A Bill for an Act
Page 1, Line 101Concerning the regulation of kratom.
Bill Summary
(Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov.)
Section 1 of the bill repeals certain provisions regarding the regulation of kratom that are included in sections 2 and 3 with amendments.
Section 2 prohibits a processor from manufacturing, packaging, labeling, or distributing in the state a food or dietary supplement that consists of kratom leaf or kratom leaf extract (kratom product) unless the manufacturer of the kratom product has obtained a registration of the kratom product (registration) from the executive director of the department of revenue (executive director). The manufacturer must pay a fee and provide proof of certain certificates and a registration from the federal food and drug administration to receive a registration for the kratom product from the executive director.
The executive director is required to establish an annual fee paid by manufacturers of kratom products that are manufactured, packaged, labeled, or distributed in the state. The fees are credited to the kratom consumer protection cash fund, which is created in section 2 and may be used by the executive director for the administration and enforcement of state laws regulating kratom.
A manufacturer of a kratom product that is manufactured, packaged, labeled, or distributed in the state without a registration is subject to a civil penalty of:
- No more than $1,000 for the first violation;
- No more than $5,000 for the second violation; and
- At least $5,000 and no more than $20,000 for a third or subsequent violation.
- Knowingly preparing, distributing, advertising, selling, or offering to sell a kratom product under certain circumstances;
- Preparing, distributing, advertising, selling, or offering to sell a kratom product that does not clearly and conspicuously set forth certain information on the kratom product's label;
- Displaying or storing kratom products in a retail location in a manner that will allow the products to be accessed by individuals under 21 years of age; or
- Manufacturing, packaging, labeling, or distributing a kratom product that contains synthesized or semi-synthesized kratom alkaloids or has a level of 7-hydroxymitragynine in the alkaloid fraction that is greater than 2% of the alkaloid composition of the product.
In the event of a third or subsequent violation, the manufacturer is prohibited from manufacturing or distributing kratom products in the state for 3 years after the date the civil penalty is assessed.
Section 3 prohibits a person from:
A person that conducts these prohibited activities engages in a deceptive trade practice.
This Unofficial Version Includes Committee
Amendments Not Yet Adopted on Second Reading
Page 2, Line 1Be it enacted by the General Assembly of the State of Colorado:
SECTION 1. In Colorado Revised Statutes, repeal 44-1-105.
Page 2, Line 2SECTION 2. In Colorado Revised Statutes, add article 15 to title 44 as follows:
Page 3, Line 1ARTICLE 15
Kratom Regulation
Page 3, Line 244-15-101. Definitions.As used in this article 15, unless the context otherwise requires:
Page 3, Line 3(1) "Adulterated" means the addition of fentanyl or any
Page 3, Line 4other controlled substance, a synthesized alkaloid or
Page 3, Line 5semi-synthesized alkaloid, or another substance prohibited by law.
Page 3, Line 6(2) "Alkaloid fraction" means a portion of a plant or plant extract that contains primarily alkaloid compounds.
Page 3, Line 7(3) "Controlled substance" means a substance listed in part 2 of article 18 of title 18.
Page 3, Line 8(4) "Fund" means the kratom consumer protection cash fund created in section 44-15-103 (2).
Page 3, Line 9(5) "Independent laboratory" means a laboratory that is
Page 3, Line 10accredited under the standards of the International
Page 3, Line 11Organization for Standardization 17025.2017 accreditation or
Page 3, Line 12from an accreditation body that is a signatory to the
Page 3, Line 13International Laboratory Accreditation Cooperation Mutual Recognition Arrangement.
Page 3, Line 14(6) "Kratom leaf" means the leaf of the Mitragyna
Page 3, Line 15speciosa plant, in fresh or dehydrated form, that is subject to no postharvest processing other than:
Page 3, Line 16(a) Drying or size reduction by cutting, milling, or other similar procedure; or
Page 3, Line 17(b) Cleaning or sterilization through the application of
Page 4, Line 1heat, steam, pressurization, irradiation, or other standard treatment applied to a food ingredient.
