Mo. Code Regs. tit. 19 § 100-1.120

Current through Register Vol. 49, No. 20, October 15, 2024

Section 19 CSR 100-1.120 - Packaging, Labeling, and Product Design

PURPOSE: Under Article XIV, Sections 1 and 2 of the Missouri Constitution, the Department of Health and Senior Services is authorized to promulgate rules necessary to ensure the safe use of marijuana product, including rules related to labeling and packaging standards. This rule explains what packaging, labeling, and product design regulations apply to all medical and marijuana facility licensees.

(1) All marijuana product shall be produced, packaged, and labeled in a manner that protects public health and is not attractive to children.

(A) No marijuana product may be manufactured, packaged, or labeled in a false or misleading manner, such as by inaccurately representing product ingredients.

(B) Product and packaging design.

1. No marijuana product or packaging may be designed using the shape or any part of the shape of a human, animal, or fruit, including realistic, artistic, caricature, or cartoon renderings.

2. No marijuana product or packaging may be designed in such a way as to cause confusion between a marijuana product and any product not containing marijuana, such as where products or packaging are visually similar to any commercially similar product that does not contain marijuana.

3. All marijuana product packaging, with the exception of marijuana seeds and plants, shall be resealable, opaque, and certified as child resistant. Where marijuana product is packaged in a series of containers, the container closest to the product, excluding methods of administration or wrappers, must be compliant with this requirement.

4. All marijuana product packaging, with the exception of marijuana seeds and plants, shall be constructed from FDA-approved food contact substances. Where marijuana product is packaged in a series of containers, the container closest to the product, including methods of administration or wrappers, must be compliant with this requirement, unless the department approves application of this rule to a different container in the series.

5. All marijuana product packaging design, including that for exit packaging, may only utilize-

A. Limited colors, including a primary color as well as up to two (2) logos or symbols of a different color or colors, whether images or text, including brand, licensee, or company logos, provided that the widest part of a logo or symbol is no wider than the length or height, whichever is greater, of the word "Marijuana" on the packaging;

B. A product name;

C. Text indicating side effects and behavioral effects of usage;

D. A label required by this rule; and

E. A QR code linking to a website where a purchaser can learn more about the product.

6. Marijuana product packaging must be in compliance with applicable local, state, and federal requirements.

(C) Labeling. Except as specifically identified herein, labeling requirements apply to containers, wrappers, packages, and methods of administration that contain marijuana product, except seeds or plants. The labels required herein are not required on the paper for prerolls.

1. Unless alternative placement of "Marijuana" or the universal symbol has been approved by the department, all marijuana product shall be clearly and conspicuously labeled with "Marijuana" printed at least as large as any other words used, as well as a prominently displayed universal symbol in red and white print that consists of the following:

A. A diamond containing the letters "THC";

B. The letter "M" located under the "THC" within the diamond; and

C. For infused products, the number of milligrams of THC in the package, placed directly under the diamond.

2. Unless alternative placement of a label has been approved by the department, the marijuana product container closest to the product shall bear a label displaying only the following information, in the following order, from top to bottom and left to right:

A. All active and other ingredients, which shall not include groupings of ingredients that obscure the actual ingredients, such as "natural flavors" or "botanically derived terpenes" and shall include solvents used in the manufacturing process;

B. Servings and doses per package for marijuana licensees or doses per package for medical licensees;

C. A "best if used by" date;

D. The license number of the licensed entity from which the final marijuana product originated;

E. The testing licensee where the final marijuana product passed mandatory testing;

F. The state-wide track and trace system tag number associated with the mandatory testing results for the final marijuana product;

G. The exact total weight of the marijuana included in the package-

(I) For dried, unprocessed marijuana, concentrates, prerolls, and infused prerolls, weight shall be listed in grams;

(II) For infused products other than infused prerolls, weight shall be listed by milligrams of delta 9 tetrahydrocannabinol;

H. The exact delta-9-tetrahydrocannabinol ([DELTA]9-THC), delta-9-tetrahydrocannabinolic acid ([DELTA]9-THCA), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabinol (CBN), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), and delta 8 tetrahydrocannabinol ([DELTA]8-THC) per serving/dose, listed in milligrams;

I. Results of terpene analysis, if tested during mandatory testing;

J. Instructions for use;

K. Estimated length of time the serving or dosage will have an effect;

L. The department-issued product packaging approval number;

M. The following warning: "Cognitive and physical impairment may result from the use of marijuana. Keep out of reach of children."

3. Marijuana seeds and plants shall be clearly and conspicuously labeled with "Marijuana" printed at least as large as any other words used on the packaging and a universal symbol designed as described in this rule.

A. Marijuana seed packaging must bear a label with the strain information.

B. Marijuana plant packaging must bear a label with the strain information and propagation date.

4. Marijuana product packaging may not contain any information other than that specifically required by this subsection, except information to be in compliance with applicable local, state, and federal requirements.

(2) Prior to use, all marijuana product designs, packaging designs, and label designs must be submitted to the department for review of compliance with section (1) of this rule.

(A) Submission must be made through a department provided, web-based system by the licensee that is responsible for ensuring compliant packaging and labeling, pursuant to section (3) of this rule.

(B) Within thirty (30) days of submission, the department will communicate in writing to the licensee whether the submission is complete.

1. If deemed incomplete, the department will identify reasons why it determined the submission is incomplete and will deny the application.

2. If deemed complete, the submission will be approved or denied within sixty (60) days of the original submission.

(C) Once a design has been approved, the licensee will receive an approval number for the marijuana product, packaging, and label design, as a whole.

(3) All marijuana product shall be compliantly packaged and labeled by the cultivation, manufacturing, or microbusiness wholesale facility providing the final marijuana product for sale except where cultivation or microbusiness wholesale facilities are providing dried, unprocessed marijuana to dispensary licensees for use in creating prerolls or for dispensing directly to consumers or qualifying patients in custom amounts. In such a case, the dispensary facility is responsible for ensuring the product is compliantly packaged and labeled prior to sale.

(4) Final marijuana product shall not be packaged in a manner that exceeds three (3) ounces of dried, unprocessed marijuana, or its equivalent.

(5) Product packaging may not be designed in a manner such that the required elements for packaging and labeling are easily removed or separated from the package, such as placing required information on part of the package that must be removed in order to access the product.

(6) Any violation of this rule shall be punishable by an appropriate and proportional department sanction, up to and including an administrative penalty of five thousand ($5,000) dollars for each product/packaging category, identified by approval number, in which a requirement is violated.

19 CSR 100-1.120

Adopted by Missouri Register March 1, 2023/Volume 48, Number 5, effective 2/3/2023

Amended by Missouri Register June 15, 2023/Volume 48, Number 12, effective 7/31/2023