MMCC Expands Compliance Testing and Bans Vitamin E Acetate in Medical Cannabis Vape Products

 

Frequently Asked Questions

 

What is the impact of MMCC Bulletin 2019-013?

 

On November 15, 2019, the Maryland Medical Cannabis Commission (MMCC) issued MMCC Bulletin 2019-013, which (1) bans the use of vitamin E acetate in medical cannabis vape products and (2) expands required laboratory compliance testing to include vitamin E acetate. The bulletin only applies to medical cannabis vape products sold in licensed medical cannabis dispensaries regulated by the MMCC.

 

As a result of the bulletin, vape products may not be released for sale to patients unless they have passed the expanded compliance testing requirements. Vape products currently available for sale to patients will be placed on administrative hold until expanded compliance testing has been completed.

 

A copy of the bulletin may be viewed here.

 

Why has the MMCC expanded compliance testing to include vitamin E acetate?

 

The MMCC has expanded mandatory compliance testing to include vitamin E acetate in light of the recent findings released by the U.S. Centers for Disease Prevention and Control (CDC) identifying vitamin E acetate as a chemical of concern among people with e-cigarette, or vaping, products use associated lung injury (EVALI). The CDC conducted laboratory testing on bronchoalveolar lavage (BAL) fluid samples (fluid samples collected from the lungs) from 29 patients with EVALI submitted to CDC from 10 states and found vitamin E acetate in all of the samples. THC was identified in 82% of the samples and nicotine was identified in 62% of the samples. As a result, the CDC recommends that “until the relationship of vitamin E acetate and lung health is better understood, vitamin E acetate should not be added to e-cigarette, or vaping, products.”

 

As of November 13, 2019, 2,172 cases of EVALI, including 42 deaths have been reported to CDC from 49 states, and the District of Columbia. As of November 12, the Maryland Department of Health has identified 49 cases of EVALI in Maryland.

 

This is a preemptive safety measure for medical cannabis patients implemented as a result of the CDC’s findings. Current licensees have reported to the Commission that they do not manufacture any vape products using this ingredient.

 

What products are subject to the expanded compliance testing requirements?

 

E-cigarette, or vaping, product use associated lung injury (EVALI) is linked to the use of e-cigarette and vaping products. Subsequently, the expanded compliance testing for vitamin E acetate will apply to all medical cannabis vape products, including vape products that passed the previous compliance testing requirements.

 

If a vape product had previously passed compliance testing, it must only be tested for vitamin E acetate. The complete compliance panel does not need to be re-done.

 

How can products that have previously passed compliance testing be re-tested?

 

All medical cannabis vape products currently on dispensary shelves will require the vitamin E acetate assay in order for the administrative hold to be lifted. Appropriate sampling will be done in the following order:

 

  1. Sampling from existing production lots at the processor;
  2. Sampling from retention sample if available; or
  3. Sampling from available dispensary product (this will require a manual override in Metrc and MMCC will need to be notified prior to the sampling).

 

How will the administrative hold be removed from vape products once they have passed expanded compliance testing?

 

Each registered independent testing laboratory should contact the MMCC with the results of any vitamin E acetate testing. Upon receipt of test results indicating a batch or lot of vape products passed the expanded compliance testing for vitamin E acetate, the MMCC will remove the administrative hold in Metrc. This will enable vape products associated with that batch or lot to be sold to patients.   

 

 

If a patient is concerned their vape product may contain vitamin E acetate, are they able to return the product?

 

The MMCC has not ordered a recall of any vape products. Concerned patients or caregivers may contact the licensed dispensary or processor to determine how unused vape product may be returned for disposal.