) The sale or distribution of an article that is a cannabis product and that contains alcohol, caffeine, or nicotine.

“(4) The failure of a manufacturer or distributor to notify the Attorney General and the Secretary of the Treasury of its knowledge of cannabis products used in illicit trade.

“(ggg)

“(1) The introduction or delivery for introduction into commerce of any cannabis product that is adulterated or misbranded.

“(2) The adulteration or misbranding of any cannabis product in commerce.

“(3) The receipt in commerce of any cannabis product that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

“(4) 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 cannabis 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.

“(hhh) The failure to comply with the requirements of section 524C.”

(c)
Seizure authorities— Section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended—
(1)
in subsection (a)—
(A)
in paragraph (1), by inserting “cannabis product,” after “drug,”; and
(B)
in paragraph (2), by inserting “or cannabis product” after “tobacco product”;
(2)
in subsection (d)(1), by inserting “cannabis product,” after “tobacco product,”; and
(3)
in subsection (g), by striking “or tobacco product” each place it appears in paragraphs (1) and (2)(A) and inserting “, tobacco product, or cannabis product”.
(d)
Factory inspection— Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended—
(1)
in subsection (a)—
(A)
by inserting “cannabis products,” after “tobacco products,” each place it appears;
(B)
by striking “or tobacco products” each place it appears and inserting “tobacco products, or cannabis products”; and
(C)
by striking “and tobacco products” and inserting “tobacco products, and cannabis products”; and
(2)
in subsection (b)(1), by inserting “cannabis product,” after “tobacco product,”.
(e)
Publicity— Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 375(b)) is amended by inserting “cannabis products,” after “tobacco products,”.
(f)
Presumption— Section 709 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379a) is amended by inserting “cannabis product,” after “tobacco product,”.
(g)
Imports and exports— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended—
(1)
in subsection (a)—
(A)
by inserting “cannabis products,” after “tobacco products,”;
(B)
by striking “or tobacco products” each place it appears and inserting “, tobacco products, or cannabis products”; and
(C)
by striking “or section 905(h)” and inserting “, 905(h), or 1104”; and
(2)
in subsection (e), by striking “tobacco product or” and inserting “tobacco product, cannabis product, or”.

Sec. 503 Expedited review

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:

“524B. Expedited review of certain drugs containing cannabis

“(a) Establishment of program—The Secretary shall establish a program to expedite the development and review of applications for drugs containing cannabis that are manufactured by a small business concerned owned and controlled by socially and economically disadvantaged individuals or Native entities that operate in the cannabis industry.

“(b) Request for designation—A sponsor of a drug containing cannabis that is manufactured by a small business concern owned and controlled by socially and economically disadvantaged individuals or Native entities that operate in the cannabis industry may request that the Secretary designate such drug for expedited review under this section. A request for designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act.

“(c) Actions—The actions to expedite the development and review of an application designated for expedited review under this section may include, as appropriate—

“(1) holding meetings with the sponsor and the review team throughout the development of the drug;

“(2) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable; and

“(3) priority review, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

“(d) Expedited review guidance—Not later than 1 year after the date of enactment of the Cannabis Administration and Opportunity Act, and after good faith, meaningful, and timely consultation with Native entities, the Secretary shall issue guidance on the implementation of this section. Such guidance shall—

“(1) set forth the process by which a person may seek a designation under subsection (b); and

“(2) identify the criteria the Secretary will use in evaluating a request for designation under this section.

“(e) Definitions—In this section:

“(1) Drug containing cannabis—The term drug containing cannabis means any drug that contains any article made or derived from cannabis.

“(2) Native entity—The term Native entity means—

“(A) an Indian Tribe (as defined in section 3 of the Cannabis Administration and Opportunity Act);

“(B) a Native Corporation (as defined in section 3 of the Alaska Native Claims Settlement Act (43 U.S.C. 1602)); and

“(C) a Native Hawaiian-serving entity.

“(3) Native Hawaiian-serving entity—The term Native Hawaiian-serving entity means—

“(A) a Native Hawaiian organization (as defined in section 6207 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7517));

“(B) the Department of Hawaiian Home Lands; and

“(C) the Office of Hawaiian Affairs.

“(4) Small business concern owned and controlled by socially and economically disadvantaged individuals—The term small business concern owned and controlled by socially and economically disadvantaged individuals has the meaning given the term in section 8(d)(3)(C) of the Small Business Act.

