Welcome to Hemp, Legally Speaking. I'm Jonathan Miller, the chair of Frost Brown Todd's Hemp Practice Group, but also the general counsel for the U.S. Hemp Roundtable. And I'm really pleased to be joined today by the newest member of our Frost Brown Todd team, Andrea Steel, who joins us from Houston, Texas, our Houston, Texas office.

Andrea, welcome to Hemp, Legally Speaking.

Thank you. It's a pleasure to be here. Thanks for having me on.

Yeah. So Andreas has been an expert in the field when it comes to hemp as it's grown both in terms of in Texas, where she's from, but also nationally. And today we're going to talk about something called novel cannabinoids.

And I don't want to insult the intelligence of some of our more veteran listeners, but some other folks that are listening to this podcast might not know where the novel cannabinoid is or even what a cannabinoid is. So, Andrea, will you give us a good brief description of your definition of novel cannabinoids?

Sure. So when people who don't study cannabis, think about it. The things that come to mind are THC. And these days, CBD, that's very prevalent. People are very familiar, at least with those two cannabinoids are.

But we're not talking about novel cannabinoids Right? I'm talking about other constituents at the plant that had different compounds, different chemical makeups.
So we're seeing things like that. Delta 8 that's a big one. And you and Nolan
just recently did a podcast on Delta 8. That's a novel cannabinoid, its novelty is wearing off about two years now into that.

And we've got some new ones on board that we're starting to see. And this is also very timely, considering the FDA and CDC recent health alerts on Delta 8 THC, which included reference to other emerging cannabinoids. These novel cannabinoids typically don't occur in nature at the concentration levels that we're seeing in the products.

So in addition to the questions about legality, which you addressed on the podcast with Nolan, there are also concerns about potential adverse health effects. And we're not going to go into detail on it on this podcast episode, but we do have an article up on Hemp Legally Speaking blog on the Frost Brown Todd website, and it's also posted on my LinkedIn page.

Yeah. So we you know, we had a podcast earlier with Nolan Jackson about Delta 8 and the big controversy. But share with us some of the laundry list of of novel cannabinoids that you're we're starting to hear about or that are either already on the market or are poised to be on the market.

Yeah, absolutely. We're starting to see some THC alt-acetate on shelves and websites. And this cannabinoid is a type of THC that is being created from hemp extracts, but it does not exist in nature. So while Delta 8 is converted from CBD.

It can also be found in nature. But THC alt-acetate does not exist naturally. It can only be created in a lab. Some say THC alt-acetate is more potent than even Delta 9 THC, that it may last longer than it may have effects similar to psychedelics.

So say some of the claims out there. The method used to create THC alt-acetate can theoretically be used on other cannabinoids. So we may start to see products like CBD acetate, CBG acetate , CVN acetate and the like.

There's also some companies selling THCV, which is thought to be much less potent, perhaps not intoxicating at all, but is sometimes touted as an appetite suppressant. Also, in the last year or so, THCP and CBDT were discovered to exist, and these products have been marketed to consumers as well. So THCP and CBDT have a molecular makeup that causes them to bind to our receptors even more readily than Delta 9 and CBD, indicating the potential of THCP to have much more potency than Delta 9, and increased potency at this level could have effects that are more akin to synthetic THC

like K21 Spice, which in the past have been associated with more dangerous effects on consumers. So this is something to be very wary of. Another quickly rising cannabinoid is HHC or HEXAHYDRO cannabinoids. And this is a chemical that has a structure similar to THC. But instead of double bonds, which is where we get the Delta reference with Delta 9, Delta 8, Delta 10, this is a process that is done to hydrogenate and replace the double bonds.

So the end result becomes more stable. They say they have a much longer shelf life than THC products. Like THC, there are various forms of HHC, like we have Delta 8, Delta 9, Delta 10. There's different isomers of HHC as well. And while HHC is not a THC at all, they still often have intoxicating effects. So it's been said that HHC occurs naturally in small amounts, but similar to Delta 8.

It's not feasible to extract. So these products are instead created in a lab using a hydrogenation process. So this is another process that can be potentially performed in other cannabinoids. So we may start to see other hydrogenated cannabinoid spinoffs. I've also seen CBE, CBL, CBT, CBC.

So many cannabinoids the market is not familiar with, and it's still being discovered and in some cases created. So I don't think there's a lot of research on it, if any, at all. And let me emphasize, I am not a chemist.

