R70. Agriculture and Food, Regulatory Services.
R70-580. Kratom Product Registration and Labeling.
R70-580-1. Authority and Purpose.
Pursuant to Section 4-45-107, this rule establishes the requirements for labeling and registration of products made from and containing
kratom.
R70-580-2. Definitions.
1) "Certificate of Analysis (COA)" means a certificate from a third-party laboratory describing the results of the laboratory's testing of a
sample.
2) "End Consumer" means an individual who does not resell the purchased kratom product.
3) "Food" means a raw, cooked, or processed edible substance, ice, or ingredient used or intended for use or for sale in whole or in part for
human consumption, or chewing gum.
4) "Label" means the display of all written, printed, or graphic matter upon the immediate container of a kratom product or a statement by
the kratom processor directly related to and accompanying the kratom product bearing the label.
5) "Third-party Laboratory" means a laboratory that has no direct interest in a processor of kratom product that is capable of performing
mandated testing utilizing validated methods.
6) "Approved Kratom Delivery Form" means a kratom product in raw leaf, capsule, tablet, powder, liquid tincture, tea bag, concentrated,
extract, or gummy forms. The following are not an approved kratom delivery form:
a) any form that is combustible or intended to be used for vaporization;
b) any form that is intended to be added to food; or
c) any form that mimics a candy product or is manufactured, packaged, or advertised in a way that appeals to children.
7) "Kratom Type" means the specified strain of Mitragyna speciose.
8) "Kratom Processor" means any kratom product manufacturer, distributor, or retailer who offers a kratom product for sale or resale to
consumers in the state.
9) "Kratom Product" means a product manufactured or processed from kratom raw materials acquired by a kratom processor that is certified
to be compliant with provisions of Title 4, Chapter 45, Kratom Consumer Protection Act.
10) "Kratom Retailer" means a kratom processor who sells a kratom product to an end consumer.
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
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 person whose name will appear on the label, if other than
the kratom processor;
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 for 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 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 prior to 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) 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 laboratory they shall include a copy of the laboratory accreditation with the registration;
h) certification that:
i) the kratom manufacturer has not added any substance to the kratom product that is listed in Title 58, Chapter 37, Utah Controlled
Substances Act;
ii) the kratom manufacturer has not mixed or packed any nonkratom substance that affects the quality or strength of the kratom product to
such a degree as to render 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 full responsibility and liability for the product; and
v) that the registered kratom product is compliant with current state and federal guidelines for food safety.
4) A non-refundable registration fee, as set forth in the fee scheduled 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: