Public Health- Health Services- Senate and House

Call this meeting to order. Uh, first on the agenda is the approve the adoption of the, uh, previous meeting minutes. Do I have a motion? Yeah, have a 2nd. Thank you. Uh, now we'll move on to item C, discussion of interim study proposal. Uh, by Senator Boyd. I know, uh, we have quite a few people here today to discuss this topic, uh, and I think it'll be a pretty lengthy meeting, so my hope is that we can get, uh, we can get out of here by 3 p.m. That should give us plenty of time, I think, to adequately discuss this, but, um, so as since we do have so many people here to speak, I just would ask that everyone they do speak, try not to repeat comments made by previous presenters, um, and just be mindful of the time. Center board you're recognize. Thank Thank you, Mr. Chair. um, today we're here to hear an Aonum study proposal on legalizing kratom in the state of Arkansas. So some people say kratom, some people say kratom. We're gonna say, we're gonna try to say kratom today, but if somebody says Kra I understand that there's kind of an, an industry discussion on, uh, the, the appropriate way to say that, um, so my interest in this really starts with there is. Information that kratom can help people. Get off opioids, stay off opioids. It's well documented in the American story about how dangerous opioids are. And right now we have a barrier in place from the state that prevents people from accessing it. So what I'm wanting to do is evaluate if we put in the right regulatory framework can we safely legalize kratom in the state of Arkansas. And that's what this interim study proposal, uh, lines out is a, a mechanism to do that. And so, uh, I hope you all will be listening carefully and, uh, be ready to To ask questions. Uh, with that said, uh, Mr. Chair, I'd, Move we, we get started with the, the people who are the, the actual experts in this, uh, rather than me. Doctor Smith. You recognize. Oh. I said, all right. Uh, please introduce yourself, uh, for the committee and, and begin once you're done. Thank you, Mr. Chairman, members of the committee, uh, my name is Mac Haddo. I'm the senior fellow on public policy with the American Kratom Association. Our association represents consumers, not vendors. Uh, we represent the more than 200 million Americans who are using kratom today, uh, about a third of which use it as a replacement for a cup of coffee, for example, for an energy boost in the morning. Uh, some use it, uh, at a little higher dose to help them feel better, to have mood elevation, to be able to function in life, and then another third use it in the category of those that are seeking some alternative in helping them deal with acute. And chronic pain and trying to get off of opioids which are often prescribed, and some are engaged in illicit drugs that have serious side effects and kratom offers a lifeline away from those. And so you will hear today, some scientists, much smarter than me, that will be able to explain to you exactly that segment of the population and why Kratom is essentially a safe product when it is regulated properly. Uh, there are 13 states that have adopted the legislation that is before you for consideration, which Essentially establishes a regulatory framework for the sale of raden products in the state of Arkansas. In those states, they found success in being able to regulate those products to identify adulterated kratom products and to remove them from the marketplace. It is a tool that is effective and is a far better alternative than banning kratom. So what I wanted to talk to you today for just a few moments is about the changes in the policy and science on kratom. If you open up Uh, a Google search on Kratom, it is a horror show in terms of accurate information, as sometimes happens on the internet driven largely by the circumstances that we found ourselves in when the FDA first decided that they were going to attempt to regulate kratom. With respect to Arkansas, the timeline for the scheduling of kratom occurred in 2015, a petition by Doctor Thomas Atkinson at the Springfield Treatment Center in, in Springdale, Arkansas reported to The Department of Health that he observed that some of the patients that he was working with in the addiction recovery area we're experiencing opioid like uh symptoms with the use of kratom and so we reported it combined with the FDA's narrative about ratom, which was extremely negative. The Department of Health opened up a public hearing that they convened for the purpose of having a scheduling, uh, procedure for kratom. That was opened on September 1st of 2015 at 10:00 a.m. Closed at 5 p.m. that same day, public comment ended. They cited the fact that it was noncontroversial, which had it been more widely distributed, I can assure you that having participated in hundreds of hearings around the country where thousands of people that will come and testify about the value that comment period was closed after that seminar period, they they decided that the Department of Health decided to list kratom as a Schedule One substance, meaning all of the criminal penalties associated with that, and it was effective on February 1st of 2016. The catalyst that started this deaths in a 12-month period in Sweden from consumption of a Public health event that every public health official in the world should have been concerned about, and the FDA was properly concerned about it. What they didn't do was look at what happened after that when a group of scientists in Sweden published a peer reviewed article examining those 9 deaths. And what they found that in each instance, the death was caused course it's going to have the kinds of powerful effects that opioids have, and when it was introduced into this ratom product as an adulterant, it led to the deaths of these individuals. Unfortunately, the FDA didn't make that distinction, one that they should have made. They decided that they were going to launch their war on Kratom, and they imposed an import alert on all rat and raw materials. Kratom grows ubiquitously in Southeast Asia. There are only two places in the United States that currently are growing kratom. It requires a tropical environment and that's in Florida and Hawaii, and not all parts of Florida because some parts of Florida have a frost zone, so it has to be in the southern regions, but it grows and it matches the kinds production of kratom leaves that occur in Southeast Asia. But the point is that the kratom today is available and legally sold across the country except in the six states that were convinced by the FDA, including Arkansas, to schedule kratom prior to 2016. On August 31st of 2016, the drug enforced to an administration published a federal register notice at the behest of the Food and Drug Administration to classify kratom as a Schedule One substance. That's when I first was contacted by the American Kratom Association some 8 years ago. They asked me to help. I told them it was impossible. There has never been a recession of a federal register notice published under that section of the Controlled Substances Act ever. And there was no hope that they would have, and the only chance they had was to build a public record for a couple of years, 2 years was the expiration when the DA had to finalize its permanent scheduling, they could do that. But I was wrong because in the first time in the history of the Controlled Substances Act, the DA withdrew their notice of scheduling because the FDA's information and data was insufficient to justify what they were doing. They invited the FDA to provide a more robust scientific dossier, they invited public comment. More than 23,000 Americans responded to the DEA unprecedented in their view, at that time of scheduling recommendations, pleading the majority, which 99.9. 9% saying do not schedule kratom, it's saving my life or it's helping me. You had first responders, you had veterans who were talking about how Crayton was helping them. Those, those were added to 147,000 Americans who went on to the We the People website signed a petition at the White House saying, don't ban kratom. The result was that there were 226 Republicans in 25 Democrats in the United States House of Representatives who signed a letter in a two-week. Period during that review period saying don't schedule kratom. 13 United States senators, one of whom was Bernie Sanders from Vermont and Orrin Hatch from Utah, which tells you that wide philosophical and political divide was breached by science and because of the need to protect this substance from the scheduling procedures. On October 13th of 2016, the DA withdrew their Schedule I notice on Kratom. As I mentioned, unprecedented. On November 17th of 2017, the FDA submitted its It's 2nd scheduling request that was withdrawn by the Assistant Secretary of Health on August 16th of 2018, and I'll tell you why in a second again, unprecedented. And then on July 23rd of 2021, the FDA took its 3rd strike on Kratom. They recommended that through the UN Commission on Narcotic Drugs, of which the United States is a treaty partner, and if Kratom were scheduled internationally under a far less rigorous standard, then we would have been compelled in the United States as a treaty partner to commence scheduling of kratom in the United States. Because it was a less standard, uh, we were concerned at the American Cratium Association that the FDA was using the end run around thetrolled Substances Act, which is the standard that we follow in the United States. And by the way, we were right, uh, that review was conducted by a group called the Expert Committee on Drug Dependence. 12 international experts from around the globe whose duty and responsibility it is and all experts in substance abuse and addiction recovery unanimously agreed The kratom did not meet the lesser standard for international scheduling that the FDA was recommending. And so that seminal moment on December 1st of 2021, where they found that there was insufficient evidence really put the nail in the coffin of the FDA's War on Kratom, you would have thought. When the disclosure of the withdrawal of the kratom recommendation was made in 2021, unfortunately wasn't, I'm sorry, 2020 in January, it wasn't disclosed because the FDA withheld the public disclosure of that withdrawal, claiming the exemption under the federal, uh, the, the, uh, Freedom of Information Act as an ongoing regulatory matter. When it was publicly disclosed that Doctor Gottlieb, the Assistant Secretary for Health, responded to complaints from the FDA saying the FDA. Doesn't schedule, it only recommends and here's what he said that was most important. The FDA's recommendation was rejected because of embarrassingly poor evidence and data and a failure to consider the overall public health. His letter is something every one of you should read because it goes into detail about why he believes that the FDA missed the mark and why Kratom, and he's not a kratom advocate. Doctor Zo told me, he said, I don't know whether Kratom is good or bad, but I know good science when I see it, and the FDA didn't produce. And that's what we should have as the established standard for kratom in the United States. However, the FDA to this moment and why I referenced the horror show on the internet, if you go to Google and search it, you will see the FDA saying that kratom is a dangerous substance that it should not be sold to any American. It cautions everyone despite the fact that that is the same embarrassingly poor evidence and data that doctorso pointed out that they continue to rely upon. A federal judge in the Southern District of California ordered the FDA to come to his courtroom precisely to answer the question with documents and witnesses as to whether kratom is dangerous. In his sentencing memorandum on the individual that had been accused of, of inappropriately importing kratom into the United States calling it fertilizer, which he was stone cold guilty of doing, uh, which he pled guilty to, but the judge was concerned that in the sentencing memorandum produced by the government, the FDA was claiming that was dangerous and it was killing people and he reviewed all of the evidence that was provided and you can see the quote here. He said that it's legal to sell and buy and consume in the United States, which is true in 44 states, 13 states have protected it in terms of regulations which we hope Arkansas will join. He said there's some municipalities that are in some states have banned it. The federal government has not banned it. They have not prohibited the sale of it, and they have not prohibited the consumption of it. And that's the truth of the matter, despite what you read on the FDA's website. As they go forward, he went on to say on the question of whether kratom is dangerous or not. So the evidence that I have based on the evidentiary hearing is that the FDA has now come into line, so to speak, with the other regulatory bodies they have jurisdiction over this general subject matter. That is the Drug Enforcement Administration, the National Institutes on Drug Abuse to take the position that Kratom is not a dangerous substance. That's the fact of the matter. Adjudicated by a federal judge, and when the FDA was compelled to come to his class or to his classroom, his courtroom. The answer was no, we have not yet determined whether kratom is dangerous or not. I would ask you to listen carefully to the scientists who are going to follow me here today. Uh, we encourage good science. The American Kratom Association believes that science should dictate what the actual public policy on kratom is not the inflammatory language of a group of bureaucrats who got it wrong as Doctor Zo said, because they produced evidence that was not in keeping with the standards that we require for such scheduling and the unfortunate part is, and I'll leave with this, that in the hearings that I referenced earlier, the hundreds of them that I've been in and listened to the people who are A consumers of Kratom. They say it saved their lives. For many, it just helps them. It just makes them feel better, gives them a boost of energy. For some people, it helps them get through the day in a productive way, but for many it saves their lives, and we hope that Arkansas will repeal the current ban and come into line as, as Judge Robinson said, with the current thinking, the kratom is not dangerous, but it should be regulated and the bill that's before you hopefully will do that. So thank you, Mr. Chairman, members of the committee. Glad to answer any questions if anyone has any. Representative Ray, you're recognized for a question? Thank you, Mr. Chairman. I'm just curious, you, you say that people take this because it makes them feel better or gives them more energy. Is there, is there a particular condition or set of Conditions that people take this for. Or, or would they just take it like they would. Take an energy drink or a cup of coffee or something. Can you explain that? So the, the, uh, product forms that kratom comes in is a powder, uh, it is bitter tasting and that's giving it a kind word. It's hard to take, so a lot of people like a capsule or a pill form, and some people drink beverages. Uh, those are the product forms. The important part is that whatever product form it is that it's regulated properly so that it's not enhanced. It's not adulterated and that it's properly labeled with instructions for use. Uh the people would consume it about 13 based on a consumer survey conducted by the University of Florida, about a third of the people use it for an energy boost in the morning for increased focus, like a cup of coffee. Another third use it because it makes them feel better, makes them more productive, gets them through the day, uh, in order to get through a long, hard day at work, and that's where it's used in Southeast Asia primarily by field workers, uh, to experience that hard labor, uh, Crayton was introduced into the United States by Vietnam War veterans coming back from Southeast Asia. Who found the chewing on ratom leaves to help them get through the long days in the jungles. And