Currently, beverages are submitted via email to the Enforcement Specialist. Beginning in December 2025, all applications to create or reformulate a marijuana-infused beverage will be submitted through the ACA portal. Information on how to submit applications can be found here.
The biggest change to the beverage submission process is how it is submitted. Beginning in December 2025, the submission process will occur through the ACA portal instead of via email.
The documentation required for submission remains largely the same, with a few differences. These differences are described below:
The Product Safety Plan is a reference to the Food Safety Plan requirements described in 21 CFR 117 subpart C. Much of the difference between the two is nomenclature, but there are some distinctions. Both the HACCP plan and Food Safety Plan utilize a hazard analysis to identify hazards needing process controls; however, a Food Safety Plan requires preventive controls for sanitation, allergens, and your supply chain if identified as a hazard needing control during your hazard analysis. Additionally, a Food Safety Plan is required to have a recall plan, whereas a HACCP plan is not.
The CRA Is not requiring producers to comply fully with subparts C and G currently. As such, the modified Product Safety Plan required for beverage submissions will be like current HACCP requirements. It must include the following:
The CRA is moving toward utilizing Product Safety Plans to align nomenclature utilized in 21 CFR 117. Additionally, the FDA reserves HACCP plans for food products with specific hazards, such as seafood (21 CFR 123) and juice (21 CFR 120). These regulations have separate HACCP requirements, and to differentiate between these specialized processes and 21 CFR 117, the CRA is utilizing the same nomenclature.
You most likely can utilize your HACCP plan as a foundation for a Product Safety Plan. It must contain the specific sections described in #3.
Maybe. Products of similar production style, with the same hazards and controls, can be identified collaboratively on one Product Safety Plan. If different products differ in hazard or control, a separate product safety plan must be developed for each product.
For example, if you produce three flavors of infused seltzer water, and the only difference between the three is the flavoring used, these products can be included in one Product Safety Plan. If you produce infused seltzer water and infused juice, your processes and controls are most likely different, therefore you would need separate Product Safety Plans.
A PCQI is a preventive controls qualified individual. Each facility is required to employ a PCQI that prepares and audits the Product Safety Plan, validates preventive controls, reviews records, and ensures the plan is effective. An individual may become a PCQI by either:
You do not need to include documentation indicating your PCQI meets these qualifications with your beverage application, but your Product Safety Plan must include the name and title of the PCQI responsible for its development and implementation. If you utilize more than one PCQI, please include all involved.
While documentation of training or experience is not required, please note that if your PCQI fails to demonstrate appropriate training or experience, your Product Safety Plan will need to be revised by a qualified individual.
A prerequisite program is a set of procedures followed by your facility that lay the foundation for safe production. These are the processes you do regardless of the specific hazards associated with your products and are separate from your food safety plan. GMPs are a good example of a prerequisite program – they are the minimum requirements to ensure sanitary production at every facility.
Each facility must create written SOPs documenting how they comply with the GMPs listed in 21 CFR 117 subpart B and may create additional documentation for other prerequisite programs, if utilized.
Yes, each beverage formulation must be approved prior to production. This means that applications for each variety, including different flavors and potencies, must be received and approved before manufacturing.
No, the CRA will no longer be reviewing laboratory results for marijuana-infused beverages in R&D testing. Licensees are responsible for ensuring that their products are compliant and that R&D testing results support any claims made by product labeling. Acknowledgement letters for shelf-life testing will no longer be issued.
Maybe. If you are producing an acidified or low acid canned product, as defined in 21 CFR 114.3, you are required to work with a process authority with expertise in thermal processes to develop a scheduled process and parameters for safe production. If you are unsure if your product is an acidified or low acid canned product, you must work with a process authority to classify the product. Processes for other products, such as juices, would not require a process authority, but must be developed by your PCQI and adequately address any hazards.
Beginning on December 2, 2025, some beverage submissions may require an onsite consultation to be conducted before approval is issued. The onsite consultation is used to determine the adequacy of the physical facilities, processes, equipment, training, and other factors that are difficult to determine from a desk audit alone.
Onsite consultations will be performed prior to issuing approval for facilities that are new to the production of marijuana-infused beverages, and for products that meet the definition of an acidified or low-acid canned product as described in #10. The onsite consultation is not an inspection, however, if the facilities, processes, training, or other factors do not adequately control the hazards of producing a marijuana-infused beverage, or indicate that production would lead to a violation, approval for production will not be issued until corrective actions are completed.
For lower risk products, consultations may also be performed in conjunction with routine inspections. These consultations are typically performed independently of approval.
A notice will be provided through ACA when an onsite consultation is required. These consultations are announced and scheduled; several time and date options will be provided. Contact CRA-Beverages@michigan.gov if the provided dates and/or times will not work.
Attached to the notice will be the Onsite Consultation Expectations for Marijuana-Infused Beverages handout. This provides examples of documentation that will be reviewed, such as SOPs, records examples, etc, in addition to a review of the physical facilities, equipment, and other processing parameters.
Yes. Every beverage variety your facility is currently producing will require its own record and therefore will need to be submitted separately. If you want to replace a product with another size without changing the formulation, a Beverage Change Request may be appropriate.
It is the responsibility of the processor to ensure that the marijuana-infused beverages they manufacture are compliant and remain compliant throughout their entire shelf-life. There are many factors that go into a well conducted shelf-life study that are not captured in testing results, and as such the shelf-life acknowledgement letters issued prior to December 2025 may be misleading. Instead of reviewing results, the CRA has created the Research & Development Project Proposal to proactively review the planned study itself. The Proposal template requires a processor to identify the maximum/minimum acceptable parameters for a variety of testing results, and appropriate corrective actions in place if a beverage does not meet these parameters.
Email your questions or concerns to CRA-Beverages@michigan.gov, or contact us via phone at 517-284-8599.
No. As of December 2025, CRA will no longer review R&D studies. You must ensure your studies demonstrate compliance and support the indicated shelf-life and you must maintain these results for the CRA to review during inspection and upon request.
Submissions sent before November 22, 2025, must be resubmitted through ACA unless you are explicitly provided with other directions from the CRA. All currently unapproved submissions have been received greater than 30 days prior and were deemed deficient, therefore making resubmission the best path forward to approval.
Timelines depend upon the completeness of the application and supporting documentation, as well as completion of any onsite consultation necessary (as applicable). The CRA is dedicated to ensuring timely review and expects that most applications can be completed within 30 days, or less, from submission.
To help ensure timeliness, the CRA will require any documentation needed to supplement a deficient application to be submitted through the ACA portal within 10 days. Delays in receiving documentation require the reviewer to restart the review from the beginning anyway, and as such, any application that does not provide the requested documents within 10 days will be closed. The applicant must then resubmit the application if they wish to continue the review process.
We understand that some things take time to gather or correct. Upon written request received before the submission deadline, the CRA may grant up to 30 days to receive the requested documentation. Requests greater than 30 days will be considered on a case-by-case basis.
Send an email to CRA-Beverages@michigan.gov indicating you wish to withdraw your application. Please include the application number in your request.
If you receive notification that the wrong application type was submitted, it means that a Beverage Change Application was submitted, but a New Beverage Application is required, or vice versa. Review of your submitted documentation indicated that the other application type would be more appropriate. You must resubmit your application under the appropriate type, along with the required supporting documentation.
