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From Farm Bill to FDA: The Legal Landscape of CBD with Michael C. Barnes | Executive Feature · CareTalk: Healthcare. Unfiltered.

• 0:00
  CBD based products are everywhere and many customers swear by them. But the market's largely unregulated, leaving consumers in the dark about product purity, safety and effectiveness.
• 0:11
  Congress recently took a first step, authorizing a regulatory framework to address public health while maintaining access. What should the federal role be? How should states get involved, and what does the 2018 Farm bill have to do with it?
• 0:33
  Welcome to Caretalk Executive features a series where we spotlight innovative organizations and leaders working to advance the healthcare field.
• 0:41
  I'm your host, David Williams, president of health Business Group. My guest today is Michael C. Barnes, counsel to aimed alliance and managing attorney at SQL Health Law. Michael, welcome to Caretalk.
• 0:53
  Thank you, David. I'm happy to join you on CareTalk. Outstanding.
• 0:57
  Well, my first question is, what is CBD?
• 1:02
  CBD is one of the two best known cannabinoids. The other is delta nine THC.
• 1:10
  And cannabinoids are a class of compounds that bind to the cannabinoid receptors in the body and yield various responses.
• 1:17
  They can be found in the cannabis plant. And so there's one FDA approved CBD medication.
• 1:24
  CBD is cannabidiol, and that is an FDA approved prescription drug. And then there are also consumer products that are in the form of pills, gummies, lotions, vape devices, and widely available. Well, you talk about widely available.
• 1:39
  I mean, I see CBD products everywhere. Somebody had heard there was a medical marijuana store opening and someone was excited to go for CBD. And I said, you can go to the gas station and get CBD. I mean, CBD products are just all over the place. And a lot of times I see them marketed for their medicinal effects. And I wonder, are they actually safe and effective? Well, one CBD product is because the FDA has approved one CBD medication, and then that's available by prescription. But all of the others that we know are marketed for pain or anxiety or depression, even acne to slow Alzheimer's or as antibacterials or antivirals to prevent Covid-19. None of those are actually proven effective to do those things. And furthermore, their safety is unknown because this is a field in which the federal government is not adequately regulating consumer products.
• 2:34
  And so consumers don't know what is in these products. And that could mean that they're getting pesticides or fertilizers or intoxicating THC or no CBD at all. And then, as we will discuss in greater detail, there's not credible evidence of effectiveness for these claims around depression, acne, Alzheimer's. And so we've seen the FDA send warning letters, because there are some companies that are saying, hey, we can prevent or diagnose or treat or cure this disease, and that's just not the truth. It's amazing how far things come and how much they're still the same. If you think about snake oil, it's literally some of the same sorts of things from 100 years or so or more before the FDA even existed, and some of the things that actually prompted the FDA to come into place in the first place.
• 3:21
  So it's sort of striking to see those. I think a lot of those products are mostly alcohol, and they may have had all sorts of nonsense in them, but I digress. I'd like to know what we talked about, CBD. But I'd like to know what's the difference between CBD and THC.
• 3:39
  CBD generally is not intoxicating, meaning producing the euphoric type of effects like we know delta nine THC does. There's one prescription medication. It's illegal to market CBD, actually as a dietary supplement or food additive. I think most people don't know that, but it occupies this gray area in the law where the federal government hasn't actually started to regulate adequately hemp derived cannabinoid containing consumer products. And so we see all those types of consumer products, like vaping devices, gummies, as well as drinks and other sorts of lotions.
• 4:21
  All kinds of products. Delta nine THC, on the other hand, is the primary intoxicating cannabinoid in marijuana. And so there are three synthetic prescription medications that are THC. Many States have legalized delta nine THC in marijuana as part of their regulated cannabis or marijuana markets. But it's actually still illegal under federal law, except when the delta nine THC is found in hemp or hemp derivatives that have 0.3% delta nine THC or less.
• 4:58
  That's really the standard that, under federal law distinguishes marijuana, which is illegal, from hemp, which is legal under federal law. Got it. All right, I was going to come back and ask that, because we talked about CBD, THC, FDA, and the other TLA three letter acronyms that populate Washington, D. C. But I got to ask you now, so what is the difference between hemp and marijuana? It really goes to that definition that Congress created in what was known as the 2018 farm bill, where hemp is the cannabis plant and its derivatives with 0.3% delta nine THC or less.
• 5:42
  And so that is legal under federal law. Marijuana, on the other hand, is the cannabis plant and derivatives with more than 0.3% delta nine THC, and it's illegal under federal law. But we know that in 24 states and in DC, there is adult use under state law that's permitted in very tightly regulated markets.
• 6:04
  And then there's therapeutic use that's permitted in some form in 38 states as well. So those products that were talked about in the regulated market are marijuana, more than 0.3%, delta nine THC, and still illegal under federal law.
• 6:23
  I love the acronyms, as I've said, but I also love some of the euphemisms that are there. And one of my favorites is actually adult use, which I think otherwise known as recreational use. And somebody said adult use once, and a person sitting next to me leaned over and says, what do you call, like, when a 15 year old uses it? Is that adult use by children? So I know that's not your definition, but it's just illegal. Right.
• 6:48
  So it's a non adult use.
• 6:51
  Okay, cannabinoids. So what are cannabinoids?
• 6:55
  First of all, I'm glad I could say it, but what are cannabinoids? And why is clarity needed in regulating them?
• 7:02
  Cannabinoids are a class of compounds that bind to the body's cannabinoid receptors, that cannabinoids can be found naturally in the human body. They can be found in plants like the cannabis plant. And I think there are 100 or more cannabinoids in cannabis plants. And then they can also be synthetic.
• 7:20
  So they can be basically created by extracted CBD, for example, from hemp plants, and then added to consumer products. Right. So they can actually be synthetically created or derived from various hemp products and added to consumer products. And so cannabinoids are cbD. But delta nine THC we've talked about, there's also delta eight THC, which is sort of this new type of product that's being marketed now, given the lack of clarity and lack of regulation. Delta ten THC, and there are claims around. One is delta nine THC light, right. A lighter euphoric effect, and one is more of a stimulant. Right. So all sorts of claims, not just around health claims in cannabinoids, but also what they do in intoxicating people.
• 8:12
  And so their safety, especially these novel cannabinoids that are new on the market, their safety is largely unknown. But we know from research into CBD that in humans, there can be liver abnormalities and drug interactions. In animals, CBD can alter male reproductive processes.
• 8:32
  And so when Congress created a legal market for hemp, it didn't create a regulatory framework for the cannabinoids that are derived from hemp and put into consumer products.
• 8:47
  It was the agricultural committee that was creating sort of a product for an agricultural industry. It wasn't a health committee that was deeming the appropriate way to allow these products to come to market, given that they can be intoxicated and their safety is not known. And so that lack of federal regulatory clarity is obviously being exploited.
• 9:11
  And so we see that consumers are exposed to potentially harmful products in interstate commerce, and then states are having a difficult time protecting their consumers, right?
• 9:22
  Because states typically regulate health and safety, their public health obviously is undermined, and their regulated markets are undermined when these interstate products from the Internet, for example, are coming and fitting in as though they were the regulated products in their carefully regulated cannabis market.
• 9:43
  But they're not. And we don't know what's in them until they have been analyzed by a laboratory, because there's no appropriate labeling requirements. And so the industry, CBD industry, for example, blames this regulatory uncertainty for its slow sector growth. So we really see that consumers have problems with this. They're not getting what they think they're getting. States have problems because they can't protect their consumers and public health and their regulated markets.
• 10:12
  And then industry is also claiming that there's confusion and it's affecting our growth. So something needs to be done. It certainly seems like there's a diagnosis there for something to be done.
• 10:23
  You talked about a little bit synthetic marijuana. Some synthetic compounds are out there. And I know there are serious safety concerns there, certainly here, anecdotally challenges that are out there. And I think that just adds to the concern about a lack of regulation, lack of clarity, that is very scary for any consumer, especially as it relates to access for children. Right.
• 10:46
  And when a kid can go into a gas station and buy gummies that are marketed as delta eight, THC or THC light, how many cannabinoids?
• 10:58
  What percentage of cannabinoids are in that particular product? What's going to be the intoxicating effect? How would it affect the person if he or she takes medications? Do we know if it's going to cause liver abnormalities long term? All those questions are unanswered.
• 11:13
  And parents, I think, don't know really that the risks are out there. So what are specific concerns that you have regarding consumer protection in the cannabinoid industry, and how would that differ from any other industry that might be regulated? Well, as it relates to cannabinoids, the consumer protection issue is why aimed alliance got involved with this issue.
• 11:39
  It's a not for profit health and safety organization. And so we want to make sure that consumers know what they're getting. When they think they're buying a consumer product for their health, they get what they think they're purchasing.
• 11:56
  And right now, there are no standards for purity of the product or consistency of the product. So some product could have a certain level of delta nine THC, and then the next batch from a different field, in a different state could have a different level of THC. They might be contaminated with fertilizers or pesticides or solvents from an extraction process to add to a consumer product. They could have psychoactive effects depending on the types of cannabinoids that are in these products.
• 12:26
  And there are no clear rules for labeling or marketing, in addition to the lack of clear rules for purity or consistency. And so there might be more cannabinoid content than that which is labeled. No safety warnings about the potential psychoactive effects. And then we also know that the marketing to children is pretty egregious, right? Not just the product types with gummies and lollipops, for example. But if you look at the cartoon like characters and the bright colors and the approach to marketing, it's far worse than the Joe Camel approach that the cigarette industry used years and years ago, before it was called to account and better regulated. And so there are also no limits on cannabinoids per the package or per the serving. And some of those chocolate bars, for example, that might technically be consistent with federal law in terms of the 0.3% delta nine thc or less on a dry weight basis, it could comply with that, but it could actually have, because the chocolate bar is heavy.
• 13:28
  It could have as much delta nine thc content as a state regulated marijuana cigarette could have. Right. And so federal law allows that.
• 13:39
  State laws typically don't. And it creates this confusion that's ultimately really costly and leading to litigation that's further confusing the market. So there's all that plus just the lack of research. And then when we get into the vaping questions, where kids are actually vaping products that contain CBD or other cannabinoids, that has whole new implications for lung injury that the FDA has also warned about. I think it's very confusing for everybody involved. If you think about a chocolate bar, you mentioned your. .3 I was going to ask you about this before. It's like 0.3 of what? I mean, if you have a little, if it's within, let's say, a cigarette, which is a standard size. That's one thing. A chocolate bar. Some of these bars are a lot bigger than I was a kid, so they could be endless. I know my wife is a school teacher, too, and it's enough concern to say, what is somebody snacking on in class or vaping or whatever. It's really a lot to ask. And I get concerned when I go into a store and I see these products that are out there.
• 14:37
  It's not like back in the day where it maybe is just filled with too much sugar, know, artificial coloring or something like that.
• 14:43
  And it's like serious health risks that are sitting right there.
• 14:46
  As you say, Joe Camel has been retired or at least put behind the counter.
• 14:51
  Not so for some of these other products. That's right. And it's not just kids.
• 14:55
  Even if older adults think that they're getting a cannabinoid containing product that will help with arthritis or something, it's marketed as such, and it ultimately has more cannabinoids than what they expect. If they start to experience either drug interactions or psychoactive effects, it could result in a fall. Right. It could result in a lot of negative repercussions for adults, especially older adults as well.
• 15:21
  Mike, I thought it was very interesting that the National foundation for Women Legislators, they recently passed a resolution that called on Congress to provide the FDA with the authority and the resources to regulate hemp derived cannabinoids. Can you explain to me the significance of that resolution? I am not aware of them passing a lot of resolutions of this mean, what's behind that? What's the significance?
• 15:47
  This is an issue that aimed alliance worked with the National foundation for Women with legislators on. That's an association of women who are elected at state and local levels, and they have an annual conference every year. They came together in Orlando last month, and my colleague and I from AMD alliance spoke about the lack of federal cannabinoid regulation.
• 16:10
  And we worked with the National Foundation's policy committee to introduce a resolution calling on Congress to provide FDA the authorities and the resources to regulate hemp derived cannabinoids. And so we spoke at the conference, and then we had a discussion. Q A. And then the membership discussed this question and passed a resolution that we had proposed that would call on the FDA to take on this issue and appropriately enforce it in a meaningful way. And so this is important because these women who represent state and local governments are the ones who are largely responsible in our american system of government for regulating health and safety.
• 16:51
  That's typically been an area where government has said states are responsible for health and safety. The federal government regulates interstate commerce. Right? And so these state regulations, at this point, not all states have laws that enable the state government to enforce around these cannabinoid containing products. But to the extent that they do, how does one state control all of interstate commerce, right. When you've got the Internet and anything can be shipped in from anywhere, it's really hard for the states to regulate when these products are marketed as federally legal hemp derived products.
• 17:33
  And so additionally, these state legislators, in, what, 38 states that have therapeutic marijuana markets and then the 24 plus DC that have the adult use markets, they've created carefully regulated markets for cannabis products to allow responsible adult use. And so these hemp derived products are coming in and tainting those markets and basically unregulated. Right. And competing with the people who've been carefully selected in those states or the district to be able to manage this industry. And so it's a really complex matter where if the Congress does its job, it'll affect all 50 states and DC.
• 18:18
  And that's really what the women legislators were expressing through their resolution.
• 18:23
  I got it. So with that in mind, what is or what should be the role of federal legislation in this area?
• 18:33
  Food and Drug Administration at the federal level has actually asked for a federal legislation because it's concluded that existing law related to food and dietary supplements or food additives, they are not adequate to manage the risks of these consumer products. The FDA notice was specific to CBD, but it really applies to all cannabinoid containing consumer products. And so the FDA needs new authorities and then, of course, the resources, basically the budget to be able to enforce new rules. And so Congress should legislate. And by the way, their request for information recently wasn't the first. I mean, we've dealt with this issue, I think, five years ago as well. So this is just an area where the federal government hasn't acted over a course of many years.
• 19:26
  But really, FDA should be entitled and authorized to regulate these consumer products containing hemp derived cannabinoids so that there will be consistency and purity standards for these products and per serving and per package limits on cannabinoids, right. So you don't get that child friendly, labeled and marketed candy bar that has as much delta nine THC as a state regulated marijuana cigarette. Right. You get the labeling of the cannabinoid content, and that will be accurate safety warnings about potential psychoactive effects. And then, of course, there need to be federal rules around no marketing to children. Right. And so Congress should also allow FDA the discretion to adjust its regulations as it learns more. Because this is an area where there is a lot of scientific and medical research.
• 20:24
  Hopefully, that research will yield more FDA approved drug products, but it also might yield more information that causes a need for changes to regulations that shouldn't engage Congress every time, because we know Congress takes years to act, and when it does, it doesn't act as thoroughly sometimes or as appropriately as we would like. Well, I like the idea of telling Congress to do their job. You're not the only one saying know they have to elect and keep a house speaker. I guess they managed to do that job.
• 20:53
  At least there's that pass some spending bills. So let's say the federal government does its job in terms of legislation, FDA has its authority and so forth.
• 21:05
  Where does that leave the states? Where should the states get involved? Do they have a role? And what concerns will the state regulators, what concerns do they have now, and what concerns might they still have even with federal legislation in place? Okay, well, let's start with currently, most states, as I said, don't have the laws providing state enforcement authority around these hemp derived cannabinoids. And so they can't really do much. Furthermore, state enforcement agencies are naturally reluctant to enforce federal law more stringently than the federal government actually enforces the federal law as it relates to these cannabinoid containing consumer products.
• 21:45
  And so the state regulations, if they even exist, typically can't really regulate interstate commerce. Right. So these products still find their ways to the markets. And so the states are concerned for consumer safety, public health, for their carefully regulated marijuana and cannabis markets. But if Congress does its job and Congress actually gives the FDA the authority to enforce, then we could see that there would be a similar type of federal response to that which we saw when the federal government started regulating Internet pharmacies, right. Dried up the market for illegal products that are coming in from the Internet, prescription drugs and controlled substances, the same thing. The FDA would be able to enforce against these websites that are selling gummies and lollipops and other high cannabinoid containing products to children, for example.
• 22:44
  And so that's going to have a tremendously beneficial impact across all 50 states and DC. So not just the authorizations, but actually the enforcement mechanisms and the enforcement budget are going to be necessary for this to have the appropriate effect for all the states and public health.
• 23:02
  I can see where it's a challenge for the states. If the feds may have laws on the books that they're not enforcing, what is the state supposed to do makes it very challenging.
• 23:13
  So having that clarity, I think, would be quite important.
• 23:17
  I want to ask you about 2018 and the farm bill.
• 23:20
  I thought maybe we're talking about, like, farmville, some sort of a game, but no, deadly serious 2018 farm bill seems to play a major role in the regulation of cannabinoids. Can you explain why that is and if that presents any issues or if, in fact, that is the right place to be discussing this topic?
• 23:37
  Yes. The 28 farm bill is the vehicle through which Congress created a legal market for hemp. Right. And so it was the agricultural committee that had jurisdiction and did this from an agriculture perspective.
• 23:52
  That's how it came up with that definition that looks at the delta nine thc percentage on a dry weight basis. And so the law removed hemp from the federal schedule of controlled substances.
• 24:06
  Basically, it carved it out from the definition of marijuana under federal law. And so, as we know, we've got this definition that's 0.3 delta nine thc or less on a dry weight basis. And that makes sense if you're talking about measuring it in a marijuana plant. Right. It doesn't make sense if you're talking about measuring it in that chocolate bar that we're talking about that has high level of cannabinoid content.