There's probably chemists out here cringing at how I'm describing some of these. But that just goes to show that you can have these conversations, you can't have these conversations in a vacuum. It's important to talk with not only your layers, but also your lab and your manufacturers. These issues are a lot more complex than some people may think. And because we don't have clarity from the courts. Little differences can have a lot of impact.

You know, we've been talking about drawing the line between intoxicating compounds and non intoxicating compounds so hemp derived CBD is non intoxicating by its definition. Delta 9 THC is what we all know is the the component in marijuana that gets you high.

How many of these you mentioned THC V is not intoxicating. Are the rest intoxicating when you say more potent? Are you are you saying that they're actually more intoxicating, they're going to get you higher or higher quick, more quickly than the typical Delta 9 THC that we're all familiar with?

You know, I think bringing up intoxicating vs nonintoxicating is really interesting. And it's an important topic because I think that's very difficult to determine whether something is more intoxicating or less intoxicating because oftentimes depends on the consumer. But that said, I think that some of these are, generally speaking, thought to be more intoxicating, at least more

intoxicating maybe than Delta 8, certainly more intoxicating than CBD. Anything that has, as one says, except THCV, even in large quantities, would probably produce effects. And I think that's the same even with what's thought to be non-intoxicating.

If CBD is consumed in large enough quantities, there may be a psychoactive effect. So I think the intoxicating vs nonintoxicating. Delineation is probably a slippery slope to go down.

Yeah, it's really tough, as we're trying to develop laws in states right now and ultimately the federal government to help distinguish between these products, we're always struggling with how we draw that line. And just putting the word intoxicating into a statute is not, it doesn't work, because, as you mentioned, something is intoxicating for someone and

not intoxicating for others. But do you get the sense that most of these products are going to be marketed to get people high? To get people to, you know, take a break from reality as opposed to what we would consider more of a relaxing or or calming effect that CBD has, for example?

Yeah. Yeah, I do think so. Especially in states where marijuana is illegal or access to marijuana on the medical side is very limited. There's a large demand for products that produce an effect that people can feel. And some consumers are looking for access to something like that.

It's affordable, convenient, whether it's for recreational purposes or for self-medicating. But absolutely. Especially I feel like we live under a lot of stress these days and people are looking for ways to check out.

So the other distinction between some of these compounds is whether they are extracted or whether they are isomerized or converted. Can you help explain what those distinctions mean?

Absolutely. So this has to do with the processing method and where these cannabinoids, how they are created. So an extracted cannabinoid, would be, you can extract THC you can extract CBD, you can pull it out of the plant through a processing that exists in large enough quantities that you don't have to change what it is and then make it into something else.

But some of these converted ones like Delta 8, and although Delta 8 does exist in nature, it doesn't exist in high enough quantities. Nolan brought that up on the Delta 8 podcast. That's the same concept with some of these other cannabinoids.

They don't exist either in nature at all or they don't exist in high enough quantities to be extracted. So they've got to be tinkered with in a laboratory so to speak. And catalyzed in order to trigger a conversion from one abundant cannabinoid like CBD into one of these more rare ones.

So that brings us into another really interesting issue, is whether it's naturally existing or whether it's synthetic.

Yeah. No, this is the other big debate that we have. Kind of what's the significance of the naturally occurring in synthetic in again, how do you how would you define that line?

So the DEA has not before really had to go into whether or not something is synth-derived or whether or not THCs were synthetically derived or not or naturally occurring, because before the 2018 Farm Bill, all THCs were controlled substances.

And so after the definition that was created in the 2018 Farm Bill, which pulls out not only the definition of hemp, but then goes further and pulls out THC in hemp from being controlled substances.

When a DEA published its rule about a year ago, interim final rule, they specifically differentiated between, and I quote, synthetically derived THC and that's different from materials that are derived from the cannabis plants. And so here we have this differentiation, which in the past really only related to spice and K2 and these completely lab-created chemicals.

But now we're trying to figure out what is synthetically derived when you have products that originate from a cannabis plant. Take some tinkering within a laboratory to convert into a product that either is or doesn't need or does or does not exist in nature.

But it starts with the cannabis plant. And I think that's where there's some difficulty, because if you're organically, you begin organically with the cannabis plant and you also have a synthesis involved. Does that make it synthetic or not?

