A Bill for an Act
Page 1, Line 101Concerning the regulation of kratom, and, in connection
Page 1, Line 102therewith, making an appropriation.
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:
Page 2, Line 2SECTION 1. Short title. The short title of this act is the "Daniel Bregger Act".
Page 3, Line 1SECTION 2. In Colorado Revised Statutes, repeal 44-1-105.
Page 3, Line 2SECTION 3. In Colorado Revised Statutes, add article 15 to title 44 as follows:
Page 3, Line 3ARTICLE 15
Kratom Regulation
Page 3, Line 444-15-101. Definitions.As used in this article 15, unless the context otherwise requires:
Page 3, Line 5(1) "Adulterated" means the addition of fentanyl or any
Page 3, Line 6other controlled substance, a synthesized alkaloid or
Page 3, Line 7semi-synthesized alkaloid, or another substance prohibited by law.
Page 3, Line 8(2) "Alkaloid fraction" means a portion of a plant or plant extract that contains primarily alkaloid compounds.
Page 3, Line 9(3) "Controlled substance" means a substance listed in part 2 of article 18 of title 18.
Page 3, Line 10(4) "Fund" means the kratom consumer protection cash fund created in section 44-15-103 (2).
Page 3, Line 11(5) "Independent laboratory" means a laboratory that is
Page 3, Line 12accredited under the standards of the International
Page 3, Line 13Organization for Standardization 17025.2017 accreditation or
Page 3, Line 14from an accreditation body that is a signatory to the
Page 3, Line 15International Laboratory Accreditation Cooperation Mutual Recognition Arrangement.
Page 3, Line 16(6) "Kratom leaf" means the leaf of the Mitragyna speciosa plant, in fresh, dehydrated, or dried form.
Page 4, Line 1(7) "Kratom leaf extract" means the material extracted
Page 4, Line 2from a kratom leaf through the application of a solvent
Page 4, Line 3consisting of water, ethanol, food-grade carbon dioxide, or
Page 4, Line 4another solvent allowed by federal or state law to be used in the manufacturing of a food ingredient.
Page 4, Line 5(8) "Kratom product" means a food or dietary supplement
Page 4, Line 6that consists of, or contains, any part of a kratom leaf, a
Page 4, Line 7kratom leaf extract, or any kratom alkaloid, kratom
Page 4, Line 8constituent, or kratom metabolite and does not include any synthesized alkaloids or semi-synthesized alkaloids.
Page 4, Line 9(9) (a) "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(b) "Processor" does not include a facility that prepares
Page 4, Line 13a kratom product on site and offers the kratom product for sale at the preparation site.
Page 4, Line 14(10) "Semi-synthesized alkaloid" means an alkaloid or
Page 4, Line 15alkaloid derivative contained in a kratom leaf extract that has
Page 4, Line 16been exposed to chemicals or processes that would confer a
Page 4, Line 17structural change in the alkaloids, such as oxidation,
Page 4, Line 18reduction, and ring opening and closing, resulting in material that has been chemically altered.
Page 4, Line 19(11) "Synthesized alkaloid" means an alkaloid or
Page 4, Line 20alkaloid derivative of the kratom leaf that has been created by
Page 4, Line 21chemical synthesis or biosynthetic means, including
Page 4, Line 22fermentation, recombinant techniques, yeast-derived
Page 5, Line 1techniques, and enzymatic techniques, rather than by
Page 5, Line 2traditional food preparation techniques such as heating or extracting.
Page 5, Line 344-15-102. Registration - suspension or revocation. (1) (a) A
Page 5, Line 4processor shall not manufacture, package, label, or distribute
Page 5, Line 5a kratom product in the state unless the manufacturer of the
Page 5, Line 6kratom product has obtained a registration of the kratom
Page 5, Line 7product from the executive director. A manufacturer may
Page 5, Line 8include in and obtain a single registration for multiple kratom
Page 5, Line 9products that contain the same kratom ingredients and that are
Page 5, Line 10in the same delivery form but that are in different containers, packages, or volumes.
Page 5, Line 11(b) A registration is valid for one year from the date of issuance by the executive director and is nontransferable.
Page 5, Line 12(2) The executive director shall not issue a registration
Page 5, Line 13for a kratom product unless the manufacturer pays the fee
Page 5, Line 14described in section 44-15-103 and provides to the executive director:
Page 5, Line 15(a) Proof of a current good manufacturing practices
Page 5, Line 16certificate from a third-party, independent auditor, indicating
Page 5, Line 17that the processor's operations are generally consistent with
Page 5, Line 18the federal food and drug administration's good manufacturing
Page 5, Line 19practice requirements specified in 21 CFR 111 or 117, as
Page 5, Line 20applicable and as those parts existed on July 1, 2025, for any facility that manufactures the kratom product;
Page 5, Line 21(b) Proof of a current food facility registration from the
Page 5, Line 22federal food and drug administration for any facility that manufactures, packages, labels, or holds the kratom product;
Page 6, Line 1(c) A copy of the kratom product's label to demonstrate compliance with section 6-1-737 (2)(b); and
Page 6, Line 2(d) Proof of a certificate of analysis from an independent
Page 6, Line 3laboratory confirming the alkaloid content of the kratom product, which certificate of analysis must:
Page 6, Line 4(I) Confirm that the kratom product has a level of
Page 6, Line 57-hydroxymitragynine in the alkaloid fraction that is two
Page 6, Line 6percent or less of the alkaloid composition of the kratom product; and
Page 6, Line 7(II) Include a statement from the processor certifying
Page 6, Line 8that there are no synthesized alkaloids or semi-synthesized alkaloids in the kratom product.
Page 6, Line 9(3) If the executive director receives evidence that a
Page 6, Line 10kratom product registered pursuant to this section may be
Page 6, Line 11adulterated in violation of section 6-1-737 (2)(a)(I), the
Page 6, Line 12executive director may require a third-party test of the kratom
Page 6, Line 13product by an independent laboratory chosen by the executive director.
Page 6, Line 14(4) (a) The executive director may suspend or revoke a
Page 6, Line 15registration issued pursuant to this section in the event of a violation of:
Page 6, Line 16(I) This section or the rules adopted pursuant to this section; or
Page 6, Line 17(II) Section 6-1-737.
Page 6, Line 18(b) A manufacturer that registers a kratom product
Page 6, Line 19pursuant to this section is responsible for the direct costs
Page 7, Line 1associated with a third-party test described in subsection (3) of
Page 7, Line 2this section or enforcement action related to the kratom
Page 7, Line 3product if the third-party test or enforcement action leads to
Page 7, Line 4the suspension or revocation of the kratom product's
Page 7, Line 5registration or the assessment of a civil penalty pursuant to section 44-15-104.
Page 7, Line 644-15-103. Annual fee - cash fund - loan - gifts, grants, and
Page 7, Line 7donations - repeal. (1) The executive director shall establish an
Page 7, Line 8annual fee paid by a manufacturer of a kratom product that is
Page 7, Line 9knowingly manufactured, packaged, labeled, or distributed in
Page 7, Line 10the state. The state treasurer shall credit the annual fees to the fund.
Page 7, Line 11(2) (a) The kratom consumer protection cash fund is
Page 7, Line 12created in the state treasury. The fund consists of annual fees
Page 7, Line 13credited to the fund pursuant to subsection (1) of this section,
Page 7, Line 14civil penalties credited to the fund pursuant to section 44-15-104
Page 7, Line 15(3), any amounts the department receives and transmits for
Page 7, Line 16deposit in the fund pursuant to subsection (4) of this section, and
Page 7, Line 17any other money that the general assembly may appropriate or
Page 7, Line 18transfer to the fund, including the amount transferred to the fund pursuant to subsection (3) of this section.
Page 7, Line 19(b) The state treasurer shall credit all interest and
Page 7, Line 20income derived from the deposit and investment of money in the fund to the fund.
Page 7, Line 21(c) Subject to annual appropriation by the general
Page 7, Line 22assembly, the executive director may expend money from the
Page 7, Line 23fund for the administration and enforcement of this article 15.
