Addiction Medicine Made Easy | Fighting back against addiction

Gas Station Heroin and the Loopholes Fueling “Legal Highs” In America

• Casey Grover, MD, FACEP, FASAM

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A brightly colored box at a smoke shop should not hit like an opioid, yet that’s the business model behind “gas station heroin.” We dive into how tianeptine—a foreign antidepressant with mu‑opioid activity—landed on American countertops as a “dietary supplement,” and why that mirrors a broader playbook: repackage potent psychoactives, exploit loopholes, pivot fast when bans arrive, and let consumers pay the price. Joined by Matthew Lowe, executive director of the Global Kratom Coalition, we trace the supply chain from warehouses to wallets and separate leaf kratom from the synthetic isolates hijacking its name.

We break down the risk gradient inside the kratom category: natural leaf with fiber and mixed pharmacology, concentrated extracts that raise potency, and seven‑hydroxymitragynine products that function like a novel opioid. Matthew explains why the FDA’s percentage‑based scheduling of 7‑OH is a smart, surgical fix that preserves traditional use while ejecting synthetic opioids from the “supplement” aisle. We also tackle hemp’s loophole economy—Delta‑8 and Delta‑10 THC derived from hemp yet delivering marijuana‑like effects with far less oversight—plus contamination, cross‑stocking, and the handful of distributors fueling multiple “legal high” trends at once.

Beyond policy, we talk people. When regulators finally pull a dangerous product, dependent users are often left stranded. We outline a practical path: better labeling that discloses opioid activity and dependence risk, age gates, potency caps, and targeted enforcement against unapproved drugs sold as supplements. Just as crucial, clinicians need straightforward guidance to assess what patients took, why they took it, and how to transition them to safer, evidence‑based care without stigma.

Curious how these products keep showing up, what “novel synthetic opioid” really means, and how we can protect choice where risk is low while acting decisively where harm is high? Press play, share this episode with a friend, and leave a review with the one reform you think would make the biggest difference. If this helped you learn something new, subscribe so you never miss an update.

To contact Dr. Grover: ammadeeasy@fastmail.com

SPEAKER_00:

Welcome to the Addiction Medicine Made Easy podcast. Hey there, I'm Dr. Casey Grover, an addiction medicine doctor based on California's Central Coast. For 14 years, I worked in the emergency department, seeing countless patients struggling with addiction. Now, I'm on the other side of the fight, helping people rebuild their lives when drugs and alcohol take control. Thanks for tuning in. Let's get started. Today's episode is about tyaneptine and the so-called legal high market. Let's unpack this a bit. First of all, what are legal highs? Well, they are what they sound like. They are substances that are legal and are not controlled substances, but they are psychoactive and can be just as strong as illegal drugs, alcohol, and controlled substances. And speaking of so-called legal highs, what the heck is tioneptine? Well, tioneptine is an atypical tricyclic antidepressant that is not available to be prescribed by doctors here in the United States, but it is used in some other countries in the world. In addition to being an antidepressant, it turns out that it also activates the opioid receptor. So, here in the United States, given that we have a huge problem with opioids and therefore a big market of people who want to buy opioids, tyaneptine started showing up in gas stations and smoke shops as a supplement that people could buy, and it was being sold as a legal high. And this situation has led to Tyaneptine getting the nickname Gas Station Heroin here in the United States. And there are other substances like this here in the US. We did an episode on Fenibut back in 2023, which is a Russian psychiatric medication that is not available to be prescribed by doctors here in the US. It's actually very similar to baclefin and benzodiazepines, and yet it's available here in the US in smoke shops as a supplement. You can imagine this is a big problem, right? We have medications that the U.S. medical system does not deem to be useful enough to approve for doctors to prescribe here, and yet you can get them at a smoke shop without a prescription as a supplement. So, in today's episode, we catch up again with Matthew Lowe from the Global Kratom Coalition. But we won't just be speaking about Kratom. We will be speaking about how businesses of questionable legitimacy are skirting U.S. laws that regulate medications to bring medications from other countries onto the shelves of smoke shops here in the US as supplements. And we will also talk about 7-hydroxymetrigynine and how it's essentially a novel synthetic opioid, which comes from Kratom. We will talk about what Matthew and his coalition think we need to do about it, and I'll give you a few points before we start to give you some context for this interview. First, my recommendation as a doctor is that people not use Kratom as it has the potential to cause harm, addiction, and dependence. Matthew's perspective as a Kratom user is that we should keep Kratom in its natural form, which is leaf kratom, as it's fairly weak and therefore the risk of using Kratom is low. I don't know if I agree, but I certainly see his point. Second, regarding Kratom, in the United States, the Food and Drug Administration, or FDA, has made a recommendation to the Drug Enforcement Administration, the DEA, that 7-hydroxymetriene should be made a controlled substance, as it's again essentially a novel opioid. Matthew and I both agree that this is a great thing. And finally, a point about cannabis. Matthew mentions Delta 8, Delta 9, and Delta 10 throughout the episode. Let's unpack this a bit. It turns out that the THC that we get from the cannabis plant that we use to get high is actually technically named Delta 9 tetrahydrocannabinol. Marijuana and hemp are two different forms of the cannabis plant. Hemp naturally contains less than 0.3% Delta 9 THC, and as you can imagine, it's therefore regulated differently. It's often grown to make commercial items such as paper, rope, plastic, textiles, and more. It's actually not even a controlled substance. And unfortunately, and this is a theme in this episode, this opened a loophole. Manufacturers started extracting Delta 8 THC and Delta 10 THC from the hemp plant and selling them as cannabis products. As you can guess from the names, Delta-8 THC, Delta 9 THC, and Delta 10 THC are very similar, and they actually produce very similar effects in humans. But because Delta 8 THC and Delta 10 THC are derived from hemp, there is so much less regulation. It's a bit of a mess, and the market is being flooded with Delta 8 and Delta 10 products. And with that, buckle your seatbelt because we are going to be learning about legal highs, the American food and drug regulation system, and how drug distributors are constantly taking advantage of loopholes here in the US to bring more and more drugs to the market, often sold in smoke shops. All right. Well, I am so glad to welcome you back again to the Addiction Medicine Made Easy podcast. Why don't you remind our listeners who you are and what you do?

SPEAKER_01:

Thank you, Dr. Grove. It's good to see you again. My name is Matthew Lowe. I'm the executive director of the Global Kratum Coalition.

SPEAKER_00:

Now we're going to talk about tie-inptine today, also known as Gas Station Heroin. What makes you as the Global Kratom Coalition interested in such a product?

SPEAKER_01:

Yeah, it's a good question. And I think it it comes down to where these products are coming from. So you can walk into a gas station or a smoke shop, really, anywhere in the United States and get substances that are not natural, that in some countries in relation to TNP are the prescription drugs, and you can buy them over the counter for$5,$10,$20 without giving your ID forward, without getting a prescription. And I always ask myself the question how and why is this happening? You don't see this anywhere else in the world. You see it in the United States. And it's not just TN Neptine, it's TN Neptine, it's nitrous oxide, it's synthetic um alkaloid products, it's delta 8, delta 9, delta 10, and whichever new synthetic um hemp product comes onto the market. And if you dig a bit deeper and you go through the layers, it's a coordinated drug trafficking ring, really is what we're seeing. It's a gentrified drug trafficking rink because these drug traffickers have figured out that they can find substances or develop substances that mimic scheduled narcotics, wrap them up in nice packaging, call them, you know, names like perks or Zazar Red or Tia or Neptune's Fix. Call them a dietary supplement and sell them in these shops. And I want to be very clear, that's not legal. What they're doing is not legal. It's highly illegal. But they've got away with it for so long that there's no consequences for that action. So you see these individuals go from substance to substance to substance, knowing that eventually it's going to catch up to them and the products are going to get going to get scheduled or gonna get banned, but they've already moved on to the next thing. So it's it's it's an interesting point in time because I think people have started to realize this is what's going on. And you've seen the number of smoke shops go from X number to 4X, 5X, 10X over a period of five years. And I think legislators, regulators are catching on and are making an impact. So really the people that get lost in this are the are the consumers because consumers are getting tricked. And in some cases, and this is where a problem lies, is they're getting addicted. And in the case of TNF team, that is very, very much the case. And they're getting addicted, and then it gets taken away, and they're left without an option. And it's not their fault that they started taking the product and now they're left without an option. It shouldn't have been there in the first place. So it leaves a bit of a social conundrum. So education, I think, is everything. And you could say to the average person, well, what is TNP? And they go, I I've got no idea. I've got no idea what that is. And that's because you shouldn't know what it is unless your doctor prescribed it to you and you live in France. So TNP specifically is a atypical antidepressant. It was developed in France in the 1960s and was given to people for severe depression, for anxiety, etc. But it doesn't work like a normal SSRI. It gives you the same effects at the right dose levels, but it actually works and attaches to the opioid receptors in a very pure manner. So with that comes a therapeutic dose, which is beneficial to people, but they build their tolerance, they start to consume too much, they become addicted, and that's where the problems start. So even in those countries where TNeptine is a prescribed drug, there's countries that have banned it. Italy has banned TNP because they saw the issues that were coming from the use of an opioid over and over and over again. And we know that story with opioids. Not saying that opioids are bad, but if set in an uncontrolled environment, you will consume too much, and that's where the problems start, particularly if you've got a proclivity for substance use disorder.

SPEAKER_00:

Yeah, it's very interesting. Let's unpack a number of the things that you said. So, you know, Matthew, I learned from you on our first episode that as a Kratom advocate, you want better labeling. And people tell me, you know, Dr. Grover, we want to ban Kratom. What are your thoughts? And I said, Well, what would a ban on Kratom actually do? And the way I explained it to them is some people have a substance use disorder and they go on the internet and they read about it and they find that Kratom is a substance that acts like an opioid and they seek it out knowing that it acts like an opioid. Where I see a Kratom ban being beneficial is the consumer who does not have a substance use history and reads on the package that it helps with energy or helps with mood. And because the package doesn't show it's an opioid and that it's habit forming, that consumer then three weeks later doesn't understand why they feel so sick when they stop Kratom. So my guess is that the GKC's perspective would be why don't we just label Kratom better? And then we don't necessarily have to ban it. Like if you go buy a pack of cigarettes as an adult, you know what you're getting.

SPEAKER_01:

Well, I think it's so labeling is a very important piece of this puzzle, but it's not a solvable. And I think product categorization at the first instance is the most important. And something that we always talk about when it comes to Kratum is well, what are you talking about? You say Kratom to me, what are you talking about? True. Show me the product, show me the product you took. Because I'm gonna guess that if you've gotten into a really bad problem with Kratum, it's not the natural leaf. The natural leaf is low potency, 50% of that leaf is fiber. 50% of the leaf is fiber. That is an incredible amount of fiber. You can you can get your your daily fiber dose from consuming your Kratum. 25% of that leaf is antioxidants. Only 2% of those leaf are naturally occurring kratom alkaloids. And the interesting part about natural creatum leaf is it is a partial muopioid agonist, but it's also got serotonergic and adrotinergic um activity. So there's a modulating effect of that consumption of that kratum leaf in terms of your experience with it. And because of the fiber content and the low potency, it's very hard to over-consume the leaf. And I'm not in any way saying that it's not habit forming. It is habit forming, absolutely. But that habit forming, and it's shown in the survey data, it's a mild to moderate severity of use disorder in the people that it's prevalent in. And if you map that across a relative landscape, and then you look at the the outcomes of that addiction, it's very similar to a caffeine addiction in that it's highly physical. Now, that's the leaf. Then you can get a kratom extract, which has stripped all the fiber out, stripped all the antioxidants out. It's high, a lot more potent, big concentration. You can consume a lot more of it. Now, of course, the risk factor changes. And then what we've seen more recently in the last two years is the introduction of synthetic isolate alkaloids. So 7-hydroxyometriganine or concentrated synthetic 7-hydroxyometriene is the talk of the moment because then FDA stood up and said, enough is enough. And this is in direct relation to what I was speaking about before. Enough is enough. Stop poisoning Americans with these drugs. And these synthetic 70H products are a perfect example of that because you had an individual, one individual in the in the US, I'll I'll have you, and then it's kind of expanded, that figured out oh, there's this one tiny little alkaloid that's 0.04% of the weight of the leaf material and creatine leaf called 7-hydroxymetraganine. Now, 7-hydroxymetraganine in the leaf, if you pick it off the tree, isn't even in the leaf. You dry the leaf, it becomes apparent in small amounts. Now, in the leaf material, it's pharmacologically uh irrelevant. And a lot of science and study being done around this because it is such a strong alkaloid. It on its own is a full opioid agonist 13 times more potent than morphine. So someone looked at it and said, well, what is if I could isolate it and concentrate it? I could have an opioid. And I could claim it's tradeum, or I could claim it's natural. And that's what they did. They isolated, they took an extract, they didn't isolate it, so it's not some like they basically took an extract, they added heat, light, and pool chemicals, pool shock. And they converted the mitragynine into 7-hydroxymitrogynine, turned it into a tablet, and put it on the shelves, calling it Kratum, which it's not, doesn't have the fiber, doesn't have the antioxidants, doesn't have the 49 other alkaloids. Put it onto the shelf at$6 a pill. And on top of that, and this is the most nefarious part, they called it perks. They called it oxy. They called it roxy, they called it cosmic lewds. They knew exactly what they were doing. It was a dog whistle, two individuals with opioid-seeking behavior. And guess what? It went like a freight train. It went from zero dollars two years ago to nine billion dollars today and left devastation in its wake. And it's really sad because you speak to individuals and they just didn't know what they were getting themselves into. They saw this brightly colored packaging and it wasn't labeled appropriately, they started taking it, and now they've developed this addiction and they're embarrassed in many cases because they're going, like, how did this happen to me? And I also speak to a lot of Kratum advocates who have used Leaf for 15 years. I mean, you know, leaf has been around for 400 years in Southeast Asia, for 50 years in the United States, and we haven't seen this sharp increase and this like pandemic hit. There's been some issues, but you've got 23 million consumers. 90% of those consumers, 95% of those consumers are using it safely. The further you move away from the leaf, that's where the problems start. And then when you get to these concentrated synthetics, I was speaking to someone the other day, they used Pratim Leaf for 15 years, net positive to their lives. It really was a game changer for them. Three months of using 7 hydroxymetryine or synthetic concentrated 7OH, they were in debt, remortgaged their house, messed up with their family, and they were consuming$100,$200 of the stuff a day. So it really is very different. And in some cases, they're embarrassed because they should have known better. In other cases, they were just given a free sample and said, this is the new Kratum.

SPEAKER_00:

Wow. Yeah, that goes back to the point you were saying about these products like Tyaneptine and you know, I I I call them basically semi-synthetic opioids of these 70H products. Is to your point, people get introduced to them, don't necessarily know what they are. And then if it does get banned, it leaves them really high and dry of like, how do I get help? And so when we were talking about our ban on Kratom, we have to educate doctors and we have to educate patients. So if we're going to do this right, people have to know where to land. And so for me as a doctor in California, since I've been working more on Kratom and been podcasting about it, I get emails probably once or twice a week from somebody in all parts of the United States, like, Dr. Grover, you seem like you know what you're doing. Can you help me? And when people can see me because they're in California, because that's where I'm licensed to practice, they are so grateful that I actually can help them by understanding like, what are you taking? What are you, what are you getting from it? Is it the anti-inflammatory effects? Is it the stimulant effects? So we actually very thoughtfully said the only way we can really ethically ban Kratom is if we educate the healthcare provider so patients can get help. Because most people tell me, I asked my doctor and they had to Google it during the visit. And then we had to create some patient-facing information too. So that comes back to your point about tying epine, is that this this seems to be a repetitive thing where a medicine with maybe a questionable safety profile from another country comes into the U.S. as an over-the-counter product, and then what do we do about it? And funny you should mention that, because I was at a middle school 45 minutes ago educating the kids about drugs, and a seventh grader asked me about fenibit, which is a Russian psychiatric medication similar to similar to bacclefin and benzodazipines that has a pretty bad withdrawal syndrome.

SPEAKER_02:

Yeah. So quite a bit to unpack there. And let me start off by saying is that we are obviously very against a broadband on Kratom.

SPEAKER_01:

We think that natural Kratom leaf has got a place in the market. We believe it needs to be regulated. There's absolutely no doubt about it. Age gates, labeling, etc. But we believe that it's got a place in the market and we believe that it's serving the better good. And we think there's low risk for kids and those types of things because it it tastes terrible, it's not a fun experience. But as you move further away from it, that that whole equation changes. We've seen this time and time again where a natural substance that has got some rewarding activities or rewarding um perspectives to it gets adulterated, synthesized, and turned into something else, and the baby gets thrown out with the bathwater. Cocoa leaf? Yeah, we said it at the same time. Cocoa leaf cocaine. Cocoa leaf's amazing. It's an amazing plant, but people made crack out of it. So where do you draw that line? And I don't think it's about throwing the baby out with the bathwater. I think it's exactly what the FDA have recommended to the DEA, and this is the first time that they're doing something like this. They said, We've got a problem. We've got concentrated synthetic 70H products on the market. 70H only is a tiny part of the Kratum Leaf. These products are entirely different. We see the benefit in Kratum Leaf. So how do we deal with this? Well, we schedule at a percentage. So we say, well, 70H can only be in 0.04% of the leaf material of Kratum Leaf. Anything over and above that is scheduled. It's out, it's gone. And that's what they're doing, that's what the Florida AG did. When it comes to TNeptine, it's a much simpler case because you're not talking about a natural substance. You're talking about something that was created to be a pharmaceutical. Then the way that we solve this crisis is we need to bring those individuals to book. We need to bring the foreign manufacturers that are importing it into the country to book, and we need to bring those manufacturers who are making it and spreading it into the smoke shops to book. Because the secret that no one will tell you, because no one knows, is that this is actually not being run by 4,000 different companies. There's probably five or six companies that are doing this. And if you went into their warehouse or their 10 warehouses because they operate in the shadows, you will find Delta 8, Delta 9, Delta 10, you will find FennyBut, you'll find TNeptine, you will find concentrated synthetic 70H products and these other different alkaloid products. Now we're starting to see them bring out hallucinogens. So you're gonna find the magic mushrooms, the synthetic magic mushrooms, you're gonna find Eboga root and it synthesized Eboga root. So it's the same things over and over and over again. And probably when it comes to TN Neptune, probably the biggest product was a product called Neptune's Fix. Now, Neptune's Fix was put onto the market, it became quite a big thing, and then the FDA cottoned onto it because it made a whole lot of people sick. And they tested it, and of course it had TN Neptune in, which was a problem, but it had also been contaminated with Delta 8, Delta 9, Delta 10. And why do you think that is? Is because they're all coming from the exact same place. That individual took TNP's fix off the market and then launched a brand the next day called Morpheus's fix. So they just do it over and over and over again because there hasn't been enough consequences for their action. TNP's a straight line to the goal. You are bringing an unapproved drug to the market and you're selling it as a dietary supplement. That is federally illegal, and you can be put in jail for 20 years for doing that. That's what needs to happen with these individuals. Because if the consequences are there for this behavior, then people are going to stop doing it because they're not going to see it as free money. And I think that that's what this new administration is doing is they're going to say enough is enough. They're going to bring it to order. And what we're seeing, and it's hopeful, is that they're not going to throw the baby out of the bath water. There's a place for certain substances to be used in certain ways. And there's not a place for others. And when it comes to any of these drugs, if you rarely because this is also the frustrating part is these trade groups and these companies will say, Oh, well, it's helping so many people, right? We've it treats pain, it helps with opioids, it's actually helping people get off opioids. I think it definitely can treat pain. Certainly 70H, synthetic 70H can. It's a pure opioid. I think that people do stop taking traditional opioids when they take concentrated synthetic 70H. But it's not because they've susated off opioids, they've just switched to a different variety. So the problem hasn't gone away. It's the same problem. But that's not the reason why they launched those products. They launched those products because they knew they would be addictive and they knew they would make a lot of money. And they have a pathway to go to market if they want to, and that is do your clinical trials, do your preclinical trials, do your new drug um application, and put it to market as a pharmaceutical. That's what Pfizer has to do. That's what Bayer has to do. That's what whoever has to do. And they skip that step.

SPEAKER_00:

Can I just ask? So I heard you say Iboga, and I didn't realize that was the plant behind Ibigaine. Ibigaine being a substance that you can take, it's a hallucinogen, it's supposed to be this journey through seeing your addiction. So I've had a few patients go to Mexico and get treated with Ibigaine because it's not legal in the US. Can you talk to me how are synthetic versions of these plant-based compounds being synthesized? Like how are they creating a synthetic psilocybin or a synthetic iboga?

SPEAKER_01:

I I don't know the answer to that, to be honest. I'm not a chemist. I know very well on synthetic 70H and on the Delta 8, Delta 9 side. I don't know on that side, but it'll be a very similar process. They're either doing the spice thing where they are making it in a lab, or they're taking the natural compound and just like they're doing with synthetic 70H, they're figuring out how to convert it, concentrate it, and make it more potent. And I think that's that's what we're seeing there. I mean, the Delta 8, Delta 9, Delta 10 thing is interesting because so hemp got legalized, and that was for industrial hemp and CBD, right? Those are the use cases. There was a big loophole because they only put a concentration level on one of the deltas, and the people went, well, it's below 0.03%, but then they just stack these other new synthetic cannabinoids on top of it. But what's fascinating is that many of these products are actually just marijuana. They've skipped the step of even synthesizing it, and they're just putting actual marijuana into the products because they can just do it. And the whole legal marijuana industry, which has to go through dispensaries, has to pay taxes, is completely undercut because you can just walk into a smoke shop and get something that is pretty much the same thing or acts in the same way. But even in that space, we're seeing problems because and this is a tale as old as time, but today's marijuana is not your grandfather's pot, it is so much stronger. And the basic tenet of toxicology is the poisons in the dose, and it's just this race to the top. How do we make it as strong and as potent as possible to take out the competition? And that leads to adverse events. Now schizophrenia rates have doubled because of the strength of these of these narcotics. So don't mess with Mother Nature. I think that you know I think that these substances, particularly that have been used for centuries, have a place in society. But as soon as you start to mess with them and amp them up and make them more potent and isolate them, we've got to realize we're creating something new. We're creating something different and we don't know what the downstream effects are. But quick way to understand the downstream effects is look at the pharmacology. And if the pharmacology is that of a pure opioid, you know you're gonna what you're gonna get. So if I'm thinking about it from if I'm putting my bad guy hat on, I'm going, well, I'm gonna go after that because it's gonna get people addicted. If I'm putting my regulator hat on, I'm going, well, that's gotta be a bad idea. We've got to put a stop to it. And the nuance or the surgery is, well, how do we do that with the least amount of damage? And that's what we're grappling with at the moment.

SPEAKER_00:

So let me come back to my question because I think I asked it incorrectly of you. Is I wasn't asking, like, what's the chemical way that they're synthesizing these novel compounds? So let's take a look at THC, right? So you have the cannabis plant, which I think has like 400 different chemicals in it, and like I think 60 of which are cannabinoids. So are these people that are planning to take advantage of loopholes, are they working with chemists to synthesize new compounds? Are they extracting existing compounds? Or are they just looking in a research library of chemicals and pulling out stuff that was previously enlisted as I okay, that way I figured all all of the above.

SPEAKER_01:

So the guy that brought concentrated synthetic 70H to the market, he quite remarkable, but he was on a podcast about a year ago bragging about this. This is what I did. And I said, Well, how did you come up with that idea? He says, Well, I was reading a paper from from NIDA, a National Institute of Drug Abuse, and it said in there, Cratum Leaf has got tremendous promise, but seven hydroxymetragynine, if you're a pharmaceutical company, you should look into it because it seems like it might be a potential opioid. We don't know if. it's safer, if it's more efficacious. But this could be something that could be turned into a drug and could be administered to people. And who knows? We're looking for safer alternatives. And he went, Oh, that's interesting. Let me go look. Has anyone done this? Patents did it? No, no one has. So I did it. And you're like, well I mean enough said. So you created a drug and now you're selling it on the market. And then he goes on to say, well, there's no regulations for this. And you're like, well, there absolutely are regulations for creating a new drug and putting them onto the market. You just have ignored them.

SPEAKER_00:

How was it regulated in terms of a chemical versus for human consumption? I mean obviously a new cleaning chemical is going to be regulated differently than say a new medicine. So how how do they choose which loopholes to use? Or again, it probably is just all of the above, whatever can make the money, but can you talk a little bit about the difference and how that's regulated?

