Ep 49: Understanding Kratom with Mac Haddow: Science, Politics, and Personal Experience

0:00 This vendor handed me, it was a little shot of kratom, and he said try it. And so I took and selected down and I took a double dose and didn't know it. I mean, I should have only taken half of it. But about 20 minutes later, it hit me. And, you know, I felt this calm feeling and I felt, you know, at the same time a little bit of energy. I thought it was an interesting experience. I'm not prone to, you know, just taking substances like that. I don't even like taking pills, but this was an interesting thing. Welcome to Kratom Stories, a weekly podcast where we share stories of how this amazing plant has changed our lives. I'm your host, Madeleine Sklar.

0:40 Each week I'll bring you a new episode featuring interviews with experts, advocates, and everyday people who've experienced the benefits of kratom first hand. Join me as we dive deeper into the world of this botanical wonder and discover the amazing stories behind this incredible plant. The Kratom Stories Podcast is presented solely for educational purposes. Neither the podcast nor its host promote or endorse the use of kratom, a substance not yet regulated or approved by the FDA. The views and opinions expressed by guests are theirs alone and do not necessarily reflect those of the host or the podcast. The content is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions regarding the use of kratom.

1:54 So I'm here with Mack Haddow. So many people in the kratom community know who this is. He is the face of the American Kratom Association. Mack, thank you so much for coming on to the Kratom Stories podcast. I'm glad to do it. This is a a new kind of experience for me because we're not talking policy, although we might, but she's talking about personal experience as kratom. It's great. Yeah, I know, 'cause like you're always, yeah, I mean, you're all about policy. You're, you're the senior fellow on public policy for the American Kratom Association. You do so much to help us as consumers keep legal access to this plant. And I just appreciate all that you do for all of us. So thank you. Well.

2:35 Thank you. But yeah, I'm eager to hear your kratom journey. So let's start off with you telling us a bit about yourself and life before you ever heard about kratom. Well, I first got involved in the political world as a college student at Brigham Young University when I was growing up in Pittsburgh, PA. My stepfather was an abusive alcoholic. The joke in our family was that when my mother married and he he did not know she had five children at the time and he wasn't a happy camper with any of us. And it's one of those experiences where as you grow up in those kinds of tents surroundings that you look for anchors in your life. And one of the anchors in in my life and my brother's lives was a two people, Jess and Helen Hatch, who were the parents of Oren Hatch.

3:23 And they had come to Pittsburgh in seeking work during the Depression. Orrin Hatch's father was a, a wood wire and leather metal lather. And so he was just looking for work. And he became sort of the the key person in the Pittsburgh area in bringing the religious view from Mormonism into that area. And our family had converted to Mormonism when I was 10 years old. And so Jess and Helen Hatch were just like surrogate parents to me growing up. So when I was at school at Brigham Young University and Orrin Hatch announced that he was going to run for the United States Senate, I called him up. And I said to Warren, what can I do to help you? And he said, well, the most important thing is you need to arrange meetings with delegates to the state convention.

4:06 Utah has a convention system for vetting its candidates. They now change that a little bit. So there's a pathway to do actual signatures and primaries. But at the time, it was just the convention. And he said, I really need to win the convention or at least come in second so that I can get into the primary election against a fellow Republican. There were five Republicans that had filed. And so I was assigned and I took on the challenge of doing Utah County, which is the second largest county in Utah. And it's the area where Brigham Young University is located. And so I started calling, and I set up these meetings. And I would call his campaign headquarters and say, I got this state, this state, this state. And every time I called, they said fine, no problem. And I after a while, I started to wonder what is going on?

4:48 There are 29 counties in Utah. How in the world can I get every date? That's statistically that's just not possible. And finally, I asked the scheduler and he said, well, the truth is you're the only one that's working on this. We don't get any other contacts or calls. And so and I became friends with the scheduler who was retired Air Force Colonel that knew Orrin Hatch from his neighborhood where they lived. And he said to me one day said, look, I made a commitment to my wife two years ago before this campaign we got underway that I was going to take her to Hawaii on a vacation. And I've got to do that or I'm going to get divorced. He said, would you come to the headquarters and just run the scheduling operation for a couple of weeks? And so I agreed to do it. And the first day I was asked to go to the airport to pick up a consultant from the Republican National Committee who was coming out to evaluate the Hatch campaign to see if there was any possibility that he could win.

5:42 And I picked him up at the airport and on the way to downtown Salt Lake, which is about a 20 minute drive. He said to me, what's your assessment of the campaign? I didn't have any assessment of the campaign. All I saw was negatives. And I said, well, I can tell you what I know and I don't know much, but this is what I learned. And it doesn't look like there's much going on. And he said, fine, thank you. And I picked him up to take him back at the airport about four in the afternoon. And he got in the car and he said, it's a lot worse than you thought. He said, this is a disaster of a campaign. He said Hatch is going to ask you to drive him to Logan tomorrow, which is about two hours from Salt Lake, north of Salt Lake. He's going to ask you to be his new campaign manager, he said, and you need to tell him no. I said. That's easy. First off, I'm in school, in my senior year of college.

