104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 HB3215 Introduced , by Rep. Marcus C. Evans, Jr. SYNOPSIS AS INTRODUCED: New Act Creates the Illinois Kratom Consumer Protection Act. Provides for procedures for kratom product registration, with certain requirements. Provides for labeling requirements for kratom products. Provides for enforcement and criminal and other penalties. Exempts a processor for any kratom products that has been reviewed and approved by the Department for safe consumption in combination with psychoactive compounds under clearly defined conditions of use. Exempts a retailer if it is shown by a preponderance of the evidence that the retailer relied in good faith upon the representations of certain entities. Requires the Department of Financial and Professional Regulation to adopt rules, with certain requirements. Conditions rulemaking upon federal promulgation of regulations in certain circumstances. Defines terms. LRB104 08737 BDA 18791 b A BILL FOR 104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 HB3215 Introduced , by Rep. Marcus C. Evans, Jr. SYNOPSIS AS INTRODUCED: New Act New Act Creates the Illinois Kratom Consumer Protection Act. Provides for procedures for kratom product registration, with certain requirements. Provides for labeling requirements for kratom products. Provides for enforcement and criminal and other penalties. Exempts a processor for any kratom products that has been reviewed and approved by the Department for safe consumption in combination with psychoactive compounds under clearly defined conditions of use. Exempts a retailer if it is shown by a preponderance of the evidence that the retailer relied in good faith upon the representations of certain entities. Requires the Department of Financial and Professional Regulation to adopt rules, with certain requirements. Conditions rulemaking upon federal promulgation of regulations in certain circumstances. Defines terms. LRB104 08737 BDA 18791 b LRB104 08737 BDA 18791 b A BILL FOR
104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 HB3215 Introduced , by Rep. Marcus C. Evans, Jr. SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Illinois Kratom Consumer Protection Act. Provides for procedures for kratom product registration, with certain requirements. Provides for labeling requirements for kratom products. Provides for enforcement and criminal and other penalties. Exempts a processor for any kratom products that has been reviewed and approved by the Department for safe consumption in combination with psychoactive compounds under clearly defined conditions of use. Exempts a retailer if it is shown by a preponderance of the evidence that the retailer relied in good faith upon the representations of certain entities. Requires the Department of Financial and Professional Regulation to adopt rules, with certain requirements. Conditions rulemaking upon federal promulgation of regulations in certain circumstances. Defines terms.
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A BILL FOR
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1 AN ACT concerning kratom.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 1. Short title. This Act may be cited as the
5 Illinois Kratom Consumer Protection Act.
6 Section 5. Definitions. As used in this Act:
7 "Attractive to children" means (i) in the shape of
8 cartoons or animals or (ii) in a form that bears any reasonable
9 resemblance to an existing candy product that is familiar to
10 the public as a widely distributed, branded food product such
11 that a product could be mistaken for the branded product,
12 especially by children.
13 "Department" means the Department of Financial and
14 Professional Regulation.
15 "Distributor" means a person that sells, prepares,
16 distributes, or maintains kratom products, or advertises,
17 represents, or holds itself out as selling, preparing, or
18 maintaining kratom products.
19 "Independent testing laboratory" means a laboratory that
20 is accredited by a third-party accrediting body as a competent
21 testing laboratory pursuant to ISO/IEC 17025 of the
22 International Organization for Standardization.
23 "Kratom" means the plant Mitragyna speciosa or any part of
104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026 HB3215 Introduced , by Rep. Marcus C. Evans, Jr. SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Illinois Kratom Consumer Protection Act. Provides for procedures for kratom product registration, with certain requirements. Provides for labeling requirements for kratom products. Provides for enforcement and criminal and other penalties. Exempts a processor for any kratom products that has been reviewed and approved by the Department for safe consumption in combination with psychoactive compounds under clearly defined conditions of use. Exempts a retailer if it is shown by a preponderance of the evidence that the retailer relied in good faith upon the representations of certain entities. Requires the Department of Financial and Professional Regulation to adopt rules, with certain requirements. Conditions rulemaking upon federal promulgation of regulations in certain circumstances. Defines terms.
