November 3, 2025 • 52 mins
A brightly colored box at a smoke shop should not hit like an opioid, yet that’s the business model behind “gas station heroin.” We dive into how tianeptine—a foreign antidepressant with mu‑opioid activity—landed on American countertops as a “dietary supplement,” and why that mirrors a broader playbook: repackage potent psychoactives, exploit loopholes, pivot fast when bans arrive, and let consumers pay the price. Joined by Matthew Lowe, executive director of the Global Kratom Coalition, we trace the supply chain from warehouses to wallets and separate leaf kratom from the synthetic isolates hijacking its name.
We break down the risk gradient inside the kratom category: natural leaf with fiber and mixed pharmacology, concentrated extracts that raise potency, and seven‑hydroxymitragynine products that function like a novel opioid. Matthew explains why the FDA’s percentage‑based scheduling of 7‑OH is a smart, surgical fix that preserves traditional use while ejecting synthetic opioids from the “supplement” aisle. We also tackle hemp’s loophole economy—Delta‑8 and Delta‑10 THC derived from hemp yet delivering marijuana‑like effects with far less oversight—plus contamination, cross‑stocking, and the handful of distributors fueling multiple “legal high” trends at once.
Beyond policy, we talk people. When regulators finally pull a dangerous product, dependent users are often left stranded. We outline a practical path: better labeling that discloses opioid activity and dependence risk, age gates, potency caps, and targeted enforcement against unapproved drugs sold as supplements. Just as crucial, clinicians need straightforward guidance to assess what patients took, why they took it, and how to transition them to safer, evidence‑based care without stigma.
Curious how these products keep showing up, what “novel synthetic opioid” really means, and how we can protect choice where risk is low while acting decisively where harm is high? Press play, share this episode with a friend, and leave a review with the one reform you think would make the biggest difference. If this helped you learn something new, subscribe so you never miss an update.
To contact Dr. Grover: ammadeeasy@fastmail.com
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
SPEAKER_00 (00:00):
Welcome to the Addiction Medicine Made Easy
podcast.
Hey there, I'm Dr.
Casey Grover, an addictionmedicine doctor based on
(00:20):
California's Central Coast.
For 14 years, I worked in theemergency department, seeing
countless patients strugglingwith addiction.
Now, I'm on the other side ofthe fight, helping people
rebuild their lives when drugsand alcohol take control.
Thanks for tuning in.
Let's get started.
Today's episode is abouttyaneptine and the so-called
(00:44):
legal high market.
Let's unpack this a bit.
First of all, what are legalhighs?
Well, they are what they soundlike.
They are substances that arelegal and are not controlled
substances, but they arepsychoactive and can be just as
strong as illegal drugs,alcohol, and controlled
substances.
And speaking of so-called legalhighs, what the heck is
(01:07):
tioneptine?
Well, tioneptine is an atypicaltricyclic antidepressant that is
not available to be prescribedby doctors here in the United
States, but it is used in someother countries in the world.
In addition to being anantidepressant, it turns out
that it also activates theopioid receptor.
So, here in the United States,given that we have a huge
(01:30):
problem with opioids andtherefore a big market of people
who want to buy opioids,tyaneptine started showing up in
gas stations and smoke shops asa supplement that people could
buy, and it was being sold as alegal high.
And this situation has led toTyaneptine getting the nickname
Gas Station Heroin here in theUnited States.
(01:52):
And there are other substanceslike this here in the US.
We did an episode on Fenibutback in 2023, which is a Russian
psychiatric medication that isnot available to be prescribed
by doctors here in the US.
It's actually very similar tobaclefin and benzodiazepines,
and yet it's available here inthe US in smoke shops as a
(02:13):
supplement.
You can imagine this is a bigproblem, right?
We have medications that theU.S.
medical system does not deem tobe useful enough to approve for
doctors to prescribe here, andyet you can get them at a smoke
shop without a prescription as asupplement.
