(1) "Advertised Cannabinoid" means a cannabinoid listed on the product or label.(2) "Batch or lot" means a quantity of cannabinoid product produced on a particular date and time, following clean up until the next clean up during which industrial hemp concentrate is used.
(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) "Conventional Food" means:
(a) an article used for food or drink for human consumption or the components of the article; or
(b) chewing gum or chewing gum components.
(5) "Industrial Hemp" means any part of a cannabis plant, whether growing or not, with a concentration of less than 0.3% tetrahydrocannabinol by weight.
(6) "Label" means the display of each written, printed, or graphic matter upon the immediate container or statement accompanying a cannabinoid product.
(7) "Third-party laboratory" means a laboratory with no direct interest in a grower or processor of industrial hemp or cannabinoid products that is capable of performing mandated testing utilizing validated methods.
R66-35-3. Product Registration.
(1) To register a cannabinoid product, a registrant shall submit an application to the department that includes the following information:
(a) a complete copy of the label as it will appear on the product in a legible format;
(b) a COA from the department's analytical laboratory for the amount of any THC analogs present in the sample; and
(c) a COA from the department's analytical laboratory or a third party testing laboratory for adulterants presence as required in this rule.
(2) The department may deny registration for an incomplete application.
(3) The department requires a new registration for any of the following changes:
(a) in the cannabinoid product ingredients;
(b) to the directions for use; and
(c) of the name for the product.
(4) 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. (5) The registrant is responsible for the accuracy and completeness of information submitted.
(6) The department may not register a cannabinoid product if the product:
(a) uses the cannabinoid as a food additive; or
(b) is represented for use as a conventional food, [with the exception of]except for: (i) a gummy [if the gummy is ]shaped as a gelatinous cube, [or ]gelatinous rectangular cuboid, or [in ]another basic geometric shape [and not in a shape that could be considered]that does not appeal[ing] to children, such as a star shape, fruit, or animal shape; or (ii) a liquid suspension under two ounces.
R66-35-4. Certificate of Analysis (COA).
(1) Conduct testing on the product in its final form within 12 months of registration for:
(a) the cannabinoid profile by percentage of mass, performed by the [D]department's analytical laboratory; (b) solvents;
(c) pesticides;
(d) microbials;
(e) heavy metals; and
(f) mycotoxins.
(2) Report test results required in Subsection R66-35-4(1) in accordance with Rule R66-31, including the specified units of measure.
(3) The COA shall include the following information:
(a) the batch identification number;
(b) the date the laboratory received the sample;
(c) the date of test completion;
(d) the method of analysis for each test conducted; and
(e) proof that the COA connects to the product.
R66-35-5. Label Requirements.
(1) A cannabinoid product label shall legibly display the following information:
(a) product name or common name, on the front of the label;
(b) brand name, on the front of the label;
(c) the size of the container or net count of individual items, on the front of the label;
(d) the suggested use of the product, including serving size if the product is intended for consumption;
(e) list of ingredients, including:
(i) the amount of any advertised cannabinoid listed as present on the COA; and
(ii) the amount of any THC or any THC analog listed as present on the COA;
(f) manufacturer, packer, or distributor name and address, as verified through the application; and
(g) batch number.
(2) The label of each product intended for human consumption [or intended to be vaporized for inhalation ]shall include the following text, 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." or a similar statement. (3) In addition to the requirements of Subsections R66-35-5(1) through R66-35-5(5), a cannabinoid product label shall include a scannable barcode, QR code, or web address with an easily located COA for the batch identified, containing the information required in Section R66-35-4.
[(4) Cannabinoid products may not contain medical claims on the label.] ([5]4) Cannabinoid product labeling may not: