HB 2058 — 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
 1   Amending the act of April 14, 1972 (P.L.233, No.64), entitled
 2      "An act relating to the manufacture, sale and possession of
 3      controlled substances, other drugs, devices and cosmetics;
 4      conferring powers on the courts and the secretary and
 5      Department of Health, and a newly created Pennsylvania Drug,
 6      Device and Cosmetic Board; establishing schedules of
 7      controlled substances; providing penalties; requiring
 8      registration of persons engaged in the drug trade and for the
 9      revocation or suspension of certain licenses and
10      registrations; and repealing an act," providing for
11      regulation of kratom.
12      The General Assembly of the Commonwealth of Pennsylvania
13   hereby enacts as follows:
14      Section 1.    The act of April 14, 1972 (P.L.233, No.64), known
15   as The Controlled Substance, Drug, Device and Cosmetic Act, is
16   amended by adding a section to read:
17      Section 13.10.    Regulation of Kratom.--(a)   A processor or
18   retailer that sells, provides or distributes a kratom product in
19   this Commonwealth shall register with the department and renew
20   the registration annually. A processor or retailer that is not
21   registered with the department under this subsection may not
 1   sell, provide or distribute a kratom product in this
 2   Commonwealth.
 3      (b)    The department shall establish fees for initial
 4   registration and annual renewal, which shall be transmitted to
 5   the Legislative Reference Bureau for publication in the next
 6   available issue of the the Pennsylvania Bulletin. Fees collected
 7   for initial registration and annual renewal under this
 8   subsection shall be deposited into a restricted account within
 9   the General Fund to be used exclusively by the Department of
10   Drug and Alcohol Programs for addiction treatment and recovery
11   services.
12      (c)    A processor or retailer may not sell, provide or
13   distribute a kratom product:
14      (1)    to an individual under 21 years of age; or
15      (2)    that meets any of the following criteria:
16      (i)    is mixed or packed with a nonkratom substance, which
17   affects the quality or strength of the kratom product to such a
18   degree as to render the kratom product injurious to a consumer
19   of the kratom product; or
20      (ii)     contains a poisonous or otherwise deleterious nonkratom
21   ingredient, including:
22      (A)    a controlled substance listed under section 4 or 28 Pa.
23   Code Ch. 25 Subch. A (relating to controlled substances, drugs,
24   devices and cosmetics); or
25      (B)    a substance temporarily scheduled as a controlled
26   substance by the secretary under section 3(d);
27      (iii)    contains a kratom extract with residual solvent levels
28   exceeding the standards specified in the most recent edition of
29   the United States Pharmacopeia (USP 48-NF 43) published as of
30   the effective date of this section;

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 1      (iv)     contains a level of 7-hydroxymitragynine in the
 2   alkaloid fraction exceeding 2% of the total alkaloid composition
 3   of the kratom product;
 4      (v)     contains a synthetic alkaloid, including synthetic
 5   mitragynine, synthetic 7-hydroxymitragynine or any other
 6   synthetically derived compound of the kratom plant; or
 7      (vi)     lacks adequate labeling of ingredients and directions
 8   necessary for the safe and effective use of the kratom product
 9   by a consumer in accordance with subsection (e).
10      (d)     A processor or retailer may not sell, provide,
11   distribute or advertise a kratom product in a manner that is
12   attractive to children.
13      (e)     A processor or retailer shall ensure that a kratom
14   product bears a label that includes, at a minimum, the following
15   information:
16      (1)     The name and address of the processor responsible for
17   manufacturing, packaging, labeling or distributing the kratom
18   product.
19      (2)     A complete list of ingredients and the quantity of each
20   ingredient in the kratom product.
21      (3)     The following recommendations and advisories:
22      (i)     The kratom product is not recommended for individuals
23   under 21 years of age, pregnant or breastfeeding.
24      (ii)     Consultation with a health care professional is advised
25   before use of the kratom product.
26      (iii)     Kratom may be habit-forming and may interact with
27   certain medications.
28      (iv)     Kratom overdose may occur, with symptoms resembling
29   opioid overdose.
30      (4)     Directions for use, including the recommended serving

