II 

118TH CONGRESS 

1ST SESSION S. 3039 

To protect access to kratom. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 4, 2023 

Mr. LEE 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 Kratom Con5 sumer Protection 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 

12 hold at least one hearing that provides an open 


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1 forum for the discussion on the current scientific 

2 data and information about safety and use of prod3 ucts containing kratom or kratom-derived products 

4 marketed as a food, dietary ingredient, or dietary 

5 supplement. 

6 (2) HEARING REQUIREMENTS.—The hearing 

7 under paragraph (1) shall— 

8 (A) include input from leading scientific 

9 researchers on kratom and kratom-derived 

10 products; and 

11 (B) consider— 

12 (i) how many individuals in the 

13 United States consume kratom and 

14 kratom-derived products; 

15 (ii) the scope, scale, and degree of de16 pendence or addiction associated with 

17 kratom, mitragynine, and 7– 

18 hydroxymitragynine; 

19 (iii) the causality of deaths in which 

20 kratom or kratom-derived products are as21 sociated, including instances in which— 

22 (I) a kratom-containing product 

23 or kratom-derived product was con24 sumed together with legal or illegal 

25 drugs; or 


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1 (II) the kratom-containing prod2 uct or kratom-derived product con3 sumed was contaminated with a dif4 ferent non-drug adulterant known to 

5 endanger health; 

6 (iv) whether use of kratom or kratom7 derived products is directly linked to the 

8 use of more dangerous scheduled sub9 stances; 

10 (v) any adverse health impacts that 

11 could be expected if kratom or kratom-de12 rived were no longer available; and 

13 (vi) the potential health and wellness 

14 benefits of kratom and kratom-derived 

15 products. 

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

17 after the date of enactment of this Act, the Sec18 retary shall open a public docket for submission of 

19 public comments for consideration at the hearing 

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

21 public docket open for comments for not fewer than 

22 30 days before the hearing takes place. 

23 (4) PUBLICATION OF INFORMATION.—The Sec24 retary shall publish on the website of the Food and 

25 Drug Administration the transcripts of all hearings 


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1 conducted pursuant to paragraph (1), subject to sec2 tion 552(b) of title 5, United States Code. 

3 (b) TASK FORCE.— 

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

5 after the date of enactment of this Act, the Sec6 retary shall convene a task force, to be known as the 

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

8 kratom-related research conducted or supported by 

9 the Federal Government. 

10 (2) REPORTS ON KRATOM RESEARCH.— 

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

12 days after the date of enactment of this Act, 

13 the Kratom Research Task Force shall submit 

14 to Congress, the Secretary, and the Commis15 sioner a report that details all federally funded, 

16 kratom-related research that has begun or been 

17 completed prior to such date of enactment. 

18 (B) SUBSEQUENT QUARTERLY REPORTS.— 

19 Not later than 90 days after submission of the 

20 report under subparagraph (A), and quarterly 

21 thereafter, the Kratom Research Task Force 

22 shall submit to Congress, the Secretary, and the 

23 Commissioner a report that includes— 

24 (i) a progress report on all federally25 funded kratom-related research and findVerDate Sep 11 2014 23:59 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3039.IS S3039

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1 ings made during the applicable quarter; 

2 and 

3 (ii) an analysis of the results of all 

4 such research. 

5 (3) PUBLIC MEETINGS.—The Kratom Research 

6 Task Force shall convene public meetings with ap7 propriate experts and stakeholders to increase public 

8 awareness concerning the current state of kratom-re9 lated research. 

10 (4) PUBLICLY AVAILABLE INFORMATION.—The 

11 Secretary shall— 

12 (A) publish the report submitted under 

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

14 and Drug Administration; and 

15 (B) update such website in accordance 

16 with the quarterly reports submitted under 

17 paragraph (2)(B), upon receipt of each such re18 port. 

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

20 date that is 2 years after the initial report is sub21 mitted by the Kratom Research Task Force under 

22 paragraph (2)(A), such task force shall be termi23 nated. 

24 (c) PROTECTION OF KRATOM FROM CURRENT REGU25 LATIONS.—The Secretary shall not— 


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1 (1) impose requirements on kratom or kratom2 derived products that are more restrictive than the 

3 requirements for food, dietary supplements, and die4 tary ingredients that apply under The Federal Food, 

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

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

7 or containing kratom, as an adulterated dietary sup8 plement— 

9 (A) for containing a new dietary ingredient 

10 as described in subparagraph (B) of section 

11 402(f)(1) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 342(f)(1)); or 

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

14 section 402(f)(1); or 

15 (3) require kratom to undergo requirements for 

16 notification as a new dietary ingredient under sec17 tion 413 of the Federal Food, Drug, and Cosmetic 

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

19 (d) PROTECTION FROM FUTURE ADMINISTRATIVE

20 ACTION.— 

21 (1) IN GENERAL.—Any rulemaking the Sec22 retary initiates to regulate kratom shall— 

23 (A) comply with formal rulemaking re24 quirements under section 552(a) of title 5, 

25 United States Code; and 


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

2 (2) PUBLICATION OF INFORMATION.—The Sec3 retary shall publish on the website of the Food and 

4 Drug Administration the transcripts of all hearings 

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

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

7 (e) IMPORT ALERT REQUIREMENTS.—The Secretary 

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

9 a kratom or kratom-derived product unless the Secretary 

10 determines that there is a history of such kratom or 

11 kratom-derived product being adulterated as described in 

12 section 402(f)(1)(A) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 342(f)(1)(A)), or evidence that such 

14 kratom or kratom-derived product is adulterated as de15 scribed in such section. 

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

17 preempt any State law. 

18 (g) DEFINITIONS.—In this section: 

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

20 the Secretary of Health and Human Services. 

21 (2) COMMISSIONER.—The term ‘‘Commis22 sioner’’ means the Commissioner of Food and 

23 Drugs. 

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

25 supplement’’ has the meaning given such term in 


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1 section 201(ff) of the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 321(ff)). 

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

4 ingredient’’ means a dietary ingredient as such term 

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

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

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

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

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

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

11 botanical Mitragyna speciosa. 

12 (7) NEW DIETARY INGREDIENT.—The term 

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

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

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

Æ 


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