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Blue Ribbon Committee on Youth Exposure to Kratom and Retail-Available Substances 6.17.26 — Transcript

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20:36I hope one went well.
20:38>> All right. Good morning.
20:41Appreciate everybody being here. I'm
20:43Rick Townsen, representative of District
20:45179, St. Simons, Brunswick. and uh happy
20:49to be here on this special day. We have
20:50a special session later on today and
20:53timelinewise we're scheduled for 9 to
20:5512. There's quite a few of us need to be
20:57someplace at 11:30. So, we're going to
20:59try to push it up 30 minutes if we can.
21:01If not, we'll still go to 12. Um it's uh
21:05something that's near and dear to our
21:07hearts as a committee of
21:09a lot of people don't know much about it
21:11and so what we're trying to do is if you
21:13see the if you saw the agenda for the
21:15first one it's pretty load with people
21:17who's done a lot of research and so this
21:19first one is more dedicated definitely
21:21to the committee of finding out more
21:22aboutratom and where we need to go with
21:25it as state of Georgia and so everybody
21:28knows a little about me um I've worked
21:31on this um issue for quite a few years
21:34and we want what's best for Georgia
21:37period. We want what's best for the
21:39safety of Georgians period and so we
21:42keep an open mind throughout the
21:43process. Uh we'll have public particip
21:46public participation later may not be
21:49today but it will be at another meeting
21:50for sure to get input from everybody in
21:53the public. We'll make sure we get a
21:54notice about that if we run out of time
21:56today. But today is a tight schedule. So
21:58want everybody to understand that. I'm
22:00going to let the committee introduce
22:02themselves and then we'll get started.
22:04Like I said, one of the goals today was
22:07let's get the first meeting done. A lot
22:08of people's going to be here anyway.
22:10Let's find out some general stuff about
22:12Uratom
22:13and go from there. But I'm excited being
22:15here. Like I said, I represent St.
22:17Simon's Brunswick. Great community and
22:20um I was drawn into it because of that.
22:22We had a couple kids down there that
22:24were affected with the with the uh
22:26substance and have to figure out which
22:28way to go with it now. So anyway, I'm
22:30going start down there with Chairman
22:33Meeks if you can. We'll go from there
22:35across and back over and everybody
22:36introduce themselves and we'll go from
22:38there.
22:39>> Thank you, M. Thank you, Mr. Chairman.
22:43>> Thank you, Mr. Chairman. I'm Steven
22:44Meeks. I represent House District 178,
22:46which includes uh Apple and Wayne,
22:48Bacon, and Pierce counties. I'm a
22:50tobacco farmer, cotton cotton grower, uh
22:53corn and peanuts down in down in Wayne
22:54County. Thank you for the opportunity to
22:56be here, Mr. Chairman. Thank you.
22:59Representative Matthysse.
23:01>> Thank you.
23:04>> I'm Danny Matthysse. I represent
23:05district 133, which is Middle Georgia,
23:08Wilkinson, Twigs, Bleley, Dodge, and
23:10Half Tail Fair. Uh I appreciate being on
23:13this committee. Uh hope we can come to
23:16some resolutions on some things. Thank
23:18you.
23:20>> Thank you,
23:22>> Chairman Smith.
23:24Good morning. Good to see everybody out
23:26so bright and early on a Wednesday after
23:28a late night for some last night. I'm
23:30Tyler Paul Smith. I represent House
23:31District 18 in conference in all
23:33Harelson parts of Carol and Palton
23:36counties.
23:39Thank you.
23:44>> Representative Ridley.
23:45>> I'm Jordan Ridley. I represent Southwest
23:47Cherokee and North Central Cobb, the
23:49Lake Alatuna area. Thank you for having
23:51me.
23:52Thank you, Representative Representative
23:55Al, Dr. Al.
23:56>> Thank you so much. I'm Representative
23:58Michelle Al. I represent House District
24:0050, which is in the north uh Atlanta
24:02metro, John's Creek, and a little bit of
24:04Alpharetta. And uh my day job when I'm
24:06not here is I'm a practicing
24:08anesthesiologist and have a master's
24:09degree in public health.
24:11>> Thank you. And Chairman Corbett. Thank
24:15you, Mr. Chairman. Uh John Corbett,
24:17District 174, which is Louns, Eckles,
24:20Clinch, Wear, Charlton, and Brantley
24:22Counties, right on the Florida line. Uh
24:25excited to be on this committee. Look
24:26forward to uh working with the members.
24:28Let's come up with some common sense
24:29solutions to uh hopefully sol solve the
24:32problem that we're seeing with with
24:33addiction to cratom. Thank you, Mr.
24:35Chairman. Thank you, Chairman. Okay. I
24:38appreciate this. U
24:41appreciate everybody being here. We're
24:42going to get straight to the agenda.
24:44Like I said, tight timelines. We're
24:45going to move on. Dr. Ste,
24:49Dr. Ste comes from uh Emily University
24:52and I'll let you tell you a little about
24:53yourself and we'll get let you get
24:55started and she's got a presentation and
24:58it it's uh really appreciate you being
25:00here and and uh thank you
25:17Good morning and thank you for having me
25:19again. My name is Dr. said I faculty and
25:23firstly I am trained in emergency
25:26medicine in medical toxicology and
25:28addiction medicine board certified in
25:30all three specialties. Um I also founded
25:33and run the addiction services at Grady
25:36Memorial Hospital. So, uh, this is
25:38something that we've been seeing for
25:39quite some time and as chairman Townsen
25:43said, my role here this morning is just
25:45to kind of set, uh, a common language
25:48and make sure that we are all kind of
25:49talking about the same thing. Uh, I have
25:52no conflicts of interest or disclosures.
25:55And so, on a very high level, uh, itself
25:58is a plant. It comes from uh East Asia
26:03and has been used by indigenous cultures
26:05for millennia. It now when we're seeing
26:09it in the United States tends to come in
26:11a variety of formulations. Initially of
26:15early 2000s, 2010s, it came
26:17predominantly as powders which was then
26:20packed into capsules, stewed into teas,
26:23as you can see here. Um, it's something
26:26that's usually sold kind of in in bulk
26:29and then prepared however the the
26:31individual finds it most easy to take.
26:33We're also now seeing concentrated
26:35extracts which come uh sometimes in
26:38these little like shot bottles like a
26:405-hour energy sort of thing. Um, as you
26:43can see there in the image to the left.
26:44Um, and many of these are images that I
26:47took myself just wandering around uh
26:49different shops in the area. uh it's
26:51very accessible um and and really uh
26:55quite affordable.
26:57So I think one of the really important
26:59things to discuss when we're talking
27:01aboutratom andrredom products are the
27:03reasons that people use it. And this is
27:06data back from 2020 but there was some
27:08recent data presented at this year's
27:10addict uh American society of addiction
27:13medicine meeting which confirms these
27:16data. Most of the time people are using
27:19this for treatment of pain. Um and these
27:21are not mutually exclusive categories.
27:23So you'll notice that the percentages
27:25add up to more than 100. uh but
27:27treatment of pain and then treated of
27:29mood or psychiatric symptoms. So
27:32particularly for individuals who lack
27:35access to care uh this is something that
27:38those communities have have seen as as a
27:41real boon. Another thing and really kind
27:45of where we see it in the medical field
27:46most often are for people who are using
27:49crow as an alternative to prescription
27:52or elicit opioids either as a
27:55replacement or as an alternative method
27:58to wean themselves off of prescription
28:01or more dangerous opioids like fentinyl.
28:07There are many compounds in catam leaf
28:09in the actual plant itself but the three
28:12that are most relevant to our discussion
28:14today are metrogenine 7 hydroxy
28:17metatragginine and metrogenine
28:19pseudoindoxil. So metroenine is the
28:21primary active compound in the plant
28:24itself in either fresh or dried leaf and
28:277 hydroxy metatrogenine which is
28:29colloially known most commonly as 70 or
28:317 hydroxy and metroine pseudoindoxil
28:34which is either called pseudo or
28:36pseudoindoxil
28:38are really only present in trace amounts
28:40in the plant. Both 70 and pseudoindoxil
28:45are metabolites that the body produces.
28:47So when someone ingests catam leaf again
28:52in whatever preparation they choose to
28:53ingest it the liver will convert the
28:56metrogenine to 70oh and then converts
28:59that 70oh into pseudoindoxil.
29:02Now the body does this in low enough
29:05concentrations that we really don't
29:07think that 70oh and pseudoindoxil are
29:10responsible for the effects that people
29:11are experiencing when they take whole
29:14credom leaf. And I think this is an
29:16important point to make when we start
29:18talking about the different synthetic
29:20products that are now available because
29:22metrogenine while it is an agonist at
29:25the mu opioid receptor which is the same
29:28mechanism of action as the other opioid
29:31analesics
29:33is a fairly weak agonist at this
29:35receptor. So it doesn't produce the same
29:37amount of respiratory depression. It
29:39does not carry the same risk of overdose
29:41as things like oxycodone, heroin and
29:44fentanyl. 70 and pseudoindoxil however
29:48are more potent agonists at that
29:50muopioid receptor which means they are
29:52stronger than for instance morphine. Um
29:577 hydroxy for instance when you look at
29:59receptor binding studies seems to be
30:02about 10 times as potent as morphine.
30:05Now again, I want to point out that that
30:09data comes from test tube studies. We
30:12still don't have a really great sense of
30:16how potent this stuff is in humans
30:18because those studies just have not been
30:20completed yet. Many of them are
30:22underway. But you'll hear a lot of folks
30:25saying that 7 hydroxy and pseudoindoxil
30:27are so so so strong. Um, and that's true
30:31in a molecular sense, but we're still
30:34figuring out a lot of the landscape in
30:36humans.
30:38The effects vary based on dose. So if
30:42someone takes whole catam leaf powder
30:44and steeps it in a tea or has a very
30:47small dose and gets somewhere on the
30:48order of 5 to 10 milligs of the active
30:51ingredient, it tends to have some mild
30:54stimulatory effects which people
30:56describe as being akin to having a
30:58strong cup of coffee or a couple shots
30:59of espresso. It's not until people get
31:02into higher doses where you start to get
31:04into 40, 50, 100 milligrams of the
31:07active component, either in powder or
31:10capsule form, that you start to feel the
31:11opioid effects. So, our folks who are
31:14using this for pain or folks who are
31:16using this as an alternative
31:17detoxification regimen for other opioids
31:20are going to be using somewhere between
31:231 and 5 g of powderedratum leaf per day
31:27depending on how much opioid effect they
31:29need to either control their pain,
31:31mitigate their withdrawal symptoms, or
31:33help with their mood.
31:35One of the main concerns is that because
31:38this does act at the opioid receptors,
31:41the body gets used to it just the same
31:43way that the body gets used to other
31:44opioids. So over time, people may find
31:48that either they need increasing doses
31:50of to achieve the same effect or that if
31:53they stop the catum abruptly, they
31:55develop a withdrawal symptom that is
31:58exactly the same as what we see with
31:59opioid withdrawal. So people can get
32:02very very sick if suddenly they don't
32:04have access to this substance anymore.
32:07As I mentioned, a lot of people are
32:10using kind of the leaf product somewhere
32:12on the order of 1 to 5 grams a day,
32:14which comes out to about 50 to 150
32:16milligs of the active ingredient. It
32:19tends to be a younger population on the
32:21whole. Obviously, there's a wide range
32:24of individuals who use this, but in a
32:26recent study from um I want to say 2025,
32:30what they found was that the average
32:32user was in their early 30s and
32:35predominantly a male population. One of
32:38the concerning things to me as someone
32:40who works with folks who have substance
32:42use disorders is that there's a lot of
32:44concurrent substance use. About a third
32:46of people are usingRratom with other
32:48substances. Particularly if f folks are
32:50taking with alcohol or bzzoazipines,
32:53things that are sedating. That does
32:56increase the risk of respiratory
32:58depression and overdose from those
33:00combined effects.
33:02CRAM, as we're probably all well aware,
33:04has been increasing in use. Um, so this
33:07is data from the National Poison Data
33:11System. It's an aggregate collection of
33:13calls that come into the poison centers
33:15across the country. And what we see when
33:18we compare it to other sort of readily
33:21available kind of so-called gas station
33:23agents, things that you can buy in smoke
33:25shops or gas stations or convenience
33:28stores, things like TNT or phenibute,
33:30credum has definitely been increasing um
33:34beyond what we see in trends for those
33:37other similarly accessible substances.
33:40Now this data on the previous slide only
33:42went to 2023. There was a more recent
33:45study again looking at national data
33:47which showed that um unfortunately this
33:50got cut off. But between 2023 when that
33:53last graph ended and 2025 when this
33:56study concluded there was uh again a
33:59doubling of the number of annual calls
34:01that are coming into the poison center.
34:03Uh Dr. Filkins, who's going to speak
34:05after me, will talk a little bit more
34:06about the details of what's happening at
34:08our poison center in Georgia and the
34:10number and types of calls that we're
34:12getting. But these calls tend to be um a
34:16large number of them are asking us as
34:19toxicologists. Providers are calling and
34:21saying, "What do we do to help this
34:23person who's in withdrawal?" So many of
34:26these calls are uh withdrawals. Some of
34:28them now um are overdoses particularly
34:31as we're starting to see the synthetic
34:32products more and more frequently. And
34:34so that brings us to some of these
34:36synthetic products. Now again if you go
34:39into a shop and you buy leaf again
34:42that's the package on the right you see
34:44that the metragginine content is fairly
34:46low. I mentioned that folks to get those
34:49opioid like effects need somewhere
34:51between 50 and 150 millig. A single
34:54serving of this powdered leaf is about
34:5720% of that lower lower threshold. So it
35:01really kind of depends on how much
35:03people are taking. But we can also now
35:05get these concentrated catum extracts
35:09where instead of a single serving being
35:11only about 10 milligrams of metrogenine,
35:14a single serving in this extract on the
35:16left is 100 millig. This from a product
35:21safety standpoint is concerning to me as
35:23a toxicologist because these are not uh
35:27universally child-resistant
35:30products. And so a child getting into
35:32this dose of metrograine um can and has
35:37resulted in overdoses where children end
35:39up uh admitted to the hospital in the
35:41intensive care unit.
35:43These newerratom derived products focus
35:46primarily on those two metabolites that
35:49I talked about earlier, the 70 and
35:52pseudoindoxil. And again, these are much
35:54more potent than the metrogenine itself.
35:57So the lower doses just indicate that
36:00you need less to achieve the same
36:02effect. Again, if you look at this
36:05little package, which is very again from
36:08a child safety standpoint, very
36:10colorful. These tablets um are very
36:14small. They're very easily ingested. Um
36:17so my primary concern is children
36:19getting access to these. Um so you know
36:22drug storage, drug safety, this is not
36:24childresistant packaging. Um and a child
36:27getting into this much 70 uh could
36:29definitely end up in an overdose in a
36:31hospital admission.
36:33Similarly, when you start getting into
36:36um some of the newer marketing, you can
36:39also buy 70 products as these uh kind of
36:44pastry or candy like formulations. Um
36:47each of these cones contains 50 mg of
36:5170. Um and this here again, this is
36:54really a marketing thing. This is
36:56marketed as a catam gummy, but it really
36:58is just 70. So the packaging on this is
37:02not always consistent, not always well
37:05regulated. Um, and again, you know, you
37:07can open that and a kid just thinks
37:09those are gummies and eats them all.
37:12The pseudoindoxil has a very similar
37:15problem. Again, colorful packaging,
37:19really easily accessible, not
37:21childresistant.
37:24Um,
37:25is regulated differently in different
37:27states. Um some places have just local
37:31jurisdictions that ban or restrict the
37:34sale of these products. Some of them
37:37schedule 70 and pseudoindoxil as
37:40schedule one. So they're completely
37:41banned. And others have some
37:45different levels of regulation. For
37:47instance, you have to be 18 in order to
37:48purchase these products or you can buy
37:51catam leaf but can't buy 70 synthesize
37:5370 or pseudoindoxil. So there's a lot of
37:56variability on a state-to-state uh
37:58level. So that's all I have for the
38:00moment. Um I don't know if there are
38:02time for questions chairman or we
38:04>> Yeah, we have time for a few questions.
38:05Can you share the information too? You
38:08we you know I talked about about the uh
38:10kids. There's a slide for that I believe
38:12or a handout
38:13>> you gave.
38:15>> I I may have sent it as a as a PDF for
38:19the packet.
38:19>> Yeah, it was this one right here.
38:21>> Mhm.
38:23Um, anything you want to share regarding
38:24that regarding the uh concern or the
38:28Can you
38:30>> Okay, thank you.
38:34Also, one of the concerns that first led
38:36to the committee four years ago when we
38:37first brought the bill, uh the new the
38:40law was I've told the story before, but
38:43I was driving home from session and
38:45stopped in a gas station to get a diet
38:47coke and a candy bar or something like
38:49that to hit I-16 because I have to have
38:51a wakeup call on I16. Sometimes it gets
38:54kind of long and boring. And so I get my
38:56wife to call me and probably you guys do
38:58too. But um anyway, before I got on I16
39:03um I went to the gas station over there
39:04near the Chick-fil-A on Arkrite and they
39:07were selling them cred cupcakes right
39:09there beside the Reese's and Skittles
39:12and it was just right there out in the
39:14open. Now, that's been alleviated since
39:16now we have it behind the counter or in
39:17a lot case. But the packaging, I can see
39:20what you're saying. That is concerning
39:22>> and really my concern is um you know the
39:26the colorful marketing that's appealing
39:28to children. Um but uh just a a safety
39:33thing and this is true for any
39:34medication, not just forratom. Um any
39:37medication, you know, folks generally do
39:40not keep their meds out of sight, out of
39:42reach or locked up. And so, um, it's
39:45just easy for children to get into this.
39:47Children are very fast. They're very
39:49sneaky. And if you drop something, they
39:51pick it up and they put it in their
39:52mouth faster than you can blink. So, um,
39:55it's not always and certainly not often
39:58people being negligent or, you know,
40:01having these out on the kitchen table
40:03for their children to get into. It's
40:05just one of these things that happens.
40:07And unfortunately, as these products
40:09become more prevalent and more folks
40:11take them, it does uh increase the risk
40:13that children will be exposed. So again,
40:15I think product labeling, product
40:17safety, and product storage are really
40:19important things that we need to educate
40:22our consumers about.
40:24>> Thank you. Questions committee? Dr.
40:29>> Thank you so much. And thank you, Dr.
40:31Stack, for coming on such short notice.
40:32I appreciate you for being here. Uh, a
40:35couple quick questions and I think you
40:36were starting to lead into this when
40:37you're talking about labeling and dosing
40:39and those types of things. Thanks for
40:41showing the pictures of the packaging.
40:42That's really helpful. I couldn't read
40:43like the the point, but just just so we
40:46know how this is sort of marketed in a
40:48standard way.
40:50>> Um, is labeling for dosage and
40:53milligrams per volume standardized
40:57across formulations? That is a great
41:00question. It's not. It's incredibly
41:02variable and it is not intuitive
41:05whatsoever. So, one of the images I
41:08showed of the 70 opia product, the had
41:12the four tablets and on the front it
41:15said 80 milligrams. And if you just
41:17looked at that quickly, you might think,
41:19oh, there's 80 milligrams in this. I
41:21should take one tablet at a time. But in
41:25reality, if you read the very fine
41:27print, [laughter]
41:29the dose is half a tablet. And so the
41:32tablets are not scored. They're very
41:34crumbly. And so it's difficult to dose.
41:36Similarly, if you look at the package of
41:38the leaf,
41:40>> um the dose there was a quarter of a
41:43teaspoon. Uh and
41:46that's a very small amount. It's
41:47difficult to measure. And the doses in
41:50some products, if you look at
41:51pseudoindoxil products, they become even
41:53less intuitive where the dosing may be a
41:56quarter of a tablet. Anyone's tried to
41:58ever break a tablet into half, let alone
42:00quarters, that's going to lead to some
42:01very inconsistent dosing.
42:04>> Right. And just to follow up on that, in
42:06terms of how a dose is presented, it
42:08obviously gives an indication for
42:09someone who isn't reading the fine print
42:10of how it should be taken. So, you know,
42:12I think it's pretty reasonable for
42:15someone who picks up a pill or a tab to
42:17assume that one tab is one dose and not
42:20assume you have to break it into four
42:21pieces, which as we know is
42:22>> basically impossible. Um, for the the
42:26drinkable formulations, the shot, the
42:28shot, the 15 milliliters, um, which is
42:31about half an ounce, is
42:34>> considered the standard dose. So the
42:36whole shot, but the amount of
42:38metragenine if you're buying a catam
42:40concentrate
42:42um is going to vary between products. So
42:46it's not a standard 100 milligrams per
42:4815 mls. Uh similarly once you get into
42:51the the liquid formulations of synthetic
42:5470 and pseudoindoxil, those are equally
42:57variable in how much of each product
42:59they put in.
43:00>> Okay. Thank you.
43:01>> Okay. Thank you. And represent
43:03Matthysse.
43:06appreciate you
43:07>> this morning. Uh when I did my
43:10introduction, I didn't say I was
43:12actually in the funeral business and I'm
43:14also was corer office for over 30 years.
43:17Also a licensed EMT. So I've seen a lot
43:20of different overdoses and those type
43:24things. Well, that's uh not the real
43:27question I want to ask. One thing that
43:29disturbed me if you said that the test
43:33has not been completed on the hazards of
43:36cratom is did I understand you to say
43:39that
43:40>> there's a there are a lot of studies
43:42currently ongoing trying to characterize
43:44clinical effects in general both
43:47benefits and hazards from catam use. Um,
43:50we know on a very of general level that
43:55it alleviates pain, that it alleviates
43:57withdrawal symptoms, that some people
43:58find it helpful for mood. We also find
44:01on a very general level that it can be
44:04something that turns into a substance
44:05use disorder where people need to
44:09function in their everyday life and
44:10can't stop using it. It becomes a
44:12compulsive thing. Um, and that people
44:15can withdraw from it. So we know kind of
44:17those broad high-level clinical effects.
44:20What we don't necessarily know very
44:23clearly are the exact biochemical steps
44:25that are leading to that there. There's
44:28still a lot of active research at that
44:30kind of cellular level.
44:32>> So we're not sure exactly how it affects
44:35people in a lot of ways. Is that
44:36correct?
44:37>> We do know some of it. For instance, we
44:39know that the active ingredients act at
44:40the opioid receptors.
44:43There are also some other
44:45neurotransmitter systems that they act
44:47on. Those are still very murky because
44:49the experiments show that metrogynine
44:52and 70 will act one way in mice and a
44:55different way in dogs and yet a
44:58different way in humans. So we don't
45:01have all of those details worked out
45:03yet.
45:04>> Follow up. That kind of scares me a
45:06little bit cuz this is so available to
45:09any age person and there's no limit on,
45:12you know, how young you have to be to
45:14get this. Uh and we don't know a lot
45:17about it. Uh we do know it has side
45:20effects.
45:21>> Um that's just concerning to me, but I
45:24do appreciate your your knowledge and I
45:27appreciate you being here today. Thank
45:28you.
45:29>> Thanks, Representative Matthysse. Now,
45:30there is a current law that on the books
45:32that you have to be 21 and and um you
45:35should have that in your packet. If you
45:37don't, we'll send it to you. And if
45:39people in the audience need a copy, just
45:40let us know. We'll make sure um uh I can
45:44tell you how to get it. It's it's
45:45online. It's not hard at all. We do have
45:47some restrictions, but thank you. And
45:49then um I think two more questions.
45:52Let's go to uh Chairman Corbett.
45:55>> Thank you, Dr. Spec for being here this
45:57morning. And uh that's very very
45:59concerning when you you said one that
46:01it's 10 times more potent than morphine
46:03in certain forms. Is that correct?
46:06>> That seems to be what some of the
46:07initial data suggest. And again that's
46:10test tube data. We're uh to get to the
46:13prior question. We're still not 100%
46:17sure exactly how potent it is in humans
46:19and how it compares to the other opioids
46:22that we know that those studies are
46:24still in process. Okay. And then I guess
46:28several states have passed legislation.
46:29I mean all the way from some ban it
46:31completely, some put guard rails on it
46:34far as the age, the packaging, you know,
46:36where it's located, who who can buy it,
46:38where it's located. Uh is it a certain
46:41state that has is doing something that
46:43that youth would recommend us, you know,
46:47emulating?
46:48>> That is a great question. And to be
46:50honest, I haven't looked at the
46:52individual states in detail enough to
46:54have an informed opinion on that. Um but
46:57I do think some sort of regulation is
47:00appropriate. Um I think trying to ban
47:04substances completely leads to its own
47:07problems. Uh we know that there are some
47:09folks who find this beneficial. Um, and
47:12from my experience as an addiction
47:16medicine provider and someone who's very
47:18focused on harm reduction, I would want,
47:22if I had to choose between someone
47:25having uncontrolled
47:28use of fentanyl versus uncontrolled use
47:30ofratom, credum is much safer. Um, so I
47:34think uh
47:37having some restrictions on it, some
47:39regulations about how it's packaged and
47:42who can buy it are very beneficial. And
47:45>> thank you.
47:46>> Thank you, Representative Chairman
47:48Corbett. And now, Chairman Meeks.
47:50>> Thank you, Mr. Chairman. Thank you for
47:52being here today. And just to follow up
47:53on the question of of uh of the answer
47:56to the question you just answered,
47:59should there be uh thought given to
48:02where it is purchased, whether it be
48:04under the supervision of a pharmacist
48:06versus a convenience store or other
48:09shops that may not have anyone in that
48:12shop that can give any medical advice as
48:15to the patients and making sure that
48:17given that I mean given what it's being
48:20used to treat.
48:22Any thoughts on that?
48:24>> I do think that it should be
48:27perhaps not as freely available as it is
48:31right now. Um, however, it's not
48:35regulated by the FDA. It is not
48:37considered a pharmaceutical product.
48:39It's considered an herbal supplement.
48:41Um, and so I
48:44I think it would be difficult to
48:45restrict it to healthcare settings. I
48:48also think it would be difficult to
48:49restrict it to healthcare settings
48:50because there are a good number of
48:51physicians who don't know very much
48:53about it. Um so even putting it for
48:56instance in the hands of pharmacists or
48:58physicians or other health
49:00practitioners, you may not necessarily
49:02be getting the most um informed advice
49:05about it. It's it's very tricky.
49:08>> Thank you, Mr. Chairman.
49:09>> Okay. Thank you. Appreciate your
49:11testimony. And next we'll have Dr.
49:14Patrick Wilkins from Georgia Poison
49:16Control and Grady. And by the way, we
49:18did ask for air recognition earlier
49:19before the meeting started and checked
49:21the air yesterday. And so, uh, I think
49:24we've called and if you can touch base
49:26with Deborah again for me, see if they
49:28call GBA for me. We will keep trying,
49:30guys.
49:33>> Yes. And we I think we're not in
49:35session, so we can take our coat up
49:36coats off if we need to.
49:41>> All right. Thank you for being here and
49:43just again thank you.
49:45>> All right. Thanks, Mr. Chairman. My name
49:47is Patrick Filkins. Uh I'm a pharmacist
49:50by trade uh with additional training in
49:52emergency medicine and I actually
49:54trained under Dr. Stack in uh toxicology
49:57and I have stayed on with uh Grady and
50:01the Georgia Poison Center and um I've
50:05testified to this committee a couple
50:07times before. Um so I'll keep my
50:09comments on the brief side. The main um
50:12the main thing I wanted to speak about
50:14today is what we're actually seeing in
50:16Georgia. Um there are a lot of uh
50:20studies that have been published
50:21concerning national data. Um but here at
50:26the Georgia Poison Center, um we serve
50:28the entire state of Georgia, uh every
50:30single county. We're the only poison
50:32center in the state. And so we are uh
50:35inevitably the ones being called um by
50:38providers and by patients. um who need
50:41help um after being um exposed to these
50:45medications or uh as Dr. Steck alluded
50:47to um unfortunately going to withdrawal
50:50um from sessation of
50:53um
50:55but prior to that you know Dr. did a a
50:59good job of alluding to the fact that um
51:02all of these products are are
51:04essentially unregulated. Um they are,
51:07you know, could all be marketed as
51:10um but a study was just published in and
51:12where they kind of did a secret shopper
51:16um and went around to to different
51:18stores um and purchased a bunch of
51:20different products and tested all the
51:22products as to what they actually
51:24contained. uh and despite being marketed
51:26as uh up to 80% of them
51:30uh were actually just purified uh 7
51:33hydroxy metrophen uh products uh and
51:36some of which uh despite you know saying
51:39it contain 50 mg or 100 milligrams could
51:42contain up to uh 700 milligrams of the
51:45substance which would be at least
51:48incredibly toxic um to our pediatric
51:51population.
51:52Um, additionally that you know the FDA
51:55has determined that uh is not
51:58appropriate for use as a dietary
52:00supplement under section uh 402 um of
52:03the federal food drug and cosmetic act.
52:05And they concluded that um products are
52:08adulterated because they lack adequate
52:10safety information
52:13uh and function as unsafe food
52:15additives. Um but again in this uh same
52:19study where they went around and
52:20purchased these products and tested them
52:22um they also found that up to 60% of
52:25vendors marketing these products um uh
52:29purported these products to you know
52:31treat pain or um falsely claim that uh
52:35these products are safe in pregnancy
52:36which are certainly not. Um, so you
52:39know, the regulatory status even
52:41nationwide, um, is very murky, but I
52:46really want to touch home on what we're
52:47seeing in Georgia. So, you know, the
52:49last time I testified, I had data, um,
52:52up through 2025 and alluded to the fact
52:56that, uh, we have seen a 400% increase
52:59in pediatric exposures.
53:02Um, and the exposures that are getting
53:04called to us are going up exponentially
53:07every year. Um and since 2018 we're now
53:11to um 747 total cases but uh we have
53:16already seen 161 cases year to date this
53:20year in 2026. That has already eclipsed
53:23uh last year 2025 which was the previous
53:26highest year uh of exposures.
53:29Uh year to date we've already had um two
53:32fatalities uh related toratom reported
53:35to us. um and the cases um that we would
53:41document as uh having a a major medical
53:44effect. So something uh such as
53:48significant respiratory depression,
53:50significant alter mental status, um
53:53extremely low blood pressure, things
53:55that require pretty substantial medical
53:57intervention.
53:59um those cases have have tripled this
54:01year compared to last which was uh again
54:04our highest year on record of these
54:07sorts of exposures and you know we're
54:08not even halfway through the year yet.
54:12Um and 86%
54:15of these cases um that are getting
54:17called to us are needing treatment in a
54:20healthcare facility. So um regardless of
54:24the severity of the case um the fact
54:27that being this available uh it's
54:30increasing the healthc care burden in
54:32the state of Georgia um which can also
54:35particularly strain our rural um
54:38counties in in which healthcare
54:40resources tend to be limited um already
54:45and I alluded to pediatric exposure. Um
54:48so
54:50in 2024 um the last year in which we had
54:55uh or since 2020 or since 2018 in which
54:57we had singledigit pediatric exposures
55:00of three um we've already jumped to um
55:0513 uh year to date. Um so well above the
55:09the 400% increase.
55:12Um and in the same study in which they
55:16did um Secret Shopper repurchasing, 91%
55:20of uh the formulations available um were
55:24candy-like flavors such as cotton candy,
55:26blue raspberry um things that would be
55:31um marketable to children and things
55:34that children would go after um if found
55:37in the home.
55:39So, you know, our current law um has
55:43pretty pretty good regulations that have
55:46been enacted to to try to decrease um
55:49the unsafe exposures to the population.
55:52Um but a a recent study was published um
55:56regarding
55:58uh states with with you know these sort
56:00of restrictions um compared to states
56:03with with full ban and um states with
56:07these consumer protection laws had uh
56:09over four times the rate of severe
56:12medical outcomes that I alluded to
56:14earlier that we're seeing in Georgia.
56:16And they also have um cratom detection
56:19and fatal overdoses four times greater
56:22than states with fullban. Um so
56:27uh although you know full ban is not
56:29going to completely eliminate um the
56:32availability uh ofratom um but you know
56:37having murky regulations um compared to
56:41fullban um at least with the data that
56:44we have now um potentially would
56:47indicate that fullban may be safer from
56:49a public health perspective.
56:51Um but you know I'll conclude my
56:53comments now and and answer any Georgia
56:55specific questions that you have or any
56:58um toxicology related questions.
57:00>> Okay, we've got a few questions. I just
57:02want to say thank you for being here
57:03again and testifying and um we'll I'm
57:07going as what I can see in order and
57:09number 16 was first. So uh
57:12Representative Kendrick.
57:13>> All right. Thank you, Mr. Chair, and
57:15thank you for your testimony. I just
57:17want to be clear about the studies and
57:20um the fatalities that you mentioned.
57:22Are we you talking about the pure
57:23leafratom a combination of both of them?
57:27Um because I know we've had a lot of
57:29conversation about the differences
57:30between pure leafratom and then
57:32derivatives of it. So I want to be very
57:33clear
57:34>> of course. So, um, one of the inherent,
57:40um, kind of vulnerabilities, if you
57:42will, with the data, um, the the coding
57:45system that we use, um, to code all of
57:48these exposures. Um,
57:52it it can't keep up with the amount of
57:55products that are available on the
57:56market. Um, so, you know, I can I can
57:59track a specific brand of an
58:02acetaminophen tablet. I can track a
58:04specific brand, you know, of a blood
58:06pressure medication just because of the
58:09um the the regulatory nature and in the
58:13manufacturing um and lack of
58:15standardization. You know, it's coded
58:18generically as umratom
58:22>> um and we do have the availab
58:25availability now to um see what our port
58:30specialists are searching verbatim. Um,
58:33so you know I can tell you if the name
58:36of the product uh indicates you know
58:39it's 7 hydroxy or or pseudoindoxil.
58:44Um but unfortunately due to the
58:46marketing most products are just saying
58:48it's cratom. Um, so it's uh it's hard
58:52from our standpoint at the poison center
58:55um from you know a public health
58:57perspective
58:58um to really tease out the exact product
59:01and whether it 100% was you know pure 7
59:05hydroxy or if it was pure leaf um
59:09because again they could be marketing it
59:11as pure leaf but really you know we have
59:13no no idea um exactly what that product
59:16was.
59:18>> Okay. Thank you. Okay. Chairman Meeks.
59:22>> Thank you, sir. Thank you, Mr. Chairman.
59:24Just to add on to that previous
59:26question. So, can you tell us from the
59:29instances that you know of whether that
59:31whether those fatalities have been from
59:33the synthetic
59:35uh I guess would be 70 version or the
59:38natural leaf?
59:41>> Um I would have to uh go back and read
59:44the specific charts. Um it's probably
59:46some information I could provide to you,
59:48you know, at a later date, but um
59:51>> at the end of the year, uh we have to
59:53report all fatalities um to NPDS and
59:57it's at that point where um we we try to
1:00:01obtain, you know, medical examiner
1:00:03reports and um potentially hospital
1:00:06records to really
1:00:08uh dive in and see if um it was either
1:00:12related or a definite cause. Um, but
1:00:14again, that's something that happens at
1:00:16the end of the calendar year.
1:00:18>> Okay. Thank you. Thank you. And we'll
1:00:19follow up so we can get that info. Thank
1:00:21you.
1:00:22>> Okay. Next will be Representative
1:00:24Matthysse.
1:00:27>> Not Matthysse. I apologize. Ridley over
1:00:29here.
1:00:34>> No, no, no, no, no.
1:00:37>> I my apologies.
1:00:38>> Not a problem. I have two questions.
1:00:39>> Yeah, absolutely. So when you talk about
1:00:40the fatalities, did they have any
1:00:42co-orbidities or was it strictly cratum
1:00:44overdose was the cause of death?
1:00:46>> Yeah, again I would have to go into the
1:00:47chart um and see what was coded um to to
1:00:50see if they had any coorbidities um
1:00:53underlying if it was reported to us. Um
1:00:56so again I could you know provide
1:00:58>> because I think that's very important
1:00:59because you know saying well they had
1:01:01cratom in their system and that caused
1:01:02the overdose when they had stage four
1:01:04cancer and they were trying to take the
1:01:05pain you know it's not necessarily the
1:01:06cratom that killed them. It could have
1:01:07been the cancer. And then my second
1:01:09question and the first lady started it
1:01:11um she said in her chart she show uh
1:01:14showed that um it went up to 1500 calls
1:01:17for a year for creatum and then she said
1:01:20afterwards the last two years it jumped
1:01:21to 3,000 calls. How many total calls
1:01:23does the poison control center get and
1:01:25how do those numbers compare to things
1:01:27like alcohol, marijuana or fentanyl or
1:01:29heroin?
1:01:30>> So actually our most um I'll come out on
1:01:34the substances. Our most commonly uh
1:01:36called substances are analesics. So you
1:01:39know acetaminophen, ibuprofen, things
1:01:42like that. Um we really don't get called
1:01:45as frequently as you would think uh
1:01:47regarding marijuana or alcohol or even
1:01:50opioids unfortunately. We don't
1:01:52particularly get called on a lot. Um and
1:01:55I think a big part of that is because uh
1:01:58emergency medicine providers uh
1:02:00obviously at this juncture in the opioid
1:02:03epidemic are very well-versed in
1:02:05managing those patients. They administer
1:02:07nlloxxone. So they typically don't need
1:02:09you know um elevated expert help from
1:02:12toxicologists at this point to manage
1:02:13those cases. So um I couldn't give you
1:02:16an exact figure on how often we're
1:02:18getting called, but I will say it is
1:02:20it's I'm willing to less than than you
1:02:22would think. Um I'm sorry the first part
1:02:26>> the total number of calls y'all.
1:02:28>> Yes. Um so the total number of cases
1:02:30that we manage varies yeartoear. Um last
1:02:34year we managed about 75,000 cases were
1:02:38uh typically either the third or fourth
1:02:40busiest poison center in the country.
1:02:42>> Okay. So out of the 75,000 3,000 or so
1:02:45were forratom.
1:02:47>> Um
1:02:48so that was um I believe Dr. provided
1:02:52data nationally. Um, so
1:02:54>> also was 3,000 nationally.
1:02:56>> Correct.
1:02:56>> How many like do you know what the
1:02:58>> our year to date is 161 cases.
1:03:00>> So 161 out of 75,000.
1:03:03>> Well to today it would be
1:03:06>> okay. 35 or half that number. Yeah. So
1:03:08161 out of 375.
1:03:10>> Okay. Okay. Thank you.
1:03:12>> Yeah.
1:03:12>> Okay. Thank you. And uh Representative
1:03:15L.
1:03:17>> Thank you so much. Uh I want to go back
1:03:19to that figure that you cited before
1:03:20that there's been a 400% increase in
1:03:22pediatric exposures.
1:03:24>> That was uh that was up to 2025.
1:03:27>> So 2025. Yeah. Um obviously the the
1:03:29point of a study committee ultimately is
1:03:31to develop policy recommendations that
1:03:33we can work on uh as we come back in to
1:03:35the next session and sessions beyond.
1:03:38Let's talk just for a second about uh
1:03:39the marketing and the flavors that you
1:03:42cited um as being contributive to
1:03:45pediatric exposures in particular
1:03:47because of appealing to young children.
1:03:49I think we could probably all agree uh
1:03:51regardless of our stance on this that
1:03:52that children should not be taking the
1:03:55substance that is illegal for people
1:03:56under 21 to get in this state. Um can
1:04:00you talk a little bit about your um
1:04:02perspective on
1:04:05on something we've talked about with
1:04:07respect to for example vaping where we
1:04:10restrict the type of marketing and the
1:04:12types of flavors and presentations that
1:04:14can appeal to a younger population. For
1:04:16example, fruit and candy flavors. Um
1:04:21how it is marketed to whom these ads are
1:04:23shown. Um,
1:04:26with with the vaping, something that
1:04:27we've talked about a little bit more,
1:04:28you know, how it's presented
1:04:29commercially is oftentimes vapes are
1:04:31presented as a safer alternative for
1:04:34cessation. Sounds a little bit familiar
1:04:35in the setting, right, for smoking
1:04:37sessation, but I think it's maybe a
1:04:39little bit more of a dubious claim when
1:04:40you're trying to talk about smoking
1:04:42sessation for an older population, but
1:04:43you're selling cotton candy flavored
1:04:46vapes. Do you think there's a role for
1:04:48that type of flavor restriction or
1:04:50marketing restriction in cratom sales?
1:04:54Um certainly
1:04:57you know I think in addition to um
1:05:01minimizing the appeal to and I won't
1:05:05even say you know pediatric population
1:05:07when I when I say pediatric that uh is
1:05:09patients six years and under. So,
1:05:11obviously, you know, a six-year-old is
1:05:13not going into uh the gas station and
1:05:16and purchasing these products, right?
1:05:17It's more so uh if it's laying around in
1:05:19the home, they think it's a gummy worm
1:05:21or or what have you. Um so, you know, in
1:05:25that regard, I I think there's no reason
1:05:27to have
1:05:29marketing such as that to you don't have
1:05:32to appeal to the adult population. And I
1:05:34think a lot of people um who are using
1:05:36this product know what they're using it
1:05:38for. And you know there's there's no
1:05:40reason for it to be more accessible or
1:05:42more appealing to children. Additionally
1:05:45um you know there should certainly be
1:05:47packaging restrictions. I think a big uh
1:05:49a big uh poison prevention initiative
1:05:52historically has been child resistant um
1:05:55packaging and specifically you know if
1:05:57if they're capsules being in um a bottle
1:06:00that you know children
1:06:02under the age of six can't open you know
1:06:04within 15 minutes some something such as
1:06:07that um so I think that's another
1:06:10potential initiative that could be
1:06:12undertaken is um preventing the sheer
1:06:15amount that these children can be uh
1:06:17exposed to and you know that is
1:06:20historically done with all you know
1:06:21overthec counter medications through
1:06:22tribe resistant packaging.
1:06:25>> Okay, thank you very much.
1:06:28>> That's it.
1:06:29>> All right,
1:06:30>> appreciate you being here. We'll touch
1:06:31base again. Appreciate your uh
1:06:33involvement and work with Georgia Poison
1:06:36Control. Next will be um Jeff Breedlove,
1:06:39CEO of American Addiction Recovery.
1:06:41Also, I want to give a special shout out
1:06:42to Dr. Sam Parks Brown from I believe
1:06:45our regional director FDA.
1:06:49Yes. Thank you for being here being here
1:06:55and welcome to everybody else. Like I
1:06:57said earlier,
1:06:59>> Mr. Way.
1:07:03>> Yes.
1:07:06>> Thank you, Mr. Chairman. If it plea,
1:07:08give it please the committee. Um, I'm
1:07:10Jeff Reed Love and I am the CEO of the
1:07:14Georgia- based American Addiction
1:07:15Recovery Association. More importantly
1:07:18than that, I'm a person in long-term
1:07:20recovery from addiction. I was in active
1:07:22addiction for 30 years and I'm blessed
1:07:24to have been in recovery for nine years.
1:07:27Of course, during that time in recovery,
1:07:29I worked here at the Georgia State.
1:07:31Don't don't hold it against me, but it
1:07:32was the Senate. Sorry. Apologize.
1:07:36But I was a policy analyst for you. I
1:07:38worked for Governor Deal. I worked for
1:07:40Georgia members of Congress. And um
1:07:44you know, I was an act of addiction. And
1:07:46I'm blessed to be standing before you as
1:07:48a survivor.
1:07:50You um you honor families and and
1:07:55survivors by talking about this policy
1:07:57issue. So first and foremost make let me
1:08:00make sure on behalf of everybody
1:08:02impacted by this that I say thank you
1:08:04for taking time out of your schedules to
1:08:06talk about this policy issue. You know
1:08:08addiction itself opioids and fentanyl
1:08:11are the number one cause of death for
1:08:12Americans 18 to 45
1:08:15and the number one industry impacted is
1:08:17construction and the number two is
1:08:18agriculture and the number three is
1:08:21hospitality and entertainment and those
1:08:22are all things important to our job base
1:08:24in Georgia. So
1:08:27people
1:08:29in my space,
1:08:33this is a complex issue and I was back
1:08:35there praying about what what what I was
1:08:37going to start out with.
1:08:39And and I got to say, Mr. Filkins, what
1:08:42a great presentation. And I think the
1:08:44thing that should scare all of us to
1:08:46death is the secret shopper phenomenon.
1:08:50And he's not the first leader in this
1:08:52state. others have shared at conferences
1:08:55about the secret shopper and the testing
1:08:58at places like UG. It's never what's on
1:09:02the package. So, I thought there were
1:09:04going to be I thought I was going to say
1:09:06profoundly that there were two kinds of
1:09:08people you're going to hear from in this
1:09:09process. But I realized listening that I
1:09:13was wrong. There's three there's three
1:09:14types of people you're going to hear
1:09:16from as you do your important work. One
1:09:19group of people are going to be people
1:09:21that stand before you and and they're
1:09:25here for public health and public safety
1:09:28and they don't stand to profit
1:09:31personally from anything they testify
1:09:34about.
1:09:36Then you're going to hear from some
1:09:37people, some of my brothers and sisters,
1:09:39some wearing these shirts, some dear
1:09:41friends that really believeratom helped
1:09:44them, helped them. And it probably does.
1:09:50And I wouldn't begin to to argue with
1:09:52them
1:09:54because they probably got one of those
1:09:56packages that actually was healthy
1:09:59and it probably does help them. And I
1:10:01hope they get to testify and hear and we
1:10:03hope we hear their voice. But y'all,
1:10:05you're going to hear from some people
1:10:09who believe that greed is good.
1:10:13They're here to exploit my brothers and
1:10:15sisters in active addiction.
1:10:18They can say whatever they want to say
1:10:20to you over these next weeks and months,
1:10:22but this is the number right here,
1:10:26273.
1:10:29And it's the number for you to consider,
1:10:32and each of you will react to this
1:10:33number differently, but that's the
1:10:35number that the CDC says has died
1:10:38nationally
1:10:40from fromratom.
1:10:42And maybe that number is okay with you.
1:10:44It's clearly okay with some people,
1:10:48not okay with me. You see, I'm going to
1:10:50speak for people who can't speak today
1:10:53or won't speak today. Because the number
1:10:56one
1:10:59danger around addiction that most of us
1:11:02believe in our community isn't any
1:11:04substance we put in our bodies. It's the
1:11:06stigma around the disease.
1:11:09And some people will not come and stand
1:11:10behind a podium like I will because
1:11:13they're afraid they'll lose their job.
1:11:16They're afraid their church will ask
1:11:17them to leave the congregation.
1:11:20They're afraid they'll be made fun of at
1:11:22a school.
1:11:25So I want I want to say this medical
1:11:28assisted treat medically assisted
1:11:31treatment is important. There are
1:11:33multiple pathways to recovery
1:11:36and we should support legitimate
1:11:38scientifically based products that help
1:11:42one of my brothers and sisters who are
1:11:43still in active addiction find long-term
1:11:46recovery. Our brother and sister in
1:11:48recovery sustain recovery. I'll be the
1:11:51first one at a podium to say make that
1:11:53product legal, affordable, free if
1:11:56necessary.
1:11:59This ain't that.
1:12:02This ain't that.
1:12:06Representative Skim Kim Scoffield,
1:12:09she held up a picture at a prior study
1:12:12committee meeting or maybe it was a
1:12:14committee meeting of Funians sold in her
1:12:18district. And by the way, I don't live
1:12:20in her district, but I live very close
1:12:21to it. I live right here in downtown
1:12:23Atlanta. Funians,
1:12:26you know, you knew who that was aimed
1:12:27at.
1:12:29It's aimed at our kids. It was aimed at
1:12:31our busy parents who run into the
1:12:33convenience store, grab the product,
1:12:35throw it at their kid in the back seat
1:12:37on the way home from their second job.
1:12:41And by the way, 233,
1:12:45you know, that's deaths.
1:12:48What about the medical conditions of
1:12:50people that survive?
1:12:53Let's talk about that, too. So, if we
1:12:56come up with a product
1:13:00that one of my brothers and sisters can
1:13:01get that's safe, let's do it. But you do
1:13:04not get those at convenience stores.
1:13:07I went to a convenience store yesterday
1:13:09on purpose.
1:13:12Quick trip.
1:13:14They have little Pepto-Bismol things and
1:13:16little Tylenol things and little things
1:13:19that that you can get if you're
1:13:20traveling and and and want some relief.
1:13:23You do not go to a convenience store, I
1:13:25submit to you, to save your life, to
1:13:27find a product that's going to keep you
1:13:29in recovery from addiction.
1:13:32You don't.
1:13:34It's about integrity.
1:13:38If the men and women pushing this
1:13:40product and asking the state to allow
1:13:43them the privilege to compete in the
1:13:46free market with their product really
1:13:50cared about people, they would be
1:13:52tripping over themselves to make sure
1:13:54the product was full of integrity. And
1:13:56they had medical associations endorsing
1:13:59them left, right, and center. But they
1:14:01don't. They put it in convenience
1:14:03stores.
1:14:05Now, I'm just a guy in recovery
1:14:08and I didn't stay at a Holiday Express
1:14:10last night. So, I hope you take this for
1:14:12what it's worth.
1:14:15But I do know the FDA
1:14:18and I do know that under Biden and
1:14:20Trump, the FDA in a bipartisan manner
1:14:25continues to warn the public against the
1:14:27use of for medical treatment until
1:14:30safety and effectiveness can be
1:14:31evaluated. In fact, I know the FDA has a
1:14:34website that literally says
1:14:42the time to act is now. We can and must
1:14:44prevent the wave, the next wave of the
1:14:45opioid crisis.
1:14:48Bipartisanly FDA, Biden and Trump
1:14:51administrations. I know the Mayo Clinic.
1:14:54I've been to the Mayo Clinic in
1:14:55Minnesota. It's pretty reputable place.
1:15:01The Mayo Clinic states that has not been
1:15:03shown to be safe or to treat any medical
1:15:06condition and the FDA has warned people
1:15:10not to use them because of possible
1:15:11harm. The American Psychiatric
1:15:14Association, not a hot bed of
1:15:16conservatism,
1:15:18a bipartisan group of professionals,
1:15:22they consider
1:15:24to be opioidike components having the
1:15:27potential for dependency and addiction.
1:15:29Our attorney general Chris Gar on
1:15:32November 13th, 2025 issued a formal
1:15:35warning to Georgia about this very topic
1:15:40that it was dangerous for Georgia. And I
1:15:43want to say to to my my the first
1:15:45testifier
1:15:47uh when she commented that well compared
1:15:50to fentanel this is safe. I got news for
1:15:54you. Compared to fentanyl, that nuclear
1:15:57material in the ground in Iran, that's
1:15:59safe, too. Fentanyl is a weapon of mass
1:16:01destruction. And a little bitty grain on
1:16:03the top of a pin pencil can kill you
1:16:05dead. Of course, it's safer than
1:16:08fentanel.
1:16:12But it's not safe.
1:16:15It's not. Not today.
1:16:18Not with the packaging. Not being
1:16:20honest.
1:16:22So look,
1:16:26clinic says more than 3,400 cratom use
1:16:29uh poison reports from 2014 to 19. The
1:16:33233 deaths according to the CDC,
1:16:367% of the overdose deaths in Georgia
1:16:39involved. And I saw this this morning
1:16:43in this room.
1:16:46The GBI autopsy data according to the
1:16:48state uh medical examiner contributed
1:16:52according to the GBI to at least five
1:16:54deaths in 2016 and 11 deaths in 2017.
1:16:58And Dicab County, Georgia, the coroner
1:17:01reported that chemicals appeared in
1:17:03autopsies six times in 2025.
1:17:06Six
1:17:0811
1:17:11five. Those are not big numbers.
1:17:16to a committee,
1:17:18but they're big numbers to a family.
1:17:21They're big numbers to a community.
1:17:24Those are Georgia families. Those are
1:17:26metro Atlanta families
1:17:28who probably won't come here.
1:17:31They went to a funeral
1:17:34over a product that we're letting be
1:17:35sold like the Wild Wild West. And
1:17:38somebody's making money off of my
1:17:41brothers and sisters. And it's got to
1:17:43stop.
1:17:44So my my recommendation today is this.
1:17:49Let's get let's get a Georgia solution
1:17:51where we can get this in the hands of
1:17:53reputable medical professionals
1:17:58and let's get a product on the shelves
1:18:00that people know what they're buying,
1:18:04not aimed at kids, and it's there for
1:18:06medical purposes. Now, if people say, "I
1:18:09don't want it for medical purposes. It's
1:18:11a herb and I just want it because I'm an
1:18:13American and I can do what I want.
1:18:15That's great with me. It's none of my
1:18:16business.
1:18:18But I would think we could all agree
1:18:21we at least want to know what's in the
1:18:23packages. And we at least don't want
1:18:25packages aimed at kids. And
1:18:29if you pass any law,
1:18:32rule or regulation,
1:18:34I implore you
1:18:37to have funding available for the
1:18:39appropriate state agency to enforce the
1:18:44law you pass. It does no good
1:18:48to pass a law
1:18:51without enforcement mechanisms behind
1:18:53it. And if you don't believe me, I will
1:18:57drive you to a convenience store in
1:19:00metro urban Atlanta, suburban Atlanta,
1:19:02in rural Georgia, and show you what I've
1:19:05seen on the shelves.
1:19:08They're not going to take it off. Bad
1:19:11actors are not going to do that. So,
1:19:13it's a serious issue. It's a life and
1:19:14death issue. And I did want to say this.
1:19:23We're going to hear people I'm a
1:19:25prohibitionist. I'm intolerant. I don't
1:19:28care. No, I care about the people behind
1:19:31that 233 number. I care about the people
1:19:34who were so ashamed of what happened
1:19:36when they sought a relief. Let me let me
1:19:38be real for a minute, then I'll end. Mr.
1:19:40Chairman,
1:19:40>> thank you. Y'all, I was an act of
1:19:43addiction. I was running and gunning. I
1:19:45live in Grant Park. I was running and
1:19:48gunning on these streets. These streets
1:19:50that you can walk to from where we sit.
1:19:53I've been in places that you don't want
1:19:54to go to in your nightmares.
1:19:57I went there because of my addiction.
1:20:00It's a brain disease.
1:20:04I sought anything and everything because
1:20:06my brain wasn't functioning healthily.
1:20:12People in active addiction don't read
1:20:14government reports.
1:20:15They don't read labels on packages.
1:20:18You're right.
1:20:19It's pretty sure that they think it's
1:20:22one, you know, the whole dosage is one
1:20:23pill, not you got to break it. We're not
1:20:26reading that when we're in active
1:20:27addiction. We're not reading that when
1:20:29we're in pain in early recovery trying
1:20:31to feel better to make the pain go away.
1:20:34We trust the store it sold at.
1:20:38We trust the state wouldn't let it be
1:20:40there.
1:20:42So, I'm glad these folks are here today
1:20:45and that each of them are a blessing.
1:20:48And I thank God and my higher power,
1:20:50Christ, that they are alive.
1:20:53But they're blessed to be alive.
1:20:56They're not among the 233.
1:21:00And we've got to find that balance to
1:21:02give a safe product to people who
1:21:04deserve it,
1:21:07not have something on the shelves that's
1:21:09not. And I'll leave you with this.
1:21:13I will make a prediction as a former
1:21:14staff member.
1:21:17If you don't do what Alabama's done,
1:21:19what Florida's done, what Louisiana's
1:21:22done,
1:21:25what Arkansas's done, what Tennessee's
1:21:27done. If you don't join these other
1:21:29southern states, I mean, god forbid we
1:21:31talk about the West and the North. Let's
1:21:32forget those folks. They don't get it.
1:21:34Go dogs.
1:21:36If we don't at least do what our
1:21:37brothers and sisters across the South
1:21:39are doing in their state general
1:21:40assemblies and protect our communities,
1:21:43you will be back here within two
1:21:47election cycles
1:21:49having a committee on how you disperse
1:21:53theratom settlement dollars just like
1:21:55you're figuring out how to disperse the
1:21:57opioid settlement dollars today. Because
1:22:00there the deaths will increase,
1:22:03the lawsuits will happen and you will
1:22:06have been part of making a choice at
1:22:08this moment in history. This is a moment
1:22:10in time for you. Are you on the side of
1:22:12history of those for public health who
1:22:14will not profit, who want safety for our
1:22:17communities and our families, or are we
1:22:19on the side of hey, let it let it ride.
1:22:21It's okay. It's free enterprise. Let
1:22:23people make their choice. Don't worry
1:22:25about about about the safety problems.
1:22:28Make your choice.
1:22:30Families are watching you, but you are
1:22:33making a life and death decision with
1:22:35the study committee. Mr. Chairman, I
1:22:37thank you for the privilege to testify.
1:22:39>> Okay. Thank you very much. Uh,
1:22:41Representative Ridley,
1:22:43>> I just want to clarify a couple things.
1:22:45there 233 deaths um according to the
1:22:48CDC's website was from 2015 to 2025.
1:22:51But in that it says 79% of them had um
1:22:54another drug in their system and 62% of
1:22:56those were fentanyl and heroin which are
1:22:58already illegal. So that really only
1:23:00brings it down to 49 people over 10
1:23:02years who died of overdoses without
1:23:04another drug in their system. And the
1:23:05CDC said that there was a great chance
1:23:07they already metabolized another drug
1:23:09out of their system. They couldn't test
1:23:10for it. So they couldn't even say those
1:23:1149 wereratum only. So over a 10-year
1:23:14period, we had 49 people die from, but
1:23:16we had over a hundred die from
1:23:17ibuprofen.
1:23:19So they're saying we're going to have
1:23:20settlements and everything. Nobody's
1:23:22going after the ibuprofen company for
1:23:24killing more people than does at over
1:23:27100% higher rate.
1:23:30So again, you know, I I'm all about
1:23:33supporting people in recovery. I know
1:23:34people who have had meth addictions,
1:23:35heroin addictions, and I'm all about
1:23:37supporting them and doing everything we
1:23:39can. But I think it's a little
1:23:40disingenuous to come in here and say,
1:23:42you know, it's so bad when ibuprofen's
1:23:44killing twice as many people. And then
1:23:46also, you talked about people getting
1:23:47paid to come testify. Are you currently
1:23:49getting paid in your current role to
1:23:51testify here today for addiction
1:23:52recovery?
1:23:53>> No, I'm here with my own organization.
1:23:56>> But that organization pay you?
1:23:58>> Well, sure.
1:23:58>> So, you are getting paid to be here
1:24:00today?
1:24:00>> I run the organization. I pay myself.
1:24:03>> Okay.
1:24:05Okay. Hey, thank you, Representative uh
1:24:08Chairman U Corbett.
1:24:09>> Thank you, Mr. Chairman. Thank you, Mr.
1:24:11Belove. Thank you for your passion.
1:24:12Thank you for your testimony. Uh we
1:24:14talked about the 233 and you just y'all
1:24:16just debated trying to differentiate,
1:24:19you know, if it's all creative or not.
1:24:21But my my question, I guess, is I have a
1:24:24a friend, he's got a stepson that's
1:24:26addicted to this. They've put him in in
1:24:29recovery. uh he he stops breathing uh
1:24:32from from from from the cratom and they
1:24:34they put him in a recovery uh uh uh
1:24:37trying to get him off of the theratom.
1:24:40Is there a number of or do we know the
1:24:44number of people that's in recovery for
1:24:47cratom abuse?
1:24:48>> I couldn't testify that I know the
1:24:49number of people in recovery. I can say
1:24:51that, you know, the um
1:24:56the number that
1:24:59the Mayo Clinic, they report 3,400
1:25:02poisonings. Now, whether or not
1:25:04somebody's in recovery from that
1:25:05poisoning or not, so it's not a
1:25:07fatality.
1:25:08>> Yeah. It doesn't show up on a 233, but
1:25:09but how many's in in recovery,
1:25:12>> right, because I I know this one
1:25:15personal story, a friend of mine also.
1:25:17there's a pastor in my district that
1:25:19runs a a men's recovery recovery uh and
1:25:23you see that's that's the biggest thing
1:25:25they're seeing uh there also right now
1:25:28it's it's it's very dangerous product um
1:25:31I think it could be if it
1:25:36and if you heard my testimony fully if
1:25:39we can get a product that will help
1:25:41people sustain
1:25:44uh whatever they need medically in a
1:25:46healthy environment I don't care what
1:25:48it's called and we should use it. But
1:25:50what's out there right now, what's going
1:25:52on in our streets right now is not a
1:25:55healthy situation. There probably is a
1:25:57solution and there's probably some some
1:25:59some way to have good actors with good
1:26:02products that serve good families, but
1:26:04we have too many bad actors in this
1:26:07space right now. and and I I will stand
1:26:10up to them and I will say that it is
1:26:12completely unacceptable
1:26:14for for for
1:26:16day after day after day for products to
1:26:18be on the shelves in Georgia that do not
1:26:21contain what's in there. And we know we
1:26:25know we don't we may not know the exact
1:26:26numbers, but but but we all know
1:26:29families are being impacted by this
1:26:30product. It's not safe. It it may be not
1:26:33as dangerous as fentanyl,
1:26:36but it's not as as safe as something
1:26:40governed by a medical doctor and
1:26:42approved by our medical authorities.
1:26:45>> Thank you.
1:26:46>> Okay. Thank you. And one thing u also
1:26:49Mr. Reed Love. Reason he's testifying
1:26:51today, he is an addiction recovery
1:26:53specialist and he he sees many different
1:26:56cases and so that's why he's here today.
1:26:59uh we all will be asking questions who's
1:27:01taking money whatever and in some roles
1:27:04they'll do that you'll have a researcher
1:27:05later that's uh
1:27:08receives money from a cratom
1:27:10organization does val and reliable
1:27:13research you'll see it same way of
1:27:16others who were do post-certified
1:27:17training and they will benefit from that
1:27:20but in this case here he is testifying
1:27:22because he is a duction recovery
1:27:24specialist u and he does a good job with
1:27:26that and he's real respect in the
1:27:28recovery community. So, appreciate
1:27:30testifying, Kendrick Representative,
1:27:32real quick cuz we got to start pushing
1:27:34it.
1:27:35>> Oh, well, I'll ask him offline.
1:27:38>> Okay. Thank you. Okay, Mr. Brea, thank
1:27:40you very much.
1:27:41>> Thank you very much.
1:27:42>> Okay, next up
1:27:46will be uh Dr. Mccertie, University of
1:27:48Florida. appreciate you being here from
1:27:50Gator Country and uh let you introduce
1:27:52yourself and uh rest of speakers, we do
1:27:55have a full schedule. So, we want you to
1:27:58kind of uh get to the point too where we
1:28:00ask questions because our committee is
1:28:03asking questions as you can tell. I
1:28:04appreciate that. And committee members,
1:28:06as you know, um it we're not taking a
1:28:10break. So, if you do have to take a
1:28:11break, please go do that and come back.
1:28:14Um we understand that very much. Dr.
1:28:16McCertie, thank you very much.
1:28:18Thank you. And um thank you, Mr.
1:28:20Chairman. Thank you, committee. Uh I'll
1:28:23start by saying I'm a proud graduate of
1:28:25the University of Georgia. Go dogs. Uh
1:28:28and it was a hard day when I had to take
1:28:30that job at Florida. But [laughter]
1:28:33>> thank you.
1:28:35>> But but
1:28:36>> that's on the record.
1:28:37>> They they pay the bills. [laughter]
1:28:39So, um I want to I don't know if my
1:28:42slides are able to be shown. We're
1:28:48>> Well, Adam loaded. We practiced
1:28:50yesterday, I promise.
1:28:51>> Um I am uh well, as of yesterday, I was
1:28:54just promoted to university
1:28:56distinguished professor at the
1:28:58University of Florida. I served as the
1:28:59eminent uh Frank A. Duckworth eminent
1:29:02scholar chair, associate dean for
1:29:03faculty development um and director of
1:29:06our University of Florida center for
1:29:09translational
1:29:11um sciences institute translational drug
1:29:14development course. So my research is in
1:29:17basic science primarily um and moving
1:29:21drugs into the marketplace. Uh we do
1:29:24drug discovery and drug development. I
1:29:26also previously served as the American
1:29:29Association of Pharmaceutical Scientists
1:29:31president um in 2017 and 2018.
1:29:36Uh I'll I'll address the funding
1:29:38situation upfront. Uh we've received
1:29:41well than well over $100 million and
1:29:45federal taxpayer dollars um for funding
1:29:48our research. We've received uh closer
1:29:50to a million dollars in private
1:29:53donations from umratom
1:29:57companies uh individuals that were
1:30:00supporting our work. Those donations
1:30:02have gone into the University of Florida
1:30:03Foundation and unrestricted access funds
1:30:06for me to control. The donors have no
1:30:09control over or say so of how those
1:30:12funds are utilized. So, I want you to
1:30:14realize that no there's no influence um
1:30:17from those uh donors. I greatly
1:30:21appreciated and they allow us to do uh
1:30:24more science than than we can. So, I
1:30:27want to go back a couple steps and talk
1:30:29about where this came from. Um this is
1:30:32traditional use in Southeast Asia. This
1:30:34is a tree and this is leaves that are
1:30:37picked off of a tree in Malaysia and
1:30:40Thailand. In Malaysia, they make a
1:30:41decoction or a tea from the leaves,
1:30:44freshly picked. And in Thailand, they
1:30:47actually chew the leaves, similar to
1:30:48like what we would hear about cocoa leaf
1:30:50chewers in South America. Now, the leaf
1:30:53material itself has been used for
1:30:56hundreds of years in Southeast Asia with
1:30:58no issues of harm or um you know,
1:31:04problems, so to speak. Uh most of the
1:31:07material that comes into the United
1:31:09States actually gets imported from uh
1:31:12Indonesia, not from Malaysia and
1:31:14Thailand, but Indonesia is just a little
1:31:16further south. Um same kind of
1:31:19environment, same things like that. The
1:31:22uh material itself uh credum is um
1:31:26illegal
1:31:28for sale in Malaysia. But you can see at
1:31:30the bottom right hand of that at that
1:31:33picture there um that's a roadside stand
1:31:36out in rural uh Malaysia. It you can buy
1:31:39this stuff very easily anywhere. Um and
1:31:43and there's no real enforcement on the
1:31:47um selling of it being prohibited.
1:31:50Thailand actually outlawed uh
1:31:54in the 1940s because it was cutting into
1:31:56their opium tax revenue. um a few years
1:32:00ago they actually uh made it legal uh
1:32:03again in Thailand and they have a a
1:32:06thriving control business um in in
1:32:10Thailand. So these these products are
1:32:13still being used over there. Um and I
1:32:15want to talk about what the difference
1:32:17is in the United States and we've
1:32:18already heard a little bit of this but
1:32:20the biggest difference is is that we
1:32:22have things other than leaf.
1:32:26Okay, leaf is all of it's used in
1:32:29Southeast Asia, although they're
1:32:31starting now to sell extracts um there
1:32:35as well. But the the the way that I like
1:32:39to equate this is the way that we treat
1:32:41alcohol in this country. So alcohol we
1:32:45all know is divided into many
1:32:46categories. We have your light beers and
1:32:50your seltzers. We have your craft beers.
1:32:52We have your wine. We have your
1:32:54fortified wines. We have your spirits
1:32:56and then we have things like uh Bikardi
1:32:59151 and Everclear
1:33:03190 proof right we don't call all these
1:33:06things just alcohol we specify those
1:33:09categories
1:33:10unfortunately withratom it is all
1:33:14considered the same thing and all of
1:33:16those products fall into what we call I
1:33:19call sort of a garbage can description
1:33:22of the differentiation of these products
1:33:25is really the problem. So, leaf products
1:33:29have been the most studied particularly
1:33:31in humans and I'll talk about that in
1:33:33just a moment. Um, and then as we do in
1:33:37America, we superers size things and
1:33:39you've heard already about the extracts
1:33:40and the concentrates and unfortunately
1:33:43now these semiynthetics which aren't
1:33:44even any longer part of the plant. Um,
1:33:48but I'll talk about that as well.
1:33:51We do think there's strong therapeutic
1:33:53potential.
1:33:54These are studies that are ongoing. We
1:33:56just had a investigational new drug uh
1:34:00application approved by the FDA to study
1:34:03metroin or metrogenine the major alkyoid
1:34:06in the plant. That was after about eight
1:34:09years of study with the National
1:34:11Institute on Drug Abuse and the National
1:34:13Center for Advancing Translational
1:34:14Sciences. In and all that was about $80
1:34:18million worth of taxpayer dollars that
1:34:20went into the development of this
1:34:22product. That product is going into
1:34:24human clinical trials very soon. I meet
1:34:26with uh National Institute on Drug Abuse
1:34:29officials next week uh to discuss that
1:34:31project. We do believe that it can be
1:34:34successfully used for opioid
1:34:36detoxification or as a medicated
1:34:38assisted therapy very much like um
1:34:41suboxone or bupinorphine is used today.
1:34:44Uh we also know that some polydrug users
1:34:46are reporting that katum reduces the
1:34:48intake of methamphetamine. There are
1:34:51grants funded from the national
1:34:52institutes of health to look at harm
1:34:55reduction and alcohol use disorder, uh
1:34:58psychosimulant use disorder as well as
1:35:00opioid use disorder. So there's a a lot
1:35:03of um medical potential that's seen
1:35:06here.
1:35:08The other thing is is that the lack of
1:35:10standardized products, which is many of
1:35:12what we're talking about today, has
1:35:14really delayed rigorous clinical
1:35:16evaluation of of these products. And so,
1:35:20um, this is this is very busy. I I I do
1:35:23have a copy of these slides for everyone
1:35:25that wants them. Uh, they can be made
1:35:28available. This is many of the alkyoids
1:35:31that are present. And the only reason
1:35:32that I put this up here and you can't
1:35:34read a thing on there,
1:35:36but these are all the different proteins
1:35:39in the in the human body that this
1:35:42interacts with. It does not interact
1:35:44only with opioid receptors. It interacts
1:35:47with opioid receptors. It interacts with
1:35:49serotonin receptors which are mood
1:35:51elevation where many of the
1:35:53anti-depressant type actions of this
1:35:56plant come into being. It also interacts
1:35:58with adinuric receptors. Adronic
1:36:01receptors are our fight orflight system
1:36:03that allow us to get energy. Um, and
1:36:07those are the three main systems that
1:36:09this plant works on. All three of those
1:36:12systems are involved in pain
1:36:14transmission. And so we do not have a
1:36:17single drug approved in the United
1:36:19States that targets all three of those
1:36:21simultaneously. We do have some opioids
1:36:23that target the adinuric system as well.
1:36:27Um, but we don't have anything that is
1:36:31as unique as this is in terms of its
1:36:33potential properties. So I want to talk
1:36:36straight up to human trials and the FDA
1:36:39has sponsored now two human clinical
1:36:42trials withratom leaf. The first and we
1:36:45we were a collaborative team involved in
1:36:48those studies. The first one was what
1:36:50they call a SAD study. It's a single
1:36:53ascending dose trial. That manuscript
1:36:55actually is published now. Um, and that
1:36:58study investigated a single ascending
1:37:02dose. So they start with a low dose, one
1:37:05gram of leaf material.
1:37:08Months later they move to the next dose
1:37:10because they do all the safety reviews,
1:37:12all the reviews of blood samples,
1:37:15everything that was uh experienced by
1:37:17that individual before they pass safety
1:37:19to go to the next dose. So they went
1:37:22from 1 g to 3 g. The FDA was shocked
1:37:26that nothing happened at 3 g.
1:37:29So they skipped the next dose and went
1:37:32to 8 g, then 10 g, and then 12 g. They
1:37:36completed the full ascending dose trial.
1:37:39The end result was that there was no
1:37:41clinically significant adverse events
1:37:44that occurred in that trial. Yes, at the
1:37:48higher doses 8, 10, and 12 grams, there
1:37:51was some nausea and vomiting that
1:37:53occurred in certain individuals that
1:37:56also occurred in the placebo group in
1:37:59that study. Now, there was one finding
1:38:03from that study that made it appear to
1:38:06have some opioid-like effects, and that
1:38:09was that the um pupil size changed, but
1:38:13it changed only a fraction of an amount
1:38:15compared to what someone would be seeing
1:38:18if you're taking something like
1:38:20morphine.
1:38:22The next study that's underway at Baylor
1:38:25uh College of Medicine is the human
1:38:27abuse potential trial. So the FDA didn't
1:38:30think they would even get to the human
1:38:32abuse potential trial because they
1:38:33didn't think that they were going to
1:38:34show safety in the single ascending dose
1:38:36trial which they did. Now we're moving
1:38:38into the human abuse potential trial
1:38:40that will have three doses of cratom
1:38:44over multiple time of exposure and it
1:38:47will go up to 16 g of leaf material. I
1:38:51want to just point out these are in 500
1:38:54mgram uh encapsulated powder uh doses.
1:38:58So 500 milligrams per capsule. Somebody
1:39:01that's going to be taking 16 grams is
1:39:03going to be taking 32 capsules within a
1:39:05five minute period. Um if that doesn't
1:39:08cause you some nausea and vomiting
1:39:10thinking about it, we can understand
1:39:12why. We will see at that higher dose
1:39:15though if we have any other uh
1:39:18toxicological or serious safety concerns
1:39:21as that dose has not been studied in
1:39:22humans.
1:39:24There have been a couple of other
1:39:26studies uh in Canada that have been
1:39:28carried out on onratum
1:39:31andratom extract. Uh the extract papers
1:39:35have not been published but some of the
1:39:37leaf material has been published uh
1:39:39pretty much aligning and and agreeing
1:39:41with the study that the FDA conducted.
1:39:45Um coming back to what I said earlier I
1:39:47think this is the key underlying thing
1:39:49that not all credum is equal. uh we
1:39:51published this paper to talk about the
1:39:53distinction between native leaf and
1:39:54extract products and interestingly
1:39:56enough this came out in October of 2023.
1:40:00In that time frame the semiynthetics or
1:40:02synthetic compounds started to emerge in
1:40:04the marketplace as well. We were not
1:40:06aware of those at that point. Um so
1:40:09there's kind of two faces as we see it
1:40:13up to the synthetics and we'll talk
1:40:15about that much more in detail here in a
1:40:18second.
1:40:19>> Dr. Certie. Yep.
1:40:20>> Just to give you a heads up, we got the
1:40:21presentation late yesterday. We'll have
1:40:23to speed it up and start let the
1:40:25committee ask questions.
1:40:26>> No problem. We got this. You You heard
1:40:29about 70. It is a metabolite of Mitch
1:40:32Grind in the main product. Uh some of
1:40:34these are sold like Smurfs. They're all
1:40:36flavored tablets. You've heard all this
1:40:37before. I want to show you how
1:40:39exquisitly selective this is as an
1:40:40opioid. This is all the human drug
1:40:43targets. Over a 100 drug targets that
1:40:46have FDA approved drugs to them. You can
1:40:48see circled in red there, those are the
1:40:50opioid receptors. That's 7 hydroxy. It's
1:40:53incredibly selective for opioid
1:40:55receptors. This is the binding affinity.
1:40:58Um, I want to talk about abuse potential
1:41:00studies. We did all the abuse potential
1:41:02studies in our laboratory and published
1:41:04those that were required for preclinical
1:41:06abuse related studies as described in
1:41:09guidance by DHS or FDA. Um, and most of
1:41:13our data went into the press conference
1:41:16data package that was presented by the
1:41:18FDA uh, and July of 2025 where they
1:41:22recommended scheduling of this substance
1:41:24to the DEA.
1:41:26Um, yes, there's human abuse potential
1:41:29with this 70. We've we've heard about it
1:41:32uh already alluded to. These are studies
1:41:34that you can read more detail. Does it
1:41:37cause respiratory depression? Yes. as an
1:41:39isolated semiynthetic product this
1:41:41causes respiratory depression.
1:41:43Interestingly enough in that same study
1:41:45that we published metroin the major
1:41:47alkyoid inratum actually increases
1:41:50respiration.
1:41:52Also, we've seen uh cardopulmonary
1:41:55arrest in a patient that was revived
1:41:57with nlloxxone following reported use of
1:42:007 hydroxy
1:42:03and 708 should not even be considered a
1:42:05crowd product and I understand that
1:42:07secret shopper paper was us too. Uh so
1:42:11many of these compounds are um being
1:42:14sold under the guise of being credum
1:42:18products or catum alkyoids or enhanced
1:42:19catum alkaloids but they are 70 um or
1:42:24other synthetics and we heard about
1:42:28pseudoindoxil which actually doesn't
1:42:29exist in the plant at all. Uh it is
1:42:32another fully synthetic compound. It is
1:42:34a metabolite in humans. But one of the
1:42:37latest fully synthetic compounds which
1:42:39we're starting to see more and more
1:42:41post-mortem blood samples containing
1:42:43this substance is called MGM15.
1:42:47Um this is on the market um in Florida
1:42:50like crazy right now. In fact, some of
1:42:52the death cases that we've seen in
1:42:54Florida are from this. That picture in
1:42:56the middle of this is how we received
1:42:58the product. We had to buy it with
1:43:00cryptocurrency. Um it came to us. This
1:43:03was when it first got introduced. That
1:43:05text that's really small on the left
1:43:07side was the packaging label that came
1:43:10with it. They said their product is so
1:43:11new they have no labels yet. And it
1:43:13arrived in an empty jar like that. Uh,
1:43:16you know, clear jar, cotton balls on top
1:43:19of it. That was it. So, these are the
1:43:22things that are really scary to me and
1:43:24really concerning to me because these
1:43:26synthetics are are far from uhratom.
1:43:30They are derived fromratom but they are
1:43:33not pratom at all. So um there's a lot
1:43:37of questions that remain but regulation
1:43:39is key. Uh and I'd be happy to answer
1:43:41any questions.
1:43:42>> Thank you Dr. McCertie. Uh two things
1:43:44for I'll let uh representative ask a
1:43:46question just a second Rley. Uh first is
1:43:49uh everybody's got a copy of your
1:43:51PowerPoint. We gave everybody a copy
1:43:52here. But second too, as we go through
1:43:55this process, uh you're definitely more
1:43:57than welcome to contact Deborah, my
1:43:58officer, me, and we'll get you any stuff
1:44:00you want to send us or give us. Uh
1:44:03please, I'll we'll forward it right
1:44:04away. So, no worries about that.
1:44:06>> Thank you.
1:44:07>> And then, uh Jordan Ruther,
1:44:09>> representative,
1:44:10>> um during your presentation, you said
1:44:12there was a human abuse potential trial
1:44:14at Baylor with the FDA um currently
1:44:16going on. Do you have a target date for
1:44:18when that's going to be over?
1:44:20>> No. Okay. It's just getting started. In
1:44:22fact, we just we're just waiting for the
1:44:24final approval for uh from the
1:44:27institutional review board so that we
1:44:29can start recruiting subjects. So, it's
1:44:32just getting started. It'll be at least
1:44:33another year.
1:44:35>> Okay. Thank you. And chairman Corbett.
1:44:38Thank you, Mr. Chairman. Uh Dr. Curry,
1:44:40you uh from talk about Florida and what
1:44:43they have done, what laws they have
1:44:45passed. Now, they they have not banned
1:44:48cratom. What laws can you speak to that?
1:44:51>> Correct. I've been involved um in a lot
1:44:53of discussions with Senator Jay Collins
1:44:55who's now lieutenant governor of
1:44:57Florida. Uh he has put together quite uh
1:45:02uh a team to put regulation around this.
1:45:05Um a lot of that was developed alongside
1:45:08the American Association and the global
1:45:11uh coalition uh with input from them on
1:45:14regulation. Um he has Florida safety
1:45:18first for Floridaidians just like you
1:45:21all have Georgia safety first for all
1:45:24Georgians. Um the law that was put into
1:45:27place there is a consumer protection act
1:45:30uh very similar to what's already in
1:45:31place I think in Georgia. Uh that limits
1:45:34age um you know certain packaging has to
1:45:36be there etc. I'm not fully versed on
1:45:40the entirety of of what that is because
1:45:42every session it seems to come back up
1:45:44for a little more refinement. Um, but
1:45:47what Florida has done is put an
1:45:50emergency ban on these synthetic
1:45:52products. Thank you.
1:45:54>> And I guess one final question for me uh
1:45:58is uh when I talked to I believe Dr.
1:46:00Grummans and one of your colleagues and
1:46:02we talked on the phone. He had
1:46:03permission to talk and and emailed each
1:46:05other and one of the questions I asked
1:46:07was about the where to sell the product
1:46:10at and um
1:46:13he seemed to be more apt of to where at
1:46:16least that person uh let's say my
1:46:19neighbor can go to the pharmacist or
1:46:22someplace if they don't see their
1:46:23doctor. Is it safe? Like Joe could be on
1:46:26blood pressure medicine so he doesn't
1:46:27need to take that. Um, in your eyes as a
1:46:30researcher, do you have an opinion yet?
1:46:31You may not, of
1:46:35the way we're have the law now, is it
1:46:37fully safe like in a convenience store
1:46:40type situation or is it better where
1:46:42they can ask a professional, not have a
1:46:44prescription, but just ask a
1:46:46professional, hey, these are my meds. Am
1:46:48I safe to take this product?
1:46:50>> So, I didn't mention my original
1:46:52training and lensure is as a pharmacist.
1:46:54So, I um actually wear that hat, too.
1:46:58uh and I I am fully supportive of much
1:47:03more uh information around these
1:47:06products when they're sold. Uh and that
1:47:09should be done by someone who's educated
1:47:11to a point at least. They don't
1:47:13necessarily have to be a medical
1:47:14professional. In my ideal world, you
1:47:17would put this into a dispensary just
1:47:19like you do cannabis. Uh and that way
1:47:22the material is authenticated. We know
1:47:24the the sources. that material has been
1:47:26tested, verified to be what it says to
1:47:28be on the label. Um, but that's I I
1:47:32think that's a probably a heavy lift.
1:47:34Um, obviously the biggest problem with
1:47:38uh the legitimacy of this of these
1:47:40products at all is where they're
1:47:42available. I mean, you can't go into
1:47:45Walmart and buy it. You can't you can't
1:47:47buy it on Amazon. Uh, but you can
1:47:50certainly buy it at the convenience
1:47:51store. Many of the um retailers or
1:47:56vendors, manufacturers have their own
1:47:58websites that you can buy it from. But
1:48:00um again, those tend to have a lot more
1:48:03education because it's in a website. But
1:48:05but to the point of uh earlier speaker,
1:48:08a lot of people aren't aren't reading
1:48:10all the information that's there either.
1:48:12>> Okay. Thank you very much. Appreciate
1:48:14you being here.
1:48:15>> Thank you.
1:48:16>> Okay. Next, we have um Robert Durkin.
1:48:19He's council to Aka
1:48:22and um time permitting to we're going to
1:48:26try to Representative Reeves will is
1:48:28here as well and I've got to get him on
1:48:30the count on the agenda between
1:48:32somebody. So um we'll look at that as
1:48:34well committee members. Okay. Um
1:48:38Mr. Durkin, thank you.
1:48:39>> Uh thank you, Mr. Chairman. Thank you,
1:48:41committee. Uh I am a thorn among roses.
1:48:43Uh even earlier today, uh Chair Talson
1:48:46said I might have been a better fit for
1:48:47a different meeting uh in front of the
1:48:49committee. If that's the case, I'm more
1:48:50than happy to to do that. But uh I'm a
1:48:53practicing attorney. My name is Bob
1:48:55Durkin. I'm outside council to the
1:48:56American Cratum Association. I represent
1:48:59numerous other clients that manufacture
1:49:00and distribute food, dietary
1:49:02supplements. Uh some of these folks
1:49:04distribute products that contain. I'm
1:49:06also a pharmacist. I have a master's
1:49:08degree in molecular biology. I was a
1:49:10captain in the army for six years where
1:49:12I was residency trained and board
1:49:13certified in nuclear pharmacy at Walry
1:49:15Army Medical Center. Uh I worked at the
1:49:17Federal Food and Drug Administration for
1:49:19about 12 years. I started in the center
1:49:21for drug evaluation and research where I
1:49:24worked on pharmacy compounding,
1:49:25unapproved new drugs, overthe-c counter
1:49:27drugs, fraudulent drugs. Uh I worked on
1:49:30uh I was on a crisis management team at
1:49:32the Food and Drug Administration where
1:49:34my job was to lead a team of folks that
1:49:36when an FDA regulated product was
1:49:38hurting people, it was our job to get it
1:49:39off the market as quickly as possible to
1:49:41contain it. We did a lot of work with
1:49:42CDC and state state authorities. Uh I
1:49:45did food defense for a couple years. Uh
1:49:47that's where a small group of people
1:49:48make sure that our our food supply isn't
1:49:50intentionally contaminated by a
1:49:52disgruntled employee or a state actor.
1:49:54And then I was fortunate enough to work
1:49:56for six years as the deputy director of
1:49:58FDA's office of dietary supplement
1:50:00programs. Uh in this role I was
1:50:02responsible for policy. I was
1:50:04responsible for operations. I supervised
1:50:07the people that did good manufacturing
1:50:09practices reviews of inspections. I
1:50:12supervised folks that reviewed dietary
1:50:14supplement labels and um more
1:50:17importantly the new dietary ingredient
1:50:19notification team. uh when a new dietary
1:50:21ingredient is brought to market,
1:50:22sometimes it has to file a notification
1:50:24with the FDA. It's not an approval
1:50:26process. It's just a notification
1:50:28process. And I was uh I led that team. I
1:50:31supervised a team that reviewed those.
1:50:33And I've probably signed about a hundred
1:50:35or so, maybe 150 response letters to new
1:50:38dietary ingredient notifications on
1:50:40behalf of the Food and Drug
1:50:41Administration. Uh I'm a former
1:50:43regulator. Uh my role when I typically
1:50:45uh testify in front of committees like
1:50:46this is to provide context about
1:50:48regulation. Um you mentioned that
1:50:51there's someone else from FDA in the
1:50:52room. I I welcome their input or to
1:50:54check me if I say something a little
1:50:55off. I'd love to meet them later. Um you
1:50:58know I heard some things earlier that I
1:50:59can provide some context around. I heard
1:51:01not regulated is regulated. Ifratum is
1:51:05sold as a food or a dietary supplement
1:51:07that falls under the jurisdiction of the
1:51:08federal food drug and cosmetic act. It
1:51:10also falls under the jurisdiction of
1:51:12Georgia's food drug food and drug
1:51:14statutes and regulations. Um, is a
1:51:17botanical. Uh, one of the problems that
1:51:19I've heard today is thatratom is a
1:51:21bucket. As Dr. McCertie said and even
1:51:23the first two folks that testified and
1:51:24said, seems to be everything is uh leaf
1:51:28isratom. An extract from the leaf is
1:51:31unfortunately the synthetics now are
1:51:32being calledratom. 708 15 mg. Those are
1:51:36definitely notratom. Those are
1:51:38contaminants inratum. Those are things
1:51:40that legitimate distributors make sure
1:51:42aren't in their product. Um, at this
1:51:45point in time, you know, there there
1:51:46many of my clients that manufacture them
1:51:49are registered as food facilities with
1:51:50the Federal Drug Administration, Food
1:51:52and Drug Administration. They're
1:51:54registered with FDA. FDA knows where
1:51:56they are. Some of my clients have been
1:51:58inspected by FDA for their good
1:52:00manufacturing practices. FDA does their
1:52:03job. They evaluate the GMPS. They give
1:52:05them observations to correct and they
1:52:06leave. They don't seize the cratom. Uh a
1:52:09lot of my clients right now market
1:52:10cratom products and they have perfect
1:52:12labels. The labels follow the
1:52:14requirements under uh uh chapter 21 of
1:52:17the code of federal regulations. A
1:52:19properly labeled dietary supplement has
1:52:21all the information to inform a consumer
1:52:24about how to take it. If it requires the
1:52:26advice of a health care practitioner,
1:52:28it's on the label. Seek the advice of a
1:52:30health care practitioner before you take
1:52:31this product. If it's not intended for
1:52:33for women that are pregnant or want to
1:52:34become pregnant or that are
1:52:35breastfeeding, that's on the label.
1:52:37Don't take it if you fall in that
1:52:38category. It's on the label for 18 years
1:52:41older and up. Individuals that that
1:52:43marketratom that market any dietary
1:52:45supplement have a responsibility to know
1:52:47the safety before they go to market. The
1:52:50and that safety is based off those
1:52:52conditions of use. If your product is
1:52:53labeled for 18 and up, that's how you
1:52:56have to know it's safe. You have to know
1:52:57it's safe for 18 and up. if it excludes
1:52:59people on heart medication, if it
1:53:00excludes people with liver disease, if
1:53:02it excludes pregnant women, you don't
1:53:04have to know it's safe in them because
1:53:05you've just told them not to take your
1:53:07product. Um,
1:53:11I wonder if some of the reason that
1:53:12there's an increase in awareness
1:53:14aboutratom and that there's more reports
1:53:16aboutratom is because products now are
1:53:18actually labeled as there's a label out
1:53:21there to inform a consumer, a health
1:53:23care practitioner, a regulator or a law
1:53:25enforcement officer exactly what they're
1:53:27dealing with. 10 years ago, was sold in
1:53:30baggies. It was sold in baggies with
1:53:32with marker written on it. We've come a
1:53:34long way in the last 5 years. Like I
1:53:36said, they're registered food
1:53:37facilities. They're registered with the
1:53:39Federal Food and Drug Administration.
1:53:40They put out labels and products that
1:53:42comply with federal requirements. And in
1:53:44the state of Georgia, products comply
1:53:46with your require your requirements.
1:53:48They comply with your KCPA. They're kept
1:53:50behind the counter. They're not they
1:53:51children don't have access to them. Um
1:53:54you they're responsible to make sure the
1:53:56person buying them is over 21. So you've
1:53:59already done a lot to regulate. One of
1:54:01the earlier witnesses said they suggest
1:54:03don't ban it, regulate it. In my
1:54:05experience, when you ban something, you
1:54:07create an underground market. You create
1:54:08a black market. It's not going to stop
1:54:10it from coming down Interstate 95 into
1:54:12your into your state. It's not going to
1:54:14stop people from buying it online. What
1:54:16it's going to do is it's going to make
1:54:17your your KCPA irrelevant and people are
1:54:21going to stop following it. It's going
1:54:22to limit your jurisdiction to take
1:54:24action on it when it's in the state. You
1:54:26should regulate it, not ban it. I think
1:54:28you have an enforcement problem. I think
1:54:30you have a data problem. Everything's
1:54:33everything's not there's leaf. There's
1:54:36extracts and then there are these
1:54:37horrible synthetics. 70 a lot of what I
1:54:41heard earlier being described about
1:54:42addiction and adverse events really
1:54:44seems like it's attributable to 70. We
1:54:47heard one witness when you said what
1:54:48what actually caused the deaths and he
1:54:50said I don't know. I'd have to go back
1:54:52and read the cases. Think about that.
1:54:54They're using data but yet they have to
1:54:56go back and look at the case reports
1:54:58before they can tell you what that data
1:54:59really means. I think you have an
1:55:01enforcement problem. I think you have a
1:55:03data problem. I'm a former regulator.
1:55:06I'm a practicing attorney. I understand
1:55:07the Food Drug and Cosmetic Act pretty
1:55:09well when it comes to this. I'm happy to
1:55:11answer any questions or provide any
1:55:13context I can to the committee.
1:55:14>> Yeah, thank you. I appreciate that. Two
1:55:16questions for me, then I'll uh we'll
1:55:18have extra questions, I'm sure. customs
1:55:21and where I read recently where um if
1:55:23it's um
1:55:26they will at times seize or burn the
1:55:30shipments
1:55:32>> from
1:55:34the very secret chairman
1:55:35>> at time I read where uh if it's labeled
1:55:37as a uh uh for medical use or a food
1:55:41product uh it can be banned it can be u
1:55:44seized by customs is that still hold
1:55:46true that you know of so there is and
1:55:49we'll get more testimony Yes sir.
1:55:50>> There there is an import alert for the
1:55:52import of credratom.
1:55:53>> Okay.
1:55:53>> And the import alert at the border FDA
1:55:55has a lot of authority more authority
1:55:57than they have domestically.
1:55:58Domestically if they want to seize a
1:56:00product they have to have evidence that
1:56:01it's adulterated. They have to have
1:56:02evidence that it violates the act. At
1:56:04the border it's an appearance standard.
1:56:06It appears like it violates the act. So
1:56:08FDA has an import alert 54 5415 which
1:56:12allows them to pull over detain.
1:56:14They send the responsible party a letter
1:56:16a notice of action that says hey I have
1:56:18yourrratom. Why do you think it's legal?
1:56:20Now, I don't I I don't do imports. It's
1:56:22not what I do, sir. And what I'm told is
1:56:24that folks provide to Customs and Border
1:56:26Patrol, to FDA, proof thatratom is an
1:56:29old dietary ingredient or proof
1:56:30thatratom is is under a new dietary
1:56:33ingredient notification, which I can say
1:56:35there are at least nine. There are at
1:56:36least nine NDINs that have been sent to
1:56:38FDA with the basis for safety of told,
1:56:42I've never experienced it, that when FDA
1:56:44receives this information, they release
1:56:45the shipment.
1:56:46>> Okay. Thank you. and um 17 chairman
1:56:50Corbett.
1:56:52>> Thank you, Mr. Duran. Uh we talked about
1:56:54the phantom shoppers that was going
1:56:56around buying this stuff off the shelf
1:56:57and then they were testing it at much
1:56:59higher percentage of the 708 than what
1:57:04was any states that have put guard rails
1:57:08on on on the 708, the synthetic uh uh
1:57:12cratom. Uh who inspects it? Who enforces
1:57:15it? And what are the penalties if
1:57:17somebody violates that? Are you can you
1:57:20>> Sure. So I mean there's authority at the
1:57:21federal level for seven hydroxy FDA has
1:57:24taken a strong stance. As a matter of
1:57:25fact, the the witness on addiction that
1:57:27that pulled up his phone and he he was
1:57:29correct. The secretary of health uh
1:57:31Kennedy uh the then commissioner of the
1:57:33FDA McCary and an administrator from uh
1:57:37DEA stood on the stage and they said
1:57:39they were going to stop the next wave of
1:57:40the opioid epidemic. Sir, they were
1:57:43talking about seven hydroxygen. They
1:57:45were not talking aboutratom. During that
1:57:47same press conference, they actually
1:57:48said, "We're not worried about natural
1:57:50leafratom. We're worried about 7
1:57:52hydroxy." So there's authority. There's
1:57:54authority at the federal level and
1:57:55there's authority at the state level.
1:57:57For example, the state of Missouri just
1:57:58reached a consent decree with one of the
1:58:00largest manufacturers of 70 to prevent
1:58:02him from manufacturing and selling 70
1:58:04within his state, his home state. So
1:58:07Georgia has authority to go after 70 if
1:58:09they decide to. You could probably They
1:58:10did that under their consumer protection
1:58:12act, their advertising laws. They went
1:58:14after them and said, "You're you're
1:58:15marketing this stuff as a drug and it's
1:58:16not a drug." And he signed a consent
1:58:18decree and said he stopped doing it. If
1:58:20Missouri has a consumer protection act,
1:58:22they could probably do I'm sorry,
1:58:23Georgia has a consumer protection act.
1:58:25You all could probably do the same
1:58:26thing.
1:58:27>> Okay. Thank you.
1:58:30Represent Kendrick.
1:58:32>> Thank you, Mr. Chair. Um I'm just a
1:58:34lawyer, too, so I'm going to ask um
1:58:37uh a question. Uh so we have or there's
1:58:40been testimony about a lot of medical
1:58:42reports and I'm not going to pretend you
1:58:44know that um to understand it all. Are
1:58:47there counter reports that the
1:58:49association
1:58:51has that can maybe give perspective to
1:58:54the various reports that are out there?
1:58:56>> Yes ma'am there are I believe and I do
1:58:59have firsthand experience of reading
1:59:00some of these reports and look it it
1:59:02sucks. Somebody's hurt, somebody's dead,
1:59:05nobody wins. This is a horrible
1:59:06situation and it's a tough thing to do.
1:59:09So, condolences. I I can't I can only
1:59:12empathize. I can't you know
1:59:14it said it's always it seems like it's
1:59:16always polyarm pharmacy. It seems like
1:59:18there's always something else on board
1:59:20an illegal drug another substance
1:59:22medications prescription medications
1:59:24that might have interacted with theratom
1:59:26article whether it was I don't think
1:59:28it's often leaf. I think it's usually an
1:59:30extract or 70. But yeah, there there are
1:59:33there are folks that are skilled in this
1:59:34that have gone in and looked at those
1:59:36reports and determined that you know a
1:59:39lot of them are really polyarm pharmacy.
1:59:40I think the Tampa Bay Times looked at
1:59:42five or 6 hundred and a very esteemed
1:59:45professor a very esteemed researcher
1:59:46Marilyn Hustus reviewed those reports
1:59:48and I can't be held to the exact numbers
1:59:50but I think out of that that whole
1:59:52number she determined just six or nine
1:59:55might have been attributable to cratom
1:59:56alone. So there's always confounding
1:59:58factors. I I know FDA in one when I was
2:00:02there and it's it's public now so I can
2:00:04say it a person hadratom in their system
2:00:07confronted the police the police shot
2:00:09this person killed this person but the
2:00:12cause of death wasratom in the report so
2:00:15I mean there are some really weird
2:00:17things that happen with some of those
2:00:18reports but look I mean I think it's
2:00:21terrible that people's autopsy reports
2:00:22have become something that we have to
2:00:23talk about in the situation it's very
2:00:26complicated ma'am okay thank you Okay,
2:00:29appreciate you being here. Thank you for
2:00:30your uh testimony. Next is Dr. Andrew
2:00:33Coladney, medical director uh opioid
2:00:35policy research from I believe Brandai
2:00:38Brandise University if I pronounce that
2:00:40correctly.
2:00:41>> Thank you. Can I correct this water?
2:00:44>> Yes, please do. And we've got some extra
2:00:45waters on the side over here. Any of the
2:00:48speakers, welcome to one for sure. And
2:00:51um we can continue what you're doing. We
2:00:53sped it up. So, let's keep that momentum
2:00:55going and we'll getting uh
2:00:57Representative Ree in in just a minute.
2:01:03And just to let everybody know, there's
2:01:05quite a few people in this room, Dr.
2:01:07McCertie and
2:01:10Dr. Claudney and others who have
2:01:11traveled a long way to be here. So, we
2:01:13appreciate you.
2:01:14>> Uh thank you. Um it's a honor to be here
2:01:18uh today. Um I am an addiction medicine
2:01:21specialist. Um, and I also research
2:01:25strategies for addressing the opioid
2:01:28crisis at Brandeise University and I
2:01:30teach about the opioid crisis at
2:01:32Columbia University. I've been working
2:01:34on the opioid crisis for 20 years,
2:01:39assisting members of Congress, both
2:01:42Republicans and Democrats, assisting
2:01:45them in their investigations
2:01:48of the opioid industry and in their
2:01:50efforts to find legislative approaches
2:01:53to the opioid crisis. I've testified
2:01:55before the United States House and
2:01:58Senate. I've testified before the United
2:02:00Nations uh for the World Health
2:02:03Organization. Um and I've assisted state
2:02:07attorney generals in their efforts to
2:02:09tackle the opioid crisis. Um I've worked
2:02:12as an expert witness in the litigation,
2:02:15including for the state of uh Georgia in
2:02:17the opioid uh litigation.
2:02:20I commend you all for forming this task
2:02:24force. Uh, Chairman Townsen, I think
2:02:26it's critical to review the science and
2:02:30to use that science to inform your
2:02:32policy making. Um, I became
2:02:36especially engaged in the problem
2:02:38ofratom
2:02:39about a year ago. Uh, I had just
2:02:42returned to seeing patients again after
2:02:44not having seen patients for a few
2:02:46years. And I was just blown away by how
2:02:50all of the patients I was treating had
2:02:53become addicted using.
2:02:56When I first started treating opioid
2:02:58addiction more than 20 years ago, all of
2:03:01the patients I was treating had
2:03:03developed their opioid addiction taking
2:03:05prescription opioids. And through my
2:03:08career, I also treated patients who had
2:03:09developed opioid addiction from heroin.
2:03:12But today the patients that I'm treating
2:03:15all of them who've become recently
2:03:17addicted in the past five or six years
2:03:19it's that caused their addiction. I've
2:03:22also been treating patients who were in
2:03:25remission from their addiction to heroin
2:03:28or prescription opioids and have
2:03:30relapsed using. I wasn't sure if my
2:03:34experience was unique. So I got on the
2:03:37phone. I called colleagues from other
2:03:39parts of the United States, asked them,
2:03:41"What are you seeing?" These are
2:03:43colleagues who work in the field of
2:03:45addiction and they all said the same
2:03:47thing. And if you were to attend the
2:03:49national meeting of the American Society
2:03:51of Addiction Medicine, you will hear
2:03:53that what all of the doctors there are
2:03:55talking about is the problem of that is
2:03:58why I'm here today and that's why I'm
2:04:00now working on this issue.
2:04:03In my presentation, I'm going to explain
2:04:05thatratom is not just a botanical
2:04:09substance with opioid like effects.
2:04:13Is an opioid and I'll explain why that
2:04:16is true. I'm going to cover briefly
2:04:19lessons we should learn from the opioid
2:04:21crisis. People have wondered isratom
2:04:24helpful for the opioid crisis. Is it
2:04:26making it worse? I'll share with you my
2:04:28thoughts on that. And then lastly, I'm
2:04:30going to cover what the evidence tells
2:04:32us about states who've attempted to
2:04:34tackle this problem. A question was
2:04:37asked earlier um about, you know, what's
2:04:39working in other states. We now have two
2:04:42recently published papers that have
2:04:44looked at what's happening across the
2:04:45country and I'll share that with you as
2:04:47well.
2:04:49What is an opioid? An opioid is a drug
2:04:53that binds to the opiate receptor in the
2:04:56brain and activates the receptor. It's
2:04:59as simple as that. If the drug binds to
2:05:02the receptor and activates it and causes
2:05:05an opioid effect, that's an opioid. Now,
2:05:08we have different types of opioids. We
2:05:11have opioids that occur naturally. For
2:05:14example, inside opium, we have molecules
2:05:17that exist there naturally like codin
2:05:20and morphine. Now, you can treat those
2:05:23molecules and create stronger, more
2:05:26potent versions. That's what you're
2:05:29doing when you create heroin or when you
2:05:31create oxycodone,
2:05:33hydromemorphone, which is delotted. You
2:05:36actually to make all of those drugs, you
2:05:38start with opium. you treat them
2:05:40chemically and you make drugs that
2:05:42absorb into the brain faster and are
2:05:45more potent. And another term for those
2:05:48opioids that you make out of the natural
2:05:50ones is semiynthetic.
2:05:53We also have a third type of opioid
2:05:55which is completely synthetic where you
2:05:58need no natural substance to start. For
2:06:00example, fentinyl is completely
2:06:03synthetic. Tramodol, methadone,
2:06:07tentadol. These are all opioids that you
2:06:09make completely out of chemicals. What
2:06:12all of these drugs have in common, they
2:06:14stimulate the brain's opioid receptor.
2:06:16They cause an opioid effect.
2:06:21The opium poppy is not the only place in
2:06:24nature where we find opioids. For
2:06:27example, um this cute guy is the waxy
2:06:31monkey tree frog. And it's in the skin
2:06:35of the waxy monkey tree frog that we
2:06:38have an extremely potent opioid, more
2:06:42potent than morphine. Structurally, it's
2:06:44not even an alkyoid. It's a totally
2:06:47different type of molecule, but it
2:06:50activates the opioid receptor and it's
2:06:51an opioid.
2:06:55Contains opioids.
2:06:57Metragginine is an opioid and there are
2:07:00other opioids in theratom plant that
2:07:04exist there naturally. Now if you were
2:07:08questioning whether or notratom
2:07:11is really an opioid is Dr. Coladne just
2:07:14saying this uh we have a textbook on the
2:07:17subject one of the leading textbooks in
2:07:19the in the field of uhratom
2:07:22uh a pharmarmacology textbook it's right
2:07:25there in the title and other metroines
2:07:29the chemistry and pharmarmacology of
2:07:32opioids from a nonopium source this is
2:07:36the leading textbook onratom
2:07:40this is also a statement that the FDA
2:07:42has made perfectly clear. Several years
2:07:45ago, the FDA did a study to look at
2:07:47which receptors in the brain
2:07:51molecules interact with. And then they
2:07:53made a press statement. They announced
2:07:56compounds inratom make it so it isn't
2:07:59just a plant, it's an opioid.
2:08:03Once we understand thatratom is an
2:08:06opioid,
2:08:07much of what you've been hearing about,
2:08:09much of what we're experiencing
2:08:11nationally withratom becomes a lot more
2:08:14clear. For example, doctors across the
2:08:17United States are treating patients
2:08:20addicted toratom with the same medicine
2:08:23that we use for treating addiction to
2:08:25heroin or oxycodone or fentinyl. We are
2:08:29using buprenorphine which um is also
2:08:31called suboxone and doctors across the
2:08:34country are finding that they have no
2:08:36choice but to use suboxone for treating
2:08:39catratom use disorder. Not every patient
2:08:41addicted toratom is going to need
2:08:43suboxone. Um I think there are some
2:08:45patients who can recover without it but
2:08:47increasingly doctors are relying on
2:08:49suboxone to treat this condition.
2:08:53Understanding that is an opioid also
2:08:56helps explain why in neonatal
2:09:00intensive care units across the country
2:09:04they are treating an increasing number
2:09:06of infants who are born opioid dependent
2:09:10because during pregnancy their mothers
2:09:13used.
2:09:15These are now if you're unfamiliar with
2:09:18neonatal abstinence syndrome, it's also
2:09:20called neonatal opioid withdrawal
2:09:23syndrome. These are infants who are born
2:09:26with excruciating discomfort. They have
2:09:29a very distinctive cry. They often
2:09:32require tapering treatment with opioids
2:09:35at the beginning of life and often they
2:09:37wind up stuck in the hospital for weeks,
2:09:39sometimes even longer. I just spoke last
2:09:43week with a nurse in De Moine, Iowa, who
2:09:46has treated now several patients uh uh
2:09:49several infants for neonatal opioid
2:09:52withdrawal syndrome whose mothers had
2:09:54been using.
2:09:58We heard earlier uh we've heard uh Mitra
2:10:01Mitrain and metragginine u I think both
2:10:05are are fair to use. Um, we've heard it
2:10:07described as a weak opioid and that's
2:10:09that's true. But what does it mean when
2:10:11we talk about a weak opioid versus a
2:10:14strong opioid? I think we've heard seven
2:10:16hydroxy metrogenine referred to as a
2:10:19strong opioid. What that really means is
2:10:23if it's a weak opioid, you need to take
2:10:26more of it to achieve the same effect. A
2:10:30weak opioid is not necessarily safer.
2:10:34Certainly a very strong opioid can be
2:10:36dangerous if it's certainly if it's
2:10:38fentinyl being mixed into something. If
2:10:40you put a little too much in, you can
2:10:42have an overdose very easily. But the
2:10:45fact that it's a weak opioid certainly
2:10:47does not make it less addictive. Opioids
2:10:51vary in different ways. Some opioids
2:10:53have a very long acting effect like
2:10:56methadone. Some opioids have a shorter
2:10:59effect like fentinyl. They're they're
2:11:01different in in different ways. Um but
2:11:04when we look at opioids, we really
2:11:06should understand that we have many
2:11:09different types that are some are weak,
2:11:11some are strong um and that they all
2:11:14generally produce very similar effects.
