21 Feb Understanding Colorado Senate Bill 23-147: The Colorado Kratom Consumer Protection Act
Kratom, a Southeast Asian tree, is increasingly used as a natural remedy for chronic pain, anxiety, and opioid withdrawal symptoms. Nevertheless, the lack of regulation in the industry has prompted concerns about product quality and safety. In response, the Colorado Kratom Consumer Protection Act, or Senate Bill 23-147, has been proposed. This bill intends to introduce minimum standards and labeling requirements for kratom products, mandate registration with the Department of Revenue for kratom product processors, and enforce the provision of a certificate of analysis for the product. The law is scheduled to become effective on July 1, 2024, with the goal of enhancing consumer protection for kratom users in Colorado.
This bill outlines specific requirements for kratom processors. Before selling or offering any kratom product, processors must register the product with the Department of Revenue and provide a certificate of analysis from a third-party laboratory. This certificate should verify that the product meets the standards set by the bill, and must include a batch or lot number.
In case of any adverse event report related to a processor’s kratom product submitted to the federal Food and Drug Administration, the processor must notify the Department of Revenue. The department, when reasonable, can mandate a third-party laboratory test for a processor’s kratom product to ensure compliance and can require the processor to cover the cost of this test.
The bill’s executive director is empowered to enforce rules to administer the bill and impose fines on processors violating it. The bill also establishes the Kratom Consumer Protection Cash Fund.
Additionally, the legislation prohibits processors from knowingly preparing, selling, or offering a kratom product adulterated with fentanyl or any other controlled substance. It mandates that kratom products be labeled with the manufacturer’s identity and address, and a comprehensive list of ingredients.
Section 44-15-103 of the bill details prohibited acts, labeling requirements, enforcement, and penalties relating to the sale and distribution of kratom products in Colorado. Selling a kratom product to a person under 21 years of age or in a manner that allows access to individuals under this age is prohibited. Processors cannot sell or offer a kratom product mixed or packed with a non-kratom substance that affects the product’s quality or strength to a degree that it could harm a consumer.
Furthermore, kratom products cannot contain a harmful non-kratom ingredient, including substances listed in Part 2 of Article 18 of Title 18. Kratom extract should not exceed the residual solvents’ limits as defined by Chapter 467 of the United States Pharmacopeia.
Section 44-15-104 stipulates the registration requirements for kratom processors in the state. They must provide a certificate of analysis for the kratom product at their own expense, pay an initial registration fee, and an annual renewal fee. All collected fees will be credited to the fund by the state treasurer.
The bill also permits local governments to adopt and enforce more stringent regulations than those stipulated by the bill.
A comprehensive 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.