Building Government Frameworks for Responsible Kratom Use


Episode 119

Mac Haddow

One of the leading advocates in the kratom industry, Mac Haddow spent years working in US government relations, including acting as Chief of Staff at the US Department of Health and Human Services. Today, he is working tirelessly to protect the rights of kratom users and vendors, traveling throughout the US to promote nationwide adoption of the Kratom Consumer Protection Act. In this episode, Mac and Paul discuss the responsible use of kratom—its benefits, risks, and concerns—and also touch on the topic of corruption within the FDA regulatory and approval process.

Mac Haddow spent much of his career in government and politics, first as the campaign manager for Orrin Hatch, and later as Chief of Staff at the Department of Health and Human Services in the Reagan administration. In that role, he saw firsthand the bias of the FDA towards natural products and dietary supplements. Today, he is Senior Fellow on Public Policy at the American Kratom Association. He is dedicated to keeping kratom available for responsible use, and to fighting the FDA’s disinformation campaign against kratom.

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Podcast Highlights

  • How Mac’s background as a government insider helps with kratom advocacy today.
  • Why the FDA gets in the way of safe, responsible supplement use.
  • What will our rights look like in the future with regard to accessing plant medicine?
  • The centuries-long history of kratom’s safe and effective use.
  • How and why kratom got on the FDA’s radar, and the sneaky way they categorize it.
  • The public’s historic outrage at the government’s approach to kratom.
  • Kratom for energy, addiction, and chronic pain.
  • HHS’s recommendation to rescind scheduling kratom as a Schedule I drug - and how the FDA completely ignored it.
  • The massive disinformation campaign against kratom.
  • Compelling true stories of kratom’s life-changing benefits.
  • Why isn’t the FDA at the forefront of recognizing new science?
  • Do we need the FDA to regulate our supplement use, or can we make our own informed decisions?
  • The true addiction potential of kratom.
  • The importance of sourcing quality, unadulterated kratom.

Podcast Transcript

0:00:00.2 Paul Austin: Hey, listeners. Today, we have Mac Haddow, one of the leading advocates in the Kratom industry. He is currently traveling the country, promoting the Kratom Consumer Protection Act on a state-by-state basis, and he is a tireless and selfless individual who represents one of the leading movements to protect the rights of Kratom users and vendors in the United States.


0:00:20.3 PA: Welcome to The Third Wave Podcast. I'm your host, Paul Austin, here to bring you cutting-edge interviews with leading scientists, entrepreneurs and medical professionals who are exploring how we can integrate psychedelics in an intentional and responsible way for both healing and transformation. It is my honor and privilege to bring you these episodes as you get deeper and deeper into why these medicines are so critical to the future of humanity. So let's go and let's see what we can explore and learn together in this incredibly important time.


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0:02:03.5 PA: And this podcast is sponsored by Mindbloom. Legal psychedelic medicine is here, and it's available through Mindbloom. Mindbloom helps you transform your life with safe, science-backed psychedelic therapy. If you're looking for your depression or anxiety breakthrough, Mindbloom provides a fully-guided and clinician-monitored experience tailored just for you. Some clients see results as soon as 24 hours after their first session. Mindbloom is in fact our first official partner here at Third Wave, and a company, an organization that we support. In fact, I'm going to start my own Mindbloom experience in the coming weeks, and we'll write about my experience, going through Ketamine therapy to address both Cannabis addiction and general anxiety. The Cannabis was to cover up the anxiety, and I can't wait to share my own transformation with you.

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0:05:30.8 PA: Hey, listeners, and welcome back to Third Wave's podcast. We have a pretty interesting podcast for you today. I wouldn't say it's completely off-topic, but it's definitely covering a topic that we haven't spoken about yet, and that's about Kratom. We had sent out an email about a month, maybe six weeks ago about an organization that is working with Kratom, and we received some responses that folks are very concerned about the fact that we had publicly promoted Kratom. And I wanted to ensure that we did this responsibly like we do everything else at The Third Wave in terms of really making sure people understand the nuances around Kratom and what are the benefits, what are the risks, what are the concerns to be aware of. And so we brought on Mac Haddow, who is one of the leading advocates in the Kratom industry. He's currently traveling the country, promoting the Kratom Consumer Protection Act on a state-by-state basis. And his tireless and selfless efforts represent one of the leading movements to protect the rights of Kratom's users and vendors.

0:06:36.3 PA: Now, Mac Haddow's super interesting because he's been involved in government relations since 1986 when he was Chief of Staff at the US Department of Health and Human Services. During his tenure at the Department of Health and Human Services, he served for a year as the Acting Administrator of the Health Finance Administration. And then after leaving, he worked as an independent government relations consultant to a number of clients with interests in legislative and regulatory issues. He attended Brigham Young University with a major in Organizational Communications. And then he joined the first Orrin Hatch for Senate campaign in 1976 where he served as campaign manager. Mac was elected to the Utah House of Representatives from the 25th district that covers the Salt Lake City suburb of Sandy, Utah. He sponsored the repeal of Utah's prevailing wage law that served to artificially increase the cost of tax payer-funded public works projects, and to restrict competition by non-union contractors for state construction contracts. In 1982, after an active involvement in the campaign of Ronald Reagan for the presidency, Mac was offered a position in the Reagan Administration, which led to his appointment as the Chief of Staff at HHS.

0:07:52.2 PA: All of that is to say Mac is incredibly knowledgeable about Kratom and more specifically, Kratom is sort of the sub, the topic, the surface-level topic that we're covering, but what we really got into is, well, was the FDA and sort of how corrupt the FDA is, and what regulatory process the FDA uses. And this dovetails really interesting with the psychedelic space right now because from the get-go, as more and more companies and organizations, both for-profit and non-profit are working to get FDA approval for Psilocybin, I bring up some really interesting questions in this interview around: Well, does it make sense to trust such a corrupt industry to "give" psychedelic medicine FDA approval? Or really, do we need to be focusing on the plants? And our position at Third Wave is we're collaborative with everyone. We think the medicalization, the decriminalization, and the state-by-state legalization of these medicines is critical, but I do personally have to side with Mac on this, and that I think the role that we each play in this is educating ourselves so that we as a consumer, we as someone who are working with these plant medicines can make informed decisions and use them responsibly. And that's what we kept coming back to in this conversation, was responsible use.

0:09:13.0 PA: So Kratom, like other substances, is nuanced. It's helped so many people get off of opioids. It can be a huge factor in minimizing the opiate crisis that we're currently going through. And it's been a medicine that we've been using for thousands of years, thousands of years as it's grown in Southeast Asia. So that's just a little bit of context around today's interview. Without further ado, I bring you Mac Haddow.

0:09:40.0 PA: And welcome back to Third Wave's podcast. I'm here with Mac Haddow to talk all things Kratom today. Mack, thanks so much for joining us for Third Wave's podcast.

0:09:49.2 Mac Haddow: I'm glad to be here with you today.

0:09:51.0 PA: So I'd love for our listeners just to start with a little bit of background on you, how you became involved with Kratom as a public policy fellow, just to give some context, and then we'll get a little bit deeper into what Kratom is, and what's going on currently with the FDA, and all those sorts of good things. So just starting a little bit with your background would be amazing.

0:10:15.6 MH: That's great. I was a college student when a family friend, Senator Orrin Hatch, ran for the United States Senate the first time, and I ended up as his campaign manager because it was... There weren't any other qualified people, and I was the least qualified of those left standing to actually run that campaign. And after I went to work for him, I was introduced into the world of natural products and dietary supplements because he was a personal devotee of using those products. And he became the conscience of the United States Senate when it came to public policy matters relating to natural products, vitamins and dietary supplements.