so they self imported it back into the United States and that's where it first was introduced here. Uh, and then there's that third group that are struggling with acute and chronic pain, uh, who are using kratom at higher doses, uh, in order to manage that pain and those people are saying that it helps them stay away from potentially more dangerous and highly addictive products like opioids or illicit drugs, uh, helps them wean off of. And that's why the National Institute on Drug Abuse. has invested more than $100 million in our money to research kratom and you'll hear from some of the scientists who have done some of those studies, and the director of the National Institute on Drug Abuse has testified before Congress that kratom should not be banned, that it should be available and accessible to people, particularly those that are struggling and who need a lifeline. So that third, they're using it for that purpose are finding great success, uh, and able to help them, uh, wean off of this if quick follow up. And so, obviously, you, you may not be the best person to give the other side of the coin, but I mean, uh, help me understand the, the opposition are there? Is this, is this the opposition from law enforcement or their side effects to taking the drug, hallucinogenic hallucinogenic effects. Um, I mean, what, what, tell, tell me what generally is the opposition's argument on this. So actually I'm a good person to ask that because I hear both sides of it and we represent consumers and I hear from consumers that have problems with kratom. Some feel like kratom is making them too dependent on it, and they have trouble weaning off of it. Uh, typically that's because they're using Kratom product that has been enhanced and super concentrated and has the kind of addictive properties that typically the natural craum plant or a properly extra, extracted ratum product doesn't have. Uh, so there are those, but in terms of groups that are against it, many physicians are concerned about it because they think it should be a prescription medication. And of course, that's problematic for any botanical supplement. And by the way, because it's a botanical doesn't mean it's safe because it's botanical doesn't mean it doesn't have risks. That's why you have regulations. get put into effect. So from that standpoint, uh, people that are, that are using kratom can become dependent on it. It's not, you'll hear from other scientists talking about what that means, uh, but they're not finding addictions. They're not finding that they, they're, you know, drug seeking, they're finding it helps them and to the extent they become dependent needs to be managed. The doses in the poison, which is why regulations are critically important with, uh, labeling that says serving size and the number of servings per day and ingredients are in it so that you understand exactly. Representative Ladyman, you recognized for her question. Thank you, Mr. Chairman. I'm over here. Uh, thank you for being here. Um, sounds like something we really need to look into, but my question is, you said there were 6 states that have approved this. Proposal. Is that right? I'm sorry, there are 13 states who have approved the legislation that we're asking you to consider. 13 states 6 states banned kratom at the behest of the FDA in the 2016 time period. Arkansas was one. Vermont, who's now withdrawn, they're in the process of doing rulemaking to withdraw their scheduling, uh, at our petition and they accepted it. Rhode Island passed the Crat Consumer Protection Act. The governor vetoed it. He said because a couple of physicians called him and said, you should not, be doing this, uh, the American Medical Association in their resolution expressing concerns about Kratom following the FDA said it should not be criminalized, and that's in the AMA uh, resolution. And so the governor of Rhode Island has invited us to come back and repass the bill in this coming legislative session. So that, that one I think will be resolved. In Wisconsin, uh, the, the legislature got the legislation got stopped and the controlled substances Board was asked by the legislature to evaluate whether Meets the criteria for scheduling in the state of Wisconsin and the controlled substances Board reported back to them that it does not, but they think it should be regulated, which we agree with, by the way. The state of Illinois, I'm sorry, the state of Indiana, which is one of the banned states passed the ratum Consumer Protection Act on a vote of 53 to 40, went to the Senate. The Senate asked for an interim study, as you're doing today. And so we expect next year that we'll see that happen. The only state we haven't gotten any traction in yet is in the state of Alabama. Uh, we're working with them, but they've had some Issues with medical marijuana and they they thought that we had to wait for that to be resolved. So hopefully we're going to go there. But the 13 states that have passed it, are, are Utah, uh, Georgia, uh, Arizona, Nevada, Oregon, Colorado, Oklahoma, um, I want to make sure I get it right, uh, Kentucky, West Virginia, uh, Maryland And Florida and Texas. I wasn't gonna ask you to name all of them, but I appreciate you doing that. But I was just wondering if it was a regional thing or not. It sounds like it's. Not a regional thing. Is that correct? As far as approving this process? That's correct. It's not regional. All right, thank you. Representative Rose, you recognized for a question? Yes, thank you, sir. Uh, thank you, Mr. Chair. I had a couple of quick questions. Um, first, can you share, uh, any information about long-term, uh, health effects of kratom or anything from someone like the Mayo Clinic or any of those organizations. Thank you for the question. Uh, the Mayo Clinic, uh, the Cleveland Clinic, some others repeat what the FDA says about the potential harms of kratom, but they recently, both WebMD, uh, the Mayo Clinic have in Cleveland Clinic have amended their harsh criticism about Krats recognizing that there may be people that are actually helping with it. So on long-term effects, that's still a, a study in progress because it's only been in the United States, uh, since the early 70s. When you look at long-term, uh, clinical studies. It requires funding and requires a lot of effort. We have lots of experiential data of people that have been using it for long term, uh, uses for kratom, and they're not seeing any of the residual side effects that you expect with dangerous substances. Uh, so we're, we're looking to see more science on this, but we have enough information based on the safety data of Kratom to know that it can, if it's properly regulated, be sold without there being significant adverse effects. There are people who are using dangerously adulterated cratom. Products or products that claim their kratom and they're experiencing serious adverse events. The FDA did their own study, which you'll hear about, uh, where they found that pure cratium, it doesn't happen, uh, and that they have the FDA has acknowledged that Crayon was well tolerated at all dose levels, but if it's adulterated or super concentrated serious problem just like caffeine, the FDA today recognizes that caffeine is the most widely used psychoactive drug in the world. They have limits on what you can do in concentrations of caffeine. But we recognize caffeine is used widely across the world. I, I had a second question, but I do have a follow up to that, Mr. Chair. You recognize. Uh, you said that the Mayo Clinic, Cleveland Clinic, and a couple of others, uh, just repeated what the FDA said was, did they not do, I, I was just curious in your response, did they not do their own studies or did they just say, hey, we, we liken our belief to what the FDA has said. So if, if I can answer two specific points. One, they have not done any studies on their own. We actually went to the Mayo Clinic and asked them, uh, we had a philanthropist who had a family member who believes his family was saved. by ratom, a family member, uh, he had a deep pocket. He wrote, he said he laid the check on the table and said, I will write the check right now you do the studies and the Mayo Clinic refused and said we're following the FDA. The Cleveland Clinic actually had an agreement with the FDA to republish the FDA's information. So I'm not, I'm not saying that that's bad. I'm just saying that that's what you hear and you see. They've not done to your question, any. Independent research on ratom at those institutions. That's my last question, Mr. Chair. Uh, you're with the American Cratium Association. That's, is that correct? We might call it the Kratom Association, but yes, yes, thank you. Whichever of those two, will you guys be, uh, in some form or fashion. Like authorizing or certifying vendors or producers or anything in this field, um, Well, Are you already doing that? I guess in other states or could you potentially be doing that in our state as well? So, uh, because we're consumer-based organization and because of our concern about adulterated and, and super enhanced creating products, we developed what we call our GMP program for rat and vendors to voluntarily participate and that requires them to adhere to the GMP, uh, dietary supplement standards at the FDA publishes verified by an independent third party auditor that they're producing their products that way. We're about to enhance that program in January, which will require specific Labeling. So that's a voluntary compliance standard that about just under 50 companies adhere to in the United States. There are thousands of kratom vendors. Uh, those thousands of trade and vendors don't like the American Kratom Association. Uh, I get calls from them regularly saying you're trying to put me out of business, and I tell them, yes, I am, unless you're willing to adhere to the FDA standard for the production of good manufacturing standards to make sure these products are safe and make sure they're labeled. It's an easy business to get into, but they don't want to invest in the cost they're associated with. With equipment and protocols necessary to produce safe products. So we advocate for that. This legislation is different. It requires the registration of the product accompanied by an independent third party certificate of analysis demonstrating compliance by an independent lab by the manufacturer, and then what we recommend, and we hope you'll adopt is that if there is a problem that's identified by the state, the enforcement agency with any product that they require the vendor to update their certificate analysis. And provide independent third party verification of compliance. And if the department believes that they still aren't getting a straight answer, they would then, uh, do the test themselves and they would charge the manufacturer for the cost so that the people of Arkansas don't have to bear the burden of enforcing it in the state. That's what we recommend. It works, uh, and we found that it cleans up the industry in a hurry. One, state official in Utah said, we don't see the bad products in our state because they don't want to come here because they know we're going to take them out. Thank you, thank you, Mr. Chair. Representative Boyd, I believe you had a question or a statement. I've got a question. You recognized for your question. So I just wanted to follow up on Representative Rose's question and be more specific. So this product is presumptively been available. Kratom has been available in Southeast Asia for decades, if not, you know, centuries, um. Have we, have they seen the, are you aware of anything in Southeast Asia that says there are long-term consequences to cradle. Uh, thank you, uh, for that question. The, based on the data produced by researchers in Southeast Asia, including the University of Malaysia, the Indonesian group is called BRI, which is their equivalent of the National Institutes on Health in Indonesia. Uh, they've looked at this in their studies, they're not seeing any of those long term effects. We're concerned that uh the signal that for an adverse event may not be as sophisticated in Southeast Asia as it is in the United States. That's a two-edged sword. If it's It's too sophisticated, we get more adverse event reports than are accurate, but we can deal with that, not getting them is important, so with the caveat that they have not observed any long-term effects of ratium use in Southeast Asia. It might be because they don't have a good reporting system and we need that needs to be refined. It also may be accounted for the fact that the use of kratom leaves, which are plucked from the trees and then processed however they do it, they boil it in the tea, uh, and then they consume it that way is different than here in the. United States because in order to ship it here, they have to take the leaves, dry them, powderize them, and because of mold and yeast and fungus and other contaminants to get into the raw leaves if there's moisture in them shipping, so they powderize it and then it's used here in formulated products in the United States and that might account for some of the differences in the adverse event reports that we hear, but that said, you look at the adverse event reporting system that we, the most sophisticated in the world, you don't see a signal that would justify scheduling. If it did, the FDA would be all over it. Uh, the fact is you need to be concerned with quality of the products and they make sure they're not adult. Any other questions for this witness? CNN, thank you for your testimony. Thank you very much for this opportunity. Going down the list, we have a. Doctor McCurdy. Please come down and introduce yourself and feel free to begin your presentation. As soon as you want. Thank you, Mr. Chairman. Thank you, representatives. Um, I'm Chris McCurdy. I am from the University of Florida. Uh, Where I serve as a professor and eminent scholar. Um, and I'm recognized as probably the leading authority, uh, on the science of this plant in the world. Uh, we've been studying it since long before, uh, the DEA ever recognized it as a substance of concern, which it is, uh, still recognizes substance of concern. Um, today, I was at the University of Mississippi for 16 years before moving to Florida, uh, and so spent a lot of time, uh, in this area and I just want to kind of orient everyone back to the roots of this plant, no pun intended. Uh, but to just come back to Southeast Asia for a minute. I think I can underscore some of the things that were mentioned. Um, but Mitriganis speciosa is the, um, official name of this plant, which, uh, we recognize, um, as Tom or Kratom or, uh, Kratham. There's lots of ways to pronounce it in Southeast Asia, it's pronounced Prattam. Um, And, uh, this is found really at the intersection of the border of Thailand and Peninsular Malaysia, where it's thought to have existed, uh, from, from centuries, uh, of time. It is in the family, what's called rubiei. the important link there is that is the coffee family. The coffee plant is in that same family. This plant does not contain caffeine just like the coffee plant does not contain many of the chemicals that are found inside of, uh, coffee beans. So Um, we'll just go on from there. I really don't want to spend too much time on the background, but I do want to highlight, as was mentioned by, um, Mr. Hadel, uh, use in Southeast Asia. The use has occurred there for centuries without incident of death or at least reported linked death incident. Uh, it's been used by field workers to relieve pain as a stimulant to improve their work capacity in the hot humid environments of outdoor laboring, uh, and to reduce opioid withdrawal. And so what you can see here is a, a tree down in the bottom left, um, which is the naturally occurring plant in that area, um, at one point in time in in Thailand, it was ruled to destroy all of these trees and uh living in the South for many years, I know this plant called kudzu, uh, and This plant is very analogous to kudzu. It's impossible to eradicate. Uh, it, it just grows wildly there, um, and, and it's really hard to control. In terms of that aspect. Uh, however, the leaves are, are picked fresh, um, each morning they're boiled into what we call a decoction. Uh, that takes several hours to produce and then that juice is literally. Served, uh, in the daily, um, If you will, serving size, it's a baggie, uh, out in the, in the rural areas or in a, a former water bottle, uh, and then it's sold at roadside stands, even though it's illegal to do so, uh, it's still widely prevalent in, in Malaysia. And Recently, we know that, um, polydrug users in Southeast Asia, including those using meth, I've been able to reduce their use by utilizing uh kratom. It was mentioned that kratom is chewed, uh, in some areas, and that is the predominant way that it is consumed in Thailand. It is picked fresh off of the trees and consumed uh very similar to how coca leaves are consumed in, uh, South America, just pick fresh, uh, and chewed to help that energy and work throughout the day. The predominant active ingredient, uh, in, in Kratom is Michiganan or Metragenine. This is an alkaloid chemical, uh, that's present and usually in a natural product, we believe that the most abundant compound is the one that's primarily responsible for the pharmacological actions. Um, as such, most of the research that has been done has focused only on this chemical, uh, and I'll, I'll address a little bit of that as well. Um, in the United States, the use looks very different, as was mentioned, the leaves have to be dried and packaged, uh, and put into, uh, either just bags, um, that are sold and, and the worst thing that can happen is someone purchases a bag that just has a Sharpie marker written on it with no directions, no explanation of what it is, uh, or what's there, uh, versus products that have been labeled, um, more appropriately, uh, particularly under the, the, uh, regulatory statutes that have been passed in those. 