So, in today's episode, we catchup again with Matthew Lowe from
(02:35):
the Global Kratom Coalition.
But we won't just be speakingabout Kratom.
We will be speaking about howbusinesses of questionable
legitimacy are skirting U.S.
laws that regulate medicationsto bring medications from other
countries onto the shelves ofsmoke shops here in the US as
supplements.
And we will also talk about7-hydroxymetrigynine and how
(02:58):
it's essentially a novelsynthetic opioid, which comes
from Kratom.
We will talk about what Matthewand his coalition think we need
to do about it, and I'll giveyou a few points before we start
to give you some context forthis interview.
First, my recommendation as adoctor is that people not use
Kratom as it has the potentialto cause harm, addiction, and
(03:20):
dependence.
Matthew's perspective as aKratom user is that we should
keep Kratom in its natural form,which is leaf kratom, as it's
fairly weak and therefore therisk of using Kratom is low.
I don't know if I agree, but Icertainly see his point.
Second, regarding Kratom, in theUnited States, the Food and Drug
(03:40):
Administration, or FDA, has madea recommendation to the Drug
Enforcement Administration, theDEA, that 7-hydroxymetriene
should be made a controlledsubstance, as it's again
essentially a novel opioid.
Matthew and I both agree thatthis is a great thing.
And finally, a point aboutcannabis.
(04:01):
Matthew mentions Delta 8, Delta9, and Delta 10 throughout the
episode.
Let's unpack this a bit.
It turns out that the THC thatwe get from the cannabis plant
that we use to get high isactually technically named Delta
9 tetrahydrocannabinol.
Marijuana and hemp are twodifferent forms of the cannabis
(04:21):
plant.
Hemp naturally contains lessthan 0.3% Delta 9 THC, and as
you can imagine, it's thereforeregulated differently.
It's often grown to makecommercial items such as paper,
rope, plastic, textiles, andmore.
It's actually not even acontrolled substance.
And unfortunately, and this is atheme in this episode, this
(04:42):
opened a loophole.
Manufacturers started extractingDelta 8 THC and Delta 10 THC
from the hemp plant and sellingthem as cannabis products.
As you can guess from the names,Delta-8 THC, Delta 9 THC, and
Delta 10 THC are very similar,and they actually produce very
(05:03):
similar effects in humans.
But because Delta 8 THC andDelta 10 THC are derived from
hemp, there is so much lessregulation.
It's a bit of a mess, and themarket is being flooded with
Delta 8 and Delta 10 products.
And with that, buckle yourseatbelt because we are going to
be learning about legal highs,the American food and drug
(05:25):
regulation system, and how drugdistributors are constantly
taking advantage of loopholeshere in the US to bring more and
more drugs to the market, oftensold in smoke shops.
All right.
Well, I am so glad to welcomeyou back again to the Addiction
Medicine Made Easy podcast.
Why don't you remind ourlisteners who you are and what
(05:47):
you do?
SPEAKER_01 (05:48):
Thank you, Dr.
Grove.
It's good to see you again.
My name is Matthew Lowe.
I'm the executive director ofthe Global Kratum Coalition.
SPEAKER_00 (05:57):
Now we're going to talk about tie-inptine today,
also known as Gas StationHeroin.
What makes you as the GlobalKratom Coalition interested in
such a product?
SPEAKER_01 (06:06):
Yeah, it's a good question.
And I think it it comes down towhere these products are coming
from.
So you can walk into a gasstation or a smoke shop, really,
anywhere in the United Statesand get substances that are not
natural, that in some countriesin relation to TNP are the
(06:28):
prescription drugs, and you canbuy them over the counter for$5,
$10,$20 without giving your IDforward, without getting a
prescription.
And I always ask myself thequestion how and why is this
happening?
You don't see this anywhere elsein the world.
You see it in the United States.
(06:49):
And it's not just TN Neptine,it's TN Neptine, it's nitrous
oxide, it's synthetic umalkaloid products, it's delta 8,
delta 9, delta 10, and whichevernew synthetic um hemp product
comes onto the market.