SPEAKER_01:

Yeah. So the regulatory structure is such that you've got medicines and drugs, then you've got the umbrella of food. And within the umbrella of food you've got traditional foods and you've got dietary ingredients. And now there's complex pathways for each of them. On the medicinal side, you've got to do an investigational new drug approval. You do all your preclinical trials, you show that it's going to do what you think it's going to do. It's not going to kill rats, et cetera, et cetera. Then you kind of go phase one, phase two, phase three, millions of dollars, millions of dollars, millions of dollars, you move on to clinical trials. And ultimately you've got to prove that your new compound is safer and more efficacious than the incumbent. If you can get that right after spending$100 million,$200 million, you then get the right to sell that product and you get the right to sell that product and I won't quote the monthly, I think it's 10 years or 20 years, probably 10 years, and you can just sell it as your as as your own product. You've got control of that market. After that time then generics can come into the market. And then you that's where you see drug prices drop the generics come into the market and often it's the manufacturer now of the original product that brings the generic product to market because they know what's going to happen. So that's the medical pathway. The food and dietary supplement pathway is is different. So as a dietary supplement or dietary ingredient, you can either be an old dietary ingredient or a new dietary ingredient. So the dische is the regulatory paradigm for dietary ingredients. Old dietary ingredients are any dietary ingredient that was sold as a dietary supplement prior to October 15, 1994. If you've got one of those substances, you put it into your product there's no approval that's needed. It's been in the market it's grandfathered and it's accepted to be safe and legal. Now if you introduce something that has not been in the dietary supplement market in the United States prior to 15th of October 1994, it's a new dietary ingredient and you have to file what's called a new dietary ingredient notification with the FDA. Now that includes preclinical trials, safety, it's like a mini approval process. You submit that to the FDA and in 75 days they will either not respond and you can go to the market or they will respond and say we've got a problem with this you know you need to do more work on it. It cannot go to the market. So those are your pathways for dietary ingredients. And for a food you've either got to be sold in the market in a form unchemically altered pre-1958 and you grandfathered in like a carver would be grandfathered in as a food product because it's been sold since 1915. Or after that you can either come to market as a product that is grass, generally recognized as safe, or you've got to file a food additive petition. On the grass side of things, there are two pathways you can self-grass or you can submit your grass to the FDA and they can make a determination. Now grass relies on scientific consensus. So you put all your safety dossier together you submit it to a board of scientists and they say yay or nay you can either self-grass it take it to market if the FDA sees a problem they've got to ask you for your self-grass you've got to show it safe or you can submit it to the FDA. And that's a point of contention at the moment with with um with RFK where he's saying well this seems to have been taken advantage of as well because if you walk into any store in the United States and you read the back of a product list there's a lot of different ingredients many of them are banned in Europe. So there's a problem there as well and so those are your different pathways. What these individuals are doing is they're ignoring everything and they're just saying it's a dietary supplement, labeling it as a dietary supplement and putting it onto the market and no new dietary ingredient notification, no um assumption of or assurance of safety pre-going to the market. They're just sticking it in and letting it dry.

SPEAKER_00:

So I have to say I'm extraordinarily impressed by your knowledge of the American regulatory system. This discussion is about the the United States but I listened to a piece from the BBC on ketamine in Europe. And the fact that there are so many countries close together and they all view ketamine differently has allowed drug traffickers in Europe to use lax laws in one country around ketamine to smuggle ketamine to countries that have it more restricted. So I'm assuming for the people that are distributing these drugs as dietary supplements they need to learn the loopholes in every country to be able to go after every market or are they focusing on the United States I mean from what I understand is that the United States for these specific products is such a big market.

SPEAKER_01:

You get the US right you don't have to worry about global and I you don't see this huge smoke shop culture in Europe. So yes there's a drug culture but it's done differently and that's why I call it a bit of it's gentrified drug dealing. And that's not to say that everything in a smoke shop is bad because it's certainly not I believe people should are allowed vice and should make their own choices. It's a subsegment of the products that are sold in those shops that is that is the gentrified drug dealing. And for me it's nitrous oxide fenny button the concentrated synthetic 7OH Mitrogyne and pseudandoxyl they've got and for hydroxy now they're bringing in all these mushroom products that's where the problem is the delta 8, delta 9 delta 10 sits in a bit of a middle ground space because you know you've got this federal regulation it is a loophole. There's a lot of arguments to be made there but I think that loophole is going to be closed pretty soon here federally and you're starting to see a big crackdown in in states. I mean Ohio issued an executive order just last week outlawing synthetic intoxicating hemp. And then it becomes a fascinating conversation because you're going, okay, well are we going to do all of it and CBD and industrial hemp? Are we going to carve out industrial hemp and CBD? Are we going to allow intoxicating low dose beverage products? So it becomes a complex conversation. But the European example is interesting because you've got European Union and they've each got their own laws and ways they can control things. But the European Standards authority whether it's EFSA or the the drug authority actually has full control over the market. So if they say something's not allowed it's not allowed. If they're silent on something each of those European countries can decide on their own. But if you make something legal in I don't know Estonia or Czech Republic, you can then cross it over borders very easily and in fact I believe and I'd need to check this but I remember reading up on it probably three years ago you can sell it online across the border unless of course it's a scheduled drug in that member state. So I was doing a little Google search while you were talking do you have any insight on why the US seems to be the world's biggest drug market well I, you know what I think that's probably because it's the world's biggest market besides besides China. So I mean you've got 330 million people you've got a GDP per capita of I mean what 60$600$7000 so everyone can afford something. I come from South Africa and we are a nation of 60 million people but the majority of the population's making less than$300 a month. You know that's like 60-70% of the population there isn't a market for recreation because the money's taken up by survival I think in the United States everyone's got the luxury of recreation that's a fair answer.