2:11:18We've heard it mentioned today um I
2:11:21think it was Dr. D who mentioned that
2:11:24when somebody consumes
2:11:28that the nitrogen
2:11:30is converted in our body into 7 hydroxy
2:11:34and we now understand that or it seems
2:11:39increasingly clear that the opioid
2:11:42effects that people experience when they
2:11:45take
2:11:47is due to the conversion in our liver to
2:11:50seven hydroxy atrogynine. And this is
2:11:52important too. If you look at the top of
2:11:54the slide, I have the word human liver.
2:11:57Animal livers do this as well. Mice and
2:12:00rats where most of the studies are being
2:12:02done, their livers also do this a little
2:12:04bit. But human livers appear to be much
2:12:08better at converting metrogenine into
2:12:11seven hydroxy metroine. Which means that
2:12:13some of the animal studies may be
2:12:16underestimating the risks both the risk
2:12:19of respiratory depression and overdose
2:12:21death and the risk of of addiction. Our
2:12:25livers are especially good at making
2:12:27this conversion. And you know this is
2:12:30not unique forratom.
2:12:32When somebody takes codine that's also
2:12:35an example of a drug where our liver
2:12:39converts it into a more potent opioid.
2:12:42morphine. So, this is common with with
2:12:46other types of opioids.
2:12:49>> Dr. Claudney, I may have to speed you up
2:12:51and if we have to bring you back again,
2:12:53we will. But if you can kind of
2:12:55>> Sure.
2:12:55>> Thank you. I just scheduled a lot. I
2:12:57apologize.
2:12:58>> Sure. Sure.
2:12:59>> So, why do people take opioids? People
2:13:01take opioids because when you take an
2:13:02opioid,
2:13:04it produces very positive effects. Uh
2:13:06there's a sense of wellbeing. People
2:13:09feel good when they take an opioid. It
2:13:11can relieve pain. It certainly relieves
2:13:14anxiety. And this is the reason why
2:13:15people take opioids. And these are all
2:13:17very positive effects. And you you may
2:13:19wonder why don't we all take opioids
2:13:20more often if they feel so so great when
2:13:23you take them. It's because opioids have
2:13:25the problem of tolerance, dependence,
2:13:27and addiction. When you take an opioid
2:13:30every day, very quickly you develop
2:13:33tolerance, meaning you'll need higher
2:13:35and higher doses to get the same effect.
2:13:37And as the doses get higher, it becomes
2:13:39more dangerous. When you take opioids
2:13:41every day, you rapidly develop
2:13:43dependence, meaning you'll feel sick
2:13:46when you try and stop taking them. As
2:13:48you heard earlier, the withdrawal from
2:13:50opioids is no fromratom is no different
2:13:53than the withdrawal from heroin and
2:13:54other other opioids. And of course,
2:13:57opioids are highly addictive. An
2:14:00addiction is a life-threatening,
2:14:02lifealtering condition that can happen
2:14:05easily if you're taking a highly
2:14:07addictive drug on a daily basis.
2:14:11The effects when you go into opioid
2:14:13withdrawal are essentially the opposite
2:14:16of the effects that you feel when you
2:14:18take an opioid including a sense of
2:14:20impending doom. And it's important to
2:14:22understand that you know we think about
2:14:24when people get dopesick is you know
2:14:26what what's going to happen if say they
2:14:28go a day without taking an opioid and
2:14:30they get very sick. But it's important
2:14:32to understand that the withdrawal
2:14:34effects happen on a continuum. When
2:14:37someone who's a catratom user wakes up
2:14:39in the morning, they're already in a
2:14:41little bit of withdrawal. And when they
2:14:43take their morningratom,
2:14:45they're going to feel much better. And
2:14:47that's certainly going to reinforce the
2:14:48notion that is helping them. But when in
2:14:52reality, what theratom is doing is
2:14:54relieving the withdrawal effects of the
2:14:56previous dose wearing off. Opioids are
2:14:59highly addictive. As I mentioned, I want
2:15:00to just quickly begin to wrap up by
2:15:04talking about the opioid crisis. And you
2:15:06know these are different headlines that
2:15:09have appeared in newspapers to describe
2:15:12the opioid crisis. These are the
2:15:14different health and social problems.
2:15:16You know uh record high overdose deaths,
2:15:19babies born opioid dependent, fentinel
2:15:22flooding into non- urban areas. How
2:15:24should we really understand the opioid
2:15:26crisis? We should understand it as an
2:15:29epidemic of opioid addiction. That's
2:15:32what's fueling the problem. And you can
2:15:34see the epidemic happening over time.
2:15:36This is people across the country
2:15:38seeking treatment for addiction to
2:15:39prescription opioids. The states with
2:15:42the highest rate are red or maroon. You
2:15:44can see what happened over time. We saw
2:15:47this dramatic increase in people
2:15:50addicted to prescription opioids seeking
2:15:53treatment. This is an epidemic of opioid
2:15:55use disorder. This is really what the
2:15:57opioid crisis is. And what caused the
2:16:01North American opioid crisis? Why did
2:16:04the United States wind up with an
2:16:05epidemic of opioid addiction? The answer
2:16:08to that question is on this slide and
2:16:10it's very relevant to our discussion
2:16:12today. On this slide, the green line
2:16:15represents consumption in the United
2:16:18States of prescription opioids. And you
2:16:21could see the soaring increase in people
2:16:23consuming prescription opioids. And you
2:16:26see along with that increase a parallel
2:16:29increase in rates of addiction and
2:16:32overdose deaths. What fueled this
2:16:35problem was too many prescription
2:16:37opioids. I believe that this is exactly
2:16:40what's happening withratom today.
2:16:44Asratom consumption has increased in the
2:16:46United States.
2:16:48People are getting addicted toratom in
2:16:51greater numbers and the deaths are going
2:16:53up rapidly. And just something that has
2:16:55to be cleared up. Earlier today, the
2:16:57number of deaths from was mentioned as
2:17:00233.
2:17:02That is incorrect. That number comes not
2:17:05from the CDC, but it comes from a paper
2:17:08published by the CDC on calls to poison
2:17:11control centers that involved the death.
2:17:15The CDC has data telling us that from
2:17:182020 to 2024,
2:17:215,200 Americans have suffered creative
2:17:26involved overdose deaths. 5,200,
2:17:30not 233.
2:17:32I want you to understand that not only
2:17:34is I believe this is what's happening
2:17:36withratom today, but I want you to know
2:17:38that theratom industry is doing exactly
2:17:42what the prescription opioid industry
2:17:45did. As these lines were going up, the
2:17:48prescription opioid industry, Purdue
2:17:50Pharma, the maker of Oxycontton, they
2:17:52were paying scientists, doctors, former
2:17:56FDA officials to try and confuse this
2:17:59situation to try and and sewed doubt.
2:18:03And they were also disseminating a
2:18:05message, the opioid manufacturers, that
2:18:08all of the harms that we're hearing
2:18:10about, those are, you know, addicts
2:18:13abusing these substances. That's the
2:18:15That's the irresponsible user. Therratom
2:18:19industry is making the same argument
2:18:21thatratom is not addictive, that it's a
2:18:24safe substance, that the people getting
2:18:26into trouble were already addicts. That
2:18:29is false and that is not what I'm seeing
2:18:31in my practice and it's not what other
2:18:33doctors are seeing. I want to just
2:18:35quickly skip here to um my last couple
2:18:39of slides. Um it was asked earlier
2:18:41what's happening in other states and so
2:18:44we now have two studies that were
2:18:46recently published. Different
2:18:48researchers really came up with very
2:18:50similar ways of looking at this problem
2:18:53because we have sort of a natural
2:18:55experiment in the United States. We have
2:18:57some states that have completely
2:18:59unregulated.
2:19:01We have some states like Georgia with
2:19:04regulated and KCPA style regulations.
2:19:08And we have states that have complete
2:19:10bands. And what these researchers did
2:19:13was to compare these different states.
2:19:16The first paper looked at
2:19:18hospitalizations and severe events in
2:19:22these different states. And what they
2:19:24found was that in states that were
2:19:27regulating,
2:19:30they were doing no better than states
2:19:32with completely unregulated.
2:19:35that only the states with a ban onratom
2:19:39had substantially fewer uh severe events
2:19:44involving freedom. That was the first
2:19:46paper. The second paper did pretty much
2:19:49the exact same thing, but they looked at
2:19:51the deaths, those 5,200 deaths that I
2:19:54just mentioned from from 2020 to 2024,
2:19:58and they found the exact same thing that
2:20:00the states that had attempted to
2:20:03regulate were doing no better than the
2:20:06unregulated states. Only states with
2:20:09bans had substantially fewer deaths.
2:20:13Talked a little bit about this earlier.
2:20:15The FDA is to this day making it clear
2:20:19that their concern is not just seven
2:20:21hydroxy metrogenine that their concern
2:20:24is also regular products and this is on
2:20:27their website right now they're warning
2:20:29people not to useratom
2:20:32so I am going to uh conclude here
2:20:35contains opioids
2:20:37the opioid crisis teaches us that as you
2:20:40overexpose the population to opioids as
2:20:43you make opioids more easily easily
2:20:45available, millions will get addicted.
2:20:48And the evidence tells us that the
2:20:51approaches that are working in other
2:20:53states are bans. And just one final
2:20:56point, it's been people have wondered,
2:20:58could banning PRA make the fentinel
2:21:00problem worse? That was discussed
2:21:03earlier this morning. We now have
2:21:05evidence to answer that question as
2:21:06well. Um we have states that have banned
2:21:09pra um banned cratom and we're not
2:21:12seeing an increase in fentinel deaths.
2:21:14In fact, the state in the country which
2:21:15has had the most dramatic drop in
2:21:18fentinel deaths is a state with a ban on
2:21:21pratum. That's the state of Vermont. And
2:21:23we're seeing similar effects in other
2:21:25states.
2:21:26>> Thank you. Oh, thank you. Thank you very
2:21:28much. And right now we don't have any
2:21:30questions, but feel free to send us more
2:21:32materials and and uh very enlightening
2:21:35about u the recent research. Thank you.
2:21:38>> Thank you. And one of the things we're
2:21:39trying to do, our goal is to connect
2:21:40these researchers guys, get everybody
2:21:42together regardless of where they're at
2:21:44because they're all across different
2:21:46levels of research they're at and uh
2:21:48connect everybody. And next I'm going to
2:21:50call off and go off script go to
2:21:51representative Reeves Reeves. We'll have
2:21:53to make it quick if you can. Appreciate
2:21:55you being here. And then the other
2:21:57speakers, everybody else will have a
2:21:59little bit longer than Matt,
2:22:00Representative Reeves, but we we'll kind
2:22:02of speed up because we have a hard stop
2:22:04at 12.
2:22:04>> Thank you, Chairman Townsen and members
2:22:06of the committee. uh really appreciate
2:22:08you spearheading this issue several
2:22:09years ago and uh proud of what George
2:22:12has done so far and just wanted to uh
2:22:14come down here because some constituents
2:22:16heard you were doing followup and care
2:22:17about this issue uh of public safety.
2:22:19I've got a lot of high school students
2:22:21in my area, four big high schools and a
2:22:24lot of young people and Gwynette County
2:22:25has a vibrant addiction recovery
2:22:27community with nonprofits and people
2:22:29really care about this. It is definitely
2:22:31on their mind. Um I I did some secret
2:22:34shopping so I'll leave you with uh
2:22:36liquid pill and powder uh that's still
2:22:38available. Uh it was behind the counter
2:22:41behind the glass. Uh they did check ID
2:22:44so they are enforcing the age but
2:22:46there's a large quantity um uh and large
2:22:49variety of uh quote unquote cratom
2:22:52products and you've heard some speakers
2:22:53who've raised questions about what
2:22:55exactly is that. So I'm going to leave
2:22:56you with that and look at it. three uh
2:22:58three of them are from California, one's
2:23:00from Idaho, one's from Oklahoma. Uh some
2:23:03of them have uh ingredients uh on the
2:23:06products, some of them have some
2:23:07question marks, but I'll let you
2:23:09firsthand take a look at it to do your
2:23:11uh deep dive. Also, um am presenting you
2:23:14with laws from Virginia, Arizona,
2:23:16Florida, and Texas about their laws. I
2:23:20know the information you got today was a
2:23:22lot more detailed than we had three or
2:23:24four years ago and certainly some of
2:23:26these other states have looked at it in
2:23:27depth and some of their definitions and
2:23:30specificity uh it's at a a deeper depth
2:23:32than we had at our uh availability three
2:23:35and four years ago. So I'll leave you
2:23:37with that. A couple of models the opioid
2:23:39model that's been mentioned a few times
2:23:41today. there's transparency and civil
2:23:43liability uh on opioid uh and uh I saw
2:23:48Georgia Southern get a big check from
2:23:49DBHDD from that opioid uh trust fund. So
2:23:53there there are funds available from the
2:23:55industry to help people uh and to
2:23:58innovate and make sure that uh products
2:24:00are safe and so I think that is a model
2:24:02to study about uh transparency, civil
2:24:05liability and then compensation for
2:24:07people who were hurt or addicted. uh
2:24:09also um advertising um the ingredients,
2:24:13the type and the quality and also the
2:24:15Florida model. They have a minimum
2:24:17standard statewide, but Sarasota was
2:24:20allowed to enact a more uh restrictive
2:24:22uh set of regulations and Georgia has
2:24:24535 cities and 159 counties. So in
2:24:28addition to having our state minimum
2:24:30have an explicit authorization for the
2:24:32locals to uh have more uh restrictive
2:24:36guidelines uh like we do for a lot of
2:24:38other industries both on advertising as
2:24:40well as uh the actual products places
2:24:42with a lot of schools, a lot of
2:24:44children, a lot of people with addiction
2:24:45problems or other needs and also
2:24:47advertising, you know, just the uh
2:24:50having a big get your cratom here sign
2:24:52where you got school buses passing by
2:24:54and high traffic counts. there other
2:24:56industries that uh you have local zoning
2:24:58regulations that can address things like
2:25:00that. So, uh I don't want to take up any
2:25:02time, but I did want to pass on the
2:25:04information. I've gotten a letter to you
2:25:06by email and I think the staff may have
2:25:08sent it out and then I will I'll uh
2:25:11start it with Chairman Smith, but just
2:25:13uh we got the we got powder. Um we've
2:25:17got pills and we've got uh the two
2:25:22different types of liquid that were
2:25:24available
2:25:26and uh you know they were available in
2:25:28unlimited quantities. Uh so that's the
2:25:30status quo. Thank you.
2:25:33>> Thanks representative. Appreciate you
2:25:35doing that. And one of the things I've
2:25:37done too and it's it's the process is in
2:25:39the works where we do find something
2:25:41where we do that secret shopping and it
2:25:43is over the limits. They don't they
2:25:45don't go by the law. Report them to the
2:25:46sheriff, chief of police, whatever you
2:25:48have in municipality and uh they need we
2:25:51need to go after the bad guys. Blue
2:25:53Malone, the good actors, but go after
2:25:55the bad guys.
2:25:56>> Thank you.
2:25:56>> Okay. Thank you, Representative Reese.
2:25:58Good job. Okay. Next will be Dr. Kandle.
2:26:01Uh kudos Dr.Randle recent PhD graduate
2:26:04from Emory. Appreciate you being here.
2:26:07And I'm going reinforce uh quick as you
2:26:09can, but uh it's an honor for you to be
2:26:12here. Congratulations. It was just
2:26:13really just a few weeks ago, wasn't it?
2:26:15You got your PhD
2:26:16>> uh in March.
2:26:17>> March. Congratulations.
2:26:20>> Well, thank you very much for the
2:26:21opportunity to speak at this hearing
2:26:23committee today. My name is Dr. William
2:26:25Kandle. I'm an analytical chemist and a
2:26:27pharmarmacologist.
2:26:28My NIH funded research at Emory
2:26:30University has focused on understanding
2:26:33the polypharmarmacology as well as the
2:26:35drug metabolism of its various alkoids
2:26:38in both a preclinical and clinical
2:26:40setting. Sure. Uh we've heard a lot
2:26:42aboutratom and I need to speed up so I'm
2:26:45going to skip some stuff here but I want
2:26:47to begin by reiterating this clear
2:26:49definitional distinction and that
2:26:51isratom refers to the raw leaf and the
2:26:55natural ratios of alkaloids found within
2:26:58not all of these other products that
2:27:00we've already heard a lot about on the
2:27:02market. To further note um I think I saw
2:27:05this on some slides butratom is
2:27:07specifically the genus and species
2:27:09metroinus speciosa. So this is very
2:27:11important because this genus contains
2:27:13over 10 different species.
2:27:16Kratom has centuries of ethnobbotanical
2:27:18use with the first documentation of the
2:27:20plant in western culture by Dutch
2:27:22botonist Peter Vilhelm Corthals in 1839
2:27:25and it has a variety of uses in
2:27:27traditional context
2:27:29such as the treatment of diarrhea, fever
2:27:31pain and to boost energy.
2:27:34Traditional preparations include
2:27:36mastication and bugal absorption. That's
2:27:38the chewing of the leaves and packing in
2:27:40between the cheek and the gum as well as
2:27:42brewing the leaves in water and drinking
2:27:44the decoction. So this differs quite uh
2:27:47marketkedly from the preparations and
2:27:49what you see on the market today in the
2:27:51United States.
2:27:53Important to the pharmacology of this
2:27:55was touched on is the conversion of
2:27:57metroinine to 7 hydroxy. This occurs in
2:28:01your liver upon oral consumption and we
2:28:03have human data on this. Um this occurs
2:28:06slowly over time and around 15 to 20% of
2:28:09the metrogenine dose present inratum is
2:28:12converted to 7 hydroxy. Uh what's really
2:28:15important about this is that the
2:28:17conversion takes place over time and
2:28:19therefore the peak plasma concentrations
2:28:21never achieve levels that you could
2:28:24obtain from taking a synthetic uh
2:28:26semiynthetic product like a seven
2:28:29hydroxy tab.
2:28:33Um importantly 7 hydroxy metroinine
2:28:36shows severe respiratory depression in
2:28:38humans unlike metroinine and theratom
2:28:41leaf material and hill at all in the
2:28:43British journal of pharmarmacology have
2:28:45shown metroinine to have a sealing
2:28:47effect. So these effects are due to the
2:28:49rate limiting conversion of metroinine
2:28:5227 hydroxy in the liver.
2:28:56As you know there are various types of
2:28:58catratom related products on the market.
2:29:00products which are concentrated extracts
2:29:02containing unnaturally high abundances
2:29:04of metroinine liquid shots. Um sometimes
2:29:07these are combined with other plants
2:29:09like cava even THC and lastly multiple
2:29:12semiynthetic products uh such as 7
2:29:16hydroxy and pseudoindoxil and to be very
2:29:18clear pseudoindoxil is not found inratom
2:29:22at all. [snorts] 7 hydroxy is found only
2:29:25in trace levels and many studies have
2:29:27found that it is not present in some of
2:29:29their products that they have tested. In
2:29:32fact, that blue bottle you see there um
2:29:35contains cabba in that that cratom shot
2:29:37there.
2:29:40I've analyzed that by the way. Um I've
2:29:43I've done some secret shopping myself
2:29:45and um
2:29:48treating them as the same as these
2:29:50various types of other products is
2:29:52incorrect on both an analytical
2:29:54chemistry and pharmacological standpoint
2:29:56not just a legislative.
2:29:58So multiple human clinical trials have
2:30:01been conducted using well-characterized
2:30:03leaf. As we heard from Mccertie, the FDA
2:30:05funded a single dose escalation study
2:30:08onratomatum published in the journal of
2:30:10clinical psychopharmarmacology in 2026
2:30:13and it concludes I quote in summary the
2:30:16current study orally administered
2:30:18botanical was well tolerated with the
2:30:20most commonly reported adverse events
2:30:22observed at the highest doses eg 8 to 12
2:30:25grams and classified as mild in severity
2:30:29that's i.e grade two or lower. End
2:30:31quote.
2:30:34A second human study conducted by
2:30:36Houston at all published in journal of
2:30:37therapeutic drug monitoring in 2026 in
2:30:40which a single dose and multiple doses
2:30:42of ground cratom leaf given over a
2:30:44period of 15 days concludes I quote this
2:30:47novel single and multiple dose
2:30:50randomized placeboc control double blind
2:30:52study shows that Mspiosa derived Mitch
2:30:55relief cratratum powder was safe and
2:30:57well tolerated at the dose ranges tested
2:31:00with no evidence of meaningful abuse.
2:31:02use potential or withdrawal. End quote.
2:31:05Lastly, a study in which humans were
2:31:06given purified metroinine up to 40 mgram
2:31:09doses. So that's the main alkaloid found
2:31:12in the leaf by preet at all published in
2:31:15journal of psychopharmarmacology Berlin
2:31:17in 2024 denotes the following results. I
2:31:20quote metroinine did not significantly
2:31:23affect vital signs and only mild
2:31:25transient side effects were reported.
2:31:27End quote.ratom
2:31:30has legitimate medicinal potential as
2:31:33McCertie noted. Um the actually just on
2:31:37June 1st the NIH announced their IND
2:31:39application of the FDA has taken effect
2:31:41to assess metroining as a potential
2:31:44treatment for opioid use disorder.
2:31:47So while there is um some potential for
2:31:51mild to moderate addiction again
2:31:53mccertie presented on that with a
2:31:55relatively low salves or subjective
2:31:57opioid withdrawal scale compared to
2:32:00other opioids.
2:32:03More studies in this regard are needed.
2:32:09The products in the trials that I just
2:32:12mentioned were well defined. you you
2:32:14know the amount of metroinine and the
2:32:16total alkaloidal content which is very
2:32:18important becauseratom is not just
2:32:21metroinine it's 54 different known
2:32:23alkaloids to date and um that's very
2:32:27different from what we see on the market
2:32:29which is flooded with these adulterated
2:32:31mislabeled unccharacterized and
2:32:32concentrated extracts and specifically
2:32:35these semiynthetic products which are
2:32:36entirely different than theratom leaf as
2:32:40an analytical chemist it's quite easy to
2:32:42distinguish these semiynthetic products
2:32:44from the leaf material itself. Then I
2:32:46would like to conclude that what would
2:32:49protectratom consumers the most would
2:32:50not be legislation but rather regulation
2:32:53of products on the market. Products
2:32:56which follow good manufacturing
2:32:57procedures, quantify these alkoidal
2:32:59compositions
2:33:01do not have these extremely concentrated
2:33:04semiynthetic products and are not
2:33:06branded or labeled to minors or
2:33:09children. Thank you.
2:33:11>> Okay. Thank you Dr. Kandle. Any
2:33:13questions? I know you and I talked on
2:33:14the phone and um I think I asked you the
2:33:17question about
2:33:19where we should sell it at. If we if we
2:33:21don't ban it, do we let it stay in the
2:33:25vape shops and convenience stores or is
2:33:28it safer with the professional?
2:33:30>> You know, it was mentioned before, but
2:33:32where something is sold plays a lot on
2:33:34the kind of psychology of of what you're
2:33:36buying. So, you know, if you're buying
2:33:38uh something in a in a gas station, as
2:33:41I've done many times, to analyze this in
2:33:43the lab using techniques like mass spec,
2:33:46um you know, that might not be the best
2:33:50option. So, you know, in in Georgia, we
2:33:53have the KPCA, which as the previous
2:33:58presenter showed was ineffective. I I
2:34:00think it's not enforced. Um I can go
2:34:04into a gas station right now and buy
2:34:06pseudoindoxil. I can measure it on my
2:34:08instrument and it actually contains
2:34:09seven hydroxy metitrograin levels higher
2:34:11than what the KPCA allows.
2:34:13>> Okay.
2:34:14>> So selling in a in a place in which that
2:34:17can be controlled might be best for
2:34:19public health.
2:34:20>> Thank you.
2:34:21>> Okay. Next will be Dr. Norton University
2:34:24of Georgia
2:34:26Promisy School. Dr.
2:34:29professor I believe
2:34:32he he's appreciate his current input and
2:34:36past input and again I apologize we did
2:34:39check it yesterday and called early this
2:34:41morning and it still hasn't helped so I
2:34:43apologize
2:34:46I just want to clarify a couple of
2:34:48things I'm not getting paid by anyone to
2:34:50be here I just want to let y'all know
2:34:52that um
2:34:54my background is that I'm a clinician
2:34:57I've been a practicing pharmacist in the
2:34:59state of Georgia for over 50 years in
2:35:01multiple settings. Went back to school,
2:35:04got a new doctorate specific to the
2:35:07University of Georgia to do the
2:35:08research, which I'm really really
2:35:10excited about the researchers that have
2:35:12been presented so far today having to do
2:35:16with addiction science.
2:35:19retired
2:35:2119 in 2021 because my wife developed
2:35:24late stage 4 non-hodkkins lymphoma
2:35:28at the she was at the stage of death
2:35:31fortunately because of miracle of
2:35:33science and because of medicine she's in
2:35:36complete commission as of today and
2:35:40>> she's taking care of the dog that's why
2:35:42I'm here I have a dog that loves me and
2:35:45hates her but she decided it was
2:35:47important for me to be here So, not to
2:35:49take up your time, I'm not going to
2:35:51regurgitate uh the things that you know
2:35:54these marvelous speakers have presented
2:35:57both in a good way and and and given me
2:36:00a lot of thoughts. I've taken a lot of
2:36:02notes. But my question and my concern
2:36:06was this was a blue ribbon study
2:36:08committee on youth exposure to cradle.
2:36:12So what I wanted to do is and I haven't
2:36:14heard a lot about what happens to the
2:36:17adolescent brain when cratom
2:36:20is used as most of the researchers have
2:36:23indicated we we if it be a regulated
2:36:26state or unregulated state these kids
2:36:29are able to find the products and we
2:36:32don't know what's in them I as a
2:36:34pharmacist and I have several of the
2:36:35pharmacists here will regate I don't
2:36:37know what's in the problem you're going
2:36:39to ask me would you recommend cratom to
2:36:41one your patients and the answer is that
2:36:43no my my best advice to them is buy or
2:36:47beware because I have no clue and you
2:36:51know being a pharmacist they're think I
2:36:53got to know dosing and we have multiple
2:36:56ways to consider dosing whatever we're
2:36:58going to do the research which molecule
2:37:00are we going to dose because we got more
2:37:02than one molecule and that's been
2:37:04clarified very much today uh what's the
2:37:07tolerance curve what's the genomics you
2:37:10know what Where where how does your
2:37:12genetics affect the I know with opioid
2:37:15substance use disorders? They are people
2:37:17who are wired to be opiate use
2:37:19disordered individuals. They can take
2:37:21high amounts of an opioid and do very
2:37:24well very similar to genetic alcoholics.
2:37:27But we don't know that child. We don't
2:37:29know that. And then the adverse drug
2:37:31effects. All right.
2:37:33Because my time is short and I wanted to
2:37:35and it's hot.
2:37:37Let's talk about the adolescent brain a
2:37:39minute. The adolescent brain is the
2:37:40brain that transitions from a childhood
2:37:42brain to an adult brain. Adolescence is
2:37:44the the the culmination of taking a
2:37:47child a predominantly electrical
2:37:49somewhat chemical brain and converting
2:37:51it into adult brain which is somewhat
2:37:53electrical and chemical and it functions
2:37:56that adolescent world is about 11 to 12
2:37:59years old. You know it takes that time.
2:38:02So what happens is they're more
2:38:04vulnerable to substance use disorders.
2:38:07It takes less than two years for an
2:38:09average of an individual under the age
2:38:11of 15 using a psychoactive substance to
2:38:13develop a substance use disorder.
2:38:16Unfortunately, we don't have effective
2:38:17treatments for them because we don't
2:38:19have a lot of adolescent treatment
2:38:21facilities in the state of Georgia to
2:38:22deal with substance use disorder. It's
2:38:24another issue for another day. But I'm
2:38:26going to tell you when you talk about
2:38:28something that we're talking about here
2:38:30that has the potential the potential to
2:38:33impact an adolescent brain then the
2:38:35first thing I'm going to tell you you
2:38:36don't need to have it anywhere close to
2:38:38anybody until the science says this is
2:38:42how you take it. This is what you do
2:38:43with it. This is what we're going to do
2:38:45with it. And without that complete
2:38:48review
2:38:50>> that's approved not only from the state
2:38:53but also the FDA and all of us. Now,
2:38:56adolescence are unique in that their
2:38:59brains develop differently. As y'all
2:39:02have had adolescence, I've got two of my
2:39:04adult children in the audience. Thank
2:39:06goodness. They got through adolescent
2:39:08not a whole lot of trouble. A lot of
2:39:09money, but no trouble. But the thing
2:39:11about it is the prefrontal cortex, the
2:39:14lift reward system, the hippocampus, the
2:39:16stress circuitry, the mileinated
2:39:18executive control networks. Now, let me
2:39:20tell you something about that. My
2:39:22studies having to do with psychoactive
2:39:24substances has to deal with
2:39:26neuroinflammation.
2:39:28Neuroinflammation is the impact of a
2:39:31drug passing the bloodb brain barrier
2:39:34into the neoortex and inflaming that
2:39:37part of the brain. And that's where we
2:39:39see psychoactive drugs being. So, so if
2:39:42y'all want to research out here, y'all
2:39:44also include your neuroinflammation as
2:39:46you look at that because the thing about
2:39:48it is adolescent brain is vulnerable.
2:39:50And what happens to the bloodb brain
2:39:51barriers when these molecules begin to
2:39:53hit this bloodb brain barrier as with
2:39:55some substances guess what it creates
2:39:58holes in the dam and when them holes in
2:40:01that bloodb brain barrier has certain
2:40:03molecules get passed through. So we may
2:40:05have as we say the the mitrogenine it
2:40:08may pass through uh and maybe the 70 may
2:40:12not but as a result of impact to those
2:40:14it could. So the thing is we have that
2:40:17impact and that affects their executive
2:40:19control the reward system sensization
2:40:23changes. In other words, the dopanergic
2:40:25system, the serotonin system, the
2:40:27systems that are histaminic systems. You
2:40:30know, we got a new histamine H3 receptor
2:40:32in the brain that's responsible for a
2:40:34lot of our dementias. Guess what this
2:40:36drug is going to do? I'll guarantee you
2:40:38the researchers will find it will impact
2:40:40that brain at a young age and they can
2:40:43have early onset dementias down in their
2:40:44adulthood. And the problem that comes
2:40:47with that, y'all, is we really need to
2:40:49review these these drugs thoroughly
2:40:52before we pass anything that says
2:40:54they're legal. As many of them said, I
2:40:57I've done some of that secret so
2:40:58shopping and and and I've had some
2:41:01issues. I have calls from all kinds of
2:41:03folks in in my small practice because
2:41:05I'm mainly an educator now. I try to
2:41:08retired. I try to retire today. I could
2:41:10have been on the golf course today, but
2:41:11here I am. But thank you all for your
2:41:13committee work. I really am. I I salute
2:41:15you for that. So what we see is when you
2:41:18change that hippocample component in the
2:41:21brain, you change their learning
2:41:22component. Now you can talk to the
2:41:24department of education right now. You
2:41:26can talk to them and talk about the
2:41:27dropouts that we're having in the state
2:41:28of Georgia and the reason that we're
2:41:30having so decline in our math and and
2:41:32and reading. You know, when I
2:41:35unfortunately taught at the University
2:41:36of Georgia, you would find some of the
2:41:38finest students available. But how many
2:41:40students don't make it to that extent?
2:41:43and is a drug you know is it this
2:41:45particular drug you have mood anxiety
2:41:47and stress disorders
2:41:50which are even more significant and once
2:41:52they start y'all we can't stop them and
2:41:55then of course the risk of dependence
2:41:57and withdrawal
2:41:59and I think several of the speakers have
2:42:01indicated is isratom and I know it's got
2:42:04multiple molecules is it an opioid or if
2:42:07it's not yes it is it's you knowratom
2:42:10itself and in fact I've read some one of
2:42:13researchers some of their data on I
2:42:14think it's the University of Florida
2:42:15said it's like a coding effect which is
2:42:18a mild opioid but yet it can affect it.
2:42:21So, what I'd want y'all to know is that
2:42:24adolescents when they take a
2:42:26concentrated 70, according to this
2:42:29researcher, it can create an opioid like
2:42:32intoxication, it creates sedation that
2:42:34leads to accidents, severe impaired
2:42:37driving, respiratory risk. We combine if
2:42:40they combine it with alcohol, marijuana,
2:42:43other drugs. There's not just a single
2:42:45drug on board as a rule. rapid
2:42:47tolerance,
2:42:49severe withdrawal, compulsive use.
2:42:52And the thing that I will say about this
2:42:55particular compound, it is it is the
2:42:58gateway
2:43:00the gateway drug to other opioids that
2:43:04are now available. Do y'all realize I've
2:43:05got to do a talk in Norcross tomorrow
2:43:09and then I've got to do a talk in for
2:43:10science. Tomorrow it's prescription mis
2:43:13misuse to a group up there. And then in
2:43:16for Scythe County, I've got to go talk
2:43:17to the drug court folks about
2:43:19psychotropics and the medications can be
2:43:21used to help put those people back
2:43:22together.
2:43:24I cannot tell you how important it is to
2:43:27do your work and do it thoroughly.
2:43:28Y'all,
2:43:30um, like I say, I come voluntarily. I do
2:43:33what I do most of the time. Help
2:43:34families get treatment. Help them
2:43:37understand why I've had 59 suicides on
2:43:40my watch in my career, y'all. Multiple
2:43:42drugs. You understand? I've I I it
2:43:45saddens me. It saddens me to see the
2:43:4817year-old down the street who is
2:43:50hopefully and his his mother is a great
2:43:52neighbor call me and talk to me about
2:43:54well, he's he's using this little bottle
2:43:56of stuff and and and he says it's what
2:43:58it what can I do? What can I do? And
2:44:00many of y'all have had those same calls.
2:44:02We need to stop it. And the only way you
2:44:05stop it is you ban it until science
2:44:10comes up with an alternative. Now, I
2:44:12will say this harm reduction. I'm a big
2:44:14harm reduction person. If there's
2:44:16individuals who are in opioid withdrawal
2:44:19and they would like to have a cratomlike
2:44:21product,
2:44:23we have clinics that could be set up for
2:44:25that.Uou clinics, they already they're
2:44:27medically supervised. it would be the
2:44:29safe thing to do. And I'll be the last
2:44:31one to tell you, if you want to get your
2:44:33prescription drugs filled, you going to
2:44:35take them to a gas station to get them
2:44:36filled.
2:44:38Because I'm telling you, it's it a lot
2:44:41of these gas stations turned into be
2:44:42corporates and they're nice things, but
2:44:44they have very very sophisticated ways
2:44:46of selling things.
2:44:48But then look at the bathrooms. You
2:44:50know, you go to some of these places and
2:44:51you wouldn't think about using their
2:44:53bathroom, but yet they sell these
2:44:55products. Do they know those products?
2:44:56The answer to that is no.
2:44:58So I come here kind of as an advocate to
2:45:01protect the youth, our next generation
2:45:04of Georgians. Um
2:45:07because that's why when I retired from
2:45:10the University of Georgia, I was in
2:45:12treatment for a very long time and
2:45:13treatment works, but a lot of people
2:45:16don't make it. I went to prevention and
2:45:19that's where I spend my time now is in
2:45:21prevention. I'm thrilled so thrilled to
2:45:23everyone who presented today and who's
2:45:25been here. I've got a tremendous
2:45:27education and this information that
2:45:29they've given me and these studies and
2:45:31that information that I requested from
2:45:32you is to come is to educate physicians
2:45:36and practitioners and all of those that
2:45:38I travel the country doing all the time.
2:45:41So, thank you very much. Uh I know I
2:45:43didn't provide you any specific
2:45:45statistics. Um I don't like a lot of
2:45:48statistics because they change every
2:45:50day. So, I conclude my remarks. Any
2:45:53questions you may have?
2:45:54>> Thank you, Dr. and I appreciate it. I
2:45:56don't think so. And we'll connect again
2:45:57for sure. Thank you for making the time.
2:46:00We're making a slight switch. We have
2:46:01time for two more speakers, so we're in
2:46:03good shape. Hard stop at 12:00. Michael,
2:46:06he's online. We're going to let Eli go.
2:46:08He's got to run. I'm going to let Eli
2:46:10Cohen go for a few minutes. Then after
2:46:12that, we'll have Michael Tempton right
2:46:14after that. So, we will have them both
2:46:17be on there. And again, it's a hard stop
2:46:19at 12.
2:46:21I'm gonna be the only one bringing
2:46:23samples for you guys.
2:46:25>> Speaking in the microphone
2:46:34has two roles. Uh his role today mainly
2:46:36is going to be as a post-certified
2:46:38trainer for law enforcement for gas
2:46:40station drugs. He is also a trial
2:46:43attorney for the Weatherton Law Firm.
2:46:46and he is currently doing post-certified
2:46:48training
2:46:53and we will be on a side note studying
2:46:55other things. I know vaping is going to
2:46:56be one thing we're taking up uh since
2:46:58it's affecting adolescence and uh there
2:47:00probably one or two other drugs as well
2:47:02within this committee.
2:47:04Mr.
2:47:05>> Talson, thank you to the committee. Look
2:47:07here, my name is Eli Cohen. I'm an
2:47:08attorney at the Weatherington Law Firm.
2:47:10And let's make sure everyone understands
2:47:13I represent families of loved ones who
2:47:15have died. Um I have about 15 of these
2:47:17cases across the country. The majority
2:47:19of them are here in Georgia. All these
2:47:21families were taking some kind of cratom
2:47:23either extracts um or raw cratom. I
2:47:26don't currently have any 70 cases. Uh
2:47:29but we are starting to see those phone
2:47:31calls come in. U my background is before
2:47:35I was an attorney. I was a police
2:47:36officer here in Georgia for 12 years. I
2:47:38started just down the street at George
2:47:39State University. Uh cuz somebody told
2:47:41me that the legislature created a system
2:47:42where if you're a full-time employee,
2:47:43you get free school and that's how I
2:47:45paid for undergrad. Um then I did eight
2:47:47years in Sandy Springs where I've worked
2:47:48on all kinds of units. Uh with my last
2:47:50three years being on the SWAT team and
2:47:51that was a lot of fun. Um and then again
2:47:53because I just like people telling me
2:47:54what to wear. I'm also been in the Army
2:47:56Reserves for the last 15 years. Uh
2:47:58currently a major and an intelligence
2:47:59officer with a top secret clearance. Um
2:48:02I'm here to tell you kind of the
2:48:03landscape of Georgia. um and kind of
2:48:06talk about like what has Georgia already
2:48:07done and what have we seen since that
2:48:09happened. As you guys know, um there was
2:48:11an amendment to the previous consumer
2:48:14protection act in 2024 that did several
2:48:17things, right? It raised the age to 21.
2:48:19It limited the amount of mitroine that
2:48:23can be in a product to 150 milligrams.
2:48:26It also limited the amount of 70 that
2:48:28can be in a product per serving to 1
2:48:30milligram. That already exists in
2:48:32Georgia for 70. we and it also prevents
2:48:36synthetics, things like pseudodoxil from
2:48:38being in these products. And what you
2:48:40see getting passed around are products
2:48:42that a lot of people I've gone and
2:48:44bought products um and then I've sent
2:48:46them actually to Dr. McCertie down here
2:48:48cuz his lab tests them, which is what
2:48:49you see attached to those. And on
2:48:51several of those products that I am
2:48:52passing around, you're going to see two
2:48:54things. Some products you're going to
2:48:56see that are labeled as 7 hydroxy
2:48:58matragene and have 30 40 50 80
2:49:01milligrams of 70 in them that is already
2:49:03illegal in Georgia. Um but the issue is
2:49:06the enforcement is not happening because
2:49:08it's hard to enforce these products. Um
2:49:11the other thing you're going to see is
2:49:12you're going to see several companies
2:49:13started selling things as pseudo doxil
2:49:16because hey 70 is banned. Let me just
2:49:18sell it as pseudodoxil. And so I passed
2:49:20them around. I brought one up to show
2:49:22you because this is my favorite one. Um,
2:49:25I'll let you read that for yourself if
2:49:26you can.
2:49:28I'll say it. It says [ __ ] is what it
2:49:30says. This has the name of this product
2:49:31that they're selling. Let everybody else
2:49:33see it. Um, it is labeled as a pseudo
2:49:35pseudoindoxil product, but as Dr. Mccuri
2:49:38tested, um, it actually has nine um,
2:49:40more than 9 millig of 70 in the product.
2:49:42That is what we're seeing on the shelves
2:49:44of Georgia in both smoke shops and in
2:49:47uh, gas stations throughout the country.
2:49:49Um, and that is just consistent. The
2:49:51same is true with some of the otherratom
2:49:54products that I'm passing around, the
2:49:55extracts and the just raw powders. Um,
2:49:58these companies are not abiding by the
2:50:00regulations that you already put in
2:50:03place. Um, and why is that? Well,
2:50:05regulation is hard. It is hard for law
2:50:07enforcement to walk into every single
2:50:09one of these gas stations, buy the
2:50:11product or know that the product is
2:50:13illegal by looking at the label. Um, it
2:50:15is, you know, law enforcement is not in
2:50:16the business and of walking into a gas
2:50:18station, doing what I've done, buying a
2:50:20product, sending it to a lab, paying for
2:50:22the test, and then coming back with the
2:50:24results in order to write a warrant.
2:50:25It's just not something that gets done.
2:50:26The regulation is really hard, which is
2:50:28why I think what you've heard here today
2:50:30is that where you can buy it is so
2:50:31important. Removing these from
2:50:34especially gas stations and probably
2:50:35smoke shops is smart. We already have a
2:50:37system of well- reggulated um sellers of
2:50:41some some of these kinds of drugs. your
2:50:42low THCA oil laws already have these
2:50:45things. You heard the dispensaries. Um
2:50:47that is that could be a place where
2:50:50could go to get it out of these
2:50:52companies, these these you know gas
2:50:54stations and smoke shops that don't seem
2:50:56to care about the laws that you passed.
2:50:58Um so there's something that I I would
2:51:00strongly encourage you to think about um
2:51:02as we move forward. The other thing I
2:51:04want the committee to think about is
2:51:08what should even be on the market here
2:51:09in Georgia. Um, I'm going to throw this
2:51:12out here now because I think at some
2:51:13point the creative advocates that are in
2:51:15the front row and throughout are going
2:51:16to get to talk. Um, I don't think the
2:51:18extract should be sold at all. Period.
2:51:20Full stop. And I'd love to hear their
2:51:22thoughts on that as well. Um, the
2:51:25majority of my cases involve extracts.
2:51:27Why? Because the cratom powder per, you
2:51:29know, per gram may have 10 12 milligrams
2:51:33of metrograine in it. Um, as opposed to
2:51:36some of the products you see getting
2:51:38passed around. Some bottles will have
2:51:40300 milligrams of Matraine in a single,
2:51:42you know, 5 10 bottle. It is absolutely
2:51:46insane the amount of matraine that you
2:51:47can shove into your body with the
2:51:49products that are on the market. And
2:51:50there's just no reason there. There is
2:51:52there are no human studies that have
2:51:54gone the distance that is tested using
2:51:57raw or extract over a long period of
2:52:01time. You've heard about a single
2:52:02ascending dose where where these
2:52:05individuals many of whom were not opiate
2:52:07naive or at least had used some opiates
2:52:10in the past but were otherwise healthy
2:52:12were in these studies. That is exactly
2:52:13the kind of study that should happen
2:52:15that first level study but it's not no
2:52:18drug would be sold off of a single
2:52:19ascending dose offer of a single dose
2:52:22study. And it's we are not at a point
2:52:24where we can say any of these products
2:52:26are safe, but at the very least as a
2:52:28compromise to to save some of these
2:52:30citizens, um you should seriously
2:52:32consider banning extracts.
2:52:36Other things I want to mention.
2:52:38>> Yeah. Real quick too, don't forget
2:52:40talked a little about the postcertified
2:52:42training and y
2:52:43>> we do have one more speaker.
2:52:44>> So one of one of the things I've done
2:52:45because of the gap in the knowledge of
2:52:48law enforcement is I created a class for
2:52:50police officers in Georgia. Uh, while I
2:52:51was a police officer, I got certified as
2:52:53both a field training officer and a
2:52:54certified general instructor. I think
2:52:56the term is now I'm a senior instructor
2:52:58under under post rules. Um, and so I
2:53:00created a two-hour course of instruction
2:53:02for post-certified police officers to
2:53:03receive credit. Um, and we cover kind of
2:53:06two broad areas. Number one, we cover
2:53:08them because I want to empower the
2:53:09officers to be able to look at a label
2:53:11and immediately know if that label is
2:53:14valid or not. Because if a store is
2:53:15selling uh illegal label, that's a
2:53:17misdemeanor. That is something they can
2:53:19they can go after immediately. and it
2:53:20doesn't require testing the product, but
2:53:22that that takes a while to teach and
2:53:24pass along those classes. Um, the other
2:53:27thing we cover are other gas station
2:53:29drugs, mostly focused on THC, delta 8,
2:53:32delta 9, and um, low THC oil products
2:53:36because again, those those laws are
2:53:38still relatively new, and helping
2:53:39officers understand what's legal because
2:53:41the same is true forratom as it is for
2:53:43the THC products. And I have some in my
2:53:45magic bag if you want to see it later.
2:53:48um the same places that are selling
2:53:49these cratom products that are not
2:53:51properly labeled and are often
2:53:53mislabeled and adulterated with stuff
2:53:55with higher levels of 7H that they're
2:53:58allowed to have or sometimes lying about
2:54:00what's actually in the product are doing
2:54:01the same thing with low THC excuse me
2:54:04with delta 8 and delta 9 products and
2:54:06hemp products which is again it's just
2:54:08evidence that these
2:54:10these businesses [clears throat]
2:54:12unfortunately um aren't doing the right
2:54:15things for Georgians and maybe shouldn't
2:54:16be trusted said, "There's a reason why
2:54:18we don't sell low THC oil in gas
2:54:20stations, and that might be true for a
2:54:22lot more products than just low THC
2:54:25oils." Um, so I know we're running out
2:54:27of time and I don't want to take up too
2:54:29much of your time, but I do want to open
2:54:30up for questions if I could.
2:54:32>> Sure. Thank you, Eli. Uh, Dr. Al
2:54:35represent,
2:54:37>> thank you so much. Uh I just wanted to
2:54:38draw attention to two of these uh
2:54:40exhibits that you brought because it's
2:54:41actually pretty interesting if we're
2:54:43talking about approach to labeling and
2:54:46um regulating that. This first one
2:54:48called Hushratum energy drink. I noticed
2:54:51that in terms of the active ingredients
2:54:53that it lists, it lists um for total
2:54:57metroining content about 65 milligrams
2:54:59which is above the threshold for
2:55:01sedation as our one of our earlier
2:55:02pharmarmacology experts testified. But
2:55:05it also contains 80 milligrams of
2:55:06caffeine, which is um the same amount as
2:55:09in a Red Bull. I just held them up to
2:55:12each other to to check. Just to note
2:55:15that there's a a phenomenon of of uh a
2:55:19beverage that was banned actually for
2:55:20Loco, we remember from 2010, was banned
2:55:22because it contained both alcohol, which
2:55:24is a depressant, and a high content of
2:55:27caffeine, and it made it dangerous
2:55:28because the caffeine masked the effects
2:55:30of the depressant. So that's something
2:55:32we may want to consider in terms of um
2:55:35concurrent uh active substances packaged
2:55:38with something that is a depressant and
2:55:40may affect your sensorium and mental
2:55:42status. So that's that's the one thing.
2:55:45The second thing is this um tablet here
2:55:48>> the dopium.
2:55:48>> You know what I'm going to say right? Um
2:55:50this is an extract that we talked about
2:55:52um the seven hydroxy extract which is
2:55:56not the pure leaf cratom we talked
2:55:57about. It is 80 milligrams which is
2:55:59again above the depressant threshold for
2:56:02dosage and just in terms of the
2:56:04marketing you know we can say it's
2:56:05marketed for this and that and it's safe
2:56:07and all these things but to to
2:56:09explicitly label this supplement
2:56:13as dopamium maybe gives away the game a
2:56:16little bit of what they're trying to
2:56:17appeal to and what message they're
2:56:19trying to send to people for this
2:56:21>> that's absolutely right one of the
2:56:22products you have that um that the
2:56:23representative brought in right in front
2:56:24of you the Malay cratom bag Um it's OPMS
2:56:28cratrum they used to just call
2:56:29themselves OPMratom they literally call
2:56:31themselves OBM
2:56:32>> but you know these companies are not
2:56:33high in the ball and in fact OPMS cratum
2:56:35is one of the largest supporters of the
2:56:37American cratom association um but even
2:56:40they you know and again I am directly
2:56:42suing them in five states right now
2:56:45>> and so the these companies they're not
2:56:47hiding the ball in what they're selling
2:56:48they're selling what they want consumers
2:56:50to know as opium
2:56:52>> and again I they're not doing it the way
2:56:53you've already told them they need to
2:56:55and the products that continue to hit
2:56:56the market. This is true both inratum
2:56:59and other gas station drugs like delta
2:57:018. There's a race to the top. I need to
2:57:03make the strongest product in order to
2:57:06um sell my product. One of the things
2:57:07we've heard since 70 has become a
2:57:09problem is that raw leaf and even
2:57:12extract manufacturers are saying I'm
2:57:13losing so much business to 70 like I'm
2:57:15going to I'm going to go out of business
2:57:16because of 70. Um if you are losing your
2:57:20business to a better drug, you're not
2:57:22actually providing that kind of like
2:57:24that public health service. you're just
2:57:26a drug dealer, right? It's almost as if
2:57:28a cocaine dealer is complaining about
2:57:30crack in my opinion. Uh it's just not
2:57:32legitimate. So again, is there a place
2:57:34probably for some kind of treat use of
2:57:36cratom as a treatment in low doses as a
2:57:38raw powder form? Maybe. Um but extracts
2:57:42and anything beyond that 70 and the
2:57:44synthetics, you should bamp.
2:57:46>> Certainly. And then just to wrap it up,
2:57:47the um you know, I've noticed a lot of
2:57:49the marketing does lean on this sort of
2:57:51like natural botanical leaf symbology as
2:57:55sort of I guess indicating that it's
2:57:56safe and natural as an alternative for
2:57:58whatever you're trying to treat. But
2:58:00just to just to remind people, you know,
2:58:01just because it comes from a plant
2:58:02doesn't mean it's safe because as we
2:58:04know, opium comes from a plant. Um
2:58:07cocaine comes from a plant.
2:58:10Cannabis is from a plant, you know. So
2:58:12just to put that out there.
2:58:13>> Thank you, Representative Al. Thank you,
2:58:15Mr. Cohen. Thank you. Okay, we'll go
2:58:17online now to Michael Templeton.
2:58:20He is um
2:58:23DUA special agent, retired CEO of
2:58:26Barister uh intelligence and
2:58:32this is the last witness of the meeting
2:58:34and
2:58:36thank you for everybody for sticking
2:58:39with the hot air in here or no air.
2:58:43>> Thank Thank you, Mr. Chairman. Can you
2:58:45hear me? Okay.
2:58:46>> Uh, loud and clear. We're trying to get
2:58:48you on TV.
2:58:50>> Okay. You let me know when I can go.
2:58:52>> You're on. Thank you.
2:58:55>> Thank you, Mr. Chairman, for for
2:58:56allowing me to speak today. Um, I'm
2:58:58again, I'm a retired special agent with
2:59:00the DEA. Spent 25 years with the DEA,
2:59:02both in domestic offices, uh, small and
2:59:05midsize as well as overseas. I spent uh
2:59:09two years in in Pakistan and two and a
2:59:12half years in Afghanistan combating the
2:59:14world's leading producer of heroin. um
2:59:18uh which which is important to remember
2:59:21today that we are talking about opioids
2:59:24and uh the stimulate effects of opioids
2:59:27versus opiates and of course heroin is
2:59:29an opiate and I spent quite some time
2:59:31there combating the opiate uh excursion
2:59:35coming out of Afghanistan along with the
2:59:37terrorist financing that that went along
2:59:39with it. Uh what I'd like to talk about
2:59:41first is where is the regulations in in
2:59:45Indonesia? So we heard earlier that most
2:59:47of theratom is produced in Indonesia.
2:59:50That is correct. About 95% comes from
2:59:53the island of Borneo on the western side
2:59:55of Borneo in Indonesia.
2:59:58Um current estimates are that they are
3:00:01exporting approximately 4500 metric tons
3:00:05of into the United States per month. To
3:00:09put that in perspective, the country of
3:00:11Afghanistan, the world's largest
3:00:12producer of heroin, produces 3,000
3:00:15metric tons of heroin per year. So you
3:00:19in one month they're sending 4,500
3:00:21metric tons of cratom powder to the
3:00:24United States.
3:00:26It is uh
3:00:29perfectly legal for them to export
3:00:32theratom from Indonesia to the United
3:00:34States and other countries that will
3:00:36allow it. While there's many countries
3:00:37in in Europe and other places who have
3:00:40completely banned its importation, but
3:00:42it's important to note that the country
3:00:44of Indonesia's health minister prohibits
3:00:48any type of cratom products in food,
3:00:52beverages, vitamins, minerals in the
3:00:55country of Indonesia.
3:00:57uh and then their uh their equivalent of
3:01:01their drug enforcement administration is
3:01:03calling for uh credum to be schedule one
3:01:05in their own country. And this is the
3:01:07number one exporter of into the United
3:01:09States. So how does it get into the
3:01:12United States if it's uh if it's banned?
3:01:15If we've we've heard this import alert
3:01:17issued by the Food and Drug
3:01:18Administration. So the import alert is
3:01:21uh basically an import alert from the
3:01:23FDA to US Customs and Border Protection
3:01:26to seize on demand. If you see it, seize
3:01:29on demand. It's a like a persay. You
3:01:32don't have to prove any any any intent.
3:01:35You seize it and then they go into this
3:01:37whole regulatory thing. They can either
3:01:40the the person who is importing can
3:01:42either pay to have it destroyed or they
3:01:43can ship it back to the country of
3:01:45origin and that's it. So why is all this
3:01:49getting into the United States? It gives
3:01:51the impression that there's this
3:01:53regulatory system set up by the by the
3:01:56US customs in coordination with FDA that
3:01:59somehow another every uh every uh
3:02:02container worth of cratom that's coming
3:02:04in is inspected and improved. FDA's, you
3:02:07know, gone to these facilities and
3:02:09approved it. That's that's simply not
3:02:10the case. So
3:02:14the the amount of containers coming into
3:02:16our ports in the United States, these
3:02:17are sea containers, are about 11 11
3:02:21million containers per year. So the the
3:02:25Customs and Border Protection only
3:02:27cracks open a 40ft container based on
3:02:30intelligence. And that intelligence
3:02:31comes from CBP's National Targeting
3:02:34Center-C Cargo, which sits in which sits
3:02:37in the DC area. So imagine a fusion
3:02:40center, if you will, kind of like your
3:02:41GBI fusion center. So they're they're
3:02:43getting intelligence from all over the
3:02:44world about containers coming to the
3:02:46United States, and they prioritize
3:02:48things that they're looking for, such as
3:02:50weapons, weapons of mass destruction,
3:02:52nuclear, biological, uh uh things that
3:02:55could hurt our crops, things that could
3:02:58spread an epidemic of of to our cattle
3:03:01industry, uh illicit drugs, things that
3:03:04are scheduled by by the DEA or US
3:03:06Congress. And then down the list and
3:03:08further down the list would be uh would
3:03:11be an import alert.
3:03:13But even if something were flagged on
3:03:16this algorithm that they're using as as
3:03:19craratom there's just simply there's not
3:03:22enough bandwidth to crack open every
3:03:24container. I've done it. I've done it in
3:03:27the port of New Orleans. I've done it in
3:03:28the port of Miami. I've assisted in
3:03:30cracking up containers at at the port of
3:03:32New York when we're we were dealing with
3:03:34various things including drug
3:03:36paraffinade going to convenience stores.
3:03:38So it takes a full day for a whole team
3:03:41to search one container. Uh so we're
3:03:43talking about 11 million containers. You
3:03:45can see the the the the immense problem
3:03:48of the enforcement of this import. So
3:03:51every here's here's the important part.
3:03:53Every bit, every gram ofratom that's
3:03:56come into the United States and made it
3:03:58into the state of Georgia has come in
3:04:00through either luck or by fraud.
3:04:04Luck because the sheer immense uh job
3:04:07that the CBP has to identify the the the
3:04:10the particular containers then have the
3:04:13bandwidth and manpower to search and
3:04:14seize these things. By fraud is these
3:04:17companies which you've heard a lot about
3:04:19today, a couple of them by name. They
3:04:22will they will uh lie on their import
3:04:26documents that the product is something
3:04:29other than for human consumption. They
3:04:31will call it uh cat litter or some type
3:04:35of botanical fertilizer so that the
3:04:39algorithms don't pick up on it and so
3:04:41that it gets through customs. So in
3:04:44effect, every single importer into the
3:04:47United States has violated federal law,
3:04:50either whether they were being
3:04:51completely honest or whether they
3:04:54actually committed fraud. So the
3:04:56deceptive importer is looking at
3:04:59multiple federal statutes that they
3:05:01violated. Uh, title 18 USC 545 importing
3:05:06merchandise contrary to law based on the
3:05:08evasion of these FDA alerts carries a
3:05:11penalty of up to 20 years in federal
3:05:13prison. Making false statements to the
3:05:15federal agency 5 years in federal
3:05:17prison. Entry of goods by means of false
3:05:19statements 18 USC 542 up to two years in
3:05:22prison. Now let's talk about the
3:05:24truthful importer. Let's say an importer
3:05:26says I'm importing
3:05:29and it's it's for human consumption. and
3:05:31I'm going to convert it or I'm going to
3:05:33put it in little capsules and I'm going
3:05:34to sell it at gas stations all around
3:05:37the country. They were truthful, but yet
3:05:39it got through by luck because CBP was
3:05:42never flagged and they never searched
3:05:43their container. So, it gets through.
3:05:45They still violated federal law. So,
3:05:48there's a strict liability. It's a
3:05:49misdemeanor if it's 21 USC 331 and 333A1
3:05:54under the Food and Drug Cosmetic Act.
3:05:57It's introducing an unimproved new
3:05:59dietary ingredient or unsafe food
3:06:02additive and it carries up to one year
3:06:04in prison. You heard the lawyer for the
3:06:06AKA speak earlier that he is not an
3:06:09import specialist. Well, this is
3:06:11important to note that the that it this
3:06:15is we are we are a nation of laws and
3:06:18the state of Georgia is a nation of laws
3:06:21and so every every bit of that you guys
3:06:24are talking about was imported into the
3:06:26United States illegally and they're all
3:06:28facing if the DOJ wanted to uh jail time
3:06:32and significant uh civil penalties.
3:06:35That's not to mention the moneyaundering
3:06:37that goes into this. So for every dollar
3:06:39that was wired to Indonesia to pay for a
3:06:42for a container full of cratom they
3:06:44committed money laundering. And there's
3:06:46other statutes that I won't talk about.
3:06:48There's probably probably
3:06:51at least nine. And this has happened
3:06:53before in the state of California. The
3:06:54U. The uh US attorney's office there
3:06:56actually actually prosecuted a man for
3:07:00entry of goods by means of false
3:07:01statements and he was wiring money back
3:07:04and forth to in Indonesia. So what they
3:07:06did is they got him with money
3:07:08laundering. It's also important to note
3:07:11that all three uh organizations that you
3:07:14will hear from including the the
3:07:16American cratom association, the glo the
3:07:19globalum coalition and a and a group
3:07:22called heart are all led by convicted
3:07:25felons.
3:07:26Um the AKA's uh main spokesperson
3:07:32convicted felon. The global coalition,
3:07:36uh, cratom coalition, uh, spent nearly
3:07:39nine years in federal prison, convicted
3:07:41felon. The heart, it's har
3:07:46a large-scale marijuana producer and FBI
3:07:50informant, convicted felon. That's
3:07:52important to note because whenever I
3:07:54testified in federal court and and in
3:07:57state court and you hear witnesses who
3:08:00make the take the stand,
3:08:03if they're a civilian, their criminal
3:08:05record comes into place based to
3:08:07determine their credibility. Uh so if do
3:08:10your own research and understand who's
3:08:12going to be coming to talk to you.
3:08:15So in about about two months ago,
3:08:18>> we can we're we're kind of on tight
3:08:20timeline and if we need to get you back
3:08:22during the law enforcement section, we
3:08:24can. Anything else you want to add
3:08:26regarding DEA, what your involvement was
3:08:28and kind of heads up for us.
3:08:31>> Yeah. Let me let me finish this up with
3:08:33with gas the the history of gas station
3:08:37uh gas stations. So don't be on the
3:08:40wrong side of history on this, folks.
3:08:41I've been through it all since the since
3:08:43the the early 90s when Ephedra came into
3:08:46gas stations. It was called gas station
3:08:48speed and then spice come along this
3:08:52synthetic cathan where they sprayed
3:08:54sprayed it on an inert material and then
3:08:57it was ultimately scheduled into
3:08:58schedule one. Then comes along bath
3:09:01salts and then ultimately it was
3:09:02scheduled one. Now comes along cradle.
3:09:05So is it going to be scheduled one in
3:09:07the future by the by US Congress? I
3:09:10think so. Um, so in conclusion,
3:09:15uh, I would tell you this that from the
3:09:19horse's mouth, I was contacted from
3:09:21Indonesia by by an Indonesian supplier
3:09:24who offered me a 40ft metric container
3:09:27containing 27 metric tonses of this just
3:09:30last month for $5.50 per kilogram. and
3:09:34he told me that theratom
3:09:38works exactly like the opiates on your
3:09:40brain and will get you high and help you
3:09:43study. You guys have talked a lot about
3:09:45youth today. Well, this comes from a
3:09:48supplier in in Indonesia that that that
3:09:50tells you these things. So, listen to
3:09:52everything. I appreciate all your time
3:09:54and I welcome any any questions that you
3:09:56have.
3:09:57>> Committee, any questions? Okay. Uh no
3:10:00questions at this time. We appreciate
3:10:02it. You're welcome to send us stuff and
3:10:04such as other speakers as well. We'll be
3:10:06glad to distribute it to committee
3:10:08members. That won't be any problem at
3:10:10all. We will have minimally three more
3:10:12meetings regarding this. We will have
3:10:14public participation where one of them
3:10:16is going to be largely public
3:10:18participation, maybe a few other
3:10:19speakers. So, we will make sure we hear
3:10:21from you as well. Uh today was
3:10:23definitely a factf finding mission. I'm
3:10:25going to let everybody else start with
3:10:27uh Representative Matthysse. Any closing
3:10:29comments?
3:10:31Okay, chair Corbett,
3:10:33>> thank thank you for holding the meeting.
3:10:35Very very eye opening.
3:10:37>> Thank you, Dr. Al.
3:10:39>> Thank you for organizing today since we
3:10:40have to be
3:10:41>> Yes. And Representative Ridley,
3:10:44>> thank you for
3:10:45>> Thank you.
3:10:46>> Thank you for having me. And also, you
3:10:48know, our president had 34 felonies. So,
3:10:51>> thank you. And then, uh, I'm going to
3:10:53let you guys Sorry, officer. Y'all two
3:10:55introduce yourselves real quick. I
3:10:56failed to do that earlier.
3:11:00Tara Krendon with the Office of
3:11:01Legislative Council. I help draft the
3:11:04bills.
3:11:09Now, I'm Patrick Mock with the House
3:11:10Budget and Research Office. I'll be the
3:11:11analyst for the study committee. And if
3:11:14you Deborah, if you can raise your hand,
3:11:15you see here in the through emails and
3:11:18things like that. So even the people who
3:11:20came here just the interested stuff if
3:11:22you can't find me if you can find
3:11:24Deborah you're welcome to call our
3:11:25office if you need our numbers or email
3:11:28before you leave we'll give them to you
3:11:29but Deborah is a rockstar and
3:11:30Elizabeth's in the office too is a
3:11:32rockstar we appreciate your help and and
3:11:34um we'll make sure the air is working
3:11:36next time and where we'll be at for
3:11:39sure. Okay, thank you very much and
3:11:41y'all have a great day.

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