And I think that probably would fall under the concept of a semi-synthetic, which the DEA is familiar with, but has not had to apply it to cannabis. And so it's a really nuanced issue. And part of why making and selling these products is so risky and we don't have the answers.

And so one pathway to getting these answers is through a criminal prosecution to see what a court says and who wants to be the test case for that?

Let's get to that question, and I'd like you to. I did this exercise with Nolan and would like to do the same with you, which is I'd like you to make the argument that these novel cannabinoids are legal. And then I'd like you to make the argument that these novel cannabinoids are not legal.

So let's start with the legal why. Why would someone argue that it's OK for folks to manufacture and sell these products?

So I'm going to throw something back at you that's going to throw you off a little bit because it depends on the cannabinoids, depends on whether it exists in nature, depends on whether it's a THC.

Let's take HHC, for example, Hexahydro cannabinol, it's not a THC. Right. So I'm going to make the argument that it's legal. It's legal under the hemp bill, because it doesn't it's not THC at all. So we're not even impacted by the .3%

Delta 9 restriction. It's a derivative of hemp because it, you know, can start with the hemp plant and create something from it. So therefore, it meets the definition of hemp, and is legal.

OK, now let's just do HHC. Now tell me why it would be illegal.

So HHC and I think for HHC specifically, there's probably some issues with the analog act. Here, the analog act, well the analog act generally, is going to put in place to capture basically knock off drugs. Drugs that are created to mimic illegal drugs.

And so if HHC is substantially similar in its structure and its effects to THC, that might fall under the Analog Act. Then we have the counter argument. And that is well, it's still a derivative of hemp. So does it get pulled out? And on this spectrum of, you know, is it naturally occurring? The less likely it is to be in nature and the more likely it is to be deemed synthetic. Kind of more and more recent.

Right. So where is the THC acetates, where does that fall on the spectrum that you're talking about?

So THC acetate, I think, would be pretty risky there. It doesn't exist in nature. It can only be created in a laboratory. It definitely is a THC. So that one right there sounds like it. But again, it's a derivative, right, if it starts with hemp. We are facing a tough one, it is the spectrum of risk.

So let's talk about this issue of risk, because any good lawyer is going to tell you that she cannot give you a black and white answer as to whether these products are legal or not. For the reasons that you mentioned, there are arguments on both sides.

So we're talking really about risks here. And this, as you mentioned, some of them are more risky than others. But let's just say that you find that you're selling a product at your retail store or you've manufactured a product.

And yet there is some law enforcement official that believes that it's illegal or there are others in the community that believe that it's illegal. What are the various risks from criminal to civil that folks need to be worried about?

But I would say from criminal right, if we're talking at the highest level of risk, criminal prosecution, probably at the DEA level, federally or even state or local law enforcement.

But when you get into that, you're going to have to deal with what is, which statutory interpretation, how do we define, you know, where do we look? Because I know you mentioned before in previous podcasts, and I think this one is about the intention behind the 2018 Farm Bill.

And I would argue that according to the language of the statute, which is clear and unambiguous, that.

The definition of hemp is what it is, if the lawmakers wanted to capture other THCs they wouldn't have limited Delta 9. I think it was very clear from the definition of the 2014 Farm Bill to the 2018 Farm Bill and the change in the definition from hemp, which specifically added cannabinoids, extracts, derivatives, isomers.

There is a clear intention there to legalize or to make an opportunity for this market of these other cannabinoids. But you also have the issue when it comes to criminal prosecution, the validity.

So if a statute can reasonably be interpreted in multiple ways, it's got to be construed most favorably for the accused. And here we're dealing with chemists and lawyers who can't determine what this means. There is no consensus among us.

So. If a person has their liberty at stake and can have their freedom taken away. And you've got a statute that has it. It's not clear in how it should be interpreted. It's got to go in favor of the accused unless it produces a ridiculous result.

Right. Is it a ridiculous result for somebody to use one of these products and think that it should not be punishable?

OK, so we've talked about the potential of criminal liability, but what about civil liability and what about beyond the DEA? What about what the FDA might be able to do to you if you're a retail store selling this or a manufacturer trying to ship it interstate?

Yeah, I think a lot of people stop thinking about risk once they get past the discomfort of the DEA issues, but there's still the FDA to deal with, which does have a criminal enforcement arm and can bring criminal charges under the Food, Drug, and Cosmetic Act at a federal level or states, often almost always have their own food, drug and cosmetic act.

