Department outlines requirements for kratom product registration under Kratom Consumer Protection Act

The Nebraska State Legislature convened on March 26, 2025, to introduce Legislature Bill 230, a significant piece of legislation aimed at regulating the kratom industry within the state. The bill seeks to establish a framework for the registration and oversight of kratom products, addressing growing concerns regarding safety and quality in the market.

Key provisions of LB230 include stringent requirements for processors of kratom products. Each application for product registration must include detailed information such as the processor's name and address, a principal point of contact, the product name, and a product label. Notably, the bill mandates that a certificate of analysis be provided, confirming the alkaloid content of the kratom product, specifically ensuring that the level of 7-hydroxymitragynine does not exceed two percent. This analysis must be conducted by an independent laboratory accredited under ISO/IEC 17025 standards.

Additionally, the bill requires processors to submit a valid good manufacturing practice certificate and a current food facility registration certificate from the federal Food and Drug Administration. The registration certificate issued by the state will be valid for one calendar year and is non-transferable. The Nebraska Department of Health and Human Services may impose a reasonable fee for the registration process, which will contribute to the Department of Revenue Enforcement Fund.

The introduction of LB230 has sparked notable discussions among lawmakers and stakeholders. Proponents argue that the bill is essential for consumer protection, given the increasing popularity of kratom and the potential health risks associated with unregulated products. Critics, however, express concerns about the burden of compliance on small businesses and the potential for overregulation in an emerging market.

The implications of LB230 extend beyond regulatory compliance; it reflects a broader trend of states grappling with the complexities of managing herbal supplements. Experts suggest that if passed, the bill could set a precedent for other states considering similar regulations, potentially shaping the future landscape of the kratom industry nationwide.

As the legislative process unfolds, stakeholders will be closely monitoring the bill's progress, anticipating amendments and debates that may arise as lawmakers weigh the balance between consumer safety and industry viability. The next steps will involve committee reviews and potential votes, with the outcome likely to influence the operational framework for kratom products in Nebraska and beyond.