Agriculture and Food

Specialized Products

Rule 51: Kratom Product Registration and Labeling

Effective Date: 07/02/2026

Admin. Code Reference: R66-51

Rule Type: Current Rule

NOTICE OF SUBSTANTIVE CHANGE

TYPE OF FILING: Amendment

Rule or section number:

R66-51

Filing ID: 57960

Agency Information

1. Title catchline:

Agriculture and Food, Specialized Products

Building:

TSOB, South Bldg, Floor 2

Street address:

4315 S 2700 W

City, state:

Taylorsville, UT 84129

Mailing address:

PO Box 146500

City, state and zip:

Salt Lake City, UT 84114-6500

Contact persons:

Name:

Phone:

Email:

Amber Brown

385-245-5222

ambermbrown@utah.gov

Brandon Forsyth

801-710-9945

bforsyth@utah.gov

Camille Knudson

801-597-6010

camillek@utah.gov

Please address questions regarding information on this notice to the persons listed above.

General Information

2. Rule or section catchline:

R66-51. Kratom Product Registration and Labeling

3. Are any changes in this filing because of state legislative action?

Changes are because of legislative action.

If yes, any bill number and session:

SB 45 (2026 General Session), HB 385 (2026 General Session)

4. Purpose of the new rule or reason for the change:

This amendment aligns Rule R66-51 with statutory changes enacted by SB 45, Kratom Adjustments, and HB 385, Specialized Product Sales Amendments, from the 2026 General Session.

These legislative updates require the Department of Agriculture and Food (department) to modify retail permit requirements, product safety standards, and age-restricted sales protocols to ensure administrative rules remain consistent with current state law.

5. Summary of the new rule or change:

The proposed revisions to this rule align it with the recently passed Kratom Regulation Act, primarily by revising definitions and updating statute citations.

The changes simplify labeling requirements by removing the mandate to list alkaloid amounts on the product label and modify testing requirements by removing solvents from the Certificate of Analysis minimums.

Additionally, the violation threshold for 7-hydroxymitragynine (7-OH) content is adjusted to greater than 0.4% of the alkaloid composition.

Fiscal Information

6. Provide an estimate and written explanation of the aggregate anticipated cost or savings to:

A. State budget:

This rule imposes no fiscal impact on the state budget beyond the estimates provided in the legislative fiscal notes for SB 45 (2026) and HB 385 (2026).

B. Local governments:

This rule establishes state-level licensing procedures and product standards.

It imposes no administrative requirements or costs on local governments.

C. Small businesses ("small business" means a business employing 1-49 persons):

This rule imposes no fiscal impact on small businesses beyond the licensing fees and regulatory costs already estimated in the legislative fiscal notes for SB 45 (2026) and HB 385 (2026).

D. Non-small businesses ("non-small business" means a business employing 50 or more persons):

This rule maintains a neutral fiscal impact for non-small businesses.

All anticipated costs for large retail entities result from statutory mandates in SB 45 (2026) and HB 385 (2026) rather than the administrative requirements of this rule.

E. Persons other than small businesses, non-small businesses, state, or local government entities ("person" means any individual, partnership, corporation, association, governmental entity, or public or private organization of any character other than an agency):

This rule regulates the business-to-government relationship and imposes no fiscal impact on an individual's budget.

All corresponding financial impacts regarding individual age restrictions and penalties originate from SB 45 (2026) and HB 385 (2026) and are detailed in the legislative fiscal notes for those bills.

F. Compliance costs for affected persons:

This rule imposes no direct compliance costs on affected persons.

All applicable licensing fees, registration costs, and potential fines originate from the enactment of SB 45 (2026) and HB 385 (2026) and are detailed in the corresponding legislative fiscal notes.

G. Regulatory Impact Summary Table (This table includes only fiscal impacts the agency was able to measure. If the agency could not estimate an impact, it is excluded from this table but described in boxes A through F.)

Regulatory Impact Summary Table

Fiscal Cost

FY2026

FY2027

FY2028

FY2029

FY2030

State Budget

Local Governments

Small Businesses

Non-Small Businesses

Other Persons

Total Fiscal Cost

Fiscal Benefits

FY2026

FY2027

FY2028

FY2029

FY2030

State Budget

Local Governments

Small Businesses

Non-Small Businesses

Other Persons

Total Fiscal Benefits

Net Fiscal Benefits

H. Department head comments on fiscal impact and approval of regulatory impact analysis:

The Commissioner of the Department of Agriculture and Food, Kelly Pehrson, has reviewed and approved this regulatory impact analysis.

