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

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

   1. (a) the contents of mitragynine and 7-hydroxymitragynine in the kratom product certifying compliance with this rule and Subsection 4-45-104(1);
   2. (b) microbials;
   3. (c) heavy metals;
   4. (d) pesticides;
   5. (e) solvents; and
   6. (f) mycotoxins if requested by the department.
3. (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. (4) The certificate of analysis shall also include the following information:

   1. (a) the lot or batch identification number of the tested product;
   2. (b) the date received;
   3. (c) the date of testing completion;
   4. (d) the method of analysis for each test conducted;

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

      1. (i) a photo of the kratom product that was tested; or
      2. (ii) as determined by the department;
   6. (f) the name of the kratom processor that manufactured the product; and
   7. (g) the name and address of the laboratory that completed the testing.
5. (5) The lot or batch number on the certificate of analysis shall match the lot or batch number on the kratom product.
6. (6) An adverse or non-compliant test result shall be cause for denial of registration.

KEY: kratom, kratom processor, product registration, labeling

Date of Last Change: September 22, 2025

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