Doing compliance work in the cannabis industry, we often hear people complain about the rules, regulations, regulatory bodies, and individual regulators governing the industry. “The costs are outrageous,” “these regulations make no sense,” “that Marijuana Enforcement Division Inspector is too strict,” the list goes on. And sometimes, these complaints are valid. Compliance costs are high, regulators do mean business, and the regulations are dense. And sometimes, those in the industry find themselves asking “why?” Well, the nationwide vaping crisis that has unfolded over the past couple of months is a perfect example.
THC and the Vaping “Crisis”
In case you have been too caught up in the other national scandals (impeachment inquiries, perhaps?), there has been an outbreak across the country of lung injury associated with vaping. According to the Center for Disease Control, there have been more than 1,200 lung injury cases reported and 26 confirmed deaths. Furthermore, many of the samples tested by states or by the Federal Drug Administration as part of the ongoing investigation to determine the cause of these illnesses and deaths have been identified as vaping products containing THC.
Most of those tested samples with THC also contained significant amounts of Vitamin E acetate, an odorless, colorless substance typically present in topical consumer products and dietary supplements but is alleged to be used by illicit market producers as a thickening agent in vape cartridge mixtures. Vitamin E acetate is not known to cause harm when ingested as a vitamin supplement or applied to the skin; however, its oil-like qualities may be linked to the kinds of symptoms reported by patients: chest pain, coughing, and shortness of breath. These findings have prompted the FDA to open a criminal probe and to recommend that consumers consider avoiding using e-cigarette or vaping products, particularly those containing THC, including those purchased from retail establishments.
The Real Perps: Illicit Market Brands
This recommendation has left licensed manufacturers of tested THC-containing cartridges, and the industry as a whole, uncertain of the future. The legal cannabis market is facing a blow amid this crisis, with stock prices falling, companies struggling to obtain funding, and public disapproval, even though these dangerous, life-threatening products are coming from the illicit or black market.
Dank Vapes, a well-known, counterfeit brand of THC-containing cartridges, seems to be a major culprit in the distribution of these harmful, even deadly, illicit market products. “Dank” cartridges come in a variety of flavors and are commercially packaged in a manner that appeals to children. They are often sold online and are typically constructed out of China-made empty packaging and vape pods filled with home-brewed THC oils consisting of untested ingredients and thickening agents to dilute the oil and save costs. Another culprit is a brand of additive known as Honey Cut Diluting Agent, produced by the recently subpoenaed Santa Monica-based company, Honey Cut.
In order to find answers, one testing lab in California, CannaSafe, tested products from the illicit market as well as products from licensed, legally operating brands. Results showed that illicit market products contained high amounts of Vitamin E acetate, the additive predicted to be causing lung injuries, as well as pesticides and myclobutanil, a fungicide that can turn into hydrogen cyanide when burned. The products from licensed brands did not contain any trace of Vitamin E acetate or heavy metals, nor did they contain pesticide levels outside the allowable amount.
Remembering Why We Have Regulations
Although the costs to stay compliant are high, it is well worth it to operate in a regulated market and it is well worth it for consumers to purchase products from licensed operators. Operating in a non-regulated, illicit environment has proven far more costly because now the costs include human lives. Regulations are in place to avoid circumstances with these high stakes.
Rigorous testing requirements exist among all states with some degree of a legalized market in order to mitigate the chances of harmful chemicals, contaminants, and other substances winding up in products sold on the shelves of licensed retailers. Moreover, many regulatory bodies institute rules governing the chemicals, solvents, and pesticides to be used in the production of commercial cannabis. These requirements are going to intensify in response to these vaping related illnesses and deaths, especially as governors around the country choose to ban vaping in all forms for extended periods of time.
Industry Response: Educating Consumers and Advocating Change
It is important that consumers are informed and educated on the differences between illicit market products and products produced legally, under strict oversight, so as to promote healthy consumption, to promote illegal to legal market migration, and to keep all THC-containing products out of the hands of the youth. Furthermore, it is crucial that the industry bands together in a proactive manner to dismiss these unlicensed, illegal players and advocate for more regulations to continue to prove the industry’s commitment to consumer safety.
In Colorado, we are already seeing this play out. According to the Denver Post, cannabis industry stakeholders are not only calling for a ban on certain additives, advocating for more detailed information to be included on cannabis product labels to give users better insight into what they are consuming. We are also seeing movement in California, where one state-licensed testing lab, Cannalysis Labs, plans to invest in methods to test for Vitamin E acetate, and intends to make these methods public for use by other labs, as well. And, cannabis holding company, KushCo Holdings, has partnered with an anti-counterfeiting and authentication solutions provider to supply the company with the ability to track and authenticate products in hopes of building consumer trust.
Although the reason for these vaping-related health issues and deaths remains unclear, what is clear is that this is the time for licensed cannabis operators to prove themselves as responsible operators, promoting and selling safe products. While those of us in the industry are well aware of the mandatory testing requirements and the legitimacy of the legal market as a whole, consumers, and even some regulators may not be. Informational campaigns coupled with self-regulation, innovative product development, and advocacy for stricter rules will build confidence in the legal market, push adult consumers away from black market purchases, and continue to decrease youth access to THC products.