6:24 I don't have time to do this, I said. Secondly, I don't know anything about politics. He said, Ah, you don't need to know anything about politics. You just tell him no. Because the only way that you say yes to him is if he agrees to fire everybody on his campaign staff. And if he'll do that, then you tell him yes, and then I'll help you. I'll give you a road map on how you can at least make it credible, He said. There's no way Hatch can win. None. But he wants, if he wants to have a future in politics, he's going to have to do the following things. And he kind of laid out the road map. Next day, exactly what he had asked me to do happened all the way up to Logan Hatch beat on me. I said, no, I'm not going to do it all the way back to his house. And we sat out in front of his house for till 2:00 in the morning and find that he said, OK, I've got to do this.

7:04 And I hate doing it. These are all my friends that I've recruited to help on the campaign. But if that's what's going to happen, it's going to happen. So next morning, he gets everybody there, 12 people in the room, very small staff. And he said, I'm making changes. Mack is the new campaign manager. They didn't even know me, by the way. He said, and he'll brief you on what's going to happen next. And he walked out. So I became, they all quit, which I would have done too in their circumstances. I would. I did. You know, this is a college kid that suddenly gets thrust into this. And some of these people were older and more experienced than that. You know, all that. So I became the campaign manager. And through a variety of very interesting circumstances, Orrin Hatch won the seat in the United States Senate, toppling a incumbent that was called the safest seat in the US Senate that year.

7:46 And Hatch beat him and that suddenly I was thrust into this world of politics. And my first assignment when I got to Washington with him was he said you need to find a good dietary supplement store where I can get supplements that I used to maintain my health and well-being. And he gave me a list and I got on the Metro in DC and I started searching. I got, you know, I, I found out some stores and I went looking for these supplement stores. Most of the things that Hatch had asked me to make sure I could find, I didn't recognize. I'm a young kid. I'm not, I don't need supplements. I don't need this nonsense. And when I finally found the right location, I reported back to him. But what I saw, and Hatch's commitment to dietary botanical supplements was extraordinary because his view was the light years ahead of the FDA's view, because at that time the FDA was demonizing all dietary supplements.

8:37 And so Hatch started a crusade against the FDA, and that led and culminated in the passage of the Dietary Supplement Health and Education Act in 1994. Now, by that time I'd left his staff. I had served the term in the Utah Legislature myself. I had become the chief of staff at HHS and then I was out doing advocacy work and I was working hard on this Dietary Supplement Health and Education Act and that passed and it rained in the FDA. And so Fast forward to 1996 and on August the 30th I get a call from the American Kratom Association. Susan Ashe was then the president of the AKA and she said we need your help. The DEA is publishing a notice tomorrow that will ban kratom and make it a Schedule 1 substance. And we need desperately to get your help. And we need you to try to lean on Senator Hatch to help us as well.

9:30 I told Susan that no chance. In my experience in working with the FDA, there had never been a rescission of a Federal Register notice to schedule any substance. They've never done it before. And I said the best chance you've got is if they use, which they typically do, the emergency power section, which gives them a speedier pathway with no public comment. They have 30 days after publication, it becomes banned. I said, but it's only for two years. So you could build the case. And she said, well, that we don't want that. But if that's the best you can do it, that'll get you on board, then fine, we'll do that. And of course, I've told people what I underestimated was that the advocacy community, the passionate consumers of kratom stood up and they were counted and they they reached out and all this.

10:14 Now, that being said, that wasn't my first experience with Kratom. I already knew what it was because in my business, my brother and a couple of other guys were partners. One of the partners had come to me about a year before and said I've got this guy that has hired us and I wasn't working on this account directly at the time. It has a product called Kratom and he really needs to, he's working with the FDA. He's trying to get approval to get through the the new dietary ingredient notification process and wants to talk to Orrin Hatch. So could you introduce him to Orrin Hatch, which I did. And we went to lunch before the meeting and this vendor handed me, it was a little shot of kratom. And he said try it. And so I took it and slept it down. And I was, I took a double dose and didn't know it. I mean, I should have only taken half of it. But about 20 minutes later it hit me. And, you know, I felt this, this calm feeling and I felt, you know, at the same time a little bit of energy. I thought it was an interesting experience. I'm not prone to, you know, just taking substances like that. I don't even like taking pills, but this was an interesting thing.

11:16 So when we met with Hatch, Hatch was eager to try it. And he himself had suffered from age-related kinds of injuries that are arthritis. And then he had been injured in a plane crash in St. George, UT. A small plane landed in a very difficult airport, cracked the plane in two, and Hatch had had serious back problems from it. And from the moment that he took kratom in his office the first time, he became a big advocate for it and a consumer of it. And a year later, when we were in the midst of this battle, I sat in his office when he picked up the phone and called the DEA administrator and said, you will not schedule Creighton. I will fight you to the death on.

11:57 He said, I use it. It helps me considerably. I can imagine it's helping millions of other people, and you're not going to do this. And that, of course, was one of the elements in the decision that the DEA administrator made in pulling the recommendation for scheduling. So now I have a similar history of injury. When I was young and really, really, really dumb, I was a motorcycle racer in college and so I got banged up all the time on desert bike racing. And so I have a very bad hip and so I have this chronic pain. I have a lot of arthritis in that hip. So I was always taking Tylenol whenever and particularly when I play golf or something, when I, when I really had to stretch those muscles and gin joints.

12:37 And so after with Hatches endorsement, I started using Kratom from that day forward. And I, I usually consume at the time I was doing it probably five days a week. As I've gotten a little older, a lot older, I'm taking it every day and I take between 4:00 and 6:00 grams a day. It's not a lot, but it helps me cut the pain and I can function fully on it. And I've been doing that now for eight years. And so it's, and it's really, it has given me a perspective about how it really can help people. When I hear the personal testimonies of people, I can relate to them because I've experienced it myself. And you know, I don't experience any of the so-called addiction or the cravings for it. I don't have any of those kinds of feelings. I, I have had on occasion to not use it for a couple of days or in one case for a week.

13:22 And 1/2 when I went overseas and, and I just didn't want to be traveling with him because I was going to stop me in the country, Singapore, that it's not well liked on any drug. And so, but I've not experienced any withdrawal symptoms and none of the classic the kinds of experiences some people relate to with drugs where they get withdrawals. I don't think I'm addicted to kratom in any way. I think my major addiction is really the caffeine and Diet Coke, which is my primary addictive substance. And the kratomism is not the same experience at all. So that's my personal experience in using kratom and how I got introduced to it and how it really is helping me on a daily basis as I confront these old age symptoms and this prior injury from my stupid youth. What a wild story.

14:08 I had no idea you've been a credium consumer all these years. Wow. And Orrin Hatch too. I, I, you know, I knew about the, the Shea Act and, and his support for dietary supplements. I did not know he was also a kratom consumer. And that really says a lot about having somebody like him able to talk to the FDA and, and help put pressure on when they wanted to ban this in 2016. Was this banned that they wanted to do in 2016? Did this like just come out of nowhere? Like this was just something that there was like, were there things leading up to them wanting to ban Dan Kratom? Yeah, well, there are two things. One is the the FDA has had a long standing bias, particularly with one individual who's been there this whole time for decades about dietary supplements and botanical supplements.

14:55 And if the FDA had their way, they would repeal to shade today and they tried to nip around the edges and use regulatory authorities granted by DSHEA. And it will be that's adverse to the to the Dietary Summit and the kratom community. So they have just an inherent bias against them. But kratom got on their radar really when they started to hear reports that smoke shop owners were getting creative. They became alchemists and they started mixing kratom with other things. And you started to hear reports of adverse events. And not surprisingly, the FDA started to look at it and so did the DEA. And then in 2009, the catalyst was that you had 9 deaths in a 12 month period in Sweden that were attributed to 1 product, a kratom, a powder kratom product called Krypton.

15:42 And it was sold everywhere in Europe on the Internet. And so very popular product. And 9 deaths in a 12 month period is a matter of huge public health concern. And it resulted in a number of European countries banning kratom. The FDA didn't have that authority on their own as some other countries do. So they initiated an import alert and they started laying the foundation for how they could build the scientific dossier that would allow them to schedule kratom. So it took them longer than they thought. Now the one thing that is very disappointing about all of this and it shows the bias of the FDA against dietary supplements and botanical supplements is that when this they identified these 9 deaths. One of the things that the FDA has an obligation to do is to survey all of the peer reviewed public literature on any of substance of which they have developed a interest in from a safety perspective.

16:38 So there is a peer reviewed published article called the Cronstand Report that was published in 2011. So he had the deaths in 2009 and then you had the FDA implementing their first import alert in 2012. So the significant event between the death reports and their import alert was the publication of the Constand report, which said that the Krypton powdered kratom product had been adulterated with Odess methyl tramadol, which is the chemical used to develop the opioid tramadol. It is a powerful painkiller. It is also highly toxic and deadly if it's not managed properly.

17:19 And the report from these scientists was that it was the introduction of that adultery that was the likely cause of those deaths. The FDA had an obligation to factor that in, but they ignored it, completely ignored it. And it's one thing to say that they maybe missed it when they did the import alert. I don't think that's possible, but they they could argue that. But there's no question that when they actually filed the petition with the DEA to schedule kratom, they listed those nine deaths. So at that point, they had an absolute affirmative legal obligation to survey all peer reviewed public literature, and they chose to ignore it. And they use those nine deaths as one of their hallmark examples of how creating was dangerous. And under the eight factors, Factor 6 says that they have to prove that there's an eminent threat to the safety of the American people from the use of this substance. They used those nine guests as one of the 33 in their initial recommendation for scheduling.

18:16 It was disingenuous, it was dishonest, and yet they did. And they were not held to account. Well, they were eventually, but they weren't held to account the way that they should have been at the time. And it was only because of the outcry from the 23,000 people that eventually got their comments on the record that they were calling in advance of that, the DEA public affairs officer told me at the end of September. And the deadline was it was going to and take effect September 30th after the 30 days of the publication. He said that we got more calls on Kratom than we had on any other scheduling recommendation in the past. And so it he said it was thousands of calls. He was quoted later saying 6000 calls. That's a significant number.

18:57 And then you had 23,232 comments submitted when the when the DEO opened up their comment period and you had 147,000 petition signatures on the White House's We the People website petition platform. That was amazing and all of that. And you would think that the FDA would say, you know what, we need to look at this. We need to examine whether this is the right thing to do or not. But they didn't care. And it's largely because of one guy at the FDA who remains there to this day, who leads this war on predom. And he's influential. He obviously misled Scott Gottlieb when he became the FDA commissioner and he's misleading Commissioner Caleb today. And yet he gets away with it. And it's a tragic, and that's in it from that standpoint. Wow, it's so disappointing to hear that that like one person there, you know, it is the one that is trying to keep us from having legal access to this plan is it's helping millions of people around the US.

19:54 It's just crazy. You know, when I saw the documentary A Leap of Faith, you know, I discovered Kramer in 2019. So all this stuff y'all did prior, it's amazing to learn about it. And so I learned a lot about it in the documentary Leap of Faith. And to see that Chris Bell went on Joe Rogan's podcast and that prompted a lot of people to get active and to reach out and say please don't ban this. Do you think that helped a lot with all of those calls and in 2016 to help keep it from getting banned? What did that play a big role in it, you think? There's no question that the community, the advocacy community, consumers rallied. And I think it was a combination of that kind of influencer that was feeding into it.

20:37 I think that something that happened at that time with the vendor community where they rallied, they were putting up handmade signs on their cash registers telling people to reach out to the DEA and oppose this. You saw this. I call it an outcry. It was a passionate outcry from consumers who were saying a very simple message, this is helping me, it's not hurting me, This is saving my life. I'm not dying. And it's that kind of thing when you look at the options. And the theme of that messaging resonates to this day with the National Institutes of Drug Abuse Director Nora Volkow. That's what she says. This is a valuable, a potentially valuable harm reduction tool in our war against the opioid crisis. Why wouldn't we let people have access to a product that otherwise they're trapped in the addictions and the actual risk of death because they are using opioids? And that's exactly the message that the assistant secretary for Health, Brett Shaw said when he issued his withdrawal letter, which I think is the Bible for any crate of advocate to go read that because he said that not only was the evidence and data that the FDA provided embarrassingly poor, but then the the phrase it's often overlooked and a failure to consider the overall public health. This is about a battle that we have with people that are entrapped in this opioid crisis who are dying. And we have evidence that proves that people are able to not even go down that path because

22:09 they're managing their pain with kratom or they're able to wean off of those dangerously addictive and potentially deadly opioid products with using kratom, not the kratom as an opioid. Kratom doesn't have the same effects. Opioids are essential to the management of pain for many people. But when you're addicted to them and you're not man in your pain anymore, you are fighting a full blown addiction that traps you into a very dangerous situation, then it's got to stop. And that's what I think Doctor Zuwa was recognizing that there are people out there that are struggling that don't have access to traditional treatments. When I talked to Doctor Jawah and thanked him when I found out about his withdrawal letter, he said to me, he said, Mac, he said I am not a kratom advocate. He said, I don't know whether kratom is good or bad. I have no idea.

22:56 He said I tended to agree with the FDA when I first heard about it because they're smart and they know what they're doing. He said, but in this case, the FDA was wrong. He said, I'm an advocate for good science and I can recognize bad science when I see it. And that's what I saw in the evidence and data that was presented by the FDA in an attempt to do one of the most monumental decisions under the Controlled Substances Act, the death penalty under a schedule one for a substance like kratom. He said it made no sense to him. So that's where we were in 2016. You would think that the FDA would recognize that criticism and self examine themselves and try to figure out how they can properly regulate.

23:37 They refuse to. They still want to ban it, and they persist in that to this day, despite the many, many setbacks that they have, even by their own scientific research and even when they are called out by a federal judge. They just did it earlier this year saying show me the evidence, and they refuse to show up to do that. The FDA is so wrong on the science that it's embarrassing. And they should stand down and they should find a way to regulate this product so that it really, truly does protect the American people. Agreed. As a regular daily kratom consumer, I I would love to see regulations. I would love to see the KCPA all across the US. You know it, it is in my state of Texas, which I really appreciate as a consumer.

24:19 I would love to see this for everyone because we want to know what we're getting is safe and in following the guidelines of of what is safe kratom. Absolutely. And and there's a pathway to do that. The FDA doesn't have to take this regulatory harsh pathway that they're taking. It's just ingrained in them. Their DNA is that they are going to fight against any product that they believe should be a drug. And they know that for kratom, that's not possible unless the molecule or the alkaloid is converted into a chemical version of it, which can then be patented because they know the kratom is not patentable and there's no interest by anyone in the pharma community. But for changing the alkaloid and and, you know, synthesizing it into a dose level of kratom that would have a much more powerful effect for a therapeutic benefit. The FDA just doesn't, they don't believe in dietary supplements. They don't believe in botanical supplements. And in fact, they hate them.

25:18 And kratom is just their cause dejour today that we need to fight back on. And I think I see a pathway for the future which they're going to get overwhelmed by their own ineptitude on this issue, just like they did themselves in on dietary supplements in general. Well, I think it helps tremendously knowing that we have you on our side, Mac, as a fellow kratom consumer who has amazing influence in DC, who gets across all over the US, speaking with all these potential bands that come up, it seems like almost every day you're like traveling, you're somewhere, you're popping up in a live stream or talking about it, letting us in a webinar, letting us know what's going on. I'm just I never was that involved in politics but once I started as a kratom consumer in 2019 join the American Crime Association like right away and have been blown away at how much goes on in government all the time when it comes to this plant is mind blowing.

26:16 Yeah, it truly is. And it's fascinating to see the evolution of the understanding of politicians and regulators about kratom because that big hill to climb is when the FDA says something's bad, it must be true. We should have the faith in the FDA to do the right thing all of the time. Unfortunately, we can't. This isn't the first time they've made a mistake. It just happens to be the the one that's most important to us right now. But the bottom line is that the FDA has an affirmative statutory obligation to tell the truth and they're not doing that right now. The perfect example is to look at the FDA and kratom web page that's up on their website right now. They declare on that website, and it is the basis for actions by regulators around the country, including in this in the state of Ohio, in state of Washington and New Mexico.

27:06 It's growing because they look at that website and it says that no kratom product is allowed for sale that's formulated or treated as. And then they list a whole bunch of jargon that makes people believe that that must mean all kratom is illegal and it does not. But most importantly, the FDA's obligation to tell the truth on it. It has a an important guardrail. And that is that in order to make that declaration, they are required under the under the statutes that they have to go through the Administrative Procedures Act. They have to go through rulemaking, which allows for public comment. It would allow for scientists to step up and say, oh, you're wrong on this or you're right, depending on the perspective. It would require public comment to be able to say, here's the consumer experience that I have that you need to listen to. They did not do any of that.

27:56 And yet they're taking this affirmative stance against kratom, saying that it's illegal for sale in the United States. And unfortunately, some of the local jurisdictions are getting duped by it. I just got notice about one over the weekend in Albuquerque, NM, where a local health authority came in and relied upon the FDA's position and claiming the kratom is not legal for sale. What's happening in Las Vegas right now? There were representatives and investigators from the Southern Nevada Health District that went to a trade show in Las Vegas over the weekend and shut down 5 kratom booths at that trade show. The trade show business is huge in Las Vegas and they're now interfering with that business. And so I think that's going to cause an outcry from some of the people at the Chamber of Commerce and others who are very concerned that they're just overreacting. And they cite the FDA.

28:46 The Ohio Department of Agriculture did the same thing. This is a pernicious outcome of a policy that is driven by the bias of the FDA, not facts, not any evidence, because we already know the evidence is not there. And they cannot even prove their claim that it's dangerous in a court of law. They just like to bluster their way through. So the FDA has got to be held accountable going forward because our lives, our lives are the ones that are in the balance. They take this away. And if they're able to successfully ban it from the marketplace, where do people go? It's what Doctor Zhua said. They're going to go to more harmful, potentially more highly addictive and dangerous products in order to manage acute and chronic pain. There's no excuse for that.

29:28 And we hear voices like that, those in the military that are saying kratom has saved my life to me when I was when I was under the VA scare and I was addicted to opioids and it was ruining my life. We see one after another of those people that that are doing that. And then you have Congressman Jack Bergman, who speaks up for veterans as a former Lieutenant General in the Marine Corps. And he's passionate about this. And he says the FDA has got to come around. And he points to not just kratom, but it's psilocybin where they're proven benefits. They're available to veterans are suffering from PTSD and depression. That's helping them. And when you see the suicide problem among our veterans, because they're struggling with these issues that they acquired as a as a condition of their service, we should be doing everything we can to help them. And when you see the potential value that psilocybin can have in that area, the FDA ought to be leading the charge. And by the way, they're better on psilocybin. They are kratom, by the way, but they're still not there on either one of them.

30:24 And that's why we need to keep this fight going and we need to win in order to protect consumers. We really do. Do you feel like, I mean, for many of us kratom advocates, we feel like as Big Pharma that is in the mix somehow working with the FDACDC, all of them to like, no, don't let this amazing plant, you know, remain as is and helping all these people because it's keeping us from, you know, being in the big pharma and, you know, having all these high-powered opioids, which I took for nine years for my chronic pain, I would much rather consume kratom, which is just a plant. But I don't know, you're so involved with all of this stuff. A lot of us just kind of speculate that Big Pharma has got to be somehow meddling in all of this. Well, this is a complicated issue, but here's here's what we know.

31:13 There certainly is an incentive at the FDA to focus on products for which they receive user fees. When the Prescription Drug User Fee Act was first passed, it was intended that it would fill the gap of being able to fund resources in terms of equipment and new technology and people to run it. And it was estimated that user fees for prescription drugs would account for about 9% of the review budgets of of Cedar, which is the Center for Drug Evaluation and Research. Today, it's over 70%. So if you are sitting out there as a, you know, staffer at the FDA and you're saying, hey, I'm stressed in my job, we need more people, we need more equipment, we need new technology.

31:55 Well, the pathway to that is increasing user fees and getting it above where it is right now is a little bit impossible. But expanding the products that can contribute is a whole different bag, right? So that's what they want. And so I think there's an incentive by the regulators at the FDA to say, well, let's increase the pool of those people or products that are coming onto the marketplace to pay us the user fee. So that's one issue. The second issue, I think that it really is pernicious, but it's there is that they're the incentives are all on their head when it comes not just the financing of the way the FDA does drug evaluations and research, but it's also the companies that are involved in pain management. There is no question that they see kratom as a threat to their marketplace. And you've got powerful forces that are that are crunching them.

32:42 You've got the opioid prescription restrictions that everyone believes should have been put in place. And government like it typically does overreaction. Now the pendulum has come from the door wide open for opioids under Scott Gottlieb, by the way. And now it's swung back where they don't have the prescribing authority for physicians to be adequate to meet the needs of people in the pain population. So they've gone way too far. And this is the way government reacts, right? And you've got these companies out there that see a restricted marketplace because they're not allowed to prescribe these medications. And then when they see a product like kratom that is a direct competitor to the patient population, they're going to be down on kratom. That's not all pharma. That's just those companies that are in this cash game, right? And by the way, we're not immune to it. I see this happening right now in the kratom world. You have people in the kratom world that have products that they want to have preserved in the marketplace, but want to, they want to get rid of competing products that are not their same product formulation.

33:39 And that's happening right right now as we sit here today. I was fighting it this morning with a vendor who's just hell bent to eliminate his competition and he uses every ruse that he can under the sun. He's now his latest thing is, oh, we should eliminate all products that have any attraction to children. His definition of what's attractive to children is is completely contrary to what the the Federal Trade Commission and the the consumer products division has for what they qualify as children's products. But if you package your product and you have any logo that is vaguely resembles an animated character or a cartoonist character, then you're out. If you use a color on the packaging that might be attractive to children, you're out. This is the kind of nonsense that we get involved in, and it's all competition, and that's unfortunate. So we see this where the a couple of the big pain management companies that are trying to restrict competition in the marketplace, we're seeing in our own house. And that's got to end.

34:33 It's got it's simply, we've just got to turn our backs to that and say enough of your nonsense. We're not going to tolerate it by the by the big pharma companies that are in the pain management business and we're not going to tolerate it with creating companies. They just want to eliminate competition because there's one thing that a consumer should have choices. As long as that product is formulated safely, as long as it's labeled correctly with directions for use, that's what we should be doing. And the idea that we let a company decide that who the winners and losers are, using legislation to try to do it is just is ridiculous. And I think that's our next battle. Do we have to add to the the battlefront as we go forward in 2025 when we're working in these states? We saw what was proposed in the state of California by the Global Kratom Coalition.

35:17 They had a bill that drove a number for enforcement that would have required for a registration of a kratom product at 113, $1000 for the first year and $83,000 every year thereafter. Now that eliminates all the small to mid sized businesses. And by the way, for contrast, the state of Utah, first state that passed the Credit and Consumer Protection Act has a product registration fee of $260.00. So where does that come from? Except that they had the most onerous regulations known to man embedded in that bill. And it's largely why you're seeing the internal civil war that's developed in the in the industry here. Because I went out, I had the gall to go out and and testify to the Senate Appropriations Committee in the California and I told them this is going to decimate the workplace. You're going to you're going to restrict product availability, you're going to destroy innovation. You are going to open this marketplace to one or two products and that's it.

36:11 And you will not allow or serve the consumers to have access to products that are helping them. And and it's all about, Oh well, I want just a powdered kratom product and a low MIT content and not any of these extracts. And they make extracts the evil a product line, the good is extracts have a standardized dosing form and if they're properly extracted, where you can't artificially enhance the alkaloids power beyond what the the food grade solvents that are approved by the FDA allow, which we do for coffee, we do for all kinds of products. We consume extract products every day. And yet global credit coalition wanted to eliminate those. So that's the tragedy of the internal battle that we have because it the consumers are the losers and when this kind of thing happens. And so as I say, it's a new battlefront we've had to open up, but we're to do it.

36:57 We're going to fight tooth and nail because the one thing that we believe in is that consumers ought to have access to properly manufactured, properly labeled products where they can make a choice. And that it should be at a price point that's not going to kill them. And that's where they can't buy it. And they literally could kill them in that, in that regard, because some people desperately need access to these kratom products. And not everybody, not everybody is going to be helped by a Metrogen and content product that said 40 milligrams. We did a survey, we have kratom vendors and we have over 10 million servings and we found that the sweet spot where there are no adverse events reported is between 160 and 320 milligrams per day. Now how, how can you justify saying we're going to limit the marketplace to only our low MIT content products?

37:43 And and you know, that's fine by the way, for them to do that, but they can't eliminate their competition. I believe that the future marketplace of Kratom, when we get the FDA back in the box and we get them properly regulated Kratom, I think that they'll be a dramatic expansion of kratom's product lines in America. And you're going to see those low MIT content products being marketed in Whole Foods because that's all some people need. And it will appeal to the quote soccer moms in the world. I believe in that. But I don't think that you cannibalize the rest of the industry because that's what you want to sell, because it's your product. And that's the, the real struggle that I have with accepting this idea that we can pick winners and losers by legislation. Let's pick it by good science. Let's pick it by properly manufactured products. Let's pick it by properly labeled products so that the serving size are clearly identified. And the obligation to convey that information on safety is the manufacturer's obligation, because that's what the federal law says.

38:39 If you have a reasonable basis on the safety of your product under the conditions of use prescribed on the label, then you're good. And, and why should we be the ones to interfere with that? Because. Because it's a competitive advantage for one manufacturer over another. It's why y'all have my full support of the American KREM Association because y'all are doing things right and I appreciate all that effort. And while I personally only consume the whole leaf kratom powder, I have no need for the extracts. I do believe that they do have their place for people it, you know, in some situations, especially somebody that that's consume kratom, they understand it and and I'm totally fine with that. But I just don't like the idea that there's all this division that's been happening because you got this other group just trying to make radical changes that don't benefit the consumers overall.

39:28 That's a problem. You know, it's interesting because one of the things that we, I thought we agreed on was 7 OH products because those products are potentially far more dangerous. And here we are in a situation where there's no way to eliminate them. Because if you have the standard that the federal government requires, they should be allowed to be in the marketplace if, if the science proves it, and that's a big if. And if the labeling is sufficient to protect consumers. It's the same way that Kaaba Kratin products get on the marketplace because there's no peer review publicly public literature that says those that combination of products is safe. I asked the question, I got rebuked on even getting that information and here's the critical problem. When we confront that issue, how do we decide what the fair marketplace evaluation of the safety of these products is?