13 states. Um, this is a pre-COVID number, but, uh, American Kratom Association reported that there was about 2000 metric tons coming into the US every month. Um, if you do a quick back of the napkin, uh, calculation of a typical dose being 3 to 5 g, that's about more than 15 million users across the United States. This number is probably exceeding 200 million, uh, today since increase is known to have uh happened during. Uh, COVID times. Um, the big question has always been, is it a threat or a therapeutic and as was mentioned, it's anecdotally used for chronic pain, mood elevation, uh, and to treat opioid use disorder as an alternative. It is, um, It is known that adulterated and contaminated products have been reported, as you saw, uh, there are claims that it's severely addictive and deadly, uh, and, uh, I was, I was actually fortunate to be consulted with the World Health Organization, the United Nations, uh, when they considered, uh, international, um, banning of the substance, uh, to provide scientific information as well as we have now contributed to the US Food and Drug Administration's first studies in humans. To look at the safety profile of this plant and as was mentioned, uh, this was studied in to, um, very small doses up to 12 g doses of material, which if you look at that average daily dose or the average dose of 3 to 5 g. We're talking about significantly larger doses than what would normally be consumed, uh, and the FDA, uh, had to come out and say that up into those 12 g doses, it was, uh, tolerated. So, um, we'll just go, go on from there. What we got excited about was really the therapeutic potential of this down the road with enough science and enough controlled clinical trials to really look at this as an opioid detoxification method as a medication-assisted therapy in, in other words, something like buprenorphine, uh, or methadone. It does have a very mild withdrawal compared to opioid substances. Um, so the, the withdrawal is on what's called the Subjective withdrawal scale, uh, and Doctor Smith will speak a little bit more about withdrawal, uh, in a few moments. Um, but, Having a mild withdrawal is really equivalent to what coffee is and so, um, going without coffee in the morning, um, many people will have a headache or a foul mood, um, until they get their coffee and they can function. And we see the lines at Starbucks, uh, and as was mentioned, caffeine is regulated. In fact, caffeine tablets, uh, can contain no more than 200 mg of caffeine, 200 mg of caffeine injected IV just to put that in perspective, the poison is truly in the dose. When it comes to talking about any substance. A lack of standardized product has really prevented rigorous clinical trials, uh, until recently, as I mentioned with the FDA. Um, because of that, we started growing, uh, Mitrogan speciosa at the University of Florida. Uh, we have one of the, uh, only research programs that looks at this from the genetics of the plant all the way through, uh, the effects in humans. Uh, we know that these plants can grow well in, in the state of Florida, and they also grow well in other tropical environments, but they will not survive a freeze, so they're not adaptable to many of the places in the United States and why we're doing this is not only to the study the plant, the genetics, how it can be utilized, it could be an effective crop replacement alternative in the state of Florida for the citrus industry, which is, um, quickly dwindling due to citrus greening. Um, so there's a whole subject there we we won't touch on. Uh, there's several alkaloids within this plant. The alkaloids are essentially the chemicals I mentioned mitragynin or mitragynine being the major alkaloid that's in that plant and the one that's received the most study, but I think we always have to pay attention to the fact that this plant is a, uh, what I call a complex symphony orchestra of compounds and substances. It is not just one chemical. It is not that one chemical that has had the majority of studies done on it. Although that majority chemical is the one that is exposed most when. ingest that product. Um, we've been taking that one instrument out of the orchestra and listen to it at full blast without context of those other instruments. And what contributions, uh, they may be making. So this is just, I'm a chemist, I have to show some chemistry, uh, but I think what I want to underscore the importance of this is, as many people have said, uh, kratom is an opioid. It certainly has opioid activity. It interacts with opioid receptors in our body. It's not only interacting with opioid receptors, which is what traditional opioid medications do like OxyContin, heroin, fentanyl, those that are illicit or illicit. This molecule interacts with opioid receptors, but only in what we call a partial agonist format. That means if you turn on your faucet full blast, and water's running at full pressure. That's a full agonist. If you just turn on your faucet a little bit so that it's functioning. But it's not drowning out the area that you're putting that water into. That's kind of a partial agonist. The other way I look at it is you can think of this as a car, uh, like a Ford Fiesta or or something that's not very speedy and quick. It gets you from A to B, um, but it doesn't do it in a way that's incredibly dangerous, such as a Ferrari would do if you put the pedal to the metal, uh, which is what I kind of think of as heroin. This interacts with other receptors in our body and interacts with adrenergic receptors, adrenergic receptors are involved in our fight or flight syndrome, uh, and these have a lot of properties, um, that give that stimulatory, uh, sort of effect. Interestingly enough, poison control centers show that kratom overdoses are overexposures resemble that of stimulants and not opioids. Um, so the other problem is in the medical field, we're treating these as opioid type overdoses because of the way, um, the, the evidence has been put out wrongfully, um, in, in the medical literature. Um, I can tell you working with animals that naloxone or Narcan will not reverse, uh, an intentional. Provided overdose to these animals. It is not opioid in nature. They go into seizures and convulsions and will die. We can reverse those, um, with stimulant type antagonists, things that will. Um, one of the biggest questions that we asked early on in this was, does Mitriganin, that major alkaloid and hydroxymetrogin, a metabolite, it substitute for morphine and I'm not going to go into details here other than to tell you that morphine we know is an addictive substance we can train. to behave and inject themselves with morphine. Um, they press a lever to get an injection. They don't actually shoot up, uh, but they get that injection given to them. What we do is we train them to do that and then we simply remove the morphine, we replaced that with various doses of Mitragan and again, the major alkaloid in here and what you can see in blue squares there is essentially there's no change from saline, which is on, on the far left in that light blue or gray square. This indicates that the abuse potential is very low, uh, for this material, whereas the semi hydroxy whichtroganin and metabolite that formed in minor amounts in our bodies. It does have full opioid activity. It is a full new opioid agonist, and it does have an abuse potential. So a product that could be only sold as a 7 hydroxy Mtroganan products which are now available sadly in some of the market. Um, these could be very much like illegal opioid, but kratom or kratom itself is definitely not within that category, uh, and appears to be beneficial. Not only that, we've seen that Mitriganan alone can reduce heroin self-administration, so these animals are trained to be addicted to heroin, uh, and if we pretreat them with Mitrogenin, we actually can block that and this is not, not something where the animals are preferring Mitrogan. Over heroin. This is actually a, a study that determines those differences. This material unsurmountably blocks those animals' ability to take heroin. So this has great promise in our minds as a potential treatment down the road, um, potentially pharmaceutically, and we've been involved with a $50 million grant through the National Institute on Drug Abuse to develop Mitriganan as a clinical candidate for, uh, opioid use disorder. Now what I'll show you is the pain relief is very interesting if you look at this graph on the left side, um, we show morphine given orally and given, uh, by injection. And you can see as that curve goes all the way to the very top, that's 100% antinosisceptive effect. In other words, it is killing pain up to 100% of what that assay gives us. As we increase the dose of LKT, which is Lila kratum tea, so we make tea out of the leaves, we laughize that basically I call it astronaut ratum, uh, like astronaut, uh. Ice cream, and as we increase the dose from 1 g to 2 g to 4 g in a mouse, uh, per kilogram, you can see that there's no increase in analgesic efficacy and it does never reach 100%. So there's a ceiling effect with this. Um, that analgesia can last as long as and be almost equivalent as that of morphine, uh, even though it, it does not seem to have the issues. Um, the analgesia does appear to be mediated through opioid receptors, so some of the pain relief is coming through opioid receptors. It also is mediated through serotonergic receptors and adrenergic receptors. I don't have time to show you all of this data, but we want to show that it does not have what we call a condition place preference. This assay measures a drug's ability to cause drug-seeking behavior in animals, uh, animals do not actively seek to take this. Medication. Um, sorry, I shouldn't call it a medication. This, uh, plant. Um, we've also looked at, uh, typical things that you would look at in opioids, which is sedation, um, these materials do not cause sedation. In fact, they caused the opposite of that. And we looked at respiratory depression. Uh, because one of the major limiting, uh, side effects and, and deadly side effects of opioids is respiratory depression. Uh, and you can see him morphing in red, uh, that's a severe depression, uh, of opioid receptor, um, Um, induced, uh, respiratory depression. And what we saw with uh Lili Kratomte uh orally is that there was really no, uh, decrease in, in respiration. Um, we also have seen that it has powerful reduction of naloxone precipitated withdrawal of habituate animals to become addicted to opioids. Uh, we can treat them, pre-treat them with Lali kratum tea, uh, and then induce withdrawing those animals and what we see is that they undergo almost no withdrawal symptoms, so the, the bottom line there is what you're seeing in red is morphine, those are the withdrawal symptoms in this case, jumping frequency. Mice, we call it popcorn jumping. They just jump all over the place uncontrollably. Um, we don't see that when you pre-treat these animals with, um, Crete and we don't see it with Kratom tea alone, which is the very far right, um, Bar there. We also see teeth chattering as another measure of withdrawal, and you can see here that, um, in most cases, uh, it was much less severe and cheek chattering when we administered these to the mice that were habituated to opioids, uh, and then those mice that actually received only, uh, kratom T had no withdrawal symptoms at all when they were precipitated with naloxone. I won't go through this data, um, In, in any detail, it just kind of underscores that, but the conclusions on opioid dependence testing in mice, uh, is really that ratt and Michiganan alone displayed little to no physical dependence, and this is in mice, uh, and then substitution of kratom tea or Microganan for morphine and physically dependent mice ameliorated some of the opioid withdrawal effects. And I want to finish with, um, one last comment is that we recently published a uh commentary where, um, we are out here saying that not all kratom is equal. Um, and so there is a large proliferation of products in the marketplace. There seems to be an unofficial arms race, uh, to increase the potency of these, uh, products, making them more and more dangerous, as I said, the poison is in the dose and as we get to these higher concentrations, those can be harmful and we're in the business of trying to put the science behind where does the help come? Where does the harm reduction fall versus where does the harm start to begin from the substance because we know that it has. Both sides of the coin. Um, and this is another reason why we're anxious and really supportive of legislation around the natural leaf versus many of these very concentrated extract products that could be dangerous, so I will stop with that. Thank you for your time and be happy to answer any questions. Representative Rose, you recognized for her question. Mr. Chair. Thank you for your testimony, uh, this morning or this afternoon, uh, 11 question really derived from just kind of my search into Florida and kind of the guidelines that Florida has and the story that Florida is telling about kratom and I think if we had a conversation, we'd have different opinions on, well, these deaths are caused by this or there's no deaths that are caused just by this or why was there a lawsuit? Why was there a judgment, etc. etc. raises flags for me. But the question I wanted to ask is, why does this need to be publicly available at say gas stations, convenience stores, etc. as opposed to something that can be prescribed or something that A physician determines somebody would benefit from. So I believe, um, there's, there's two answers. To that one is, um, I, I, I really think it should be in a much better venue than a gas station. Uh, or a smoke shop. It should be in a natural products or herbal store like GNC or Walmart or anywhere. Um, right now, it is not in those outlets, um, because it has not been proven to be safe until the most recent FDA studies have started to really look into this and show that it is tolerated and safe. The second thing about um. You know, you, it's a fair point that anything can cause harm, anything can can cause death. Um, if you get to large enough concentrations of water in your system. Uh, there is a such thing as water