Utah Admin. Code R70-580-3 - Product Registration

(1) A kratom product distributed or available for distribution that is intended to be offered for sale to an end consumer in Utah, including on the internet or social media platforms, shall be:

(a) in an approved kratom delivery form; and

(b) registered with the department annually by the kratom processor.

(2) A product that contains the same kratom ingredients in the same kratom delivery form but a different container, package, or volume shall be included in a single registration.

(3) Application for registration shall be made on a form provided by the department that includes the following information:

(a) the name and address of the kratom processor and the name and address of the kratom processor whose name will appear on the label, if other than the kratom processor making the registration;

(b) the name of the kratom product included in the registration;

(c) the kratom type and recommended usage, including directions for use or serving size for the kratom product;

(d) the approved kratom delivery form;

(e) the weights or volumes, as appropriate, of the package of kratom product, offered for sale for the recommended usage and the entire package;

(f) a complete copy of the label that will appear on the kratom product or the document that can be reached via a scannable bar code, QR code, or web address, pursuant to Subsection R70-580-6(7);

(g) a certificate of analysis for the kratom product from a third-party laboratory that shall obtain and keep the 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;

(i) a third-party laboratory may test kratom product before obtaining ISO/IEC 17025:2017 accreditation provided by 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) becomes ISO/IEC 17025:2017 accredited within 18 months, by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement;

(ii) if a kratom processor uses an out-of-state third-party laboratory they shall include a copy of the laboratory accreditation with the registration;

(h) certification that:

(i) the kratom processor has not added any substance to the kratom product that is listed in Title 58, Chapter 37, Utah Controlled Substances Act;

(ii) the kratom processor has not mixed or packed any nonkratom substance that affects the quality or strength of the kratom product to such a degree as to make the kratom product injurious to a consumer;

(iii) the kratom product manufacturer has not added any synthetic mitragynine, synthetic 7-hydroxymitragynine, or any other synthetically derived compound of the kratom plant;

(iv) the registrant assumes responsibility and liability for the product based on their role in the processing of the kratom product and whether they are a kratom manufacturer, distributor, or retailer; and

(v) that the registered kratom product is compliant with applicable current state and federal guidelines for food safety.

(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) A separate registration fee shall be required for each kratom product manufactured or processed from raw materials with the same specifications, same name, and same kratom delivery form.

(6) The department may deny registration for an incomplete application.

(7) The department shall deny or withdraw registration for a kratom product that:

(a) violates Title 4, Chapter 45, Kratom Consumer Protection Act;

(b) is adulterated or contaminated with foreign materials that would be injurious to a consumer; or

(c) if there is any reasonable basis to suspect that the kratom product is unsafe or that ingredients violate state law.

(8) A new registration application is required for the following:

(a) a change in the kratom product ingredients or processes that materially alters the product;

(b) a change to the recommended usage; and

(c) a change of name for the product.

(9) Other changes shall not require a new registration application but the registrant shall submit copies of all label changes to the department as soon as they are effective.

(10) The kratom processor registering the kratom product is responsible for the accuracy and completeness of the information submitted.

(11) A registration is renewable for up to one-year with an annual renewal fee per kratom product that shall be paid on or before June 30th of each year.

(12) A kratom product that has been discontinued shall continue to be registered until the kratom product is no longer available for distribution.

(13) A late fee shall be assessed for a renewal of a kratom product registration submitted after June 30th and shall be paid before the registration renewal is issued.

Notes

Utah Admin. Code R70-580-3

Adopted by Utah State Bulletin Number 2021-08, effective 4/2/2021 Amended by Utah State Bulletin Number 2023-06, effective 2/27/2023