40:15 It should not be because I don't like it. So what we did is we went to the seven O 8 people and said our big problem here is you're calling it kratom because there's the consumer should know this is not a kratom product. So we struck an agreement that this heart group that represents a significant percentage of the 70 H community agreed that they will no longer market their products as kratom products. That was a significant step. That's what the scientists have been telling us. You can't let them call it a kratom product. We do that and suddenly it's like we shot our mother because the Global Kratom Coalition, I said, oh, my goodness. I mean, what a terrible decision that was. Well, you know what? I think it was a decision that we got to 1st and they didn't. And that's why they demonized it that hard because we agree.

40:55 We agree on the fundamentals, and yet it wasn't good enough. It wasn't fun. Yeah, we didn't give far enough into it the way that they wanted to or the way that they would have done it. Not a perfect solution because the perfect solution is for there to be well developed science that would document in human studies, not just on an in vitro with the animal studies, none of that. We need to have good science that's robust. And until then, if a company has that prerequisite that the federal standard allows, which is why we have, as I said, copacrating products, If you have the science and you have conditions of use on labeling, then you should be allowed in the marketplace until the documented adverse events you off the market. And Chris McCurdy said something fascinating in our congressional briefing. And at the end of his statement, he said that the forensics labs in America do not test for the difference between Metrogeny and seven hydroxymetrogeny or spiciosalatine or any of the other subalkaloids that are enhanced and concentrated.

41:46 So we don't know what those deaths really are. That's significant. And I that I learned something that that day when I heard that. And so we're actively looking at how we can promote better standards for these and six labs to make sure we can differentiate what the content of those products really are. That would be amazing. Would love to see that happen for sure. I know we got people listening to this going. I didn't even really know much about American Crane Association. We have a lot of people that are newer to kratom in our community. How can people get involved? You know, luckily for me, I discovered you guys very early on in my cranium journey, probably through a Google search, I imagine surprisingly. But I was like, oh, there's an advocacy group.

42:27 This is awesome. And I immediately joined and I've been getting the emails ever since in 2019 all the way to now. And it's how I stay informed of all the stuff that goes on in this community, especially all the legal issues. And it's what got me to come out to Washington, DC last year when y'all had the big congressional briefing on Capitol Hill, which was amazing, amazing to come meet you in person, other kratom vendors, other researchers, as well as fellow advocates. And we have such a strong community here. But it was all because I discovered American KREM Association. So for those are not as familiar with, I'm sure they are now after listening to you because I mean, you're explaining so much of what y'all do, but how can people get involved?

43:07 They're listening that really have no idea they could be involved. Well, thank you for that question because we need every kratom consumer to stand up. We're seeing the challenge that the FDA is now initiating at the local level. We're seeing more and more of these bans pop up and everybody citing the FDA. And it's clear that the FDA is pumping that disinformation campaign out there. They have allies. They've got the trial attorneys that are doing the same thing and the creating danger awareness group. And you know, they're weaponizing their grief. All of us feel great empathy for anyone who's lost a loved one. But the bottom line, it should be the truth that is based on what their advocacy is. And I suspect, and I know in many cases that the trial attorneys of LED these families down the Primrose path to look for the payday.

43:49 And there really isn't what they're claiming, but they're certainly, it's tragic and and I get that, but you can't weaponize your grief to the point where you're just spreading disinformation. So we need kratom consumers to stand up in these local communities more now than ever. You can go to americankratom.org and you can just sign up. Go to protectkratom.org and you can sign up. We're always looking for those new voices, bodies to fill seats to stand up before a microphone. And by the way, I know that's hard. I've sat and watched hundreds and hundreds of people stand before a microphone and I can, and I'm sitting behind them and I can see their knees shaking and I can see that they're terrified at this. But those powerful testimonies that come through because they are obviously uncomfortable doing it, but yet willing to share it with public officials, it makes a huge difference.

44:35 I can talk policy all day long and I will be countering against what the public official was looking at on his iPad on, you know, Googling the kratom horror show on Google. Nothing, nothing can replace that consumer standing up and saying this is how it's impacted my life and how it saved my life. It's helped me, It's got me back into society. And I hear so many of those stories. So we need every kratom advocate. We need to set aside our differences. And I know that there are people that say, oh, the AKA should do things differently. We're not perfect. We've made mistakes. I wish I could take back a couple of decisions that we made early on and they certainly were trying. And we may not in every implementation of decisions or even well-intentioned may not be as good at as we need to be, but we'll overcome that with voice. People that stand up, willing to set aside the petty differences and let's really, let's really do the right thing for one another.

45:25 I think that's the key. Absolutely. Well, it's just amazing all the stuff y'all do. And as a consumer, I appreciate it and I always do everything I can to help. Always sharing my testimony wherever people are directing us to share it. For legislators, anybody that where kratom becomes this issue all of a sudden and they need to hear our stories. You know, when I was in DC for the congressional briefing last December last year, I did go to see my House Rep and, and I tell people like, look, you don't have to go to DC to do this. You're House Rep has and you know, they have a location in your city that in addition to the one in DC and the one at the state level, the senators have one at your state capitol.

46:10 But because I wanted to come to DC and meet everybody and attend the congressional briefing, it's like, OK, well, while I'm here, I'm going to go try to meet the senators, go try to meet the House Rep, see how far I get. Didn't get anywhere with senators. But the House Rep, I got to sit down with an aide like unannounced. I showed up and got to sit down with the aide that that handles our FDA issues and she was really interested in hearing my story. And it was really cool to like have somebody listen that didn't know anything about Kratom. And while I could have done this locally in my city, I thought, you know, maybe that add a little oomph to it. You know, that, hey, I happen to be in town and, you know, while I'm here, I'd love to meet with somebody to talk about this.

