II 

118TH CONGRESS 

2D SESSION S. 5243 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

regulation of cannabis and cannabinoid products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 25, 2024 

Mr. WYDEN introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide for the regulation of cannabis and cannabinoid 

products, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Cannabinoid Safety and Regulation Act’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—FOOD AND DRUG ADMINISTRATION REGULATION OF 

CANNABINOID PRODUCTS 

Sec. 101. FDA regulation of cannabinoid products. 


ssavage on LAPJG3WLY3PROD with BILLS
2 

•S 5243 IS

Sec. 102. Amendments to the Federal Food, Drug, and Cosmetic Act. 

Sec. 103. Regulation of cannabinoid beverages containing tetrahydrocannabinol. 

TITLE II—PUBLIC HEALTH 

Sec. 201. Public health surveillance and data collection. 

Sec. 202. Awards to prevent underage cannabis use. 

TITLE III—CANNABIS-IMPAIRED DRIVING PREVENTION 

Sec. 301. Definitions. 

Sec. 302. Cannabis-impaired driving research. 

Sec. 303. DOT cannabis-impaired driving prevention programs. 

Sec. 304. State cannabis-impaired driving prevention grant program. 

Sec. 305. National cannabis impairment standard. 

Sec. 306. Funding. 

1 TITLE I—FOOD AND DRUG AD2 MINISTRATION REGULATION 

3 OF CANNABINOID PRODUCTS 

4 SEC. 101. FDA REGULATION OF CANNABINOID PRODUCTS. 

5 (a) IN GENERAL.—The Federal Food, Drug, and 

6 Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add7 ing at the end the following: 

8 ‘‘CHAPTER XI—CANNABINOID PRODUCTS 

9 ‘‘SEC. 1101. CENTER FOR CANNABINOID PRODUCTS. 

10 ‘‘Not later than 120 days after the date of enactment 

11 of the Cannabinoid Safety and Regulation Act, the Sec12 retary shall establish within the Food and Drug Adminis13 tration the Center for Cannabinoid Products, which shall 

14 report to the Commissioner in the same manner as the 

15 other agency centers within the Food and Drug Adminis16 tration. The Center shall be responsible for the implemen17 tation of this chapter and related matters assigned by the 

18 Commissioner. 


ssavage on LAPJG3WLY3PROD with BILLS
3 

•S 5243 IS

1 ‘‘SEC. 1102. ADULTERATED CANNABINOID PRODUCTS. 

2 ‘‘A cannabinoid product shall be deemed to be adul3 terated if— 

4 ‘‘(1) it consists in whole or in part of any filthy, 

5 putrid, or decomposed substance, or is otherwise 

6 contaminated by any added poisonous or added dele7 terious substance that may render the product inju8 rious to health; 

9 ‘‘(2) it has been manufactured, prepared, proc10 essed, packed, or held in insanitary conditions 

11 whereby it may have been contaminated with filth, 

12 or whereby it may have been rendered injurious to 

13 health; 

14 ‘‘(3) it bears or contains any poisonous or dele15 terious substance that may render it injurious to 

16 health; 

17 ‘‘(4) its container is composed, in whole or in 

18 part, of any poisonous or deleterious substance that 

19 may render the contents injurious to health; 

20 ‘‘(5) it bears or contains an unsafe color addi21 tive that is unsafe within the meaning of section 

22 721(a); 

23 ‘‘(6) the methods used in, or the facilities or 

24 controls used for, its manufacture, preparing, proc25 essing, packing, or storage are not in conformity 

26 with applicable requirements under section 1105(c); 


ssavage on LAPJG3WLY3PROD with BILLS
4 

•S 5243 IS

1 ‘‘(7) it has been manufactured, prepared, proc2 essed, packed, or held in any factory, warehouse, or 

3 establishment and the owner, operator, or agent of 

4 such factory, warehouse, or establishment delays, de5 nies, or limits an inspection, or refuses to permit 

6 entry or inspection; or 

7 ‘‘(8) it bears or contains, or has been manufac8 tured, prepared, or processed from, artificially or 

9 synthetically derived cannabinoids of any kind. 

10 ‘‘SEC. 1103. MISBRANDED CANNABINOID PRODUCTS. 

11 ‘‘A cannabinoid product shall be deemed to be mis12 branded— 

13 ‘‘(1) if its labeling, advertising, or promotion is 

14 false or misleading in any particular, except that no 

15 cannabinoid product shall be deemed to be mis16 branded solely because its labeling, advertising, or 

17 promotion uses the term ‘cannabis’; 

18 ‘‘(2) if it is a finished product, unless it bears 

19 a label containing— 

20 ‘‘(A) a prominent statement on the front 

21 of the product packaging, and on any internal 

22 product insert or packaging, that the product 

23 contains cannabinoids; 

24 ‘‘(B) the name, place of business, and con25 tact information (including, as applicable, 


ssavage on LAPJG3WLY3PROD with BILLS
5 

•S 5243 IS

1 phone number, email address, and physical ad2 dress) of its manufacturer, packer, or dis3 tributor; 

4 ‘‘(C) an accurate statement of the quantity 

5 of its contents in terms of weight, measure, or 

6 numerical count; 

7 ‘‘(D) a statement of its form as specified 

8 in regulations promulgated pursuant to section 

9 1105(a); 

10 ‘‘(E) if it is intended for animal consump11 tion or human consumption and is packaged 

12 and labeled in such a way as to suggest more 

13 than one serving, dose, or the equivalent, infor14 mation on how such product may be divisible 

15 into, or measured into, a portion equivalent to 

16 one serving, dose, or the equivalent; 

17 ‘‘(F) if it is intended for animal consump18 tion or human consumption and is packaged 

19 and labeled in such a way as to suggest more 

20 than one serving, dose, or the equivalent, a 

21 statement of the amount of total 

22 tetrahydrocannabinol, in milligrams, in one 

23 serving, dose, or the equivalent; 

24 ‘‘(G)(i) a statement of the content and 

25 amount, in milligrams, of any other 


ssavage on LAPJG3WLY3PROD with BILLS
6 

•S 5243 IS

1 cannabinoids in the product, other than natu2 rally occurring cannabinoids present at trace 

3 amounts; and 

4 ‘‘(ii) if it is packaged and labeled in such 

5 a way as to suggest more than one serving, 

6 dose, or the equivalent, a statement of the 

7 amount of such other cannabinoids in one serv8 ing, dose, or the equivalent; 

9 ‘‘(H) adequate directions for use and how 

10 to report adverse events, if deemed necessary 

11 for the protection of the public health in regula12 tions promulgated pursuant to section 1105(a); 

13 ‘‘(I) if it is intended for human consump14 tion, a statement disclosing the presence or the 

15 possibility of the presence of any major food al16 lergen or other food allergen which the Sec17 retary may, by order, require to be disclosed; 

18 ‘‘(J) if it is intended for human use, a 

19 statement disclosing any known risks to special 

20 populations, including children, individuals who 

21 are pregnant or breastfeeding, and individuals 

22 taking drugs known to interact with the prod23 uct, including the following statement: ‘Keep 

24 out of reach of children and pets. This product 

25 should not be consumed by women who are 


ssavage on LAPJG3WLY3PROD with BILLS
7 

•S 5243 IS

1 pregnant or nursing. Consult your health care 

2 provider if you have any other medical condi3 tions or are taking any medication(s). This 

4 product may be purchased only by persons 21 

5 and older.’; 

6 ‘‘(K) a statement disclosing risks posed by 

7 consuming or using the specific cannabinoid 

8 contained or purported to be contained in the 

9 product, including the risk of drug test failure; 

10 ‘‘(L) unless it is a dietary supplement that 

11 bears the statement required by section 

12 403(r)(6)(C), a statement disclosing that the 

13 Food and Drug Administration has not deter14 mined the product to be safe or effective for 

15 treating any condition, including the following 

16 statement: ‘This product has not been evaluated 

17 for safety or efficacy by the Food and Drug Ad18 ministration.’; 

19 ‘‘(M) if it is intended for use in animals, 

20 a prominently placed, conspicuous— 

21 ‘‘(i) warning that the product should 

22 not be used by humans; and 

23 ‘‘(ii) statement that the product is in24 tended for use in animals, including a 

25 specification of the intended species; 


ssavage on LAPJG3WLY3PROD with BILLS
8 

•S 5243 IS

1 ‘‘(N) the applicable universal symbol de2 scribed in section 1105(d); 

3 ‘‘(O) beginning not later than 90 days 

4 after issuance of an order or finalization of a 

5 rule under section 1105(f)(1), as applicable, in6 formation on the safety test results for such 

7 product, or information on where to obtain such 

8 safety test results; and 

9 ‘‘(P) such other information as the Sec10 retary determines, in regulations promulgated 

11 pursuant to section 1105(a), to be necessary for 

12 the protection of the public health; 

13 ‘‘(3) if it is a dietary supplement or a food and 

14 its label or labeling bears a statement describing the 

15 role of a cannabis constituent or cannabinoid in16 tended to affect the structure or any function of the 

17 body of humans or other animals, unless there is 

18 substantiation that such statement is truthful and 

19 not misleading; 

20 ‘‘(4) if any word, statement, or other informa21 tion required by or under authority of this Act to 

22 appear on the label or labeling is not prominently 

23 placed thereon with such conspicuousness (as com24 pared with other words, statements, designs, or de25 vices, in the labeling) and in such terms as to render 


ssavage on LAPJG3WLY3PROD with BILLS
9 

•S 5243 IS

1 it likely to be read and understood by the ordinary 

2 individual under customary conditions of purchase 

3 and use; 

4 ‘‘(5) if it purports to be, or is represented as, 

5 a cannabinoid product that is subject to a 

6 cannabinoid product standard established under sec7 tion 1106 unless such cannabinoid product is in all 

8 respects in conformity with such standard; 

9 ‘‘(6) if its sale, distribution, or label or labeling 

10 is not in conformity with applicable requirements 

11 under subsections (a) and (b) of section 1105; 

12 ‘‘(7) if it was manufactured, prepared, propa13 gated, compounded, processed, packaged, packed, 

14 imported, labeled, or held in an establishment not 

15 duly registered under section 1104, if it was not in16 cluded in a list required by section 1104, or if it was 

17 manufactured, prepared, propagated, compounded, 

18 processed, packaged, packed, imported, labeled, or 

19 held by or in an establishment for which the reg20 istration was suspended under section 1104 and 

21 such registration has not been reinstated; 

22 ‘‘(8) if it takes such a form as to imitate or 

23 replicate a product that is marketed to or is com24 monly associated with children or minors, imitates a 

25 commercially available candy, snack, or beverage 


ssavage on LAPJG3WLY3PROD with BILLS
10 

•S 5243 IS

1 packaging or labeling, or is in the shape of real or 

2 imagined animals, people, vehicles, or characters, in3 cluding anthropomorphic non-human animals, vehi4 cles, foods, plants, or other characters, and including 

5 cartoon characters; 

6 ‘‘(9) it is a gummy product, unless it is in the 

7 shape of a cube, rectangle, sphere, or other geo8 metric shape; or 

9 ‘‘(10) if it purports to be, or is represented as, 

10 an eye drop, nasal spray, or injectable. 

11 ‘‘SEC. 1104. REGISTRATION. 

12 ‘‘(a) REGISTRATION BY COVERED ENTITIES.— 

13 ‘‘(1) INITIAL REGISTRATION.— 

14 ‘‘(A) EXISTING FACILITIES.—Each covered 

15 entity that, on the date of enactment of the 

16 Cannabinoid Safety and Regulation Act, owns 

17 or operates a facility that carries out a covered 

18 activity shall register each such facility with the 

19 Secretary not later than 90 days after such 

20 date of enactment, in accordance with sub21 section (b). 

22 ‘‘(B) NEW FACILITIES.—Each covered en23 tity that owns or operates a facility that first 

24 carries out, after the date of enactment of the 

25 Cannabinoid Safety and Regulation Act, a covVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
11 

•S 5243 IS

1 ered activity shall register with the Secretary 

2 not later than 30 days after the date on which 

3 a covered entity first engages in such covered 

4 activity or 30 days after the deadline for reg5 istration under subparagraph (A), whichever is 

6 later, in accordance with subsection (b). 

7 ‘‘(2) RENEWAL OF REGISTRATION.—Each cov8 ered entity required to register a facility under this 

9 section shall renew such registration with the Sec10 retary on or before December 31 of each even-num11 bered year. 

12 ‘‘(b) CONTENT OF REGISTRATION.— 

13 ‘‘(1) IN GENERAL.—For each facility at which 

14 a covered entity carries out a covered activity, such 

15 covered entity shall submit to the Secretary, through 

16 the website established under paragraph (2)(A), a 

17 registration that includes— 

18 ‘‘(A) information necessary to notify the 

19 Secretary of the name (including trade name), 

20 address, and telephone number of such facility; 

21 ‘‘(B)(i) in the case of a domestic facility, 

22 the email address and telephone number for the 

23 contact person of such facility; or 


ssavage on LAPJG3WLY3PROD with BILLS
12 

•S 5243 IS

1 ‘‘(ii) in the case of a foreign facility, the 

2 email address and telephone number for the 

3 United States agent for such facility; 

4 ‘‘(C) the general activities conducted at 

5 such facility, including the 1 or more categories 

6 of cannabinoid products manufactured, pre7 pared, propagated, compounded, processed, 

8 packaged, packed, imported, labeled, or held at 

9 such facility; 

10 ‘‘(D) the facility registration number for 

11 such facility, if any, previously assigned by the 

12 Secretary; 

13 ‘‘(E) all brand names under which 

14 cannabinoid products manufactured, prepared, 

15 propagated, compounded, processed, packaged, 

16 packed, imported, labeled, or held in such facil17 ity are sold, on the condition that the Secretary 

18 shall keep such information confidential; 

19 ‘‘(F) an assurance that the Secretary will 

20 be permitted to inspect such facility at the 

21 times and in the manner permitted by this Act, 

22 including section 704; and 

23 ‘‘(G) any other information the Secretary 

24 may require. 

25 ‘‘(2) PROCEDURE.— 


ssavage on LAPJG3WLY3PROD with BILLS
13 

•S 5243 IS

1 ‘‘(A) WEBSITE.— 

2 ‘‘(i) IN GENERAL.—Not later than the 

3 applicable date described in clause (ii), the 

4 Secretary shall establish a website for sub5 mission of registration under this sub6 section. 

7 ‘‘(ii) APPLICABLE DATE DE8 SCRIBED.—The applicable date described 

9 in this clause is— 

10 ‘‘(I) 180 days after the date of 

11 enactment of the Cannabinoid Safety 

12 and Regulation Act; or 

13 ‘‘(II) if December 31 is less than 

14 180 days after such date of enact15 ment, 240 days after such date of en16 actment. 

17 ‘‘(B) NOTIFICATION OF RECEIPT; REG18 ISTRATION NUMBERS.—Not later than 30 days 

19 after the date on which the Secretary receives 

20 a completed registration submitted under this 

21 subsection, the Secretary shall— 

22 ‘‘(i) notify the applicable covered enti23 ty of the receipt of such registration; and 

24 ‘‘(ii) assign such covered entity a reg25 istration number. 


ssavage on LAPJG3WLY3PROD with BILLS
14 

•S 5243 IS

1 ‘‘(C) OWNERS, OPERATORS, AND AGENTS

2 IN CHARGE.—A registration under this sub3 section shall— 

4 ‘‘(i) in the case of a domestic facility, 

5 be submitted by the owner or operator of 

6 such facility; and 

7 ‘‘(ii) in the case of a foreign facility, 

8 be submitted by the owner or operator of 

9 such facility. 

10 ‘‘(c) UNIFORM PRODUCT IDENTIFICATION SYS11 TEM.—The Secretary may— 

12 ‘‘(1) by regulation prescribe a uniform system 

13 for the identification of cannabinoid products; and 

14 ‘‘(2) require persons who are required to list 

15 such cannabinoid products under subsection (f)— 

16 ‘‘(A) to list such cannabinoid products in 

17 accordance with such system; and 

18 ‘‘(B) to include the identification number 

19 for such cannabinoid products on the labels for 

20 such cannabinoid products. 

21 ‘‘(d) REGISTRATION INFORMATION.—The Secretary 

22 shall compile and maintain an up-to-date list of facilities 

23 that are registered under this section. 

24 ‘‘(e) FEE FOR REGISTRATION.— 


ssavage on LAPJG3WLY3PROD with BILLS
15 

•S 5243 IS

1 ‘‘(1) IN GENERAL.—The Secretary may charge 

2 a fee for registration under this section, which shall 

3 be due upon submission of such registration. 

4 ‘‘(2) ELECTRONIC PAYMENT.—Payment of the 

5 fee under paragraph (1) may be made electronically 

6 pursuant to an online method of payment provided 

7 by the Secretary. 

8 ‘‘(3) AMOUNT OF FEE; INFLATION ADJUST9 MENTS.— 

10 ‘‘(A) IN GENERAL.—If the Secretary 

11 charges a fee under paragraph (1), the Sec12 retary shall establish the amount of the fee as 

13 follows: 

14 ‘‘(i) For fiscal year 2024, an amount 

15 not to exceed $500. 

16 ‘‘(ii) For fiscal year 2025 and each 

17 fiscal year thereafter, an amount equal to 

18 the product obtained by multiplying— 

19 ‘‘(I) the dollar amount of the fee 

20 established under clause (i); and 

21 ‘‘(II) the percentage (if any) by 

22 which the Consumer Price Index for 

23 All Urban Consumers, as published by 

24 the Bureau of Labor Statistics of the 


ssavage on LAPJG3WLY3PROD with BILLS
16 

•S 5243 IS

1 Department of Labor, increased dur2 ing the most recent 12-month period. 

3 ‘‘(B) EFFECT.—Nothing in this paragraph 

4 prevents the Secretary from decreasing the 

5 amount of the registration fee under paragraph 

6 (1). 

7 ‘‘(4) REGISTRATION REFUSED OR WITH8 DRAWN.—The Secretary shall refund 75 percent of 

9 the fee paid under paragraph (1) for any registra10 tion that is denied, refused, or withdrawn. 

11 ‘‘(f) REGISTRATION INFORMATION.— 

12 ‘‘(1) PRODUCT LIST.— 

13 ‘‘(A) IN GENERAL.—Each covered entity 

14 that registers with the Secretary under this sec15 tion shall, at the time of such registration, file 

16 with the Secretary— 

17 ‘‘(i) a list of all cannabinoid products 

18 which are being manufactured, prepared, 

19 propagated, compounded, processed, pack20 aged, packed, imported, labeled, or held by 

21 such covered entity for commercial dis22 tribution and which have not been included 

23 in any list of cannabinoid products filed by 

24 such covered entity with the Secretary 


ssavage on LAPJG3WLY3PROD with BILLS
17 

•S 5243 IS

1 under this paragraph or paragraph (2) be2 fore such time of registration; and 

3 ‘‘(ii) such other information as the 

4 Secretary may require, by regulation, to 

5 carry out the purposes of the Cannabinoid 

6 Safety and Regulation Act, including the 

7 amendments made by such Act. 

8 ‘‘(B) FORM AND MANNER OF LIST.—The 

9 list under subparagraph (A)(i) shall include— 

10 ‘‘(i) the facility registration number of 

11 each facility where the cannabinoid product 

12 is manufactured, prepared, propagated, 

13 compounded, processed, packaged, packed, 

14 imported, labeled, or held; 

15 ‘‘(ii) the name and contact number of 

16 the responsible person and the name for 

17 the cannabinoid product, as such name ap18 pears on the label; 

19 ‘‘(iii) the name and contact number of 

20 the person submitting the listing; and 

21 ‘‘(iv) an electronic copy of the label, 

22 and an electronic copy of the package in23 sert, if any. 

24 ‘‘(2) REPORT OF ANY CHANGE IN PRODUCT

25 LIST.—Each covered entity that registers with the 


ssavage on LAPJG3WLY3PROD with BILLS
18 

•S 5243 IS

1 Secretary under this section shall report to the Sec2 retary as follows: 

3 ‘‘(A) Prior to the introduction into com4 mercial distribution of a cannabinoid product 

5 that has not been included in any list previously 

6 filed by the registrant, a list containing such 

7 cannabinoid product. 

8 ‘‘(B) A notice of discontinuance of the 

9 manufacturing, preparing, propagating, 

10 compounding, processing, packaging, packing, 

11 importing, labeling, or holding for commercial 

12 distribution of a cannabinoid product included 

13 in a list filed under subparagraph (A) or para14 graph (1), and the date of such discontinuance. 

15 ‘‘(C) A notice of resumption of the manu16 facturing, preparing, propagating, 

17 compounding, processing, packaging, packing, 

18 importing, labeling, or holding for commercial 

19 distribution of the cannabinoid product with re20 spect to which a notice of discontinuance was 

21 reported under subparagraph (B). 

22 ‘‘(D) A list of each cannabinoid product in23 cluded in a notice filed under subparagraph (C) 

24 prior to the resumption of the introduction into 


ssavage on LAPJG3WLY3PROD with BILLS
19 

•S 5243 IS

1 commercial distribution of such cannabinoid 

2 product. 

3 ‘‘(g) SUSPENSIONS.— 

4 ‘‘(1) SUSPENSION OF REGISTRATION OF A FA5 CILITY.—The Secretary may suspend the registra6 tion of a facility if the Secretary— 

7 ‘‘(A) determines that a cannabinoid prod8 uct manufactured, prepared, propagated, com9 pounded, processed, packaged, packed, im10 ported, labeled, or held by such registered facil11 ity and distributed in the United States has a 

12 reasonable probability of causing a serious ad13 verse effect in humans or other animals; and 

14 ‘‘(B) has a reasonable belief that other 

15 cannabinoid products manufactured, prepared, 

16 propagated, compounded, processed, packaged, 

17 packed, imported, labeled, or held by such reg18 istered facility may be similarly affected be19 cause of a failure that cannot be isolated to a 

20 product or products, or is sufficiently pervasive 

21 to raise concerns about other products manu22 factured, prepared, propagated, compounded, 

23 processed, packaged, packed, imported, labeled, 

24 or held in such registered facility. 


ssavage on LAPJG3WLY3PROD with BILLS
20 

•S 5243 IS

1 ‘‘(2) NOTICE OF SUSPENSION.—Before sus2 pending the registration of a facility under this sub3 section, the Secretary shall provide— 

4 ‘‘(A) notice to the applicable covered entity 

5 of the intent to suspend the facility registration, 

6 which shall specify the basis of the determina7 tion by the Secretary that the facility registra8 tion should be suspended; and 

9 ‘‘(B) an opportunity, within 5 business 

10 days of the notice provided under subparagraph 

11 (A), for such covered entity to provide a correc12 tive action plan to demonstrate how such cov13 ered entity plans to correct the violations found 

14 by the Secretary. 

15 ‘‘(3) HEARING.— 

16 ‘‘(A) IN GENERAL.—The Secretary shall 

17 provide a covered entity the facility registration 

18 of which is suspended under this subsection 

19 with an opportunity for an informal hearing, to 

20 be held as soon as practicable, but in any case 

21 not later than 5 business days after such reg22 istration is suspended, or such other time pe23 riod as is agreed upon by the Secretary and the 

24 covered entity, on the actions required for rein25 statement of registration and why the registraVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
21 

•S 5243 IS

1 tion that is subject to the suspension should be 

2 reinstated. 

3 ‘‘(B) POST-HEARING REINSTATEMENT.—If 

4 a covered entity requests a hearing under sub5 paragraph (A), and the Secretary determines, 

6 based on evidence presented at such hearing, 

7 that adequate grounds do not exist to continue 

8 the suspension of such registration, the Sec9 retary shall reinstate such registration. 

10 ‘‘(C) POST-HEARING CORRECTIVE ACTION

11 PLAN.— 

12 ‘‘(i) IN GENERAL.—If a covered entity 

13 requests a hearing under subparagraph 

14 (A), and the Secretary determines, based 

15 on evidence presented at such hearing, that 

16 the suspension of registration remains nec17 essary, the Secretary shall require the ap18 plicable covered entity to submit to the 

19 Secretary a corrective action plan de20 scribed in paragraph (2)(B), if not already 

21 submitted. 

22 ‘‘(ii) REVIEW.—The Secretary shall 

23 review, and approve or deny, a plan sub24 mitted under paragraph (2)(B) or clause 

25 (i), as applicable, not later than 14 busiVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
22 

•S 5243 IS

1 ness days after such submission or such 

2 other time period as is determined by the 

3 Secretary, in consultation with the applica4 ble covered entity. 

5 ‘‘(D) VACATING OF ORDER; REINSTATE6 MENT.—Upon a determination by the Secretary 

7 that adequate grounds do not exist to continue 

8 the suspension of a registration of a facility 

9 under this subsection, the Secretary shall 

10 promptly vacate such suspension and reinstate 

11 such registration. 