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 1   size, the maximum number of servings per 24-hour period and the
 2   amount of mitragynine and 7-hydroxymitragynine per serving.
 3      (5)    The following disclosures regarding the information
 4   under this subsection and the kratom product:
 5      (i)    "These statements have not been evaluated by the United
 6   States Food and Drug Administration. This product is not
 7   intended to diagnose, treat, cure or prevent any disease."
 8      (ii)    "Keep out of reach of children."
 9      (6)    Any other information deemed necessary by the
10   department.
11      (f)    A retailer shall store kratom products in a manner that
12   restricts access to authorized personnel and prevents self-
13   service by consumers, including storing kratom products in an
14   area behind a counter at the retailer's place of business in a
15   secured display that is only accessible by authorized personnel.
16      (g)    Before selling a kratom product to an individual who
17   appears to be under 35 years of age, a retailer shall verify the
18   individual's age using a transaction scan device or an
19   acceptable form of identification. Data collected from a
20   transaction scan device may not be sold or shared, except to
21   demonstrate compliance with this act to law enforcement.
22      (h)    A retailer may not:
23      (1)    sell, provide or distribute a kratom product from a
24   location visible from a school entity or licensed daycare
25   facility; or
26      (2)    use illuminated signs or brightly colored advertisements
27   to promote kratom products.
28      (i)    Within two years of the effective date of this section,
29   the department shall conduct a study on the effects and
30   addictiveness of kratom products and submit a report to the

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 1   following:
 2      (1)   The chairperson and minority chairperson of the Health
 3   and Human Services Committee of the Senate.
 4      (2)   The chairperson and minority chairperson of the Health
 5   Committee of the House of Representatives.
 6      (3)   The chairperson and minority chairperson of the Human
 7   Services Committee of the House of Representatives.
 8      (j)   Based on the conclusions of the report under subsection
 9   (i), the department shall develop and implement an educational
10   campaign to inform residents of this Commonwealth about the
11   dangers associated with kratom use.
12      (k)   As used in this section, the following words and phrases
13   shall have the meanings given to them in this subsection:
14      "Attractive to children."   Any of the following:
15      (1)   Use of images appealing to children, including cartoons,
16   toys, robots, real or fictional humans, fictional animals or
17   creatures or fruits and vegetables, except when accurately
18   describing ingredients or flavors, unless part of required
19   health warnings.
20      (2)   Likeness to images, characters or phrases commonly used
21   to advertise to children.
22      (3)   Imitation of packaging or labeling for candy, cereals,
23   sweets, chips or other food products typically marketed to
24   children.
25      (4)   Use of the terms "candy," "candies" or variants such as
26   "kandy" or "kandee."
27      (5)   Brand names or imitations of brand names of candies,
28   cereals, sweets, chips or other food products typically marketed
29   to children.
30      (6)   Packaging or images easily confused with commercially

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 1   available foods not containing kratom and typically marketed to
 2   children.
 3      (7)   Any other feature that, under the totality of
 4   circumstances, is likely to appeal to children.
 5      "Food product."    A food, food ingredient, dietary ingredient,
 6   dietary supplement or beverage intended for human consumption.
 7      "Kratom."    The plant Mitragyna speciosa or any part thereof,
 8   including all naturally occurring components.
 9      "Kratom extract."    A food product containing any part of a
10   leaf from Mitragyna speciosa that has been extracted and
11   concentrated to provide standardized dosing.
12      "Kratom product."    A food product containing any part of a
13   leaf from Mitragyna speciosa or a kratom extract, manufactured
14   as a powder, capsule, pill, beverage or other edible form.
15      "Processor."    A person who prepares or manufactures a kratom
16   product or who advertises or represents themselves as preparing
17   or manufacturing a kratom product. The term does not include a
18   retailer.
19      "Retailer."    A person who sells or distributes a kratom
20   product or who advertises or holds oneself out as selling or
21   distributing a kratom product. The term does not include a
22   processor.
23      "School entity."    A school district, intermediate unit, area
24   career and technical school, charter school, cyber charter
25   school or regional charter school.
26      "Transaction scan device."    A device capable of deciphering,
27   in an electronically readable format, the information encoded on
28   the magnetic strip or bar code of an identification card.
29      Section 2.    This act shall take effect in 60 days.



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