HB 407: Create the kratom consumer protection act - Montana

HB0407_1(6).pdf → HB0407_2(10).pdf · 6 edits

MODERATE

The bill was significantly restructured to clarify its purpose as consumer protection and to tighten safety restrictions on kratom products. Key changes include renaming the 'Department' to 'Department of Revenue', adding a specific prohibition on selling kratom to anyone under 21, and introducing new definitions for 'Kratom processor' and 'Kratom retailer'. Safety requirements were expanded to explicitly ban products containing synthesized materials or dangerous non-kratom substances, while the registration fee for processors was set at a fixed $500.

Scope change

The bill's scope was narrowed and clarified to focus on consumer protection and specific safety standards, while the applicability of the 'Department' was explicitly defined as the Department of Revenue.

DEFINITION

The definition of 'Department' was changed from a generic reference to the specific 'department of revenue'.

New definitions were added for 'Kratom processor', 'Kratom retailer', and 'Kratom distributor' to clarify roles and responsibilities.

SCOPE

A new provision was added to explicitly prohibit the sale of kratom products to anyone under 21 years of age.

REQUIREMENT

Product restrictions were expanded to explicitly ban products containing synthesized materials or adulterated with dangerous non-kratom substances.

The registration fee for kratom processors was set to a fixed amount of $500.

Registration requirements were updated to include specific certifications regarding quality testing, Good Manufacturing Practices (GMP), and FDA facility registration.

HB0407_2(9).pdf → HB0407_1(6).pdf · 5 edits

MODERATE

This bill was renumbered from HB 407.2 to HB 407.1 and significantly restructured its content. The most critical change is the removal of a delayed effective date provision, meaning the new rules will likely take effect immediately upon passage rather than waiting for a future session. Additionally, the bill's scope was narrowed by removing references to 'processor, distributor, and retailer' registration requirements in the summary, while the definitions were updated to include specific safety standards for solvents and psychoactive compounds.

Scope change

The bill's scope was narrowed in the summary description by removing explicit mentions of processor, distributor, and retailer registration, though the detailed text still addresses registration. The applicability timeline changed from a delayed effective date to an immediate one.

TIMELINE

Removed the provision for a delayed effective date, suggesting the law will take effect immediately upon enactment.

DEFINITION

Updated definitions to include specific safety criteria, such as limits on residual solvents and prohibitions on substances that inhibit liver enzymes.

REQUIREMENT

Added a specific prohibition against kratom products containing levels of 7-hydroxymitragynine greater than 2% of the alkaloid composition.

Removed the explicit mention of 'processor, distributor, and retailer' registration in the bill's summary purpose, though registration details remain in the text.

ENFORCEMENT

Changed the summary description to emphasize enforcement by the Department of Revenue and added specific misdemeanor and felony conviction language.

HB0407_2(7).pdf → HB0407_2(8).pdf · 4 edits

MODERATE

The bill was reformatted to use sentence case and lowercase for consistency. Substantive changes include adding 'beverages' to the definition of kratom products and clarifying that products must not be attractive to children. The quality testing requirements were significantly expanded to include specific limits for residual solvents, biological contaminants, and heavy metals, alongside existing concentration limits.

Scope change

The scope of regulated products was expanded to include kratom beverages sold in food establishments.

DEFINITION

Added 'beverages prepared and sold in food establishments' to the definition of 'kratom product'.

Replaced the capitalized phrase 'ATTRACTIVE TO CHILDREN' with the lowercase 'Attractive to children' and added 'or animals' to the list of prohibited shapes.

REQUIREMENT

Expanded quality testing requirements to mandate that products must not contain residual solvents, biological contaminants, or heavy metals exceeding dietary supplement standards.

TECHNICAL

Changed the text from all-caps sentence fragments to standard sentence case and lowercase throughout the document.

HB0407_2(2).pdf → HB0407_2(3).pdf · 4 edits

MODERATE

The bill updates definitions to clarify what constitutes 'Kratom' and related terms like 'Kratom Extract' and 'Synthesized Material.' It introduces strict restrictions prohibiting processors from selling products with high levels of 7-hydroxymitragynine, synthesized materials, dangerous adulterants, or those designed to attract children. Additionally, the bill mandates annual registration and $500 fees for processors, distributors, and retailers, requiring proof of quality testing and compliance with FDA guidelines.

Scope change

The bill expands its regulatory scope to include specific prohibitions on product composition and safety standards, while adding mandatory registration requirements for all entities in the kratom supply chain.

DEFINITION

Added precise definitions for 'Kratom Distributor,' 'Kratom Extract,' 'Kratom Processor,' 'Kratom Product,' 'Kratom Retailer,' 'Production Batch,' and 'Synthesized Material' to clarify regulatory boundaries.

REQUIREMENT

Established new restrictions prohibiting the sale of kratom products containing excessive 7-hydroxymitragynine, synthesized materials, dangerous non-kratom substances, or child-attractive packaging.

Required all kratom processors, distributors, and retailers to register annually with the Department and pay a $500 fee.

Mandated that registered products must have a Certificate of Analysis from an ISO 17025 laboratory proving safety standards and compliance with FDA Good Manufacturing Practices.

HB0407_1(5).pdf → HB0407_2.pdf · 5 edits

MODERATE

The bill was significantly restructured to expand regulatory oversight from just 'registrants' to include processors, distributors, and retailers. It added specific prohibitions on selling kratom to minors and introduced a new requirement for annual registration fees and quality testing certifications. The bill also updated definitions to clarify what constitutes a 'kratom product' and added stricter rules against substances attractive to children.

Scope change

The bill's scope expanded to explicitly include distributors and retailers in the registration and enforcement process, whereas the original version focused primarily on the entity placing the product into commerce.

REQUIREMENT

Added a prohibition on selling or distributing kratom products to persons under 21 years of age.

Required registrants to obtain a Certificate of Analysis from an ISO 17025 laboratory proving the product meets safety standards for solvents, contaminants, and potency.

DEFINITION

Redefined 'Distributor' to specifically include persons importing or purchasing kratom for resale, and added new definitions for 'Processor' and 'Retailer'.

Updated the definition of 'Kratom' to exclude synthesized materials and clarified that products containing them are prohibited.

FISCAL

Introduced a mandatory $500 annual registration fee for kratom processors.

LC1851.pdf → HB0407_1.pdf · 6 edits

MODERATE

The bill was renamed from LC 1851 to HB 407 and reorganized to include more detailed safety restrictions on kratom products. Key changes include stricter limits on the concentration of 7-hydroxymitragynine, new prohibitions on dangerous additives and child-attractive packaging, and expanded definitions for registrants and synthesized materials.

Scope change

The bill's scope expanded to explicitly ban products containing specific dangerous compounds, CYP450 enzyme inhibitors, and synthesized materials, while clarifying the definition of 'synthesized material' to include modern biosynthetic techniques.

DEFINITION

Added a new definition for 'Synthesized material' to include alkaloids created via fermentation, recombinant techniques, or yeast-derived enzymatic techniques, excluding traditional food preparation methods.

REQUIREMENT

Added a prohibition on selling kratom products that contain poisonous or deleterious non-kratom ingredients, including substances controlled under state or federal law.

Added a ban on kratom products mixed with compounds known to inhibit key cytochrome P450 enzymes (such as CYP3A4 or CYP2D6) unless scientifically validated as safe.

Added a prohibition on manufacturing kratom products in a manner that is attractive to children.

Added a ban on kratom products containing synthesized materials or constituents isolated to artificially increase potency without supporting safety data.

Refined the limit on 7-hydroxymitragynine to 2% of the alkaloid composition and added a ban on marketing products exceeding this limit as kratom products.

Create the kratom consumer protection act

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