Pennsylvania 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.

Bill Text

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
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.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the Kratom
Consumer Protection Act.
Section 2. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Department." The Department of Health of the Commonwealth.
"Food product." A food, food ingredient, dietary ingredient,
dietary supplement or beverage for human consumption.
"Kratom extract." A food product that contains any part of a
leaf from mitragyna speciosa, commonly known as kratom, which
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has been extracted and concentrated to provide more standardized
dosing.
"Kratom product." A food product that contains any part of a
leaf from mitragyna speciosa, commonly known as kratom, or a
kratom extract, and is manufactured as a powder, capsule, pill,
beverage or any other edible form.
"Processor." A person who prepares or manufactures a kratom
product or who advertises, represents or holds oneself out as
preparing or manufacturing a kratom product. The term does not
include a retailer.
"Retailer." A person who sells or distributes a kratom
product or who advertises, represents or holds oneself out as
selling or distributing a kratom product. The term does not
include a processor.
"The Controlled Substance, Drug, Device and Cosmetic Act."
The act of April 14, 1972 (P.L.233, No.64), known as The
Controlled Substance, Drug, Device and Cosmetic Act.
Section 3. Prohibition on preparation, manufacture, sale or
distribution of unsafe kratom products.
A processor may not prepare or manufacture, and a retailer
may not sell or distribute, a kratom product that meets any of
the following criteria:
(1) The kratom product is mixed or packed with a
nonkratom substance and the substance affects the quality or
strength of the kratom product to such a degree as to render
the kratom product injurious to a consumer of the kratom
product.
(2) The kratom product contains a poisonous or otherwise
deleterious nonkratom ingredient, including, but not limited
to, any of the following:
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(i) A controlled substance listed under section 4 of
The Controlled Substance, Drug, Device and Cosmetic Act.
(ii) A controlled substance listed under 28 Pa. Code
Ch. 25 Subch. A (relating to controlled substances,
drugs, devices and cosmetics).
(iii) A substance that is temporarily scheduled as a
controlled substance by the Secretary of Health under
section 3(d) of The Controlled Substance, Drug, Device
and Cosmetic Act.
(3) The kratom product contains a kratom extract with
levels of residual solvents higher than the standards
specified in the current edition of the United States
Pharmacopeia/National Formulary 467 on the effective date of
this paragraph.
(4) The kratom product contains a level of 7-
hydroxymitragynine in the alkaloid fraction that is greater
than 2% of the overall alkaloid composition of the kratom
product.
(5) The kratom product contains a synthetic alkaloid,
including a synthetic mitragynine, a synthetic 7-
hydroxymitragynine or any other synthetically derived
compounds of the kratom plant.
(6) The kratom product does not include adequate
labeling of ingredients and directions necessary for the safe
and effective use by a consumer of the kratom product,
including a recommended serving size.
Section 4. Prohibition on sale or distribution of kratom
products to individuals younger than 21 years of age.
A retailer may not sell or distribute a kratom product to an
individual younger than 21 years of age.
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Section 5. Duties of department.
The department shall have the duty of enforcing the
provisions of this act. The department may promulgate
regulations as necessary to implement this act.
Section 6. Penalties.
(a) Penalties.--In addition to any other penalty provided
under The Controlled Substance, Drug, Device and Cosmetic Act,
the department shall impose an administrative fine on a
processor or retailer who violates section 3, section 4 or
subsection (c) in accordance with the following:
(1) For a first offense, an administrative fine of not
less than $100 and not more than $500.
(2) For a second offense, an administra