Agriculture and Food

Specialized Products

Rule 51: Kratom Product Registration and Labeling

Effective Date: 03/04/2026

Admin. Code Reference: R66-51

Rule Type: Expired Emergency Rule

NOTICE OF EMERGENCY (120-DAY) RULE

Rule or section Number:

R66-51

Filing ID: 57833

Effective date:

03/04/2026

Agency Information

1. Title catchline:

Agriculture and Food, Specialized Products

Building:

Taylorsville State Office Building, 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:

Camille Knudson

801-597-6010

camillek@utah.gov

Brandon Forsyth

801-710-9945

bforsyth@utah.gov

Amber Brown

385-245-5222

ambermbrown@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)

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

The Department of Agriculture and Food (Department) is filing this emergency rule to maintain existing regulatory standards while the Utah Legislature finalizes the statutory framework for kratom. SB 45 (2026 General Session) initially proposed a total ban on kratom products by classifying them as Schedule I controlled substances. However, recent legislative substitutes have shifted toward a restrictive "pure leaf" model and new retail licensing requirements.

Because the legislative intent moved from total prohibition to a complex regulatory transition, the Department has deferred permanent rulemaking to avoid implementing standards that would be immediately invalidated or contradicted by the final enacted law.

5. Summary of the new rule or change:

This emergency filing maintains the labeling and registration standards established on 11/04/2025, while the Department awaits the outcome of SB 45 (2026), which initially proposed a total ban on kratom before moving toward a "pure leaf" regulatory model.

This rule strikes the requirement for child-resistant packaging in Section R66-51-7 to resolve conflicts with federal authority and replaces "Food and Drug Administration" with "governmental entity" in labeling requirements to correctly identify state oversight.

Additionally, the term "children" is replaced throughout this rule with "an individual under 18 years old" to align with state statutory definitions. These changes ensure an enforceable regulatory framework exists until the new statutory mandates take effect.

6A. The agency finds that regular rulemaking would:

☐

cause an imminent peril to the public health, safety, or welfare;

☐

cause an imminent budget reduction because of budget restraints or federal requirements; or

☒

place the agency in violation of federal or state law.

B. Specific reasons and justifications for this finding:

Regular rulemaking would place the Department in violation of state law because it would require the agency to finalize permanent rules based on revising the current statutory framework. The initial version of SB 45 (2026) would have rendered all current administrative rules for kratom obsolete by banning the product entirely.

With the bill's evolution into a restrictive licensing and "pure leaf" model, the Department must wait for the final codified language to ensure permanent rules regarding testing (R66-52), labeling (R66-51), and permitting (R66-50) are legally consistent with the new mandates.

(EDITOR'S NOTE: The emergency rule for Rule R66-50, ID 57832, and the emergency rule for Rule R66-51, ID 57833, and the emergency rule for Rule R66-52, ID 57834, all effective on 03/04/2026, are in this issue, April 1, 2026, of the Bulletin.)

Fiscal Information

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

A. State budget:

This filing has a neutral fiscal impact as it maintains the current operational status quo and avoids administrative waste by delaying permanent rulemaking until the final statutory requirements of SB 45 (2026) are established.

B. Local governments:

This filing has no fiscal impact on local governments as the Department maintains exclusive authority over kratom product registration; local entities do not participate in the program.

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

This filing has a neutral fiscal impact on small businesses as it maintains current regulatory requirements and avoids potential compliance costs associated with technically unenforceable or legally preempted standards.

D. Persons other than 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 filing has a neutral fiscal impact on other persons, including consumers, as it ensures continued market access to registered products while maintaining current safety standards during the legislative transition.

E. Compliance costs for affected persons:

There are no anticipated compliance costs for affected persons, as the Department's administration of the registration and labeling program remains unchanged by this extension.

F. Comments by the department head on the fiscal impact this rule may have on businesses (Include the name and title of the department head):

This rule will not have a fiscal impact on businesses. Kelly Pehrson, Commissioner

Citation Information

8. 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

Agency Authorization Information

Agency head or

designee and title:

Kelly Pehrson, Commissioner

Date:

03/04/2026

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 of food, measured as an integer, that['s] is 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]an individual

under 18 years old.

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) 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) A single registration may include products that contain the same kratom ingredients in the same kratom delivery form but in a different container or volume.

