R66-51-3. Product Registration

(1) The department shall require a separate registration fee for each kratom product unless: (a) the label is identical; (b) the product delivery form is identical; and (c) the product ingredients are identical. (2) A single registration may include products that contain the same kratom ingredients in the same product delivery form but in a different container or volume. (3) To register a product, a registrant shall: (a) apply on a form provided by the department; and (b)(i) include a Certificate of Analysis (COA) for the kratom product from a third-party laboratory, based on tests performed within the previous six months. (ii) The third-party laboratory shall have International Organization for Standardization (ISO) 17025:2017 accreditation from an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement. (iii) A third-party laboratory may test a kratom product before obtaining ISO/IEC 17025:2017 accreditation, provided the third-party laboratory: (A) adopts and follows minimum good laboratory practices which satisfy the OECD Principles of Good Laboratory Practice and Compliance Monitoring published by the Organization for Economic Co-operation and Development; and (B) is currently in the process of becoming ISO/IEC 17025:2017 accredited by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement. (4) A non-refundable registration fee, as outlined in the fee schedule approved by the Legislature, shall be paid to the department with the submission of a registration application. (5) The department shall deny or withdraw registration if: (a) the kratom product violates Title 4, Chapter 45, Kratom Regulation Act; (b) there is any reasonable basis to suspect that the kratom product is unsafe or that ingredients violate state law; (c) the kratom product is in a shape that is appealing to children; or (d) the product contains an adulterant as defined in Section R66-52-2. (6) The department requires a new registration application for a change in the following: (a) kratom product ingredients or processes that materially alters the product; (b) the recommended usage; or (c) name for the product. (7) Other changes may not require a new registration, but the registrant shall submit copies of each label change to the department as soon as they are effective. (8) The registrant is responsible for the accuracy and completeness of information submitted. (9) Kratom product registrations shall expire on June 30 of each year, and the department may not prorate these registrations. (10) The department shall deny product registration if products violate Title 4, Chapter 45, Kratom Regulation Act.