To register a kratom product with the Specialized Products Division, product Labeling and a Certificate of Analysis (COA) must be submitted with each product that demonstrates that the kratom product meets specific safety and quality standards. 

The information outlined below is not inclusive of all requirements contained within the KCPA, R66-51 Kratom Product Registration and Labeling, and R66-52 Kratom Product Testing. You need to read them in their entirety, as you are responsible for those requirements as well.

Requirements for Certificates of Analysis (COA)

The certificate of analysis must:

• • Come from a third-party laboratory that holds and maintains International Organization for Standardization (ISO) 17025:2017 accreditation.
    • A third-party laboratory may test kratom products before obtaining ISO/IEC 17025:2017 accreditation if they adopt and follow minimum good laboratory practices (OECD Principles) and are working to become ISO/IEC 17025:2017 accredited.

The COA submitted for product registration must include the following information:

• • The lot or batch identification number of the tested product.
    • Must match the lot/batch number on the kratom product.
  • The date received.  
  • The date of testing completion.
    • Performed within the last 6 months prior to registration.
  • The method of analysis for each test conducted.  
  • A photo of the kratom product that was tested.  
  • The name and address of the kratom processor that manufactured the product.  
  • The name and address of the laboratory that completed the testing.  

Required Testing for Product Registration

Testing must be performed on the finished product in its final packaged form.

• • Mitragynine and 7-hydroxymitragynine content:
    • The product must have <2% 7-OH of the kratom alkaloid fraction.  
  • Foreign Matter Testing: 
    • The sample can’t contain visible foreign matter or microscopic matter considered to be harmful.
  • Microbial Standards: Must not exceed the amounts listed in Table 1.
  • Heavy Metal Standards: Must not exceed the amounts listed in Table 2.
  • Pesticide Standards: Must not exceed the amounts listed in Table 3.
  • Residual Solvent Standards: Must not exceed the amounts listed in Table 4.
  • Mycotoxin(When Requested): Must not exceed the amounts listed in Table 5.
  • Additives: A kratom product can not contain controlled substances as defined in Section 58-37-2; psilocin, muscimol, ibotenic acid, muscarine, any cannabinoids, or anything else the department deems to be deleterious.

All Tables can be found in R66-52 Kratom Product Testing

Product Categories:

Labeling Requirements

Accurate and compliant labeling is essential for all kratom products

General Labeling Standard:

• • The label shall identify the product by a unique batch or lot number.
    • This number must match the lot or batch number on the Certificate of Analysis (COA).
  • The suggested use of the product, including serving size (measured as an integer) and recommended daily intake.
  • The amount of mitragynine and 7-hydroxymitragynine.
  • The manufacturer, packer, or distributor name and address.
  • A statement similar to “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”.

Prohibited Labeling Claims and Marketing:

• • Any 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.
  • Any likeness bearing resemblance to a cartoon character or fictional character.
  • Appear to imitate a food or other product that is typically marketed toward or that is appealing to an individual under 18 years of age.
    • This includes candy-like flavors or another flavor that appeals to children.
  • Any statements that remove responsibility or liability for the use of the product.

Departmental Testing and Enforcement

The Specialized Products Division conducts randomized inspections and periodically samples, analyzes, and tests kratom products distributed in Utah for compliance with registration, labeling, and COA requirements.

A kratom product that is found to be non-compliant can lead to withdrawal or denial of product registration.

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