And if you dig a bit deeper andyou go through the layers, it's
a coordinated drug traffickingring, really is what we're
(07:12):
seeing.
It's a gentrified drugtrafficking rink because these
drug traffickers have figuredout that they can find
substances or develop substancesthat mimic scheduled narcotics,
wrap them up in nice packaging,call them, you know, names like
perks or Zazar Red or Tia orNeptune's Fix.
(07:35):
Call them a dietary supplementand sell them in these shops.
And I want to be very clear,that's not legal.
What they're doing is not legal.
It's highly illegal.
But they've got away with it forso long that there's no
consequences for that action.
So you see these individuals gofrom substance to substance to
substance, knowing thateventually it's going to catch
(07:57):
up to them and the products aregoing to get going to get
scheduled or gonna get banned,but they've already moved on to
the next thing.
So it's it's it's an interestingpoint in time because I think
people have started to realizethis is what's going on.
And you've seen the number ofsmoke shops go from X number to
(08:17):
4X, 5X, 10X over a period offive years.
And I think legislators,regulators are catching on and
are making an impact.
So really the people that getlost in this are the are the
consumers because consumers aregetting tricked.
And in some cases, and this iswhere a problem lies, is they're
(08:39):
getting addicted.
And in the case of TNF team,that is very, very much the
case.
And they're getting addicted,and then it gets taken away, and
they're left without an option.
And it's not their fault thatthey started taking the product
and now they're left without anoption.
It shouldn't have been there inthe first place.
So it leaves a bit of a socialconundrum.
So education, I think, iseverything.
(09:00):
And you could say to the averageperson, well, what is TNP?
And they go, I I've got no idea.
I've got no idea what that is.
And that's because you shouldn'tknow what it is unless your
doctor prescribed it to you andyou live in France.
So TNP specifically is aatypical antidepressant.
It was developed in France inthe 1960s and was given to
(09:22):
people for severe depression,for anxiety, etc.
But it doesn't work like anormal SSRI.
It gives you the same effects atthe right dose levels, but it
actually works and attaches tothe opioid receptors in a very
pure manner.
So with that comes a therapeuticdose, which is beneficial to
(09:44):
people, but they build theirtolerance, they start to consume
too much, they become addicted,and that's where the problems
start.
So even in those countries whereTNeptine is a prescribed drug,
there's countries that havebanned it.
Italy has banned TNP becausethey saw the issues that were
coming from the use of an opioidover and over and over again.
(10:06):
And we know that story withopioids.
Not saying that opioids are bad,but if set in an uncontrolled
environment, you will consumetoo much, and that's where the
problems start, particularly ifyou've got a proclivity for
substance use disorder.
SPEAKER_00 (10:25):
Yeah, it's very interesting.
Let's unpack a number of thethings that you said.
So, you know, Matthew, I learnedfrom you on our first episode
that as a Kratom advocate, youwant better labeling.
And people tell me, you know,Dr.
Grover, we want to ban Kratom.
What are your thoughts?
And I said, Well, what would aban on Kratom actually do?
(10:48):
And the way I explained it tothem is some people have a
substance use disorder and theygo on the internet and they read
about it and they find thatKratom is a substance that acts
like an opioid and they seek itout knowing that it acts like an
opioid.
Where I see a Kratom ban beingbeneficial is the consumer who
does not have a substance usehistory and reads on the package
(11:12):
that it helps with energy orhelps with mood.
And because the package doesn'tshow it's an opioid and that
it's habit forming, thatconsumer then three weeks later
doesn't understand why they feelso sick when they stop Kratom.
So my guess is that the GKC'sperspective would be why don't
we just label Kratom better?
And then we don't necessarilyhave to ban it.
(11:33):
Like if you go buy a pack ofcigarettes as an adult, you know
what you're getting.
SPEAKER_01 (11:38):
Well, I think it's so labeling is a very important
piece of this puzzle, but it'snot a solvable.
