Speaker 1 (00:00):
I've had the pleasure of working with many people on the frontier of innovation, innovation in healthcare, innovation in government, innovation in business, working to make things better. But not all innovation is positive.
(00:14)
Dark innovations in chemistry have exacerbated the addiction crisis in this country. Synthetic opioids like carfentanil and the substance we're here to take action on today, 7-Hydroxymitragynine.
(00:27)
7-OH carries a high risk of addiction, on purpose. It is a powerful opioid agonist, many times more potent than morphine. We've seen a disturbing rise in reports of overdoses, poisonings, and emergency room visits linked to products containing 7-OH. These substances are often sold online, or in convenience stores with no quality control, no dosage control, and no warnings. This is a recipe for public health disaster.
(00:53)
Young people, veterans, and people who suffer from chronic pain or addiction are being misled into thinking that these are safe alternatives. They're not. Here at HHS, we're committed to gold-standard science, safety, and compassion. We know people are looking for relief, but that relief must be grounded in reality. We owe it to the American people to act decisively, and that's what we're doing today, initiating a process to schedule 7-OH as an illicit substance.
(01:21)
To share more, I'd like to welcome to the stage my good friend and colleague, the Commissioner of Food and Drugs, Dr. Marty Makary.
Dr. Marty Makary (01:34):
Thank you, Deputy Secretary O'Neill. It's great to be here. 7-OH is not just like an opioid, it does not just have opioid-binding properties. 7-OH binds to the μ receptor, which means scientifically, by definition, it is an opioid. And yet it is sold in vape stores, and smoke shops, and convenience stores and gas stations that are popping up all over the United States, and nobody knows what it is.
(02:06)
It is a synthetic concentrated byproduct of Kratom. Our focus is not on Kratom. Our focus is on 7-OH, which according to the Journal of Medical Chemistry, is 13 times more potent than morphine. We have a history in public health of being asleep at the wheel.
(02:28)
30 years after cigarettes were widely used, then we started raising public health concerns. After heroin, crack, cocaine and other street drugs became popular, about 10 years later, the medical establishment and public health community responded. 18 years after the approval of Oxycontin by the FDA, we woke up to a terrible crisis that may have killed almost a million Americans. And then again, right afterwards, with fentanyl. We have a history of being asleep at the wheel. For the sake of our nation's children, let's not get caught flat-footed again.
(03:11)
Public health is supposed to prevent disasters, not just clean them up after they killed thousands and thousands of people. Why do we get caught flat-footed time and time again? In my opinion, it's because of a disconnect between the ivory towers and the streets.
(03:35)
Have experts been to the vape stores? It affects what we see in the operating room. I learned from living and working in inner-city Baltimore that you have to be proximate to a problem to understand it. We can't just talk about it on panels, at medical conferences, and in the ivory towers of the medical establishment. I saw on the streets of Baltimore how some of my patients, that I would bump into, switched from the prescription opioid that I would prescribe to heroin, because they couldn't afford the copay. I've been surprised going to these vape stores at what I'm seeing. First of all, roughly 85% of the vape products are illegal vape products. We know that because the FDA publishes a list of legal vape products, and no cutesy, fruity flavor designed to appeal to children, or a video game vape product device, is legal or approved by the FDA.
(04:38)
I've been surprised that the candies and gummies and drinks and ice cream cones. Here's one drink with 7-OH H in it. There are other products that get added to drinks. Do we understand what 7-OH is at public health scale? Let's not get caught flat-footed again.
(05:02)
We're not targeting the Kratom leaf or ground-up kratom. We are targeting a concentrated synthetic byproduct that is an opioid. The Trump Administration is deeply committed to preventing another wave of the opioid epidemic, and this is deeply personal for many people.
(05:21)
It's deeply personal for the Secretary of Health and Human Services, who will share how at a young age he struggled with addiction. It's personal for a family friend, a good family with a good kid who is addicted, knows their addicted, wants to stop their addiction but can't stop. That story is going on all across the United States, and we don't have research, or numbers, or statistics on the scale of that problem. Let's not allow another wave of the opioid epidemic to get catch us blindsided again. I've met some of these families. Let's be honest, there's also a lot we don't know. This may be the calm before the storm, it may be the tip of the iceberg, but let's be aggressive and proactive.
(06:13)
Today, the FDA is announcing that we are initiating action to recommend scheduling of 7-OH as a controlled substance by the DEA. We are also releasing a report on 7-OH to educate the public, including the other names that goes by. And finally, we need to educate the public, including the medical community. I've talked to many doctors who don't know what 7-OH is. We need to be proactive so we don't get caught blindsided. Again, thank you very much.
(06:51)
Now I'd like to introduce DEA Assistant Administrator, Tom Pervoznik. Tom, if you could come up here. He leads the Diversion Control Program office and he's worked with HHS to uncover billions in healthcare fraud. Thank you, Tom.
Tom Prevoznik (07:07):
Thank you. Good morning, and thank you all for being here.
(07:17)
Let me start by saying, DEA's mission is to protect the public health and safety. That means taking action when dangerous, unregulated substances threaten American lives.
(07:33)
DEA just received the Department of Health and Human Services formal recommendation for 7-Hydroxymitragynine. And now that we have it, we'll review it exponentially, thoroughly, and in accordance with the law. We don't play politics with science, and we don't cut corners when it comes to public safety. DEA is the agency charged with making the final scheduling decisions under the Controlled Substances Act, but we don't act alone. We rely on HHS and the FDA to conduct rigorous science-based evaluations, including the eight-factor analysis that considers abuse potential, medical use, and public health risks.
(08:29)
DEA will now begin the legal rulemaking process, which includes an opportunity for the public to comment before any final scheduling decision is made, that means full transparency and all voices will be heard.
(08:51)
DEA will do what we've always done, follow science, follow the law, and do what's right to keep our communities safe.
(09:02)
Thank you.
Dr. Marty Makary (09:09):
Thank you, Tom.
(09:11)
One of the dangerous things about 7-OH is how much confusion it can cause. Many 7-OH products are marketed as "Kratom extracts" or "enhanced kratom," but in reality, they are the concentrated, synthetic, potent form that is an opioid.
(09:27)
Our next speaker, Melody Wolf, Melody, come on up here, has experienced suffering, looking for pain relief, and she's going to share a bit about her story and how the dangerous 7-OH product affected her life.
(09:41)
Thank you, Melody.
Melody Wolf (09:47):
So very good to be here today.
(09:49)
My name is Melody Wolf, and I'm from Kalamazoo, Michigan. I have three grown children, and I'm going to be celebrating my 39th wedding anniversary on July 31st. So
Melody Wolf (10:00):
I'm very happy to get to do this and have my family see me doing this today. I'm also a 20-year chronic pain patient. I spent 8 of those years in bed. Our home was a pretty dismal place. My kids had fans on in their rooms at night because they needed to sleep and they couldn't hear me crying in the downstairs. They were able to go to very few activities 'cause I was bedridden and they had no parent to take them. My husband was working and so losing out on a lot of activities that they should have been at. And to be quite truthful, my marriage was headed for a divorce. What? Remember, I'm celebrating my 39th wedding anniversary soon.
(10:46)
I saw many doctors at the Cleveland Clinic, the University of Michigan Rheumatology, and so many specialists. I was taking up to 11 medications at one time from one doctor and one of them being the highest patch count for fentanyl. It didn't really help my pain. It made it easier to take 'cause it made me sleep a lot, it made me groggy. But you know what, it also made me mean.
(11:17)
And like I said, our house was a dismal place and I'm just so thankful that I found a botanical called Kratom and right away, my life improved. I was out of bed, I was doing activities with my kids, and I lost a lot of weight. Being in bed for eight years, it affects your health very negatively. So I got my life back. I had taken tent camping trips to both eclipses and things just turned around for my family. And in 2022, during COVID time, my daughter and son-in-law lost their childcare. I got a call, "Mom, would you like to come move in with us for the year?" I said yes immediately, "Don't you have to ask Dad?" "No." So it was very, very thrilling for me to get to spend the entire year with my granddaughter.
(12:11)
And it was Kratom only, the powdered leaf that saved my life. And now I'm seeing something very dangerous happen. 7-OH is being sold over-the-counter and it is not the plant, it's a concentrated substance that is very dangerous to consumers. 7-OH is not what helped me get out of bed and get a quality of life again that I enjoy. I check out my smoke shops, make sure that they're selling products appropriately, that there's labeling on them, that they have A no minors, and that Kratom is behind the counter locked up. I did that on Sunday. I said, "Where are your Kratom products?" He said, "Oh, here they are." He handed me a 7- OH product. And I said, "That's not Kratom," and he was very confused. He said, "It's not? I thought it was." And I said, "No, it's not." I briefly explained it to him. And then when I told him that I do not take 7-OH, I never would, he said, "Well, I'm very glad to hear that because many of my customers tell that it takes them back to their heroin days," and there is the big danger. So this is what's happening. 7-OH is pulling people away from the opioid use that they've been trying to get away from. 7-OH needs to be off of the shelves. Thank you.
Dr. Marty Makary (13:50):
Thank you, Melody. Now, we're going to hear from Senator Markwayne Mullin from Oklahoma, and he has been a champion in Congress on addressing the opioid epidemic.
(14:03)
Senator Mullin, great to have you here and thanks for speaking.
Markwayne Mullin (14:06):
Thanks. Great. Thank you, sir. Appreciate it.
(14:08)
You know, we all get involved in issues for purposes of either passion or personal experiences. And with the opioid crisis or the drug epidemic, we've had throughout the country, it's affected almost all of us, either directly or indirectly. For us, my wife and I, it's affected us directly. Unfortunately, we have family members that we love and we want to take care of. And if you've ever dealt with a family member that is struggling with drug use and you're the caregiver of that individual, they go missing for days and you're worried about your phone ringing. You're afraid to be away from your phone. The phone rings at 2 o'clock in the morning, you pick it up because you're afraid to hear what you're worried about 24x7, is they found him dead.
(15:12)
And typically it's, "Hey, I got arrested. I got in a fight. I'm in trouble. I got stabbed. Can you come get me?" The list goes on. And I could give you horror stories of all the phone calls that my wife and I received over the last 20 years. And then when someone goes and they go to rehab and you get out because, my lord, we've been to every rehab center you can imagine, and I'm sure some of you guys have experienced the same thing, and they're clean or doing better and they find out they can go to a gas station or a vape shop or a skate shop or a bike shop and they can find something that's legal for them to take that gives them the same high and they can still pass drug tests even though they're on probation, and yet it's a road to the same addiction.
(16:13)
And you see the pattern, you see it in their face, you see it in their eyes, you see it in their words, you see it in their behavior. And you're going, "Oh my gosh, here we go again." And you go get them drug tests, and they're passing and you're going, "What is going on? How can they pass this? What are you doing?" "I'm not doing anything. I'm not doing anything illegal." But you can read it because you've been with that loved one so long, you see it and you're helpless. And once again, you know where the road is headed. And then honestly, those of our family members that we've struggled with addiction, when they actually get put in prison, it's probably the first night you actually sleep well because you know where they're at. You know you are not going to get that phone call. You don't like it, but you can breathe for the first time.
(17:06)
And in our case, the person gets out after years in prison and they find it in a drug store again. And these individuals that are selling know what they're doing. They know they individuals are targeting. They know the loophole and sell it as a dietary substance. Well, they probably do lose weight, but not for the purposes that we would like them to. And now, that industry has grown from nothing to over a $9 billion industry, more than even opioids that are selling on the street, which is at $5 billion a day because they justify it, it's legal. But it's an addiction that's ruining lives. It's an addiction that's truly killing people because it leads them down a road that sometimes they'll never recover from.
(18:03)
And we've known this and for the first time, we have a Secretary that not only has the backbone to do something about it, but he does it because he has personal experience. He understands addiction better than probably any of us in this room. And it takes somebody like that that understands the danger that this causes to stand up and push against this, I say, illegal industry because they're using every loophole they possibly can and once again, selling it as an energy drink or a dietary, but yet the packages look like it came off the shelf of a cereal box or a candy bar or one of their favorite Mountain Dew drinks, the list goes on. They know who they're targeting.
(18:57)
And so Secretary Kennedy, thank you for standing up and actually doing something about this 'cause this isn't anything new, this has been around for years. But without your leadership, this would never happen. So from my family and every single family that has dealt with this, God bless you and thank you.
Robert F. Kennedy Jr. (19:29):
Thank you very much. Thank you for those kind words, Markwayne. Thank you to Jim O'Neill, to Tom Prevoznik, to Marty Makary, and to Wendy as well. Thank you for that, for sharing your story.
(19:47)
I spent 14 years as a heroin addict and I've been 43 years in recovery. So I spent a lot of time talking about addiction and reading about it. And typically, in most societies,
Robert F. Kennedy Jr. (20:00):
… societies. You have about 10% of the population that suffers from addiction. But when there is availability, that can become a crisis. And you can have, for example, in Yemen, virtually 100% of the adult population is addicted to khat because it's available on every corner. And my addiction started because of… Let me say this, it was precipitated by availability. In April of 1968, three months before my dad died, the French connection, the biggest heroin bust in history, heroin recovery happened altogether. They got out of one automobile, 200 pounds of heroin, pure heroin, and they ended up getting I think about 1,600 pounds over time. That heroin was then stolen from the evidence locker room in the Manhattan DA's Office, and it was distributed on the streets of New York.
(21:11)
And for several years there was $2 heroin, so it was available in deuces. And there were people on every corner in Harlem, every corner in Lower East Side who were selling $2 heroin. And 72nd Street in Central Park, there were over 100 dealers selling it at that time. And I had iron willpower in other parts of my life. I gave up candy for Lent when I was 13. I never ate candy again until I was in college. I gave up desserts for Lent the following year, and I never had another dessert till I was playing sports in college and trying to bulk up for sports. I felt I could do anything with my willpower, but this compulsion was absolutely impervious to my will. And part of the problem was just the availability. It was too easy to get this drug for me.
(22:08)
And if you look at the waves of addiction that Marty talked about throughout history, they're all precipitated by availability. Morphine was invented in 1803 and during the 1880s and 1890s, there was an addiction crisis in this country. One, because the availability of opium that was coming in through immigrant supply trains. And the other was there was a lot of Civil War veterans would become addicted and it was widely available. Cocaine was available in medicinal drinks and in popular drinks like Coca-Cola. And Congress, in response to that crisis made heroin and cocaine illegal in 1914, and we had a break from it for many, many years.
(23:02)
And then the drug culture began in the 1960s where it was psychedelics, et cetera. But the real addiction crisis began after 1969 when heroin became available. And you got a whole generation that was hooked on that. And then in 1970, Congress again acted to criminalize heroin possession. And we got a little bit of freedom until the 1980s, when there was the drug cartels in Mexico and elsewhere developed supply lanes through The Bahamas and Mexico that the DEA was not ready for at that time. There were huge surpluses of cocaine in our country, and the drug dealers figured out a way to market it very cheaply through a new form of cocaine called crack. And throughout the '80s and '90s, we had the crack crisis in our country because of the availability.
(24:01)
And then in 2000, we had the oxycodone crisis because suddenly opiate pills were available partly because of the agency capture at FDA that Marty is now dismantling. And with that, FDA's action abetted that crisis. And so when we have that availability, it turns into a national crisis and we're still losing 80,000 kids a year. Three years ago, we lost 106,000 kids to addiction. That's double the number of children that died, of American kids who died during the 20-year Vietnam war. It's two Vietnam wars worth of casualties a year from this crisis. And as Mark Wayne said, "All of us are touched." President Trump is touched. His family also suffered from addiction. My family, I lost a brother to this disease. I lost a niece during COVID, a niece who I raised in my house who was like a daughter to me. I lost another niece to injuries who's now a quadriplegic because of this disease.
(25:24)
But all of our families are touched. Every American family. The financial cost to our country is in the trillions. And what we're determined to do is to avert a fourth wave of addiction. I became an addict because it was so available, but I still had to go to Harlem or I had to go to the South Bronx or I had to go to the Lower East side. And now you can go to any gas station and the people who are marketing these drugs… We met with Pam Bondi yesterday talking about this issue and with these people from the DEA, and they showed us maps of the places where the vape shops and the smoke shops where this stuff is being sold. And they're around military reservations in our country.
(26:18)
And the DEA has done measurements of urine in our troops and they skyrocket. The more it is directly correlated, the number of vape shops in their area. They're putting them around schools, they're putting them in our poorest neighborhoods, and now they're putting them in every gas station. And they're marketed for children. They're gummy bears, they're bright colors, they're candy flavored. This is really a sinister, sinister industry. As Marty pointed out, our agencies been asleep in the wheel for all of these other crises. And now we're going to wake up and we're going to stop this before it starts. So I want to thank all of these ladies and gentlemen for their commitment to making sure that this does not happen again in our country and averting the fourth wave of addiction. Thank you very much.
Speaker 2 (27:21):
Thank you, Secretary Kennedy. We're now going to take questions from the press. If you can please keep your questions to the reason we're here today, and also give your first name, last name, and outlet.
David Lim (27:42):
My name's David Lim with Politico.
Speaker 2 (27:43):
We have a microphone for you.
David Lim (27:47):
David Lim with Politico. Thanks for taking my question. In 2018, former FDA Commissioner Scott Gottlieb said FDA scientists conducted an analysis suggesting that kratom compounds had opioid-like properties. And he said that there was "no evidence to indicate kratom is safe or effective for any medical use". I know the FDA's warning letter in the actions today are concentrated on concentrated 7-OH products. But does the government today believe kratom itself is safe to consume? And then secondly, the DEA previously attempted to temporarily schedule 7-OH in 2016 bfore backing off, after receiving public blowback? Is the Trump administration prepared to finalize the scheduling process even if it received similar concern now?
Dr. Marty Makary (28:33):
So first of all, we're not prepared to say anything is 100% safe, especially when it has psychoactive properties. But what we are saying is that our focus is on synthetic concentrated kratom. And you point out a good point, and that is that if we talk about all 7-OH, then we're not distinguishing to the public the risk stratification of the synthetic concentrated from the trace amounts of 7-OH that naturally appear in the kratom leaf and have for centuries and have been used in teas and other things. So our scheduling recommendation will delineate trace amounts from synthetic concentrated amounts. Great question. Thank you.
Lizzy Lawrence (29:21):
Hi, Lizzy Lawrence, reporter with STAT. I'm curious how many, if there are any, known cases there are of 7-OHbeing recorded as the sole cause of a fatal overdose?
Dr. Marty Makary (29:35):
We have terrible statistics because if somebody comes in with 7-OH overdose, I'm not even sure a doctor would know to ask about 7-OH. Very few doctors I've spoken with know what's in these vape stores or know what 7-OH is. I've had to explain it to the dozen or so doctors I've talked to. So I think we're just starting to understand. It's very, very reminiscent
Dr. Marty Makary (30:00):
… of when we prescribed opioids to patients who didn't need them after minor surgical procedures or too many opioids for those who did need an opioid. And we would notice some people were coming back for refills at a very high rate, but we hadn't put the two together because we hadn't recognized the addictive nature. So we need better statistics. There is a commitment from NIH to do some research to try to understand this, but this is not something where after 50,000 Americans have died from it, we want to start that process. Thank you, Lizzie.
Speaker 3 (30:37):
Hi. Sarah from All CNN to David's question, what kind of regulation and guidance or scientific evaluation could we see in the future about natural kratom?
Dr. Marty Makary (30:48):
Look, I think there have been physicians who have had concerns about some claims around natural kratom. We have to prioritize what we work on. So we are going after the killer first, which is the synthetic concentrated kratom. And then we can look into that other question, but we think it's night and day in terms of the public health risk. Thank you.
Speaker 4 (31:16):
Hey, thank you. I'm Scott with CBS. You mentioned the doctors need to become more familiar with the danger here and you've issued a letter I think today to doctors, but what in fact changes today? I'm sorry. Are you issuing a new regulation? Are you going to do the scheduling? What actual change is HHS affecting today?
Dr. Marty Makary (31:38):
Yeah. So great question. Thank you for that. So a couple things. One, we're issuing a report, an FDA report on 7-OH, explaining it. We are putting that out there and we'd love for you to let Americans know about that report so they can learn. It has both a deep science component and a section for laypeople so they can understand the issue. We think every school board should be talking about this.
(32:08)
We are, number two, issuing a letter today to the DEA to recommend scheduling above a concentration threshold as a controlled substance. Number three, we are sending a dear doctor letter to every physician in the United States warning them about this and we're going to continue to try to educate the public. So a couple very definitive actions today. And of course we announced a couple of weeks ago that we have let distributors to the retail stores know that we have serious safety concerns and specified those concerns.
Speaker 5 (32:53):
Hi. Margaret Manto with NOTUS. You said that you were thinking about this in terms of concentration where it's like trace amounts of 7-OH and kratom versus the much more concentrated product. Is this a framework that you think the FDA could use for other dietary supplements?
Dr. Marty Makary (33:12):
I think it's a good idea. Thank you for suggesting it. We do something called an eight factor analysis. So our scientific team and the scientific team at the DEA independently try to evaluate is there a threshold? And they look at animal studies and a whole bunch of other criteria to look at dependence and addictive thresholds. So we have a threshold that is calculated in two different mathematical ways to try to distinguish what we're talking about with concentrated kratom from the trace amounts that appear in the kratom leaf. Thank you.
Speaker 6 (33:52):
Thank you. Katrina Saf, Gray Media. I know you said this process is just beginning, but of course that takes time. So in the meantime, can you tell us how quickly can we see these products removed from shelves or at least made harder to obtain? And then what message do you want to give to Americans who are seeing this and saying, "Oh, I thought it was totally safe" and maybe still today can actually go and get it?
Dr. Marty Makary (34:16):
So effective immediately. The letters are out to the distributors and we've actually gotten some positive feedback from some of those distributors. So we're sounding the alarm with the distributors of the synthetic concentrated kratom. We also want to create a national conversation where parents talk to their children. Kids are sometimes using these substances and the parents don't know. And sometimes the kids are using it and they don't actually know what's in these substances. So this is a time, as with other new addictive substances that enter the United States, for us to have these conversations. And I hope school boards, places of worship, all talk about the illegal substances in these vape and smoke shops and gas stations. Thank you.
Speaker 7 (35:08):
Hi, Liz White with the Wall Street Journal. Also very present in smoke shops and vape shops are high potency cannabis products and synthetic cannabis products such as Delta-9, Delta-8, THCA, high THC products. And these have been linked in the medical literature already to psychosis. Is there a reason that this kind of well-established smoke shop problem is not something you're going after?
Dr. Marty Makary (35:35):
So I personally, in my writings as a physician in my statements and also the Department of Health and Human Services have expressed serious concerns about people using these cannabis products. We don't want kids to use them. Cannabis use disorder is a real thing. And as you appropriately mentioned, there are now studies linking it to psychosis and even cardiovascular problems. So that is an entirely separate public health campaign and it's an important issue. Thank you.
Speaker 9 (36:11):
Very last question right here.
Speaker 8 (36:15):
Thank you. Amanda Seitz with the Associated Press. I was wondering if you could say what class you're recommending that it be scheduled and how quickly you're expecting the DEA to act?
Dr. Marty Makary (36:28):
Class 1, it is an opioid by definition. It will be ultimately up to the DEA to decide. Thank you.
Speaker 9 (36:34):
Thank you so much.