As of November 9, 2026, Florida’s Office of Medical Marijuana Use (OMMU) requires medical marijuana treatment centers (MMTCs) to file their product variance requests using one of four product type categories. OMMU announced the change in MMTC Variance Highlight 26-1, a letter sent to all MMTCs on November 3, 2026. Furthermore, products that pair a delivery device with another product, such as prefilled cartridges, all-in-one vapes and pre-rolls, now need two requests. Each request runs on its own review timeline.
An MMTC cannot sell a new product or delivery device until OMMU approves it through a variance request. New licensees spend their first months after licensure getting cultivation and processing facilities approved. Product approval is often left for later. A full product menu now means more requests to prepare and track. Products that aren’t approved can’t generate revenue, even after the facility is ready to produce them. Drafting each request to address all required elements from the start reduces requests for additional information and shortens the path to approval.
What changed under Variance Highlight 26-1?
OMMU identified four case types in its Licensing Portal for product variance requests. They are Derivative Product, Delivery Device Only, Whole Flower and Edibles. An MMTC seeking approval for a product comprised of more than one product type must now submit a separate variance request for each applicable case type. A product that pairs a delivery device with another product type, such as a pre-roll, requires two requests.
MMTCs that file outside the Licensing Portal can still select “Derivative Product and Marijuana Delivery Device” on Form DH8019-OMMU-11/2018 but must submit a separate request for each product type.
Each request runs on its own review timeline. A gap in one request can hold up that product type while the others move forward. Vicente LLP’s Florida team can help MMTCs map each planned product to the case types it needs before filing.
Why Florida MMTC Product Approvals Run Through Variances
Section 381.986(8)(e), Florida Statutes, lets the Department of Health grant an MMTC a variance from the representations made in its initial application. The MMTC must show that its proposed alternative serves the same or a similar purpose and will not be a lower standard than what the application promised. Rule 64-4.023, Florida Administrative Code (Medical Marijuana Treatment Center Variance Procedure), sets the procedure and bars an MMTC from moving forward with a change until the Department approves it.
Almost any new activity requires prior approval, including every new product and delivery device.
What OMMU Expects in a Product Variance Request
The MMTC must provide OMMU with sufficient evidence that the product will be formulated, packaged and labeled in compliance with all applicable statutes and rules. A typical request includes:
- Standard operating procedures for making the product
- A complete ingredient list
- Documentation that the packaging is child-resistant
- Package designs free of prohibited colors, graphics and words
- Labels with all required information
OMMU’s checklists are long and differ by product type. Derivative products, whole flower, edibles and delivery devices each have their own requirements.
How long does OMMU take to approve a product?
OMMU has 30 days after receiving a request to identify errors or omissions. If anything is missing, it issues a request for additional information. OMMU then has another 30 days to review the MMTC’s response and may continue requesting additional information until the request includes all required elements. Once the request is complete, OMMU has up to 90 days to approve or deny it. These deadlines come from section 120.60(1), Florida Statutes, which governs applications to amend a license, including MMTC variance requests.
Most product approvals take at least 60 days. A request that leaves gaps in its compliance evidence can take several months, since each round of questions starts a new 30-day review.
Why does turnaround time matter for new MMTCs?
New licensees compete with established MMTCs whose full product menus are already approved and on dispensary shelves. Every product still in review is one that patients will buy from a competitor instead.
How Vicente LLP Helps MMTCs With Product Variances
Christine Senne, counsel at Vicente LLP, is a former director of compliance for an MMTC who has obtained hundreds of variance approvals. She helps new MMTCs prepare complete product variance requests from the start, with the goal of fewer requests for additional information and a shorter path to approval.
Vicente LLP also provides full legal support for MMTC operations, including packaging and labeling review, variance assistance and on-site audits to prepare for OMMU inspections. To plan a product variance request or respond to a request for additional information, contact Christine Senne.
Contact Our Florida Team
Vicente LLP has two Florida offices. Christine Senne is counsel in the firm’s Tampa-area office, where she handles regulatory, licensing and litigation matters. Partner Sally Kent Peebles opened the Jacksonville office in 2018 as the state implemented its voter-approved medical marijuana program. Sally leads the office and focuses her practice on licensing, corporate, commercial real estate and regulatory matters for Florida cannabis businesses.
Vicente LLP is excited to welcome Christine Senne to the firm as Counsel in Florida, working statewide from the Tampa area. Christine handles regulatory, licensing and litigation matters for clients…
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