II 

117TH CONGRESS 

2D SESSION S. 5316 

To protect access to kratom. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 20, 2022 

Mr. LEE (for himself and Mr. BOOKER) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To protect access to kratom. 

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. 

4 This Act may be cited as the ‘‘Federal Clarity for 

5 Kratom Consumers Act’’. 

6 SEC. 2. ACCESS TO KRATOM. 

7 (a) OPENNESS IN RESEARCH.— 

8 (1) IN GENERAL.—During the period that be9 gins 30 days after the date of enactment of this Act 

10 and ends 90 days after such date of enactment, the 

11 Secretary, acting through the Commissioner, shall 


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1 hold at least one hearing that provides an open 

2 forum for the discussion on the current scientific 

3 data and information about safety and use of prod4 ucts containing kratom or kratom-derived products 

5 marketed as a food, dietary ingredient, or dietary 

6 supplement. 

7 (2) HEARING REQUIREMENTS.—The hearing 

8 under paragraph (1) shall— 

9 (A) include input from leading scientific 

10 researchers on kratom and kratom-derived 

11 products; and 

12 (B) consider— 

13 (i) how many individuals in the 

14 United States consume kratom and 

15 kratom-derived products; 

16 (ii) the scope, scale, and degree of de17 pendence or addiction associated with 

18 kratom, mitragynine, and 7– 

19 hydroxymitragynine; 

20 (iii) the causality of deaths in which 

21 kratom or kratom-derived products are as22 sociated, including instances in which— 

23 (I) a kratom-containing product 

24 or kratom-derived product was conVerDate Sep 11 2014 01:52 Jan 05, 2023 Jkt 039020 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S5316.IS S5316

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1 sumed together with legal or illegal 

2 drugs; or 

3 (II) the kratom-containing prod4 uct or kratom-derived product con5 sumed was contaminated with a dif6 ferent non-drug adulterant known to 

7 endanger health; 

8 (iv) whether use of kratom or kratom9 derived products is directly linked to the 

10 use of more dangerous scheduled sub11 stances; 

12 (v) any adverse health impacts that 

13 could be expected if kratom or kratom-de14 rived were no longer available; and 

15 (vi) the potential health and wellness 

16 benefits of kratom and kratom-derived 

17 products. 

18 (3) PUBLIC DOCKET.—Not later than 30 days 

19 after the date of enactment of this Act, the Sec20 retary shall open a public docket for submission of 

21 public comments for consideration at the hearing 

22 under paragraph (1). The Secretary shall leave such 

23 public docket open for comments for not fewer than 

24 30 days before the hearing takes place. 


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1 (4) PUBLICATION OF INFORMATION.—The Sec2 retary shall publish on the website of the Food and 

3 Drug Administration the transcripts of all hearings 

4 conducted pursuant to paragraph (1), subject to sec5 tion 552(b) of title 5, United States Code. 

6 (b) TASK FORCE.— 

7 (1) ESTABLISHMENT.—Not later than 30 days 

8 after the date of enactment of this Act, the Sec9 retary shall convene a task force, to be known as the 

10 ‘‘Kratom Research Task Force’’, to coordinate 

11 kratom-related research conducted or supported by 

12 the Federal Government. 

13 (2) REPORTS ON KRATOM RESEARCH.— 

14 (A) INITIAL REPORT.—Not later than 90 

15 days after the date of enactment of this Act, 

16 the Kratom Research Task Force shall submit 

17 to Congress, the Secretary, and the Commis18 sioner a report that details all federally funded 

19 kratom-related research that has begun or been 

20 completed prior to such date of enactment. 

21 (B) SUBSEQUENT QUARTERLY REPORTS.— 

22 Not later than 90 days after submission of the 

23 report under subparagraph (A), and quarterly 

24 thereafter, the Kratom Research Task Force 


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1 shall submit to Congress, the Secretary, and the 

2 Commissioner a report that includes— 

3 (i) a progress report on all federally 

4 funded kratom-related research and find5 ings made during the applicable quarter; 

6 and 

7 (ii) an analysis of the results of all 

8 such research. 

9 (3) PUBLIC MEETINGS.—The Kratom Research 

10 Task Force shall convene public meetings with ap11 propriate experts and stakeholders to increase public 

12 awareness concerning the current state of kratom-re13 lated research. 

14 (4) PUBLICLY AVAILABLE INFORMATION.—The 

15 Secretary shall— 

16 (A) publish the report submitted under 

17 paragraph (2)(A) on the website of the Food 

18 and Drug Administration; and 

19 (B) update such website in accordance 

20 with the quarterly reports submitted under 

21 paragraph (2)(B), upon receipt of each such re22 port. 

23 (5) TERMINATION OF TASK FORCE.—On the 

24 date that is 2 years after the initial report is sub25 mitted by the Kratom Research Task Force under 


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1 paragraph (2)(A), such task force shall be termi2 nated. 

3 (c) PROTECTION OF KRATOM FROM CURRENT REGU4 LATIONS.—The Secretary shall not— 

5 (1) impose requirements on kratom or kratom6 derived products that are more restrictive than the 

7 requirements for food, dietary supplements, and die8 tary ingredients that apply under The Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); 

10 (2) treat kratom, or any product derived from 

11 or containing kratom, as an adulterated dietary sup12 plement— 

13 (A) for containing a new dietary ingredient 

14 as described in subparagraph (B) of section 

15 402(f)(1) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 342(f)(1)); or 

17 (B) pursuant to subparagraph (C) of such 

18 section 402(f)(1); or 

19 (3) require kratom to undergo requirements for 

20 notification as a new dietary ingredient under sec21 tion 413 of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 350b). 

23 (d) PROTECTION FROM FUTURE ADMINISTRATIVE

24 ACTION.— 


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1 (1) IN GENERAL.—Any rulemaking the Sec2 retary initiates to regulate kratom shall— 

3 (A) comply with formal rulemaking re4 quirements under section 552(a) of title 5, 

5 United States Code; and 

6 (B) require public, in-person hearings. 

7 (2) PUBLICATION OF INFORMATION.—The Sec8 retary shall publish on the website of the Food and 

9 Drug Administration the transcripts of all hearings 

10 conducted pursuant to paragraph (1)(B), subject to 

11 section 552(b) of title 5, United States Code. 

12 (e) IMPORT ALERT REQUIREMENTS.—The Secretary 

13 may not issue, implement, or enforce an import alert for 

14 a kratom or kratom-derived product unless the Secretary 

15 determines that there is a history of such kratom or 

16 kratom-derived product being adulterated as described in 

17 section 402(f)(1)(A) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 342(f)(1)(A)), or evidence that such 

19 kratom or kratom-derived product is adulterated as de20 scribed in such section. 

21 (f) NONPREEMPTION.—Nothing in this section shall 

22 preempt any State law. 

23 (g) DEFINITIONS.—In this section: 

24 (1) SECRETARY.—The term ‘‘Secretary’’ means 

25 the Secretary of Health and Human Services. 


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1 (2) COMMISSIONER.—The term ‘‘Commis2 sioner’’ means the Commissioner of Food and 

3 Drugs. 

4 (3) DIETARY SUPPLEMENT.—The term ‘‘dietary 

5 supplement’’ has the meaning given such term in 

6 section 201(ff) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 321(ff)). 

8 (4) DIETARY INGREDIENT.—The term ‘‘dietary 

9 ingredient’’ means a dietary ingredient as such term 

10 is used in section 201(ff)(1) of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 321(ff)(1)). 

12 (5) FOOD.—The term ‘‘food’’ has the meaning 

13 given such term in section 201(f) of the Federal 

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

15 (6) KRATOM.—The term ‘‘kratom’’ means the 

16 botanical Mitragyna speciosa. 

17 (7) NEW DIETARY INGREDIENT.—The term 

18 ‘‘new dietary ingredient’’ has the meaning given 

19 such term in section 413(d) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 350b(d)). 

Æ 


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