Federal Clarity for Kratom Consumers Act
Bill: S.5316 | Sponsor: Sen. Lee, Mike (R-UT)
Policy area: Health

Summary:
Federal Clarity for Kratom Consumers Act
This bill requires the Food and Drug Administration (FDA) to hold a hearing and establish a task force on the health and safety of products with kratom (an herbal substance that produces opioid- and stimulant-like effects). It also prohibits the FDA from regulating kratom products in a manner that is more restrictive as compared to regulations for food, dietary supplements, or dietary ingredients.

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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