Missouri marijuana regulators issue new guidance and waivers regarding packaging rule changes
Missouri marijuana operators should look to familiarize themselves with upcoming changes regarding packaging compliance and the approval process.
Regulators with the Missouri Division of Cannabis Regulation (DCR) have issued new guidance and waivers regarding final packaging regulations for marijuana products. DCR states that the aim of the new regulations is to ensure consumer safety and product compliance.
The proposed final rules become effective July 30, 2023. The rules include various requirements for packaging, labeling, and product design. However, DCR has also issued waivers for certain specific requirements, providing licensees with additional time to prepare for and become compliant with the new regulations.
One of the waived requirements, outlined in 19 CSR 100-1.120(1)(C)2.H, pertains to additional labeling requirements related to mandatory testing. DCR is temporarily waiving the requirement to list exact tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), and delta 8 tetrahydrocannabinol (Δ8-THC) per serving/dose in milligrams. This waiver allows testing licensees to develop compliant testing methods and provide licensees with accurate results for inclusion on labels. It’s important to note that while these three specific areas of the rule are waived, all other requirements must still be met. Licensees must comply with 19 CSR 100-1.120(1)(C)2.H related to THCV, CBDV, and Δ8-THC by February 1, 2024.
Another waived requirement, stated in 19 CSR 100-1.120(1)(C)2.L, pertains to the inclusion of the Department-issued product packaging approval number on the label. This requirement is waived from July 30, 2023, through August 31, 2023. However, beginning September 1, 2023, all new marijuana products must go through the Item Approval process and include the Item Approval number on the label. Licensees should be aware that compliance with 19 CSR 100-1.120(1)(C)2.L is required for all new marijuana products created after August 31, 2023.
Additionally, 19 CSR 100-1.120(2) stipulates that all final marijuana product designs, packaging designs, and label designs must be submitted to the Department for review and approval prior to use. This requirement is waived from July 30, 2023, through August 31, 2023. Starting from September 1, 2023, licensees must comply with 19 CSR 100-1.120(2) for any new items created in the statewide track and trace system, Metrc.
Once effective, licensees must obtain pre-approval from DCR for each marijuana product SKU produced, including its packaging, labeling, and product design. Once an item is approved, the licensee will receive an approval number for the packaging, that approval number must be featured on the product’s label.
Licensees will submit requests for approval to DCR through Metrc, the state’ seed to sale tracking system. This process, known as the Item Approval process, requires the submission of supplemental documentation, such as information on product ingredients, child-resistant certifications, and verification of FDA-approved food contact compliance. DCR will provide further guidance on these supplemental submissions later this month. The Packaging and Labeling Guide will be sent via email to designated contacts and made available on DCR’s website at https://health.mo.gov/safety/cannabis/index.php. Licensees may also reach out to DCR at CannabisProductCompliance@health.mo.gov for any questions regarding these rule requirements.
Beginning September 1, 2023, licensees may submit requests for new final marijuana product packaging and label designs to DCR through the Item Approval process.
DCR has issued a grace period until January 31, 2024, for the use of existing stock and items. Licensees can continue to use existing marijuana products and packaging until January 31, 2024, but after that date, any unsold products will be considered noncompliant. Licensees will have the option to convert these noncompliant products to approved designs. Starting February 1, 2024, all marijuana products must have an item approval number from the Department prior to sale. At that time, all marijuana products that lack an Item Approval number associated with the product, packaging, and labeling design must be removed from dispensary shelves and can no longer be sold.
DCR has stated the waivers are granted in order to provide licensees with additional time to come into compliance with the changed or additional requirements outlined in the final proposed rules. However, it is essential for licensees to actively work towards compliance during the waiver period to ensure they meet the compliance dates outlined above. Failure to comply with the applicable rules upon expiration of the waivers may result in disciplinary actions.
Preparing for the Item Approval process, licensees should be aware that changes to the item categories in the Metrc system will be implemented on July 28, 2023.
Licensees should complete these changes by August 31, 2023, to ensure their final marijuana products are appropriately categorized for review.
You can read Guidance Document – 07.06.23 Packaging, Labeling, and Product Design in full here and the Packaging, Labeling, and Product Design Waiver letter in full here.
Important Dates and Actions
- July 28, 2023: New Item Categories will be available in the statewide track and trace system, Metrc. See guidance for licensee responsibilities.
- July 30, 2023: New final rules go into effect.
- August 31, 2023: Any new final marijuana product, packaging, or labeling design created in a “final packaging” item category in the statewide track and trace system, Metrc, after this date will be required to go through the Item Approval process.
- September 1, 2023: The Item Approval process in the statewide track and trace system, Metrc, goes live, and any final marijuana product created in a “final packaging” item category will be required to go through the Item Approval process.
- January 31, 2024: Last day for licensees to sell or convert all final marijuana products, packaging, and labeling designs in existence prior to September 1, 2023.
- February 1, 2024: All products that do not have an Item Approval number associated with the product, packaging, and labeling design must be pulled from dispensary shelves and may no longer be sold. Any products in the statewide track and trace system, Metrc, without an Item Approval number will be discontinued.