SB 233 — An Act prohibiting the preparation, manufacture, sale or distribution of unsafe kratom products and the sale or distribution of kratom products to individuals younger than 21 years of age; providing for duties of Department of Health; and imposing penalties.

PRINTER'S NO.   186

                   THE GENERAL ASSEMBLY OF PENNSYLVANIA



                        SENATE BILL
                        No. 233
                                              Session of
                                                2025

     INTRODUCED BY PENNYCUICK, BROWN, LANGERHOLC, FONTANA, KANE,
        HAYWOOD, STEFANO AND DUSH, FEBRUARY 4, 2025

     REFERRED TO HEALTH AND HUMAN SERVICES, FEBRUARY 4, 2025


                                   AN ACT
 1   Prohibiting the preparation, manufacture, sale or distribution
 2      of unsafe kratom products and the sale or distribution of
 3      kratom products to individuals younger than 21 years of age;
 4      providing for duties of Department of Health; and imposing
 5      penalties.
 6      The General Assembly of the Commonwealth of Pennsylvania
 7   hereby enacts as follows:
 8   Section 1.   Short title.
 9      This act shall be known and may be cited as the Kratom
10   Consumer Protection Act.
11   Section 2.   Definitions.
12      The following words and phrases when used in this act shall
13   have the meanings given to them in this section unless the
14   context clearly indicates otherwise:
15      "Department."   The Department of Health of the Commonwealth.
16      "Food product."   A food, food ingredient, dietary ingredient,
17   dietary supplement or beverage for human consumption.
18      "Kratom extract."   A food product that contains any part of a
19   leaf from mitragyna speciosa, commonly known as kratom, which
 1   has been extracted and concentrated to provide more standardized
 2   dosing.
 3      "Kratom product."      A food product that contains any part of a
 4   leaf from mitragyna speciosa, commonly known as kratom, or a
 5   kratom extract, and is manufactured as a powder, capsule, pill,
 6   beverage or any other edible form.
 7      "Processor."      A person who prepares or manufactures a kratom
 8   product or who advertises, represents or holds oneself out as
 9   preparing or manufacturing a kratom product. The term does not
10   include a retailer.
11      "Retailer."      A person who sells or distributes a kratom
12   product or who advertises, represents or holds oneself out as
13   selling or distributing a kratom product. The term does not
14   include a processor.
15      "The Controlled Substance, Drug, Device and Cosmetic Act."
16   The act of April 14, 1972 (P.L.233, No.64), known as The
17   Controlled Substance, Drug, Device and Cosmetic Act.
18   Section 3.      Prohibition on preparation, manufacture, sale or
19                   distribution of unsafe kratom products.
20      A processor may not prepare or manufacture, and a retailer
21   may not sell or distribute, a kratom product that meets any of
22   the following criteria:
23             (1)   The kratom product is mixed or packed with a
24      nonkratom substance and the substance affects the quality or
25      strength of the kratom product to such a degree as to render
26      the kratom product injurious to a consumer of the kratom
27      product.
28             (2)   The kratom product contains a poisonous or otherwise
29      deleterious nonkratom ingredient, including, but not limited
30      to, any of the following:

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 1                 (i)    A controlled substance listed under section 4 of
 2          The Controlled Substance, Drug, Device and Cosmetic Act.
 3                 (ii)    A controlled substance listed under 28 Pa. Code
 4          Ch. 25 Subch. A (relating to controlled substances,
 5          drugs, devices and cosmetics).
 6                 (iii)   A substance that is temporarily scheduled as a
 7          controlled substance by the Secretary of Health under
 8          section 3(d) of The Controlled Substance, Drug, Device
 9          and Cosmetic Act.
10          (3)    The kratom product contains a kratom extract with
11      levels of residual solvents higher than the standards
12      specified in the current edition of the United States
13      Pharmacopeia/National Formulary 467 on the effective date of
14      this paragraph.
15          (4)    The kratom product contains a level of 7-
16      hydroxymitragynine in the alkaloid fraction that is greater
17      than 2% of the overall alkaloid composition of the kratom
18      product.
19          (5)    The kratom product contains a synthetic alkaloid,
20      including a synthetic mitragynine, a synthetic 7-
21      hydroxymitragynine or any other synthetically derived
22      compounds of the kratom plant.
23          (6)    The kratom product does not include adequate
24      labeling of ingredients and directions necessary for the safe
25      and effective use by a consumer of the kratom product,
26      including a recommended serving size.
27   Section 4.    Prohibition on sale or distribution of kratom
28                 products to individuals younger than 21 years of age.
29      A retailer may not sell or distribute a kratom product to an
30   individual younger than 21 years of age.

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 1   Section 5.     Duties of department.
 2      The department shall have the duty of enforcing the
 3   provisions of this act. The department may promulgate
 4   regulations as necessary to implement this act.
 5   Section 6.     Penalties.
 6      (a)   Penalties.--In addition to any other penalty provided
 7   under The Controlled Substance, Drug, Device and Cosmetic Act,
 8   the department shall impose an administrative fine on a
 9   processor or retailer who violates section 3, section 4 or
10   subsection (c) in accordance with the following:
11            (1)   For a first offense, an administrative fine of not
12      less than $100 and not more than $500.
13            (2)   For a second offense, an administrative fine of not
14      less than $500 and not more than $1,000.
15            (3)   For a third offense, an administrative fine of not
16      less than $1,000 and not more than $3,000.
17            (4)   For a fourth or subsequent offense, an
18      administrative fine of not less than $3,000 and not more than
19      $5,000.
20      (b)   Defense.--A retailer shall not be subject to an
21   administrative fine under subsection (a) if, by a preponderance
22   of the evidence, the retailer acted in good faith reliance upon
23   a processor that the kratom product is not in violation of
24   section 3.
25      (c)   Plan of correction.--The department may order a
26   processor or retailer to comply with a plan of correction which
27   the department deems necessary to correct a violation of section
28   3 or section 4. A processor or retailer who fails to comply with
29   a plan of correction shall be subject to an administrative fine
30   under subsection (a) as a separate offense.

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 1      (d)   Credit.--Money received from the administrative fines
 2   imposed under subsection (a) shall be paid into the State
 3   Treasury and shall be credited to the general government
 4   appropriations of the department for administering and enforcing
 5   this act.
 6      (e)   Administrative Agency Law.--The provisions of this
 7   section shall be subject to 2 Pa.C.S. Chs. 5 Subch. A (relating
 8   to practice and procedure of Commonwealth agencies) and 7 Subch.
 9   A (relating to judicial review of Commonwealth agency action).
10   Section 7.   Effective date.
11      This act shall take effect in 60 days.




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