intoxication that can cause death and does cause deaths, uh, every year, but we don't ever think about banning water or making it illegal. It's an essential part of life. Um, that's just an extreme example. But you would also find that uh we are in the process of working through many of these things like you say, like as physician could prescribe this, uh, as I mentioned, we've been working with the National Institute on Drug Abuse and trying to make a pharmaceutical out of this, um, from that main compound, uh, the National Institute on Drug Abuse has put in well over $50 million toward that effort and we'll be, uh, filing an IND, uh, investigational on new drug application. with the FDA to start human clinical trials to look at this in the harm reduction of opioid use disorder, opioid withdrawal. Um, so at some point in time, that would make it a prescribed medication if it has an actual medical claim to it. Again, the FDA has a route called the FDA Botanical drug route. Um, and that is something that can be pursued for specific indications that a doctor would prescribe. The other side of this coin is that, um, right now, millions of people have access to this product. Um, we don't see. 10s of thousands or hundreds of thousands of issues, um, with poison control centers or or any of that. And we're talking about millions of people having access. If we were to remove that access. It is more than likely many of these people will revert back to more, uh, dangerous illicit substances and could find themselves, um, back in the situation where they were prior to finding this substance. I'm not saying that it has proven therapeutic value, um, and that's why it can't be sold or prescribed by physicians. Follow up, Mr. Chair. Are you familiar with the 3 point? Or the, the three-piece article study investigation by the Tampa Bay Times. I was part of it. OK. So I, I read through that and it, it gives me concern because we're, we're talking about people dying and, and. I, if I'm understanding your, your testimony correctly, you're saying it's not advisable that this be sold at convenience stores or or gas stations. It's it's not advisable that it be sold anywhere where it's not been labeled properly with instructions, with the risks and with the. Ability for someone to know what they're buying and, and utilizing. Now, right now, that's where it's available. I don't think it should be available there with no direction. Uh, if I had, if I had the best ways to say it, it should be in a herbal shop in a pharmacy, somewhere where someone with medical. Expertise or herbal expertise could provide direction on how it's utilized. Last fall was true. So it's your opinion, your expert opinion, uh. That it really should be sold somewhere where somebody is more Educated, more experienced, or certified or licensed to where they could adequately provide directions, labeling instructions, dosage, etc. Is that correct? That's correct. And I believe that's the intention of the regulatory framework that's being proposed for y'all's consideration. Um, that this be labeled properly, that it be determined how it should be sold, where it should be sold, uh, obviously up to, to you all, um, certainly, uh, it, it needs to have a lot more information than just being sold in a plastic bag. At a smoke shop with uh Sharpie marker written on it. Yeah. Thank you, Mr. Chair. Senator O'Sullivan, you're recognized for a question? Thank you, Mr. Chair. So, being from Florida, what is Florida's current policy on that? Florida this legislation. Um, and in fact, we've been in discussions with them to, um, actually strengthen it even more. Strengthen it meaning putting more uh. Just putting more regulation and information for consumers behind what has already been approved. is any the reaction been positive or negative from the consumer. Or do you know? I honestly don't know too much and you know, my, I'm, I'm, my work is mostly all in rodents, and I don't deal with the public as much around this, um, but yeah, lucky me, um, they just bite, but, but yeah, I don't, I don't generally Florida has accepted the policy, it's working generally well and they're having enough success that they want to proceed along the lines that you're suggesting. OK. Um, Florida is very interested in it from uh a state level, as I mentioned, as potential alternative crops. OK, thank you. Thank you, Mr. Chair. Sent her boy you recognized for a question? This time I take a little liberty to, uh, give an answer if, if that's our question. OK. So, let me give a little bit of thought on why this is presented the way it is in a regulatory fashion. And I think you've heard some of this from the, the testimony and you can draw your smart people, you can draw your own conclusions, but from the pharmacist who is also a state senator perspective. If you go coca leaves were brought up. If you go look at coca leaves, which, you know, we think coca, we think cocaine. Right? Well, they've been chewed by indigenous people in South America for. Decades or Centuries or what have you, without any known harm, right? So, same thing over here in Southeast Asia. The concern I have is, I hate to say it, but science, right? So I'm, I'm a pharmacist and we're all about the science. And so what we're doing is we're taking a complex. Product which has multiple chemicals and we're isolating one specific thing, OK? Where else has this been done? This has been done in marijuana, right? So we have THC versus we have CBD and the THC is what is believed to get you high, the CBD. A lot of people have a belief has other effects that don't get you high, but they, they help with, you know, different things, um. Again, it's not gone through the FDA, so you can't say THC or CBD either, well, actually, there, there are some derivatives of THC that are prescription drugs. But for the most part, our, our CBD I should say, um, you, you can, they have gone through that process and you can label them with a prescriptive or a Medicaid as a medication. You can say there is a therapeutic effect because it has followed the science. So all this science is going on over here and The black markets are going to take notice, right? That's what's happened with marijuana. That's what's happened in, in other things, uh, we dealt with legislation this last session on some other derivatives of marijuana, right? So we're, I'm coming from with this is appropriate regulation. I believe is the best hedge against black markets that start to pick up on, here's one isolated chemical that's in the plant that maybe it's the one that really has the bad effects, right? Um, so I, that's why I agreed to run this as a. We're going to legalize it, but we're going to put in a regulatory framework. I hope that is beneficial to help people understand. I didn't say that in the, in the beginning, but I hope that's appropriate context. Thank you. Thank you for the statement, Senator Boyd. Are there any other questions for this witness? See now, thank you for your testimony. And we'll have, uh. Doctor Smith with John Hopkins University next. Uh, feel free to come down, introduce yourself, and then, then begin, and I'll just a reminder we're already about an hour in, so, um. I appreciate everyone's patience and we have a lot of people to get to, so just. Keep the Keep time in mind. Appreciate it. Thank you. OK, um, I will do that and thank you very much. It's an honor to be here today and I do briefly want to say that, and I, I said this at lunch to a couple of people, you know, I, I bring the human element to this, like there's, we talked about these products, we talked about the chemicals, but there are a lot of people behind this plant and I think, can you introduce yourself and who you're with the record, yeah, yeah, yeah, um, my apologies. My name is Doctor Kirsten Smith, and actually we'll, we'll go ahead and do this. I'm an assistant professor at Johns Hopkins University, uh, in the department of psychiatry and Behavioral Science, and I'm funded by the National Institute on Drug Abuse and I do have, uh, consulting work I do and expert witness work I do. And importantly, the views expressed today are on my own. They do not necessarily represent those of Johns Hopkins School of Medicine. Uh, so with that said, I'm gonna actually bring this rainbow up of products and, and we see these and this is, this is the point, right? We're here to talk about the science, but the regulation as well. And, and I do want to just briefly note, you know, the the human element to this, which is, you know, I got into this and 2015 when I was an addiction, uh, therapist in training and I had a client in eastern Kentucky who was addicted to OxyContin, come to me and say, you know, I'm using this, uh, this, you know, tea from Vietnam called Kratom. And it's helping me with my opioid cravings and I feel good, but I don't feel high. I'm like, well, who, who cares, right? Like this is not, if you're not getting intoxicated, why should I really be concerned? And, and the clinical significance of what he said was actually pretty remarkable. Uh, that young man got kicked out of treatment for using kratom because it was an abstinence only program, ended up trying heroin because that's right around the time when he was coming into mid-sized communities and ended up dying of a, of an overdose. Now, I'm not saying Crayon would have saved his life. I'm not making any medical claim. But that's how I got involved with this. It was part of this bigger story. And we see this proliferation of creating products, um, that really do need some regulation around them because, you know, as Dr. McCarty testified, there's a lot of, uh, chemicals here and they're not all equal, uh, and there should be some, uh, guardrails in place for consumers in addition to labeling. And so, you know, between 2007 and 2017, we really do have, um, this emergence of creating use in the United States, particularly among people with chronic pain conditions and people who are trying To substitute kratom, um, or, uh, opioids using kratom. And this is because we have this convergence of epidemics, and we still have this convergence of epidemics. I was walking down Main Street here yesterday and saw someone doing drugs like out in the open, right? So we have a polydrug epidemic. We have a chronic pain epidemic. We have a psychiatric health epidemic, and, you know, as asked about earlier, why not get a prescription for this. A lot of the systems of care are maxed out, a lot of, uh, pharmacotherapies we have do not work for many people, and so there's a lot of reasons why people do turn to these kind of natural. products or botanical products or cannabis or things like that. Uh, so people, you know, we have a crisis and people have kind of gotten desperate. Um, to give you a sense of who is using kratom in the United States, uh, people in their 30s on average. Uh, Chris mentioned the, the, the prevalence estimates. I, I think we don't know how many, but I, it's in the many, many of millions, right? So that's not a niche thing. It's not a trivial number. Uh, most people are in their mid-thirties. It's about equal number of males and females. Uh, a lot of them high school educated or even, you know, college educated and beyond, mostly non-Hispanic white, uh, and many at this point have been using for several years. I mean, we have people that are coming in some of my studies who've been using for over a decade. Um, many who use daily are using 2 to 4 times a day, and as I'm going to show, it's pretty regimented. So what, what is on the screen here is is a lot of stuff, and I'm gonna walk you through it because it's the most granular, uh, assessment we have of Craom use globally or in the United States, and this was done when I was still at the National Institute on Drug Abuse. So we had people who use ratom regularly enroll into a study where there, it's called ecological momentary assessment, which is a fancy way of saying that we're getting data in real time using smartphone apps and things like that. We know when they go to bed, when they wake up, we have over 13,000 unique cratom use events over this 15 day period. And what we did with this is, uh, a type of analysis where we could identify people based on how much they were using during this 15 day period. And we see that, you know, some people in this group they are using more often in group. using least often, but I want to really draw your attention to something. People are using this more in the first half of their waking hours. We did not see binge-like use. We did not see more weakened use. We did not see super late night use. This is the thing that is being used when people are trying to be productive and function. Going back to what I said earlier, if people want to get high, they can get high way, way, way cheaper than using this. Um, so this is gonna be kind of a narrative. So why are people using so across these different groups, these broad reasons for use. Uh, we've seen it here and in other studies managing, um, Psychiatric and, uh, drug withdrawal. And these again are very broad reasons why they kind of start to use kratom. Quality of life, increase in energy, pain for recreation. Also some perceived safety compared to pharmaceuticals, which we know have some adverse effect profiles that are pretty hardcore. And then as a long-term drug substitution. And so these acute effects, and again we're talking 13,000 different use events in which we are getting the facts reported to us in real time. People are overwhelmingly reporting increased energy. Focus, alertness, sociable, talkative, some euphoria, but again, these more stimulatory effects, right? So not this heavy sedation. And this is at multiple different serving sizes. The proximal or real-time motivations for you. So this is not broadly speaking, why did I start kratom? It's why in this exact moment am I taking this thing? And we see that these are very consonant with the, with the motivations, right? So analgesia or sorry, for NG is a uh relieving pain. Improving mood, increasing energy, productivity, focused alertness, feeling good, um. And these are really like the main drivers notice that we also did see people say that they want to feel good. No one is saying that I want to feel high, which we also assessed for. So we did ask about that and that was not one of the main things. Um, this fits into kind of a larger pattern that we've been observing for the past 7 years, which is what we call instrumental use. So when I had my coffee this morning, that is what is referred to as instrumental use. It is helping me give this talk, albeit in Perfectly much better than I would have had I not had my coffee. So, um, it's not impairing me and it is something that is kind of basically in keeping with my roles and responsibilities. You know, we ask people, you know, is it compatible? Is it helpful? And people usually say both, and when they say it's not both, they at least say it's compatible, which I kind of likened to a glass of wine or a cocktail. If I drink wine at the end of the day, it's not necessarily helpful to my life, but it's not impairing it either. If used responsibly, of course. Um, so again, it's perceived not as a hindrance but a help. And I think that's the kind of context that, uh, is often missing from these more sensationalized headlines that we see on the internet. I do want to touch on the harm reduction, um, because this is what, this is what got me into studying this. Um, a third of our sample here reported using cranium as a long-term substitute for opioid alcohol alcohol or stimulants, mostly for opioids, and this group was more likely to be using kratom in a much more regimented way. There were also more likely to report perceiving kratom as life-saving, but also as habit forming, uh, and you know, and again, you know, we, we talk about buprenorphine and methadone, which can clearly be misused. We have diverted buprenorphine and methadone problems. Um, but these folks here, many of them had been using this for many, many years, uh, I'm not going back, uh, to heroin. And we, we have demonstrated this too in the lab with confirmed, you know, urine analysis as well to see what they test positive for. Uh, so with respect to creating physical dependence and addiction. So this is something I'm uniquely qualified to talk about. I'm one of the few people globally who's assessed substance use. disorder for kratom, I routinely talk to clinical groups. I have the, the health, the Department of Health for Arkansas, the letter that, uh, the interim Secretary of Health wrote in 2023. I read it last night. I did not have it earlier to, to add to this. But I talked to health departments, I talked to clinical groups nationally and locally. I'm, I'm happy to talk to the one here in Arkansas, uh, because many clinicians do not know about ratum pharmacology and they Google it and they see opioid. They treat it like an opioid when we know that it has serotonergic activity, alpha andrenergic activity, dopaminergic activity, um, in addition to the faucet analogy that Dr. McCurdy had about this opioid, mild opioid activity. So understanding what physical dependence and addiction looks like with kratom is. On some level, not that different from anything else, but on another level, people just want to lump it with an opioid, and that's not really appropriate. Regardless, when we have assessed this both in this sample, it was a national sample, but in several others as well, using systematic validated measures that insurance companies use that are, are well established within clinical, uh, protocols and, and practice. Uh, we see that most people do not meet criteria for a substance use disorder for Crayon. Of those that do, it is typically mild to moderate, and that means you have to meet two symptoms out of a total of 11 in order to get to that. So when we look at the symptoms, and this is absolutely critical because you can have 10 people, all with the substance use disorder do the same thing, and they could all have different combinations of symptoms. I mean really you could have far more than that. So it's, it's kind of confusing and you think like one size substance use disorder fits all. And that's not the case. What we see with kratom consistently is that we have what are called physical dependent symptoms, which are defined by tolerance and or withdraw or used to avoid withdrawal. And again, We know that these are typically mild to moderate in nature and oftentimes self-managed people have certain, I've done lots of interviews with people. They have different ways of, of dealing with this. I'm doing a supervised withdrawal study at Hopkins now. And measuring this. So it really is mostly mild to moderate. What we don't see here and what we've not seen elsewhere are these indicators of severe psychosocial impairment. People are not going out and robbing liquor stores to go buy kratom. They are not abandoning their children. Like again, go back to the earlier slide in terms of when people are using this. It is during their waking hours when they're typically working. And so again, it's this feeling good without being intoxicated, which I should say we have much more, um, granular And, and, um, Controlled assessments for it. So I want to touch on the safe or dangerous thing people ask me is created a safe or dangerous, and I say neither. It's there's a risk profile, and I think certain products are more risky, certain products are less risky, and, and it's very complicated, but what we do know is that there are very few, and I'm talking shockingly few cratum-related morbidities and mortality, and also creative use disorder, addiction. I have read literally every case report on this subject, um, and when we see these headlines like the Tampa Bay A Times story, which, um, is great. If you go back and look at the forensic toxicology, it gets really complicated really quickly. Um, so again, we have very few case reports than the ones that we do have many confounding factors. Among the small pharmacokinetic studies we have, there are no serious adverse events. We had some GI upset, and that's it to date. I do want to touch on the FDA single ascending dose study. So there's a lot here. The main point, because people have touched on this briefly. We had 40 healthy adults. Again, this is conducted by FDA, um, In each cohort, there were 8 people, 6 people took kratom at different doses and 2 got placebo. The main thing to understand is that only at doses of 8 g and or higher, were there adverse events that were greater than placebo and that was vomiting. I want you to imagine eating 8 g of green powder. It is not something that I think I would be able to keep down. So there's a question of was this GI upset related to the material or the effects, but regardless, there are no serious adverse events and even then this was not a human abuse potential. study, which they are moving forward with, uh, the, the tools and uh the questionnaires that they use to kind of help indicate, does this have abuse potential? They were, they were very flat. They did not see a lot of people liking, uh, Kratom, uh, in ways that people typically like stimulants or OxyContin or something like that. So when I was at the National Institute on Drug Abuse. We had people come in and take their own kratom, right? So this is not well characterized, uh, standard kratom. This is whatever people are buying on on a gas stations and coming and taking it, we had Doctor McCurdy's lab analyze the products. We did not see respiratory depression. Again, we had no adverse events. Uh, we had psychomotor tasks that we conducted to see our people actually getting impaired or are they just lying about not getting impaired. We saw no changes in impairment, um, and I have, I have more to say about this, but I know that we're pressed for time, so I'll just skip to this, this slide, which is Uh, we also put people in a driving simulator that is validated to detect cannabis and alcohol impairment. We did not detect any impairment. We had one participant who showed a, uh, what's kind of a, a change in standard devi deviation of lateral position and a decrease in in a coherence score on one task of one of many dozens of outcomes. So again, these are people who take kratom daily. If we were to put a creative naive person in there and give them some high octane craton extract, I think we would get different. results, which is again, why this needs to be regulated and people need to understand, particularly people who have never taken Kratom before, what it is that they are consuming. Um, but at least among chronic consumers, we are not seeing indicators of impairment. So the takeaway continues to be used for harm reduction and chronic pain, but also used for recreation, improving mood, quality of life, um, the abuse potential is unknown, but my data, um, and the assessments I've done with use disorder and talking to clinicians, frankly, uh, we don't have strong indicators in humans, and we need to do those studies, but as Chris talked about the, um, nonhuman animal models. We don't see strong indicators for for metrogying, uh, as having abuse in those studies. So I do think we need more science, but in the meantime, clearly more regulation. I really would just end by saying that two things. One, the FDA. Web page, if you go and look at it, is very short, doesn't have many citations on it. If you go to the National Institute on Drug Abuse webpage on Kratom. It's very lengthy, it's updated regularly, and there's a lot of citations. I would urge you to look at that one, because it is more comprehensive. I would also kindly ask that the Secretary of Health provided an updated letter because reading what was provided to you all in 200 or 2023, there's a lot of context missing and there's a lot of outdated. Information and I, I say this with a lot of respect, um, that I, I really would urge you to request a more up to-date letter from that, uh, secretary. And I thought I was properly shut up. Any questions for this witness? See now and thank you for your testimony. Thank you. Um, we're running a little late on time. Can all members of the Arkansas Department of Health, uh, come to the table for their testifying. I might just kind of speed things up a little bit. I, uh, well. We'll get to that witness after ADH. I just want I know they've got some other meetings this afternoon, so I just wanna make sure we get to everybody in a timely manner. Everyone will be able to, to testify today, so don't worry. I'll be here All night if I have to. Matt Gilmore, Department of Health. Laura Shu, general counsel for the Department of Health. Uh, Shane David, pharmacist, uh, branch chief Health Systems licensing and certification, Department of Health please proceed with your comments. Thank you, Mr. Chair, members of the committee. Um, as you all, uh, know, I am currently serving as Chief general counsel at the Department of Health. I've been there for 6 years. I've been practicing law in Arkansas for 30 years. Um, some of you may know that I practiced criminal law for 20 years representing the state in various capacities. Uh, today I just want to do a quick overview of what the criminal law provides in this area and kind of a procedural history just to inform you what we have done in Arkansas on this issue. Um, you all know that the uniform Controlled Substances Act was, um, added to our statutory authority in uh the 70s, in 1979, the director of the Department of Health, or it's duly authorized agent, um, was authorized to schedule controlled substances in Arkansas. So obviously, you've got federally controlled substances and then you have the substances that are controlled in the state. Originally, uh, the substances were scheduled 1 through 5. Schedule 6 was, um, added in 1979, uh, the department administers the act and we are tasked by law, um, under the authority that the legislature has given us to add or delete substances pursuant to the administrative Procedure Act. There's review and approval by the ALC, you know, since, uh, 2015, uh, the legislative council has had the authority to review and approve all of our rules, uh, since the, uh, Amendment 92. was added to the Arkansas constitution in 2014. There is an 8-factor analysis that is provided for under the statute under 564-201. And that is the analysis that the director conducts, uh, the law mandates that the Department of Health promulgate the rules. Arkansas law also mandates that the Secretary of Health revise and republish the list of schedules annually under 5-64-216. So, as you know, you all have seen us, uh, before you in the legislative council and rules committee meetings where we bring the list of controlled substances to you each. year. So that is updated and reviewed and revised every year. Uh, the schedule by rule is a part of the substantive law. And then the courts use it in criminal cases. Law enforcement use these schedules in order to enforce criminal laws. The law also provides for the criteria for the schedules, and the law also provides for emergency rule process to add or delete substances, which we have done recently with substances like epidiolex, um, that was a drug that was for pediatric seizure patients. The law provides for certain substances that are listed inches 1 through 6, in addition to the ones that are listed by the Department of Health, specific substances were also added by legislation. You all may remember us after, uh, reports of a so-called date rape drug, the legislature added a DHB to Schedule 6 in 1999, uh, because the federal, uh, government later scheduled that drug as Schedule 1 in 2000. The Arkansas law was amended in 2001 by an act to allow for the Department of Health to Scheduled GHB in a manner consistent with the procedures that are allowed by law. And you all may remember that time period in 2011 and 2013 when the legislature added synthetic substances like synthetic catammaoids, also known as K2 and spice and bath salts to the controlled substances list. So there are instances where the legislative body has added specific substances to the controlled substances list. Arkansas maintains its independence through current law, while Arkansas law is, um, uh, mandated to follow the federal schedule, uh, the director and the secretary of Health can reject a federal schedule. And so that way there's no unlawful delegation of authority to the federal, um, government in scheduling our drugs. We have maintained our independence through current law. In this particular case, the Board of Health and the state health officer and the director schedule. Kratom 1 and the two psychoactive ingredients and kratom in 2015. We had a notice of proposed change, uh, to the list in 2015, we had a public meeting. Arkansas Legislative Council reviewed and approved it back in 2015 and the final adoption by the Board of Health was in October of 2015. The scheduling process was completed. In November, and we had the, uh, final rule scheduling this drug, the two drugs, uh, back in that, that time, we have, um, had it on the list since then. We have revisited this particular substance 3 times, uh, since I started back in the Department of Health in 2018, we've revisited this particular issue 3 times, and the last being, uh, last year when the association filed a petition under the Arkansas procedure, um, administrative Procedure Act, and we submitted The copy of the petition response to you all as an exhibit to show you the 8 factor analysis that was conducted at that time. Um, we do have Shane David present. He has over 20 years of experience as a licensed pharmacist. He earned his doctor of pharmacy, um, his degree from UAMS. He is a branch chief and has served as pharmacy director for the Department of Health since 2018, and he has over 17 years of public health experience beginning in pharmacy services in Arkansas, uh, since 2007. So we'd like for him to provide you with a little bit more information on this particular substance. Thank you very much. Um, so going forward with the presented material. Um, what you're gonna find is that specifically the endo alkaloids specifically mitroginine and seven hydroxymitroginine are considered controlled substances in the state of Arkansas. The products that are indicated as being brewed in a tea or capsule formulations are available products. However, um, there have been, uh, websites that have indicated these products is available. in, um, edible products and vaping products as well. Um, The FDA has indicated that Kratom is not lawfully marketed in the US as a drug, product, or dietary supplement or a food additive in conventional food. So it's important to note that, um, that makes it difficult from a regulatory standpoint to have products that are regulatory inspected if they're not recognized by the FDA and by the, uh, previous indications that they are looking to follow the FDA required good manufacturing practices. Um, There's also concern over the 7 hydroxymetragenin. And as you're aware, this is a product that is a metabolite of metragenine. This product itself is, um, potent for opiate receptors. It is being sold and marketed here in the United States. It's primarily utilized in tablet formulations, and vaping products, but it has, um, The the West has exploded the use of this product where it is, uh, it is dangerous. Um, the process of these agents or there's also an additional metabolite called metragenine, uh, pseudoanoxxy, which is also another metabolite that's being, uh, reviewed for its opiate receptor agonist activity. Um, I will point out that there are also, um, drug interactions as it does interact with enzyme systems within the body. Specifically, cytochrome P450 and P glycoprotein. There are other ones that are being utilized for this, uh, they're being tested for these interactions. The issue would be in individuals with utilizing these products. And we've, they're over the myriad of different uses. If we're utilizing these products for things like mood enhancement, focus, attention deficit. It, um, opioid use disorder, which is a very complicated disorder. It can interact with specific substances if someone was already obtaining those. So, for instance, if you're already on specific serotonin selective reuptake inhibitor products for for depression and these products do interact with the serotonergic nervous system, would we put people at risk for specific types of drug interactions. Also, there are, um, potential issues with, um. use of these products that have been reported, uh, elevated lem for enzymes, hepatic injury, um, agitation, tachycardia, some people experience drowsiness, uh, insomnia, vomiting, and confusion are all things that have been, uh, listed as potential side effects of, uh, of various products, um. It's also important to note that there have been reports of neonatal abstinence syndrome with the utilization, these are case reports and, um, an FDA port indicating that using these products, uh, could create delays in patients from obtaining, uh, recovery, putting them at risk for increased use of opiates or opioid overdose. So I think with the indications with the products here. Um, we're also looking at this from a standpoint of importation. Um, I'm, it is unclear how the metric ton. Products are being this metric ton amount of Kratom is being shipped into the United States. Um, I think that that would probably bear some, some clarification, uh, indicating if that's being imported or how much of that is being regulated here in the United States. Um, lastly, I would also report that, um, with these various enzyme systems in the body. Um, there are, um, also concerns with other pharmaceutical agents. And the lack of human trials, which is desperately what's needed in order to finite determined finite doses, recommendations, concerns would be, uh, easier for clinicians, for anybody out there to utilize these products in a, in a manner that would be safe and effective, but I think the lack of human clinical trial data makes it Difficult because we have a variation of dosage ranges, and, um, products available, making it difficult to correlate what's effective and what isn't. So with that, um, I'll yield. Mhm Senator Sullivan, you're recognized for her question. You've used the word several times potential, uh, exploitation concerns used several times, more clarification. So I guess my question, there are a number of states that have also been past the law and are you seeing those Concerns, uh, addressed in those states are they having those same problems that you're saying you're saying suggesting? Well, sir, can't speak to the other states and their, their, their issues with it. Um, what I can speak to is the concern over, uh, specific products in the, in the state of Arkansas without having a full, uh, compliment package that would regulate how much to take. What to take and if this product has been adulterated and how it would be regulated in order to ensure it's, its efficacy to ensure that it's not been adulterated, those would be the concerns that would be raised due to its pharmacological profile. I can't speak to what other states have experienced other than, um, I think, They had indicate, uh, previous, uh, indication that they were looking to strengthen regulatory process in Florida if I'm not mistaken, but I can't speak to that. The So your inability to speak to it, does that, do I take that to mean that it's not important to how it's being regulated in other states. It, it is important, but I think, um, When certain there are a variety of states that have it as unregulated, and there are some states that have what's called that consumer Protection Act, and it's my understanding that there are some states that just have age restrictions. So I think with the variety of different, uh, mechanisms in place, it's hard for me to ascertain what an overall encompassing process would look like here in Arkansas, utilizing their credit and Protection Act. I can't speak to what that's going to look like as far as how do we. Combat some of these other concerns that we have as far as from a regulatory standpoint. So would you be willing to work with, uh, these folks that are presenting this to us to take us from a totally restrictive state to a more uh relaxed state of regulation. Would you be willing to work with them towards that end, or do you see that not as a possibility. Well, sir, I think, um, going forward as far as part of being helpful in any way that we can as the department, I will certainly convene with our leadership and we'll do whatever is required of us to do, great, perfect. Thank you, thank you, Mr. Chair. Thanks and uh Senator Boyd, you're recognized. Thank you, Mr. Chair. This time it's a question. Uh, Doctor David, uh, you, you brought up some valid concerns as a pharmacist, you know, uh, I would, I would share many of those. I guess my question though is, is, is the Department of Health looking at things such as Saint John's work, which would also have serotonergic interactions and potentially making Saint John's Ward a Schedule One substance. Uh, so as far as speaking to any concerns over listing Saint John's Ward as a controlled substance. There's been no indication for us to do so. However, um, there are specific herbal supplements that we are taught as, as you're aware in school that do have various drug interactions. So Saint John's Wort, um, Ginkgo biloba, we are aware of those. As a pharmacist, then I think it would be important to understand this full, the full account of what those are in order to. Make safe and effective recommendations as a healthcare provider. Representative Ray, you're recognized for her question. OK. Thank you, Mr. Chair. Um, so, I think it's, even though this substance is illegal in Arkansas, currently, I think it's safe to assume that given the other states that it's legal in and just the Popularity of it, there are people in our state that are using it. Um, so my question would be, does the department have any statistics on Uh, incidents related to this. Whether it's deaths or trips to the ER, um, overdoses, things like that, I mean, I'm curious what, what you can share in that regard. I can, I, I would like to validate and provide you with any information that we have. It's my understanding that we, we have recently reached out to the Arkansas Poison Control Center, Drug information and Poison Control Center, and rather than tell you a specific figure, I can give you an estimate or I can provide that information to. If you would like. It related to calls in regard to their, uh, reports to them. If you could share it, that would be great. And, um, what might be even more helpful would be to see it. In a list in comparison to several other commonly known substances, right? It's for a, for a point of comparison, yes. So I mean, we look at the reporting measures as far as what, uh, specific measures you would like if you'd be happy to, uh, let us know. We'll be happy to try to get whatever data we can from them. OK, thank you. Senator Irving, you are recognized or V, Senator Irving, you are recognized Irvin, Senator Irving, you are recognized or V sorry, always put the G on it. I'm sorry about that. Thank you, Mr. Chair. Um, thank you for everybody's presentations. I thought they were, sorry, I missed maybe the first part of the meeting, um, I, I know the job that you have before you all at the Department of Health and having to like, I mean, it's your job to, um, obviously operate within the regulatory frameworks that we have and the federal and FDA and all of that. Um, in your opinion or just from a pharmaceutical pharma pharmacological, uh, point of view is, is marijuana. On par, more dangerous than kratom. What's the comparison between Kritom and, and marijuana as it's grown and. Well, I think that's a, that's a very good question. I think the issue would be is that they don't pharmacologically act in the same manner. So I think it makes it difficult to make any kind of correlation between marijuana and Kratom. Kratom is to their, to their point, is a very complex plant or botanical product that has a myriad of different, uh, substances or alkaloids, um, if I'm not mistaken, uh, 40 plus alkaloids that would be in the plant that make it difficult for us to. Um, make any kind of correlation to marijuana other than that marijuana would act in the endocannabinoid system and potential interact and potential actions of Kratom would be indications in the serotonergic, alpha adrenergic nervous systems adrenergic system, excuse me. I get tongue tied with that. And the opiate receptors. So I think they're a correlation to what those products are would be very difficult for us to compare them together. OK. Um, Before the pandemic. Oh, and, and I, I come from a medical background a little bit, um, but before the pandemic, I wouldn't have been. I think I would have been more accepting of our regulatory and I am still. However, I become very, very suspicious of the amount of money that is made. And I know. Quite often serving in this body that regulation. Generally means somebody's gonna make money from it. When it's a plant like this in a tree-based product, is it the manipulation of that? That somebody will then benefit from dramatically. Um, if it's highly regulated. It, it freezes out the market. Or is it the plant itself. So I think specifically in regards to the regulatory component that they're proposing. Looking at it from a framework to try to get a handle on the Certain the specific alkaloid of 7 hydroxymetragenine from being synthesized and being produced in a tablet or specific product that somebody could consume in order to. Have that, um, effect on the opiate receptors. Having a limited amount of product will vary depending upon Uh Chemical processes, how long it's harvested. Um, I think there's, there's some variations in there that I can't speak to as I'm not a, a, uh, I don't harvest the product personally. So, uh, but the, the process of it is going to vary. If we put restrictions and limitations on the, on the products itself, to say that it's going to benefit someone or not is difficult for me to say other than if whoever would have control over the specific processing and manufacturing. I think the other issue of concern would be the, the inspection component and how you regulate that if those processes are not being done in the state of Arkansas or where they're being done if they're being done overseas or in the United States, that, that kind of creates some. Some challenges that I can't speak to. Yeah, understand. Thank you. I've got a comment, um, and so this is the senator kind of touched on this a little bit and I've been thinking this as we've been kind of talking about the regulatory process. I mean, obviously when medical marijuana was passed by the voters back in 2016. I think I hear a lot of similar issues that we had going on. And so, I mean, is that not provide a roadmap for y'all to follow with something like this? Well, I, I'll start and turn to them. I think they've kind of outlined a process here. It looks like under the Department of Ag, so it'd be a little bit different, um, you know, I think it mentioned some laboratory testing, third party labs, so. Some of that could be, you know, flushed out down the road, what that would look like, but uh, You know, I The devil's in the details. Got you. All right, are there any other questions? Oh, I see, uh, Representative Long, you're recognized for a question. Thank you, Mr. Chairman. Uh, Doctor, um, My wife and I have taken many supplements over the years, um, a few things we've had, you know, maybe a little bit of a reaction, but we're adults, we figure out it's like, that's not good, we're not gonna take that again, um. But a lot of the things we've taken we've had really good benefits from, uh, you know, we, we like to, to use things that are more natural rather than pharmaceutical for our different ailments as we get older. Uh, I think we tried, you know, Saint John's Ward and geeko in my household with no adverse effects, but, um, to me it seems like we should make an error, it should be on the side of, of, of freedom of choice for the adults in Arkansas to choose whether or not after doing their own research, what they're going to take. And, you know, we, we make it legal, uh, if there starts to be a lot of problem and and people are having a lot of adverse reactions at that point we could always go back and and, you know, do. regulations, but to me to, to over regulate something on the front end, which, you know, as you mentioned a moment ago, there was not enough data at this point to, to say good or bad about it and, and obviously, I guess people are not falling over dead in these 13 other states or we would probably heard about it but now, don't you think it would be better to err on the side of freedom? Well, thank you for the question. Um, so first, let me reiterate, um, when we're discussing processes for lack of human trial data. I think the lack of clinical human trials indicates a decrease in knowledge of knowing what's effective, what's appropriate, and what's safe and what warnings and what information can be provided to those patients in order to make that freedom of choice. I think there is a uh a myriad of studies that are going on that they have pointed out to, but I think not having that information makes it very difficult to know what is effective, what isn't, what is certainly in in danger to the patient, depending on their age, depending on their medication history, depending upon, um, Uh, other, other issues may be underlying that may predispose individuals to having reactions to things as far as allergens and plus, um, we, It's difficult to say that we need freedom without understanding of allowing patients to utilize these products effectively, safely without any kind of issue. So it's hard to kind of correlate that without that information. Center for, you're recognized for. question mainly statements. So first of all, I just want to make an official request of the committee, Mr. Chair, that if we could ask the poison aspresentative Ray had, had asked if we could make a request from the committee for some data for like a two year period or or something with some parameters on any reports that they've had so that the whole committee would have access to, to such data. I think that would be helpful. Uh, so I, I would appreciate that. Then secondly, Uh, it will get that to the committee, so perfect. Thank you so much. And then secondly, um, as far as this, this is uh a study proposal and it was pointed out the Department of Ag, you know, has oversight. I, I'm confident that there would be You know, an opportunity to say Department of Health rather than Department of Agriculture or a combination there of, you know, if, uh, there were a willingness to to work with the parties to, to make it happen. Thank you. Alright. Uh, Senator Clark, you're recognized for her question? Your light was on. Is it OK. Thank you. Any other questions? Representative Lady Manna, you're recognized for her question. Thank you, Mr. Chairman. Yeah, I mean. Talking about the Department of Agriculture. Uh, well, not controlling this, but being involved in analyzing and maybe finding and that sort of thing. Uh, you know, we, if you a couple of years ago, we put in a smoke requirement for the rice farmers up in northeast Arkansas where I'm at. And, uh, Department of Agriculture was supposed to monitor that and control that. And it did not go very well. I mean, the, the, because not, not, I'm not saying bad things about the Department of Agriculture, they're just not equipped with a good enforcement arm. In my opinion, that's not their fault, but I mean, do y'all feel like that the Department of Agriculture is really the right place to put this. I know you mentioned the Department of Health, your enforcement unit would be better positioned to do this than the Department of Agriculture. I would think, what, what do y'all think? Well, I'll I'll make a statement or two and then turn it over to Laura or Shane, but, you know, Uh Whatever the will this body is, that's, that's totally up to y'all. I, I think, you know, alcoholic beverage control ABC has more enforcement measures, um, in these types of substances, so that may be something y'all want to look at. I think the Department of Health, we are, um, we haven't gotten in this type of territory before, so I think it, the type of substance it is, uh, it would make more sense, I think, and. Um, To be in a regulatory agency has law enforcement type power and that sort of thing. Please. Uh, I don't know whether it's the same substance or not. I think it was. I, I don't know how long this has been around in the United States, but back in the early 2000s. Uh, when I was mayor, we had some, I think this product sold at the gas stations is a leafy product in a little plastic bag. Um, and we had issues at that time. This was an uncontrolled substance at that time. And our police officer had issues, they would stop people and they'd. Seemed like they were high, but they didn't have anything but this little bag of leaves. So we actually passed an ordinance to stop the selling of that product within our city limits. Uh, so I say that because we know there's one element in this particular product that if purified. Uh, could be a very big problem. And I don't understand how we could control that because you know how this goes. If you can purify it, it will be purified. So I think when we look at it, and I'm not asking a question, I'm more making a comment I guess, but, but that's something that with this interim study, we really need to, to look at and make sure that we can control those. I think there's two elements in here that might be problematic. Uh, how do we do that? How do we control that? Because we're not actually, um, analyzing this, we're just kind of waiting on violations. That's where I read the interim study if I'm wrong, or correct me, but we're not gonna have them bring in 10% of their product and we check it. Nothing in here does that, I don't believe. Anyway, I'd like some comments on that. How, how are we gonna control the quality aspects of this product? Or is that something we need to work on? You know, Representative Laman, I don't know the Department of Health can answer that question, but I do think that maybe we should have, um, our regulatory administrator from DFNA who's over, you know, marijuana raising, ABC to come and, and talk with us. Uh, I think that'd be more helpful, uh, they could probably provide a little more insight. All right. Any other questions for Department of Health? CNN, thank you for your testimony. Thank you. Thank you very much. Doctor Hennington. Please come down, introduce yourself and who you're with and as soon as you're ready, uh, feel free to begin your presentation. I'm sorry, do you want, I wasn't turned on. Should I start over? Please do. OK, I'm Jack Edward Henningfield. I live in Baltimore. I'm a Johns Hopkins University adjunct professor, part-time at this point. I've been there for more than 40 years. I formerly was with the National Institute on Drug Abuse. I've been doing research on substances and medicines development and how they get regulated by the FDA for, uh, more 40 years, the research for half a century. And at Penny Associates I consult on development of medicines, dietary supplements. And so actually know, understand the regulatory pathways because I meet with FDA on what does it take to get something accepted as a dietary and approved as a drug and so forth. I work with the DEA over decades. That was part of my job working for the drug and for with the drug enforcement Administration on controlled substances scheduling that goes back. Just about 40. Years ago now. With respect to Kratom, I got involved in this more than 10 years ago when because I work, do a lot of work on opioid issues and the. drug crisis. And the most of the drugs that are approved for treating opioid and other addictions I've helped develop or get regulated and that includes buprenorphine, Suboxone, naltrexone, and so forth that you've probably heard about. So Kratham was really interesting because it seemed to be offering benefits to people without the risk of opioid overdose death and that was really intriguing when opioid overdoses started skyrocketing. And Nida, my old institute was also interested in that, and they started research, but they really wrapped it up in the last 5 years to Dr. McCurdy and others, and then when DEA announced that it was going to ban Kratom. With a Schedule One rule. Um, I thought people are going to die. You're going to create a black market. The market will be the legal market that is probably mostly decent vendors will be replaced by a black market. And This is going to be a real problem, as Mr. Haddow mentioned earlier, uh, DEA has not withdrawn a proposal such as that in my experience, it hadn't. And I contacted the American Kratom Association and said people are going to die. My group will help you pro bono. Because DEA probably isn't going to change its mind. I'm not getting paid for this. But we want to get the truth out. And it was amazing, but DEA looked more closely and they withdrew, withdrew their proposal within about a month in part that was because thousands of kratom consumers came forward and said this is my lifeline. Why are you going to do this? and then amazingly bipartisan effort from Congress and the Senate, uh, asked DEA to reconsider. They did. DEA is never recognized Kratom as a national drug threat. They say it's a substance of concern. That's their job. They're monitoring it. But they don't list it as a national drug threat, and that's the difference and so DEA unusually teamed up essentially with NIH against FDA. I had never seen that before. Nida said wait a second, people are using this to self manage their opioid dependence, and we need to research it more. And Schedule one is a bad idea for a lot of reasons. One, it makes it harder to research. You've got great researchers right here in Arkansas. And they're not getting this NIH money. To study kratom because it's more problematic to do the research. There's a couple of groups at um the medical center that can do Schedule One drug research. They do it for DEA. They know this stuff, um, they should be at the table. And there are people there that can also do drug and substance testing. There were questions about testing. How do you test it? How do you sure. Well, we all agree, I think that there needs to be guardrails on the products. Where it's sold, I don't think is the issue, but the product, any product legally sold in the state. A consumer should be able to be assured that they have the same. Standard for any product, a bottle of water, dog food, whatever, that there are some agency that says it's not contaminated, it's not adulterated. Then it really doesn't matter much where the product is sold, unless it's a drug, but this isn't a drug. This is a dietary. Now that brings another issue. FDA has created, has tied itself into a knot. They got it wrong. In 2016. They were overruled by Assistant Secretary Brett Jar who said FDA failed to consider the public health consequences and they had embarrassing data. And overruled them. But FDA, so now FDA is trying to dance around the own its own knot that it created. It's not trying to badden Kratom. And if you go to its website, it says what are we doing to make to protect people. Well, we're monitoring products and we're sending out warning letters to bad products were it's and so forth that sort of thing. They don't say we're taking them off the market. They are legally sold in 44 states. So proposals as have been made and me and others have contributed to what would be the elements of a good proposal. It includes basics like every product should not exceed basically what nature made. Be natural doesn't mean something. Inherently safe, but in this case, nature got it right. Like with coffee, like with tea, there's lots of strains of coffee and tea and oranges and apples, and they're not all identical, but you can be assured that if they're basically a natural product. They're all in this window. And researchers like Doctor McCurdy has looked at hundreds of products across the nation. And I think he mentioned that earlier, um, but basically they're all in the same window. Now there's problematic substances like seven hydroxy, and I think we all agree that that doesn't occur in meaningful quantities in the plant. It's a metabolite, but some bad actor. Sellers say let's bike it with 7 hydroxy. And others do even worse. So you've got a real simple solution to that. You've got a regulatory framework in Arkansas where consumers say, OK, if I buy this product and it's on the shelves and it's registered by the state, that means it can't have 7 hydroxy exceeding whatever is the legal standard. Just like the water can't exceed a legal standard for lead and certain microbials, even though it's not distilled and even though you could overdose on water if you drank enough in terms of asking the health department about data. I think that's a great idea, but ask them for how many actual deaths. were caused Because the FDA backed away from its numerical death count of 1st 9, then 11, then 42 and 2018 to now it just says deaths associated associated with kratom are rare. Why don't they give you a number? Because out of the more than 100,000 drug overdose deaths last year and the years before. We don't know how many, if any, were caused purely by kratom. We can't say none were. But the numbers are so small that people that care about the opioid crisis and the stimulant crisis which remained crises. are recognizing that for a lot of people kratom is their lifeline away and what we need to do is find a path for people to make their own choices, which brand of product, the products have, you know, there are different strains. It doesn't look like the strain makes much difference, you know what kind of coffee beans do you like or what kind of store? They all make their own claims. But they shouldn't be making medical claims. You shouldn't have a company saying, oh, use our white grain, our white strain from, um, white veins train for depression, use our green vein strain for pain. Those are medical claims. That's why you need regulation that is balanced, but a lot of it comes down to something, um, Matt Haddo, whoified earlier and I both had the same boss for a while in the early and that was Surgeon General CFre Kop, who was appointed by Ronald Reagan. And he said, what we have to do in public health is make it tougher for people to get the stuff that kills them and easier. To get what can save their lives. So let me just finish with one point. When I started working on this and opposed DEA scheduling and then DEA got it right and then the FDA went off the deep end and said it was a dangerous addictive narcotic, said what? It doesn't produce the signature effects of narcotics. It doesn't produce respiratory depression, which kills people. It doesn't produce the morphine, heroin, fentanyl like high. Doctor McCurdy showed you some of the animal data. There have been actually quite a few clinical studies. You don't see that. I did a study that used FDA's own model and we use oxycodone and the rats with the high doses of oxycodone, it was Death Valley drop in respiratory depression at the higher doses. And deaths with Kratom Mitraginine we went as high of levels as we could pump into the little animals and you are restricted on how much you can pump into their little bodies. It was flat as a pancake. In other words, it's not a narcotic like opioid. So FDA has backed away from that. But a lot of people in health are still following what FDA was saying 345 years ago, they should read what FDA is saying now. Don't be confused by the fact that FDA is saying, well, it's not a legal dietary supplement because we haven't accepted it. They don't approve, they accept supplements. Um, but we're not actually trying to ban it. We're trying to do something to make it safer by cracking down on the bad actors. They're not even coming close to cracking down on the bad actors like can be done at the state level if every single Product sold on a store shelf has been um. Registered with the state and the state has the ability to withdraw. And you're making them pay for the testing. And again, you've got the resources right here in Arkansas to do this at the university. I, I listened to the discussion with the health department. The answer is a lot of them are in this room and down the street, um, one last thing, when I got involved in this. One of my colleagues at Johns Hopkins. Sent me an email and she said, um, Jack, thank you for what you're doing. This is really important. And it was a little more personal. Her son went to school with my son. She's in my department. She's the vice chair of education and addiction medicine certified psychiatrist. Uh, one of the best in the country. And I said thank you, um, FDA got it wrong in the science, they got it wrong on the regulation, but this is about people whose lives Hanged by the thread of kratom. She got back, Jack, our son, Jasper is one of those real people. She said he got into heroin and other drugs, almost overdosed, got into buprenorphine program. I helped develop that. I'm proud of it, but she said he hated it. He didn't get his life back. She said he tried kratom. And she said we were skeptical. This is a person at one of the best addiction treatment centers in the world with all the resources she couldn't help her son. He helped himself. With Krautham, he got his life back, went back to school, got a job that was now 7-8 years ago and he's doing great. He got his life back and that's When you hear all the surveys and all the science, a lot of times in science we're chasing what a lot of people already know. Uh, and we're finding out that a lot of what they know they were spot on. Uh, we need science that helps guide the regulation and in terms of medicines, why don't we make it a medicine? Well, a couple billion dollars and 5, 10 years from now, maybe we'll have a medicine and it'll be some purified product that will appeal to some people. And my wife would probably reject it because she's tried all the medicines. She, she doesn't use kratom, but for her acid reflux, and none of them work, but the right combination of dietary products works for her. There are a lot of people like that in America. Thank you. Thank you for that. Um, Representative Rose, you recognize her question. Thank you, Mr. Chair. Um, Thank you for your testimony today. Uh, could you share, uh, with the experience you have, I'm sure you've written a number of articles or, or medical journal. Analysis of, of, of different types of addictive drugs over the years. Can you liken the similarity between the addictive properties of Kratom, kratom, and say something like nicotine. Is there, is there a similarity between the two, or how, how would, how would you liken those to one another. So in terms of by several different measures and if you Google my name and comparing addictive drugs, you get some Our most embarrassing things to go back to the 1980s when my job was to figure out his nicotine of addictive. Um, and what I did at NTA and what I still do for pharmaceutical companies is evaluate addictiveness for drug scheduling. That's my time, I guess I'm a nerd in that sort of thing. So right at the top, you've got fentanyl-like substances in terms of an explosive euphoriant effect. And really deadly, deadly effect on respiratory depression. Cocaine, smoked or injected is really high. Not as deadly, deadly. When it was in Coca-Cola a century ago. It was at very low doses, but so it's partly the dose that makes the poison. What's great about Kratom from a safety perspective in part is that if you drink too much or chew too much, you feel nauseated and back off. And it in animal studies, we don't know what the lethal dose is because it's really hard to kill animals with it and um. And we tried, and others have tried. The most recent, um, I sent around I hopefully will get it, a summary of a couple of studies, but over the last couple of years, the studies are being published several 100 studies just in the last couple of years. And that includes a clinical study which was just completed with more than 200 people, 3 forms of kratom. And 4 doses of ra. Now we've got the FDA study. So there is a lot out there. Caffeine