0:10:53.8 MH: I did, during the Reagan Administration, work as the Chief of Staff at the Department of Health and Human Services. And in that role, I had a lot of interactions with the Food and Drug Administration, and saw firsthand the bias that they have towards any product that is not qualified as a new drug application and goes through that process in order to have access to the marketplace. And after I left the government and started my advocacy career in government relations, I worked with many companies that were in the dietary supplement field, and was engaged in a number of efforts, including the battle that led to the enactment of the Dietary Supplement Health and Education Act in 1994, where the FDA had used the kinds of tactics that they use even today against natural products and demonizing them, claiming that they're killing people, claiming that there's a host of adverse events, when actually, those are largely the result of their failure to regulate those industries to assure that bad actors that adulterate and contaminate the products are removed from the marketplace.

0:12:05.0 MH: The Congress, in 1994, in an unprecedented action, unanimously, and I know that sounds strange to anybody today that looks at the Congress that they could ever agree unanimously on anything, but you had 435 members of the House and 50 members of the Senate or 100 members of the Senate that actually agreed that the FDA should be constrained when it came to the regulation of dietary supplement and vitamin products. But even today, decades later, the FDA would, if they were empowered to do so, would repeal that bill and force all dietary supplements and vitamins through the new drug application process, despite the fact that we have decades of safe use, it's a $53 billion industry today. More than 80% of American families rely on those products to maintain their health and well-being, where they make independent choices, and hopefully, informed choices, about the use of those products. But the FDA hates them, and I think that's true for many of the natural products that are on the marketplace today, that the FDA would like to remove, including Kratom, which is I think the subject of our discussion today. So in the broad spectrum of things in my 40-plus-year career in government relations work, this is an example of the FDA doing what they have done for decades in trying to get in the way of the freedom of consumers to have access to otherwise safe products that are used when they're used responsibly.

0:13:30.0 PA: And before we hop into the Kratom, this is really relevant to our audience. So most of the podcasts and a lot of our information and education is around psychedelic substances. And there's this current medicalization happening of Psilocybin and MDMA and Ketamine for treatment of depression, addiction and things like that. And there's always sort of a constant battle there with the FDA about, "Well, why can't we have Psilocybin mushrooms instead of the synthetic Psilocybin? Or why can't there be something like Ayahuasca instead of just DMT?" And it's sort of a back and forth.

0:14:03.9 PA: And so I think at the surface level, what we're covering is Kratom, but I think what we'll get deeper and deeper into is why is the FDA, and you've already explained some of this, but so against these whole food supplements, these sort of natural substances? And what do we as consumers have sort of... What rights do we have? How might this continue to evolve into the future? But we'll dive into that as it emerges through the conversations. So just to keep things simple and straightforward for our audience at this point in time, I would love if you could just provide a little bit of background about what is Kratom from maybe the ancient history in terms of how it was used in Southeast Asia for thousands of years. How it's been used more recently. And then maybe getting a little bit into what's some of the controversy with the FDA that's occurred over the last few years as it relates to Kratom for certain medical issues.

0:15:02.3 MH: Glad to. Kratom is grown in Southeast Asia, principally because of the climate and the soil conditions there that are ideal. Workers in centuries ago found that by plucking the leaf that grows on the tree, it's part of the coffee family, but it grows on a tree that goes from about 30-60 ft high, they would pluck the leaves and chew on it, and they found that it gave them an energy boost and increased focus. And if you're a laborer working in the fields during the day, that the pain relief that it also provided was very valuable. And so Kratom has been used safely for centuries, except for occasions where people try to mix it with other substances where you get into problems and, on occasion, because it is a botanical product, the leafy product, the potential for contamination of salmonella, E coli, and in some cases, heavy metals, obviously, create potential safety risks for consumers that have to be addressed. But over the entire history of Kratom consumption in Southeast Asia, in some cases, prolonged high-dose use of Kratom, there has not been a death that's been associated solely with the Kratom plant, but rather with the mixtures and adulterants that are added to the plant.

0:16:18.4 MH: So its popularity in the United States actually came about as a result, in the early '70s, after the Vietnam War, as our soldiers were coming home, they had found Kratom to be very useful during the war, where long days out in the jungle, they would chew on that leaf, give them that energy boost, and the analgesic effect, it's small doses, to get them through the day. So that was an interesting thing to have them just want to have it imported to them from friends in Vietnam and other areas in Southeast Asia. And then there was a dramatic surge in immigration of the Hmong population into the United States that occurred about that same time. And you had concentrations of those populations in the Denver area of Minneapolis and they, there were many, several ethnic delis that popped up that would offer Kratom products because it was used in the Hmong population for a number of dietary foods that they used. So it sort of percolated along, and people, by word-of-mouth, would say, "Hey, you ought to try this Kratom. It gives you that same effect as coffee with the increased focus and boost of energy. It might help with a little bit of pain," until about the mid-90s.

0:17:31.8 MH: And then some of the tobacco shops and some of the smoke shop people who obviously are always looking to innovate, and they saw Kratom and said, "Well, if Kratom does this, the one thing it doesn't do is it doesn't give you the euphoric high that you would with a substance that may, in fact, give you a... Hit your pleasure centers." And so they would mix it with things, Kratom with those kinds of substances, and they experimented. And that, of course, got on the radar of the Drug Enforcement Administration and the FDA. And it's a natural evolution of products. It's not one that you should look at in a negative way, unless, of course, there are adverse public health impacts that merit the attention of those agencies.

0:18:16.1 MH: But in 2009, a very significant event happened over in Sweden with respect to Kratom. There was a cluster of nine deaths in a 12-month period attributed to a single product that was purchased on the Internet, and that was called Krypton. And that cluster of deaths in that short period of time legitimately got the attention of every public health official in the world, and it did. There were several European countries that immediately banned it.

0:18:42.1 MH: In the United States, the FDA does not have the authority to ban any product, that is reserved under the Controlled Substances Act for a decision made by the Drug Enforcement Administration in consultation with and reacting to recommendations submitted from the Department of Health and Human Services and collaborating, and that recommendation will collaborate with the FDA and the National Institutes on Drug Abuse. So the FDA decided, "Well, since we can't ban it, we're gonna impose an import alert on all Kratom raw materials." And they have since added another one. So there are two import alerts that the FDA has hoped would stop the growth of Kratom utilization in the United States. And by banning the raw material, they thought they could accomplish that.

0:19:29.2 MH: The problem is that they created an entirely new authority under import alerts in that they were not banning a specific known source in the form of a vendor that was importing into the United States a substance that they, the FDA, believed was dangerous or contaminated or adulterated. They were banning all Kratom raw materials. And there's been examples of where they've done a little bit of that since they've, for example, in Indonesia, they banned all shrimp exports because there was a contamination in the shrimp. And they were able to resolve that by an application from the vendors of the shrimp that was being exported into the United States got together, they cleaned up the problem at the source, and the FDA relinquished that import alert, lifted it, so that it was available.

0:20:19.0 MH: Well, there's no basis to do that with Kratom because the FDA has realized that if they just target contaminants like salmonella or E coli or heavy metals, that someone could petition to get off the import alert. And so they added another layer by saying that the reason that they were imposing this import alert was that Kratom is an unapproved drug. Well, that's an interesting characterization because that's a classification the FDA gave to it, not one that's being sought by anyone, and it goes to the heart of this issue about free speech. Companies are restricted from making claims about products in terms of their therapeutic benefits, unless they have gone through the regulatory channels that are provided under the Food, Drug and Cosmetic Act, either through the, what's now the DSHEA Act Standard for Dietary Supplements, which is they have to apply... A company would have to apply for a new dietary ingredient notification. They have to support that application with good, solid scientific data. And then after 90 days, having submitted that, unless there's an objection raised by the FDA, they are free to market their product. With a new drug application, far more complex, typically, it takes $3-$5 billion of an investment, a lot of human clinical trials, 10 years of review, and then they could get that.

