[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5316 Introduced in Senate (IS)]
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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.
Be it enacted by the Senate and House of Representatives 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 begins 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 forum for the discussion on the current scientific data
and information about safety and use of products 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
dependence or addiction associated with kratom,
mitragynine, and 7-hydroxymitragynine;
(iii) the causality of deaths in which
kratom or kratom-derived products are
associated, including instances in which--
(I) a kratom-containing product or
kratom-derived product was consumed
together with legal or illegal drugs;
or
(II) the kratom-containing product
or kratom-derived product consumed was
contaminated with a different 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 substances;
(v) any adverse health impacts that could
be expected if kratom or kratom-derived 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 Secretary 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 Secretary shall
publish on the website of the Food and Drug Administration the
transcripts of all hearings conducted pursuant to paragraph
(1), subject to section 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 Secretary 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 Commissioner 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 findings
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 appropriate experts and
stakeholders to increase public awareness concerning the
current state of kratom-related 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 report.
(5) Termination of task force.--On the date that is 2 years
after the initial report is submitted by the Kratom Research
Task Force under paragraph (2)(A), such task force shall be
terminated.
(c) Protection of Kratom From Current Regulations.--The Secretary
shall not--
(1) impose requirements on kratom or kratom-derived
products that are more restrictive than the requirements for
food, dietary supplements, and dietary 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 supplement--
(A) for containing a new dietary ingredient as
described in subparagraph (B) of section 402(f)(1) of
the Federal Food, Drug, and Cosmetic 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 section 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 Secretary initiates to
regulate kratom shall--
(A) comply with formal rulemaking requirements
under section 552(a) of title 5, United States Code;
and
(B) require public, in-person hearings.
(2) Publication of information.--The Secretary 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 Cosmetic Act (21
U.S.C. 342(f)(1)(A)), or evidence that such kratom or kratom-derived
product is adulterated as described 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 ``Commissioner'' means the
Commissioner of Food and Drugs.
(3) Dietary supplement.--The term ``dietary supplement''
has the meaning given such term in section 201(ff) of the
Federal Food, Drug, and Cosmetic 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)).
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