An Herbal Supplement for Pain (Kratom) That the Government Want’s To Make Illegal- Interview with Mac Haddow

Intro: 0:02

Get ready to hear the truth, the whole truth, and nothing but the truth about the United States healthcare system with your host of the medical truth podcast, James Egidio.

James Egidio: 0:20

Hi, I’m James Egidio Your host of the medical truth podcast, the podcast that tells the truth. The whole truth and nothing but the truth about the American healthcare system. The number of drug overdose deaths involving prescription opioids in 2021 was nearly five times the number in 1999. In 2021 45 people died each day from a prescription opioid overdose. Totaling 17,000 deaths. That does not include well over a hundred thousand deaths. In 2021 from heroin and fentanyl pouring into the United States due to open borders from the south of Mexico. My guest has been involved in government relations activities since 1986 when he left as chief of staff at the U S department of health. And human services to go to the private sector. Today he is a lobbyist and advocate in Washington, DC. Where, he is fighting hard to keep the natural herbal supplement, Kratom them legal and accessible for consumers and patients who are suffering from chronic pain and addiction to opiates. It is an honor and a pleasure to have on the medical truth podcast. My guest, Mr. Mack Haddow. Mac, how are you doing today? Welcome to the medical truth podcast. Appreciate it. For the listeners and viewers of the medical truth podcast, just share a little bit about who you are and what you do.

Mac Haddow: 1:47

So my name is Mac Haddow. I’m the senior fellow on public policy with the American Kratom Association. And we’re a consumer advocacy organization that fights to make sure that quality and manufactured products are allowed to be on the marketplace without undue restrictions.

James Egidio: 2:04

Nice. So I know it’s specifically for Kratom and for the listeners and viewers, cause we’re as consumers of, let’s say, nutritional supplement products. A lot of people are. inundated with so many different products. what is kratom?

Mac Haddow: 2:22

So kratom is a plant that grows in Southeast Asia ubiquitously because of climate and soil conditions. It has recently been introduced into the United States. It’s grown in some parts of Florida and in Hawaii. The majority of the Kratom originates in Indonesia and in Thailand, about 97 percent of the raw materials that are used in the production of Kraatom products originates there. It is a plant that has for centuries has been had some medicinal effects. People recognize that when they are working out in the fields, they chew on a Kratom leaf and it gives them an energy boost and increased focus. Traditionally, people will brew it into a tea. and they’ll drink it. It has a bitter taste. And so you have to acquire the taste. That’s principally one of limitations on why kids don’t like it because it doesn’t taste great. And it also has some, it hits the same Mu opioid receptors in the brain as do opioids, for example. But it’s what’s called a partial agonist, which means that it doesn’t have the same effects nor as powerful in effect, just hits the same receptor and hear lots of critics, including the FDA, will say, oh, it hits the same Mu opioid receptor. The truth is, and they know it, that things like cheese hit the same Mu opioid receptors and a ton of other products but gets up. its effects by going to the sector of the brain that helps with analgesia, with pain relief. It also helps with symptoms of depression. It boosts your mood a little bit. And so those are things that make it very attractive. And at high doses, people are finding it to be an effective option for managing acute and chronic pain and for some that are struggling with opioid addictions. They report that it helped them with withdrawing from the opioids and replacing with kratom. There’s a study done by Johns Hopkins University that documented that. So there’s a, it’s one of the medicinal plants that has great, powerful benefits. And traditionally, as we’ve seen in the dietary supplement and botanical supplement industry in the United States, The FDA hates it. They want to have a control of it. They want to ban it. They want to make sure that the only access people have is through a prescription medication. And of course, that’s not the way nature intended it. It’s not the way that we ought to regulate these kinds of products. But nonetheless, the FDA maintains its very strong anti kratom position to this day.

James Egidio: 4:38

Yeah, and you mentioned some of the benefits and I know I had pulled up a infographic on the use of Kratom and we’re looking at some of these here. As you had mentioned that the, there are a lot of benefits for pain and for opiate use. So what you’re saying in essence is that it’s got almost like a dual effect of the pain to ward off some of the pain or pain, chronic pain, as well as Being used maybe as a substitute for patients that are addicted to opiates or people that are addicted to opiates,

Mac Haddow: 5:13

correct? That’s correct. And this particular survey of adult kratom users was done by Johns Hopkins University. It has great data that supports the notion for those who are experiencing these addictions to very dangerous, highly addictive and potentially deadly opioids that 84 percent I’m sorry, the 87 percent reported that they got relief from withdrawal symptoms, which is the hardest part. of getting off of an opioid that you’re addicted to, and 35 percent reported they were free from the opioids within a year, replacing with kratom. Now that’s important because the National Institutes on Drug Abuse, which is one of the leading research organizations in the U. S. government, is a strong proponent Of Kratom as a potential harm reduction tool and they maintain that Kratom should be available to people that are struggling with these addictions. And again, it’s about the dose, the amount of serving size you take of Kratom you probably have to take more in order to achieve this particular result. Most people use it in much lower serving sizes for that energy boost. They pick me up in the morning for the staving off feelings of anxiety at a little higher dose and that and feelings of depression. So it is really a wonderful plant that if it’s properly manufactured and labeled appropriately, really does help people. Yeah,

James Egidio: 6:32

it’s interesting as you’re saying this, I’m thinking to myself why would the FDA? Get themselves involved with wanting to regulate a natural herbal supplement such as kratom when and especially for pain or to help people get off of opiates when we have, uh, an issue with prescription medications, fentanyl and, heroin that’s coming across our open borders.

Mac Haddow: 7:02

Yeah, there are two answers to that question. First is it’s the 64,000 question that NIDA asks in the midst of this crisis we have in America with overdose deaths that topped 107, 000 last year. If there’s a harm reduction tool available, why wouldn’t we encourage its use rather than trying to ban it? But the second of the answers is the one that is probably more appropriate to discussing why the FDA takes this position. The FDA has been an opponent of dietary and botanical supplements for decades. We all remember back in the early nineties, leading up to the passage of what was known as the Dietary Supplement Health and Education Act, the FDA was trying to ban all dietary supplements and vitamins on the premise that there were products that were poorly formulated in the dietary supplement space that were causing adverse events and in some cases deaths. They were right. But the solution wasn’t to ban it. It is to properly regulate it. Make sure that those products are meeting good manufacturing standards, that they’re formulated with safe ingredients and not being adulterated in order to spike the effects of a product with dangerous substances. That’s the solution. But the FDA always goes to the position that they want to regulate it as new drugs. And if that were true, If the FDA had gotten their way back in 1994, when instead the Congress passed the DeShay Act, they would have banned all these dietary supplements that are today over a 100 billion industry. And more than 80 percent of the American people use dietary supplements and botanical supplements for their health and wellbeing. The FDA just has their heads in the sand. They, this isn’t a battle against kratom. This is a battle that they have sustained over four decades fighting all botanical and dietary supplements. Because they just don’t like them and they would rather they were regulated as new drugs.

James Egidio: 8:51

Yeah, and it sounds like they want to get to a point where they control it and corner the market in addition to, let’s say, the opiate market that they already control. So it sounds like it’s just, it sounds like it’s more about control, power and money that’s involved then the wellbeing of the person that’s using it responsibly, because it seems like anything you can go overboard with. You can drink too much coffee. You can eat too much. If you had to put a label on fast food McDonald’s, you’d have to ban it, for health reasons.

Mac Haddow: 9:25

exactly right. And it’s interesting, James you bring up a great point because right now this penchant that the FDA has, in order to put everything into that bucket of being a prescription medication and requiring them to go through that five to$10 billion. exercise to prove the safety and efficacy of these kind of products is a huge lift. And most dietary supplement and botanical supplement companies wouldn’t be in the business. They just are hell bent that they’re going to make sure that they control this particular space. And they don’t. And it was interesting. I had a conversation with an FDA official. They won’t meet with me here in the United States, but I was actually at the U.N.. Commission on Narcotic Drugs in Vienna, Austria, and had the opportunity to meet in an off the record discussion with an FDA official who told me that most of the people at the FDA that are comprised of the scientific group that, that really govern policy, understand that kratom is probably a benign, no big deal, but what they don’t like is that people are sitting at home self medicating themselves with kratom when they think that person for whatever the reason that person self medicate themselves should be going to a doctor. Now that’s an interesting discussion, but it strips people of their freedom. It strips people of their right to make the kinds of decisions about their health and wellbeing and who gave the FDA the power to make that kind of decision as opposed to simply regulating products that are presented into the marketplace to evaluate. based on their safety and efficacy. But we know the FDA is not interested in that because there is a pathway for what the botanical supplement pathway that was passed by the Congress. And it’s been in effect for about 18 years right now. During that time period, 800 botanical supplement products have been submitted for review by the FDA. 500 of them were able to get an institution drug application review. So the protocols for the study to demonstrate their safety. were met in that 15 or 18 year period of 800 applications, 500 with a qualified protocol for the study. to have been approved. That demonstrates the bias that the FDA has. And it’s time for Congress to rein in the FDA in this area, just as they did in 1994 when they passed the Dietary Supplement Health and Education Act, when they told the FDA, you can’t play this game with dietary supplements, you have to regulate them appropriately. And we’re hopeful that the now federally filed Kratom Consumer Protection Act will put those parameters on the FDA and require them to do the job that they were intended to do. But I’ll tell you right now, when you hear the reports that people say, Oh Kratom caused the death of a loved one or Kratom caused this adverse event. In every case that we’ve been able to identify, it’s always been because it is an adulterated product or because of poly drug use. And Kratom was not the culprit in this situation, but the FDA refuses to do their job, refuses to do their job to make sure that happens. And so you see the string of lawsuits. that are filed by trial attorneys, which make Kratom the culprit. You don’t see them filing lawsuits against the FDA for their failure to regulate products. You see them saying, Oh, we’re gonna go after the creative manufacturers because that’s where the deep pocket is. That’s a complete A wrongful action by these trial attorneys, but it’s facilitated by the lack of FDA regulation that they should be involved

James Egidio: 12:49

in. And meanwhile, they’re running amuck releasing this bio weapon that they call a vaccine and using everybody under what I call experimental use authorization instead. Emergency use authorization and people are dying left and right and being injured and not doing a thing about it. The attorneys are not doing a thing about it. So it seems like to me, the whole system is rigged with this whole thing is what it seems like.