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A BILL FOR
New Act
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1 that plant, including all components present in the natural
2 plant.
3 "Kratom extract" means a substance or compound obtained by
4 extraction of the Mitragyna speciosa leaf, intended for
5 ingestion, containing more than trace amounts of Mitragyna
6 speciosa and containing other alkaloids of the kratom plant,
7 which does not contain any controlled substances or levels of
8 residual solvents higher than is allowed in the U.S.
9 Pharmacopeia 467.
10 "Kratom food service establishment" means any person who
11 sells kratom as a beverage prepared on-site, or sells
12 pre-packaged kratom beverages or finished kratom products, at
13 a licensed food service establishment.
14 "Kratom product" means a food, food ingredient, dietary
15 ingredient, dietary supplement, or beverage intended for human
16 consumption which contains any part of the leaf of the plant
17 Mitragyna speciosa or an extract of the Mitragyna speciosa
18 leaf and is manufactured or served as a powder, capsule, pill,
19 beverage, liquid, or other edible form.
20 "Registrant" means a person or processor that sells,
21 prepares, manufactures, distributes, or maintains kratom
22 products, or advertises, represents, or holds itself out as
23 selling, preparing, or maintaining kratom products.
24 "Retailer" means any person that sells, distributes,
25 advertises, represents, or holds itself out as selling kratom
26 products.
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1 "Synthesized material" means an alkaloid or alkaloid
2 derivative that has been created by chemical synthesis or
3 biosynthetic means, including, but not limited to,
4 fermentation, recombinant techniques, yeast derived, or
5 enzymatic techniques, rather than traditional food preparation
6 techniques, such as heating or extracting that synthetically
7 alters the composition of any kratom alkaloid or constituent.
8 Section 10. Kratom Product Limitations. No person shall
9 prepare, distribute, sell, or expose for sale any of the
10 following:
11 (1) A product containing a level of
12 7-hydroxymitragynine in the alkaloid fraction that is
13 greater than 2% of the alkaloid composition of the kratom
14 product. Any product that contains a level of
15 7-hydroxymitragynine greater than the 2% limit as provided
16 in this paragraph cannot be marketed, labeled, or contain
17 any reference on its packaging, that it is a kratom
18 product or that it is derived from the alkaloid
19 mitragynine.
20 (2) A kratom product that is adulterated with a
21 dangerous non-kratom substance. A kratom product is
22 adulterated with a dangerous non-kratom substance if it
23 contains a poisonous or otherwise deleterious non-kratom
24 ingredient, including, but not limited to, the substances
25 listed as a controlled substances under State or federal
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1 law.
2 (3) A kratom product that contains dangerous
3 psychoactive compounds, which include, but are not limited
4 to, synthetic cannabinoids, synthetic cathinones, or any
5 other compound that significantly alters the safety
6 profile of the kratom product. A kratom product is mixed
7 with another compound that is known to inhibit key
8 cytochrome P450 enzymes, including CYP3A4 or CYP2D6 or a
9 combination of CYP3A4 and CYP2D6, shall be deemed to be
10 adulterated unless such specific product mixtures are
11 scientifically validated as safe under the intended
12 conditions of use and are specifically permitted by the
13 Department.
14 (4) A kratom product in any form that is combustible,
15 intended to be used for vaporization, or injectable.
16 (5) A product containing kratom that does not fall
17 into the definition of "kratom product" as defined in
18 Section 5 is prohibited.
19 (6) A kratom product that is manufactured in a manner
20 that is attractive to children.
21 (7) A kratom product that contains any synthesized
22 material as defined in Section 5 or that contains
23 alkaloids or other plant constituents that have been
24 isolated or manipulated to artificially increase their
25 potency, other than using the approved extraction method
26 provided herein, unless the manufacturer has safety data
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1 to support the increased potency according to the
2 conditions for use on the label in the populations the
3 data supports.
4 (8) A substance or compound obtained by extraction of
5 the Mitragyna speciosa leaf, intended for ingestion,
6 containing more than trace amounts of Mitragyna speciosa,
7 that contains levels of residual solvents higher than in
8 the definition of "kratom extract" in Section 5.
9 Section 15. Kratom product registration.
10 (a) The party responsible for placing a kratom product
11 into commerce in the State shall register annually to
12 offer for sale kratom products manufactured in an approved
13 kratom delivery form and pay a fee, adjusted annually, to
14 cover all administrative costs for processing and
15 administering such registrations, including the necessary
16 staff and the publication and maintenance of a kratom
17 registration webpage as provided in subsection (e) of this
18 Section.
19 (b) Parties seeking to register a product listed under
20 Section 10 shall be required to pay a fee based on the
21 costs the Department incurs to retain the services of
22 qualified experts to review the safety data provided by
23 the registrant to allow the Department to conduct a review
24 and make a final decision.
25 (c) The registration shall include the following sworn
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1 certifications from the processor:
2 (1) The kratom product was manufactured,
3 processed, or held in a facility that is in compliance
4 with current good manufacturing practices that meet
5 requirements of 21 CFR 111.
6 (2) A statement that the processor has a
7 reasonable basis that the product is safe for
8 consumption under the conditions of use set forth on
9 the label. The registrant assumes responsibility and
10 liability for any such products offered for sale.
11 (3) The submission of a certificate of analysis
12 from a certified independent third-party laboratory
13 showing compliance with the requirements of this Act
14 for residual solvents, 7-hydroxymitragynine content,
15 contaminants, and synthesized materials.
16 (d) A product that contains the same kratom
17 ingredients in the same kratom delivery form, but a
18 different container, package, or volume, shall be included
19 in a single registration.
20 (e) The Department shall publish and maintain a kratom
21 registration page on its official website listing all
22 currently registered kratom products for sale by retailers
23 that allows retailers to verify registered kratom products
24 they are permitted to sell to consumers.
25 Section 20. Labeling.
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1 A kratom product produced, manufactured, distributed,
2 offered, sold, or offered for sale shall have a label that
3 clearly and conspicuously provides all of the following
4 information on each retail package:
5 (1) A statement against the use by individuals who are
6 under 21 years of age, who are pregnant, or who are
7 breastfeeding.
8 (2) A recommendation to consult a health care
9 professional prior to use.
10 (3) A statement that kratom may be habit forming.
11 (4) The following statement: "These statements have
12 not been evaluated by the United States Food and Drug
13 Administration. This product is not intended to diagnose,
14 treat, cure, or prevent any disease."
15 (5) The name and the address for the place of business
16 of the registrant.
17 (6) Directions for use that include the following:
18 (A) A recommended amount of the kratom product per
19 serving that is (i) clearly described on the label for
20 product forms such as capsules, gummies, prepackaged
21 single serving units, and similar product forms; or
22 (ii) for beverages, liquids, or loose powders, a clear
23 instruction or a mark on the package or container that
24 clearly informs the consumer on the recommended
25 serving size.
26 (B) A recommended number of servings that can be
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1 safely consumed in a 24-hour period.
2 (C) A listing of the servings per container.
3 (D) A listing of kratom alkaloids and other
4 ingredients in the product, including quantitative
5 data not to exceed declarations of the amount per
6 serving of each of the following: (i) Mitragynine and
7 (ii) 7-hydroxymitragynine.
8 (E) A kratom food service establishment who sells
9 kratom as a beverage prepared on-site shall provide an
10 equivalent label in card form or prominently display
11 the required language in a location next to the
12 point-of-sale device to the customer at the time the
13 beverage is purchased by the consumer.
14 (F) Any kratom product that contains psychoactive
15 compounds otherwise permitted must be clearly labeled
16 with a full disclosure of all active ingredients, the
17 exact concentration of each compound, and adequate
18 warning statements about the potential interactions
19 and risks associated with the combined use of these
20 substances.
