Marijuana regulators make changes to item approval process for marijuana products
The Missouri Division of Cannabis Regulation (DCR) has announced significant changes to its Item Approval process for marijuana products, aiming to boost efficiency and reduce the regulatory burden for licensees. These modifications, effective immediately, are expected to expedite the review period for product designs, packaging, and labeling, ensuring they meet public health standards.
Introduced on September 1, 2023, the Item Approval process mandated licensees to submit all marijuana product designs and related materials for a compliance review before use. The process and implementation were heavily criticized by industry operators and elected officials in the time since.
According to the guidance document, “These changes will significantly reduce the amount of information and time required for licensees to submit items for review, as compliance with certain rules will be conducted after this process.”
Key Changes in the Approval Process
- Elimination of Certain Documentation Requirements: Licensees are no longer required to submit child-resistant certifications, packaging specification sheets, and FDA compliance statements during the preapproval stage. However, they must maintain these documents for compliance verification.
- Simplified Submission for Template-Based Items: For items based on previously approved templates, licensees need not resubmit common elements like die-lines and logos. They must, however, clearly indicate the template approval number and any differences in the new submission.
- Streamlined Communication: The submission of supplemental information, including the Item Approval Application and QR codes, is now centralized via email to CannabisProductCompliance@health.mo.gov, eliminating the need for box.com links except for large file sizes.
- Reduced Review Time: The DCR aims to exceed the 30-day and 60-day review timeframes, anticipating a reduction in average review time by 10-15 days for single items and more for template-based items.
The increased efficiency does come with additional caveats. Historically, DCR has allowed for operators to amend or correct packaging mistakes with temporary fixes including stickers and cover labels, those solutions will no longer be viable according to the guidance, “DCR continues to expect full compliance with 19 CSR 100-1.120 and will not allow temporary fixes on noncompliant packaging as has been allowed for in the past. Therefore, if a licensee fails to comply with rules that were attested to during the Item Approval process, DCR is prepared to initiate recalls, destruction orders, and other penalties as necessary in lieu of allowing a licensee to use non-compliant packaging while compliant packaging is ordered and distributed.”
View the guidance document in full below:
