(1) Prior to marijuana items being sold or transferred to a registered cardholder the container holding the usable marijuana items must have a label that has the following information:

(a) licensee business or trade name and licensee registration number;

(b) date of harvest of marijuana or date the marijuana item was manufactured;

(c) name of strain or marijuana item (common or usual name);

(d) net weight or volume in U.S. customary and metric units;

(e) concentration by weight or volume of THC, THCA, CBD, and CBDA; and

(f) unique identification number.

(2) Labels must include a consumer warning that states:

(a) "For use by Montana Medical Marijuana Program registered cardholders only. Keep out of reach of children.";

(b) "It is illegal to drive a motor vehicle while under the influence of marijuana."; and

(c) "This product is not approved by the U.S. Food and Drug Administration (FDA) to treat, cure, or prevent any disease."

(3) If the marijuana item has passed required testing, the licensee must include on the label: "This Product Has Been Tested and Meets the Quality Assurance Requirements of the State of Montana."

(4) Licensees with ten or fewer registered cardholders who are not required to submit marijuana items for testing and have not submitted marijuana items for testing must include on the label: "This Product Has Not Been Tested for compliance with Quality Assurance Requirements of the State of Montana."

(5) Additional labeling requirements for marijuana topicals, ointments, suppositories, and other marijuana products not intended to be administered orally must include:

(a) "DO NOT EAT" in bold capital letters; and

(b) a list of ingredients in descending order or predominance by weight or volume used to process the product.

(6) Additional labeling requirements for edible marijuana products and tinctures must include:

(a) "BE CAUTIOUS" in bold capital letters, followed by "This product can take up to two hours or more to take effect";

(b) if the marijuana item is perishable, a statement that the marijuana item must be refrigerated or kept frozen;

(c) list of potential major food allergens;

(d) a "contains" statement to summarize the major food allergen information at the end of or immediately adjacent to the ingredient list; or

(e) a statement of the appropriate major food allergen in parenthesis within the ingredient list after the common or usual name of the ingredient derived from that major food allergen.

(7) Additional labeling requirements for marijuana concentrates and extracts must include:

(a) "DO NOT EAT" in bold capital letters;

(b) extraction method and solvent.

(8) Labels required by these rules must:

(a) be placed on the container and on any packaging, that is used to display marijuana items for sale or transfer to a registered cardholder;

(b) be in no smaller than eight point Times New Roman, Helvetica, or Arial font;

(c) be in English; and

(d) be unobstructed and conspicuous.

(9) Marijuana items may have one or more labels affixed to the container or packaging if necessary.

(10) Licensees may use a peel-back or accordion label with the required information if the peel-back or accordion label can be easily identified by a registered cardholder as containing important information.

(11) A label may not:

(a) contain any untruthful or misleading statements; or

(b) be attractive to minors. For the purpose of this rule, "attractive to minors" means packaging, labeling and marketing that features:

(i) cartoons;

(ii) designs, brands, or names that resemble a non-cannabis consumer product of the type that is typically marketed to minors;

(iii) symbols or celebrities that are commonly used to market products to minors;

(iv) images of minors; or

(v) words that refer to products that are commonly associated with minors or marketed by minors.

(12) If a marijuana item is placed in a package that is being reused, the old label or labels must be removed and it must have a new label or labels.

(13) Exit packaging must contain a label that reads: "Keep out of the reach of children."