Page 8, Line 1(3) (a) (I) On July 1, 2025, or as soon as possible thereafter,
Page 8, Line 2the state treasurer shall transfer two hundred eighty
Page 8, Line 3thousand six hundred six dollars from the tobacco litigation
Page 8, Line 4settlement cash fund created in section 24-22-115 to the kratom
Page 8, Line 5consumer protection cash fund for the purpose of defraying
Page 8, Line 6expenses incurred by the department before it receives annual
Page 8, Line 7fees pursuant to subsection (1) of this section or any civil penalties pursuant to section 44-15-104 (3).
Page 8, Line 8(II) Notwithstanding any other law, state fiscal rule, or
Page 8, Line 9generally accepted accounting principle that could otherwise be interpreted to require a contrary conclusion:
Page 8, Line 10(A) The department may accept and expend any money transferred pursuant to this subsection (3);
Page 8, Line 11(B) The transfer required in subsection (3)(a)(I) of this
Page 8, Line 12section is a loan from the state treasurer to the department that is required to be repaid; and
Page 8, Line 13(C) The transfer required in subsection (3)(a)(I) of this
Page 8, Line 14section is not a grant for purposes of section 20 (2)(d) of article X of the state constitution or as defined in section 24-77-102 (7).
Page 8, Line 15(b) (I) As the department receives sufficient revenue in
Page 8, Line 16excess of expenses, the department shall repay the state
Page 8, Line 17treasurer for the principal amount of the loan plus
Page 8, Line 18accumulated interest as determined pursuant to subsection
Page 8, Line 19(3)(b)(II) of this section and shall fully repay the principal and interest on the loan no later than June 30, 2027.
Page 8, Line 20(II) Interest accrues on the money borrowed from the
Page 8, Line 21tobacco litigation settlement cash fund at a rate equivalent to
Page 9, Line 1the rate per annum on the most recently issued ten-year United
Page 9, Line 2States treasury note, rounded to the nearest one-tenth of one
Page 9, Line 3percent, as reported by the "Wall Street Journal", as of the
Page 9, Line 4date the transfer required by subsection (3)(a)(I) of this section
Page 9, Line 5is made. Interest accrues at the rate specified in this subsection
Page 9, Line 6(3)(b)(II) beginning on the date of the transfer until the date on
Page 9, Line 7which the total amount borrowed, including accrued interest, is repaid.
Page 9, Line 8(c) This subsection (3) is repealed, effective July 1, 2028.
Page 9, Line 9(4) The department may seek, accept, and expend gifts,
Page 9, Line 10grants, or donations from private or public sources for the
Page 9, Line 11purposes of this article 15. The department shall transmit all
Page 9, Line 12money received through gifts, grants, or donations to the state treasurer, who shall credit the money to the fund.
Page 9, Line 1344-15-104. Civil penalty. (1) A manufacturer of a kratom
Page 9, Line 14product that is manufactured, packaged, labeled, or distributed
Page 9, Line 15in the state without a registration issued pursuant to section 44-15-102 (1) is subject to a civil penalty of:
Page 9, Line 16(a) No more than one thousand dollars for the first violation;
Page 9, Line 17(b) No more than five thousand dollars for the second violation; and
Page 9, Line 18(c) At least five thousand dollars and no more than twenty thousand dollars for a third or subsequent violation.
Page 9, Line 19(2) In the event of a third or subsequent violation, the
Page 9, Line 20manufacturer is prohibited from manufacturing or distributing
Page 9, Line 21kratom products in the state for three years after the date the civil penalty is assessed.
Page 10, Line 1(3) The state treasurer shall credit the civil penalties to the fund.
Page 10, Line 244-15-105. Compliance with federal law - rules. (1) A kratom
Page 10, Line 3product sold, offered for sale, or introduced into commerce in
Page 10, Line 4the state must be manufactured, packaged, labeled, and
Page 10, Line 5distributed in compliance with 21 CFR 111 or 117, as those parts
Page 10, Line 6existed on July 1, 2025, or as updated by the executive director by rule.
Page 10, Line 7(2) A person that manufactures, packages, labels, or
Page 10, Line 8holds a kratom product to be distributed in the state shall hold
Page 10, Line 9a current food facility registration from the federal food and drug administration.
