On Thursday, December 28, 2023, the Missouri Division of Cannabis Regulation (DCR) released a waiver and variance that modifies the provisions of 19 CSR 100-1.110(7)(G)2 as it relates to Vitamin E Acetate. The variance and waiver impact the registry number for the Chemical Abstract Service (CAS), action limit, and final products required to be tested for Vitamin E Acetate until February 29, 2024.

According to DCR’s email, the Division determined there was good cause for granting the variance because it provides accurate standardization of the method reference material for testing licensees, reduces the risk for false failures, and ensures Vitamin E Acetate is not added to marijuana product.

The presence of Vitamin E acetate in inhalable cannabis products, particularly vapes, is a significant health concern. Just a few years ago, Vitamin E Acetate was all over the news linked to the E-cigarette and Vape Associated Lung Injuries (EVALI) outbreak that killed over 70 people and hospitalized close to 3,000. EVALI cases have been reported in all 50 states, from both legal cannabis vapes, as well as illicit products.

DCR’s recent modification of testing requirements for Vitamin E acetate in cannabis products marks a pivotal moment. This regulatory shift, reflective of the industry’s growing pains, stirs a crucial debate about the balance between scientific rigor and practical feasibility in ensuring product safety.

DCR previously proposed a stringent 0.2 ppm limit on this compound, aiming to mitigate potential health risks. The new variance extends the waiver for Vitamin E acetate testing until February 29, 2024. Following this date, the testing parameters will increase the action limit to 0.5 ppm.

Lisa Cox, Communications Director at the Missouri Department of Health and Senior Services told Greenway, “Mandatory testing of vitamin E acetate (VEA) for products categorized as Vapes & Concentrates and Infused Plant Material & Prerolls is necessary to protect public health and safety. Both the CDC and FDA have stated VEA should not be added to e-cigarettes and vaping products. Under 19 CSR 100-1, VEA is a banned analyte in the state of Missouri. The initial action limit for VEA screening was set for ≥0.2ppm (0.00002% by weight).

“Missouri testing licensees contacted the Division of Cannabis Regulation (DCR) concerning the VEA screening action limit and false failures due to natural vitamin E levels in plant material encountered during their validation processes. Licensees expressed concern the initial action limit of ≥0.2ppm may be so low failures may appear in products not produced with VEA at all.

“DCR conducted additional research in response to the concerns expressed by the testing licensees. It was determined that raising the VEA action limit to 5ppm (0.0005% by weight) accounts for any naturally occurring vitamin E, which has not been identified as a health and safety concern upon inhalation, and prevents false failures for VEA screening. This allows Missouri to remain hyper-vigilant in screening for VEA while also preventing natural vitamin E concentrations from interfering with our true purpose.”

The extension and subsequent adjustments, as explained by DCR, aim to enhance the accuracy and reliability of testing while reducing false failures.

Missouri’s original limit of 0.2ppm for Vitamin E Acetate was not appropriately established in the first place.  This is typical in cannabis, as analytical limits are established by state regulators who generally lack scientific, analytical, or toxicological experience.

From a scientific perspective, the new limit of 0.5ppm is still rigorous enough to detect any Vitamin E acetate, but will not create false positive results from naturally occurring Vitamin E. This move by DCR simply represents an adjustment to make the limit more appropriate relative to today’s testing environment, in combination with what we have learned EVALI was attributed to.

But the response from patients and the community has been one of serious concern. Their apprehension underlines the need for robust safety measures in the cannabis industry, akin to those in place for food and drugs. FOCUS has received dozens of inquiries from upset Missouri citizens. Given the tragic situation with EVALI just a few years ago, they have valid reasons to be alarmed. Patients and consumers do not understand the science of cannabis, and hearing about increasing the limits of any contaminants rightfully sends off alarm bells. The initial communications from DCR were targeted at licensees and did not clearly convey to consumers the reason for the change, leaving many questions unanswered.

State cannabis agencies across the country must realize they serve stakeholders beyond cannabis businesses.  Patients and consumers are what keep a market going. Without them, there would be no businesses. This problem is not specific to Missouri’s cannabis agency, but the recent guidance has provided a clear example of just how far state cannabis programs have yet to go.

 

Lezli Engelking | FOCUS

Lezli Engelking is the Founder & President of Foundation of Cannabis Unified Standards (FOCUS). Established in 2014 as The Cannabis Health and Safety Organization, FOCUS is a nonprofit that addresses the many shortcomings in quality, safety, and consistency that have become evident with the explosive growth of the global cannabis industry. FOCUS is not a cannabis company, an industry trade association, nor is FOCUS an advocacy organization. FOCUS does not advocate on behalf of or push cannabis policy. FOCUS exists to help assure the rapidly growing global cannabis industry has the necessary protections in place for the health, safety, success, and welfare of everyone.  Our autonomy fosters a principled, objective organization that protects end users, and acts as the much-needed neutral, nonpartisan bridge between industry and regulatory.

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