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PRIOR PRINTER'S NO. 1029 PRINTER'S NO. 1319
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 899
Session of
2025
INTRODUCED BY PENNYCUICK, KANE, DUSH, FONTANA, BROWN, HAYWOOD,
STEFANO, J. WARD, FLYNN, LAUGHLIN AND MILLER, JUNE 30, 2025
SENATOR BROOKS, HEALTH AND HUMAN SERVICES, AS AMENDED,
NOVEMBER 18, 2025
AN ACT
Amending the act of April 14, 1972 (P.L.233, No.64), entitled
"An act relating to the manufacture, sale and possession of
controlled substances, other drugs, devices and cosmetics;
conferring powers on the courts and the secretary and
Department of Health, and a newly created Pennsylvania Drug,
Device and Cosmetic Board; establishing schedules of
controlled substances; providing penalties; requiring
registration of persons engaged in the drug trade and for the
revocation or suspension of certain licenses and
registrations; and repealing an act," further providing for
prohibited acts and penalties SCHEDULES OF CONTROLLED
SUBSTANCES.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 13(a) of the act of April 14, 1972
(P.L.233, No.64), known as The Controlled Substance, Drug,
Device and Cosmetic Act, is amended by adding a clause and the
section is amended by adding a subsection to read:
Section 13. Prohibited Acts; Penalties.--(a) The following
acts and the causing thereof within the Commonwealth are hereby
prohibited:
* * *
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(41) (i) The preparation, manufacture, sale or distribution
of a kratom product to a minor that meets any of the following
criteria:
(A) The kratom product is mixed or packed with a nonkratom
substance and the substance affects the quality or strength of
the kratom product to a degree that renders the kratom product
injurious to a consumer of the kratom product.
(B) The kratom product contains a poisonous or otherwise
deleterious nonkratom ingredient, including, but not limited to,
any of the following:
(I) A controlled substance listed under section 4.
(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 under section 3(d).
(C) 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 (USP/NF) 467 on the effective date of this clause.
(D) 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.
(E) 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.
(F) The kratom product does not include adequate labeling
directions necessary for the safe and effective use by a
consumer of the kratom product, including a recommended serving
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size.
(ii) A retailer shall not be subject to criminal liability
under this clause if, by a preponderance of the evidence, the
retailer acted in good faith reliance upon a processor that the
kratom product was not in violation of this clause.
(iii) The following words and phrases when used in this
clause shall have the meanings given to them in this subclause
unless the context clearly indicates otherwise:
"Food product" means a food, food ingredient, dietary
ingredient, dietary supplement or beverage for human
consumption.
"Kratom extract" means a food product that contains any part
of a leaf from mitragyna speciosa, commonly known as kratom,
which has been extracted and concentrated to provide more
standardized dosing.
"Kratom product" means 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" means 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" means 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.
* * *
(q) (1) Any person who knowingly or intentionally violates
subsection (a)(41) and is a processor is guilty of a misdemeanor
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of the first degree.
(2) Any person who knowingly or intentionally violates
subsection (a)(41) and is not a processor is guilty of a
misdemeanor of the second degree.
SECTION 1. SECTION 4(1) OF THE ACT OF APRIL 14, 1972
(P.L.233, NO.64), KNOWN AS THE CONTROLLED SUBSTANCE, DRUG,
DEVICE AND COSMETIC ACT, IS AMENDED BY ADDING A SUBCLAUSE TO
READ:
SECTION 4. SCHEDULES OF CONTROLLED SUBSTANCES.--THE
FOLLOWING SCHEDULES INCLUDE THE CONTROLLED SUBSTANCES LISTED OR
TO BE LISTED BY WHATEVER OFFICIAL NAME, COMMON OR USUAL NAME,
CHEMICAL NAME, OR TRADE NAME DESIGNATED.
(1) SCHEDULE I--IN DETERMINING THAT A SUBSTANCE COMES WITHIN
THIS SCHEDULE, THE SECRETARY SHALL FIND: A HIGH POTENTIAL FOR
ABUSE, NO CURRENTLY ACCEPTED MEDICAL USE IN THE UNITED STATES,
AND A LACK OF ACCEPTED SAFETY FOR USE UNDER MEDICAL SUPERVISION.
THE FOLLOWING CONTROLLED SUBSTANCES ARE INCLUDED IN THIS
SCHEDULE:
* * *
(IX) ANY MATERIAL, COMPOUND, MIXTURE OR PREPARATION THAT
CONTAINS 7-HYDROXYMITRAGYNINE IN A CONCENTRATION EQUAL TO OR
EXCEEDING 2% OF THE TOTAL ALKALOID CONTENT OR 1 MILLIGRAM PER
RECOMMENDED SERVING SIZE, OR ANY SYNTHETIC, SEMI-SYNTHETIC OR
CHEMICALLY MANIPULATED FORM OF MITRAGYNINE, 7-
HYDROXYMITRAGYNINE, MITRAGYNINE PSEUDOINDOXYL OR ANY OTHER
SYNTHETIC, SEMI-SYNTHETIC OR CHEMICALLY MANIPULATED ALKALOID,
METABOLITE, DERIVATIVE OR ANALOGUE OF THE MITRAGYNA SPECIOSA
PLANT.
* * *
Section 2. This act shall take effect in 60 days.
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