“524C. Security requirements for drugs containing cannabis

“(a) In general—The sponsor of any application under section 505 for a drug containing cannabis shall provide effective controls and procedures to guard against theft and diversion of such drug, which may include, if the Secretary determines necessary, a risk evaluation and mitigation strategy under section 505–1.

“(b) Standards—The Secretary shall prescribe, by regulation, standards for controls and procedures for drugs described in subsection (a).

“(c) Definition—For purposes of this section, the term drug containing cannabis means any drug that contains any article made or derived from cannabis.”

Sec. 504 Regulation of cannabidiol

(a)
CBD as a dietary supplement— Section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(3)(B)) is amended, in the matter preceding subclause (i), by inserting “, except in the case of cannabidiol derived from hemp (as defined in section 297A of the Agricultural Marketing Act of 1946)” after “include”.
(b)
Adulteration— Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following new subsection:

“(j)

“(1) If it is a dietary supplement that contains cannabidiol, unless—

“(A) such dietary supplement contains no more than an amount of cannabidiol per recommended daily serving that the Secretary may establish (and revise or repeal as appropriate), subject to paragraph (2), through an interim final rule, notwithstanding any requirement for notice and comment that may otherwise apply under section 553 of title 5, United States Code;

“(B) such dietary supplement is the subject of a notification submitted to the Secretary in accordance with section 413(a)(2); and

“(C) the labeling and packaging of such dietary supplement conforms with any requirements that the Secretary establishes regarding labeling or packaging of dietary supplements containing cannabidiol (which may be promulgated (and revised or repealed as appropriate) by the Secretary through an interim final rule, notwithstanding any requirement for notice and comment that may otherwise apply under section 553 of title 5, United States Code).

“(2)

“(A) The amount of cannabidiol established in accordance with paragraph (1)(A)—

“(i) shall be a threshold above which the Secretary may not accept new dietary ingredient notifications; and

“(ii) shall not be interpreted as a determination that lower amounts of cannabidiol are safe.

“(B) The Secretary shall establish such a threshold based on such factors as the Secretary determines to be appropriate, which may include a consideration of whether the review of new dietary ingredient notifications for products containing higher levels of cannabidiol may be unduly burdensome.”

(c)
New dietary ingredient— Section 413(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b(a)(1)) is amended by inserting “contains no cannabidiol and” before “contains only dietary ingredients”.
(d)
New prohibited act— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 502(b)(6), is further amended by adding at the end the following:

“(iii) The introduction or delivery for introduction into interstate commerce of any product labeled as a dietary supplement that fails to meet the definition of a dietary supplement under section 201(ff).”

(e)
New import exclusion— Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended in paragraph (3) of the third sentence by striking “section 301(ll)” and inserting “paragraph (ll) or (iii) of section 301”.
(f)
New seizure authorities— Section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended—
(1)
in subsection (a)(1), in the first sentence, by inserting “or any article which may not be introduced or delivered for introduction into interstate commerce under section 301(iii),” before “shall be liable”; and
(2)
in subsection (d)(1), in the first sentence, by inserting “, or any product otherwise introduced or delivered for introduction into interstate commerce in violation of section 301(iii) and condemned under this section,” after “under this section”.
(g)
CBD as a food additive—
(1)
In general— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall issue draft guidance describing criteria by which the Secretary intends to evaluate the safety of cannabidiol as a food additive in any food additive petition under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348). The Secretary shall publish final guidance within 180 days of the close of the public comment period on such draft guidance.
(2)
Advisory committee— Before issuing draft guidance under paragraph (1), the Secretary shall convene and consult an advisory committee, which shall include experts qualified in the subject matter.