12 ‘‘(4) EFFECT OF SUSPENSION.—If the registra13 tion of a facility is suspended under this subsection, 

14 no person shall carry out a covered activity at such 

15 facility. 

16 ‘‘(h) DISCLOSURE.— 

17 ‘‘(1) IN GENERAL.—The list described in sub18 section (d), any information submitted by a covered 

19 entity pursuant to this section, and any information 

20 derived from such list or information, shall be ex21 empt from disclosure under section 552 of title 5, 

22 United States Code, to the extent that such list or 

23 information discloses the identity or location of a 

24 registered facility, unless such information was pre25 viously lawfully disclosed to the public. 


ssavage on LAPJG3WLY3PROD with BILLS
23 

•S 5243 IS

1 ‘‘(2) APPLICABILITY.—For purposes of para2 graph (1), this section shall be considered a statute 

3 described in section 552(b)(3)(B) of title 5, United 

4 States Code. 

5 ‘‘(i) REGULATIONS.—The Secretary may promulgate 

6 such regulations as may be necessary to carry out this 

7 section. 

8 ‘‘(j) DEFINITIONS.—In this section: 

9 ‘‘(1) COVERED ACTIVITY.—The term ‘covered 

10 activity’ means— 

11 ‘‘(A) in the case of a domestic facility, the 

12 manufacturing, preparing, propagating, 

13 compounding, processing, packaging, packing, 

14 importing, labeling, or holding of a cannabinoid 

15 product for commercial distribution in the 

16 United States; or 

17 ‘‘(B) in the case of a foreign facility, the 

18 manufacturing, preparing, propagating, 

19 compounding, processing, packaging, packing, 

20 labeling, or holding of a cannabinoid product 

21 that is imported or offered for import into the 

22 United States. 

23 ‘‘(2) COVERED ENTITY.—The term ‘covered en24 tity’ means any person who owns or operates a doVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
24 

•S 5243 IS

1 mestic facility or foreign facility that is engaged in 

2 a covered activity. 

3 ‘‘(3) DOMESTIC FACILITY.—The term ‘domestic 

4 facility’ means a facility located in any State. 

5 ‘‘(4) FOREIGN FACILITY.—The term ‘foreign fa6 cility’ means a facility that manufactures, prepares, 

7 propagates, compounds, processes, packages, packs, 

8 labels, or holds a cannabinoid product that is im9 ported or offered for import into the United States. 

10 ‘‘SEC. 1105. GENERAL PROVISIONS FOR CONTROL OF 

11 CANNABINOID PRODUCTS. 

12 ‘‘(a) RESTRICTIONS ON SALE AND DISTRIBUTION.— 

13 ‘‘(1) REMOTE SALES.—Not later than 2 years 

14 after the date of enactment of the Cannabinoid Safe15 ty and Regulation Act, the Secretary shall propose, 

16 and not later than 3 years after such date of enact17 ment, the Secretary shall finalize, regulations re18 garding the promotion, sale, and distribution of 

19 cannabinoid products intended for human consump20 tion and that contain detectable levels of any 

21 tetrahydrocannabinol that occur through means 

22 other than a direct, face-to-face exchange between a 

23 retailer and a consumer, in order to prevent the sale 

24 and distribution of cannabinoid products to individ25 uals who have not attained the age of 21, including 


ssavage on LAPJG3WLY3PROD with BILLS
25 

•S 5243 IS

1 requirements for age verification. Such regulations 

2 shall require age to be verified at the time of pur3 chase or prior to shipment, either through use of a 

4 reliable online age verification service or by obtain5 ing and examining a copy of a valid, non-expired 

6 government-issued identification, including identi7 fication issued by an Indian Tribe (as defined in sec8 tion 1110). 

9 ‘‘(2) PREVENTING USE OF CANNABINOID PROD10 UCTS IN MINORS.—The Secretary shall, by regula11 tion, impose such restrictions on sales of 

12 cannabinoid products as the Secretary determines 

13 necessary and appropriate to prevent the consump14 tion or application of cannabinoid products intended 

15 for human consumption by individuals under 21 

16 years of age. Such regulations shall prohibit sales of 

17 cannabinoid products, whether directly or indirectly, 

18 to individuals under 21 years of age, and any other 

19 action that has the primary purpose of initiating or 

20 increasing the use of cannabinoid products in such 

21 individuals. 

22 ‘‘(3) GOOD FAITH CONSULTATION WITH INDIAN

23 TRIBES.—In issuing regulations under paragraphs 

24 (1) and (2), the Secretary shall conduct good faith, 


ssavage on LAPJG3WLY3PROD with BILLS
26 

•S 5243 IS

1 meaningful, and timely consultations with Indian 

2 Tribes (as defined in section 1110). 

3 ‘‘(b) LABELING STATEMENTS.—The label and label4 ing of a cannabinoid product shall bear such appropriate 

5 statements of the restrictions required by a regulation 

6 under subsection (a) as the Secretary may in such regula7 tion prescribe. 

8 ‘‘(c) STANDARDIZED INFORMATION PANEL FOR IN9 GESTIBLE CANNABINOID PRODUCTS.—The Secretary may 

10 prescribe by order a standardized format or label for label11 ing information required under this chapter for 

12 cannabinoid products intended for human consumption. 

13 ‘‘(d) UNIVERSAL SYMBOL.— 

14 ‘‘(1) IN GENERAL.—The universal symbol re15 ferred to in section 1103(2)(N) is, as applicable— 

16 ‘‘(A) the most recent international symbol 

17 established by ASTM International indicating 

18 that a product contains intoxicating 

19 cannabinoids; or 

20 ‘‘(B) the most recent international symbol 

21 established by ASTM International indicating 

22 that a product contains nonintoxicating 

23 cannabinoids. 

24 ‘‘(2) STATE AUTHORITY.— 


ssavage on LAPJG3WLY3PROD with BILLS
27 

•S 5243 IS

1 ‘‘(A) IN GENERAL.—The State in which a 

2 cannabinoid product is offered for sale may de3 termine which of the universal symbols de4 scribed in subparagraphs (A) and (B) of para5 graph (1) shall be required to be included on 

6 the label for such cannabinoid product for pur7 poses of section 1103(2)(N). 

8 ‘‘(B) STATE LABELS.—Before the date on 

9 which an international symbol described in 

10 paragraph (1)(B) is established, the State in 

11 which a cannabinoid product is offered for sale 

12 may establish, for purposes of section 

13 1103(2)(N), a symbol that indicates that a 

14 product contains either intoxicating 

15 cannabinoids or nonintoxicating cannabinoids. 

16 ‘‘(e) TAMPER-EVIDENT AND CHILD SAFETY PACK17 AGING.— 

18 ‘‘(1) IN GENERAL.—The Secretary may estab19 lish by order requirements for tamper-evident and 

20 child safety packaging for cannabinoid products in21 tended for human consumption and that contain 

22 more than 1 serving and are packaged in a container 

23 that exceeds 4 ounces. 

24 ‘‘(2) EFFECT.—Nothing in this subsection shall 

25 authorize the Secretary to prescribe by order or ruleVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
28 

•S 5243 IS

1 making specific packaging designs, product content, 

2 package quantity, or, with the exception of authority 

3 granted in section 1103, labeling and packaging. 

4 ‘‘(f) GOOD MANUFACTURING PRACTICE REQUIRE5 MENTS.— 

6 ‘‘(1) IN GENERAL.—Not later than 9 months 

7 after the date of enactment of the Cannabinoid Safe8 ty and Regulation Act, the Secretary shall promul9 gate regulations to require that the methods used in, 

10 and the facilities and controls used for, the manufac11 ture, preparing, processing, packing, and holding of 

12 a cannabinoid product conform to current good man13 ufacturing practice, including testing of cannabinoid 

14 products. 

15 ‘‘(2) CERTIFICATION.—The Secretary may re16 quire each covered entity with a registered facility 

17 under section 1104 to certify with respect to such 

18 registered facility compliance with the good manu19 facturing practice regulations described in paragraph 

20 (1). 

21 ‘‘(g) GOOD TESTING PRACTICE REQUIREMENTS.— 

22 ‘‘(1) IN GENERAL.—Not later than 18 months 

23 after the date of enactment of the Cannabinoid Safe24 ty and Regulation Act, the Secretary shall promul25 gate regulations or issue an order to require a 


ssavage on LAPJG3WLY3PROD with BILLS
29 

•S 5243 IS

1 cannabinoid product to be tested for safety in a lab2 oratory certified, accredited, licensed, or otherwise 

3 formally recognized for the testing of cannabinoid 

4 products in the State in which the cannabinoid prod5 uct is produced. Such regulations may include re6 quirements for laboratory accreditation standards, 

7 such as ISO 17025 of the International Organiza8 tion for Standardization (or a successor standard). 

9 ‘‘(2) REQUIREMENTS FOR ENTITIES CON10 DUCTING TESTING.—The regulations or order under 

11 paragraph (1) shall require that an entity con12 ducting a test of a cannabinoid product described in 

13 such paragraph— 

14 ‘‘(A) be registered and accredited for the 

15 testing of cannabinoid products or cannabis 

16 products in the applicable State; or 

17 ‘‘(B) be registered and in good standing 

18 with the Drug Enforcement Agency as a Hemp 

19 Analytical Testing Laboratory. 

20 ‘‘(3) REQUIREMENTS FOR TESTING.—The regu21 lations or order under paragraph (1) shall require 

22 that a test of a cannabinoid product described in 

23 such paragraph— 

24 ‘‘(A) shall be completed using— 


ssavage on LAPJG3WLY3PROD with BILLS
30 

•S 5243 IS

1 ‘‘(i) statistically valid sampling of the 

2 cannabinoid product; and 

3 ‘‘(ii) analytical testing methodologies 

4 that are— 

5 ‘‘(I) based on published, peer-re6 viewed methods validated for cannabis 

7 testing by an independent third party; 

8 or 

9 ‘‘(II) verified by the testing enti10 ty for compliance with the Official 

11 Methods of Analysis of AOAC Inter12 national, 22nd edition (or any suc13 cessor edition); 

14 ‘‘(B) shall include— 

15 ‘‘(i) testing for— 

16 ‘‘(I) pesticides and other chem17 ical residues or residual solvents, re18 gardless of whether a tolerance for 

19 such pesticides or other chemical resi20 dues or residual solvents has been es21 tablished; 

22 ‘‘(II) synthetic inputs used to 

23 produce semi-synthetic cannabinoid 

24 products, including hydrochloric acid 

25 and sulphuric acid; 


ssavage on LAPJG3WLY3PROD with BILLS
31 

•S 5243 IS

1 ‘‘(III) heavy metals, including ar2 senic, cadmium, lead, and copper, re3 gardless of whether a tolerance for 

4 such heavy metals has been estab5 lished; and 

6 ‘‘(IV) foreign matter, including 

7 mildew, organic materials foreign to 

8 the product, and inorganic materials; 

9 and 

10 ‘‘(ii) a potency analysis, which may 

11 not be adulterated or manipulated by any 

12 means, including by the addition of 

13 trichromes or other matter incidentally re14 moved while manipulating the product for 

15 testing, including measurements of— 

16 ‘‘(I) the total 

17 tetrahydrocannabinol content of the 

18 finished product; 

19 ‘‘(II) the total cannabinoid con20 tent of the finished product; 

21 ‘‘(III) the concentration of 

22 tetrahydrocannabinol; and 

23 ‘‘(IV) the concentration of 

24 cannabinoids; 


ssavage on LAPJG3WLY3PROD with BILLS
32 

•S 5243 IS

1 ‘‘(C) shall be conducted subject to quality 

2 assurance protocols to ensure the validity and 

3 reliability of test results; 

4 ‘‘(D) shall use analytical method selection, 

5 validation, and verification that ensure that the 

6 testing method used is appropriate for the prod7 uct type and method of consumption by the end 

8 user, including post-decarboxylation, if applica9 ble; 

10 ‘‘(E) shall ensure that analytical tests are 

11 sufficiently sensitive for the purposes of the de12 tectability requirements of required testing; and 

13 ‘‘(F) shall use testing protocols that in14 clude an effective disposal procedure for non15 compliant samples that do not meet the require16 ments of this section. 

17 ‘‘(4) PRODUCT SAFETY THRESHOLDS.—The 

18 regulations or order under paragraph (1) shall es19 tablish thresholds for cannabinoid product safety 

20 with respect to residual solvent levels, heavy metals, 

21 foreign matter, mycotoxin levels, and byproducts of 

22 semi-synthetic manufacturing processes. 

23 ‘‘(h) FOODS CONTAINING CANNABINOIDS.— 

24 ‘‘(1) IN GENERAL.—A food may also be a 

25 cannabinoid product, or contain a cannabinoid prodVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
33 

•S 5243 IS

1 uct, if it otherwise complies with all applicable re2 quirements for food under chapter IV and all appli3 cable requirements for cannabinoid products under 

4 this chapter. 

5 ‘‘(2) EFFECT.—A food that is also a 

6 cannabinoid product, or that contains a cannabinoid 

7 product, shall not be deemed— 

8 ‘‘(A) adulterated under section 

9 402(a)(2)(C)(i) solely on account of constitu10 ents made or derived from cannabinoids; or 

11 ‘‘(B) a food to which has been added a 

12 drug approved under section 505 or a drug for 

13 which substantial clinical investigations have 

14 been instituted and for which the existence of 

15 such investigations has been made public for 

16 purposes of section 301(ll) solely on account of 

17 constituents made or derived from cannabis. 

18 ‘‘(i) DIETARY SUPPLEMENTS CONTAINING

19 CANNABINOIDS.— 

20 ‘‘(1) IN GENERAL.—A dietary supplement may 

21 also be a cannabinoid product, or contain a 

22 cannabinoid product, if it otherwise complies with all 

23 applicable requirements for dietary supplements and 

24 food under chapter IV and all applicable require25 ments for cannabinoid products under this chapter. 


ssavage on LAPJG3WLY3PROD with BILLS
34 

•S 5243 IS

1 ‘‘(2) EFFECT.—A dietary supplement that is 

2 also a cannabinoid product, or that contains a 

3 cannabinoid product, shall not be— 

4 ‘‘(A) deemed adulterated under section 

5 402(f) solely on account of constituents made 

6 or derived from cannabinoids; or 

7 ‘‘(B) excluded from the definition of die8 tary supplement under section 201(ff)(3) solely 

9 on account of constituents made or derived 

10 from cannabis. 

11 ‘‘(j) MANUFACTURING, PROCESSING, AND PRODUC12 TION OF CANNABINOIDS AND SEMI-SYNTHETIC

13 CANNABINOIDS.— 

14 ‘‘(1) IN GENERAL.—The Secretary may promul15 gate regulations regarding the manufacturing, proc16 essing, or production of artificially or synthetically 

17 derived cannabinoids and semi-synthetic 

18 cannabinoids in order to protect the public health. 

19 ‘‘(2) SAFETY; REMOVAL OF DANGEROUS

20 CANNABINOIDS.—If promulgated, the regulations 

21 under paragraph (1)— 

22 ‘‘(A) shall determine the safety of artifi23 cially or synthetically derived cannabinoids and 

24 semi-synthetic cannabinoids across various 

25 methods of administration; and 


ssavage on LAPJG3WLY3PROD with BILLS
35 

•S 5243 IS

1 ‘‘(B) may establish a process for the re2 moval from the market of— 

3 ‘‘(i) dangerous artificially or syn4 thetically derived cannabinoids or semi5 synthetic cannabinoids; or 

6 ‘‘(ii) artificially or synthetically de7 rived cannabinoids or semi-synthetic 

8 cannabinoids that cause a serious adverse 

9 effect (as defined in section 201(tt)(5)). 

10 ‘‘SEC. 1106. CANNABINOID PRODUCT STANDARDS. 

11 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

12 date of enactment of the Cannabinoid Safety and Regula13 tion Act, the Secretary shall, by regulation, adopt 

14 cannabinoid product standards that are appropriate for 

15 protection of the public health and that distinguish dif16 ferent cannabinoid product types. 

17 ‘‘(b) CONTENT OF STANDARDS.—A cannabinoid 

18 product standard established under this section shall in19 clude provisions— 

20 ‘‘(1) on the ingredients of the cannabinoid 

21 product, including, where appropriate— 

22 ‘‘(A) cannabinoid yields of the product, 

23 which may consider or address, as appropriate, 

24 different types of cannabinoids and the inter25 action between the constituents of the product; 


ssavage on LAPJG3WLY3PROD with BILLS
36 

•S 5243 IS

1 ‘‘(B) provisions respecting the construc2 tion, components, ingredients, additives, con3 stituents, including smoke constituents, and 

4 properties of the cannabinoid product, which 

5 may consider, as appropriate, the interaction 

6 between constituents and components of the 

7 cannabinoid product; and 

8 ‘‘(C) provisions for the reduction or elimi9 nation of harmful constituents or components 

10 of the product, including smoke constituents; 

11 ‘‘(2) for the testing of the cannabinoid product, 

12 including requiring that the testing of the 

13 cannabinoid product be done by a person licensed, 

14 certified, or otherwise authorized to perform such 

15 testing in the State where such testing occurs; 

16 ‘‘(3) requiring that the results of testing the 

17 cannabinoid product show that the cannabinoid 

18 product is in conformity with applicable standards, 

19 including with respect to the level of heavy metals, 

20 chemical byproducts, or pesticide residues; 

21 ‘‘(4) for the measurement of the characteristics 

22 of the cannabinoid product, where appropriate, in23 cluding total product weight, size, color, appearance, 

24 and other distinguishing features; 


ssavage on LAPJG3WLY3PROD with BILLS
37 

•S 5243 IS

1 ‘‘(5) requiring that the sale and distribution of 

2 the cannabinoid product be restricted but only to the 

3 extent that the sale and distribution of a 

4 cannabinoid product may be restricted under a regu5 lation under this Act; 

6 ‘‘(6) where appropriate, requiring the use and 

7 prescribing the form and content of labeling for the 

8 proper use of the cannabinoid product and any po9 tential serious adverse effects of the product; and 

10 ‘‘(7) requiring cannabinoid products containing 

11 foreign-grown hemp or cannabinoids to meet the 

12 same standards applicable to cannabinoid products 

13 containing domestically grown cannabis. 

14 ‘‘(c) PERIODIC REEVALUATION OF STANDARDS.— 

15 The Secretary shall provide for periodic evaluation of 

16 cannabinoid product standards established under this sec17 tion to determine whether such standards should be 

18 changed to reflect new medical, scientific, or other techno19 logical data. 

20 ‘‘SEC. 1107. RECALL AUTHORITY. 

21 ‘‘(a) IN GENERAL.—If the Secretary finds that there 

22 is a reasonable probability that a cannabinoid product 

23 would cause a serious adverse effect, the Secretary shall 

24 issue an order requiring the appropriate person (including 

25 the manufacturers, importers, distributors, or retailers of 


ssavage on LAPJG3WLY3PROD with BILLS
38 

•S 5243 IS

1 the cannabinoid product) to immediately cease distribution 

2 of such cannabinoid product. The order shall provide the 

3 person subject to the order with an opportunity to appear 

4 and introduce testimony, to be held not later than 20 days 

5 after the date of the issuance of the order, on the actions 

6 required by the order and on whether the order should 

7 be amended to require a recall of such cannabinoid prod8 uct. If, after providing an opportunity to appear and intro9 duce testimony, the Secretary determines that inadequate 

10 grounds exist to support the actions required by the order, 

11 the Secretary shall vacate the order. 

12 ‘‘(b) AMENDMENT OF ORDER TO REQUIRE RE13 CALL.— 

14 ‘‘(1) IN GENERAL.—If, after providing an op15 portunity to appear and introduce testimony under 

16 subsection (a), the Secretary determines that the 

17 order should be amended to include a recall of the 

18 cannabinoid product with respect to which the order 

19 was issued, the Secretary shall, except as provided in 

20 paragraph (2), amend the order to require a recall. 

21 The Secretary shall specify a timetable in which the 

22 cannabinoid product recall will occur and shall re23 quire periodic reports to the Secretary describing the 

24 progress of the recall. 


ssavage on LAPJG3WLY3PROD with BILLS
39 

•S 5243 IS

1 ‘‘(2) NOTICE.—An amended order under para2 graph (1)— 

3 ‘‘(A) shall not include recall of a 

4 cannabinoid product from individuals; and 

5 ‘‘(B) shall provide for notice to persons 

6 subject to the risks associated with the use of 

7 such cannabinoid product. 

8 ‘‘(3) USE OF RETAILERS.—In providing the no9 tice required by paragraph (2)(B), the Secretary 

10 may use the assistance of retailers and other persons 

11 who distributed such cannabinoid product. If a sig12 nificant number of such persons cannot be identi13 fied, the Secretary shall notify such persons pursu14 ant to section 705(b). 

15 ‘‘SEC. 1108. RECORDS AND REPORTS ON CANNABINOID 

16 PRODUCTS. 

17 ‘‘(a) IN GENERAL.—Each person who is a 

18 cannabinoid product manufacturer or importer of a 

19 cannabinoid product shall establish and maintain such 

20 records, make such reports, and provide such information, 

21 as the Secretary may by regulation reasonably require to 

22 assure that such cannabinoid product is not adulterated 

23 or misbranded and to otherwise protect public health. 

24 ‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.— 

25 ‘‘(1) REQUIREMENT.— 


ssavage on LAPJG3WLY3PROD with BILLS
40 

•S 5243 IS

1 ‘‘(A) IN GENERAL.—Except as provided in 

2 paragraph (2), the Secretary shall by regulation 

3 require a cannabinoid product manufacturer or 

4 importer of a cannabinoid product to report 

5 promptly to the Secretary any corrective action 

6 taken or removal from the market of a 

7 cannabinoid product undertaken by such manu8 facturer or importer if the removal or correction 

9 was undertaken— 

10 ‘‘(i) to reduce a risk to health posed 

11 by the cannabinoid product; or 

12 ‘‘(ii) to remedy a violation of this 

13 chapter caused by the cannabinoid product 

14 which may present a risk to health. 

15 ‘‘(B) RECORDS.—A cannabinoid product 

16 manufacturer or importer of a cannabinoid 

17 product who undertakes a corrective action or 

18 removal from the market of a cannabinoid prod19 uct that is not required to be reported under 

20 this subsection shall keep a record of such cor21 rection or removal. 

22 ‘‘(2) EXCEPTION.—No report of the corrective 

23 action or removal of a cannabinoid product may be 

24 required under paragraph (1)(A) if a report of the 


ssavage on LAPJG3WLY3PROD with BILLS
41 

•S 5243 IS

1 corrective action or removal is required and has been 

2 submitted under subsection (a). 

3 ‘‘SEC. 1109. PROHIBITION ON FLAVORED ELECTRONIC 

4 CANNABINOID PRODUCT DELIVERY SYSTEM. 

5 ‘‘(a) IN GENERAL.—Except as provided in subsection 

6 (b), any electronic cannabinoid product delivery system 

7 shall not contain an added artificial or natural flavor, in8 cluding mint, mango, strawberry, grape, peach, orange, 

9 berry or mixed berry, clove, cinnamon, pineapple, vanilla, 

10 coconut, licorice, cocoa, chocolate, cherry, watermelon, 

11 lemon, lime or lemon-lime, coffee, any combination there12 of, or any other flavor that the Secretary may determine 

13 by order. 

14 ‘‘(b) APPLICATION TO TERPENES.—An electronic 

15 cannabinoid product delivery system may contain added 

16 or naturally occurring terpenes, including naturally occur17 ring non-cannabis terpenes, on the conditions that— 

18 ‘‘(1) if the cannabinoid product delivered by the 

19 electronic cannabinoid product delivery system con20 tains added terpenes but not naturally occurring 

21 terpenes, not greater than 5 percent of the total 

22 weight of such cannabinoid product shall be added 

23 terpenes; 

24 ‘‘(2) if the cannabinoid product delivered by the 

25 electronic cannabinoid product delivery system conVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
42 

•S 5243 IS

1 tains naturally occurring terpenes but not added 

2 terpenes, not greater than 6 percent of the total 

3 weight of such cannabinoid product shall be natu4 rally occurring terpenes; and 

5 ‘‘(3) if the cannabinoid product delivered by the 

6 electronic cannabinoid product delivery system con7 tains both added terpenes and naturally occurring 

8 terpenes, not greater than 6 percent of the total 

9 weight of the cannabinoid product shall be such nat10 urally occurring terpenes and added terpenes. 

11 ‘‘(c) DEFINITION.—In this section, the term ‘elec12 tronic cannabinoid product delivery system’ means an elec13 tronic device that delivers a cannabinoid product via an 

14 aerosolized or vaporized solution to the user inhaling from 

15 the device, and any component, liquid, part, or accessory 

16 of such a device, whether or not sold separately. 

17 ‘‘SEC. 1110. EFFECT. 

18 ‘‘(a) PRESERVATION OF FEDERAL, STATE, TRIBAL, 

19 AND LOCAL AUTHORITY.— 

20 ‘‘(1) EFFECT.— 

21 ‘‘(A) IN GENERAL.—Except as provided in 

22 subparagraph (B), nothing in this chapter, or 

23 rules promulgated under this chapter, shall be 

24 construed to limit the authority of a Federal 

25 agency (including the Armed Forces), a State 


ssavage on LAPJG3WLY3PROD with BILLS
43 

•S 5243 IS

1 or political subdivision of a State, or the gov2 ernment of an Indian Tribe to enact, adopt, 

3 promulgate, and enforce any law, rule, regula4 tion, or other measure with respect to 

5 cannabinoid products that is in addition to, or 

6 more stringent than, requirements established 

7 under this chapter, including a law, rule, regu8 lation, or other measure relating to or prohib9 iting the manufacture, sale, distribution, posses10 sion, exposure to, access to, advertising and 

11 promotion of, or use of cannabinoid products by 

12 individuals of any age, information reporting to 

13 the State or Indian Tribe, or measures relating 

14 to fire safety or environmental standards for 

15 cannabinoid products. No provision of this 

16 chapter shall limit or otherwise affect any 

17 State, Tribal, or local taxation of cannabinoid 

18 products. 

19 ‘‘(B) RESTRICTION.—No State or political 

20 subdivision of a State may enact, adopt, pro21 mulgate, and enforce any law, rule, regulation, 

22 or other measure for the labeling of 

23 cannabinoid products that is not identical to the 

24 requirements for the packaging or labeling of a 


ssavage on LAPJG3WLY3PROD with BILLS
44 

•S 5243 IS

1 cannabinoid product required by section 1103 

2 (including regulations). 

3 ‘‘(C) TRANSPORTATION OF CANNABINOID

4 PRODUCTS.—No State or Indian Tribe may 

5 prohibit the transportation or shipment of 

6 cannabinoid products produced in accordance 

7 with this chapter (including regulations) 

8 through the State or land under the jurisdiction 

9 of the Indian Tribe. 

10 ‘‘(2) RULE OF CONSTRUCTION REGARDING

11 PRODUCT LIABILITY.—No provision of this chapter 

12 relating to a cannabinoid product shall be construed 

13 to modify or otherwise affect any action or the liabil14 ity of any person under the product liability law of 

15 any State or Indian Tribe. 

16 ‘‘(3) DEFINITION OF INDIAN TRIBE.—In this 

17 subsection, the term ‘Indian Tribe’ means the gov18 erning body of any individually identified and feder19 ally recognized Indian or Alaska Native tribe, band, 

20 nation, pueblo, village, community, affiliated Tribal 

21 group, or component reservation included on the list 

22 published most recently as of the date of enactment 

23 of the Cannabinoid Safety and Regulation Act pur24 suant to section 104(a) of the Federally Recognized 

25 Indian Tribe List Act of 1994. 


ssavage on LAPJG3WLY3PROD with BILLS
45 

•S 5243 IS

1 ‘‘(b) AUTHORITY OF USDA.—Nothing in this chap2 ter affects the jurisdiction of the Secretary of Agriculture 

3 over the planting, cultivation, growing, and harvesting of 

4 hemp (as defined in section 297A of the Agricultural Mar5 keting Act of 1946).’’. 

6 SEC. 102. AMENDMENTS TO THE FEDERAL FOOD, DRUG, 

7 AND COSMETIC ACT. 

8 (a) DEFINITIONS.—Section 201 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 321) is amended— 

10 (1) in paragraph (g)(1)(C), by striking ‘‘(other 

11 than food)’’ and inserting ‘‘(other than food or 

12 cannabinoid products)’’; 

13 (2) in paragraph (ff)(1), by striking ‘‘(other 

14 than tobacco)’’ and inserting ‘‘(other than a tobacco 

15 product or a cannabinoid product)’’; 

16 (3) in paragraph (rr)(4), by inserting 

17 ‘‘cannabinoid product,’’ after ‘‘medical device’’; and 

18 (4) by adding at the end the following: 

19 ‘‘(tt)(1)(A) The term ‘cannabis’ means— 

20 ‘‘(i) all parts of the plant Cannabis sativa L., 

21 whether growing or not; 

22 ‘‘(ii) the seeds of such plant; 

23 ‘‘(iii) the resin extracted from any part of such 

24 plant; and 


ssavage on LAPJG3WLY3PROD with BILLS
46 

•S 5243 IS

1 ‘‘(iv) every compound, manufacture, salt, deriv2 ative, mixture, or preparation of such plant, its 

3 seeds or resin, or other constituent element derived 

4 from such plant. 

5 ‘‘(B) The term ‘cannabis’ does not include— 

6 ‘‘(i) any cannabis plant actively under cultiva7 tion that is being cultivated in accordance with the 

8 requirements of subtitle G of the Agricultural Mar9 keting Act of 1946; 

10 ‘‘(ii) a cannabinoid product; or 

11 ‘‘(iii) the mature stalks of the plant Cannabis 

12 sativa L., fiber produced from such stalks, oil or 

13 cake made from the seeds of such plant, any other 

14 compound, manufacture, salt, derivative, mixture, or 

15 preparation of such mature stalks (except the resin 

16 extracted therefrom), fiber, oil, cake, or the sterilized 

17 seed of such plant that is incapable of germination. 

18 ‘‘(2) The term ‘cannabinoid’ means any of the fol19 lowing: 

20 ‘‘(A) Any chemical in any plant of the genus 

21 Cannabis that is unique in nature to such plant, in22 cluding any of the following chemicals: 

23 ‘‘(i) Tetrahydrocannabinol. 

24 ‘‘(ii) Cannabinol. 

25 ‘‘(iii) Cannabidiol. 


ssavage on LAPJG3WLY3PROD with BILLS
47 

•S 5243 IS

1 ‘‘(iv) Cannabigerol. 

2 ‘‘(v) Cannabichromene. 

3 ‘‘(vi) Tetrahydrocannabivarin. 

4 ‘‘(vii) Cannabivarin. 

5 ‘‘(viii) Cannabidivarin. 

6 ‘‘(ix) Cannabielsion. 

7 ‘‘(x) Cannabicyclol. 

8 ‘‘(xi) Cannabitriol. 

9 ‘‘(xii) Cannabicitran. 

10 ‘‘(B) Any isomer of a chemical described in 

11 clause (A), and any acids, acetates, salts, esters, 

12 ethers, and derivatives thereof. 

13 ‘‘(C) Any chemical, regardless of origin or 

14 method of production, that is equivalent in chemical 

15 structure to a chemical referred to in clause (A), or 

16 has both a similar terpenophenolic chemical struc17 ture and pharmacological effect to a chemical re18 ferred to in clause (A). 

19 ‘‘(D) Any chemical derived from a plant of the 

20 genus Cannabis that is a CB–1 or CB–2 receptor 

21 agonist or partial agonist. 

22 ‘‘(E) Any chemical that the Secretary has, by 

23 order, deemed to be a cannabinoid. 


ssavage on LAPJG3WLY3PROD with BILLS
48 

•S 5243 IS

1 ‘‘(3)(A) The term ‘cannabinoid product’ means any 

2 article or product, including its components or parts, 

3 that— 

4 ‘‘(i) contains or purports to contain any quan5 tity of 1 or more cannabinoids that are derived from 

6 hemp (as defined in section 297A of the Agricultural 

7 Marketing Act of 1946); and 

8 ‘‘(ii) is intended for use in, through any route 

9 of administration, or to be applied to, the body of 

10 humans or other animals. 

11 ‘‘(B) The term ‘cannabinoid product’ does not in12 clude— 

13 ‘‘(i) a drug that is subject to the requirements 

14 of chapter V or section 351 of the Public Health 

15 Service Act; 

16 ‘‘(ii) a device that is subject to the requirements 

17 of chapter V; 

18 ‘‘(iii) any cannabis plant actively under cultiva19 tion that is being cultivated in accordance with the 

20 requirements of subtitle G of the Agricultural Mar21 keting Act of 1946; or 

22 ‘‘(iv) a virus, serum, toxin, or analogous prod23 uct subject to the requirements of the eighth para24 graph of the matter under the heading ‘BUREAU OF


ssavage on LAPJG3WLY3PROD with BILLS
49 

•S 5243 IS

1 ANIMAL INDUSTRY’ in the Act of March 4, 1913 

2 (commonly known as the ‘Virus-Serum-Toxin Act’). 

3 ‘‘(4) With respect to cannabis or a cannabinoid prod4 uct, the term ‘manufacture’ does not include the planting, 

5 cultivation, growing, or harvesting of cannabis. 

6 ‘‘(5) With respect to a cannabinoid product, the term 

7 ‘serious adverse effect’ means that use of the product— 

8 ‘‘(A) results in— 

9 ‘‘(i) death; 

10 ‘‘(ii) a life-threatening adverse experience; 

11 ‘‘(iii) inpatient hospitalization or prolonga12 tion of existing hospitalization; 

13 ‘‘(iv) a persistent or significant disability 

14 or incapacity; 

15 ‘‘(v) a congenital anomaly or birth defect; 

16 or 

17 ‘‘(vi) other serious medical event; or 

18 ‘‘(B) requires, based on reasonable medical 

19 judgment, a medical or surgical intervention to pre20 vent an outcome described in clause (A). 

21 ‘‘(uu) The term ‘intended for human consumption’, 

22 with respect to a cannabinoid product, means a 

23 cannabinoid product intended for ingestion or inhalation 

24 by a human. 

25 ‘‘(vv) The term ‘tetrahydrocannabinol’ means— 


ssavage on LAPJG3WLY3PROD with BILLS
50 

•S 5243 IS

1 ‘‘(1) the chemical substance found in the Can2 nabis sativa L. plant, including the delta–6a, delta– 

3 7, delta–8, delta–9, delta–10a, and delta–10 forms, 

4 whether naturally occurring in the Cannabis sativa 

5 L. plant or synthetically or semi-synthetically de6 rived; 

7 ‘‘(2) all isomers of tetrahydrocannabinol, and 

8 any acids, acetates, metabolites (including 11-hy9 droxy-THC, 3-hydroxy-THC, and 7-hydroxy-THC 

10 and their isomers), salts, esters, ethers, and deriva11 tives thereof, including its precursor form, 

12 tetrahydrocannabinolic acid; 

13 ‘‘(3) tetrahydrocannabivarins, including delta-8 

14 tetrahydrocannabivarin, and exo15 tetrahydrocannabinol; 

16 ‘‘(4) hydrogenated forms of 

17 tetrahydrocannabinol including hexahydrocannabinol, 

18 hexahydrocannabiphorol, and 

19 hexahydrocannabihexol; 

20 ‘‘(5) analogues of tetrahydrocannabinols with 

21 an alkyl chain of four or more carbon atoms, includ22 ing tetrahydrocannabiphorols, 

23 tetrahydrocannabiocytls, tetrahydrocannabihexols, or 

24 tetrahydrocannabutols; and 


ssavage on LAPJG3WLY3PROD with BILLS
51 

•S 5243 IS

1 ‘‘(6) any combination of the chemical sub2 stances described in subparagraphs (1) through (5) 

3 whether naturally or artificially derived or syn4 thetically or semi-synthetically produced. 

5 ‘‘(ww)(1) The term ‘artificially or synthetically de6 rived cannabinoid’ means a cannabinoid or a cannabinoid7 like compound that is produced using chemical synthesis, 

8 chemical modification, or chemical conversion, including 

9 by using in-vitro biosynthesis or other bioconversion. 

10 ‘‘(2) The term ‘artificially or synthetically derived 

11 cannabinoid’ does not include— 

12 ‘‘(A) a cannabinoid or a cannabinoid-like com13 pound produced through the decarboxylation of nat14 urally occurring cannabinoids from their acidic 

15 forms; 

16 ‘‘(B) a cannabinoid product or input that un17 dergoes the removal of solvents, catalysts, or other 

18 unwanted materials from the cannabinoid product or 

19 input; or 

20 ‘‘(C) a semi-synthetic cannabinoid. 