21 Section 25. Enforcement.
22 (a) A registrant is prohibited from selling any kratom
23 product that does not have a current registration with the
24 Department, a distributor is prohibited from distributing any
25 kratom product that does not have a current registration with
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1 the Department, and a retailer is prohibited from selling any
2 kratom product that does not have a current registration with
3 the Department. Any kratom product not registered shall be
4 seized and destroyed, and the costs associated with such
5 enforcement shall be assessed to the party responsible for its
6 availability for sale in the State.
7 (b) Kratom products that are intended for human ingestion
8 may not be sold in this State to a person who is under 21 years
9 of age. A person who knowingly and willfully violates this
10 subsection commits a Class B misdemeanor. A person who
11 knowingly and willfully commits a second or subsequent
12 violation of this subsection within one year after the initial
13 violation commits a Class A misdemeanor.
14 (c) A registrant that knowingly and willfully
15 manufactures, delivers, holds, offers for sale, distributes or
16 sells a kratom product that contains any controlled substance
17 listed in State or federal law shall be guilty of a Class 4
18 felony.
19 (d) A registrant that knowingly and willfully
20 manufactures, delivers, holds, offers for sale, distributes or
21 sells a kratom product that contains synthetic mitragynine,
22 synthetic 7-hydroxymitragynine, or any other synthetically
23 derived compound of the plant Mitragyna speciosa commits a
24 Class B misdemeanor. Any violation of this subsection shall
25 result in the immediate seizure and destruction of the
26 adulterated kratom products and may result in civil or
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1 criminal penalties as provided in State law. Repeat offenders
2 shall be subject to enhanced penalties, including permanent
3 revocation of licenses to sell or distribute kratom products.
4 (e) Upon receipt of a violation report on any kratom
5 product offered for sale, the Department shall require the
6 registrant to produce an updated and current certificate of
7 analysis in a reasonable time frame from a certified
8 independent third-party laboratory showing compliance with the
9 requirements of this Act for safe kratom products. If the
10 registrant does not provide the certificate of analysis in the
11 specified time frame, the registration for that product shall
12 be revoked and a stop sales order will be issued for products
13 covered by this registration.
14 (f) If the Department has a reasonable basis to require an
15 independent third-party test of a registered kratom product by
16 a laboratory of the Department's choice, the registrant shall
17 be required to submit payment for the test within a reasonable
18 time frame. If the registrant does not tender payment to the
19 Department within 30 days of receipt of the invoice for the
20 testing, the Department shall revoke the registration for that
21 product and a stop sales order will be issued for products
22 covered by this registration.
23 (g) A processor does not violate this Section for any
24 kratom product that has been reviewed and approved by the
25 Department for safe consumption in combination with
26 psychoactive compounds under clearly defined conditions of
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1 use.
2 (h) A retailer does not violate this Section if it is shown
3 by a preponderance of the evidence that the retailer relied in
4 good faith upon the representations of a manufacturer,
5 processor, packer, or distributor of food represented to be a
6 kratom product.
7 Section 30. Rules.
8 (a) The Department shall adopt rules to implement this
9 Act. The rules must provide for:
10 (1) The process for a registration of a kratom product
11 by a processor, distributor, or a retailer.
12 (2) The requirements for enforcing the restriction on
13 the sale of any kratom product to a person under the age of
14 21.
15 (3) Proof of appropriate quality testing from an ISO
16 17025 laboratory in the form of a Certificate of Analysis
17 representing the product does not contain levels of
18 residual solvents, biological contaminants or heavy metal
19 contaminants that meet the standard for dietary supplement
20 products.
21 (b) If at any time on or after the effective date of this
22 Act, the federal government or any department or agency
23 thereof, including but not limited to the federal Drug
24 Enforcement Agency or Food and Drug Administration, regulates
25 7-hydroxymitragynine, 7-hydroxymitragynine extracts,
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1 7-hydroxymitragynine products, any other derivative of the
2 plant Mitragyna speciosa, 7-hydroxymitragynine processors, or
3 7-hydroxymitragynine retailers, including the acceptance by
4 the Food and Drug Administration of a new dietary ingredient
5 notification, the Department of Financial and Professional
6 Regulation may adopt rules not inconsistent with such federal
7 regulations.
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