produces physical dependence. Some people report needing help to give up caffeine because it is problematic, but as Dr. Smith mentioned, you've got extremes from almost every drug at both ends. So caffeine is not listed as an official substance use disorder by the American psychiatric Association, but they say some people get it. And caffeine withdrawal is recognized. So just because something can produce it and some people doesn't mean it should be a controlled substance. Uh, on this range from fentanyl to Let's say cocaine like drugs and sedatives and alcohol down here, caffeine down here. I put caffeine or kratom someplace down here. In terms of nicotine, nicotine was a problematic drug to get over the counter because it can produce dependence and withdrawal. It's not a controlled substance. And when I worked on the early studies in the 80s and it went to FDA. The FDA committee said, Were at the horns of a dilemma. We have a product, nicotine gum that meets all criteria for a controlled substance, but it doesn't make any sense. And it didn't make any sense that you would leave cigarettes basically in vending machines and gas stations, and nicotine gum, you'd have to get a doctor's prescription and then be a controlled substance. So a few years, so it was approved, it wasn't controlled. A lot of things that could be controlled, antihistamines, glue, which certain kinds of glue you have to be minimum age to buy it. We don't control it. Um, And then a few years later Surgeon General Coop testified without being paid that we should make nicotine gum over the counter. That means it could be sold in gas stations that sell, um, the nicotine gum products and you can probably see them all over the place. Why make it easier to get what can save lives. Sorry for the long answer, but I've worked on that for a few decades. Sure, no, it's fine, uh, follow up, Mr. Chair, and I'll be done. You. Uh, you mentioned earlier in your testimony that, uh, In terms of like a data driven answer for how many deaths could Kratom, kratom be responsible for you more or less said, well, we can't tell you, there's none and we can't tell you exactly how many because there's so many drug-induced deaths that That it's hard to get down into these. Maybe lesser known causes of death. And just in short form, am I interpreting your response correctly? Not quite close with, with, uh, how many opioid deaths, how many stimulant deaths, how many sedatives, benzoyl alcohol actually got numbers. With Kratom, the numbers are so small. That all FDA or anyone can say is that it's very rare. Because the relatively few deaths that are reported. That are listed by a medical examiner as Kratom contributing. Other adults drugs were involved that more likely in most of the cases that we've seen caused the death. So you can't say Kratom had no involvement. But another words, it's very, very small, and that's why the FDA itself literally in February of this year adopted the language used by NIDA. Which is rare and stopped talking about a number. I, I wanted to make sure I understood your, um, your testimony correctly and I'm just want to reiterate the question for you to answer as well, is that there's, we don't have any good answers yet on long-term effects. We've had some data and the evidence is from Southeast Asia in part where they have done studies in what they call their clinical field studies where they send people out, um, and do medical evaluations and they've been going on those for a couple of decades, I believe. Because there they have people that have been using Kratom for decades. Or grown up on it. Um, and they don't see the kinds of serious adverse effects or decrease mortality that you see with heavy alcohol, cigarette smoking, and certainly not with opioids in this country, when I was first looking at it, I thought, well, How many deaths are out there and they and and we started looking in it and it's really difficult. To find because despite being used for decades by some people. Probably the wave started with returning Vietnam veterans. That You're not seeing it. Um, I, I should have mentioned the veteran issue before, but in the US Congress, there is a bipartisan group of former veterans, uh, Senator or Congressman Jack Bergman and others that have been very active on the Kratom issue because they're well aware that many veterans. Our managing their own addictions, post-traumatic stress disorder and so forth with Kratom. Despite the fact that it's not medically approved, so they're not saying ban it because it's not medically approved. They're saying, and Jack Bergman, I circulated this, but hopefully you'll get it. He said his, um, commentary was let's prevent the feds from jeopardizing veteran addiction recovery. And he's not alone in Congress. It's nice to work on issues in the US Congress where there's active bipartisan agreement that we should let people. have better access to things that can help them. And hopefully get the FDA. To set standards. Instead of just playing cop and going after the bad guys on occasion, FDA has the authority to set standards for the products. I think they'll get there in the meantime, I hope Arkansas joins the other states. That are already there. Thank you, Mr. Chair. Thank you. See, no other questions, uh. Appreciate your testimony today. I think the last on our agenda is Mason Sanders. Here to testify, so feel free to come down, introduce yourself, and, um. Feel free to be in. OK. My name is Mason Sanders. I'm a citizen of Arkansas. Um, I originally reached out to Senator Boyd just to ask how the kratom, uh, legalization process was going when I saw he put forward a study proposal late last year. Um, he invited me to come speak here today. I originally wrote out a pretty long presentation going over the psychopharmacology and the pharmacokinetics of the drug, but since most of that has been covered, um, I'm just going to address a couple things that I've heard here today. So there's been a lot of conversation about social functioning and how people operate while under the influence of the. and the idea that there is very little clinical data, it's just incorrect. It's been studied for decades, potentially centuries at this point in that way, and many studies out of Malaysia have showed that the vast majority of kratom users are not addicts, they go to work, they are healthy people. And they live highly functioning lives. Um, there's also the idea of talking about deaths. Um, I have a really hard time understanding why that's even in the conversation, when tobacco kills more people than all other drugs combined, and it's perfectly legal for people over the age of 21 to go by. I have a hard time sympathizing with that style of argument revolving around drug policy, but there are, um, Good reasons why Kratom does not kill so many people as other opioids and the respiratory depressive effects have been touched on, but it also causes sedation in other ways that do not activate the beta resin 2 pathway, which causes respiratory depression, and there's also metabolic processes and I do have a study in the packet that was handed out to you guys that talks about this, um, people have mentioned 7 hydroxymetrognine today, and that one does cause dose-dependent respiratory depressive effects, and it's an active metabolite of nitrogenin, but that. Metabolism is capped, so there is a ceiling effect on how much respiratory depression this drug can cause. Um, and when you are taking just mitrognine, it's capped, so that's why you don't have these respiratory depressive deaths. Um, the vast majority of deaths attributed to kratom should really be attributed to just uh poor quality kratom, so there's another study in the packet that was handed out to you guys that talks about phenetla contamination that caused the brain hemorrhage in multiple people and killed them. There have been a lot of salmonella outbreaks with ratom products. That are unregulated and a lot of heavy metal contamination. So all of the worries that people have brought up today with using kratom use in terms of toxic toxicological concerns. They are all exacerbated and amplified when the drug is illegal because there is no regulatory oversight. This is not a new phenomenon. The same thing happened during alcohol prohibition, tens of thousands of people were blinded, maimed and killed because alcohol was not regulated. As soon as the government began regulating the product, those deaths and those issues went away pretty much overnight. So there's nothing happening here that can't be predicted if we were to regulate the kratom market, um, there would be a marked increase in the safety, um, for the users and the people distributing and manufacturing the drug because it's not as if whenever we banned Crater here in 2016 that everyone in Arkansas just stopped using it. Um, they just had to start facing an unnecessary set of risks that was implemented by our government for no real reason. Like there, there's no. Logical reason that kratom should be banned while tobacco is still perfectly legal. I mean, more people in the US use opioids today, then use tobacco and tobacco kills 5 times as many people still. So, again, I just have a hard time sympathizing with the deaths being a contributing argument to whether or not this drug should be legalized. Um, and the last thing that I would like to discuss is disappointingly, I feel like there has been a Issue taken with kratom extracts here, even from the people who are on the side of kratom legalization. Um, the most commonly reported side effect for prolonged kratom use and high doses to treat chronic pain or opioid withdrawal is mild to moderate constipation, um, that is partly due to its pharmacology since it is a partial immu mu opioid receptornes that slows down the GI tract. That's why heroin and fentanyl and all these other drugs cause constipation as well, but it's also insoluble fiber with plant matter that will clog up your bowels and it adds a lot of bulk to your bowel movements and it prevents people from From being able to go to the bathroom as often as they would, and that's just generally unhealthy. It's not something you want. Everyone to be experiencing and these kratom extracts take that insoluble fiber aspect out of it, all while being able to provide the same amount of benefits without having to shove 88 to 12 g of plant matter into your stomach. Um. I think that about covers everything I wanted to say since the pharmacology and. Toxicology aspects were covered later or earlier in the day. favor that testimony. Are there any questions for this witness? and I appreciate you coming out and testifying and sorry it took so long to get to you. It's been a, been a long meeting, but I appreciate you sticking out there. Thank you. All right, um. See no other business, uh, represented Boyd, I'll turn over you for some final comments. Thank you, Mr. Chair. So just, just since we've been sitting here, there's been a recall on eggs. And so I, I'm gonna predict that we're not going to suddenly try to outlaw eggs, uh, because someone might get hurt from some contaminated eggs. Um, this is a Schedule One substance cradle in the state of Arkansas. Schedule One, it doesn't. It's, there's not any higher level of scheduling. I mean, that is the most strict, the most illegal there is. The difference between Schedule 1 and Schedule 2 is Schedule 2 specifically has a medicinal purpose, but Schedule One comes with the same penalties as you having possession of a schedule, you know, 1 or 2, it's the same thing. So that puts it in the category of LSD, methamphetamine, uh, cocaine, um, hydrocodone, oxycodone, heroin. You name it, so. I guess my question is, is where are the stories of problems, where are the stories of death, um, we did start with, there were 9 deaths. Um, there was testimony given that those in essence were debunked. I didn't hear any other testimony saying, No, they, they really were absolutely the fault. It was, it was labeled as one specific product and that seemed to be the issue. So what I'd suggest is the easy thing to do is leave this to Schedule one and just say, look, I'm concerned someone might get hurt, uh, but I would say what we really should do is we should really roll up our sleeves, uh, do the heart hard thing and find the right balance to allow access. Uh, to this botanical with appropriate oversight. I, I, again, I'm concerned that if you just say, hey, Metrogynine and 7 hydroxymetrogynine are, are legal in the state of Arkansas, you're, you are going to hurt people, but I think that there is enough evidence that says if we do this the right way, people can have safe access to it, um, I wanna say it is my understanding that other people were invited to have testimony. Uh, I reached out to some to make sure everybody knew and, and I. Don't have, and the people here, the people who had an interest in this, right? So there was, you know, the drug director's not here. I don't see law enforcement. I'm confident they knew this, this was happening, so I just hope you keep all of that in, in mind as, as we move forward, um, so, Mr. Chair, uh, thanks for doing a great job of, of chairing today and I'll turn it back over to you. I think we have one more person here to testify who did not get on the agenda. Would you like to come up and say a few words? Sorry about that, come Introduce yourself since we don't have you on the agenda. Sorry, Representative Boyd kind of stole your thunder of your closing remarks, but I just want to make sure everyone's able to testify who came here today, uh, like you said, I, I know we want people to be here to who are interested in it to come out and. Uh, let us know how they feel and, and, uh, I think for a lot of us on this committee this is a very new topic that we're not as familiar with, so I appreciate it. Ma'am, please, uh, introduce yourself, who you're with, and then proceed with your comments. Um, hello. My name is Julian Price. I am from Northeast Arkansas. I'm a resident there in Jonesboro. Um, I learned about kratom because of my dad. Uh, Marshall Price. He benefited from Kratom after nearly two decades of an opioid use disorder. Gratham helped him first through his withdrawals. And he continued to take kratom for the next 3 years. Uh, in that time, he gained weight, gained employment, reconnected with his family and kept his opioid addiction at bay? In 2021, he was arrested for trafficking a Schedule One controlled substance, kratom. He was arrested with a personal amount that he purchased legally. And in 2022, he was sentenced to 10 years in the Department of Correction. Three weeks into his sentence on December 8, 2022. Marshall Price dies as a result of medical neglect, violation of constitutional rights and recent blood force injuries. He suffered tremendously and almost 2 years since his passing, Marshall Price's family has grieved. We have wished that kratom had never been banned. And that our dad had never been sentenced. He left a major hole in our lives, where he served as a son, brother, father, and a grandfather. Uh, Marshall's not the only Arkansan to have benefited from kratom, from nurses and doctors to factory workers. I've heard of amazing pain and injury benefits given by Kratom. It's just a way for them to get their day started to be productive, and to enjoy their lives. So my biggest hope, especially going into 2025 is that we can, instead of criminalizing kratom consumers and demonizing kratom consumers. Uh, we can be a state that supports the kratom Consumer Protection Act. Thank you. Thank you for that testimony. Is there any questions for this witness? See no. Thank you, thank you for coming here today. And sharing that story, um. I know this was adopted by the uh larger public health committee, so there's no action we need to take today, uh, but I think it's good discussion and, and Representative Boyd, I think there's, uh, multiple pathways to pursue this, and I think you've kind of heard. Uh, He ways to make that a reality. So I'm excited to see this during session. So appreciate y'all. I appreciate everyone coming here today. With that, we are adjourned.