21 ‘‘(3)(A) For purposes of subparagraph (2)(C), the 

22 term ‘semi-synthetic cannabinoid’ means a substance that 

23 is created by a single chemical reaction that converts one 

24 cannabinoid extracted from a cannabis plant directly into 


ssavage on LAPJG3WLY3PROD with BILLS
52 

•S 5243 IS

1 a different cannabinoid that is found in more than trace 

2 amounts in a cannabis plant. 

3 ‘‘(B) For purposes of subparagraph (2)(C), the term 

4 ‘semi-synthetic cannabinoid’ includes a cannabinoid that 

5 is produced by the conversion of cannabidiol, including 

6 cannabinol and delta–8 tetrahydrocannabinol. 

7 ‘‘(C) For purposes of subparagraph (2)(C), the term 

8 ‘semi-synthetic cannabinoid’ does not include a 

9 cannabinoid that is produced through the decarboxylation 

10 of naturally occurring acidic forms of cannabinoids into 

11 the corresponding neutral cannabinoid through the use of 

12 heat or light, without the use of chemical reagents or cata13 lysts, and that results in no other chemical change.’’. 

14 (b) PROHIBITED ACTS.—Section 301 of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend16 ed— 

17 (1) by inserting ‘‘cannabinoid product,’’ after 

18 ‘‘tobacco product,’’ each place it appears in para19 graphs (g) and (h); 

20 (2) in paragraph (j), by striking ‘‘or 920(b)’’ 

21 and inserting ‘‘920(b), or 1104’’; 

22 (3) in paragraph (p)— 

23 (A) by striking ‘‘510 or 905’’ and inserting 

24 ‘‘510, 905, or 1104’’; 


ssavage on LAPJG3WLY3PROD with BILLS
53 

•S 5243 IS

1 (B) by striking ‘‘or 905(j)’’ and inserting 

2 ‘‘905(j), or 1104(g)’’; and 

3 (C) by striking ‘‘or 905(i)(3)’’ and insert4 ing ‘‘, 905(i)(3), or 1104(g)(2)’’; 

5 (4) in paragraph (q)(2) by inserting ‘‘, 

6 cannabinoid product,’’ after ‘‘device’’; 

7 (5) in paragraph (r), by inserting ‘‘cannabinoid 

8 product,’’ after ‘‘device,’’ each place it appears; and 

9 (6) by adding at the end the following: 

10 ‘‘(jjj)(1) The sale or distribution of a cannabinoid 

11 product intended for human consumption and that con12 tains detectable levels of any tetrahydrocannabinol to any 

13 person younger than 21 years of age. 

14 ‘‘(2) The sale or distribution of an article that is a 

15 cannabinoid product and that contains alcohol, tobacco, 

16 nicotine, or another substance with effects that could 

17 interact with cannabinoids or enhance or alter the effects 

18 of cannabinoids, as determined by the Secretary through 

19 rulemaking. 

20 ‘‘(3) The failure of a manufacturer or distributor to 

21 notify the Attorney General of its knowledge of 

22 cannabinoid products used in illicit trade. 

23 ‘‘(kkk)(1) The introduction or delivery for introduc24 tion into commerce of any cannabinoid product that is 

25 adulterated or misbranded. 


ssavage on LAPJG3WLY3PROD with BILLS
54 

•S 5243 IS

1 ‘‘(2) The introduction or delivery for introduction 

2 into interstate commerce of an article intended for inges3 tion in tablet, capsule, powder, softgel, gelcap, liquid, or 

4 other form, which is not represented as a conventional 

5 food and not represented for use as a sole item of a meal 

6 or of the diet if it— 

7 ‘‘(A) contains any synthetic ingredient with a 

8 molecular structure that does not occur in nature; 

9 and 

10 ‘‘(B) does not meet the definition of a dietary 

11 supplement in section 201(ff), except that this sub12 section does not apply to any article introduced or 

13 delivered for introduction into interstate commerce 

14 in compliance with chapter V, VI, or IX or with sec15 tion 351 of the Public Health Service Act. 

16 ‘‘(3) The adulteration or misbranding of any 

17 cannabinoid product in commerce. 

18 ‘‘(4) The receipt in commerce of any cannabinoid 

19 product that is adulterated or misbranded, and the deliv20 ery or proffered delivery thereof for pay or otherwise. 

21 ‘‘(5) The alteration, mutilation, destruction, oblitera22 tion, or removal of the whole or any part of the labeling 

23 of, or the doing of any other act with respect to a 

24 cannabinoid product, if such act is done while such article 

25 is held for sale (whether or not the first sale) after shipVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
55 

•S 5243 IS

1 ment in commerce and results in such article being adul2 terated or misbranded. 

3 ‘‘(lll)(1) The sale or distribution of a cannabinoid 

4 product intended for human consumption that contains 

5 multiple servings, unless the contents of such cannabinoid 

6 product are readily divisible into portions equivalent to one 

7 serving. 

8 ‘‘(2) The sale or distribution of a cannabinoid prod9 uct intended for human consumption that is in liquid 

10 form, unless such cannabinoid product— 

11 ‘‘(A) contains not more than one serving; or 

12 ‘‘(B) if the serving size is less than 1 fluid 

13 ounce, includes a convenient device for measuring 

14 servings, such as a dropper or measuring cup, unless 

15 it is a food.’’. 

16 (c) PENALTIES.—Section 303(f) of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended— 

18 (1) in paragraph (5)— 

19 (A) in subparagraph (A)— 

20 (i) in the first sentence, by striking 

21 ‘‘or (9)’’ and inserting ‘‘(9), or (11)’’; and 

22 (ii) by inserting ‘‘or no-cannabinoid23 product-sale order’’ after ‘‘no-tobacco-sale 

24 order’’ each place it appears; 

25 (B) in subparagraph (B)— 


ssavage on LAPJG3WLY3PROD with BILLS
56 

•S 5243 IS

1 (i) by inserting ‘‘or no-cannabinoid2 product-sale order’’ after ‘‘no-tobacco-sale 

3 order’’ each place it appears; and 

4 (ii) in the second sentence, by insert5 ing ‘‘or cannabinoid products, as applica6 ble,’’ after ‘‘tobacco products’’; 

7 (C) in subparagraph (C), in the first sen8 tence, by striking ‘‘or (9)’’ and inserting ‘‘(9), 

9 or (11)’’; and 

10 (D) in subparagraph (D) by inserting ‘‘or 

11 no-cannabinoid-product-sale order’’ after ‘‘no12 tobacco-sale order’’; 

13 (2) in paragraph (6), by inserting ‘‘or no14 cannabinoid- product-sale order’’ after ‘‘no-tobacco15 sale order’’ each place it appears; and 

16 (3) by adding at the end the following: 

17 ‘‘(10) CIVIL MONETARY PENALTIES FOR VIOLA18 TION OF CANNABINOID PRODUCT REQUIREMENTS.— 

19 ‘‘(A) IN GENERAL.—Any person who vio20 lates a requirement of this Act that relates to 

21 cannabinoid products shall be liable to the 

22 United States for a civil penalty in an amount 

23 not to exceed $15,000 for each such violation, 

24 and not to exceed $15,000,000 for all such vio25 lations adjudicated in a single proceeding. 


ssavage on LAPJG3WLY3PROD with BILLS
57 

•S 5243 IS

1 ‘‘(B) ENHANCED CIVIL PENALTIES.—Any 

2 person who knowingly violates a requirement of 

3 this Act that relates to cannabinoid products 

4 shall be subject to a civil monetary penalty of— 

5 ‘‘(i) not to exceed $250,000 per viola6 tion, and not to exceed $10,000,000 for all 

7 such violations adjudicated in a single pro8 ceeding; or 

9 ‘‘(ii) in the case of a violation that 

10 continues after the Secretary provides writ11 ten notice of the violation to such person, 

12 $250,000 for the first 30-day period (or 

13 any portion thereof) that the person con14 tinues to be in violation, and such amount 

15 shall double for every 30-day period there16 after that the violation continues, not to 

17 exceed $10,000,000 for any 30-day period, 

18 and not to exceed $20,000,000 for all such 

19 violations adjudicated in a single pro20 ceeding. 

21 ‘‘(11) REPEATED VIOLATIONS RELATING TO

22 CANNABINOID PRODUCTS.— 

23 ‘‘(A) IN GENERAL.—If the Secretary finds 

24 that a person has committed repeated violations 

25 of a requirement of this Act that relates to 


ssavage on LAPJG3WLY3PROD with BILLS
58 

•S 5243 IS

1 cannabinoid products at a particular retail or 

2 online outlet, or association of retail or online 

3 outlets, then the Secretary may impose a no4 cannabinoid-product-sale order on that person 

5 prohibiting the sale of cannabinoid products in 

6 that outlet. A no-cannabinoid-product-sale order 

7 may be imposed with a civil penalty under para8 graph (1). 

9 ‘‘(B) HEARING.—Prior to the entry of a 

10 no-cannabinoid-product-sale order under this 

11 paragraph, a person shall be entitled to a hear12 ing pursuant to the procedures established 

13 through regulations of the Food and Drug Ad14 ministration for assessing civil money penalties, 

15 including, at a retailer’s request, a hearing by 

16 telephone, or at the nearest regional or field of17 fice of the Food and Drug Administration, or at 

18 a Federal, State, or county facility within 100 

19 miles from the location of the retail outlet, if 

20 such a facility is available.’’. 

21 (d) SEIZURE AUTHORITIES.—Section 304 of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 334) is 

23 amended— 

24 (1) in subsection (a)— 


ssavage on LAPJG3WLY3PROD with BILLS
59 

•S 5243 IS

1 (A) in paragraph (1), by inserting 

2 ‘‘cannabinoid product,’’ after ‘‘drug,’’; and 

3 (B) in paragraph (2)— 

4 (i) by striking ‘‘and (H) Any punch’’ 

5 and inserting ‘‘(H) Any punch’’; and 

6 (ii) by inserting before the period at 

7 the end the following: ‘‘, and (I) Any adul8 terated or misbranded cannabinoid prod9 uct’’; 

10 (2) in subsection (d)(1), by inserting 

11 ‘‘cannabinoid product,’’ after ‘‘tobacco product,’’; 

12 and 

13 (3) in subsection (g), by striking ‘‘or tobacco 

14 product’’ each place it appears in paragraphs (1) 

15 and (2)(A) and inserting ‘‘, tobacco product, or 

16 cannabinoid product’’. 

17 (e) FACTORY INSPECTION.—Section 704 of the Fed18 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) is 

19 amended— 

20 (1) in subsection (a)— 

21 (A) by inserting ‘‘cannabinoid products,’’ 

22 after ‘‘tobacco products,’’ each place it appears; 

23 (B) by striking ‘‘or tobacco products’’ each 

24 place it appears and inserting ‘‘tobacco prod25 ucts, or cannabinoid products’’; and 


ssavage on LAPJG3WLY3PROD with BILLS
60 

•S 5243 IS

1 (C) by striking ‘‘and tobacco products’’ 

2 and inserting ‘‘tobacco products, and 

3 cannabinoid products’’; and 

4 (2) in subsection (b)(1), by inserting 

5 ‘‘cannabinoid product,’’ after ‘‘tobacco product,’’. 

6 (f) PUBLICITY.—Section 705(b) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 375(b)) is amended 

8 by inserting ‘‘cannabinoid products,’’ after ‘‘tobacco prod9 ucts,’’. 

10 (g) PRESUMPTION.—Section 709 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 379a) is 

12 amended by inserting ‘‘cannabinoid product,’’ after ‘‘to13 bacco product,’’. 

14 (h) IMPORTS AND EXPORTS.—Section 801 of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 

16 is amended— 

17 (1) in subsection (a)— 

18 (A) by inserting ‘‘cannabinoid products,’’ 

19 after ‘‘tobacco products,’’; 

20 (B) by striking ‘‘or tobacco products’’ each 

21 place it appears and inserting ‘‘, tobacco prod22 ucts, or cannabinoid products’’; and 

23 (C) by striking ‘‘or section 905(h)’’ and in24 serting ‘‘, 905(h), or 1104’’; and 


ssavage on LAPJG3WLY3PROD with BILLS
61 

•S 5243 IS

1 (2) in subsection (e), by striking ‘‘tobacco prod2 uct or’’ and inserting ‘‘tobacco product, cannabinoid 

3 product, or’’. 

4 SEC. 103. REGULATION OF CANNABINOID BEVERAGES CON5 TAINING TETRAHYDROCANNABINOL. 

6 Not later than 60 days after the date of enactment 

7 of this Act, the Secretary of Agriculture, the Commis8 sioner of Food and Drugs, the Attorney General, and the 

9 Director of the Alcohol and Tobacco Tax and Trade Bu10 reau, acting jointly, shall publish a report that includes 

11 recommendations for a Federal regulatory framework for 

12 cannabinoid beverages that contain tetrahydrocannabinol 

13 (as defined in paragraph (vv) of section 201 of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 321)) that— 

15 (1) is modeled on the Federal regulatory frame16 work for alcohol; and 

17 (2) delineates responsibilities among the De18 partment of Agriculture, the Food and Drug Admin19 istration, the Department of Justice, and the Alco20 hol and Tobacco Tax and Trade Bureau, for label21 ing, taxation, manufacturing, and adulteration 

22 standards of cannabinoid beverages that contain 

23 tetrahydrocannabinol. 


ssavage on LAPJG3WLY3PROD with BILLS
62 

•S 5243 IS

1 TITLE II—PUBLIC HEALTH 

2 SEC. 201. PUBLIC HEALTH SURVEILLANCE AND DATA COL3 LECTION. 

4 (a) IN GENERAL.—Section 392A of the Public 

5 Health Service Act (42 U.S.C. 280b–1) is amended— 

6 (1) in the section heading, by inserting ‘‘AND

7 ADVERSE HEALTH EFFECTS OF CANNABIS

8 USE’’ after ‘‘SUBSTANCES’’; 

9 (2) in subsection (a)— 

10 (A) in paragraph (2)— 

11 (i) in subparagraph (C) by inserting 

12 ‘‘and adverse health effects of cannabis 

13 use’’ before the period; and 

14 (ii) in subparagraph (D) by inserting 

15 ‘‘, cannabis, and polysubstance use’’ before 

16 the period; and 

17 (B) in paragraph (4), by inserting ‘‘and 

18 collect data to better understand the use and 

19 health effects of cannabis, stimulants, and 

20 polysubstances, and’’ after ‘‘conduct studies 

21 and evaluations’’; 

22 (3) in subsection (e), by striking ‘‘$496,000,000 

23 for each of fiscal years 2019 through 2023’’ and in24 serting ‘‘$596,000,000 for each of fiscal years 2024 

25 through 2028’’; and 


ssavage on LAPJG3WLY3PROD with BILLS
63 

•S 5243 IS

1 (4) by adding at the end the following: 

2 ‘‘(f) ADDITIONAL FUNDING.—In addition to amounts 

3 otherwise available, there is appropriated, out of any funds 

4 in the Treasury not otherwise appropriated, $100,000,000 

5 for each of fiscal years 2024 through 2028 to carry out 

6 this section.’’. 

7 SEC. 202. AWARDS TO PREVENT UNDERAGE CANNABIS USE. 

8 Part D of title V of the Public Health Service Act 

9 (42 U.S.C. 290dd et seq.) is amended by adding at the 

10 end the following: 

11 ‘‘SEC. 553. AWARDS TO PREVENT UNDERAGE CANNABIS 

12 USE. 

13 ‘‘(a) IN GENERAL.—The Secretary, acting through 

14 the Assistant Secretary, shall award grants, contracts, and 

15 cooperative agreements to eligible entities to prevent and 

16 reduce underage use of cannabis. 

17 ‘‘(b) ELIGIBLE ENTITIES.—To receive an award 

18 under this section, an entity shall be a State, a political 

19 subdivision of a State, an Indian Tribe or Tribal organiza20 tion, an urban Indian organization, a nonprofit commu21 nity-based organization, or any other nonprofit entity the 

22 Secretary determines appropriate. 

23 ‘‘(c) USE OF FUNDS.—An eligible entity receiving an 

24 award under this subsection shall use funds from such 

25 award to— 


ssavage on LAPJG3WLY3PROD with BILLS
64 

•S 5243 IS

1 ‘‘(1) establish, enhance, and support culturally2 and linguistically-appropriate programs, including 

3 community-based, school-based, and higher-edu4 cation based programs, and programs that target 

5 youth within the juvenile justice and child welfare 

6 systems, that offer screening, prevention, early inter7 vention, diagnosis, treatment, referral, and recovery 

8 support services related to underage cannabis use; 

9 ‘‘(2) design, test, evaluate, and disseminate evi10 dence-based and evidence-informed strategies to 

11 maximize the effectiveness of community-wide ap12 proaches to preventing and reducing underage can13 nabis use; 

14 ‘‘(3) educate children, adolescents, youth, par15 ents, health care providers, and communities about 

16 the dangers of underage cannabis use, including im17 paired driving due to cannabis use; 

18 ‘‘(4) collect data on underage cannabis use to 

19 identify and address needs, service gaps, and trends; 

20 ‘‘(5) strengthen collaboration among commu21 nities, the Federal Government, and State, local, 

22 and Tribal governments to prevent underage can23 nabis use; 

24 ‘‘(6) address community norms regarding un25 derage cannabis use, reduce opportunities for underVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
65 

•S 5243 IS

1 age cannabis use, and reduce the prevalence of nega2 tive consequences associated with underage cannabis 

3 use; and 

4 ‘‘(7) support other evidence-based and evidence5 informed practices to reduce underage cannabis use, 

6 as determined by the Secretary. 

7 ‘‘(d) SUPPLEMENT NOT SUPPLANT.—Funds award8 ed under this section shall supplement, and not supplant, 

9 existing State, Federal, local, and Tribal funds to prevent 

10 and reduce underage cannabis use. 

11 ‘‘(e) PRIORITY CONSIDERATION.—In making awards 

12 under this section, the Secretary shall give priority to eligi13 ble entities that serve medically underserved communities, 

14 communities with high rates of underage cannabis use, 

15 and communities that have historically experienced dis16 proportionate arrest and conviction rates related to the 

17 sale, possession, use, manufacture, or cultivation of can18 nabis (but not counting convictions involving distribution 

19 of cannabis to a minor). 

20 ‘‘(f) FUNDING.—In addition to amounts otherwise 

21 available, there is appropriated, out of any funds in the 

22 Treasury not otherwise appropriated, $25,000,000 for 

23 each of fiscal years 2024 through 2028 to carry out this 

24 section. 

25 ‘‘(g) DEFINITIONS.—In this section: 


ssavage on LAPJG3WLY3PROD with BILLS
66 

•S 5243 IS

1 ‘‘(1) CANNABIS.—The term ‘cannabis’ means 

2 cannabis or a cannabinoid product (as such terms 

3 are defined in section 201(tt) of the Federal Food, 

4 Drug, and Cosmetic Act). 

5 ‘‘(2) INDIAN TRIBE.—the term ‘Indian Tribe’ 

6 means the governing body of any individually identi7 fied and federally recognized Indian or Alaska Na8 tive tribe, band, nation, pueblo, village, community, 

9 affiliated Tribal group, or component reservation in10 cluded on the list published most recently as of the 

11 date of enactment of the Cannabinoid Safety and 

12 Regulation Act pursuant to section 104(a) of the 

13 Federally Recognized Indian Tribe List Act of 1994. 

14 ‘‘(3) TRIBAL ORGANIZATION.—The term ‘Tribal 

15 organization’ means the governing body of an Indian 

16 Tribe. 

17 ‘‘(4) URBAN INDIAN ORGANIZATION.—The term 

18 ‘urban Indian organization’ has the meaning given 

19 such term in section 4 of the Indian Health Care 

20 Improvement Act.’’. 

21 TITLE III—CANNABIS-IMPAIRED 

22 DRIVING PREVENTION 

23 SEC. 301. DEFINITIONS. 

24 In this title: 


ssavage on LAPJG3WLY3PROD with BILLS
67 

•S 5243 IS

1 (1) ADMINISTRATOR.—The term ‘‘Adminis2 trator’’ means the Administrator of the National 

3 Highway Traffic Safety Administration. 

4 (2) CANNABIS.—The term ‘‘cannabis’’ means— 

5 (A) cannabis (as defined in paragraph (tt) 

6 of section 201 of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 321)); and 

8 (B) a cannabinoid product (as so defined). 

9 (3) SECRETARY.—The term ‘‘Secretary’’ means 

10 the Secretary of Transportation. 

11 (4) THC.—The term ‘‘THC’’ means 

12 tetrahydrocannabinol (as defined in paragraph (vv) 

13 of section 201 of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 321)). 

15 SEC. 302. CANNABIS-IMPAIRED DRIVING RESEARCH. 

16 (a) CANNABIS-IMPAIRED DRIVING DATA.— 

17 (1) IN GENERAL.—The Secretary shall collect 

18 and, as appropriate, share with the Secretary of 

19 Health and Human Services, data relating to can20 nabis-impaired driving, or a combination of cannabis 

21 and another substance, including through the collec22 tion of crash data specific to crashes involving driv23 ers with— 

24 (A) THC in their system; or 


ssavage on LAPJG3WLY3PROD with BILLS
68 

•S 5243 IS

1 (B) a combination of THC and another 

2 substance in their system. 

3 (2) NATIONAL ROADSIDE SURVEY.— 

4 (A) IN GENERAL.—Not later than 1 year 

5 after the date of enactment of this Act, the Ad6 ministrator shall initiate a National Roadside 

7 Survey to collect data on drivers with THC in 

8 their system. 

9 (B) REPORT.—Not later than 3 years after 

10 the date of enactment of this Act, the Secretary 

11 shall submit to the Committees on Commerce, 

12 Science, and Transportation, Environment and 

13 Public Works, and Health, Education, Labor, 

14 and Pensions of the Senate and the Committee 

15 on Transportation and Infrastructure of the 

16 House of Representatives a report summarizing 

17 the data acquired, and conclusions drawn, from 

18 the National Roadside Survey required under 

19 subparagraph (A). 

20 (b) RESEARCH ON RISKS OF CANNABIS-IMPAIRED

21 DRIVING.— 

22 (1) STUDY REQUIRED.— 

23 (A) IN GENERAL.—Not later than 3 years 

24 after the date of enactment of this Act, the SecVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
69 

•S 5243 IS

1 retary shall carry out a study to evaluate and 

2 quantify the risks of cannabis-impaired driving. 

3 (B) REQUIREMENTS.—The study required 

4 under subparagraph (A) shall analyze— 

5 (i) whether there is an increased like6 lihood of crashing a motor vehicle after re7 cent cannabis use; 

8 (ii) the effect of cannabis on driving 

9 behavior; 

10 (iii) whether there is a correlation be11 tween THC level (as tested in oral fluids 

12 or through any other test designated by 

13 the Secretary in consultation with the Sec14 retary of Health and Human Services) and 

15 level of impairment; 

16 (iv) whether the current Standard 

17 Field Sobriety Test developed by the Na18 tional Highway Traffic Safety Administra19 tion accurately identifies cannabis impair20 ment and impairment due to cannabis and 

21 other substance use; 

22 (v) whether driving behavior changes 

23 depending on frequency of cannabis use; 


ssavage on LAPJG3WLY3PROD with BILLS
70 

•S 5243 IS

1 (vi) whether there are any measurable 

2 increased risks associated with using can3 nabis together with another substance; 

4 (vii) whether there is a measurable ef5 fect of cannabis use by drivers on pedes6 trian safety; and 

7 (viii) any other data necessary to im8 prove safe driving outcomes, as determined 

9 by the Secretary. 

10 (2) REPORT.—Not later than 3 years after the 

11 date of enactment of this Act, and annually there12 after until the date on which the study required 

13 under paragraph (1) is complete, the Secretary shall 

14 submit to the Committees on Commerce, Science, 

15 and Transportation, Environment and Public Works, 

16 and Health, Education, Labor, and Pensions of the 

17 Senate and the Committee on Transportation and 

18 Infrastructure of the House of Representatives a re19 port summarizing the data acquired, and conclusions 

20 drawn, from the study required under paragraph 

21 (1). 

