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.
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
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 registration is valid for
Page 5, Line 6one year from the date of issuance by the executive director and is nontransferable.
Page 5, Line 7(2) The executive director shall not issue a registration
Page 5, Line 8for a kratom product unless the manufacturer pays the fee
Page 5, Line 9described in section 44-15-103 and provides to the executive director:
Page 5, Line 10(a) Proof of a current good manufacturing practices
Page 5, Line 11certificate from the American National Standards Institute
Page 5, Line 12(ANSI), or its successor organization, for any facility that manufactures the kratom product;
Page 5, Line 13(b) Proof of a current food facility registration from the
Page 5, Line 14federal food and drug administration for any facility that
Page 5, Line 15manufactures, packages, labels, or distributes the kratom product;
Page 5, Line 16(c) A copy of the kratom product's label to demonstrate compliance with section 6-1-737 (2)(b); and
Page 5, Line 17(d) Proof of a certificate of analysis from an independent
Page 5, Line 18laboratory confirming the alkaloid content of the kratom product, which certificate of analysis must confirm that:
Page 5, Line 19(I) The kratom product has a level of
Page 5, Line 207-hydroxymitragynine in the alkaloid fraction that is two
Page 6, Line 1percent or less of the alkaloid composition of the kratom product; and
Page 6, Line 2(II) There are no synthesized alkaloids or semi-synthesized alkaloids in the kratom product.
Page 6, Line 3(3) If the executive director receives evidence that a
Page 6, Line 4kratom product registered pursuant to this section may be
Page 6, Line 5adulterated in violation of section 6-1-737 (2)(a)(I), the
Page 6, Line 6executive director may require a third-party test of the kratom
Page 6, Line 7product by an independent laboratory chosen by the executive director.
Page 6, Line 8(4) (a) The executive director may suspend or revoke a
Page 6, Line 9registration issued pursuant to this section in the event of a violation of:
Page 6, Line 10(I) This section or the rules adopted pursuant to this section; or
Page 6, Line 11(II) Section 6-1-737.
Page 6, Line 12(b) A manufacturer that registers a kratom product
Page 6, Line 13pursuant to this section is responsible for the direct costs
Page 6, Line 14associated with a third-party test described in subsection (3) of
Page 6, Line 15this section or enforcement action related to the kratom
Page 6, Line 16product if the third-party test or enforcement action leads to
Page 6, Line 17the suspension or revocation of the kratom product's
Page 6, Line 18registration or the assessment of a civil penalty pursuant to section 44-15-104.
Page 6, Line 1944-15-103. Annual fee - cash fund. (1) The executive
Page 6, Line 20director shall establish an annual fee paid by a manufacturer
Page 6, Line 21of a kratom product that is manufactured, packaged, labeled,
Page 7, Line 1or distributed in the state. The state treasurer shall credit the annual fees to the fund.
Page 7, Line 2(2) (a) The kratom consumer protection cash fund is
Page 7, Line 3created in the state treasury. The fund consists of annual fees
Page 7, Line 4credited to the fund pursuant to subsection (1) of this section,
Page 7, Line 5civil penalties credited to the fund pursuant to section 44-15-104
Page 7, Line 6(3), and any other money that the general assembly may appropriate or transfer to the fund.
Page 7, Line 7(b) The state treasurer shall credit all interest and
Page 7, Line 8income derived from the deposit and investment of money in the fund to the fund.
Page 7, Line 9(c) Subject to annual appropriation by the general
Page 7, Line 10assembly, the executive director may expend money from the fund for the administration and enforcement of this article 15.
Page 7, Line 1144-15-104. Civil penalty. (1) A manufacturer of a kratom
Page 7, Line 12product that is manufactured, packaged, labeled, or distributed
Page 7, Line 13in the state without a registration issued pursuant to section 44-15-102 (1) is subject to a civil penalty of:
Page 7, Line 14(a) No more than one thousand dollars for the first violation;
Page 7, Line 15(b) No more than five thousand dollars for the second violation; and
Page 7, Line 16(c) At least five thousand dollars and no more than twenty thousand dollars for a third or subsequent violation.
Page 7, Line 17(2) In the event of a third or subsequent violation, the
Page 7, Line 18manufacturer is prohibited from manufacturing or distributing
Page 7, Line 19kratom products in the state for three years after the date the civil penalty is assessed.
Page 8, Line 1(3) The state treasurer shall credit the civil penalties to the fund.
