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:
Page 2, Line 2SECTION 1. Short title. The short title of this act is the "Daniel
Page 2, Line 3Bregger Act".
Page 3, Line 1SECTION 2. In Colorado Revised Statutes, add 6-1-737 as follows:
Page 3, Line 26-1-737. Kratom - deceptive trade practice - definitions.
Page 3, Line 3(1) As used in this section, unless the context otherwise requires:
Page 3, Line 4(a) "Adulterated" means the addition of fentanyl or any
Page 3, Line 5other controlled substance, a synthesized alkaloid or
Page 3, Line 6semi-synthesized alkaloid, or another substance prohibited by law.
Page 3, Line 7(b) "Alkaloid fraction" means a portion of a plant or plant extract that contains primarily alkaloid compounds.
Page 3, Line 8(c) "Controlled substance" means a substance listed in part 2 of article 18 of title 18.
Page 3, Line 9(d) "Kratom leaf" means the leaf of the Mitragyna speciosa plant, in fresh, dehydrated, or dried form.
Page 3, Line 10(e) "Kratom leaf extract" means the material extracted
Page 3, Line 11from a kratom leaf through the application of a solvent
Page 3, Line 12consisting of water, ethanol, food-grade carbon dioxide, or
Page 3, Line 13another solvent allowed by federal or state law to be used in the manufacturing of a food ingredient.
Page 3, Line 14(f) "Kratom product" means a food or dietary supplement
Page 3, Line 15that consists of, or contains, any part of a kratom leaf, a
Page 3, Line 16kratom leaf extract, or any kratom alkaloid, kratom
Page 3, Line 17constituent, or kratom metabolite and does not include any synthesized alkaloids or semi-synthesized alkaloids.
Page 3, Line 18(g) "Semi-synthesized alkaloid" means an alkaloid or
Page 4, Line 1alkaloid derivative contained in a kratom leaf extract that has
Page 4, Line 2been exposed to chemicals or processes that would confer a
Page 4, Line 3structural change in the alkaloids, such as oxidation,
Page 4, Line 4reduction, and ring opening and closing, resulting in material that has been chemically altered.
Page 4, Line 5(h) "Synthesized alkaloid" means an alkaloid or alkaloid
Page 4, Line 6derivative of the kratom leaf that has been created by chemical
Page 4, Line 7synthesis or biosynthetic means, including fermentation,
Page 4, Line 8recombinant techniques, yeast-derived techniques, and
Page 4, Line 9enzymatic techniques, rather than by traditional food preparation techniques such as heating or extracting.
Page 4, Line 10(2) A person shall not:
Page 4, Line 11(a) Knowingly prepare, distribute, advertise, sell, or offer to sell a kratom product:
Page 4, Line 12(I) That is adulterated;
(II) To a person under twenty-one years of age;
Page 4, Line 13(III) That contains a level of 7-hydroxymitragynine in the
Page 4, Line 14alkaloid fraction that is greater than two percent of the alkaloid composition of the kratom product;
Page 4, Line 15(IV) That is a confection; mimics a candy product; or is
Page 4, Line 16manufactured, packaged, labeled, or distributed in a way that
Page 4, Line 17is appealing to children, including in the distinct shape of a human, an animal, or fruit; or
Page 4, Line 18(V) That is combustible or intended for vaporization;
Page 4, Line 19(b) Prepare, distribute, advertise, sell, or offer to sell a
Page 4, Line 20kratom product that does not have a label that clearly and
Page 4, Line 21conspicuously sets forth on each retail package:
Page 5, Line 1(I) The name and address for the place of business of the manufacturer or distributor of the kratom product;
Page 5, Line 2(II) The full list of ingredients in the kratom product;
(III) Disclosure and advice:
Page 5, Line 3(A) Against use by individuals who are under twenty-one years of age, pregnant, or breastfeeding;
Page 5, Line 4(B) To consult a health-care professional prior to use;
(C) That kratom may be habit forming; and
Page 5, Line 5(D) That kratom may interact with certain medications, drugs, and controlled substances;
Page 5, Line 6(IV) The following statements:
Page 5, Line 7(A) "These statements have not been evaluated by the
Page 5, Line 8food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease."; and
Page 5, Line 9(B) "Keep out of reach of children."; and
(V) Directions for use that include:
Page 5, Line 10(A) A recommended amount of the kratom product per serving;
Page 5, Line 11(B) The number of recommended servings per package;
Page 5, Line 12(C) A recommended number of servings of the kratom
Page 5, Line 13product that can be safely consumed in a twenty-four-hour period; and
Page 5, Line 14(D) Quantitative declarations of the amount of
Page 5, Line 15mitragynine and the amount of 7-hydroxymitragynine per serving of the kratom product;
Page 5, Line 16(c) Display or store kratom products in a retail location
Page 5, Line 17in a manner that will allow the products to be accessed by individuals under twenty-one years of age; or
Page 6, Line 1(d) Manufacture, package, label, or distribute a kratom product that:
Page 6, Line 2(I) Contains synthesized alkaloids or semi-synthesized alkaloids; or
Page 6, Line 3(II) Has a level of 7-hydroxymitragynine in the alkaloid
Page 6, Line 4fraction that is greater than two percent of the alkaloid composition of the product.
Page 6, Line 5(3) A person that conducts the activities described in
Page 6, Line 6subsection (2) of this section engages in a deceptive trade practice.
Page 6, Line 7SECTION 3. In Colorado Revised Statutes, 18-13-132, amend (3) as follows:
Page 6, Line 818-13-132. Furnishing kratom products to persons under
Page 6, Line 9twenty-one years of age - definition. (3) As used in this section,
Page 6, Line 10"kratom product"
has the meaning set forth in section 44-1-105 (1)Page 6, Line 11(a) Any part of the leaf of the Mitragyna speciosa plant
Page 6, Line 12if the plant contains the alkaloid mitragynine or 7-hydroxymitragynine; or
Page 6, Line 13(b) A synthetic material that contains the alkaloid mitragynine or 7-hydroxymitragynine.
Page 6, Line 15SECTION 4. Applicability. This act applies to conduct occurring on or after the effective date of this act.
Page 6, Line 16SECTION 5. Safety clause. The general assembly finds,
Page 6, Line 17determines, and declares that this act is necessary for the immediate
Page 7, Line 1preservation of the public peace, health, or safety or for appropriations for
Page 7, Line 2the support and maintenance of the departments of the state and state institutions.