22 SEC. 303. DOT CANNABIS-IMPAIRED DRIVING PREVENTION 

23 PROGRAMS. 

24 (a) IN GENERAL.—The Secretary shall research and 

25 implement data-driven strategies to educate the public 


ssavage on LAPJG3WLY3PROD with BILLS
71 

•S 5243 IS

1 about the dangers of cannabis-impaired driving, which 

2 shall include the following: 

3 (1) CANNABIS-IMPAIRED DRIVING USE PREVEN4 TION BEST PRACTICES.— 

5 (A) IN GENERAL.—Not later than 1 year 

6 after the date of enactment of this Act, the Sec7 retary shall develop and issue best practices for 

8 States and communities to prevent cannabis-im9 paired driving, including impaired driving in10 volving the use of cannabis and another sub11 stance and practices targeting drivers under the 

12 age of 21, in consultation with the Director of 

13 the Centers for Disease Control and Prevention, 

14 the Secretary of Health and Human Services, 

15 and the heads of other Federal agencies as ap16 propriate. 

17 (B) UPDATES.—Not less frequently than 

18 biannually, the Secretary shall update and re19 issue the best practices required under subpara20 graph (A) as new research and data becomes 

21 available. 

22 (2) CANNABIS-IMPAIRED DRIVING USE PREVEN23 TION CAMPAIGNS.—Not later than 2 years after the 

24 date of enactment of this Act, the Secretary shall esVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
72 

•S 5243 IS

1 tablish and carry out national campaigns to prevent 

2 cannabis-impaired driving, including— 

3 (A) cannabis-impaired driving involving the 

4 use of cannabis and another substance; and 

5 (B) cannabis-impaired driving among driv6 ers under the age of 21. 

7 (b) CAMPAIGN EVALUATION.—Not less frequently 

8 than once every 3 years, the Secretary shall evaluate the 

9 effectiveness of the campaigns required under subsection 

10 (a)(2) and the activities carried out by States using a 

11 grant awarded under section 409 of title 23, United States 

12 Code, by using a variety of factors, including— 

13 (1) collecting data, including behavioral data, 

14 and comparing that data from before and after the 

15 campaigns; 

16 (2)(A) engaging with stakeholders that were in17 volved in the campaigns; and 

18 (B) analyzing feedback from those stakeholders 

19 on what the stakeholders saw as strengths and 

20 weaknesses of the campaigns; 

21 (3) determining whether the campaigns accom22 plished the objectives the Secretary set out to ac23 complish through analysis of data relating to the 

24 campaigns; and 


ssavage on LAPJG3WLY3PROD with BILLS
73 

•S 5243 IS

1 (4) any other factors the Secretary determines 

2 appropriate included in the document of the Na3 tional Highway Traffic Safety Administration enti4 tled ‘‘The Art of Appropriate Evaluation: A Guide 

5 for Highway Safety Program Managers’’ and dated 

6 December 2008 (or a successor document). 

7 (c) REPORT.—Not later than 6 months after the date 

8 on which the Secretary completes an evaluation conducted 

9 under subsection (b), the Secretary shall submit to the 

10 Committees on Commerce, Science, and Transportation, 

11 Environment and Public Works, and Health, Education, 

12 Labor, and Pensions of the Senate and the Committee on 

13 Transportation and Infrastructure of the House of Rep14 resentatives a report that— 

15 (1) summarizes the data collected and provides 

16 the analysis of the data from an evaluation con17 ducted under subsection (b); 

18 (2) includes recommendations for future im19 paired driving campaigns; and 

20 (3) includes any determinations that a national 

21 campaign or an activity carried out by a State using 

22 a grant awarded under section 409 of title 23, 

23 United States Code, is ineffective at preventing can24 nabis-impaired driving. 


ssavage on LAPJG3WLY3PROD with BILLS
74 

•S 5243 IS

1 SEC. 304. STATE CANNABIS-IMPAIRED DRIVING PREVEN2 TION GRANT PROGRAM. 

3 (a) IN GENERAL.—Chapter 4 of title 23, United 

4 States Code, is amended by inserting after section 408 the 

5 following: 

6 ‘‘§ 409. State cannabis-impaired driving prevention 

7 grant program 

8 ‘‘(a) DEFINITIONS.—In this section: 

9 ‘‘(1) CANNABIS.—The term ‘cannabis’ has the 

10 meaning given the term in paragraph (tt) of section 

11 201 of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 321). 

13 ‘‘(2) GRANT PROGRAM.—The term ‘grant pro14 gram’ means the grant program established under 

15 subsection (b). 

16 ‘‘(3) THC.—The term ‘THC’ means 

17 tetrahydrocannabinol (as defined in paragraph (vv) 

18 of section 201 of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 321)). 

20 ‘‘(b) ESTABLISHMENT.—Not later than 1 year after 

21 the date of enactment of the Cannabinoid Safety and Reg22 ulation Act, the Secretary, acting through the Adminis23 trator of the National Highway Traffic Safety Administra24 tion, shall establish a program to provide grants to States, 

25 in accordance with subsection (c), to implement programs 

26 to prevent impaired driving due to cannabis use. 


ssavage on LAPJG3WLY3PROD with BILLS
75 

•S 5243 IS

1 ‘‘(c) ELIGIBILITY.—The Secretary may provide a 

2 grant under this section to any State that— 

3 ‘‘(1) describes how the State will use the grant 

4 funds in accordance with a highway safety program 

5 under section 402, including how the State will im6 plement the best practices developed by the Sec7 retary under section 303(a)(1) of the Cannabinoid 

8 Safety and Regulation Act; and 

9 ‘‘(2) agrees to provide data and information, as 

10 determined by the Secretary, to assist with the eval11 uation of the effectiveness of the eligible activities 

12 described in subsection (d). 

13 ‘‘(d) USE OF FUNDS.—A State may use a grant 

14 awarded under this section for the following activities: 

15 ‘‘(1) Enforcement activities, including— 

16 ‘‘(A) to train public safety personnel to de17 tect impaired driving due to the use of cannabis 

18 or a combination of cannabis and another sub19 stance; 

20 ‘‘(B) to increase the capacity of impaired 

21 driving toxicology testing laboratories in the 

22 State to support impaired driving investiga23 tions, including to purchase equipment, hire 

24 staff, provide training, and improve procedures, 

25 including to improve toxicology testing standVerDate Sep 11 2014 02:04 Oct 11, 2024 Jkt 059200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6201 E:\BILLS\S5243.IS S5243

ssavage on LAPJG3WLY3PROD with BILLS
76 

•S 5243 IS

1 ards to be consistent with the standards con2 tained in the document of the National Safety 

3 Council entitled ‘Recommendations for Toxi4 cological Investigation of Drug-Impaired Driv5 ing and Motor Vehicle Fatalities–2021 Update’ 

6 (or a successor document); 

7 ‘‘(C) to train for and implement impaired 

8 driving assessment programs or other tools de9 signed to increase the probability of identifying 

10 the recidivism risk of an individual convicted of 

11 driving under the influence of cannabis, or a 

12 combination of cannabis and another substance, 

13 and to determine the most effective mental 

14 health or substance abuse treatment or sanction 

15 that will reduce that risk; 

16 ‘‘(D) to develop and implement high-visi17 bility enforcement efforts relating to cannabis18 impaired driving; and 

19 ‘‘(E) for court support of high-visibility en20 forcement efforts, to train and educate criminal 

21 justice professionals (including law enforcement 

22 personnel, prosecutors, judges, and probation 

23 officers) to assist those professionals in— 

24 ‘‘(i) handling cannabis-impaired driv25 ing cases; 


ssavage on LAPJG3WLY3PROD with BILLS
77 

•S 5243 IS

1 ‘‘(ii) hiring traffic safety resource 

2 prosecutors; 

3 ‘‘(iii) hiring judicial outreach liaisons; 

4 and 

5 ‘‘(iv) establishing driving while intoxi6 cated courts. 

7 ‘‘(2) Data collection activities, including— 

8 ‘‘(A) to collect data relating to the use of 

9 cannabis, drugs, or multiple substances by driv10 ers, including the prevalence of the use of those 

11 substances among drivers arrested for impaired 

12 driving; and 

13 ‘‘(B) to increase drug testing and report14 ing for all fatal crashes and serious injuries to 

15 better understand the scope of cannabis-im16 paired driving, or a combination of cannabis 

17 and another substance. 

18 ‘‘(3) Education activities, including— 

19 ‘‘(A) to develop and carry out educational 

20 campaigns to better educate the public about 

21 the harms associated with cannabis-impaired 

22 driving, including impaired driving associated 

23 with the use of cannabis and another substance; 

24 and 


ssavage on LAPJG3WLY3PROD with BILLS
78 

•S 5243 IS

1 ‘‘(B) to participate in national campaigns 

2 organized by the Secretary under section 

3 303(a)(2) of the Cannabinoid Safety and Regu4 lation Act. 

5 ‘‘(e) PROHIBITION.—The Secretary may prohibit the 

6 use of grant funds for an activity described in subsection 

7 (d) if the Secretary determines that the activity is ineffec8 tive at preventing cannabis-impaired driving after con9 ducting an evaluation required under section 303(b) of the 

10 Cannabinoid Safety and Regulation Act. 

11 ‘‘(f) GRANT AMOUNTS.— 

12 ‘‘(1) IN GENERAL.—The allocation of grant 

13 funds to a State under this section for a fiscal year 

14 shall be in proportion to the apportionment of funds 

15 a State receives under section 402(c)(2). 

16 ‘‘(2) REQUIREMENT.—Not less than 10 percent 

17 of the funds allocated to a State under this section 

18 shall be used to carry out activities described in sub19 section (d)(1)(B). 

20 ‘‘(g) FEDERAL SHARE.— 

21 ‘‘(1) IN GENERAL.—For the first 3 fiscal years 

22 after the date on which the grant program is estab23 lished under subsection (b), and each fiscal year 

24 thereafter for a State that meets the condition de25 scribed in paragraph (2)(B) during that fiscal year, 


ssavage on LAPJG3WLY3PROD with BILLS
79 

•S 5243 IS

1 the Federal share of the costs of activities carried 

2 out with a grant awarded under the grant program 

3 shall be 80 percent in any fiscal year in which the 

4 State is awarded a grant. 

5 ‘‘(2) DECREASED FEDERAL SHARE.— 

6 ‘‘(A) IN GENERAL.—For any State that 

7 does not meet the condition described in sub8 paragraph (B), the Federal share of the costs 

9 of activities carried out with a grant awarded 

10 under the grant program shall be— 

11 ‘‘(i) 70 percent in the fourth fiscal 

12 year after the date on which the grant pro13 gram is established under subsection (b); 

14 ‘‘(ii) 60 percent in the fifth fiscal year 

15 after that date; and 

16 ‘‘(iii) 50 percent in the sixth fiscal 

17 year after that date and each fiscal year 

18 thereafter. 

19 ‘‘(B) CONDITION.—The condition referred 

20 to in paragraph (1) and subparagraph (A) is 

21 that the State shall implement an open con22 tainer law relating to cannabis products. 

23 ‘‘(h) FUNDING.—In addition to amounts otherwise 

24 available, there is appropriated, out of any money in the 

25 Treasury not otherwise appropriated, $40,000,000 for 


ssavage on LAPJG3WLY3PROD with BILLS
80 

•S 5243 IS

1 each of fiscal years 2024 through 2028 to carry out this 

2 section.’’. 

3 (b) CLERICAL AMENDMENT.—The analysis for chap4 ter 4 of title 23, United States Code, is amended by insert5 ing after the item relating to section 408 the following: 

‘‘409. State cannabis-impaired driving prevention grant program.’’. 

6 SEC. 305. NATIONAL CANNABIS IMPAIRMENT STANDARD. 

7 (a) IN GENERAL.—Not later than 3 years after the 

8 date of enactment of this Act, and once every 2 years 

9 thereafter, the Secretary shall make a determination as 

10 to whether or not it is feasible to establish a national 

11 standard for determining impairment for cannabis-im12 paired driving. 

13 (b) RULEMAKING REQUIRED.—If the Secretary de14 termines that establishing a national standard relating to 

15 cannabis-impaired driving under subsection (a) is feasible, 

16 the Secretary shall, not later than 1 year after that deter17 mination, promulgate regulations establishing a model 

18 cannabis impairment standard for States. 

19 SEC. 306. FUNDING. 

20 In addition to amounts otherwise available, there is 

21 appropriated, out of any money in the Treasury not other22 wise appropriated, $30,000,000 for each of fiscal years 

23 2024 through 2029 to carry out sections 302 and 303. 

Æ 


ssavage on LAPJG3WLY3PROD with BILLS