Mac Haddow: 13:13

It certainly is. And in the case of the trial attorneys, a great example is that there was a florida case where a woman ingested a Kratom product that was marketed calling. It was called space dust. It was marketed as a super potent extract. Of Kratom products the judge awarded this family 11 and a half million dollars. Now, part of the reason he did so is that the manufacturer of that product didn’t show up in order to defend themselves. So we don’t have a record that shows us what the autopsy report showed, or the tox screen. We’d love to see that because that would be illuminate as to what the actual product contained. We don’t know if there was an adulterant in the creative product, or we don’t know if there was an underlying health condition that contributed to that death. But what we do know is that the FDA refused to regulate a product that they knew had been on the market for a year called space dust. It came in a plastic pouch where someone wrote with a sharpie space dust. And when you flip it over where you would expect to see directions for use labeling that showed exactly how it was manufactured and what the contents of the product were. It’s blank. How could that product have been allowed to be on the marketplace in the first place? It was, but the trial attorneys aren’t suing the FDA for their malfeasance. They’re suing, they sued the company that did. Now certainly, that company shouldn’t have been allowed to market that product on the market, but the FDA should have done their job a year before and taken it off the market.

James Egidio: 14:41

Yeah, and that’s what’s I’m showing right there on the screen in that particular article where they mentioned that was an NPR article that just broke, right? Yeah. And so I think it seems to me too, that it’s a product that’s Effective for what it is as an herbal supplement. I see it they, I know they advertise it and they market it in a lot of these smoke shops. And it just seems like that maybe that’s something that needs to be changed as far as the actual reputation of the product or the marketing of the product. Cause it’s sold amongst. In a lot of smoke shops, I notice.

Mac Haddow: 15:29

Yeah. So there’s two reasons why that’s true. First is that it was sold in GNC stores and on Amazon prior to the FDA coming down hard, making the claim that Kratom was going to be scheduled. And that, that occurred in 2015 and 2016. So the marketplace shrunk because these retailers didn’t want the liability of the FDA coming in and saying this was a dangerous product and they would be responsible for that. So it got withdrawn from the traditional retail channels. Now it’s been reintroduced into many of those channels now, and it continues to grow because the record of safety for Kratom, if it’s not adulterated, if it’s properly manufactured and properly labeled, is actually very good. So what the FDA’s. Power over the marketplace is changing. But that promise in 2016 never came to fruition. They tried. They went to the Drug Enforcement Administration and published a notice to schedule Kratom as a schedule one substance using the emergency power section. of the Controlled Substances Act. That was a devious tool because they knew they didn’t have to prove much to do that. That section of the law is designed for those products that are street drugs that are introduced into the commerce and they’re causing deaths and they immediately have to remove them from the marketplace. Kratom had been on the market for years, since the early seventies, they use that device, but the DEA in an unprecedented action they’d never withdrawn a scheduling request like that from the federal register. They did in this case. And they told the FDA, we’re going to give you from October 13th of 2016 to December 1st to prove your case. 23, 326 people wrote in 99. 1 percent of them. favored Kratom being allowed on the marketplace. 147, 000 people signed a petition in the White House. We the people website saying don’t ban Kratom. 51 members of the House of Representatives within a 20 day period signed a letter and that was astounding. Signed a letter to the DEA administrator and said don’t ban it. 51 51 members, 26 Republicans, 25 Democrats. Very balanced. 13 members of the Senate did the same thing. And just to give you a flavor, November 27, 2018. for the bipartisanship here. You had on one hand, Orrin Hatch, who at the time was one of the most conservative members of the United States Senate and you had Bernie Sanders on the other end signing that letter. Those are strange political bedfellows, except that this was an issue where the FDA overreached. They went too far and they had to get slapped down. And that’s what the DEA did. They said we withdrew it. The FDA never provided. within that time frame, the documentation for the safety and efficacy evidence that they claim proved that kratom shouldn’t be on the marketplace. They did a year later. And when they submitted that, they did it when there was an acting assistant secretary for health, they snuck it through and it was over at the DEA for consideration when Dr. Brett Shaw, was confirmed into that position. He is the responsible official to look at new drug app. I’m sorry, we look at the scheduling under the Controlled Substance Act. He reviewed the FDA’s documentation and he published a scathing, unprecedented letter which essentially said the FDA is wrong. And he pointed out a road map that the FDA would have to meet. Now, this is in 2016 on August 16, 2016, I’m sorry, 2018. He published this letter, gave the FDA the road map for what they have to do in order to prove their scientific evidence. They haven’t done a single thing since then. Now, when he was asked on a Twitter exchange with Dr. Scott Gottlieb, the commissioner of the FDA at the time and Gottlieb challenged his actually not banning kratom what Dr. Juha said was fascinating. He said, first off, the FDA doesn’t get to schedule, they get to recommend. He said, and your evidence and data was embarrassingly poor evidence and data and a failure to consider the overall public health. Think about that. You have an independent arbiter evaluating what the FDA did. The FDA took a third chance at this. They went to the UN Commission on Narcotic Drugs. They appealed to them to ban kratom, much lower standard at the international level for scheduling of substances. But they knew that as a treaty partner, we would have, we’d be obligated if the UN commission agreed to schedule kratom internationally. We would have to follow suit. They went and gave it their best shot. They threw the kitchen sink at it. There are 12 independent scientists. who populate a group called the expert committee on drug dependence. They reviewed that. They looked at all of the evidence and what they did is they came back and said there is insufficient evidence, even though much lower standard for scheduling at the international level, the FDA is wrong. They’ve been smacked down by experts. And today you have the lone wolf. in the federal government in the FDA trying to ban kratom. And you have the National Institutes on Drug Abuse, which full throatedly supports people having access to kratom. You have the U. S. Congress that in the last three appropriations bills has encouraged more research and open access for kratom to the american people. The FDA is wrong. They’re isolated and they were just as wrong on kratom as they were on dietary supplements when they tried to ban them. Yeah. Back in 1994.

