(4) "Analyte" means a substance or chemical component undergoing analysis.(5) "Certificate of Analysis (COA)" means a certificate from a laboratory describing the results of the laboratory's analytical testing of a sample.
(6) "Extract" means:
(a) the product of any chemical or physical process applied to naturally occurring biomass that concentrates or isolates the alkaloid contained in the biomass; and
(b) any amount of a natural, derivative, or synthetic alkaloid in the synthetic alkaloid's purified state.
(7) "Foreign matter" means any matter that is present in a kratom:
(a) lot that is not a part of the kratom plant; or
(b) product that is not listed as an ingredient.
(8) "Kratom manufacturer" means an entity that holds, stores, packages, or labels a kratom product.
(9) "Pesticide" means any:
(a) substance or mixture of substances, including a living organism, that is intended to prevent, destroy, control, repel, attract, or mitigate any insect, rodent, nematode, snail, slug, fungus, weed, or other forms of plant or animal life that are normally considered to be a pest or that the commissioner declares to be a pest;
(b) any substance or mixture of substances intended to be used as a plant regulator, defoliant, or desiccant; and
(c) any spray adjuvant, such as a wetting agent, spreading agent, deposit builder, adhesive, or emulsifying agent with deflocculating properties of its own, used with a pesticide to aid in the application or effect of a pesticide.
(10) "Total alkaloid" means the sum of the determined amount of alkaloids from Mitragyna speciosa.
R66-52-3. Required Kratom Product Tests.
(1) Testing shall be performed on finished products identified with a lot or batch number.
(2) A kratom manufacturer may not register or sell a kratom product unless a third-party ISO/IEC 17025:2017 accredited testing laboratory has tested a representative sample of the kratom product to determine:
(a) the amount of any alkaloids present in the sample; and
(b) the presence of adulterants in the sample.
(3) Each batch or lot of kratom product shall include a certificate of analysis, in accordance with Section R66-51-5.
R66-52-4. Foreign Matter Standards.
A sample and related batch of kratom product fail quality assurance testing if:
(1) the sample contains foreign matter visible to the unaided human eye;
(2) the sample is found to contain microscopic foreign matter considered to be harmful or estimated to comprise greater than 3% of the mass of the representative sample as determined by the testing laboratory; or
(3) foreign matter is found that is suspected to have been intentionally added to the sample to increase its visual appeal or market value.
R66-52-5. Potency Testing and Standards.
(1) At a minimum, the [certificate of analysis]COA for each batch of kratom product shall include the following test results, when applicable: (a) the contents of mitragynine and 7-hydroxymitragynine in the kratom product certifying compliance with this rule and Subsection 4-45-104(1);
(i) the department may require testing of alkaloid content of a kratom product by the department lab for verification, at the cost of the registrant.
(b) the level of microbials in the kratom product that does not exceed the amounts listed in Table 1 when one gram or greater sample is tested;
(c) the levels of heavy metals in the kratom product that do not exceed the amounts listed in Table 2;
(d) the levels of pesticides in the kratom product do not exceed the amounts listed in Table 3;
(e) the levels of residual solvents in the kratom product that do not exceed the amounts listed in Table 4; and
(f) if required by the department, mycotoxin levels that are compliant with Section R66-52-10.
R66-52-6. Microbial Standards.
(1) A sample and related batch of kratom product fail quality assurance testing for microbiological contaminants if the results exceed the limits in Table 1.
TABLE 1
Kratom Plant Matter
Microbial Limit Requirement
Total Aerobic Microbial Count
Total Combined Yeast and Mold
Salmonella spp.,
Shiga-toxin producing E. coli (STEC),
Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, and Aspergillus terreusc
