In early August, Wisconsin health officials urged people in the Badger State to refrain from using vape products. A mysterious illness had stricken 11 teens and young adults who were hospitalized with severe lung disease.
At the time, Wisconsin’s health department had little information about why these young people were experiencing “unexplained breathing problems.” Less than a week later, reports of new illnesses popped up in neighboring Illinois and Minnesota and as far away as California, according to an Aug. 14 New York Times article.
During the next two months, health officials attributed hundreds of new cases, including dozens of deaths, to e-cigarette use and vape products containing THC. As of press time, Oct. 28, that number had ballooned to 1,604 lung injury cases and 34 deaths across 49 states (all except Alaska); Washington, D.C.; and one U.S. territory, according to the Centers for Disease Control and Prevention (CDC).
While many theories exist about why people are getting sick, no single cause has been verified by government agencies. Meanwhile, licensed manufacturers of cannabis products and state-legal retailers are grappling with a host of supply chain, quality and safety issues on a scale not previously experienced in the nascent industry.
The Cannabis Business Times staff has covered the issue closely since it was first considered a public health threat. Here, we recap some of this coverage, including the impact on the industry, how it’s responded to the crisis and what cannabis growers, producers and retailers can expect in the future.
What Do We Know So Far?
The earliest theories on the cause of vape illnesses focused on the use of vitamin E acetate in illicit-market products. Vitamin E acetate is a preservative often found in nutritional supplements or beauty products. The New York State Health Department cited the chemical when calling out the flood of unregulated cannabis products that have hit streets around the Northeast, Midwest and beyond.
While most major news media outlets have picked up the department’s advisory on vitamin E acetate (including Cannabis Business Times), the actual public understanding of oil vaporization and degradation is a bit murkier.
Dr. Arup Sen, CEO of Infusion Biosciences, a biotech company focused on discovering and commercializing cannabis technologies, said in a September interview with CBT that legally manufactured vape products could contain substances that may pose risks, as well.
“Given the shockingly low bioactivities reported for THC and CBD preparations of the present day, I would not be surprised if we find compounds in the current preparations that are 100 to 1,000 times more potent than THC or CBD,” he said. “In fact, synthetic molecules similar to THC have been reported to be more than 2,000 times more potent in a number of cell culture assays that determine biochemical effects at the cellular level.”
Sen said he wasn’t “convinced that anyone really knows what vitamin E acetate preparation is being used and what impurities there might be.”
Not much information exists about the impact of heating primary substances in vape products and the minor components in cannabis liquids used in the vape pens, including propylene glycol, a common thinning agent in vape pens of all types. “Very little is known about the interaction between the materials used to make the cartridges and compounds present in vape liquids at high temperatures,” Sen said.
Of course, cannabinoids are far from the only chemical compounds found in the oil that cannabis consumers and patients are vaping. Much of the industry conversation has turned to terpenes—both organic and synthetic—and their role in the safety of these products.
“Terpenes can be dangerous,” said Dr. Robert Strongin, chemistry professor at Portland State University. “Their use should be limited.” He noted that his research shows terpenes degrade more rapidly during vaping than THC and that adding relatively large concentrations of terpenes to relatively pure cannabinoid distillates is not recommended based on his research team’s findings.
Mojave Richmond and Robert C. Clarke, CBT columnists and co-founders of BioAgronomics Group, said, “Not all terpenes are good terpenes.” Richmond added, “We should tread lightly when it comes to adding large quantities of what are essentially solvents into cannabis products.”
In early October, a new theory emerged related to the possible cause of the vaping illnesses. Following a recent report from Mayo Clinic researchers in the New England Journal of Medicine, scientists at Colorado Green Lab, a cannabis product development and consulting company in Denver, had begun publishing a blog series hypothesizing that the illness (referred to as vaping-associated pulmonary injury, or VAPI, or more recently named by the CDC: e-cigarette, or vaping, product use associated lung injury (EVALI), is due to metal fume exposure.
The Mayo Clinic researchers noted that VAPI lung micrograph images of patients from Illinois and Wisconsin appear to more closely resemble chemical burns.
“The underlying cause is now believed to be chemical exposure, and not an infectious disease,” Colorado Green Lab co-owners Frank Conrad and Cindy Blair wrote. “The VAPI syndrome is strongly correlated with the use of black-market THC vape cartridges, but the CDC has yet to conclusively identify a vaping product, or additive common to all cases.”
