I 
117TH CONGRESS 
2D SESSION 
H. R. 9634 
To protect access to kratom. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 20, 2022 
Mr. POCAN introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To protect access to kratom. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Federal Clarity for 
Kratom Consumers Act’’. 
SEC. 2. ACCESS TO KRATOM. 
(a) OPENNESS IN RESEARCH.— 
(1) IN GENERAL.—During the period that be-
gins 30 days after the date of enactment of this Act 
and ends 90 days after such date of enactment, the 
Secretary, acting through the Commissioner, shall 
hold at least one hearing that provides an open 
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forum for the discussion on the current scientific 
data and information about safety and use of prod-
ucts containing kratom or kratom-derived products 
marketed as a food, dietary ingredient, or dietary 
supplement. 
(2) HEARING
REQUIREMENTS.—The hearing 
under paragraph (1) shall— 
(A) include input from leading scientific 
researchers on kratom and kratom-derived 
products; and 
(B) consider— 
(i) how many individuals in the 
United 
States 
consume 
kratom 
and 
kratom-derived products; 
(ii) the scope, scale, and degree of de-
pendence or addiction associated with 
kratom, 
mitragynine, 
and 
7– 
hydroxymitragynine; 
(iii) the causality of deaths in which 
kratom or kratom-derived products are as-
sociated, including instances in which— 
(I) a kratom-containing product 
or kratom-derived product was con-
sumed together with legal or illegal 
drugs; or 
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(II) the kratom-containing prod-
uct or kratom-derived product con-
sumed was contaminated with a dif-
ferent non-drug adulterant known to 
endanger health; 
(iv) whether use of kratom or kratom- 
derived products is directly linked to the 
use of more dangerous scheduled sub-
stances; 
(v) any adverse health impacts that 
could be expected if kratom or kratom-de-
rived were no longer available; and 
(vi) the potential health and wellness 
benefits of kratom and kratom-derived 
products. 
(3) PUBLIC DOCKET.—Not later than 30 days 
after the date of enactment of this Act, the Sec-
retary shall open a public docket for submission of 
public comments for consideration at the hearing 
under paragraph (1). The Secretary shall leave such 
public docket open for comments for not fewer than 
30 days before the hearing takes place. 
(4) PUBLICATION OF INFORMATION.—The Sec-
retary shall publish on the website of the Food and 
Drug Administration the transcripts of all hearings 
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conducted pursuant to paragraph (1), subject to sec-
tion 552(b) of title 5, United States Code. 
(b) TASK FORCE.— 
(1) ESTABLISHMENT.—Not later than 30 days 
after the date of enactment of this Act, the Sec-
retary shall convene a task force, to be known as the 
‘‘Kratom Research Task Force’’, to coordinate 
kratom-related research conducted or supported by 
the Federal Government. 
(2) REPORTS ON KRATOM RESEARCH.— 
(A) INITIAL REPORT.—Not later than 90 
days after the date of enactment of this Act, 
the Kratom Research Task Force shall submit 
to Congress, the Secretary, and the Commis-
sioner a report that details all federally funded 
kratom-related research that has begun or been 
completed prior to such date of enactment. 
(B) SUBSEQUENT QUARTERLY REPORTS.— 
Not later than 90 days after submission of the 
report under subparagraph (A), and quarterly 
thereafter, the Kratom Research Task Force 
shall submit to Congress, the Secretary, and the 
Commissioner a report that includes— 
(i) a progress report on all federally 
funded kratom-related research and find-
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ings made during the applicable quarter; 
and 
(ii) an analysis of the results of all 
such research. 
(3) PUBLIC MEETINGS.—The Kratom Research 
Task Force shall convene public meetings with ap-
propriate experts and stakeholders to increase public 
awareness concerning the current state of kratom-re-
lated research. 
(4) PUBLICLY AVAILABLE INFORMATION.—The 
Secretary shall— 
(A) publish the report submitted under 
paragraph (2)(A) on the website of the Food 
and Drug Administration; and 
(B) update such website in accordance 
with the quarterly reports submitted under 
paragraph (2)(B), upon receipt of each such re-
port. 
(5) TERMINATION
OF
TASK
FORCE.—On the 
date that is 2 years after the initial report is sub-
mitted by the Kratom Research Task Force under 
paragraph (2)(A), such task force shall be termi-
nated. 
(c) PROTECTION OF KRATOM FROM CURRENT REGU-
LATIONS.—The Secretary shall not— 
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(1) impose requirements on kratom or kratom- 
derived products that are more restrictive than the 
requirements for food, dietary supplements, and die-
tary ingredients that apply under The Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); 
(2) treat kratom, or any product derived from 
or containing kratom, as an adulterated dietary sup-
plement— 
(A) for containing a new dietary ingredient 
as described in subparagraph (B) of section 
402(f)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 342(f)(1)); or 
(B) pursuant to subparagraph (C) of such 
section 402(f)(1); or 
(3) require kratom to undergo requirements for 
notification as a new dietary ingredient under sec-
tion 413 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350b). 
(d) PROTECTION FROM FUTURE ADMINISTRATIVE 
ACTION.— 
(1) IN
GENERAL.—Any rulemaking the Sec-
retary initiates to regulate kratom shall— 
(A) comply with formal rulemaking re-
quirements under section 552(a) of title 5, 
United States Code; and 
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(B) require public, in-person hearings. 
(2) PUBLICATION OF INFORMATION.—The Sec-
retary shall publish on the website of the Food and 
Drug Administration the transcripts of all hearings 
conducted pursuant to paragraph (1)(B), subject to 
section 552(b) of title 5, United States Code. 
(e) IMPORT ALERT REQUIREMENTS.—The Secretary 
may not issue, implement, or enforce an import alert for 
a kratom or kratom-derived product unless the Secretary 
determines that there is a history of such kratom or 
kratom-derived product being adulterated as described in 
section 402(f)(1)(A) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 342(f)(1)(A)), or evidence that such 
kratom or kratom-derived product is adulterated as de-
scribed in such section. 
(f) NONPREEMPTION.—Nothing in this section shall 
preempt any State law. 
(g) DEFINITIONS.—In this section: 
(1) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(2) 
COMMISSIONER.—The 
term 
‘‘Commis-
sioner’’ means the Commissioner of Food and 
Drugs. 
(3) DIETARY SUPPLEMENT.—The term ‘‘dietary 
supplement’’ has the meaning given such term in 
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section 201(ff) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(ff)). 
(4) DIETARY INGREDIENT.—The term ‘‘dietary 
ingredient’’ means a dietary ingredient as such term 
is used in section 201(ff)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(ff)(1)). 
(5) FOOD.—The term ‘‘food’’ has the meaning 
given such term in section 201(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)). 
(6) KRATOM.—The term ‘‘kratom’’ means the 
botanical Mitragyna speciosa. 
(7) NEW
DIETARY
INGREDIENT.—The term 
‘‘new dietary ingredient’’ has the meaning given 
such term in section 413(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350b(d)). 
Æ 
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