On Wednesday, Nov. 27th, 2019, the Marijuana Regulatory Agency (MRA) released a technical bulletin in accordance with Rule 3 of the Emergency Rules for Manufacturing of Marihuana. This bulletin advises licensees on the requirements for selling marijuana products “intended for inhalation” (aka THC containing products that can be vaped).
On Nov. 22nd, the MRA issued a “vape ban” on existing THC oil cartridges. This move came a few months after Gov. Gretchen Whitmer issued an executive order banning flavored vaping products that contained nicotine, citing a “public health concern” among young people.
However, according to mLive, marijuana vape products are slowly returning to vape shop’s shelves, which is why this bulletin was drafted to clarify any compliance issues. However, many source their vaping products through vape store sites online anyway.
What is required on product labels?
(1) All inactive ingredients shall be clearly listed on the product label for any marihuana product intended for inhalation produced after the effective date of these rules.
Can licensees add inactive ingredients to their marijuana products?
(2) A licensee is prohibited from adding an inactive ingredient (such as vape flavors and other vaping liquids) to a marihuana product intended for inhalation. Unless it has been approved by the United States’ Food and Drug Administration (FDA) for inhalation. The concentration of any inactive ingredient in a marihuana product intended for inhalation shall not exceed the maximum concentration listed in the FDA Inactive Ingredient database.
Are formulation records required to be kept?
(3) Processors and marihuana processors shall keep records of formulation for a minimum of two years after the use of the formulation is discontinued for all marihuana products intended for inhalation.
Where should formulation records be submitted to?
(4) All records of formulation and changes to formulations must be submitted to the agency for all marihuana products intended for inhalation.
Any product created after Nov. 22nd, 2019, must be accompanied by the Record of Formulation for Marijuana Products Intended for Inhalation form emailed directly to MRA-Compliance@michigan.gov. When submitting the form, please include the following items in the subject line:
- Facility Name
- Submission of Formulation Record
Additionally, all marijuana products intended for inhalation that are brought into the licensed market as external transfers must undergo full compliance testing, as well as the additional test for Vitamin E Acetate.
What is Vitamin E Acetate?
Vitamin E Acetate is a synthetic form of vitamin E. It melds well with THC oil and is difficult for consumers to detect. While it does not appear harmful when ingested or applied to the skin, it can interfere with normal lung function when inhaled. The oil can become sticky and linger in the user’s lung, causing lung injuries.
The Center for Disease Control (CDC) suspects vitamin E acetate of causing 47 deaths and 2,990 lung illnesses nationwide. Two deaths and 55 vaping related illnesses have been reported in Michigan. Several safety compliance facilities stated that they have not found evidence of vitamin E acetate in legal Michigan marijuana products.
However, they did discover this in black market products. Testing the product’s THC potency could point to the addition of vitamin E acetate, as the potency would be lower.
If an external transfer is used to create marijuana vape cartridges, the licensee would need to submit a record of formulation. This record should state that the product does not contain the presence of Vitamin E Acetate.
*MRA Disclaimer: This technical bulletin does not constitute legal advice and is subject to change. It is intended to provide a technical clarification only to the Marijuana Regulatory Agency (MRA) Administrative Rules.
Licensees are encouraged to seek legal counsel to ensure their operations comply with the Medical Marihuana Facilities Licensing Act and Michigan Regulation and Taxation of Marihuana Act and associated Administrative Rules.