Citation Information

7. Provide citations to the statutory authority for the rule. If there is also a federal requirement for the rule, provide a citation to that requirement:

Section 4-45-107

Public Notice Information

9. The public may submit written or oral comments to the agency identified in box 1.

A. Comments will be accepted until:

06/16/2026

10. This rule change MAY become effective on:

06/23/2026

NOTE: The date above is the date the agency anticipates making the rule or its changes effective. It is NOT the effective date.

Agency Authorization Information

Agency head or

designee and title:

Kelly Pehrson, Commissioner

Date:

05/01/2026

R66. Agriculture and Food, Specialized Products.

R66-51. Kratom Product Registration and Labeling.

R66-51-1. Authority and Purpose.

[(1) ]Pursuant to Section 4-45-107, this rule establishes the requirements for labeling and registration of kratom products.

R66-51-2. Definitions.

(1) "7-OH" means 7-hydroxymitragynine (CAS 174418-82-7).

(2) "Batch or lot" means a uniquely processed quantity identified by a specific date and the timeframe between two consecutive cleanups.

(3) "Certificate of Analysis" (COA) means a document produced by a testing laboratory listing the quantities of the various analytes for which testing was performed.

(4) "Finished product" means a reasonably homogenous kratom product in its final packaged form.

(5) "Label" means the display of any written, printed, or graphic matter upon the immediate container of a kratom product or a statement by or under the control of the kratom processor [or distributor, ]which is directly related to the kratom product bearing the label.

(6) "Registrant" means a person who assumes responsibility for the compliance of the product registration.

(7) "Serving Size" means a [specific amount ]discrete unit of [food]product, measured as an integer[, that's used as a standard reference to

help consumers make informed choices].

(8) "Third-party Laboratory" means a laboratory that has no direct interest in a processor [or distributor ]of kratom products that can

perform mandated testing utilizing validated methods.

[(9) "Unapproved delivery form" means:

(a) any form that is combustible or intended to be used for vaporization; or

(b) any form that mimics a candy product or is manufactured, packaged, or advertised in a way that appeals to children.]

R66-51-3. Product Registration.

[(1) A registrant shall register any kratom product distributed, available for distribution, or that is intended to be offered for sale to an end

consumer, including on the internet or social media platforms, annually with the department.]

([2]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

([3]2) A single registration may include products that contain the same kratom ingredients in the same [kratom ]product delivery form but

in a different container or volume.

([4]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.

([5]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.

([6]5) The department shall deny or withdraw registration if:

(a) the kratom product violates Title 4, Chapter 45, Kratom [Consumer Protection ]Regulation Act;

(b) there is any reasonable basis to suspect that the kratom product is unsafe or that ingredients violate state law;

(d) the product contains an adulterant as defined in Section R66-52-2[a prohibited additive as outlined in Section R66-52-11].

(6) The department requires [A]a new registration application [is required ]for a change in the following:

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

(b) [a change to ]the recommended usage; or

(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[:

(a) ] violate [Chapter ]Title 4, Chapter [-]45, Kratom [Consumer Protection]Regulation Act.[; or

(b) are in an unapproved delivery form.]

R66-51-4. Product Renewal.

(1)(a) Beginning on May 1 of each year, a registrant shall renew a product registration by submitting payment of an annual renewal fee per kratom product on or before June 30.

(b) The department shall assess a late fee for a renewal of a kratom product registration submitted on or after July 1 and may not issue a renewal until paid.

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

R66-51-5. Certificate of Analysis.

(1) Testing shall be performed on finished products identified with a lot or batch number.

(2) At a minimum, the [certificate of analysis]COA for each batch of kratom product in its final form shall include the following test

results:

(a) the contents of mitragynine and 7-hydroxymitragynine in the kratom product certifying compliance with this rule[ and Subsection 4-

45-104(1)];

(b) microbials;

(d) pesticides; and

[(e) solvents; and]

([f]e) mycotoxins if requested by the department.

(3) The test results required in Section R66-51-5 shall be reported in accordance with the requirements for a kratom product in Rule R66-52, including the specified units of measure.