• 24:34
  And furthermore, the farm bill only really addresses delta nine THC. And so it created loopholes by allowing the derivatives of hemp to be illegal, because then we have some of these other cannabinoids that may be naturally occurring, like delta eight THC, that are pulled out of CBD and really increased.
• 25:01
  Right. They're sort of consolidated and then added back into with a stronger potency, these consumer products. And so it creates a high level of THC that is not addressed by the federal law. Right. And so it's technically legal because the delta nine THC falls under that federal level that makes the product permissible under federal law.
• 25:28
  But it has other psychoactive cannabinoids that have been derived from legal product. Right. And then aggregated and put into a finished product that make it psychoactive. And so then the farm bill obviously doesn't provide the sorts of regulatory methods for ensuring consumer safety and doing things like preventing marketing to children and appropriately labeling. And so that is why we're calling on Congress to take this from a health perspective and have this go to FDA, where the FDA can regulate the products content and safety and ensure consumer safety and public health.
• 26:12
  So, Mike, you mentioned quite a few areas here of concern about the lack of regulation and oversight, the potential harms. And I'm sure some actual harms that have occurred to people, whether children, older people or whomever, and how widespread this phenomenon is. And so I know that there's been a number of court cases about cannabinoids, and I'm curious if you could lay out some of the key legal challenges that are facing the industry.
• 26:41
  Yes. These cases between states and members of the cannabinoid industry are pretty complex. Some of them deal with federal preemption of state law where the federal law would supersede.
• 26:55
  But the short version of this answer around litigation is that we know that states regulate health and safety. The federal government regulates interstate commerce.
• 27:07
  On this issue, they clash, right, because you've got a product circulating in interstate commerce that is affecting health and safety. States are trying to act, right. But industry is saying, but wait, we followed federal law, right? And so they're winding up in federal court, and the courts are coming up with varying decisions, varying results based on differing legal premises. And so this winds up being very confusing and costly, both for industry as well as for the states.
• 27:39
  There's a November 2023 Washington Post article that goes into the litigation happening in a variety of states. I recommend that article. But in the meantime, really, we're dealing with the fact that the federal government has laid out a rule as it relates to interstate commerce.
• 27:59
  The state governments are trying to protect public health and safety, and there's a conflict, and the results of litigation are also conflicting. Got it. We'll make sure to link to that Washington Post article in the show notes so people can check it out for themselves. Great idea. Thanks. I have a final question for you, which is about how are these court cases affecting the development of the industry? I mean, it's one thing if you're embroiled in the litigation and settlement discussions and having to go to court and so on, but what is the bigger picture impact on how the industry develops?
• 28:32
  We have read that the industry blames this confusion for the lack of sector growth.
• 28:40
  For example, in the CBD market, they were expecting the growth to be much faster and much higher. But there is that lack of regulatory clarity and certainty that creates an amount of confusion that is already in an industry that is already troubled. So we have an industry that contains some companies that are trying to do the right thing, that want to make a product available to consumers in a way that would be consistent with federal law. Federal law is just not adequately clear at this point. On the other hand, we have some bad actors that are marketing to children and affecting those legitimate producers in a way that undermines their own commitment to health and safety. And so, to achieve its potential, the industry also needs to have new federal rules that create a baseline of regulation from the federal government. Now, I'm Delanche's position is that states obviously would have an interest in regulating above that if they deem it appropriate to regulate even further.
• 29:43
  But there need to be the rules and resources at the federal level to reach that baseline. Right?
• 29:50
  And so that would entail consistency and purity standards for the products. The per serving and per packaged cannabinoid limits labeling of the cannabinoid content, the safety warnings, and the marketing to children. And that's something that will wind up benefiting consumers because they will have access to a legal market for these products, like CBD consumer products. And hopefully, children will be protected from the delta eight and the delta ten types of products that are currently using cartoon characters to appeal to them. The states will be better off, right? They'll be able to protect their consumers. They'll be able to protect public health and appropriately regulate the markets that they've created for cannabis. And then the industry itself will have this clarity.
• 30:32
  The lack of risk of having products pooled and recalled by state governments, as well as the lack of expense associated with costly litigation that ultimately is going to go to a higher level, and you're going to see conflicts across the courts, and it's got to be resolved in some way or the other. And the best way to do that is for Congress to do its job well. That's it for the latest episode of the Caretalk Executive feature series. I'm David Williams, president of health Business Group. My guest today has been Michael C. Barnes, counsel to aimed alliance and managing attorney at SQL Health Law. If you enjoyed this show, please leave a rating and subscribe on your favorite service. Mike, thanks so much for joining me today on Caretalk. Thank you,