Page 8, Line 244-15-105. Compliance with federal law - rules. (1) A kratom
Page 8, Line 3product sold, offered for sale, or introduced into commerce in
Page 8, Line 4the state must be manufactured, packaged, labeled, and
Page 8, Line 5distributed 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 6(2) A processor shall hold a current food facility registration from the federal food and drug administration.
Page 8, Line 744-15-106. Rules.The executive director may adopt rules
Page 8, Line 8that are necessary for the administration and enforcement of this article 15.
Page 8, Line 9SECTION 3. In Colorado Revised Statutes, add 6-1-737 as follows:
Page 8, Line 106-1-737. Kratom - deceptive trade practice - definitions.
Page 8, Line 11(1) Unless the context otherwise requires, the definitions in section 44-15-101 apply to this section.
Page 8, Line 12(2) A person shall not:
Page 8, Line 13(a) Knowingly prepare, distribute, advertise, sell, or offer to sell a kratom product:
Page 8, Line 14(I) That is adulterated;
(II) To a person under twenty-one years of age;
Page 8, Line 15(III) That contains a level of 7-hydroxymitragynine in the
Page 8, Line 16alkaloid fraction that is greater than two percent of the alkaloid composition of the kratom product;
Page 8, Line 17(IV) That is a confection; mimics a candy product; or is
Page 9, Line 1manufactured, packaged, labeled, or distributed in a way that
Page 9, Line 2is appealing to children, including in the distinct shape of a human, an animal, or fruit; or
Page 9, Line 3(V) That is combustible or intended for vaporization;
Page 9, Line 4(b) Prepare, distribute, advertise, sell, or offer to sell a
Page 9, Line 5kratom product that does not have a label that clearly and conspicuously sets forth on each retail package:
Page 9, Line 6(I) The identity and address of any processor involved in
Page 9, Line 7manufacturing, packaging, labeling, or distributing the kratom product;
Page 9, Line 8(II) The full list of ingredients in the kratom product;
(III) A recommendation:
Page 9, Line 9(A) Against use by individuals who are under twenty-one years of age, pregnant, or breastfeeding; and
Page 9, Line 10(B) To consult a health-care professional prior to use;
(IV) An advisement that kratom may:
Page 9, Line 11(A) Be habit forming; and
(B) Interact with certain medications;
Page 9, Line 12(V) The following statement: "These statements have not
Page 9, Line 13been evaluated by the United States food and drug
Page 9, Line 14administration. This product is not intended to diagnose, treat, cure, or prevent any disease."; and
Page 9, Line 15(VI) Directions for use that include:
Page 9, Line 16(A) A recommended amount of the kratom product per serving;
Page 9, Line 17(B) A recommended number of servings of the kratom
Page 9, Line 18product that can be safely consumed in a twenty-four-hour period; and
Page 10, Line 1(C) Quantitative declarations of the amount of
Page 10, Line 2mitragynine and the amount of 7-hydroxymitragynine per serving of the kratom product;
Page 10, Line 3(c) Display or store kratom products in a retail location
Page 10, Line 4in a manner that will allow the products to be accessed by individuals under twenty-one years of age; or
Page 10, Line 5(d) Manufacture, package, label, or distribute a kratom product that:
Page 10, Line 6(I) Contains synthesized alkaloids or semi-synthesized alkaloids; or
Page 10, Line 7(II) Has a level of 7-hydroxymitragynine in the alkaloid
Page 10, Line 8fraction that is greater than two percent of the alkaloid composition of the product.
Page 10, Line 9(3) A person that conducts the activities described in
Page 10, Line 10subsection (2) of this section engages in a deceptive trade practice.
Page 10, Line 11SECTION 4. In Colorado Revised Statutes, 18-13-132, amend (3) as follows:
Page 10, Line 1218-13-132. Furnishing kratom products to persons under
Page 10, Line 13twenty-one years of age. (3) As used in this section, "kratom product" has the meaning set forth in section
44-1-105 (1)Page 10, Line 14SECTION 5. Applicability. This act applies to conduct occurring on or after the effective date of this act.
Page 10, Line 15SECTION 6. Safety clause. The general assembly finds,
Page 10, Line 16determines, and declares that this act is necessary for the immediate
Page 10, Line 17preservation of the public peace, health, or safety or for appropriations for
Page 11, Line 1the support and maintenance of the departments of the state and state institutions.