71-3807.

Kratom products; registration; required, when procedure; certificate of registration; fee.

(1) The department shall establish, operate, and administer a program to register kratom products. The Tax Commissioner shall designate an implementation date for such program which date is on or before January 1, 2026.

(2) Beginning on the implementation date designated by the Tax Commissioner pursuant to subsection (1) of this section:

(a) No processor may manufacture, package, label, or distribute a kratom product to be offered for sale in the State of Nebraska unless the product has been registered with the department;

(b) Applications for product registration shall be submitted on a form prescribed by the department. Each application shall include:

(i) The name, address, and state of organization for the processor of the product;

(ii) A principal point of contact for the processor and contact information for the point of contact;

(iii) The name of the product;

(iv) The product label;

(v) A certificate of analysis for the kratom product that states the kratom product's alkaloid content and certifies that the kratom product has a level of 7-hydroxymitragynine that is less than two percent of the alkaloid composition of the kratom product from an independent laboratory. Such laboratory shall obtain and maintain an International Organization for Standardization and International Electrotechnical Commission (ISO/IEC) 17025 accreditation for testing and calibration laboratories from an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement;

(vi) A valid good manufacturing practice certificate issued by an accredited third-party certification body in compliance with 21 C.F.R. part 111; and

(vii) A current food facility registration certificate issued by the federal Food and Drug Administration for all facilities where kratom products are manufactured, prepared, packaged, or labeled;

(c) A certificate of registration shall be valid for one calendar year after the date of issue and shall not be transferable;

(d) The department may charge a fee for product registration applications and may adjust such fee annually. The fee shall be reasonable and shall not exceed any reasonable or necessary costs to administer the Kratom Consumer Protection Act. The department shall remit such fees to the State Treasurer for credit to the Department of Revenue Enforcement Fund; and

(e) A product that contains the same kratom ingredients in the same kratom delivery form, but is packaged, sold, or offered for sale in a different container, package, or volume shall be included in a single registration.

(3) If an application is incomplete or deficient, the department shall, in a timely manner, notify the applicant in writing describing the reason or reasons and request additional information. If such application is not corrected or supplemented within thirty days after the department's request, the department shall deny the application.

(4) If any false statement is made in any part of an application, the department shall deny the application.

(5) A person aggrieved by the denial of an application may request a hearing pursuant to section 71-3811.

(6) A processor or retailer is not prohibited from selling, preparing, manufacturing, distributing, maintaining, advertising, representing, or holding itself out as selling, preparing, or maintaining kratom products in the State of Nebraska prior to the implementation date designated by the Tax Commissioner pursuant to subsection (1) of this section, or while the first product registration applications submitted by processors operating in the State of Nebraska as of January 1, 2025, are pending approval or denial by the department.