(4) 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) A registrant shall pay the 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) The department shall deny or withdraw registration if:

(a) the kratom product violates Title 4, Chapter 45, Kratom Consumer Protection 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 a prohibited additive as outlined in Section R66-52-11.

(6) The department requires [A]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; 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 4-45 Kratom Consumer Protection 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 registrant shall continue to register discontinued kratom products [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 (COA).

(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;

(e) solvents; and

(f) 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]COA 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 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;

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

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

(g) 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]rules relating to the labeling of food, including

Title 4, Chapter [4-]5, Utah Wholesome Food Act.

(4) A kratom product label may not:

(a) contain claims that the product [is ]intends[ed] 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) appear to imitate a food or other product that is typically marketed toward or that is appealing to [children]an individual under 18 years

old; or

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

(5) 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 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]an

individual under 18 years old.

(3) A kratom processor may not shape a kratom product in any way that appeals to [children]an individual under 18 years old.

[(4) 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]COA.

(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) The department shall consider [A]a kratom product that [is found to ]contains a prohibited substance [shall be considered]as adulterated

and 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% 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]an individual under 18

years old.

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

KEY: kratom, kratom processor, product registration, labeling, inspection, and testing

Date of Last Change: March 4, 2026[September 22, 2025]

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

!--dar--

NOTICE OF EMERGENCY (120-DAY) RULE

Rule or section Number:

R66-51

Filing ID: 57833

Effective date:

03/04/2026

Agency Information

1. Title catchline:

Agriculture and Food, Specialized Products

Building:

Taylorsville State Office Building, 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:

Camille Knudson

801-597-6010

camillek@utah.gov

Brandon Forsyth

801-710-9945

bforsyth@utah.gov

Amber Brown

385-245-5222

ambermbrown@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)

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

5. Summary of the new rule or change:

6A. The agency finds that regular rulemaking would:

☐

cause an imminent peril to the public health, safety, or welfare;

☐

cause an imminent budget reduction because of budget restraints or federal requirements; or

☒

place the agency in violation of federal or state law.

B. Specific reasons and justifications for this finding:

Fiscal Information

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

A. State budget:

B. Local governments:

This filing has no fiscal impact on local governments as the Department maintains exclusive authority over kratom product registration; local entities do not participate in the program.

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

E. Compliance costs for affected persons:

There are no anticipated compliance costs for affected persons, as the Department's administration of the registration and labeling program remains unchanged by this extension.

F. Comments by the department head on the fiscal impact this rule may have on businesses (Include the name and title of the department head):

This rule will not have a fiscal impact on businesses. Kelly Pehrson, Commissioner

Citation Information

8. 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

Agency Authorization Information

Agency head or

designee and title:

Kelly Pehrson, Commissioner

Date:

03/04/2026

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.

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

(7) "Serving Size" means a specific amount of food, measured as an integer, that['s] is 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]an individual

under 18 years old.

R66-51-3. Product Registration.

(2) 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) A single registration may include products that contain the same kratom ingredients in the same kratom delivery form but in a different container or volume.

(4) 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.

(iii) A third-party laboratory may test a kratom product before obtaining ISO/IEC 17025:2017 accreditation, provided the third-party laboratory:

(5) A registrant shall pay the 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) The department shall deny or withdraw registration if:

(a) the kratom product violates Title 4, Chapter 45, Kratom Consumer Protection 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 a prohibited additive as outlined in Section R66-52-11.

(6) The department requires [A]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; 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 4-45 Kratom Consumer Protection 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 registrant shall continue to register discontinued kratom products [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 (COA).

(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;

(e) solvents; and

(f) 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]COA 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 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;

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

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

(g) 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.

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

Title 4, Chapter [4-]5, Utah Wholesome Food Act.

(4) A kratom product label may not:

(a) contain claims that the product [is ]intends[ed] 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) appear to imitate a food or other product that is typically marketed toward or that is appealing to [children]an individual under 18 years

old; or

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

(5) 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 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]an

individual under 18 years old.

(3) A kratom processor may not shape a kratom product in any way that appeals to [children]an individual under 18 years old.

[(4) 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.

(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) The department shall consider [A]a kratom product that [is found to ]contains a prohibited substance [shall be considered]as adulterated

and 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% 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]an individual under 18

years old.

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

KEY: kratom, kratom processor, product registration, labeling, inspection, and testing

Date of Last Change: March 4, 2026[September 22, 2025]

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

!--dar--

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Rule 51: Kratom Product Registration and Labeling