James Egidio: 20:37

Yeah. I want to back up for a minute too because you mentioned something very interesting about kratom as well. Not only its effects on pain and getting off opiates, but also depression. And I had just interviewed a few days ago, Dr. Healy, who’s an expert on antidepressants and the dangers of antidepressants. And I, in fact, just Two days ago, I interviewed Kim Witczak, whose husband was commit suicide on antidepressants. And then tomorrow I’m interviewing Dr. Peter Breggin, who’s an expert and was an expert witness for some of the mass shootings that took place at some of the schools with the dangers of antidepressants. But you’re talking about… something that’s safe and effective. And I was watching a video that you had mentioned with this study with the United Nations, with Dr. Jack Henningfield who had come up with a lot of anecdotal evidence, supporting, um, and comparing kratom to opiates and its safety and effect efficacy. So where is the pushback coming from with the FDA and who are the experts on their side that are supporting this, or is this just some kind of draconian across the board, Kratom is dangerous and we got to regulate it and that’s it. And that’s all we know. Is that what it is?

Mac Haddow: 22:00

Unfortunately, it’s closer to the ladder here, where you have a small group of people at the FDA who are not scientists who just have a bias against botanical and dietary supplements who have looped Kratom him into that bucket and they want to pursue their effort because they think it will build credibility for them on all dietary supplements, having to be regulated or banned. And that’s unfortunate, but the truth is they can’t prove it by the science. And you referenced Dr. Henningfield, there wasn’t just anecdotal evidence when the presentation was made. to the U. N. Commission on Narcotic Drugs. The expert committee on drug dependence. You had Dr Jack Henningfield who described to them the detailed analysis and scientific research that had been done about kratom, including on its addiction, liability and safety. You also had former NIDA scientist, Dr. Marilyn Eustace, who talked about the so called deaths associated with kratom and she went through her research that shows that there’s not a toxic level that has been identified by the FDA or anyone else in terms of what would cause a death with kratom. You also had Dr. Kirsten Smith, who at the time was a NIDA scientist. and worked on Kratom who presented data about studies that they had done and and described in fact, the not yet published, but described how there is an intoxication study, a driving study on Kratom and that it didn’t intoxicate or impair people in driving, which goes to the heart of the issue that the FDA is pushing. And finally, Dr. Chris McCurdy made a presentation. These are four of the leading scientists in the world who lined up against the FDA and said that they’re wrong. And of course, that goes back to what Dr. Joie said, when I spoke to Dr. Joie after he made his decision, I thanked him, and he said you need to understand that I am not an advocate for kratom, he said, I don’t know one way or the other, whether it’s good or bad, but I am an advocate for good science, he said, and it is an obligation of the FDA. to use good science to document its regulatory decisions. And in this case, the FDA has failed to do that. They want to take their opinion, interpose it as though it being the law of the land. And they want to dictate to the American people that they’re going to do it their way or the highway. And we think that the FDA is wrong. And that’s why we’re fighting so hard to get the Kratom Consumer Protection Act passed at the federal level, mirroring what we’re doing in the States. We’ve had 11 States that have passed the state Kratom Consumer Protection Act. And that is all designed to protect consumers. Make sure products that are introduced into the marketplace are manufactured correctly, not adulterated, properly labeled and restricted for kids. And we think that’s a model that ought to apply to all Kratom products.

James Egidio: 24:35

Yeah. And when you compare apples to apples It seems especially when you start getting the Drug Enforcement Administration involved in the game, uh, here we are in 2023 and they’re relaxing the laws on medical marijuana and edibles. And now they’re talking about legalizing or bring, rolling out psilocybin. You’re talking about people that are going to purchase these. Products from say a dispensary, right? And there’s really no way to control once you eat an edible of THC to control your faculties, uh, based on how it’s released in the body. Cause it’s almost like a time release and you’re sitting there driving around intoxicated on THC. And it can really wipe somebody out and they’re worried about Kratom, right? Same thing with these vaccines or these bioweapons that are killing people and injuring people. So they’re not really focusing on what’s good for the, what’s good for the person for the, that’s purchasing these products. They’re more concerned about power. and money. It seems