Page 10, Line 1044-15-106. Rules.The executive director may adopt rules
Page 10, Line 11that are necessary for the administration and enforcement of this article 15.
Page 10, Line 1244-15-107. Local government regulation.Nothing in this
Page 10, Line 13article 15 or rules adopted by the executive director pursuant
Page 10, Line 14to this article 15 limits the ability of a local government to
Page 10, Line 15enact or enforce an ordinance, resolution, regulation, or other
Page 10, Line 16law relating to the manufacture, sale, offer for sale, transfer,
Page 10, Line 17possession, or use of any kratom product within the local
Page 10, Line 18government's jurisdiction so long as the local government
Page 10, Line 19ordinance, resolution, regulation, or law is no less restrictive than the requirements of this article 15.
Page 10, Line 20SECTION 4. In Colorado Revised Statutes, add 6-1-737 as
Page 10, Line 21follows:
Page 11, Line 16-1-737. Kratom - deceptive trade practice - definitions.
Page 11, Line 2(1) Unless the context otherwise requires, the definitions in section 44-15-101 apply to this section.
Page 11, Line 3(2) A person shall not:
Page 11, Line 4(a) Knowingly prepare, distribute, advertise, sell, or offer to sell a kratom product:
Page 11, Line 5(I) That is adulterated;
(II) To a person under twenty-one years of age;
Page 11, Line 6(III) That contains a level of 7-hydroxymitragynine in the
Page 11, Line 7alkaloid fraction that is greater than two percent of the alkaloid composition of the kratom product;
Page 11, Line 8(IV) That is a confection; mimics a candy product; or is
Page 11, Line 9manufactured, packaged, labeled, or distributed in a way that
Page 11, Line 10is appealing to children, including in the distinct shape of a human, an animal, or fruit; or
Page 11, Line 11(V) That is combustible or intended for vaporization;
Page 11, Line 12(b) Prepare, distribute, advertise, sell, or offer to sell a
Page 11, Line 13kratom product that does not have a label that clearly and conspicuously sets forth on each retail package:
Page 11, Line 14(I) The name and address for the place of business of the manufacturer or distributor of the kratom product;
Page 11, Line 15(II) The full list of ingredients in the kratom product;
(III) Disclosure and advice:
Page 11, Line 16(A) Against use by individuals who are under twenty-one years of age, pregnant, or breastfeeding; and
Page 11, Line 17(B) To consult a health-care professional prior to use;
Page 11, Line 18(C) That kratom may be habit forming; and
Page 12, Line 1(D) That kratom may interact with certain medications, drugs, and controlled substances;
Page 12, Line 2(IV) The following statements:
Page 12, Line 3(A) "These statements have not been evaluated by the
Page 12, Line 4food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease."; and
Page 12, Line 5(B) "Keep out of reach of children."; and
(V) Directions for use that include:
Page 12, Line 6(A) A recommended amount of the kratom product per serving;
Page 12, Line 7(B) The number of recommended servings per package;
Page 12, Line 8(C) A recommended number of servings of the kratom
Page 12, Line 9product that can be safely consumed in a twenty-four-hour period; and
Page 12, Line 10(D) Quantitative declarations of the amount of
Page 12, Line 11mitragynine and the amount of 7-hydroxymitragynine per serving of the kratom product;
Page 12, Line 12(c) Display or store kratom products in a retail location
Page 12, Line 13in a manner that will allow the products to be accessed by individuals under twenty-one years of age; or
Page 12, Line 14(d) Manufacture, package, label, or distribute a kratom product that:
Page 12, Line 15(I) Contains synthesized alkaloids or semi-synthesized alkaloids; or
Page 12, Line 16(II) Has a level of 7-hydroxymitragynine in the alkaloid
Page 12, Line 17fraction that is greater than two percent of the alkaloid
Page 12, Line 18composition of the product.
Page 13, Line 1(3) A person that conducts the activities described in
Page 13, Line 2subsection (2) of this section engages in a deceptive trade practice.
Page 13, Line 3SECTION 5. In Colorado Revised Statutes, 18-13-132, amend (3) as follows:
Page 13, Line 418-13-132. Furnishing kratom products to persons under
Page 13, Line 5twenty-one years of age. (3) As used in this section, "kratom product" has the meaning set forth in section
44-1-105 (1)Page 13, Line 6SECTION 6. In Colorado Revised Statutes, 24-22-115, add (6) as follows:
Page 13, Line 724-22-115. Tobacco litigation settlement cash fund -
Page 13, Line 8health-care supplemental appropriations and overexpenditures
Page 13, Line 9account - creation - repeal. (6) (a) On July 1, 2025, or as soon as
Page 13, Line 10possible thereafter, the state treasurer shall transfer two
Page 13, Line 11hundred eighty thousand six hundred six dollars from the
Page 13, Line 12tobacco litigation settlement cash fund created in this section
Page 13, Line 13to the kratom consumer protection cash fund created in section
Page 13, Line 1444-15-103 (2). The amount transferred pursuant to this
Page 13, Line 15subsection (6) is a loan from the state treasurer to the
Page 13, Line 16department of revenue that is required to be repaid in accordance with section 44-15-103 (3)(b).
Page 13, Line 17(b) This subsection (6) is repealed, effective July 1, 2028.
Page 13, Line 18SECTION 7. In Colorado Revised Statutes, 24-75-1104.5, amend (1.7) introductory portion; and add (10) as follows:
Page 13, Line 1924-75-1104.5. Use of settlement money - programs - repeal.
Page 13, Line 20(1.7) Except as otherwise provided in subsections (1.3), (1.8),
andPage 13, Line 21and (10) of this section, and except that disputed payments received by
Page 14, Line 1the state in the 2015-16 fiscal year or in any year thereafter are excluded
Page 14, Line 2from the calculation of allocations pursuant to this subsection (1.7), for
Page 14, Line 3the 2016-17 fiscal year and for each fiscal year thereafter, the following
Page 14, Line 4programs, services, and funds receive the following specified percentages
Page 14, Line 5of the total amount of settlement money received by the state in the preceding fiscal year:
Page 14, Line 6(10) (a) For the 2025-26 fiscal year, the total amount of
Page 14, Line 7settlement money received by the state in the preceding fiscal
Page 14, Line 8year shall be reduced by two hundred eighty thousand six
Page 14, Line 9hundred six dollars before the calculation of allocations
Page 14, Line 10under subsection (1.7) of this section, which amount shall be transferred in accordance with section 24-22-115 (6).
Page 14, Line 11(b) This subsection (10) is repealed, effective July 1, 2026.
Page 14, Line 12SECTION 8. Appropriation. (1) For the 2025-26 state fiscal
Page 14, Line 13year, $280,606 is appropriated to the department of revenue. This
Page 14, Line 14appropriation is from the kratom consumer protection cash fund created
Page 14, Line 15in section 44-15-103 (2)(a), C.R.S. To implement this act, the department may use this appropriation as follows:
Page 14, Line 16(a) $103,108 for use by the kratom division for personal services,
Page 14, Line 17which amount is based on an assumption that the division will require an additional 1.3 FTE;
Page 14, Line 18(b) $33,059 for use by the kratom division for operating expenses; and
Page 14, Line 19(c) $144,439 for the purchase of legal services.
Page 14, Line 20(2) For the 2025-26 state fiscal year, $144,439 is appropriated to
Page 14, Line 21the department of law. This appropriation is from reappropriated funds
Page 14, Line 22received from the department of revenue under subsection (1)(c) of this
Page 15, Line 1section and is based on an assumption that the department of law will
Page 15, Line 2require an additional 0.6 FTE. To implement this act, the department of
Page 15, Line 3law may use this appropriation to provide legal services for the department of revenue.
Page 15, Line 4SECTION 9. Applicability. This act applies to conduct occurring on or after the effective date of this act.
Page 15, Line 5SECTION 10. Safety clause. The general assembly finds,
Page 15, Line 6determines, and declares that this act is necessary for the immediate
Page 15, Line 7preservation of the public peace, health, or safety or for appropriations for
Page 15, Line 8the support and maintenance of the departments of the state and state institutions.