SPEAKER_00:

I have wondered that myself I mean because I I think when I look at addiction as an addiction doctor, addiction at its core is using something to feel different. And I realize that there is there's nuance to that right you might be tired and you know chewing leaf cratom in the afternoon picks you up and you can go to do your thing. You can also be depressed and take an antidepressant from a doctor. Addiction is where really taking something to feel different goes off the rails and we see the three C's of addiction cravings, compulsive use and consequences. But usually what I do as an addiction doctor is I help people understand what are you using, why are you using it, what are you feeling, and how can I get you on my medicines instead of whatever you're buying and I just wonder if there's some sort of just kind of mental health issue in America that's different in other countries. I don't know. I've always wondered what it is about the United States I I I don't want to talk out of turn.

SPEAKER_01:

I mean I've I I've traveled a lot probably a hundred countries maybe more and each country's different and each culture's different there's a a big culture of consumption in the United States it's a big big consumer culture and that's what keeps the economy ticking that's what keeps people people going forward that's what drives the entrepreneurial spirit but it is very distinct walking into the United States and you just need to get off the plane and walk into the first coffee shop and there are 40 different types of coffee that you can drink all with different flavors and which syrup do you want and this and that and you know you walk into a coffee shop in Italy it's like do you want espresso? Do you want a cappuccino not after 11 o'clock it's comp you don't drink a cappuccino after 11. You've got very simple options and in the US options are ubiquitous and you know coffee is a great example and there's nothing wrong with coffee but coffee's a psychoactive substance that gives you energy makes you feel different and it is addictive. You get withdrawals when you stop it I don't know if you've ever stopped drinking coffee but I can't because the headaches are too bad.

SPEAKER_00:

My my wife gets really bad caffeine withdrawal headaches.

SPEAKER_01:

Yeah go ahead sorry and you know the the the health consequences of of caffeine consumption aren't aren't you know detrimental I don't believe and you know so it's cool and the same with nicotine you know the whole nicotine culture's changed so much we can maybe get into that that there's a different culture of consumption in the United States for better and for worse. And I think that that's got a lot to do with it. People are looking to consume they're looking to experiment they more risk loving and the consequences of making a mistake aren't so severe. When you in Africa the consequence of making a mistake are sick is significant. So people won't change a brand of toothpaste or brand of soap because the cost of making a mistake to something that they don't like is not worth it because they have to go buy another one and they can't afford to do that. So you're very risk averse. And I think that that risk aversion isn't so prevalent in the United States or any you know wealthy nation.

SPEAKER_00:

The other thing I would say as an American myself is we like to get stuff over with quickly the so-called culture of instant gratification. And we see it as American physicians is, you know, people really want quick fixes and we've talked about this with some of the addiction doctors that I work with here in the US that I can see why people find Kratom to go see a doctor you have to make an appointment there's a wait time you have to see if your insurance will cover it. You go see the doctor they might recommend something different than what you think you need. And then if they do write the prescription that you want, you have to go to a pharmacy, oops, it's out of stock and oh your insurance has a copay oops needs prior authorization. Like it could be six weeks before you're actually able to get what you need you walk into a smoke shop and you pick up your you know your favorite brand of Kratom and you're in and out in two minutes. So I think uniquely for Americans I I I think there's also that instant gratification culture of just we we want to get it over with quickly. And and I I didn't realize you know the the economic differences between us and other countries of just having so much financial freedom that that makes very good sense too.

SPEAKER_01:

Yeah the financial freedom aspect is something that hits me in the face actually to be quite frank when I travel anywhere that's a first world country it's just so so different for the majority of the population. And you know your typical African would kill for a$15 an hour job in a McDonald's they wouldn't believe that's possible. So it is it is very very different and America is one of the greatest nations in the world and it's very affluent and and the best things have come from America in many cases. And a lot of those things have been driven by the need to deliver quickly and be instantaneous and and these are all good things. It's increased productivity etc you look at Amazon you can now get your stuff in 24 hours you know or even less and that's a great thing. So like with everything there's the good and the bad and I do think that that America's heading into a space of real change and I think that's good. People are becoming a lot more aware of the things that they're putting into the body particularly when it comes to food because food since the I don't know 80s has been poisoning us. And I'm not gonna get on my soapbox now but you know I think about things that my parents gave me when I grew up I would never give my kids that now because I know what's in it you know but they had no idea. They had no idea they're like well it's from you know Kellogg's or Monsante or whatever it must be okay.