Mac Haddow: 25:51

like I think that every decision that’s made about a product that has a potential health benefit to the American people has to be driven by good science again, not by the agenda of a regulatory agency like the FDA that has a long standing record of going too far overregulating overreaching. I don’t have an opinion because I don’t know enough about the science on some of those other substances you referenced, but I know for certain that the FDA is tone deaf, blinded with their zeal for regulations and banning kratom to not even look at the data. There was a study that was done that looked at it’s an animal study, which is the gold standard for dietary supplements where they test against what’s called the oxycodone protocol. This is a safety study. The FDA has developed a protocol to for any substance that wants to prove that they are not unsafe, that they have to match it against what they know are the levels of oxycodone that will cause and then fill in the blank as to what the adverse events are. When this study was done, the researchers went and went to the FDA and said, is there anything that we’re missing on the published oxycodone study protocol that we should include in our research on kratom? And the FDA actually made some recommendations. they thought they were poison pills, right? So they told them you should do this and this in the end, the scientists accepted that in the first tranche, there were three tranches of this study. They know that the first level of oxycodone levels, they know exactly what the outcomes are. And predictably, that’s what happened for Kratom. The director of the scientific research project came back to the scientist and said, I’m going to do this, but you are wasting your money because I didn’t even see a blip on the signal safety signal at that first tranche. He said, you’re going to see the same thing because Kratom just doesn’t have this kind of power in order to create a problem. He said, I recommend. that you let me boost the amount in the second tranche. Now, if I were making that study and I wanted an outcome that hopefully was going to be obviously as good as the scientists thought, I probably wouldn’t have said okay. But the scientists did because they were pursuing the truth about it. In the second tranche, which they boosted the metrogenin, which is the alkaloid and kratom levels to test its safety. All of the oxycodone animals had the predictable reactions to oxycodone and the kratom at the boosted level. nothing. And so the researcher came back, the head researcher and said, look, you’re going to think I’m crazy, but you’re going to see nothing in Kratom because it’s not boosting any signal here. So let me put as much metrogenin, the alkaloid in kratom into an aqueous solution that I can inject into these rats, these test rats, and let’s see what happens there. Now they boosted that level to 400 times what any human could consume in a day. And so that’s real problems here, right? So they did that. And at the end of the day, Zippo for Kratom the they had some sedation obviously at that high level, but they had the oxycodone test animals either had major seizures or deaths. That was predictable. That’s what they know happens at those levels of oxycodone. The U S food and drug administration, when they were presented with that data, they had, as it was described to me, a group of scientists in the room and a group of policy makers. And when the scientists got the data and reviewed it, they said collectively, wow, this changes our perception about Kratom. The policymaker said meeting over, this is the kind of blind spot that the FDA has for good science. They don’t care about what the science says. They only care about their crusade to ban Kratom, and that’s tragic, and that’s why the US Congress has to step in.

James Egidio: 29:26

Why do you think they’re so hell bent on wanting to ban Kratom?

Mac Haddow: 29:30

It’s their first start in going after other substances because if they can selectively pick out the substances they want to ban, like kratom. Then they know if they get a win under their belts, they’re headed down the road for the next thing that they want to go after. We see them doing probes into the dietary supplement space now and they start to pick out products and they select them out and say, these are now dangerous and so we’re not gonna let you have them on the marketplace anymore. That’s the game the FDA has now taken and they’re very clever about it because when they do these regulatory actions, they make sure that they don’t go to what’s called Final agency action. They will put out an alert. They will scare consumers and retail channels out of the marketplace. And then they control the marketplace that way. That’s tragic when it comes to Kratom, I hear, and you made the point earlier maybe we need to improve the retail channel. And I agree with that, but ultimately. Ultimately, Dr Jack Henningfield made a point that was powerful in testifying before the Louisiana Legislature when he was asked by one of the legislators, Don’t you think it’s a bad idea for Kratom to be sold in gas station convenience stores? And I have not heard the response to that question from Dr Henningfield before. And he said, No, actually, I think it should, as long as it’s properly manufactured and properly labeled, it ought to be available in any outlet because there are people who are struggling right now. We’re trying to maintain acute and chronic pain management and get off of opioids. I don’t care where they get it, as long as it’s a properly manufactured and properly labeled product. And if they don’t have the stigma of having to go into a doctor’s office, they don’t have the stigma of trying to go to a recovery center, and they don’t have the stigma or the financial resources to take advantage of those kinds of treatment options. Dr. Hegel said, I think we need to make this available. And I thought that was a pretty astounding point because I would’ve agreed and said, yeah, let’s get it outta there and let’s put it in these traditional, very high-end retail establishments. But I, he persuaded me and I think that’s the right policy as long as we regulate it so that it’s manufactured properly and label properly.

James Egidio: 31:27

Yeah. When I was in the nutritional supplement industry, back in the early 90s, I was doing formulation and design of products, specialty products. I remember we were going through this scrutiny. I mentioned this to you offline with the industry itself. And there was a product many years ago, back in the early 90s, they were really going after the FDA. And I remembered back then The FDA was pretty much regulated up with one desk. You’d act, you’d actually call the FDA back then. You couldn’t even reach them. There weren’t, they were so under unmanned. It was like a couple of people working for him to regulate that particular industry. And there was a product in particular called ma huang. It was a Chinese herb which acted like a Broncodilator and almost like an ephedrine or a type of stimulant, and they went after that product. because it was causing a lot of tachycardia and issues like that. But it wasn’t even there. They didn’t even stop there. They were looking to regulate pretty much most products across the board in the early nineties and into the mid nineties. So there was a lot of back and forth with manufacturers and marketers of supplements back then. I remember that.

Mac Haddow: 32:41

Yeah, in fact, when the F.D.A. Did that the consumer population and dietary supplement industry rose up. They had over 300, 000 phone calls that went into the U. S. Congress to the white into the Capitol building. They actually shut down the phone system, so they had to rebuild and redesign the phone system so that today they can handle that volume of calls. This is before emails. There were 900,000 letters that were sent. Now, the result of that you have the FDA out there saying we have got to ban all dietary supplements. They were unabashed about it. They built their record over two decades to get that decision and the U. S. Congress on a unanimous vote passed the DeShay Act, telling the FDA, no, you’re going to regulate them appropriately. And now is it the perfect piece of legislation? No but it was done in order to rein in the FDA. I wish we could, without opening up Pandora’s box, go back in and say. We made a few mistakes. We need to tweak this a little bit, but the FDA would come in hard and try to ban the dietary supplements and botanical supplements. So we have to live with what we’ve got, but it’s far better than the alternative where the FDA gets to unilaterally make these decisions to ban products because they don’t like them. It’s their regulatory agenda that’s the problem.

James Egidio: 33:54

Yeah. Yeah. And I know the thing is, and you’re right it’s a very delicate balance in this industry too, because CGMPs good manufacturing practice, certificates of good manufacturing practice have to be implemented for manufacturers, because I do know from being on the manufacturing and the marketing side of nutritional supplements, that a lot of these supplements are what they call adulterated. Yeah. I know in the market with a lot of herbs that get imported from Asia and whatnot, and very good herbs that are very potent and very effective get adulterated to where they take the active ingredient out of the herb in order to make the tinctures, which are more concentrated that can be sold for a higher cost on the market and then they’ll take the herb that where they took the active ingredient out and make the capsules out of it Right or and there’s no regulation with that. Okay, or what they did with a lot of the products for erectile dysfunction the natural supplements recently in the last i’d say 10 years Is they would sell let’s say a supplement on the market for erectile dysfunction, a natural herbal supplement, and then they would put some sildenafil citrate in it, right? Which is the active ingredient in Viagra. And the FDA got ahold of some of those products. So that’s what they’re concerned about. I know you mentioned too, where some of the, these products, Kratom products were tainted with. What was it? Some kind of active ingredient. That was similar to what Tramadol, I believe, or something like

Mac Haddow: 35:39

that. Yeah. These were nine deaths that occurred in Sweden. Yeah. And in 2011 and all of those products and the FDA, by the way, uses those deaths as examples of a Kratom death, but all of those deaths, but in a peer reviewed published article examining the tox screens and the autopsies revealed that they were adulterated with Odemethyltramadol. which is the chemical that’s used in the production of the opioid tramadol at a toxic level. It wasn’t the kratom. It was this adulterant. So that’s the problem. And the FDA doesn’t care about the facts. They continue to tell that there are 44 deaths, the nine that I just referenced. I’ll give you an example. We, we FOIA’d Freedom Information Act request to the FDA. They gave us on all 44. They claim they gave all of them to us except one. Okay. They said that one was protected by HIPAA restriction by the family. That’s the Privacy Act. So we couldn’t argue with that. We had an independent forensics toxicologist review all of the 43, and she came back and said it was shockingly disappointing work by the FDA. They didn’t do any due diligence, and that none of those deaths could be attributed to Kratom itself. Shortly thereafter, I got a call from a reporter from Huffington Post, and he said you know that one death they claim is protected by HIPAA? He said I have a copy of the autopsy and It’s not protected in any way and I was working I was working on a different story and I asked for an autopsy for a different story and I got it just withheld it because they didn’t want you to see it. I said, why? Because the kid died of two gunshot wounds to the chest. It involved apparently a drug sting where the informant was ordered out of the car by the police along with the seller. They were, I think the kid was selling marijuana and the kid, the informant jumped out, but the seller did not and he was ordered out of the car. He reached for what the police thought was a weapon and they shot him. He died of two gunshot wounds to the chest and that’s what’s on the autopsy. It just shows that earlier in the day he had drunk a kratom tea and he had four or five other toxic drugs in his system illegal drugs, right? He died of two gunshot wounds to the chest and yet the FDA with a straight face will say That’s a kratom death. These people are off the rails and they don’t have any accountability because they get away with it. They think when it says it, that it must be right. And you and I have been in this sphere long enough to know that the FDA ain’t always right. And the FDA will frequently say things that are blatantly not true in order to achieve a regulatory agenda that they want to accomplish.

James Egidio: 38:08

Yeah. Yeah. And it’s interesting. It sounds eerily familiar to Dr. Scott Jensen, who I interviewed several months ago about the whole thing with COVID where he’s a he’s out of Minnesota. He’s been a physician there, 2016 family physician of the year, and he was instructed by the hospital that he worked at to report COVID deaths, no matter whether it was COVID or not. And he blew the whistle. And they were looking to take away his license for that, so it’s a coverup and that, that was going to be one of my next questions is that when you look at some of the suspected deaths from Kratom or may have been caused by Kratom, what are some of the things that need to be taken into consideration that may have been overlooked?

Mac Haddow: 38:55

So the first thing is that there’s never been a toxic level of metronidine or any of the other alkaloids in the natural plant or it’s. metabolites that’s been identified as toxic. So any death that is reported by a medical examiner who typically just follow the FDA, there’s a metrogeny intoxication needs to be examined. Excuse me. So we need to do that. So we look at those deaths. We’ve collected every publicly available autopsy intoxicant report On these deaths. And what we’re finding is that none of them are caused by Kratom alone. They’re always polydrug use, or there are other underlying health factors that cause the death. We think, the investigations need to be made. These are tragic circumstances for families that lose a loved one to an overdose or to some other unknown event. And they like to blame Kratom because the trial attorneys are encouraging it, right? They wanna collect these. cases that they can go and sue the child attorneys aren’t suing the FDA for failure to regulate. They’re suing the manufacturers. And first off, I think manufacturers should act responsibly. They should meet the standards, even if the FDA doesn’t require it right now. They don’t. They should meet FDA requirements for GMP regulations and they should label their products absolutely. And anybody that doesn’t, they’re at risk in the marketplace and they should be penalized. And while my heart goes out to families that have lost family members, finding a trial attorney dragging them into this. This quagmire of saying, oh, this was a Kratom death with the flimsiest of evidence. And I say Flimsiest, and it makes no sense to us. We had a call from a from a coroner in the state of Idaho who volunteered to us that he had a death. That he had reported on of a young man. It was in, in Bannock County, Idaho. And the young man had gone into a bar, had become intoxicated, had he had weed and other substance in his system, including kratom by the way. He had drunk a Kratom tea, very low level Kratom had walked out drunk into the middle of winter. tripped and fell into a ditch and passed out, and he died of hypothermia. Now, when the tox screen was published, it showed among these other substances, a very high alcohol content level in his blood showed the other substances that he was obviously taking, and it showed kratom in a very low level. He said the FDA called him up and said, we need you to change the cause of death to mitragynine intoxication. He said, why would I do that? It had nothing to do with the death. Yes, but Mitragynine showed up on the tox screen and we need to highlight Kratom deaths. He said, I’m not gonna do that. They said we want to talk to your superior. He said, I’m the duly elected coroner in Bannon County, Idaho. I am the superior. I’m not doing it. They said we’re gonna report you then to the Medical Examiner’s Association of Idaho. He said, Hey, hang on. I’ll get the director on the phone. It’s not a problem. He put them on hold, tried to connect them. We went back, the FDA hung up. This is their game. These people have no business trying to put their thumb on the scale and tip the scales against Kratom. They have no business doing that, but that’s the only way they can make their case. And that’s really unfortunate.

James Egidio: 41:58

It is. I remember there was a time when we were doing we were getting patients off of opiates with the use of suboxone. And when we would have a patient come in and we would screen the patient, they were on multiple medications that they were being prescribed, or they were using heroin to get on the suboxone. So they, they were polypharmacy, they were using Xanax, they were using heroin. It’s just, it’s a multitude of medications that they’re using. But I can remember back then we would even go as far as saying, Hey, look, what even works better than that is the Suboxone is the Kratom. And they were getting such great results from Kratom as opposed to suboxone. And they were even getting off the heroin. With the use of Kratom,

Mac Haddow: 42:52

yeah, you’ve highlighted one of the problems in our dealing with these addiction liability and trying to find a better space. We substitute. One addiction for another and and that’s unfortunate because suboxone is a product. It is has its own downsides It does toxic and I think that should be our goal we should find what’s best for the individual the best treatment protocol for them as they struggle through this and Certainly do not lock the door on something that could help them that just because the FDA doesn’t like it And I think that’s why night is so supportive of us as we go forward here. This has been to my mind one of the biggest challenges we have in the healthcare space. As you look at the opioid addiction crisis, when you have a product that can help, that’s a lifeline, we should use it. And Dr. Nora Volko of the the National Institute on Drug Abuse agrees. Why is GFK the outlier?

James Egidio: 43:45

I want to share with the listeners and viewers of the Medical Truth Podcast a couple videos of some of the people who have benefited from Kratom through your organization.