Sec. 505 Transition periods

(a)
Transition period for cannabis products— With respect to a cannabis product that was marketed in the United States within 30 days of the date of enactment of this Act pursuant to a State law permitting the marketing of such product, such product shall not be considered to be in violation of chapter XI of the Federal Food, Drug, and Cosmetic Act (as added by section 501) or section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by this title, as applicable, during the 18-month period following the date of enactment of this Act.
(b)
Submission of applications for previously marketed drugs containing cannabis—
(1)
Transition period for drugs containing cannabis— With respect to a drug containing cannabis that was being marketed in the United States within 30 days after the date of enactment of this Act pursuant to a State law permitting cannabis for medical use, such drug shall not be considered to be in violation of chapter V or section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331; 351 et seq.) during the 3-year period following the date of enactment of this Act.
(2)
Submission of applications—
(A)
In general— As a condition for continuing to market a drug described in paragraph (1) during the 3-year period specified in such paragraph, during the 18-month period beginning on the effective date of this Act, the manufacturer shall submit a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 355(b)) for such drug.
(B)
Transition period— Except as provided in subparagraph (C), with respect to a drug containing cannabis for which an application is submitted as described in subparagraph (A), the manufacturer of such product may continue to market such drug in the State described in paragraph (1) during the 3-year period beginning on the effective date of this Act.
(C)
Exception— If the Secretary of Health and Human Services issues an order refusing to approve an application under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) for a drug that contains cannabis, such drug shall not be eligible for continued marketing under subparagraph (B).
(3)
End of transition period— Beginning on the date that is 3 years after the date of enactment of this Act the Secretary may take enforcement action, as appropriate, for a drug described in paragraph (1) (including such a drug that is the subject of a pending application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)) found to be in violation of chapter V or section 301 of the Federal Food, Drug, and Cosmetic Act.
(4)
Rule of construction— Nothing in this subsection shall be construed to prohibit the marketing of a cannabis product otherwise in compliance with relevant provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(c)
Definition— For purposes of this section, the term drug containing cannabis means any drug that contains any article made or derived from cannabis.

Sec. 506 Amendment to the Poison Prevention Packaging Act

Section 2(2)(B) of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471(2)(B)) is amended by striking “or cosmetic” and inserting “cosmetic, or cannabis product,”.

Sec. 507 Funding for FDA

In addition to amounts otherwise available, there is appropriated, out of any funds in the Treasury not otherwise appropriated, $425,000,000 for each of fiscal years 2023 through 2027 to carry out this title and the amendments made by this title.

B Federal cannabis administration

Sec. 511 Federal cannabis administration

(a)
In general— The Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) is amended by adding at the end the following:

“III Cannabis

“301. Unlawful businesses without cannabis permit

“(a) Import—It shall be unlawful, except pursuant to a permit issued under this title by the Secretary—

“(1) to engage in the business of importing cannabis into the United States; or

“(2) for any person so engaged to sell, offer or deliver for sale, contract to sell, or ship, in interstate or foreign commerce, directly or indirectly or through an affiliate, cannabis so imported.

“(b) Manufacture and sale—It shall be unlawful, except pursuant to a permit issued under this title by the Secretary—

“(1) to engage in the business of cultivating, producing, manufacturing, packaging, or warehousing cannabis; or

“(2) for any person so engaged to sell, offer or deliver for sale, contract to sell, or ship, in interstate or foreign commerce, directly or indirectly or through an affiliate, cannabis so cultivated, produced, manufactured, packaged, or warehoused.

“(c) Resale—It shall be unlawful, except pursuant to a permit issued under this title by the Secretary—

“(1) to engage in the business of purchasing cannabis for resale at wholesale; or

“(2) for any person so engaged to receive or to sell, offer or deliver for sale, contract to sell, or ship, in interstate or foreign commerce, directly or indirectly or through an affiliate, cannabis so purchased.

“(d) Transition rule—Subject to section 302(e), in the case of a person who has filed a complete and accurate application for a permit under this section within 90 days of the date on which the Secretary has issued any necessary guidance and forms with respect to such applications, this section shall not apply to such person during the period prior to any determination under section 302 as to the entitlement of such person to such permit, provided that such person is in compliance with—

“(1) any applicable regulations under this title; and

“(2) payment of any taxes imposed under chapter 56 of the Internal Revenue Code of 1986.

“302. Procedure for issuance of cannabis permits

“(a) Entitlement to permit

“(1) In general—The Secretary shall issue a permit for operations requiring a permit under section 301 unless the Secretary finds that—

“(A) the applicant (or if the applicant is a corporation, any of its officers, directors, or principal stockholders) has been convicted of a disqualifying offense;

“(B) the operations proposed to be conducted by the applicant are in violation of the law of the State in which they are to be conducted; or

“(C) the applicant is not likely to maintain such operations in conformity with Federal law.