(4) The [certificate of analysis]COA shall also include the following information:

(a) the lot or batch identification number of the tested product;

(b) the date received;

(d) the method of analysis for each test conducted;

(e) proof that the certificate of analysis is connected to the product documented by:

(i) a photo of the kratom product that was tested; or

(ii) as determined by the department;

(f) the name of the kratom processor that manufactured the product; and

(g) the name and address of the laboratory that completed the testing.

(5) The lot or batch number on the certificate of analysis shall match the lot or batch number on the kratom product.

(6) An adverse or non-compliant test result shall be cause for denial of registration.

R66-51-6. Label Requirements.

(1) The label of a kratom product shall satisfy the requirements of Subsection 4-45-104(1)(b) and contain the following information,

legibly displayed:

(a) product name or common name, on the front of the label;

(b) the suggested use of the product, including serving size and recommended daily intake;

[(c) the amount of mitragynine and 7-hydroxymitragynine contained in the packaged kratom product;]

([d]c) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;

([e]d) identification of each kratom product by a unique batch or lot number, specifically linking each kratom product to a specific batch or

lot manufactured by the kratom processor;

([f]e) manufacturer, packer, or distributor name and address; and

([g]f) the following statements:

(i) "this product has not been evaluated by [the Food and Drug Administration]a governmental entity" or an equivalent statement; and

(ii) "this product is not intended to diagnose, treat, cure, or prevent any disease" or an equivalent statement.

(2) If there is not sufficient room on the kratom product label, the kratom product may include a scannable bar code, QR code, or web address linked to a document containing any additional required information.

[(3) A kratom product shall meet the standards of any applicable state laws and regulations relating to the labeling of food, including

Chapter 4-5, Utah Wholesome Food Act.]

([4]3) A kratom product label may not:

(a) [ contain claims that the product is intended to diagnose, treat, cure, or prevent any health condition or disease on the label or labeling

unless the product has been registered with the FDA;

(b) ] have any likeness bearing resemblance to a cartoon character or fictional character;

([c]b) appear to imitate a food or other product that is typically marketed toward, or that is appealing to children; or

([d]c) contain statements that remove responsibility or liability for the use of the product.

([5]4) A registrant misbrands a kratom product if:

(a) its label is false or misleading in any way; or

(b) it fails to conform to any requirement specified in this section.

R66-51-7. Product Appearance and Flavor.

(1) A kratom processor may not produce or package a kratom product that is designed to mimic a candy product.

[(2) A kratom processor may not produce a product that includes a candy-like flavor or another flavor that appeals to children.]

([3]2) A kratom processor may not shape a kratom product in any way that appeals to children.

([4]3) A kratom product shall be packaged in child-resistant packaging.

R66-51-8. Inspection and Testing.

(1) The department shall conduct a randomized inspection of kratom products distributed or available for distribution in the state for compliance with this rule.

(2) The department shall periodically sample, analyze, and test a kratom product distributed within the state for compliance with registration and labeling requirements and the certificate of analysis.

(a) Each department sample shall include at least ten grams of kratom product.

(b) The department may test a kratom product for [any substance listed in Rule R66-52 as well as for ]any substance the department deems

necessary.

(c) A kratom product that is found to contain a prohibited substance shall be considered adulterated in violation of this rule.

(3) The department may conduct an inspection of kratom products distributed or available for distribution for any reason the department deems necessary.

(4) The sample taken by the department shall be the official sample.

(5) Upon request, a kratom processor shall provide documentation certifying that any batch of kratom raw materials acquired pursuant to a compliant specification purchase that is used to process or manufacture a kratom product is compliant with Section R66-51-5.

R66-51-9. Violation.

(1) Each improperly labeled kratom product shall be a separate violation of this rule.

(2) Kratom products not meeting the labeling requirements shall be considered misbranded.

(3) Kratom products shall be considered falsely advertised if they do not meet the labeling requirements of this rule.

(4) It is a violation to distribute or market a kratom product that is not registered with the department.

(5) It is a violation to distribute or market a kratom product that contains 7-OH at greater than [2].4% of the alkaloid composition.

(6) It is a violation to distribute or market a kratom product that has not been tested as required by Rule R66-52.

(7) It is a violation to distribute or market a kratom product that is marketed toward or is appealing to children.

(8) It is a violation to submit a fraudulent COA to the department.

KEY: kratom, kratom processor, product registration, labeling

Date of Last Change: 2026[September 22, 2025]

Authorizing, and Implemented or Interpreted Law: 4-45-107

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