Dr. Willie McKinney spoke at the Keller and Heckman E-Vapor and Tobacco Law Symposium.

We gave a presentation on the latest regulatory frameworks for cannabis products at the Keller and Heckman Symposium. This is our transcript and video recording.

Today, this is my theme song, “I get knocked down, but I get up,” and there’s a gospel song, “We Fall Down, but we get up,” as well. So, that’s where we are. Mapping the global cannabis product landscape: implications for quality and regulations. We did some actual original work, pulling some data together, and we worked with Fertin Pharmaceutical. I want to say that they were heavily involved in all of that work. In addition, we used a third-party lab to generate some of the experimental study data. At that time, there was no McKinney Specialty Labs, just want to say that. But McKinney Regulatory Science Advisors provided scientific and regulatory advice and support.

So, cannabis, I mean, this is really one on one given what you guys just heard. But as you know, there are more than 80 or several biologically active chemicals, most commonly known Delta-9 THC and CBD. Delta-9, of course, has a high potential for abuse, which is attributable in large part to the psychoactive effects of THC. CBD products contain trace amounts of THC, defined by regulatory standards; they’re not considered psychoactive.

So, what do we know? Let’s focus on CBD for a moment. And again, you heard some of this earlier. It’s a naturally occurring compound found in the plant, not intoxicating, not psychoactive, and there’s little scientific evidence for the efficacy of CBD in managing medical conditions. It’s very sparse, but consumers are using it for their general well-being, inflammation, convulsions, anxiety, mental health, etc. As a matter of fact, it’s anticipated to be a 64 billion market by 2032. If you look at the market in 2022, it’s 15 billion, with 67% of that revenue coming from the United States. I think the UK falls next right behind that. So, it’s growing, but very little regulation.

So, what about the regulatory environment? I think if I were to summarize what I heard, it’s evolving slowly and inconsistently. And so, what happens with the lack of regulatory infrastructure for cannabis products? I’ll tell you what happens: you get poor quality products, perhaps, right? Unknown CBD and other cannabinoid levels, psychoactive compound contamination, unacceptable harmful constituents, and then you get misleading communications as well, incorrect labels, and also unsubstantiated health claims.

So, what is the impact of this inconsistent and evolving regulatory environment on globally marketed CBD products? So, we did a study, and the aim of the study was to assess CBD and THC from the US, Swiss, UK, and EU markets for CBD and THC concentrations, the relationship between the labeled and measured CBD concentrations. We also looked at other cannabinoids.

Now, we did this, I call this a kind of quick and dirty study, right? So, we did this by searching the scientific literature and going to manufacturer’s websites. And so, we were able to obtain all this information for the EU, Switzerland, UK, and the US for CBD and THC. For the UK, we had to supplement the data, so we actually pulled products and did a little bit of testing.

So, what did we find? Let’s talk about CBD content in the e-liquids. What you’re looking at is a graph, and it’s small, I even have to explain. CBD content, percent weight by weight in the EU, Switzerland, UK, and the US. We also looked at illicit products in the US. The colors represent the concentrations, but the bottom line, the most interesting thing that happened, is that the levels among the illicit THC products were very tightly clustered around the median concentration. And that’s for CBD, but you would expect that they’re THC products, so they’re not focused on CBD. The highest concentration of CBD products was found in the UK.

So, what about the label and the actual measured CBD amounts? There are white circles on the chart. Actually, let me look at them. You can see them. The white circles, which are around the 100% line, the concentration of CBD on the label was plus or minus 10%. The gray circles were greater than plus or minus 10%. In general, what you see is, combined across the countries and the regions, the proportion of e-liquids falling within the plus or minus 10% label was only 22%.

So, what about the content of other cannabinoids in e-liquids? First of all, there are established regulatory limits for CBD products. We heard this, like in Switzerland for THC, for Delta-9 THC. The limits for CBD are less than 1% in the US and EU. The limits are 0.2%, 0.3%. And what we found was, when you look at THC in these CBD products, they were basically below established regulatory limits, which are far more than products intended to be psychoactive.

And that’s the far right side over there. So, it looks like manufacturers are complying with sensible regulation. That’s what I’m pulling from this. And THC products, of course, had higher levels of THC. That’s the far right, the red circles.

What about other cannabinoids in CBD products? Well, we measured other cannabinoids at trace amounts, and you see here CBC, CBA, keep going, keep going, keep going. But you know, the interesting thing about these is that perhaps they’re inherent to the product, right? Or they’re caused by the degradation of CBD or they result from poor manufacturing.

So, ultimately, regulation of other cannabinoids should consider the source. And think about this now, Delta-8, interestingly, we only measured that in significant amounts in THC products in the US. In fact, some of these products had over 66, 67, 70% Delta-8. And I said a little bit about Delta-8 here. Derived from hemp, it’s considered illegal. What we heard, all other regulations here, regulations vary by state. So, state regulations are attempting to close the federal regulatory loop, but it’s so confusing that some of these products may be illegal in certain states; they may not be illegal, but clearly, people are adding Delta-8 at quite high levels.

In summary, consumer use of cannabis products is increasing, and it’s evolving faster than regulation. Clear regulatory standards can be effective in protecting consumers, and I probably should have said reasonable regulations. Current cannabis product regulations are incomplete and inconsistent. Oftentimes, regulations drive science, which then supports regulations.

So, what should be considered for a cannabis product regulatory framework? Well, for a comprehensive regulatory framework: product standards. These products are on the market, perhaps providing standards. I think manufacturers would try to comply with very clear standards, pre-market evaluation requirements. You heard FDA has concerns about these products. Manufacturing practices, health-based guidance, marketing guidance. I imagine tomorrow, if you go to TPE, you’re going to see some products that are probably marketed are going to be attractive to kids. Labeling requirements, as you saw, the label doesn’t necessarily match the content of the cannabinoids. And then lastly, alignment of federal and state regulations. It is confusing. I’m glad we have Keller and Heckman to keep up with that.

That’s it for me. I want to acknowledge a couple of people, … for doing some of the measurements. That’s it. Appreciate you guys.