Video: 43:58

The pain was just so bad that I couldn’t work. I couldn’t even get out of bed on certain days. I love to travel. I love to be around my grandkids. I love to hike. All the things that I loved to do in my life, I couldn’t do anymore because of the pain. The doctors wanted to put me on synthetic medications. I started off two every four hours and then within a month I tripled that because they just quit working. I’m trained to think the pharmaceuticals are the only way to go. And when I was introduced to Kratom I didn’t think that it was going to work because it’s just a plant. But then I tried Kratom. And I literally sat and cried in my car because for the first time in years, I didn’t feel pain. I was able to think clearly, this stuff is amazing. I have not felt this level of calm and this level of being pain free in years. Having this all natural plant has literally given me my life back. I can live. So I want to I can be that medical professional that I need to be and I can work with a clear head and I can work at the level I need to because I’m no longer in pain without this plant. I honestly don’t think I would be here. I would tell the legislators. Please listen to us. This plant is saving lives for those of us with chronic pain. It’s giving these people back their lifestyle that they had before they got sick. Go to ProtectKratom. org to send a message to your elected official about Kratom. I have severe pain in my lower back. And there’s times when if I did not have the pain medication, I would want to put a gun to my head. Doctors will tell you, you’re going to be on pain medication for the rest of your life. But it’s just not sustainable. You start building up a tolerance. You need more to relieve more pain. You just keep moving up and you’re still in pain. As a scientist, I just didn’t think it was going to work. And it was just a plant. Just a ground up leaf and I was like, this is not going to be able to take away my pain. Because I was on such a high dose of morphine at the time. And when I took it, it did. It blew my mind. I couldn’t believe that the Kratom actually worked. With Kratom, my quality of life is like I was a 20 year old without any back problems at all. Things that I enjoy, like going out hiking with my dogs, going RVing across country, I couldn’t do that on pain medicine. And with Kratom, it totally gave me back my life. I love Kratom because it’s a plant, it’s all natural, and it’s taking away my pain. It is a miracle. It’s pretty awesome. Kratom saves lives. Contact your elected officials. Help protect Kratom in Colorado. Worked 13 years in law enforcement from corrections officer to police officer. I was attached to a gang task force for the state of Missouri. I was going to interview two gang members in a jail. I was attacked by an inmate with a knife for three minutes and I was basically left to die. It just compacted in my mind. And I was having panic attacks. I was puking in a trash can before I went to work every day. It was said at that point that I was unemployable. I was just in an absolute pit of despair. I was diagnosed with post traumatic stress disorder and major depression. I gave my life to law enforcement and when that was taken away from me, I was just, I was totally devastated. I saw a therapist. I saw Different doctors, I took prescriptions and nothing helped until I found Kratom. It has been an absolute life changer for me. I’m able to get out of bed in the morning. I’m motivated, I have energy, and I feel normal. I wasn’t stony or in a fog. I’m a law enforcement officer. I do not want to take drugs or narcotics. Kratom is a plant. It’s related to coffee. I feel like my life’s purpose is back and I have a lot of interest and still helping people. So I started an armed security agency and it’s been doing extremely well. We are keeping the critical infrastructure of a town that was drastically affected by category one. FEMA disaster. I’m able to help people and I’m able to contribute to society and create them, help make that possible. If they did take this away, you were going to affect 5 million people across the country, just like me, that are in Professional careers that are going to have no other options. Kratom saves lives and it helped me get my life back, which allowed me to overcome post traumatic stress so that I can come out here and perform my duties efficiently and effectively. Legislators, please protect pure, safe Kratom. Go to protectkratom. org to send a message to your elected official about Kratom.

James Egidio: 48:48

There we go. I

Mac Haddow: 48:49

can’t say any better than that. That was fabulous.

James Egidio: 48:53

We have to keep this stuff out of the hands of the government as far as regulation is concerned. It’s so important. And, it’s so interesting about that is that when you look at these are functioning people, these are real people. Real careers that are have, I’m sure are married and have families. And when they’re going through that chronic pain, it affects the marriage, it affects everything, it affects your entire life, it affects your sleep cycle, everything.

Mac Haddow: 49:26

No question about it. And I think that the time has come for everyone. Whether you take creative or not really isn’t the issue. If you love freedom, if you know that the FDA shouldn’t be allowed to arbitrarily issue these kinds of edicts without good science behind it, then it’s time to stand up and say enough. And that’s why we’re asking everyone to join us in the federal creative Consumer Protection Act and in the states where you’re KCPA hasn’t passed yet. We need to help. So we and I appreciate your time here, James, letting me come on and talk about this very

James Egidio: 49:55

much. Absolutely. And I’ll continue. And I want you to keep us updated listeners and viewers. I’m going to also be posting a lot of information, content, and I’d like to have you come back on the show. Maybe we could even get Dr Henningfield back on and we can talk about the physiological effects of the of the, of kratom and go from there. Thank you. Great idea. We can help facilitate that thing. I’m here to support you on all this. And again, your website is go ahead.

Mac Haddow: 50:23

It’s a www.KratomAnswers.Org. www.ProtectKratom.org and www.AmericanKratom.Org. Yeah. All of the

James Egidio: 50:31

resources and I’ll post all those links on the free resources page of the medical truth podcast. But I really appreciate your time Mac for coming on to the medical truth podcast. Thank you so much.

Mac Haddow: 50:43

We’re grateful

James Egidio: 50:43

as well. Thank you. Thank you, sir. Have a good night. Thanks. All right.

50:48

Thanks for listening to the Medical Truth Podcast. For the latest episodes, go to www. medicaltruthpodcast. com. You can also find the Medical Truth Podcast on Rumble, as well as all the major podcast platforms like Apple Podcasts, Spotify, Stitcher, and iHeart.