46:51 And it was just a lot of validation to be able to get your story heard by people in power that can change our lives. But there's no question and then let me let me tell you that the influencers in the community and and you know, I'm I'm an observer in most cases of the way social media has transformed public advocacy. And if I were going to name, and we have at the AKA, by the way, as you know, that name the heroes, it's that that Madeleine at the Kratom stories podcast and it's the Kratom Gals podcast and it's it's Mike over the Kratom guy show. I mean, all these people that are influencers and people that are not necessarily fans of ours. Brian Gallagher is a great example. I mean, his heart's in the right place. He's pushing hard to get the right story out about kratom. We can have disagreements and we can have we have personal feelings of animosity.

47:41 That's fine that we should set those aside if to the extent we can and not take the things personal. We're all human beings and we all come to the table here, to the battlefield, actually, with different perspectives. And we may not agree on everything together, but we should agree on the common goal, which clearly is to keep this plant legal. And by whatever means that is necessary to do that. Whether it means coming to Washington DC and what you did and visiting with your congressional representatives, whether it's getting on a phone call with them or emailing them, or going out to these local jurisdictions where kratom is under threat. Those are the battlefields that we need to be there with. There's many of the weapons that we can and our weapons are our voices and our personal testimonials.

48:21 And so I'm, I'm in awe of the work that you do. It's selfless. It's something that makes a huge difference in keeping people informed and motivating people and reassuring people that their voice really does matter. So I'm grateful, and the AKA is deeply grateful for all the work that you and your colleagues do. Well, we all appreciate it and none of us set out to be influencers in the Kratin community. We're just all super passionate about how this plant has changed our lives and we we want to share that enthusiasm we have with anybody that will listen because it's been incredibly life saving. When I get the kratom gals together each week for our live stream, we always, it always seems to come up in the conversation how we all don't take this plan for granted that our lives have been transformed because of it.

49:05 We all suffer from chronic pain and several of the gals, you know, also in addition had some addiction issues. And because of this plant, our lives have been completely changed for the better. And it's just amazing. And we just, we don't want to hold that in, you know, we want people to know. And it's just so validating to get this message out in a variety of ways. Social media helps tremendously, Podcasts like this, live streams like the kratom gals. And it's something that anybody can do. So I really hope in all the stuff I'm doing that inspires others to do things as well and just get their story out there in whatever way they can is incredibly important. We'll definitely get the link to the AKA and protect kratom.org on the website.

49:48 Make sure people know they can easily just go click on the link to sign up. My last question for you, Mac. This is such an amazing conversation, by the way. But knowing everything you know now about kratom, you know a lot. You've been in this for quite a while. What advice would you give to someone who was just getting started in their own kratom journey? Yeah. I think that as new products have come on a landscape here and into the market, consumers need to be careful about, you know, their experience with kratom and start slow. As I said, the first time I took it, I took twice as much as I should have and it hit me a little harder. I learned from that experience. But now you can take other people's experiences and learn from that and start slow.

50:28 Find out what that right spot is for the kind of experience that you're seeking with kratom and take time to just feel it out. Experiment with it to find that right serving size. The serving sizes that are recommended in packaging today rightfully should be cautious. So you need to observe that and then find the right spot. I think that the reassuring thing that is certainly a milestone in our safety journey with kratom is the FDA dose finding study. Because the FDA has demonized kratom to the point where they believed and they told the clinicians who were part of their dose finding study and that's where they take start at 1g and they escalated up until they see a serious adverse event. They predicted that they were going to see serious adverse events at 6 grams.

51:12 Now remember that was 6 grams taken in a 5 minute period. So they literally predicted people would be flopping on the floor and riding into seizures at that level in that short period of time. They blew right past 6 grams. They got to 8, they got to 10, they got the 12 grams consumed in a 5 minute period and they saw a mild, not considered serious in any way, adverse event by both the kratom human subjects and the placebos because you were consuming that plant material in a 5 minute period at 12 grams, it's a lot of material. So they got nauseous and that's when the FDA said, okay, well, the scientists said enough and the FDA agreed. They said that kratom is well tolerated at all dose levels. So I think that's instructive to people that now we have this affirmation from the FDA that kratom is not dangerous. And so you take the responsibly manufactured products and you, you know, obviously feel it out, you're going to be fine and and find what you need it for.

52:05 My wife uses it in order to they have the boost of damaging increase focus. I use it for pain. I don't have problem, at least I don't think I have problem focusing. Some people may think I do but I use it for pain others you know, depending on that experience you're looking for they about 1/3 of the American population according to studies done of consumer behaviors by the University of Florida demonstrates that people use kratom as a replacement for a cup of coffee or for the energy boost and increase focus. Another third, use it for mood boosting and fighting back feelings of depression. And then that third tranche of people at higher doses are using it to manage acute and chronic pain and to deal with opioid addictions. Those, whatever you are on that journey, whatever your need is, then appropriately dose yourself to that point and I think you'll have a very positive experience with kratom. Excellent advice.

52:53 Thank you back so much for spending time with us and sharing your journey with kratom and how we can all get involved as consumers. I appreciate it. And this has been my pleasure. Thank you so much. Thank you for listening. You can get more information at kratomstoriespodcast.com, including show notes from this episode.