0:21:38.1 MH: So it was a pretty good trick for the FDA to say, "Well, it's an unapproved drug, right?" Now, no one's applied, that I know of, for an NDA for a Kratom. So how could they say it's an unapproved drug and characterize it as a drug when in fact, it's true genetics are as a coffee plant? And the fact that it has some therapeutic benefits, which an individual under the free speech standard; and you have commercial speech, which is restricted as I've described, but then, you have individual speech where an individual can consume a product and they can attest to, on their own, for their own experience, some therapeutic benefit as Kratom consumers have done.

0:22:19.0 MH: So the FDA stretched this definition by characterizing it, but they did it for a very perverse reason. They knew that in order to apply for a scheduling recommendation to place Kratom and its alkaloids on a Schedule I, they had to say that there was no approved medical use. So by calling it an unapproved drug, they actually put it into that category for the purposes of submitting their application for a scheduling recommendation. So they did that, by the way, in 2016. They saw that the import alert wasn't working in terms of stopping people from shipping Kratom into the United States. They then made application and submitted, in collaboration with the National Institutes on Drug Abuse. So NIDA is responsible for assessing the addiction liability of any suspect substance. They looked at Kratom and they said, "Okay, we think that it has an addiction liability," and they signed off on the recommendation that the FDA made. And under the Controlled Substances Act, the FDA then takes the document, it can be one of two ways to do it. One is called a three-factor emergency scheduling request. That's the one that the FDA elected to do in 2016. So it's an abbreviated criteria that's set forth in the Controlled Substances Act in order to take street drugs that pop up out of nowhere very quickly and they wanna shut them down.

0:23:47.3 MH: Well, they shoehorned into that, the FDA did, into that emergency scheduling authority, this claim about Kratom, and one of the criteria is that you have to show a public safety issue. Well, the FDA looked at deaths over a six-year period globally, hardly the criteria for a street drug that they... That particular section was designed to address. But they did it, they said there were 33 deaths that they had associated with Kratom, and they submitted the application. The DEA, when they published the notice on August the 31st of 2016, had no idea what they were about to encounter because using that emergency scheduling authority, there was no public comment period allowed, and there's no judicial review; 30 days later, that baby pops and it's done, right? And they had done that 82 previous times without any incident. But suddenly, on that significant day, on August 31st of 2016, they unleashed a storm of Kratom consumers' views of it.

0:24:50.1 MH: Now, I was called because I've had experience in the area of dietary supplements and drug products, and I was asked by the American Kratom Association if I could help them. And candidly, I told them there was nothing they could do, that the best that they could hope for at the end of that 30-day process would have been to develop an administrative record that would allow for them to challenge the decision by the Drug Enforcement Administration, on a constitutional basis, on the abusive authority under the Administrative Procedures Act. Because the law was clear, there was no comment period, there was no way to stop it once they had filed it. What I didn't know, and what I don't think anyone else clearly understood, was the fact that there were so many Kratom consumers out there who were enraged by the decision that was being made by the DEA at the behest of HHS and NIDA and FDA.

0:25:42.3 MH: And the interesting thing was that this same thing happened back in 1994 when the FDA tried to ban dietary supplements and vitamins. And there were no emails in those days to speak of, and the main way of communicating with Congress was picking up the phone and calling them. In one day, they had more than 300,000 phone calls into the US Capitol switchboard, it literally shut down the switchboard, which prompted them to modernize their system so they wouldn't have that problem in the future. And there were almost a million letters sent in. And that's why it was unanimous vote of the DSHEA Act to say, "We're gonna restrict the FDA's authority to regulate dietary supplements and vitamins."

0:26:19.2 MH: So you fast-forward to August of 2016, and then in that 30-day window, you had 6,000 people who literally called the DEA, their phones were ringing off the hook, and by the DEA's Public Affairs description, they had no idea what Kratom was, they had no idea there was this big interest in Kratom, and consumers were ringing their phones off the hook, demanding that they rescind this application at the We the People platform for petitions at the White House. It gained over 146,000 signatures and of course, that blew everybody away. And then we worked up on the Congress with Matt Salmon, then a Congressman from Arizona, a conservative Republican, led the Republican effort; and Mark Pocan, a Democrat from Wisconsin, led the Democratic effort. And within just a week-and-a-half, we had 51 signatures, 26 Republicans, 25 Democrats, that signed a letter saying to DEA, "Do not ban Kratom. This needs further review. This is not the way to do it. And it was an abuse of the procedures that the FDA and HHS should be following in order to do it."

0:27:25.0 MH: On the Senate side, there were 13 members of the Senate, again, in very compressed time to get these signatures on a letter in order just to convince the DEA to stop. And just to give you a flavor for that one, you had, on one hand, Senator Orrin Hatch, then the Senator from Utah, who arguably, was one of the most conservative members of the US Senate. And you had Bernie Sanders on the other side, where there was no argument, he's one of the most liberal members. So it wasn't, in any way, a partisan issue. This was a philosophical issue where, "Should the FDA have this kind of authority and overlay it to the DEA to restrict the substance that didn't meet the criteria that the Congress had intended under the Controlled Substances Act?" And as I mentioned earlier, the FDA was shoehorning in the criteria in order to make it fit by reclassifying Kratom as an unapproved drug when it wasn't and isn't, and also mischaracterizing the deaths.

0:28:17.0 MH: And to give you an idea, the 33 deaths that they cited, they claimed were all Kratom, the Kratom deaths. It was Kratom alone. And after a little scrutiny was applied to that, they had to amend that characterization and say, "Well, they're Kratom-associated deaths." Well, when you look at the database and you see what the FDA used, it was astounding at how much they stretched that definition. They used the nine deaths in Sweden that I referenced earlier. What the FDA's never disclosed, even though they have a statutory obligation to do so, is that there was a peer-reviewed published article. So it's part of the literature that the FDA is supposed to include in any analysis of Kratom, and that article that was published said that of those nine deaths in Sweden, that all were caused by an adulterant that was added to the Kratom powdered product, O-desmethyltramadol, that was designed to give that Kratom product a boost. It was supposed to give you a greater effect than the natural Kratom would do. And the problem was that the manufacturer who adulterated the product didn't understand that that dose of O-desmethyltramadol, if you were to take enough of the Kratom powder, would kill you. And in fact, that that dose in a cup of coffee in the morning or a glass of orange juice, you'd be dead within minutes.

0:29:32.2 MH: So it wasn't Kratom that killed people; it was O-desmethyltramadol. And we have found since that every single one of the deaths for which there is a autopsy report with a blood toxicology screen, all are the result of either poly-drug use. By the way, not surprising because many Kratom consumers have found that they can successfully use Kratom in order to reduce withdrawal symptoms of opioids and other drugs that they're on, and that you can be free from those opioids or other drugs within a short period, relatively short period of time. So if a person dies in the middle of that transition period because they've overdosed, then having Kratom in your system would not be surprising. But yet, what the FDA did is every time there was an identification in the tox screen of mitragynine, then they'd call it a Kratom-related death.

0:30:21.2 MH: To give you an idea how absurd that was and is today, there was one death that was cited that a young man who had suffered from a lot of mental health issues throughout his life, and in fact, had been released a week before his death where he hung himself from a mental institution. At the time he hung himself, he had a number of illicit drugs in his system. He also had consumed a Kratom product earlier in the day. He hung himself. And he obviously suffered from life-long mental health issues and was abusing other drugs and yet, that was listed by the FDA as a Kratom-caused death. There's no more relationship to the amount of Kratom in that young man's tox screen than anything else. It was ridiculous, but it shows how far they'll stretch.

0:31:05.8 MH: And to give you another example, they had the nine deaths that were obviously listed from Sweden. They had that death I just referenced. They also, as a part of their analysis, did a sweep of literature. They excluded the what's called the Kronstrand report about the nine deaths in Sweden. So that was deliberate. They obviously did not want to acknowledge that there was a contraindication of the deaths. But there's a study that they referenced and still do today, it's called the Domingo Study. And the Domingo Study is a German study that looked at two deaths; one with the highest known concentration of mitragynine in the bloodstream of a decedent known to, at that point, two researchers, with the lowest level, and they wanted to see if there was any relationship in the amount of mitragynine, which is the alkaloid in Kratom that is one of the two that were suspect. They wanted to see if there was a relationship to the deaths. So the headline talked about two deaths in mitragynine. And so I think the FDA just looked at the headline. What the conclusion of the article was, there was no relationship to the lowest level to the highest level to the death of those two individuals from the consumption of Kratom. [chuckle] Makes no sense. And it doesn't even support the thesis that the FDA wanted to make and yet, that's concluded in their report.

