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:
a) violates Title 4, Chapter 45, Kratom Consumer Protection Act;
b) is adulterated with foreign materials that would be injurious to a consumer;
c) makes a material change in the alkaloid content of the kratom product; or
d) 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 a one-year period 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 in Utah 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.
R70-580-4. Establishment Registration.
1) Pursuant to Subsection 4-45-104(5), a kratom processor shall register as a food establishment under Section 4-5-301.
2) A kratom processor may be registered in another state that meets or exceeds the requirements in Section 4-5-301, if they provide the
department with a copy of the registration from the federal or state regulatory agency.
3) A kratom processor shall be subject to any statutes, rules, regulations, policies, and procedures for food establishments specific to the
form of the kratom product offered for sale in Utah.
4) A kratom processor shall not have more than one DBA.
5) The application for registration shall include a certification that the kratom processor maintains a master manufacturing record (MMR)
that documents:
a) batch-to-batch uniformity;
b) that each batch conforms to kratom raw material specifications;
c) that each batch record shows that each step of the MMR was performed;
d) that the product processes, controls, and tests ensure reliable, reproducible results; and
e) that the finished kratom product meets each specification before the product is released for distribution.
5) MMR testing shall be performed on finished kratom product as identified by lot or batch number.
6) Each MMR shall also include the following information:
a) the lot or batch identification number of the tested product;
b) the date received;
c) the date of testing completion;
d) the method of analysis for each test conducted;
e) a photo of the kratom product that was tested;
f) the name and address of the kratom processor that manufactured the product; and
g) the name and address where the MMR records are maintained and available for inspection by the department.
R70-580-5. Certificate of Analysis.
1) At a minimum, the certificate of analysis for each batch of kratom product 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) at a minimum, test results that indicate:
i) that the level of pathogens in the kratom product do not exceed the amounts listed in Table 1 when a one gram or greater sample is tested;
TABLE 1
Microbial Analytes and Action Levels
Microbial Limit Requirement
Total Aerobic Microbial Count NMT ≤10,000,000 cfu/g
Total Combined Yeast and Mold NMT ≤100,000 cfu/g
Total Bile-tolerant Gram-negative Bacteria NMT <10,000 cfu/g
Absence of Salmonella spp. & E. coli in 100g
ii) that the levels of heavy metals in the kratom product do not exceed the amounts listed in Table 2;
TABLE 2
Heavy Metals
Metals Natural Health Products Acceptable
limits in parts per million
Arsenic <2
Cadmium <0.82
Lead <1.2
Mercury <0.4
2) Testing shall be performed on finished kratom product as identified by lot or batch number.
3) The certificate of analysis shall also include the following information:
a) the lot or batch identification number of the tested product;
b) the date received;
c) the date of testing completion;
d) the method of analysis for each test conducted;
e) a photo of the kratom product that was tested;
f) the name and address of the kratom processor that manufactured the product; and
g) the name and address of the laboratory that completed the testing.
4) The lot or batch number on the certificate of analysis shall match the lot or batch number on the kratom product and shall be conspicuously
placed on the container or label of the kratom product.
5) Upon receipt of an adverse or non-compliant test result, the kratom processor shall be required to produce a new certificate of analysis
from an independent third-party laboratory on the reported product to affirm compliance.
6) Failure to submit a new certificate of analysis shall be cause for withdrawal or denial of a product registration.
7) Mycotoxin testing of a kratom product may be required if the department has reason to believe that mycotoxins may be present.
R70-580-6. Label Requirements.
1) A kratom product shall be labeled pursuant to 21 CFR 101.1, 21 CFR 101.2, 21 CFR 101.3, 21 CFR 101.4, 21 CFR 101.5, 21 CFR 101.7,
21 CFR 101.9(j)(13), 21 CFR 101.9(j)(17), 21 CFR 101.15, and 21 CFR 101.36.
2) The label shall contain the factual basis upon which the kratom processor represents the product as a kratom product.
3) The label shall identify kratom product by batch or lot number for each container that shall match the batch and lot number on the
certificate of analysis.
4) A kratom product shall not contain claims that the product is intended to diagnose, treat, cure, or prevent any medical condition or disease
on the label.
5) Each kratom product label shall include the following text pursuant to 21 CFR 101.93 (c), prominently displayed:
"This product has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent
any disease."
6) A kratom product shall meet the standards in 21 U.S.C. 9, the Food Drug and Cosmetic Act, other applicable federal laws and regulations,
and all applicable state laws and regulations relating to the labeling of food and cosmetics.
7) If there is not sufficient room on the kratom product label, the kratom product shall display on the label a scannable bar code, QR code,
or web address linked to a document containing the information required in Subsections (1) through (6).
8) No other information, illustration, or depiction shall appear on the label.
R70-580-7. 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 the facility knows or should know
appeals to children.
3) A kratom processor may not shape a kratom product in any way that appeals to children, including fruit, stars, cartoon renderings, humans,
and animals.
4) A kratom product shall be packaged in child-resistant packaging, pursuant to 16 CFR 1700.
R70-580-8. Inspection and Testing.
1) The department shall conduct randomized inspection of the kratom product 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 Utah 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 kratom product for any substance listed in Subsection R70-580-5(1) as well as for any of the following, at the
discretion of the department:
i) any pesticide;
ii) any fentanyl derivative;
iii) any of the following cannabinoids with an action level of 0.01% (w/w):
A) delta-9-THC;
B) delta-8-THC;
C) THCA;
D) CBD;
E) CBDA;
F) CBG;
G) CBGA; or
H) any other cannabinoid tested for by the laboratory with an action level of 0.01% (w/w);
iv) cocaine; or
v) any of the following Benzodiazepines:
A) diazepam;
B) alprazolam;
C) triazolam;
D) lorazepam; or
E) clonazepam.
c) Kratom product that is found to contain a prohibited substance shall be considered adulterated in violation of this rule.
3) The department may conduct inspection of any kratom product distributed or available for distribution if there is any reasonable basis to
suspect that the kratom product is unsafe or that ingredients violate state law or rules.
4) The test results from the department inspection samples shall be the official sample results.
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 R70-580-5.
R70-580-9. Retailer Responsibilities.
1) A retailer shall:
a) ensure that kratom product is labeled correctly; and
b) ensure that kratom product offered for sale is properly registered with the department.
2) A retailer shall provide the identity of the processor of a kratom product sold by the retailer upon request of the department.
3) A retailer shall register a kratom product in lieu of the kratom processor if the product is not registered.
R70-580-10. Violation.
1) Each improperly labeled kratom product shall be a separate violation of this rule.
2) A kratom product shall be considered misbranded if it does not meet the labeling requirements of this rule.
3) A kratom product shall be considered adulterated if it is found to contain pathogenic microorganisms, mold, or fungus.
4) It is a violation to distribute or market a kratom product that is not registered with the department.
5) Each unit manufactured or processed from a batch of raw material or on a single retail invoice shall be considered a separate violation of
this rule for an unregistered product marketed for sale.
6) It is a violation:
a) to prepare, distribute, sell, or offer for sale a kratom product that violates Subsection 4-45-104 (1);
b) to prepare, distribute, sell, or offer for sale a kratom product that is not in an approved kratom delivery form, including adding or processing
kratom into another form of food;
c) to prepare, distribute, sell, or offer for sale a kratom product that would be potentially harmful to consumers;
d) for a kratom processor to fail to register as a food establishment pursuant to Section 4-5-301 or Subsection R70-580-4(2);
e) for a kratom processor to distribute, sell, or offer for sale a kratom product to an individual under 18 years of age; and
f) for a kratom processor to improperly sample, test, falsify a certificate of analysis, or knowingly submits a falsified certificate of analysis
for a kratom product.
R70-580-11. Penalties.
Any violation of or failure to comply with any provision of this rule or any specific requirements, may be grounds for issuance of citations,
fines, recall of kratom product, revocation of registration, or denial of future registration pursuant to Section 4-2-303 and 4-2-304.
KEY: kratom, kratom product registration, kratom processor
Date of Enactment or Last Substantive Amendment: April 2, 2021
Authorizing, and Implemented or Interpreted Law: 4-45-107