Page 4, Line 2(7) "Kratom leaf extract" means the material extracted
Page 4, Line 3from a kratom leaf through the application of a solvent
Page 4, Line 4consisting of water, ethanol, food-grade carbon dioxide, or
Page 4, Line 5another solvent allowed by federal or state law to be used in the manufacturing of a food ingredient.
Page 4, Line 6(8) "Kratom product" means a food or dietary supplement
Page 4, Line 7that consists of, or contains, kratom leaf or kratom leaf
Page 4, Line 8extract and does not include any synthesized alkaloids or semi-synthesized alkaloids.
Page 4, Line 9(9) "Processor" means a person that manufactures,
Page 4, Line 10packages, labels, or distributes kratom products or advertises
Page 4, Line 11or represents itself as a manufacturer, packager, labeler, or distributor of kratom products.
Page 4, Line 12(10) "Semi-synthesized alkaloid" means an alkaloid or
Page 4, Line 13alkaloid derivative contained in a kratom leaf extract that has
Page 4, Line 14been exposed to chemicals or processes that would confer a
Page 4, Line 15structural change in the alkaloids, such as oxidation,
Page 4, Line 16reduction, and ring opening and closing, resulting in material that has been chemically altered.
Page 4, Line 17(11) "Synthesized alkaloid" means an alkaloid or
Page 4, Line 18alkaloid derivative of the kratom leaf that has been created by
Page 4, Line 19chemical synthesis or biosynthetic means, including
Page 4, Line 20fermentation, recombinant techniques, yeast-derived
Page 4, Line 21techniques, and enzymatic techniques, rather than by
Page 4, Line 22traditional food preparation techniques such as heating or extracting.
Page 5, Line 144-15-102. Registration - suspension or revocation. (1) (a) A
Page 5, Line 2processor shall not manufacture, package, label, or distribute
Page 5, Line 3a kratom product in the state unless the manufacturer of the
Page 5, Line 4kratom product has obtained a registration of the kratom
Page 5, Line 5product from the executive director. A manufacturer may
Page 5, Line 6include in and obtain a single registration for multiple kratom
Page 5, Line 7products that contain the same kratom ingredients and that are
Page 5, Line 8in the same delivery form but that are in different containers, packages, or volumes.
Page 5, Line 9(b) A registration is valid for one year from the date of issuance by the executive director and is nontransferable.
Page 5, Line 10(2) The executive director shall not issue a registration
Page 5, Line 11for a kratom product unless the manufacturer pays the fee
Page 5, Line 12described in section 44-15-103 and provides to the executive director:
Page 5, Line 13(a) Proof of a current good manufacturing practices
Page 5, Line 14certificate from an auditor accredited by the American
Page 5, Line 15National Standards Institute (ANSI), or its successor
Page 5, Line 16organization, for any facility that manufactures the kratom product;
Page 5, Line 17(b) Proof of a current food facility registration from the
Page 5, Line 18federal food and drug administration for any facility that
Page 5, Line 19manufactures, packages, labels, or distributes the kratom product;
Page 5, Line 20(c) A copy of the kratom product's label to demonstrate
Page 5, Line 21compliance with section 6-1-737 (2)(b); and
Page 6, Line 1(d) Proof of a certificate of analysis from an independent
Page 6, Line 2laboratory confirming the alkaloid content of the kratom product, which certificate of analysis must confirm that:
Page 6, Line 3(I) The kratom product has a level of
Page 6, Line 47-hydroxymitragynine in the alkaloid fraction that is two
Page 6, Line 5percent or less of the alkaloid composition of the kratom product; and
Page 6, Line 6(II) There are no synthesized alkaloids or semi-synthesized alkaloids in the kratom product.
Page 6, Line 7(3) If the executive director receives evidence that a
Page 6, Line 8kratom product registered pursuant to this section may be
Page 6, Line 9adulterated in violation of section 6-1-737 (2)(a)(I), the
Page 6, Line 10executive director may require a third-party test of the kratom
Page 6, Line 11product by an independent laboratory chosen by the executive director.