“(2) Disqualifying offenses

“(A) In general—For the purposes of paragraph (1), a disqualifying offense is any felony violation of any provision of Federal or State criminal law relating to cannabis or cannabis products (including the taxation thereof), if the conviction occurred after the date of enactment of the Cannabis Administration and Opportunity Act and not later than 3 years before the date of the application.

“(B) Waiver pursuant to finding of mitigation or rehabilitation and fitness for occupation—Notwithstanding subparagraph (A), an offense shall not be considered a disqualifying offense if, pursuant to a submission of waiver request by the applicant to the Secretary, the Secretary finds (following a review and recommendation with respect to such waiver request by the Cannabis Products Advisory Committee established under section 602 of the Cannabis Administration and Opportunity Act) that the applicant has established sufficient mitigation or rehabilitation and fitness to maintain cannabis operations in compliance with State and Federal law by providing—

“(i) evidence showing that—

“(I) the applicant has not been convicted of a crime that occurred after the date on which the offense with respect to which the waiver was requested occurred; and

“(II) the applicant has complied with all terms and conditions of probation or parole; or

“(ii) any other evidence of mitigation and present fitness, including—

“(I) the circumstances relating to the offense, including mitigating circumstances or social conditions surrounding the commission of the offense;

“(II) the age of the applicant when the applicant committed the offense;

“(III) the period of time that has elapsed since the applicant committed the offense;

“(IV) additional evidence of educational, training, or work activities that the applicant has participated in, including during any period of incarceration;

“(V) letters of reference by persons who have been in contact with the applicant since the applicant was released from any correctional institution; and

“(VI) completion of, or active participation in, rehabilitative drug or alcohol treatment.

“(b) Refusal of permit; hearing—If upon examination of any application for a permit the Secretary has reason to believe that the applicant is not entitled to such permit, the Secretary shall so notify the applicant and, upon request by the applicant, afford the applicant due notice and opportunity for hearing on the application. If the Secretary, after affording such notice and opportunity for hearing, still finds that the applicant is not entitled to a permit hereunder, the Secretary shall by order deny the application stating the findings which are the basis for the order.

“(c) Form of application

“(1) Generally—The Secretary shall—

“(A) prescribe the manner and form of applications for permits under this title (including the facts to be set forth in the application);

“(B) prescribe the form of such permits; and

“(C) specify in any permit the authority conferred by the permit and the conditions of that permit in accordance with this title.

“(2) Separate types of applications and permits—To the extent deemed necessary by the Secretary for the efficient administration of this title, the Secretary may require separate applications and permits with respect to the various classes of cannabis, and with respect to the various classes of persons entitled to permits under this title.

“(3) Disclaimer—The issuance of a permit under this title does not deprive the United States of any remedy for a violation of law.

“(d) Conditions

“(1) In general—A permit under this title shall be conditioned upon—

“(A) compliance with all other Federal laws relating to production and sale of cannabis, as well as compliance with all State laws relating to said activities in the State in which the permit applicant resides and does business;

“(B) payment to the Secretary of a reasonable permit fee in an amount determined by the Secretary to be sufficient over time to offset the cost of implementing and overseeing all aspects of cannabis regulation by the Federal Government; and

“(C) compliance with—

“(i) the labor laws described in paragraph (1) of subsection (j), as determined in accordance with paragraph (2) of such subsection; and

“(ii) the reporting requirements of subsection (j)(3).

“(2) Waiver of permit fee—Pursuant to regulations prescribed by the Secretary, the permit fee described in paragraph (1)(B) shall be waived in the case of an individual who—

“(A) has had an income below 250 percent of the Federal Poverty Level for not fewer than 5 of the 10 years preceding the date on which the individual submits an application for a permit under this title; and

“(B) is a first-time applicant.

“(e) Revocation, suspension, and annulment

“(1) Generally—After due notice and opportunity for hearing, the Secretary may order a permit under this title—

“(A) revoked or suspended for such period as the Secretary deems appropriate, if the Secretary finds that the permittee has willfully violated any of the conditions of the permit, but for a first violation of the conditions the permit shall be subject to suspension only;

“(B) revoked if the Secretary finds that the permittee has not engaged in the operations authorized by the permit for a period of more than 2 years; or

“(C) annulled if the Secretary finds that the permit was procured through fraud, or misrepresentation, or concealment of material fact.

