21 Feb Understanding Colorado Senate Bill 23-147: The Colorado Kratom Consumer Protection Act
Kratom, a tree native to Southeast Asia, has gained popularity in recent years as a natural remedy for chronic pain, anxiety, and opioid withdrawal symptoms. However, the unregulated nature of the industry has raised concerns about the quality and safety of kratom products. To address these concerns, the Colorado Kratom Consumer Protection Act, or Senate Bill 23-147, has been proposed. The bill aims to establish minimum standards and labeling requirements for kratom products, require processors of kratom products to register with the Department of Revenue, and provide a certificate of analysis for the kratom product to the department. The proposed law would become effective on July 1, 2024, and aims to provide greater consumer protection for those who use kratom products in Colorado. To read the full text of the bill, click here.
Senate Bill 23-147, also known as the Colorado Kratom Consumer Protection Act, is a proposed law that would regulate the processing of kratom products in Colorado. The bill aims to establish minimum standards and labeling requirements for kratom products, require processors of kratom products to register with the Department of Revenue, and provide a certificate of analysis for the kratom product to the department.
The bill requires that before a processor can sell or offer for sale any kratom product, they must register the product with the Department of Revenue and provide a certificate of analysis for the kratom product to the department. The certificate of analysis must come from a third-party laboratory and show that the kratom product does not violate the standards set by the bill. The certificate must also include a batch or lot number for the product.
If an adverse event report is submitted to the federal food and drug administration for any of the processor’s kratom products, the processor must notify the Department of Revenue. If there is a reasonable basis, the department can require a third-party laboratory to test a processor’s kratom product for compliance and can require the processor to pay the department’s cost for the test.
The executive director of the department is required to promulgate rules to administer and enforce the bill and is authorized to impose fines on processors that violate the bill. The bill also establishes the Kratom Consumer Protection Cash Fund.
The bill prohibits processors from knowingly preparing, distributing, advertising, selling, or offering to sell a kratom product that is adulterated with fentanyl or any other controlled substance listed in Part 2 of Article 18 of Title 18. It also requires processors to sell kratom products that have a label that clearly sets forth the identity and address of the manufacturer and the full list of ingredients in the kratom product.
Section 44-15-103 of the bill outlines the prohibited acts, labeling requirements, enforcement, and penalties related to the sale and distribution of Kratom products in the state of Colorado. According to the section, it is prohibited to prepare, distribute, advertise, sell, or offer to sell a Kratom product that is adulterated with Fentanyl or any other controlled substance listed in Part 2 of Article 18 of Title 18. It is also prohibited to sell a Kratom product that does not have a label clearly stating the identity and address of the manufacturer and the full list of ingredients in the Kratom product.
Additionally, a Kratom product cannot be sold knowingly to a person under 21 years of age, and Kratom products cannot be displayed or stored in a retail location in a manner that allows access by individuals under 21 years of age. Furthermore, a processor cannot advertise, distribute, sell, or offer for sale a Kratom product that is mixed or packed with a non-Kratom substance that affects the quality or strength of the Kratom product to such a degree as to render the Kratom product injurious to a consumer.
Moreover, a Kratom product cannot contain a poisonous or otherwise harmful non-Kratom ingredient, including any substance listed in Part 2 of Article 18 of Title 18. The Kratom extract must not have levels of residual solvents that are higher than allowed by Chapter 467 of the United States Pharmacopeia.
A Kratom product advertised, distributed, sold, or offered for sale in the state must include a label or a Quick Response code or a website address for a website that contains the name and address of the Kratom processor, adequate directions, a product fact panel listing all ingredients that are expressed by numerical count or in volume or weight, and the amount of Mitragynine and 7-Hydroxymitragynine contained in the Kratom product.
Furthermore, it must identify a batch number or lot number that matches the batch or lot number on the certificate of analysis submitted for the Kratom product, include a disclaimer that states that the product has not been evaluated by the United States Food and Drug Administration and is not intended to diagnose, treat, cure, or prevent any disease, and not include any claims that the Kratom product is intended to diagnose, treat, cure, or prevent any medical condition or disease.
A processor that violates subsection (2) or (3) of this section or fails to comply with section 44-15-104(1) is subject to a fine.
Section 44-15-104 of the legislation outlines the requirements for processors of kratom products in the state. Before advertising, distributing, selling, or offering to sell any kratom product in the state, each processor must register and maintain current registration of the kratom product with the Department. They must also provide a certificate of analysis for the kratom product at their own expense and pay an initial registration fee and an annual renewal fee determined by the Executive Director by rule. The fees collected must reflect the actual and direct costs incurred by the Department in implementing this article.
If the Department receives credible notice that a kratom product violates Section 44-15-103 (2)(b) or (2)(c), the Executive Director will require the processor to submit a current certificate of analysis for the kratom product at their own expense within a period determined by the Executive Director by rule. If the processor does not submit a current certificate of analysis within the required period, the Department may revoke the processor’s registration for the applicable kratom product.
All fees collected under this section must be transmitted to the state treasurer, who will credit them to the fund.
The bill also allows local governments to adopt and enforce additional regulations that are more stringent than the bill’s requirements.
The bill would become effective on July 1, 2024. A complete breakdown and summary of the bill is included below.
Overview:
The bill establishes minimum standards and labeling requirements for kratom products in Colorado. It requires processors of kratom products to register with the Department of Revenue (DOR) and provide a certificate of analysis for each product. The DOR is authorized to test a processor’s kratom product by a third-party laboratory and impose fines for violations.
Section 1: Repeal
Repeals section 44-1-105 of the Colorado Revised Statutes.
Section 2: Addition
Adds article 15 to title 44 of the Colorado Revised Statutes.
Article 15 – Colorado Kratom Consumer Protection Act
Section 44-15-101: Short Title
Establishes the short title of this article as the “Colorado Kratom Consumer Protection Act”.
Section 44-15-102: Definitions
Defines key terms used in the bill, including “certificate of analysis”, “kratom extract”, “kratom product”, “processor”, and “retailer”.
Section 44-15-103: Prohibited Acts – Labeling Requirements – Enforcement – Penalties
Prohibits processors from knowingly preparing, distributing, advertising, selling, or offering for sale adulterated kratom products, and requires all kratom products to have a clear label with the manufacturer’s identity and address and a full list of ingredients. The section also establishes enforcement mechanisms, including the DOR’s authority to test kratom products and impose fines for violations.
Section 44-15-104: Registration of Kratom Products
Requires processors of kratom products to register each product with the DOR and provide a certificate of analysis for each product.
Section 44-15-105: Adverse Event Reporting
Requires processors to notify the DOR if an adverse event report is submitted to the federal Food and Drug Administration for any of their kratom products.
Section 44-15-106: Third-Party Testing
Allows the DOR to coordinate with a third-party laboratory to test a processor’s kratom product for compliance with the bill’s requirements.
Section 44-15-107: Cost of Testing
Requires processors to pay the DOR’s cost for any third-party laboratory testing.
Section 44-15-108: Kratom Consumer Protection Cash Fund
Establishes the Kratom Consumer Protection Cash Fund to receive fines imposed by the DOR for violations of the bill.
Section 3: Effective Date
The bill will take effect on July 1, 2024.