0:32:24.0 MH: So and the long and short of all that was after all of that public outcry, for the first time in the history of the Controlled Substances Act where 82 previous emergency scheduling requests were made, the DEA formally withdrew it and they said, "We're gonna open up a formal public comment period. We wanna hear what the public has to say on a formal basis. And we are going to invite the FDA to produce a full eight-factor analysis," which under regular rule-making, is what's needed in order to justify a scheduling. And they gave them a deadline for all of that by December 1st of 2016. There were 23,232 comments submitted; 99.1% of which were positive for Kratom. It included scientific researchers, it included first responders, police personnel, fire personnel who found Kratom to be valuable. It included average consumers. It included a large number of these researchers who are studying all of this. And then of course, as I said, the regular consumers. All of these people were talking about the benefits of Kratom and how it didn't have the attributes that the FDA was associating with the consumption of Kratom.

0:33:36.1 MH: And one of the scientists, of course, pulled back the onion about what the argument that this was somehow an addictive substance. One of the signature characteristics of an addictive substance is that it gives you this euphoric high, reinforcing high. We wanna come back to it. Kratom doesn't do that. Kratom also, even though it hits the same mu-opioid receptor, they call it a binding effect, is what's known as a partial agonist, so it does not travel to your respiratory system. So if you're consuming an opioid, you put yourself at risk for an overdose. The overdose actually suffocates you because it suppresses your respiratory system. Kratom doesn't have any significant activity in that area. So in the same way that the mu-opioid receptor responds to chocolate and cheese and a variety of other consumer products, Kratom has the same effect, binding effect, partial agonist, doesn't go to the respiratory system, and it doesn't give you a high. And suddenly, people started looking at that and saying, "Well then, what's the basis for this? Why, why... Unless it's poly-drug use, where people are mixing Kratom in with this, there's really not a problem with the safety aspect of it." So it undermined what the FDA said.

0:34:46.0 MH: A prominent researcher in this field stepped up and volunteered to the American Kratom Association on a pro bono basis to produce a full eight-factor analysis. It's Dr. Jack Henningfield. He had spent 17 years at NIDA doing this kind of research, so he knew exactly what the components of the eight-factor analysis had to be. He did the full literature search, he provided his analysis of it, and he concluded that like many substances that we have that are consumer... Available to consumers in the United States, Kratom could potentially be scheduled, but it shouldn't be, and he listed why. And one of the biggest things that he... Arguments he made was that people are successfully using Kratom on an individual basis to wean off of more dangerous products. So if they're trying to manage acute and chronic pain, why not let them use something that's less harmful than the substances that are chemically formulated that are favored by the FDA that have all these addiction liabilities and safety issues?

0:35:45.2 MH: So he submitted that a day before it was due to the DEA. The FDA didn't. They didn't submit anything. They just let the deadline go by. And so we thought that we were in a pretty good place. The FDA finally did get together and put their eight-factor analysis together and they submitted it on October the 17th of 2017. So they were about a year late, but they got it in. They expanded the number of deaths to 44. So we immediately foiled all 44 of those deaths. And there was one that they said was a family-reported death. So there was no autopsy, no blood screen, so we don't know what happened there. And so that one is, let me say it, 43 that are left. They gave us 42 of the things. They said that one of the autopsies was restricted by the family, invoking the HIPAA restriction, which is the privacy law that the Federal government allows. So we obviously did not have access to that one. So we analyzed... We had an independent forensic toxicologist and an attorney look at those 42. Her conclusion was that all were poly-drug use or adulterated Kratom products or an underlying medical condition where the person would have died irrespective of what they were taking. Just happened to be while they were taking, they had this medical condition that led to their death. So that undermined completely what the FDA was saying.

0:37:08.0 MH: Dr. Gottlieb, then the FDA Commissioner, [chuckle] he is a vociferous critic of Kratom, then came out in a defensive way knowing that we had done this analysis, and he decided, "Well, I'm gonna call it an opioid." Well, its chemistry is not an opioid. Its pharmacologic action is not an opioid. It's not opioid-like other than if you believe that chocolate and St. John's wort are opioid-like substances, it hits the mu-opioid receptor, it doesn't have the same effects, doesn't have the same euphoric reinforcing high, none of the things that an opioid has. He thought it was important to be able to do that. Excuse me.

0:37:47.5 MH: He thought it was important to do that in order to characterize Kratom as this unapproved drug. He had to reinforce that argument. And they announced this really unique thing, they called it their PHASE system, so they said "This is a novel computer modeling system that we are using with Kratom that the FDA scientists have developed," and it was gonna be that conclusive document which showed the Kratom was this, from a chemical structure, was this opioid-like substance that was gonna be highly addictive. Scientists came out of the woodwork and said, "This is nonsense."

0:38:24.3 MH: If I walked into the FDA and wanted to use this PHASE system to justify any policy decision by the FDA, they would laugh us out of the room. This is just theoretical. It has nothing to do with the real world and doesn't characterize properly Kratom in any way. But they were stretching to find whatever they could. The National Institute on Drug Abuse, which is responsible under the Controlled Substances Act in an agreement with the FDA to identify the addiction liability of the Kratom product, and all of this discussion by these independent scientists led them to go out and contract two independent animal studies on the addiction liability of Kratom, the two alkaloids are mitragynine and 7-hydroxymitragynine. They wanted to know because they had checked the box, signed off and recommended its scheduling. And here you have all this, some respected NIDA-associated scientists saying, "Not true."

0:39:17.2 MH: So they did these animal studies. Those results were concluded about two weeks apart. The first one was the Hemby study, and they came in and said "There is no addiction liability to Kratom, none." And interestingly, in the test animals, they observed that there was a reduction in the cravings for the reference drug, morphine, validating the point that people were reporting that "I can wean off of opioids if I'm using Kratom."

0:39:40.5 MH: And so that was something was dramatic. And then two weeks later, the second study came out, both of these are peer-reviewed published articles today, it's called the use study, and they concluded essentially the same thing. They said there's no significant addiction liability, a little different language, and then observed the same interesting effect that the test animals had a reduction in the cravings for the reference drug. So that led NIDA to do a couple of things. One, they published a revised estimate of the causes of deaths on their website. The FDA freaked out. In fact, they demanded that NIDA take down the re-characterization of the deaths, which all said they were poly drug use, exactly what we said, or adulterated Kratom products or natural causes. So they went through a three-month battle with the FDA, they re-published it in September of 2020, repeating exactly what I've just said.

0:40:28.3 MH: So the FDA was left as the outlier, and NIDA officially withdrew its support for the scheduling of Kratom because they were doing these studies, and in testimony before the House Appropriations Committee in 2019, the Director of NIDA said before the appropriations committee when asked, that she didn't think you should ban Kratom or have it on a scheduled substance list because it would restrict research that was desperately needed because this offered such potential, and certainly, she said, we've heard all these reports, people are successfully using it to wean off of far more dangerous substances in the management of acute and chronic pain.

0:41:09.0 MH: So while all of this is going on, we are vigorously, at the American Kratom Association, trying to get a meeting with the Food and Drug Administration, because we thought that the scientific evidence that we had amassed from independent sources was convincing and compelling enough that they should reconsider their position. They refused to meet with us despite our monthly entreaties to say, "Please let's have a discussion about this." But the Department of Health and Human Services, which under the Controlled Substances Act is the actual conveyor of a scheduling recommendation, agreed to meet. So we met with the Assistant Secretary of Health who is the designated HHS appointee that would make these recommendations. And Dr. Jack Henningfield, the world-renowned scientist on addictive substances, made the presentation, and it was amazing as just a participant, a bystander listening to this.

0:42:02.0 MH: I thought it was great. At the end of the meeting, the scientist, a team from the Assistant Secretary for Health's office said, "That was compelling." That was their word, compelling. They asked for some additional information, which we provided to them within a week. I kept calling them for about six months and asking what the status was, and each time I got this response, "Nothing to report." And I thought that was an interesting characterization, but after six months, we finally said, "Okay, that didn't work. We thought it did, but it didn't." Then about six weeks ago, I received a call from the appointee at the HHS who was a Trump appointee and was leaving the administration because of the change in the administration. And he said, "You know, you really need to look into this because we thought the presentation was not only compelling, it was actionable." He said, "So we withdrew the scheduling recommendation on August the 16th of 2018." I said, "What?" He goes, "Yeah, we sent the letter." He said, "I said in the meeting where the decision was made to transmit this letter, 'Do you want me to let the American Kratom Association know?' and the answer was, from the FDA, 'No, we want to continue to restrict access to that under what's called the regulatory review exemption [unclear speech].'" But he said, "Now I'm leaving," and he said, "You cannot get that letter because it's restricted. But a member of Congress can get it."

0:43:30.1 MH: And so Congressman Pocan from Wisconsin, and Congressman Griffith from Virginia made a bipartisan request of HHS to provide the letter, and the letter is now public. It is damning to the FDA because the Assistant Secretary for Health said that since its application to HHS to then transmit to DEA, new science has emerged, which shows that the criteria that is required under the Controlled Substances Act has not been met. So this new science eclipse the recommendation made by the FDA, and so therefore, it's not actionable. They also listed then the five areas of science that had to be resolved prior to any scheduling recommendation being considered by HHS for transmittal to the DEA. Those scientific criteria are the right ones. We know that the FDA can't meet that threshold. They cannot meet that burden because the sciences currently available is discrediting the FDA's position, and most of it's coming from the National Institute on Drug Abuse. They've now funded over $15 million in studies. The US Congress has authorized clinical trial work, human clinical trial work for Kratom constituents and users, and so the FDA is left in a very hard place at this point.

0:44:50.1 MH: They're not gonna be able to meet that criteria. But the thing that the Assistant Secretary for Health said that was most interesting was he concluded that if we were to ban Kratom, you create a significant public health risk for the millions of Kratom consumers who are using it in order to wean off of these deadly opioids. And he said, "You'll have deaths that will result if we were to ban Kratom," and so they rescinded the scheduling recommendation that was being deliberated on by the DEA, had not yet acted upon, and they certainly hadn't published anything. Well, that is a landmark decision, and that has never happened in the history of the Controlled Substances Act, where HHS has withdrawn a formally transmitted recommendation for scheduling. They did it for the right reasons, by the way. The FDA is wrong on the science, they're wrong on the policy, and yet today, they continue. And the best evidence, this assault and this war on Kratom with their disinformation campaign, the day after, on August the 17th of 2018, after they knew that HHS had withdrawn the recommendation for scheduling, Scott Gottlieb went on a Twitter war against Kratom the next day, repeating all of the nonsense that's in the discredited application for scheduling that was made by the FDA.

0:46:06.3 MH: So how can they be viewed with any credibility if they're not gonna govern their actions by the science? And we see this by the way with other substances. You've seen it with Psilocybin, you see it with other potentially beneficial products. Now, I should tell you that based on what we have learned, there is also a war within the FDA. There are people who get it in the FDA. There are scientists who understand it. And then you have these policy people over on the other side who want to just continue this agenda of hyper-regulation. They wanna ban everything. They wanna have complete total control, and they want to regulate what the American people can have and make the decisions about those kinds of substances, including Kratom, and just make sure that no one has access to them unless they go through the new drug application process. So it's an unfortunate circumstance that we're in today, and yet it's where we are because you have the FDA who continues to spite their having been called out. And when they were asked about by reputable media outlet, "Why didn't you release that letter on the date that it was actually submitted to the DEA from HHS?" and their answer was, "We're under no obligation to release it."

0:47:20.5 MH: That's all they said. Now, is it good public policy? Yes, they should have released it. There is a law called the Information Quality Act that I think contradicts their position. The Information Quality Act says that if an agency of the US government has information that they know will lead to a public policy decision, they are obligated to release it, and you could avoid a bad public policy or support a good one, but they are obligated to release it. And they just willy-nilly say, "Well, we didn't have any obligation to release that letter." They're the ones who submitted it, they publicly acknowledged that they had submitted the scheduling recommendation, and yet when it's receded, suddenly they go mute and say, "We don't have any obligation to talk about that." What they wanted to do was to continue this war against Kratom so that local governments and states would continue to enact bans. There have been six states that were seduced by the FDA's disinformation campaign between 2012 when they enacted the import alert, and 2016 when they submitted their recommendation for scheduling. Those six states banned Kratom and based on the bad information about the deaths.

0:48:30.0 PA: Which states are those, Mac? Do you know those off-hand?

0:48:33.4 MH: It's Arkansas, Alabama, it's Wisconsin, Indiana, Vermont, and Rhode Island. So those states have banned it. Since then, there have been 18 states who proposed bans and we've defeated them by showing the evidence... Now, by the way, we didn't have the letter from HHS, that would have been fabulous to have to show why you shouldn't ban Kratom, but we did it on the science, and we did it for the same reasons that the Assistant Secretary for Health said, "Let's not ban it," because the policy's there. But then we realize that this... We're playing whack-a-mole with the FDA because they're out telling law enforcement agencies, medical examiners and coroners, they're telling public health agencies, boards of pharmacy, "Kratom is dangerous and you've gotta ban it," and they have these multi-level disinformation campaigns going. You read it on WebMD, you read it in the Mayo Clinic site, you read it on MedWatch. They just populate the information about Kratom with all of this disinformation. And so any time a state legislator or a local city commissioner or a county supervisor types in Kratom, you get to see all this Google search results with all this negative campaign that really is just an information loop that's created by the FDA, and then they repeated each other and suddenly it looks like it's real.

0:49:51.7 MH: So we decided at the American Kratom Association, we're gonna go on the offense. So we created what's called the Kratom Consumer Protection Act, and we asked states to consider it. And what that law does essentially says a vendor cannot sell an adulterated Kratom product that contains a substance that's dangerous as defined by the Controlled Substances Act. So if it's a banned substance, you can't mix it. So the adulterant of choice for Kratom today, according to the CDC, is fentanyl, and then morphine is after that, and then heroin, because that gives you that euphoric high right? And so people are spiking it... These are unscrupulous vendors trying to encourage sales, they're spiking Kratom products. You go to the store, you buy a Kratom product, you think it's pure, and you take it and you go, "Wow, that felt really good. That's better than the Kratom I brought over here last week," and suddenly they're hooked on an adulterated Kratom product and it could lead, and does occasionally, lead to deaths. So there's... We have to ban that.

0:50:47.6 MH: And this is critical too, there are adulterations of the Kratom plant where people will artificially synthesize the alkaloids. So we mitragynine, which is the major alkaloid in the Kratom plant that's responsible for the analgesic effect, and then there is another alkaloid, there are 40-some alkaloids total, but the two prominent ones, second one is called 7-hydroxymitragynine. Now, that's a metabolite of the drying process and the body's reaction to it. In the natural plant, it never exceeds 2% of the total fraction of the alkaloid content, and at that level, it's not dangerous. So God made the plant right, but people that go in and chemically synthesize 7-OH and enhance it, it becomes a very dangerous product.

0:51:29.5 MH: So the Kratom Consumer Protection Act says you cannot synthetically enhance the alkaloids of the plant, then it has to be manufactured following good manufacturing practices, which allows for the testing of salmonella, E. Coli, and heavy metals, then it has to be labeled, and then we're appropriate, we allow for the states to impose an age limit, and that's usually 18 years old. All of that works. So Utah, 24 to one in the Utah Senate, a very conservative Republican state, in Georgia, it passed unanimously in the Senate, it was 164 to one in the House. In Arizona, it passed both Houses unanimously. In Nevada, it was unanimous in the Nevada Senate, overwhelming margins. So we got four in 2019. In 2020, we had it being considered in 12 states, had passed in New Hampshire Senate unanimously, had passed the Oklahoma House unanimously, it was 139 to six in the Missouri house.

0:52:22.4 MH: In Wisconsin, a banned state, they opened up a bill filed to repeal the ban and replace it with a KCPA in the Senate Health Committee, and that was a unanimous vote. So we were cooking, and then COVID hit, and everybody shut down. So this year, we have bills in, I think two dozen states right now. We think we're gonna see it pass in Oregon, in Colorado, in Missouri. In Missouri, the vote was unanimous, I think, in the House, and it's over in the Senate now. In Oklahoma, it was unanimous in the House. In Wisconsin, we think they're gonna re-up the bill... Legislates there all year. In Rhode Island, the Director of Public Health has opened up a formal review of the ban, and he's gonna look at the KCPA, and then the bill is filed in both houses there. In Vermont, the bill's filed to repeal the ban and replace it with... Just release the ban. They might consider the KCPA.

0:53:13.9 MH: So we've just seen dramatic impacts around the country with this, and it's the right policy. Now, it's what the FDA should be doing. They refused to do it. That's the sad part of all this. So here we are, back in 2016, when I gave the lousy advice to the KCPA that they were cooked, nothing they could do about it, and they'd be involved in this long protracted legal battle, we actually have secured a safe supply of Kratom products to the American consumers and kept it legal because of this great advocacy, and that's... The reason that has occurred is that when I've gone to literally dozens of legislative hearings around the country and listened to Kratom consumers who give their testimony before state legislatures, and in some cases, local governments, and the stories are unbelievable. People that say, "Here's my circumstance, I was trapped in opioid addiction, or that I... Because of an accident, or because of a drug addiction, or because of a medical condition I'm suffering from, and then someone told me about Kratom," and they tell stories about how Kratom has improved the quality of their life, and in many cases, literally saved their lives.

0:54:24.3 MH: In the state of Utah, when the governor signed the Kratom Consumer Protection Act, he walked in and sat down and he was looking at the bill and he looked up, he said, "What is Kratom?" [chuckle] So it was kind of funny, but we had invited a couple of the citizens who had testified about it just to be there for the photo op, and this woman stepped up and said, "Well, Governor, let me tell you." And she opened up this little canister that she had in her purse of Kratom powder, she said, "This has saved my life." She said "I had a very rare brain condition. I've been through three operations," one of which was to insert an electrical stimulator in the brain in attempt to control the pain that she was suffering from. She said "I was totally debilitated. I couldn't work, I lost my job, I couldn't function as a wife or a mother for my family." She goes, "I just spent all day in bed." And she said, "And I suffered from this horrendous pain all the time, and it got to the point where I can only take opioids that would allow me to function for about eight hours a day. So I either had to choose to sleep or to be awake during those times. I was just in an impossible situation." She said, "And then a friend of mine called me and said, 'Have you tried this stuff called Kratom?'" And what she said next was just astounding.

0:55:37.4 MH: She said, "The first time I took it, I felt immediate relief." She was saying, "And I have not," except for rare occasions when she has a flare, "relied on any opioid." She goes, "It doesn't take my pain away completely, but it's restored my life." She goes, "I can now work, I'm a mother to my children, I function in a family." That's an incredible story, and that's the typical of what we hear of a person who takes a natural product that the FDA hates, and yet is able to restore the quality of her life in so many ways. And we had a veteran who said because of service-related injuries that he had become, in his...

0:56:18.0 MH: By his description, he said, "I felt like an addict." He said, "I went from one VA, a doctor to another who kept prescribing more and more opioids to try to control his pain," he goes, "Then I found Kratom," he said, "and it helped to get me off of those opioids and I could manage pain." He said, "Before, I couldn't even walk," he said, "suddenly I was jogging and pretty soon," he said, "I become a runner again." And we produced some ads by the way that was shown nationally that tell these stories, and they're incredible, but they're representative of thousands of people that have testified about this. And I'll conclude this with, and then open it for discussion, Johns Hopkins University did a study on adult Kratom users, and this goes to I think the heart of what the FDA's complaint is. They looked at people that were using Kratom to manage acute and chronic pain that were having opioid, using opioids, and what they found was that more than 87% reported that Kratom helped them to reduce their withdrawal symptoms as they tried to get off of opioids, and that 35% were opioid-free within a year of using Kratom.

0:57:22.4 MH: Now, with that kind of data, there is no justification, none, that the government should be interfering with the right of people to use a safe product, because none of the deaths that the FDA claims were actually valid. And by the way, I forgot to tell you the best story about the FDA, the one that I told you that was restricted by HIPAA privacy restriction? A reporter from Huffington Post was doing a story, he had worked on Kratom issues too, he was doing a completely unrelated story at the FDA and he ran across that autopsy, when they gave us the autopsy, it was completely redacted, all you saw was the case number at the top, 14 pages of redacted material. He said, "I got the autopsy." He said, "It's on another database. There's no HIPAA restriction on it. They just didn't wanna give it to you."

0:58:07.3 MH: I said, "Why?" And he said, "Well, wait... " He said, "I'm writing a story about it first," he said, "but then I'll give you the autopsy." The cause of death were two gunshot wounds to the torso of the deceased. He had in his blood stream, illegal drugs and had consumed the Kratom product earlier in the day. The autopsy revealed that those two gun shots, and the story behind that were this young man was involved in selling Marijuana, the police had organized a drug sting, they surrounded the car while this transaction was taking place, demanded that the individuals get out of the car, they refused, there was, according to the police, a report that someone said they were getting a gun, they opened fire, and this young man would die as a result of the gunshot wounds from the police. Had nothing to do with Kratom, nothing, and yet that's listed today as one of their 44 deaths. And they didn't wanna release that autopsy because they knew how absurd it would be, the claim that they were saying it was a Kratom death when in fact, the kid died of the gunshot wounds in a firefight with the police."

0:59:04.0 MH: This just shows you how little credibility the FDA has left on these issues, and I think it carries over. It's not just Kratom, it's they're broad-based attack on any natural product, and we know that there are other natural substances that people have, and scientists have said, "This needs to be looked at in the proper context and not in this anti mode that the FDA is in against anything that isn't a new drug application product." And I think that's the essence of the issue that we're facing here today with Kratom and other substances like it.

0:59:40.8 PA: Well, and there's a lot of threads there, thank you. Wow. That was phenomenal. It's like encyclopedic, your knowledge about this, and how... And I was just riveted the whole entire time because I've done Kratom a few times myself, I have friends who have used it, not so much to get off opioids, but instead of alcohol, to minimize alcohol use, to be drinking less alcohol, people will use Kratom instead. And there is a lot of misinformation. When you made the point about how, when you search for Kratom, it's just like the disinformation that is cycling through Google, when we started... I started Third Wave as a psychedelic platform about six years ago for the same reason, because I noticed when I typed in Psilocybin mushrooms or Ayahuasca, it was a cycle of disinformation at the top that was just reiterating things that weren't true.

1:00:36.3 PA: And so the couple of threads that I thought of us as you were going through this, one was specific to Psilocybin mushrooms, which I mentioned at the beginning, there's this really interesting dynamic happening in the psychedelic space where you have researchers at Johns Hopkins that are doing pioneering research on Psilocybin, as well as NYU and a few other places that are adamant that we need to get FDA approval in order to sort of validate the use of Psilocybin, and you have, I would say more of the activist types, people who are de-criminalizing Psilocybin in Denver and Oakland who are saying, "No, we don't. We have the research, we've had the research that shows this is anti-addictive, we've had the research for 50 years that shows this is effective. This is simply because the FDA is corrupt."

1:01:27.9 PA: And so you get a lot of folks who are like, "Why would we trust a group like the FDA... " As you said, there are some good folks in there in terms of the scientists, but the admin side of things is so sort of perverse in terms of how it makes these decisions that a lot of folks are very skeptical of, "Well, why are we trying to get Psilocybin approved by the FDA based on their historical track record of how they've approached everything before?" And so it just sort of brings that up again. And obviously the considerations are different. Psilocybin mushrooms, if you eat three or four or five grams, you can have a very significant experience, there can be a lot of risks involved. With Kratom, it's a little bit different 'cause people are taking lower amounts. And that's something that I just wanted to clarify with you. Is it possible to overdose on Kratom, or is...

1:02:22.3 PA: What's sort of the situation there in terms of how people are using it, how much they're usually taking, how often they're doing it, what's... From a consumer level, how are people actually approaching working with this plant and this medicine?

1:02:36.8 MH: So thanks for asking that question 'cause it's an important one. What we don't know right now is what is the level at which Kratom can become dangerous and potentially fatal. And the reason we don't know is that we haven't found anyone who has hit that level yet, that is a Kratom-only death. Nobody should say that Kratom is 100% safe. We know that there are consumer products on the shelves today that are in the same category as Kratom, that you shouldn't overuse them. So you should use them responsibly. What we do know about Kratom is that it has a ceiling effect. So no matter how much you take, you can't hurt yourself, you will vomit before you can take enough to hurt yourself. I'm talking pure Kratom here. If it's a product that has been chemically formulated or is adulterated, it's a problem.

1:03:31.6 MH: Dr. Chris McCurdy, who is the scientist out of the University of Florida, who is sort of the godfather of all Kratom research, characterized it in an interesting analogy. He said, "It's like a governor you put on a gas engine, no matter how hard you press the pedal to the metal, you're not gonna have any greater effect and you won't go any faster with Kratom because it has a ceiling effect, so no matter how much you take." Now that... There's always the outlier. We know, for example, there's a... Senator Curt Bramble of Utah, who was the sponsor of the Kratom Consumer Protection Act, talked about how a constituent in his district had accidentally overdosed their daughter, forcing her to drink water as a punishment for her refusing to do something, and it upset the chemical balance of the electrolytes in her system and she died. So she literally died of an overdose of water. And people say water is a completely safe thing. Well, it depends on how it's done, right? Same too, I think with substances like Kratom, so we should be careful, and argue for responsible use.

1:04:34.6 MH: Now, Dr. Jack Henningfield, who I referenced earlier, did a study on the risks of an overdose of opioids versus Kratom, and based on his research, peer-reviewed published article, he said that, "You are at a thousand times or greater risk of overdosing on a opioid drug than you are of Kratom." So I think that the safety risk is well within the tolerance levels. There have been the animal studies conducted that show that at consumption levels 40 times what the average human could consume in a day and you have no deaths from Kratom.

1:05:11.2 MH: There's another study that's... I'm told that it's completing, it's gonna show even a more dramatic number in terms of the daily dose. So we're not as concerned about the amount of Kratom that you consume. We know that it has that ceiling effect, as Dr. McCurdy referenced. What we're concerned about is the adulterated products, the extracts that may have more power. We need to study those. We think they're safe in terms... In many ways, more safe because they standardize the dose, but then we need to say, "What is the dose in a extract product?" And I think that's pretty important. Dr. McCurdy also made the point, and he's great with these analogies, he said that, "If you were to take the alkaloids from Kratom and someone makes a big deal about how 7-hydroxymitragynine, that alkaloid that occurs at a very low level in the plant, less than 2% of the total fraction of alkaloids, if you were to take that and evaluate it chemically, it is a very dangerous substance.

1:06:10.4 MH: So if you escalate the 7-OH outside of the balance that occurs in a natural plant, you have a dangerous product." And he described it as saying, "It's like an orchestra. If you listen to the orchestra in some of these famous numbers that are done, and you were to take one instrument and extract it from the orchestra, and then amplify it at the maximum volume, which it would never be in the orchestra's playbook," he said, "Then you could make that case that it's dangerous, but it's silliness to do that, because that's not the way the orchestra works and that's not the way the Kratom plant works."

1:06:42.6 MH: So I think that when we look at this issue about, "Is it safe? Is it 100% safe?", no, you have to use it responsibly. Can you overdose on it? We don't know yet, but that's the key point. We don't know. So no one should be out there indiscriminately thinking, "Oh, I'm 100% safe using Kratom." You should use it responsibly. And that's why we advocate for, on the labeling instructions of a Kratom product, that they have a recommended serving size that they consume on a daily basis. And I think that's important. And we know that at low doses of Kratom, that you have the stimulant effect, it increases your focus. At very high doses, it has a sedative effect, and a sedative effect can have its own safety risk if you're operating a motor vehicle, if you're engaged in some dangerous activity that requires you to be acutely aware of what's going on, then you should follow that.

1:07:33.1 MH: So we tell people, don't take these absolutes. Don't think that Kratom is 100% safe. Don't think you can't overdose on Kratom. Use it responsibly. And just as we do other consumer products, caffeine is a good example, we know that caffeine is safe when used responsibly, but when you concentrate caffeine into a tablet and ingest it, it will kill you. And that's why the FDA has banned concentrated caffeine tablets. We think the same is true with Kratom. If they wanna ban concentrated Kratom products where they have high levels of 7-OH, ban them, but don't ban Kratom just because someone might do that. And I think that's the key point.

1:08:12.3 PA: And it speaks to a point you made earlier, which is these sort of God-given plants naturally have a sort of mechanism built in so that you can't necessarily overdose, you can't necessarily take too much, 'cause the same thing is true with Psilocybin mushrooms, if you try to eat, and there are a couple of folks who have done this, 20 to 30 grams of dried Psilocybin mushrooms, the average dose is about two grams, you'll vomit, your body has a natural sort of reaction to self-regulate. And I think that's also a philosophical part of what you're talking about is how do we empower the individual consumer, how do we empower each people to be able to make educated decisions so that they don't feel like their freedoms are restricted by certain government institutions that have perverse incentives, or that are fairly corrupt? And I think what you're speaking to, particularly around the Consumer Protection Act that you know had passed in several states and you were instrumental in developing, is key in that because it speaks to what we as sort of communities can do to watch out for one another. We don't necessarily need a big government to tell us what we can and cannot do, we can actually take the initiative to ensure that those who are using these substances, like you said, do so responsibly, understand the benefits and risks.

1:09:35.3 PA: A lot of things that people don't know is what you had mentioned, which at low doses, it helps to focus, at high doses, it's a sedative. So just that nuance is part of what I'm calling like literacy for just general drug education. We've just been told these drugs are legal, and initially it was caffeine, tobacco, alcohol, all these other drugs are illegal or bad, and don't worry about why they're illegal or bad, they'll harm you, and that's it. And I think what we're getting to now, especially with Cannabis and Kratom and psychedelics is, well, let's look at the pros and cons because even the substances that are legal, tobacco and alcohol and caffeine, there can often be a greater risk profile, not only for addiction, but for potential death for how it impacts the liver in the case of alcohol and other sort of bodily systems, so that nuance is really, really key, and I'm so glad that you brought that up.

1:10:29.9 MH: Well, and I think the disappointing thing is that the FDA knows a couple of things; one, they know that most of the chemical formulations of drugs come from plants, and the observation of the effects those plants have, and to discount that by saying, "Oh, everything has to be then converted into a chemical formulation of what those plants are because it's more standardized," is hardly good public policy, and yet they're wed to that, and I think that that's very disappointing. And I think the other thing that is critically important is the FDA wants to play the arbiter of these kinds of decisions that consumers make without any good science. The Assistant Secretary for Health made it clear in his letter that withdrew the scheduling recommendation for Kratom.

1:11:12.0 MH: He talked about the emerging science that had taken the FDA's position and said it wasn't credible anymore. The FDA doesn't update itself. It doesn't want to recognize new science and the lag time and the recognition is key. They should be at the forefront of recognizing good science, and yet when it doesn't fit their narrative, and it goes back to what they don't like, and they should not have the authority nor the power to restrict access of consumers, or the freedom they have to use products for their health and well-being because they don't like that product, or they may even...

1:11:47.2 MH: This is a perverse thing, but many have suggested to me that the problem is that the FDA, since the PDUFA, which is the Prescription Drug User Fee Act, which accommodated the demand within the pharmaceutical industry to speed up reviews, which the FDA said were caused by lack of resources, the pharmaceutical industry pays user fees with the understanding that they'll get a yes or no within a certain time period, a reasonable time period, rather than waiting for years because the FDA didn't have the personnel or the equipment to evaluate it. So they got all that equipment, right? Within a couple of years, it was about 9% of the total budget of the FDA in the CDER, which is the drug review division, today it's over 66%. So if you're looking at a profit center, the FDA has this inherent bias that they don't wanna deal with or approve or regulate substances for which there's not a user fee that's associated, which gives them money, and the Congress hasn't been willing to fund or hasn't been able to fund the kinds of resources they really needed.

1:12:49.1 MH: So even that you would think there would be internally a recognition of the conflict that they should be aware of and sensitive to, and yet then they just blow by it and say, "Oh well, that doesn't affect us." Well, yes, it does, because why are you out doing these things that don't make good public health sense? And to me, the thing that should guide them is harm reduction. If you know that you have a crisis in an opioid overdose death count, and it is this... Without COVID, it would be the number one health crisis in America today, and it's certainly the second right now.

1:13:22.5 MH: Why wouldn't we do everything in our power? And this is what the National Institute on Drug Abuse Director Nora Volkow said, "We should be about harm reduction, and we should allow people the freedom to do this, particularly when they're getting off of these, what are known deadly addictions." So it makes no sense. It makes no sense that the FDA thinks that they can play god in this case, and there's a readily available alternative that just requires them to regulate it properly rather than ban it. But they go right to the ban, and that's what they do with Kratom, they're doing it with Psilocybin, I think they're attempting to do it with many other substances that are naturally derived in the plant community, and they just don't want anyone to have access to those products because they think they can regulate you and us better than we can ourselves, and that's just nonsense.

1:14:13.0 PA: Total nonsense. Well, this is super informative. And I thought Kratom was addictive even coming into this conversation, so I'm just personally grateful that we had a chance to go into all these details. We've had a partnership with Kraken Kratom, which is how we were introduced, because the founder and CEO was able to connect us to have this conversation. And we even, about a month ago, sent out an email just amplifying the fact that this is a substance that is legal, that this is available. And even within our community, we had a number of people reach back out and say, "Don't you know how addictive Kratom is? Don't you know how dangerous it can potentially be?" And I didn't know which way to respond either, 'cause I'm somewhat informed but not super informed, so just to have your knowledge and your expertise, and obviously this is a huge sort of fight, an uphill battle, like education generally is, but it's just... It's been really illuminating to learn a lot more about the specifics around Kratom and... Like I told you I'm a big history buff, so to learn about the context and the background and the names and the dates, all of this is... It's a big eye opener. So I just appreciate you coming on Mac, and sharing all your wisdom and expertise and knowledge of this. It's been amazing.

1:15:32.2 MH: Well, let me say one thing that really is important, and that is this issue about addiction. Even though the animal studies show that there is not a significant addiction liability, that is a specific criteria under the Controlled Substances Act for which there is a standard to determine that. I'm not suggesting that you cannot become dependent on or even addicted to Kratom, you can, because it is a... In some cases, it's a psychological dependence, in some cases, physiological. The good news about Kratom is that we know that it doesn't lead to overdose in the classic sense as opioids do, but there can be very negative consequences to an addiction or a dependence on any substance, and it can lead to lots of detrimental things. It can disrupt people's lives and family life, and it can really be a problem. And so we need to be aware of that. And I know that there are many substance addiction centers now that are reporting that they're seeing more people present with Kratom addictions or dependences, and we get that, and I don't doubt that it happens. Now, the first test of that is, are they taking a pure Kratom product?

1:16:39.1 MH: Because if they're coming in with addiction that presents as a euphoric high, that's an adulterated Kratom product and they really need to look at the source of that. If the dependence is psychological or even physically dependent, the greatest news about that is that weaning off of that occurs within about a week. That's not the profile of an addiction to a drug that hits the mu-opioid receptor that has that euphoric high that creates that emotional and psychological dependence. And so it's a much more complicated withdrawal program to apply, what the substance addiction centers wanna do, which is to treat a Kratom dependence or addiction as they do classic opioids. That's a mistake because they're replacing, in many cases, another drug that is less addictive than the opioid in this case. Well, with Kratom, they don't have to do that, but yet, that's the model that the FDA and the SAMHSA, the HHS Agency has promoted using FDA-approved drugs to wean you off of a dangerous drug so it's less dangerous.

1:17:43.5 MH: With Kratom, you don't have that problem. Let people wean off... Dr. Grundman from the University of Florida said that, in testimony before the Arizona Board of Pharmacy, said that a typical Kratom addiction or dependence is solved within a week by people that... They'll suffer a headache, upset stomach, and maybe a runny nose, which is very similar to caffeine, again, not surprising, because that is a coffee plant in terms of its genetics. So that's what the way you should approach it and deal with it. People can present with addictions and dependence, but technically under the Controlled Substance Act, that doesn't meet the scientific criteria, but it's still real in people's lives, so we should be aware of it. And that's why we encourage response we use, and make sure that people are aware that, like anything, they have to be very careful in the way that they deal with these issues.

1:18:33.0 PA: So just as a final step for folks who wanna learn more about Kratom and everything that we got today, what are just some good websites, some good resources that they can go to and check out just to maybe find some of these scientific papers that you had mentioned and anything else that you think would be relevant?

1:18:47.8 MH: Well, of course, we recommend the american Kratom association. That has all the scientific papers up, and it goes to all of these arguments, lots of good resources there. There is a forum of the AKA that allows people to exchange information. I recommend in some cases, the Reddit forum, because I think there's good information that's... You have to dig sometimes because that's sort of the Wild West, but there's some great commentary on that, and I think that's worth looking at. And I think that then looking at responsible sources on the internet, carefully resourcing them, I think that's useful too. So I think that's the key here is that we have people that are informed, and they understand exactly what Kratom is, and they understand what responsible use profiles look like. And then most importantly, they know where they can get good quality Kratom products. We have a program at AKA where we ask vendors, and we represent consumers, so we're not a vendor organization, we ask vendors to voluntarily comply with independent third-party audits to validate their compliance with GMP regulations and not adulterating or in any way contaminating their products, and they test for it. And so consumers can go and look at those participants in the GMP program, we call it, and we ask people to buy from those vendors 'cause they've committed and they've gone to the expense of developing compliant programs to meet FDA protocols for food products.

1:20:18.2 MH: We ask people to stay away from any vendor that says, "Oh, this will get you off opioids, this is gonna help you deal with arthritis," or any other therapeutic condition, because those are infamous wild claims, probably adulterated because they won't have the effects. Kratom in its natural form doesn't have the big boost that they claim these products have. So we encourage consumers to stay away from those products. But in the end, the FDA's wrong, wrong on the science, wrong, wrong on the policy. Consumers have to be responsible, and that's what we encourage.

1:20:49.9 PA: Beautiful. Well, again, I just wanna thank you, Mac, for coming on the podcast today, for sharing everything with us, it's been a real pleasure to have you for this past hour and a quarter, so much, much appreciated.

1:21:01.3 MH: Thanks for the opportunity, I appreciate it very much.

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