Page 6, Line 12(4) (a) The executive director may suspend or revoke a
Page 6, Line 13registration issued pursuant to this section in the event of a violation of:
Page 6, Line 14(I) This section or the rules adopted pursuant to this section; or
Page 6, Line 15(II) Section 6-1-737.
Page 6, Line 16(b) A manufacturer that registers a kratom product
Page 6, Line 17pursuant to this section is responsible for the direct costs
Page 6, Line 18associated with a third-party test described in subsection (3) of
Page 6, Line 19this section or enforcement action related to the kratom
Page 6, Line 20product if the third-party test or enforcement action leads to
Page 6, Line 21the suspension or revocation of the kratom product's
Page 7, Line 1registration or the assessment of a civil penalty pursuant to section 44-15-104.
Page 7, Line 244-15-103. Annual fee - cash fund. (1) The executive
Page 7, Line 3director shall establish an annual fee paid by a manufacturer
Page 7, Line 4of a kratom product that is manufactured, packaged, labeled,
Page 7, Line 5or distributed in the state. The state treasurer shall credit the annual fees to the fund.
Page 7, Line 6(2) (a) The kratom consumer protection cash fund is
Page 7, Line 7created in the state treasury. The fund consists of annual fees
Page 7, Line 8credited to the fund pursuant to subsection (1) of this section,
Page 7, Line 9civil penalties credited to the fund pursuant to section 44-15-104
Page 7, Line 10(3), and any other money that the general assembly may appropriate or transfer to the fund.
Page 7, Line 11(b) The state treasurer shall credit all interest and
Page 7, Line 12income derived from the deposit and investment of money in the fund to the fund.
Page 7, Line 13(c) Subject to annual appropriation by the general
Page 7, Line 14assembly, the executive director may expend money from the fund for the administration and enforcement of this article 15.
Page 7, Line 1544-15-104. Civil penalty. (1) A manufacturer of a kratom
Page 7, Line 16product that is manufactured, packaged, labeled, or distributed
Page 7, Line 17in the state without a registration issued pursuant to section 44-15-102 (1) is subject to a civil penalty of:
Page 7, Line 18(a) No more than one thousand dollars for the first violation;
Page 7, Line 19(b) No more than five thousand dollars for the second
Page 7, Line 20violation; and
Page 8, Line 1(c) At least five thousand dollars and no more than twenty thousand dollars for a third or subsequent violation.
Page 8, Line 2(2) In the event of a third or subsequent violation, the
Page 8, Line 3manufacturer is prohibited from manufacturing or distributing
Page 8, Line 4kratom products in the state for three years after the date the civil penalty is assessed.
Page 8, Line 5(3) The state treasurer shall credit the civil penalties to the fund.
Page 8, Line 644-15-105. Compliance with federal law - rules. (1) A kratom
Page 8, Line 7product sold, offered for sale, or introduced into commerce in
Page 8, Line 8the state must be manufactured, packaged, labeled, and
Page 8, Line 9distributed in compliance with 21 CFR 111, as that part existed on July 1, 2025, or as updated by the executive director by rule.
Page 8, Line 10(2) A processor shall hold a current food facility registration from the federal food and drug administration.
Page 8, Line 1144-15-106. Rules.The executive director may adopt rules
Page 8, Line 12that are necessary for the administration and enforcement of this article 15.
Page 8, Line 1344-15-107. Local government regulation.Nothing in this
Page 8, Line 14article 15 or rules adopted by the executive director pursuant
Page 8, Line 15to this article 15 limits the ability of a local government to
Page 8, Line 16enact or enforce an ordinance, resolution, regulation, or other
Page 8, Line 17law relating to the manufacture, sale, offer for sale, transfer,
Page 8, Line 18possession, or use of any kratom product within the local
Page 8, Line 19government's jurisdiction so long as the local government
Page 8, Line 20ordinance, resolution, regulation, or law is no less restrictive
Page 8, Line 21than the requirements of this article 15.
