An Act amending the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act, providing for regulation of kratom.

PRINTER'S NO. 2642
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 2058
Session of
2025
INTRODUCED BY KINKEAD, PROKOPIAK, SANCHEZ, HILL-EVANS, SAPPEY,
BOROWSKI, K.HARRIS, POWELL, DEASY, RADER, HADDOCK, GALLAGHER,
CONKLIN, PASHINSKI, SHUSTERMAN, BOYD, McANDREW, RIVERA,
ARMANINI AND CEPEDA-FREYTIZ, NOVEMBER 19, 2025
REFERRED TO COMMITTEE ON HEALTH, NOVEMBER 19, 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," providing for
regulation of kratom.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. 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 section to read:
Section 13.10. Regulation of Kratom.--(a) A processor or
retailer that sells, provides or distributes a kratom product in
this Commonwealth shall register with the department and renew
the registration annually. A processor or retailer that is not
registered with the department under this subsection may not
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sell, provide or distribute a kratom product in this
Commonwealth.
(b) The department shall establish fees for initial
registration and annual renewal, which shall be transmitted to
the Legislative Reference Bureau for publication in the next
available issue of the the Pennsylvania Bulletin. Fees collected
for initial registration and annual renewal under this
subsection shall be deposited into a restricted account within
the General Fund to be used exclusively by the Department of
Drug and Alcohol Programs for addiction treatment and recovery
services.
(c) A processor or retailer may not sell, provide or
distribute a kratom product:
(1) to an individual under 21 years of age; or
(2) that meets any of the following criteria:
(i) is mixed or packed with a nonkratom substance, which
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; or
(ii) contains a poisonous or otherwise deleterious nonkratom
ingredient, including:
(A) a controlled substance listed under section 4 or 28 Pa.
Code Ch. 25 Subch. A (relating to controlled substances, drugs,
devices and cosmetics); or
(B) a substance temporarily scheduled as a controlled
substance by the secretary under section 3(d);
(iii) contains a kratom extract with residual solvent levels
exceeding the standards specified in the most recent edition of
the United States Pharmacopeia (USP 48-NF 43) published as of
the effective date of this section;
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(iv) contains a level of 7-hydroxymitragynine in the
alkaloid fraction exceeding 2% of the total alkaloid composition
of the kratom product;
(v) contains a synthetic alkaloid, including synthetic
mitragynine, synthetic 7-hydroxymitragynine or any other
synthetically derived compound of the kratom plant; or
(vi) lacks adequate labeling of ingredients and directions
necessary for the safe and effective use of the kratom product
by a consumer in accordance with subsection (e).
(d) A processor or retailer may not sell, provide,
distribute or advertise a kratom product in a manner that is
attractive to children.
(e) A processor or retailer shall ensure that a kratom
product bears a label that includes, at a minimum, the following
information:
(1) The name and address of the processor responsible for
manufacturing, packaging, labeling or distributing the kratom
product.
(2) A complete list of ingredients and the quantity of each
ingredient in the kratom product.
(3) The following recommendations and advisories:
(i) The kratom product is not recommended for individuals
under 21 years of age, pregnant or breastfeeding.
(ii) Consultation with a health care professional is advised
before use of the kratom product.
(iii) Kratom may be habit-forming and may interact with
certain medications.
(iv) Kratom overdose may occur, with symptoms resembling
opioid overdose.
(4) Directions for use, including the recommended serving
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size, the maximum number of servings per 24-hour period and the
amount of mitragynine and 7-hydroxymitragynine per serving.
(5) The following disclosures regarding the information
under this subsection and the kratom product:
(i) "These statements have not been evaluated by the United
States Food and Drug Administration. This product is not
intended to diagnose, treat, cure or prevent any disease."
(ii) "Keep out of reach of children."
(6) Any other information deemed necessary by the
department.
(f) A retailer shall store kratom products in a manner that
restricts access to authorized personnel and prevents self-
service by consumers, including storing kratom products in an
area behind a counter at the retailer's place of business in a
secured display that is only accessible by authorized personnel.
(g) Before selling a kratom product to an individual who
appears to be under 35 years of age, a retailer shall verify the
individual's age using a transaction scan device or an
acceptable form of identification. Data collected from a
transaction scan device may not be sold or shared, except to
demonstrate compliance with this act to law enforcement.
(h) A retailer may not:
(1) sell, provide or distribute a kratom product from a
location visible from a school entity or licensed daycare
facility; or
(2) use illuminated signs or brightly colored advertisements
to promote kratom products.
(i) Within two years of the effective date of this section,
the department shall conduct a study on the effects and
addictiveness of kratom products and submit a report to the
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following:
(1) The chairperson and minority chairperson of the Health
and Human Services Committee of the Senate.
(2) The chairperson and minority chairperson of the Health
Committee of the House of Representatives.
(3) The chairperson and minority chairperson of the Human
Services Committee of the House of Representatives.
(j) Based on the conclusions of the report under subsection
(i), the department shall develop and implement an educational
campaign to inform residents of this Commonwealth about the
dangers associated with kratom use.
(k) As used in this section, the following words and phrases
shall have the meanings given to them in this subsection:
"Attractive to children." Any of the following:
(1) Use of images appealing to children, including cartoons,
toys, robots, real or fictional humans, fictional animals or
creatures or fruits and vegetables, except when accurately
describing ingredients or flavors, unless part of required
health warnings.
(2) Likeness to images, characters or phrases commonly used
to advertise to children.
(3) Imitation of packaging or labeling for candy, cereals,
sweets, chips or other food products typically marketed to
children.
(4) Use of the terms "candy," "candies" or variants such as
"kandy" or "kandee."
(5) Brand names or imitations of brand names of candies,
cereals, sweets, chips or other food products typically marketed
to children.
(6) Packaging or images easily confused with commercially
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available foods not containing kratom and typically marketed to
children.
(7) Any other feature that, under the totality of
circumstances, is likely to appeal to children.
"Food product." A food, food ingredient, dietary ingredient,
dietary supplement or beverage intended for human consumption.
"Kratom." The plant Mitragyna speciosa or any part thereof,
including all naturally occurring components.
"Kratom extract." A food product containing any part of a
leaf from Mitragyna speciosa that has been extracted and
concentrated to provide standardized dosing.
"Kratom product." A food product containing any part of a
leaf from Mitragyna speciosa or a kratom extract, manufactured
as a powder, capsule, pill, beverage or other edible form.
"Processor." A person who prepares or manufactures a kratom
product or who advertises or represents themselves 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 or holds oneself out as selling or
distributing a kratom product. The term does not include a
processor.
"School entity." A school district, intermediate unit, area
career and technical school, charter school, cyber charter
school or regional charter school.
"Transaction scan device." A device capable of deciphering,
in an electronically readable format, the information encoded on
the magnetic strip or bar code of an identification card.
Section 2. This act shall take effect in 60 days.
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