Compliance Testing and Bans Vitamin E Acetate in Medical Cannabis Vape Products
What is the impact of MMCC Bulletin
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
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,
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.
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.
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
- Sampling from existing
production lots at the processor;
- Sampling from retention
sample if available; or
- 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?
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.