“(2) Order to state basis for order—The order shall state the findings which are the basis for the order.

“(3) Joint development of enforcement regulations—The Secretary, in coordination with the Secretary of Labor and the National Labor Relations Board, shall, through regulations, establish criteria for making determinations under paragraph (1).

“(4) Joint enforcement—The Secretary of Labor and the National Labor Relations Board shall provide to the Secretary any assistance in carrying out this subsection as determined necessary by the Secretary.

“(5) Certain violations under the National Labor Relations Act deemed willful—A violation of the condition under subsection (d)(1)(C) with respect to compliance with section 8 of the National Labor Relations Act (29 U.S.C. 158) as described in subsection (j)(1)(C) shall be deemed willful for purposes of paragraph (1)(A) if the National Labor Relations Board finds that the permittee has engaged in—

“(A) a discharge in violation of subsection (a) of such section 8;

“(B) a violation of such section 8 during the period in which a representation election under such Act is pending with respect to the employees of the permittee; or

“(C) a withdrawal of recognition of the recognized or certified collective-bargaining representative under such Act with respect to the employees of the permittee that is in violation of such section 8.

“(f) Service of orders—Each order of the Secretary with respect to any denial of application, suspension, revocation, annulment, or other proceedings, shall be served—

“(1) in person by any officer or employee of the Secretary designated by him or any internal revenue or customs officer authorized by the Secretary for the purpose; or

“(2) by mailing the order by registered mail, addressed to the applicant or respondent at his last known address in the records of the Secretary.

“(g) Duration

“(1) General rule—Except as otherwise provided in this subsection, a permit issued under this title shall continue in effect until suspended, revoked, or annulled as provided in this title, or voluntarily surrendered.

“(2) Effect of transfer—If operations under a permit issued under this title are transferred, the permit automatically terminates 30 days after the date of that transfer, unless an application is made by the transferee before the end of that period for a permit under this title for those operations. If such an application is made, the outstanding permit shall continue in effect until such application is finally acted on by the Secretary.

“(3) Definition of transfer—For the purposes of this section, the term transfer means any change of ownership or control, whether voluntary or by operation of law.

“(h) Judicial review

“(1) In general—A permittee or applicant for a permit under this title may obtain judicial review under chapter 7 of title 5, United States Code, of the denial of the application of that applicant or, in the case of a permittee, the denial of an application by the transferee of that permittee or the suspension, revocation, or annulment of a permit with respect to that permittee.

“(2) Labor law violations—Notwithstanding paragraph (1), with respect to a violation of the condition described in subsection (d)(1)(C), the findings of fact and conclusions of law by the Secretary, or, pursuant to subsection (e)(4), the Secretary of Labor or the National Labor Relations Board, concerning the appropriateness of suspending, revoking, or annulling a permit as provided in this title, if supported by substantial evidence on the whole, shall be conclusive.

“(i) Statute of limitations

“(1) In general—No proceeding for the suspension or revocation of a permit for violation of any condition thereof relating to compliance with Federal law shall be instituted by the Secretary more than 18 months after conviction of the violation of Federal law, or, if no conviction has been had, more than 3 years after the violation occurred.

“(2) Compromise—No permit shall be suspended or revoked for a violation of any such condition thereof if the alleged violation of Federal law has been compromised by any officer of the Government authorized to compromise such violation.

“(j) Labor laws

“(1) In general—A labor law described in this paragraph is any of the following:

“(A) Any provision under the Fair Labor Standards Act of 1938 (29 U.S.C. 201 et seq.), including any regulations promulgated under such Act.

“(B) Any provision under the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq.), including any standard promulgated under section 6 of such Act (29 U.S.C. 655) or any other regulation promulgated under such Act, or any standard or regulation promulgated under an applicable State plan approved by the Secretary of Labor under section 18 of such Act (29 U.S.C. 667) that is identical or equivalent to a standard promulgated under such section 6.

“(C) Section 8 of the National Labor Relations Act (29 U.S.C. 158), including any regulations promulgated under such section.

“(2) Findings of labor law violations

“(A) In general—For purposes of subsection (d)(1)(C)(i), a permittee shall be considered in violation of a labor law described in paragraph (1) if any of the following findings are made with respect to the permittee:

“(i) Fair labor standards act of 1938—With respect to a labor law described in paragraph (1)(A)—

“(I) a finding through an order or judgment of a Federal or State court that the permittee has violated any provision of the Fair Labor Standards Act of 1938, including any regulation promulgated under such Act; or

“(II) a finding through a final order of the Secretary of Labor that the permittee has violated any provision of such Act, including such a regulation.

