November 22, 2019 – The Marijuana Regulatory Agency (MRA) promulgated emergency rules today for marijuana products intended for inhalation to address the public health crisis of e-cigarette, or vaping, product use-associated lung injury (EVALI) to ensure the public health, safety, and welfare of adult-use and medical marijuana consumers.
"It is absolutely vital that patients and consumers know, with certainty, the ingredients in the products that they are using," said Lt. Gov. Garlin Gilchrist. "These rules require stringent testing and will continue to prioritize the health and safety of Michiganders."
"As always, our primary goal is to protect the public's health," said MRA Executive Director Andrew Brisbo. "The collaboration with our public health partners over the last several months has resulted in the issuance of these rules which will increase consumer confidence in the regulated supply of marijuana products intended for inhalation."
The MRA is now requiring that all inactive ingredients added to marijuana products be clearly listed on the product label. Additionally, marijuana licensees are prohibited from using inactive ingredients that are not approved by the Food and Drug Administration (FDA) for inhalation. All ingredients added to marijuana products intended for inhalation must be FDA-approved for inhalation and cannot exceed the maximum concentration listed in the FDA Inactive Ingredient database.
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The MRA will inspect processing facilities twice a month to ensure compliance with these manufacturing standards. Also, the MRA will require licensed safety compliance facilities to test for vitamin E acetate.
Effective immediately, licensees may not sell a marijuana product which is intended for inhalation (vaping) unless one of the following conditions is met:
- the product has received a passing test result under these rules the product was produced by a licensed processor after the effective date of these rules and in compliance with all rules promulgated by the MRA
"Prohibiting additives that could cause harm to human health is a step forward in efforts to protect the public during this outbreak of lung injury cases," said Dr. Joneigh Khaldun, chief medical executive and chief deputy for health for the Michigan Department of Health and Human Services.
The emergency rules may be read here and here.
Background on the EVALI Public Health Crisis
The Michigan Department of Health and Human Services (MDHHS) has identified 55 EVALI cases, with one patient requiring a double lung transplant. Approximately 88 percent of EVALI patients reported using a product containing tetrahydrocannabinol (THC). As part of their investigation, MDHHS sent samples from five Michigan patients to the Food and Drug Administration (FDA) for testing. The FDA found that one patient's products contained THC and vitamin E acetate; and one product – a THC cartridge called "Dank Vape Birthday Cake" – contained 23 percent vitamin E acetate. The age range of the patients is 15 to 67 years old and most have been hospitalized for severe respiratory illness; many of these persons are likely to suffer permanent effects from these illnesses.
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The Centers for Disease Control and Prevention (CDC) has confirmed 42 deaths and over 2,100 cases of EVALI across 49 states, the District of Columbia and two U.S. territories. All cases have a history of vaping products containing THC, nicotine, or a combination of THC and nicotine. The CDC announced the results of recent testing performed on bronchoalveolar lavage (BAL) fluid samples from 29 EVALI patients in 10 states, including Michigan. Vitamin E acetate was identified in 100 percent of the BAL samples tested. THC was identified in 82 percent of the samples. This is the first time that a potential toxin has been detected in biologic samples from patients with EVALI. While vitamin E acetate does not usually cause harm when ingested as a dietary supplement or applied to the skin, ongoing research suggests that inhalation of vitamin E acetate may interfere with normal lung function.
Because the number of EVALI cases continues to rise, these emergency rules are necessary to regulate the presence and addition of inactive ingredients to marijuana products intended for inhalation and require testing for those inactive ingredients. Preservation of public health requires promulgation of these emergency rules; without immediate regulation of inactive ingredients in marijuana products, the public health risk of EVALI will continue unmitigated. Preservation of public welfare also requires that consumers use the regulated marijuana market rather than the illicit market; the regulated market is tested for the presence of harmful contaminants and generates tax revenue for the people of Michigan.
Ensuring that regulated marijuana products intended for inhalation are reasonably free from contaminants will promote consumer confidence in the regulated market, and therefore will promote the preservation of public health, safety, and welfare.
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