Page 9, Line 1SECTION 3. In Colorado Revised Statutes, add 6-1-737 as follows:
Page 9, Line 26-1-737. Kratom - deceptive trade practice - definitions.
Page 9, Line 3(1) Unless the context otherwise requires, the definitions in section 44-15-101 apply to this section.
Page 9, Line 4(2) A person shall not:
Page 9, Line 5(a) Knowingly prepare, distribute, advertise, sell, or offer to sell a kratom product:
Page 9, Line 6(I) That is adulterated;
(II) To a person under twenty-one years of age;
Page 9, Line 7(III) That contains a level of 7-hydroxymitragynine in the
Page 9, Line 8alkaloid fraction that is greater than two percent of the alkaloid composition of the kratom product;
Page 9, Line 9(IV) That is a confection; mimics a candy product; or is
Page 9, Line 10manufactured, packaged, labeled, or distributed in a way that
Page 9, Line 11is appealing to children, including in the distinct shape of a human, an animal, or fruit; or
Page 9, Line 12(V) That is combustible or intended for vaporization;
Page 9, Line 13(b) Prepare, distribute, advertise, sell, or offer to sell a
Page 9, Line 14kratom product that does not have a label that clearly and conspicuously sets forth on each retail package:
Page 9, Line 15(I) The identity and address of any processor involved in
Page 9, Line 16manufacturing, packaging, labeling, or distributing the kratom product;
Page 9, Line 17(II) The full list of ingredients in the kratom product;
(III) A recommendation:
Page 9, Line 18(A) Against use by individuals who are under twenty-one years of age, pregnant, or breastfeeding; and
Page 10, Line 1(B) To consult a health-care professional prior to use;
(IV) An advisement that kratom may:
Page 10, Line 2(A) Be habit forming or create a risk of addiction; and
Page 10, Line 3(B) Interact with certain medications, drugs, and controlled substances;
Page 10, Line 4(V) The following statements:
Page 10, Line 5(A) "These statements have not been evaluated by the
Page 10, Line 6food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease."; and
Page 10, Line 7(B) "Keep out of reach of children."; and
(VI) Directions for use that include:
Page 10, Line 8(A) A recommended amount of the kratom product per serving;
Page 10, Line 9(B) The number of recommended servings per package;
Page 10, Line 10(C) A recommended number of servings of the kratom
Page 10, Line 11product that can be safely consumed in a twenty-four-hour period; and
Page 10, Line 12(D) Quantitative declarations of the amount of
Page 10, Line 13mitragynine and the amount of 7-hydroxymitragynine per serving of the kratom product;
Page 10, Line 14(c) Display or store kratom products in a retail location
Page 10, Line 15in a manner that will allow the products to be accessed by individuals under twenty-one years of age; or
Page 10, Line 16(d) Manufacture, package, label, or distribute a kratom product that:
Page 10, Line 17(I) Contains synthesized alkaloids or semi-synthesized alkaloids; or
Page 11, Line 1(II) Has a level of 7-hydroxymitragynine in the alkaloid
Page 11, Line 2fraction that is greater than two percent of the alkaloid composition of the product.
Page 11, Line 3(3) A person that conducts the activities described in
Page 11, Line 4subsection (2) of this section engages in a deceptive trade practice.
Page 11, Line 5SECTION 4. In Colorado Revised Statutes, 18-13-132, amend (3) as follows:
Page 11, Line 618-13-132. Furnishing kratom products to persons under
Page 11, Line 7twenty-one years of age. (3) As used in this section, "kratom product" has the meaning set forth in section
44-1-105 (1)Page 11, Line 8SECTION 5. Applicability. This act applies to conduct occurring on or after the effective date of this act.
Page 11, Line 9SECTION 6. Safety clause. The general assembly finds,
Page 11, Line 10determines, and declares that this act is necessary for the immediate
Page 11, Line 11preservation of the public peace, health, or safety or for appropriations for
Page 11, Line 12the support and maintenance of the departments of the state and state institutions.