So there's federal and state FDCA issues that could become involved. You know, the FDA is pretty clear about its statement regarding CBD and THC in food, not being able to market as dietary supplements, because those cannabinoids are, through their active ingredients and approved drugs. But what a lot of people also fail to recognize is let's say we're not talking about THC or CBD.

Let's say we're talking about one of these novel ones, HHC or CBC or something like that, that is not part of an active ingredient of an approved drug. But if you're putting it into food, you still have to get free market approval. You still have to be able to show that it's safe at that usage. So we don't have enough research on these to be able to show that, at least not to my knowledge.

And maybe there are people working on that, but not published yet. So there's an issue there with interstate commerce or even within a state, depending on what your state law is saying.

So the FDA has not really shown an inclination yet to enforce on these policies, but we've seen some class action lawsuits and we've seen activity behind the scenes when it comes to either banking or insurance. Could you share?

Where the concerns come from those sorts of backgrounds?

So when it comes to civil liability, class action lawsuits, a lot of those have been centered around CBD either being mislabeled or being marketed as a dietary supplement. But when we're talking about some of these novel cannabinoids, we may be talking about health and safety issues and if somebody gets hurt. Civil liability involved there is very different than some of these mis-marketed or mis-advertised products where a lot of these cases are kind of putting things on hold until there's action at the federal level.

But if a person is harmed by any of these products, that's a different ballgame when it comes to liability, which then bleeds into the insurance issue. It's hard enough in this industry to get good insurance that is reasonable, reasonably priced.

But when you're dealing with Cannabinoids, novel cannabinoids like this it is even less likely that you'll be insurable or it'll be cost effective or cost anything reasonably to be paid. And then you bleed into the banking issues. Some banks are already again, already hesitant to bank hemp clients, even more hesitant, I've had some banks that won't bank a client if they sell edibles.

And then I've got some that are comfortable with edibles, but not comfortable with novel cannabinoids. So these are all business concerns that go above and beyond the criminal potential.

So final question, there is still so much uncertainty here. What do you see as the possibility of getting some certainty, whether legal or regulatory or just plain old-fashioned risk advice that we might get in the coming weeks and months?

Weeks? The only thing I see coming in the coming weeks is probably issues at the state level with enforcement and regulatory enforcement. But I think longer, longer term, we'll see, as we did this last legislative session in many states, a lot of states picking up and making changes.

Some of them try to capture Delta 8, but weren't thinking ahead to some of these other novel cannabinoids.

Oregon did something really interesting where, you know, treated this novel issue with the creative response by coming up with a new term, artificially derived cannabinoid. And that basically will capture chemical substances that are produced outside of a typical extraction process.

And they are going to pull everything in unless it gets specifically carved out. So we've got state action. Maybe one day soon we'll get some clarity on the DEA interim final rule.

Maybe they will issue a final rule that has them some clarification, saying there is a pending lawsuit against the DEA brought by the Hemp Industries Association and a lot of businesses, I believe, and that's out there addressing part of one of the issues that DEA interim final rule that has to do with what happens in the interim process during the processing part of hemp when there are specific cannabinoids that do go up or the increases of THC above point three percent.

So there may be some rulings or opinions on the next year or so on that lawsuit that may provide some clarity. And then the farm bill every four to six years or so comes up again for discussion.

So we may see next year some revisions to this definition or to how the hemp bill or how the farm bill handles hemp. That could be coming about.

Yeah, and the U.S. Hemp Roundtable is quite active right now in helping develop some amendments to the farm bill that might address this. But there's still a lot of work to do. And every time we learn of one new cannabinoid, another one seems to pop up and challenge the hierarchy.

So it's it's going to be an ever-evolving process over the next several months and years. And if you have any questions about this ever-evolving process. Andrea Steel is the woman to ask. You can reach her at asteel@fbtlaw.com.

I'm always jmiller@fbtlaw.com. And we thank you for joining us on Hemp Legally Speaking, Frost Brown Todd's podcast, dedicated to the laws of hemp, hemp derivatives, and novel cannabinoids. Thanks for joining us.

Thanks.

If you have questions or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com.

This podcast was created for general informational purposes only as of the time of its creation and does not constitute legal advice, the formation of an attorney client relationship, or a solicitation to provide legal services.

The laws governing legal advertising in some states require the following statements in any publication of this kind:

"THIS IS AN ADVERTISEMENT."