The Marijuana Regulatory Agency (MRA) advisory bulletin, “Marihuana-Infused Products and Edible Marihuana Product-Process to Obtain Agency Approval for Production of Marijuana-Infused Beverages,” provides guidance on the process to obtain approval for the production of marijuana infused beverages. It also outlines rules and requirements for ongoing research and product development related to marijuana infused beverages. The approval process is quite involved, with detailed requirements regarding production and research.

Do you need expert help getting your marijuana infused beverage approved? Request a consultation now.

Marijuana Infused Beverage at Store

The bulletin states that, in accordance with MRA rules governing marijuana-infused products, marijuana-infused beverages must be “shelf-stable, safe for ingestion, and consistent in production.”

The bulletin further outlines a host of information that must be included in an email request to the MRA before approval for production.

As you can see, safety of the consumer and consistency of product appear to be the main focus of the bulletin and rules. 

General Requirements

The approval request must include the names of anybody involved in research or production of the beverages, receiving payment under any licensing agreements related to the marijuana-infused beverages, as well as the name and qualifications of the Quality Control Manager (QCM) at the processing facility. 

The request for approval must confirm the processor is in the process of receiving Good Manufacturing Practices (GMP) certification, and further confirm that the beverage production line is hygienically designed (unless the product is pasteurized, in which case GMP is sufficient).

When requesting approval, a processor must submit a number of completed plans, including an environmental sanitation plan, Hazardous Analysis Critical Control Points (HACCP) plan, and Standard Operating Procedures covering product creation and safety and sanitation procedures.

The request must include a signed letter from a recognized process authority, which references specific items required in the plans by page number. 

Process Requirements

Producers must submit Records of Formulation for each product, including the ingredients, source, and recipe.

Details must be provided regarding any components used for emulsification, and the quality and sterility of packages must be confirmed.

Product Requirements

Water used in the production of marijuana-infused beverages must be confirmed safe for consumption by an accredited environmental lab.

All ingredients with pH of 3 or higher must be pasteurized by the producer if not already done so by the manufacturer of the ingredient.

Emulsifiers and preservatives must be listed as safe per FDA CFR 21.

Research and Development

In order to be approved for production of marijuana-infused beverages, a producer must conduct research and development until the producer can ensure product consistency, homogeneity, and shelf-stability over time, as required by the Rules.

On an ongoing basis, producers must perform periodic checks to ensure quality control and compliance with the Rules.

The length of the study will determine the product’s shelf-life.

If the marijuana-infused beverage is shown to be consistent, safe, and stable over a three-month study, it will have a maximum three-month shelf-life.

A successful longer study can lead to a longer shelf-life.

Product that passes its labelled expiration date must be destroyed. 

One particular issue posed by the marijuana-infused beverage production process is THC leaching, where the THC concentration of a beverage decreases over time.

Producers must assure the THC content does not decrease more than the 15 percent variation permitted by the MRA rules.

The ongoing study must perform subjective and objective quality checks of:

  • potency,
  • stability,
  • separation,
  • clarity,
  • color change,
  • flavor,
  • microbial contamination, and more.

The studies must be submitted to the MRA when the producer is ready to produce the beverages for commercial sale, and quarterly thereafter for a year.

Additionally, during the first year, the producer’s QCM will have to confirm by letter to the MRA that no inconsistencies, irregularities or contaminants were discovered during production prior to every batch of infused beverage transferred to a licensee (other than a safety compliance facility).

Upon demonstrating the capability to produce a safe and stable product, this condition may be relaxed by the MRA. 

The Takeaway

Marijuana-infused beverages are here in Michigan.

It’s an exciting time as new markets and products are being developed.

However, there are lots of details, rules, and requirements involved just in requesting approval to begin production, let alone the production itself, and required ongoing research and development to ensure quality control.

It can feel intimidating to work through, but our expert legal team possesses the knowledge and experience to bring your marijuana-infused beverage to market while maintaining compliance with all laws, rules, and requirements. 

Do you need expert help getting your marijuana infused beverage approved? Request a consultation now.

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