“(ii) Occupational safety and health act of 1970—With respect to a labor law described in paragraph (1)(B)—

“(I) a finding through an order or judgment of a Federal or State court that the permittee has violated any provision of the Occupational Safety and Health Act of 1970, including any standard promulgated under section 6 of such Act or any other regulation promulgated under such Act, or any standard or regulation promulgated under an applicable State plan approved by the Secretary of Labor under section 18 of such Act (29 U.S.C. 667) that is identical or equivalent to a standard promulgated under such section 6; or

“(II) a finding through a final order issued by the Occupational Safety and Health Review Commission, or an equivalent final decision of any State agency or administrative body, that the permittee has committed a violation described in subclause (I).

“(iii) National labor relations act—With respect to a labor law described in paragraph (1)(C), a finding by the National Labor Relations Board that the permittee has violated section 8 of the National Labor Relations Act (29 U.S.C. 158), including a regulation promulgated under such section, by committing an unfair labor practice under such section.

“(B) Exception—Notwithstanding subparagraph (A), a permittee shall not be considered in violation of a labor law described in paragraph (1) if a finding described in subparagraph (A) with respect to the permittee is through an order or judgment that has been reversed, vacated, or rescinded.

“(3) Reporting requirements—Not later than 30 days after a finding described in paragraph (2) has been made with respect to a permittee, the permittee shall notify the Secretary of such finding in such form and manner as the Secretary, in coordination with the Secretary of Labor and the National Labor Relations Board, shall prescribe.

“303. Delivery of hemp inadvertently exceeding permissible concentration of delta-9 tetrahyrdrocannabinol

“(a) In general—The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Health and Human Services, shall issue regulations to establish a process for the lawful delivery of hemp described in subsection (b) to a cannabis enterprise holding a permit issued under this title and authorized pursuant to section 5911 of the Internal Revenue Code of 1986.

“(b) Hemp described—Hemp referred to in subsection (a) is Cannabis sativa L. inadvertently produced with a total tetrahydrocannabinol equivalent concentration of more than the allowable tetrahydrocannabinol equivalent amount as described in paragraph (1)(C) of section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o)—

“(1) before September 30, 2021, by an institution of higher education or State department of agriculture that grows or cultivates industrial hemp under section 7606 of the Agricultural Act of 2014 (7 U.S.C. 5940); or

“(2) by a producer of hemp under subtitle G of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o et seq.).

“304. Unfair competition and unlawful practices

“(a) In general—It shall be unlawful for any person engaged in the business of importing cannabis into the United States, or cultivating, producing, manufacturing, packaging, or warehousing cannabis, or purchasing cannabis for resale at wholesale, directly or indirectly or through an affiliate, to do any of the following:

“(1) Exclusive outlet—To require, by agreement or otherwise, that any retailer engaged in the sale of cannabis products, purchase any such products from such person to the exclusion in whole or in part of cannabis sold or offered for sale by other persons in interstate or foreign commerce, if such requirement is made in the course of interstate or foreign commerce, or if such person engages in such practice to such an extent as substantially to restrain or prevent transactions in interstate or foreign commerce in any such products, or if the direct effect of such requirement is to prevent, deter, hinder, or restrict other persons from selling or offering for sale any such products to such retailer in interstate or foreign commerce.

“(2) Tied house—To induce through any of the following means, any retailer, engaged in the sale of cannabis products to purchase any such products from such person to the exclusion in whole or in part of cannabis sold or offered for sale by other persons in interstate or foreign commerce, if such inducement is made in the course of interstate or foreign commerce, or if such person engages in the practice of using such means, or any of them, to such an extent as substantially to restrain or prevent transactions in interstate or foreign commerce in any such products, or if the direct effect of such inducement is to prevent, deter, hinder, or restrict other persons from selling or offering for sale any such products to such retailer in interstate or foreign commerce:

“(A) Acquiring or holding (after the expiration of any existing license) any interest in any license with respect to the premises of the retailer.

“(B) Acquiring any interest in real or personal property owned, occupied, or used by the retailer in the conduct of his business.

“(C) Furnishing, giving, renting, lending, or selling to the retailer, any equipment, fixtures, signs, supplies, money, services, or other thing of value, subject to such exceptions as the Secretary shall by regulation prescribe, having due regard for public health, the quantity and value of articles involved, established trade customs not contrary to the public interest and the purposes of this subsection.

“(D) Paying or crediting the retailer for any advertising, display, or distribution service.

“(E) Guaranteeing any loan or the repayment of any financial obligation of the retailer.

“(F) Extending to the retailer credit for a period in excess of the credit period usual and customary to the industry for the particular class of transactions, as ascertained by the Secretary of the Treasury and prescribed by regulations by him.

“(G) Requiring the retailer to take and dispose of a certain quota of any of such products.

“(3) Commercial bribery—To induce through any of the following means, any trade buyer engaged in the sale of cannabis products, to purchase any such products from such person to the exclusion in whole or in part of cannabis products sold or offered for sale by other persons in interstate or foreign commerce, if such inducement is made in the course of interstate or foreign commerce, or if such person engages in the practice of using such means, or any of them, to such an extent as substantially to restrain or prevent transactions in interstate or foreign commerce in any such products, or if the direct effect of such inducement is to prevent, deter, hinder, or restrict other persons from selling or offering for sale any such products to such trade buyer in interstate or foreign commerce:

“(A) Commercial bribery.

“(B) Offering or giving any bonus, premium, or compensation to any officer, or employee, or representative of the trade buyer.

“(4) Consignment sales—To sell, offer for sale, or contract to sell to any trade buyer engaged in the sale of cannabis products, or for any such trade buyer to purchase, offer to purchase, or contract to purchase, any such products on consignment or under conditional sale or with the privilege of return or on any basis otherwise than a bona fide sale, or where any part of such transaction involves, directly or indirectly, the acquisition by such person from the trade buyer or his agreement to acquire from the trade buyer other cannabis products, if such sale, purchase, offer, or contract is made in the course of interstate or foreign commerce, or if such person or trade buyer engages in such practice to such an extent as substantially to restrain or prevent transactions in interstate or foreign commerce in any such products or if the direct effect of such sale, purchase, offer, or contract is to prevent, deter, hinder, or restrict other persons from selling or offering for sale any such products to such trade buyer in interstate or foreign commerce.

“(5) Labeling—To sell or ship or deliver for sale or shipment, or otherwise introduce in interstate or foreign commerce, or to receive therein, or to remove from customs custody for consumption, any cannabis product in packages, unless such products are packaged, and labeled in conformity with such regulations, to be prescribed by the Secretary, with respect to packaging, marking, branding, and labeling and size of container—

“(A) as will prohibit deception of the consumer with respect to such products or the quantity thereof and as will prohibit, irrespective of falsity, such statements relating to manufacturing processes, analyses, guarantees, and scientific or irrelevant matters as the Secretary finds to be likely to mislead the consumer;

“(B) as will provide the consumer with information described in section 1103 of the Federal Food, Drug, and Cosmetic Act;

“(C) as will require compliance with section 112(b) of the Cannabis Administration and Opportunity Act;

“(D) as will prohibit statements on the label that are disparaging of a competitor's products or are false, misleading, obscene, or indecent; and

“(E) as will prevent deception of the consumer by use of a trade or brand name that is the name of any living individual of public prominence, or existing private or public organization, or is a name that is in simulation or is an abbreviation thereof, and as will prevent the use of a graphic, pictorial, or emblematic representation of any such individual or organization, if the use of such name or representation is likely falsely to lead the consumer to believe that the product has been indorsed, made, or used by, or produced for, or under the supervision of, or in accordance with the specifications of, such individual or organization.

“(6) Advertising—To publish or disseminate or cause to be published or disseminated by radio broadcast, or in any newspaper, periodical or other publication or by any sign or outdoor advertisement or any other printed or graphic matter, any advertisement of cannabis, if such advertisement is in, or is calculated to induce sales in, interstate or foreign commerce, or is disseminated by mail, unless such advertisement is in conformity with such regulations, to be prescribed by the Secretary, as will—

“(A) prevent deception of the consumer with respect to the products advertised and as will prohibit, irrespective of falsity, such statements relating to manufacturing processes, analyses, guaranties, and scientific or irrelevant matters as the Secretary finds to be likely to mislead the consumer;

“(B) provide the consumer with adequate information as to the identity and quality of the products advertised, the characteristics thereof, and the person responsible for the advertisement;

“(C) prohibit statements that are disparaging of a competitor's products or are false, misleading, obscene, or indecent; and

“(D) prevent statements inconsistent with any statement on the labeling of the products advertised.

“(b) Removal or destruction of label—It shall be unlawful for any person to alter, mutilate, destroy, obliterate, or remove any mark, brand, or label upon cannabis products held for sale in interstate or foreign commerce or after shipment therein, except as authorized by Federal law or except pursuant to regulations of the Secretary authorizing relabeling for purposes of compliance with the requirements of this subsection or of State law.

“(c) Exceptions

“(1) Consignment sales—Paragraph (4) of subsection (a) shall not apply to transactions involving solely the bona fide return of merchandise for ordinary and usual commercial reasons arising after the merchandise has been sold.

“(2) Labeling—Paragraph (5) of such subsection shall not apply to the use of the name of any person engaged in business as a manufacturer of cannabis products, nor to the use by any person of a trade or brand name used by him or his predecessor in interest prior to the date of enactment of the Cannabis Administration and Opportunity Act.

“(3) Advertising—Paragraph (6) of such subsection shall not apply to the publisher of any newspaper, periodical, or other publication, or radio broadcaster, unless such publisher or radio broadcaster is engaged in the business of importing cannabis into the United States, or cultivating, producing, manufacturing, packaging, or warehousing cannabis, or purchasing cannabis for resale at wholesale, directly or indirectly or through an affiliate.

“(4) State law—With respect to subsection (a)(2), subparagraphs (A), (B), (C), (E), and (F) of such subsection shall apply to transactions between a retailer or trade buyer in any State and a producer, importer, or wholesaler of cannabis products outside such State only to the extent that the law of such State imposes similar requirements with respect to similar transactions between a retailer or trade buyer in such State and a producer, importer, or wholesaler of cannabis products in such State, as the case may be.

“(5) Proprietary interest—Pursuant to regulations or other guidance promulgated by the Secretary, with respect to subparagraphs (A) and (B) of subsection (a)(2), rules similar to the rules of sections 6.27 and 6.33 of title 27, Code of Federal Regulations (as in effect on the date of enactment of this title), shall apply.

“305. Remedies for violations

“(a) Criminal fine

“(1) Generally—Whoever violates section 301 shall be fined not more than $1,000.

“(2) Settlement in compromise—The Secretary may decide not to refer a violation of such section to the Attorney General for prosecution but instead to collect a payment from the violator of no more than $500 for that violation.

“(b) Civil Action for relief—The Attorney General may, in a civil action, obtain appropriate relief to prevent and restrain a violation of this title.

“306. Definitions

“In this title—

“(1) the term cannabis has the meaning given such term in section 3 of the Cannabis Administration and Opportunity Act;

“(2) the term Secretary means the Secretary of the Treasury or the Secretary's delegate; and

“(3) the term State includes the District of Columbia, Puerto Rico, and any territory or possession of the United States.”

(b)
Appropriations— In addition to amounts otherwise available, there is appropriated, out of any funds in the Treasury not otherwise appropriated, for fiscal year 2023—
(1)
$15,000,000 to the Secretary of Labor for carrying out the activities of the Secretary of Labor under section 302 of the Federal Alcohol Administration Act, to remain available until September 30, 2027; and
(2)
$10,000,000 to the National Labor Relations Board for carrying out the activities of the National Labor Relations Board under such section, to remain available until September 30, 2027.

Sec. 512 Increased funding for the Alcohol, Tobacco, and Cannabis Tax and Trade Bureau

In addition to any other amounts otherwise available to the Alcohol, Tobacco, and Cannabis Tax and Trade Bureau, there is appropriated, out of any funds in the Treasury not otherwise appropriated, $100,000,000 for each of the fiscal years 2023 through 2027 to carry out—
(1)
sections 102 and 112 of this Act,
(2)
chapter 56 of the Internal Revenue Code of 1986 (as added by section 401 of this Act),
(3)
title III of the Federal Alcohol Administration Act (as added by section 511 of this Act), and
(4)
section 1111 of the Homeland Security Act of 2002 (6 U.S.C. 531).