As cannabis markets take shape across the globe, researchers and regulators are seeking greater uniformity when it comes to cannabis quality control.
For this reason, ASTM International, a standards organization founded more than a century ago, hosted a two-day virtual conference this month called a “global workshop on cannabis quality.” Speakers over the two-day conference included representatives from: the US Pharmacopeia, the European Directorate for the Quality of Medicines & HealthCare, Health Canada, Avisa, German BfArM, Dutch OMC, Jazz Pharma, Canopy, Bedrocan, Indena, the University of Mississippi, and cannabis regulators from the U.S., Canada, Germany, and the Netherlands.
Several themes emerged, including that regulators, the industry, and consumers are up against some serious issues with regard to THC inflation and “lab shopping,” the a checkerboard of lab rules from jurisdiction to jurisdiction, and a thriving gray market of hemp-derived products like delta-8 THC.
“We may be closer to harmonization than we might think, specifically for the medical,” said Holly Johnson, chief science officer at the American Herbal Products Association.
In her work with AHPA, which involves a lot of regulators, she has a frequent refrain that she shares, half jokingly, that would lead to more efficiency.
“I really wish the regulators and the legislators would just call a scientist before they go ahead and write a whole bunch of language that then those of us in industry and research are going to have to struggle with interpreting for the next several decades,” Johnson said.
Alan Sutton, director of botanical research at Jazz Pharmaceuticals (which acquired GW Pharmaceuticals), spoke at length about the process for bringing a cannabis-based drug to market with approval from the U.S. Food and Drug Administration. For context, GW Pharmaceuticals produced the first-ever cannabis plant-derived medicine, Epidiolex, to be approved by the FDA. That approval came at a steep cost, Sutton said, noting that it cost more than $1 billion to bring Epidiolex to market. And, Sutton shared some of what the FDA asked for during that clinical trials process, including detailed information about “non-cannabinoids” and “total amount” of cannabinoids.
“Quality, safety and efficacy are actually fundamental to what we do in our industry,” Sutton said.
Tjalling Erkelens, founder and chair of the board for Bedrocan, spoke about the path to Dutch regulatory approval, and how Bedrocan’s products are part of the legal medical supply chain in the Netherlands (not to be confused with the coffee shop system). They’re also exported throughout Europe.
While the “production of cannabis is actually quite simple,” Erkelens said, it’s all standardized to a T. “Genetic standardization is the starting point of your chemical standardization.”
Erkelens talked about the importance of making sure that cannabis plants have very low levels of heavy metals and pesticides, but it’s tough because cannabis plants, he said, essentially soak up heavy metals.
“Cannabis actually loves heavy metals,” Erkelens said. “We know that, for instance, in China, cannabis hemp is being grown to actually clean up the soil because cannabis just picks up any heavy metal it finds there.”
Another repeated theme was the difference between medical and “recreational” cannabis. Sometimes, speakers were more philosophical, and leaned toward the all-use-is-medical perspective. Other times, speakers were more definitive.
“It is very important for patients,” Erkelens said, that “whatever happens on the rec side, we keep this medicinal cannabis alive, as well. Because you cannot make patients depend on recreational cannabis of varying quality.”
Marcel Bonn-Miller, the global scientific director of Canopy Growth Corporation, said that the “reality is that the distinction” between medical and adult use cannabis is “somewhat false and that most people,” he argued, “use for some sort of medical reason,” whether that’s a condition that was diagnosed or for “coping-related reasons” like relaxation or stress alleviation. He added that “recreational use is somewhat of a red herring.”
“So, I think it’s important to really look at the industry as a whole and set the bar on a standard for the industry as a whole,” Bonn-Miller said. “We need tight standards for medical and then I would argue that those standards need to apply also to recreational.”
Bonn-Miller spoke about the studies that he’s worked on with researchers, which found issues ranging from inconsistent dosing to label inaccuracy.
The FDA, which is charged with crafting the rules for cannabis-derived products, has issued warning letters to companies making false claims, and released a Data Acceleration Plan, but otherwise, has offered little in the way of concrete regulations.
Bonn-Miller said that he and colleagues are “sounding the horn that we need regulation and we need it from the federal level of the United States. And we need it now, quite honestly, because this is really getting out of hand and it’s creating a ton of problems.”
Chris Hudalla, founder of ProVerde Laboratories, highlighted the ongoing and emerging nationwide issue and “industry challenge” of inflation of THC levels. Producers, Hudalla said, can “augment” their samples before submitting to a lab for testing, and different producers and labs also have their own methods for handling samples.
“Laboratories also have a significant incentive to manipulate the samples or the data,” Hudalla said. ”We even hear some laboratories advertising the highest potency results in the market. I don’t know how you can advertise that because the results are what the results are.”
Hudalla also called out regulators for not evaluating and releasing to the public the vast amounts of cannabis data that state track and trace programs collect. This, he said, prevents any kind of independent review of the data.
Gillian Shauer, the executive director of the Cannabis Regulators Association, or CANNRA, called for greater publication of official methods and best practices by standard making organizations, something that is “desperately needed.”
Shauer said that, of course, not all third-party testing facilities are inflating results, but it’s happening in enough of them to raise concern.
“THC inflation is a very real thing and falsifying lab results is a very real thing,” Shauer said, describing an owner of a lab whose business went under because they “refused” to inflate results.
“I don’t think, by a long shot, everybody in this space is a bad actor. But I think there are a small number of bad actors that have made this very challenging for regulators,” Shauer said.
Compounding the issue is that regulatory agencies are often “underfunded and understaffed,” so it makes education and enforcement of compliance-related areas tough.
“The enforcement piece is challenging,” she said.