SPEAKER_00:

They must have done their research yeah yeah no it's yes I mean I grew up eating Fruit Loops and Applejacks and all this stuff as did my wife and we do not serve it do not serve it to my daughter.

SPEAKER_01:

What is if anything the GKC working on in terms of trying to combat this sort of stuff yeah so we are very very focused on this the these issues and again we understand we're in a an interesting spot because we see the good and we see the bad and we see it directly in front of our face and we've just got to be very honest with what we're seeing and what we want what we want. And what we want is a marketplace particularly for Kraton that supports natural creatum leaf products that are safe that are well labeled that have been manufactured in a GPFP facility that have a basis for safety and are not too potent because potency is where everything gets killed. Everything gets killed in potency. Traditionally we know this is how Kratum has been consumed this is how much it's been consumed. It's interesting you talk to the Malaysian scientists and that study Kratum for a living or the Indonesian scientists and you say to them well you know do you see this? Do you see that? And they go like no what are you talking about? Like no you know people enjoy it and sometimes they you know take too much of it but we don't see any of the stuff that's happening here and that's because of how much it's changed and it's become more potent. So stay within those ranges of what is appropriate for use what is safe what is backed by the science and then broad based education. But it becomes really difficult to do that education when everyone's saying well Kratum it's got to be what is it leaf kratum is it a concentrated extract is it an isolate is it a synthetic let's risk stratify and you will do this in your practice too you risk stratify and then you go forward. Regulations need to be about risk stratification and then going forward. So we're very active in educating a huge amount of effort we are investing in science ourselves so we're spending a tremendous amount of time and money in making sure the science gets done we've got to know what we don't know so that we can better educate and regulate and and then regulations. So we are very supportive of the FDA action very very supportive and we're still working on a state and a local level to educate and pass regulations that get the bad products out, keep the good products in, but in a safe regulated environment. We've also got to allow people to be adults but when you cross that line into creating something new that mimics a synthetic controlled substance that's got to stop. And one thing we've got to figure out is well what do we do with these people these individuals that have fallen victim to this nefarious behavior by these companies and sometimes they get forgotten about and we don't want to forget about them either. We want to be able to offer them help and point them in the right direction to get the help that they need. So it's a it's a human experience but we can't take out that there are bad actors that are doing certain things and those products shouldn't have been on the market in the first place.

SPEAKER_00:

Yeah. I'm gonna make a a comment that might actually sound funny in America in 2025, but I would like to give credit to my congressman most Americans don't have a ton of faith in the government right now, but our local congressman's office actually reached out to me as an addiction medicine doctor and said can you help us with tyaneptine? So there Yeah so they're actually very aware of mu opioid agonism I was actually really impressed.

SPEAKER_01:

Fantastic yeah so if I can just ask is there anything specific that the Global Creatum coalition is doing around these other substances like tyaneptine like Fenibit Yeah so we are involved with a few other organizations that are taking this on in a at a more global perspective as a more bucket of of product so looking at nitrous oxide looking at TNT looking at Fenibat and looking at what at how we appropriately deal with these products it's complicated because they're already illegal. This is the crazy part it's already illegal and it's not illegal because there's a question around well is it adulterated it's illegal because it's not a dietary ingredient it's a drug and you're selling it on the market. So you know when it comes to a a natural botanical there's a much bigger conversation that needs to be had but when it comes to a drug that's been made in a lab conversation's over have you do you have your new drug application? No, you're out. So there's a lot of activity that's happened on T-11 over the last seven years. It feels weird that it's still going on but there's I think about 11 states now that have banned it and there's never anyone standing in a way in the way of that ban. It's just so obvious. And there's a a federal bill that seeks to deal with TN1 that I think should get some movement. And then again I think you're seeing an FDA that is taking this very seriously if you listen to anything that that RFK or Commissioner McCarry have said is they've said the focus of the administration is on gas station heroin. And what is gas station heroin? Well it started with TNF. So it's very much in their focus and I think that any action that's being taken in the state to deal with TNF and and schedule it is something that we would support.

SPEAKER_00:

Well as always Matthew I learn a ton every time that I speak to you. So thank you so much for your expertise we're almost out of time anything else that you wanted to add on this subject no just thank you. I I really appreciate you first of all the work that you do being open to listen to to us and and share thoughts and yeah I just appreciate you having me on awesome thank you so much before we wrap up a huge thank you to the Montage Health Foundation for backing my mission to create fun, engaging education on addiction and a shout out to the nonprofit Central Coast Overdose Prevention for teaming up with me on this podcast. Our partnership helps me get the word out about how to treat addiction and prevent overdoses. To those healthcare providers out there treating patients with addiction you're doing life-saving work and thank you for what you do. For everyone else tuning in thank you for taking the time to learn about addiction it's a fight we cannot win without awareness and action there's still so much we can do to improve how addiction is treated together we can make it happen. Thanks for listening and remember treating addiction saves lives.