The lab posited that the exposure is due to cadmium in silver solder used in “lower-end vape pens” commonly found on the illicit market. Producers of these products use silver solder because it’s a low-cost material, the lab contends. But cadmium is highly toxic.
However, Conrad and Blair stressed that the CDC had not confirmed any correlation between specific causes and effects in the VAPI matter. “The full range of findings is conflicting, and no clear pattern has emerged regarding the source or cause of the illness,” they wrote.
Still, the hypothesis is noteworthy—especially when considered in the broader industry conversation already taking chemical constituents of cannabis oil into account (like vitamin E acetate, which remains at the center of the discourse).
Industry Impact and Risk Avoidance
The illnesses have sent a ripple effect throughout the industry, which faces increased scrutiny from regulators and the general public. On Sept. 26, Medicine Man announced that it was pulling cannabis vape cartridges containing propylene glycol or vitamin E acetate from its shelves. The dispensary business operates four adult-use storefronts and one medical cannabis location in Colorado.
The uncertainty around vaping has industry veterans offering words of caution to their peers and consumers as the crisis continues to unfold. “The devil is always in the details, and safety must come first,” Richmond told CBT in September. “Anytime we add new ingredients of varying quantities into the beaker we risk an explosion in the lab. So, let’s not use consumers and patients as guinea pigs and take a step backward before we tarnish cannabis’ reputation as a safe, beneficial, medicinal plant that has been an integral part of the human experience.”
In the same CBT article, Nick Jack, chief retail officer of Denver dispensary Diego Pellicer - Colorado, said consumers should stick with legal products only sold by licensed cannabis retailers.
“I would hope that the recent series of unfortunate events will persuade [illicit] market users to purchase products—if they’re available to them—that go through regulatory testing and compliance procedures that have been put into place in the legal cannabis market, rather than purchasing a product from unverified and unregulated sources,” he said.
States also are mobilizing. Massachusetts Gov. Charlie Baker announced at the end of September that the state would become the first to enact a temporary ban on all online and retail sales of nicotine and cannabis vaping products and devices through Jan. 25, 2020.
Other states have focused on flavors. In an effort to immediately decrease interest for underage and casual consumers, Oregon Gov. Kate Brown rolled out a plan to ban all non-cannabis derived flavoring agents in both the nicotine and cannabis markets. Her office has stated that exemptions for additives like botanical derivatives that can prove inhalation safety will be considered in the future.
New rules in Colorado propose a ban on polyethylene glycol (PEG), vitamin E acetate and medium chain triglycerides (MCT oil) in cannabis concentrates or products meant to be inhaled. These additives are generally used as thinning agents to cut THC oil, rendering it able to be vaporized. As of press time, the State Licensing Authority had not yet signed off on the proposal; if it does, the new rules will go into effect Jan. 1, 2020.
Emergency rules adopted by the Washington State Liquor and Cannabis Board in October require that cannabis licensees “disclose all compounds, including but not limited to ingredients, solvents, additives, preservatives, thickening agents, terpenes and other substances used to produce or added to marijuana concentrates for inhalation or marijuana-infused extracts for inhalation at any point during production and processing, regardless of source and origin.” The board also worked with “industry representatives and marijuana licensees” to develop vaping risk warning signs that will be posted at retailers selling vapor products that contain THC.
Ben Bodamer, an attorney in Dickinson Wright’s cannabis practice group, advises cannabis companies to examine their supply chains to ensure their products are safe and compliant. He noted that class-action lawsuits have emerged in the cannabis space, and it helps to identify and address weak spots in a business’s interactions with third-party vendors or other partners.
“First of all, we don’t really know enough to know the kinds of claims that will emerge,” Bodamer said. “I know that the plaintiff’s bar is creative, but they’re also attentive. And in this context, they’re going to be following the results of ongoing investigations at the state level and at the federal level. And to the extent that [those] investigations reveal specific sources, and if those specific sources have been supplying product to individual companies, if that supply chain is in any way illegal, … I think the ease with which the plaintiff’s bar could bring claims would go up significantly.”
Getting out in front of the national news narrative with public statements on social media is one thing; showing proof of Good Manufacturing Practices or other standards and certifications will make a clear statement to the consumer base—and to public officials and private attorneys interested in parsing businesses’ tangential roles to a story with an expansive reach.
“You’re going to see scrutiny and the emergence of good actors versus bad actors from a supply chain standpoint,” Bodamer said. “It’s incumbent on good actors to point out their best practices, but it's also incumbent on people to not be bad actors.”