And I think productcategorization at the first
instance is the most important.
And something that we alwaystalk about when it comes to
Kratum is well, what are youtalking about?
You say Kratom to me, what areyou talking about?
(11:58):
True.
Show me the product, show me theproduct you took.
Because I'm gonna guess that ifyou've gotten into a really bad
problem with Kratum, it's notthe natural leaf.
The natural leaf is low potency,50% of that leaf is fiber.
50% of the leaf is fiber.
That is an incredible amount offiber.
(12:20):
You can you can get your yourdaily fiber dose from consuming
your Kratum.
25% of that leaf isantioxidants.
Only 2% of those leaf arenaturally occurring kratom
alkaloids.
And the interesting part aboutnatural creatum leaf is it is a
partial muopioid agonist, butit's also got serotonergic and
adrotinergic um activity.
(12:41):
So there's a modulating effectof that consumption of that
kratum leaf in terms of yourexperience with it.
And because of the fiber contentand the low potency, it's very
hard to over-consume the leaf.
And I'm not in any way sayingthat it's not habit forming.
It is habit forming, absolutely.
But that habit forming, and it'sshown in the survey data, it's a
(13:04):
mild to moderate severity of usedisorder in the people that it's
prevalent in.
And if you map that across arelative landscape, and then you
look at the the outcomes of thataddiction, it's very similar to
a caffeine addiction in thatit's highly physical.
Now, that's the leaf.
(13:25):
Then you can get a kratomextract, which has stripped all
the fiber out, stripped all theantioxidants out.
It's high, a lot more potent,big concentration.
You can consume a lot more ofit.
Now, of course, the risk factorchanges.
And then what we've seen morerecently in the last two years
is the introduction of syntheticisolate alkaloids.
(13:47):
So 7-hydroxyometriganine orconcentrated synthetic
7-hydroxyometriene is the talkof the moment because then FDA
stood up and said, enough isenough.
And this is in direct relationto what I was speaking about
before.
Enough is enough.
Stop poisoning Americans withthese drugs.
And these synthetic 70H productsare a perfect example of that
(14:11):
because you had an individual,one individual in the in the US,
I'll I'll have you, and thenit's kind of expanded, that
figured out oh, there's this onetiny little alkaloid that's
0.04% of the weight of the leafmaterial and creatine leaf
called 7-hydroxymetraganine.
Now, 7-hydroxymetraganine in theleaf, if you pick it off the
tree, isn't even in the leaf.
(14:32):
You dry the leaf, it becomesapparent in small amounts.
Now, in the leaf material, it'spharmacologically uh irrelevant.
And a lot of science and studybeing done around this because
it is such a strong alkaloid.
It on its own is a full opioidagonist 13 times more potent
than morphine.
So someone looked at it andsaid, well, what is if I could
(14:52):
isolate it and concentrate it?
I could have an opioid.
And I could claim it's tradeum,or I could claim it's natural.
And that's what they did.
They isolated, they took anextract, they didn't isolate it,
so it's not some like theybasically took an extract, they
added heat, light, and poolchemicals, pool shock.
And they converted themitragynine into
(15:14):
7-hydroxymitrogynine, turned itinto a tablet, and put it on the
shelves, calling it Kratum,which it's not, doesn't have the
fiber, doesn't have theantioxidants, doesn't have the
49 other alkaloids.
Put it onto the shelf at$6 apill.
And on top of that, and this isthe most nefarious part, they
called it perks.
They called it oxy.
(15:34):
They called it roxy, they calledit cosmic lewds.
They knew exactly what they weredoing.
It was a dog whistle, twoindividuals with opioid-seeking
behavior.
And guess what?
It went like a freight train.
It went from zero dollars twoyears ago to nine billion
dollars today and leftdevastation in its wake.
(15:56):
And it's really sad because youspeak to individuals and they
just didn't know what they weregetting themselves into.
They saw this brightly coloredpackaging and it wasn't labeled
appropriately, they startedtaking it, and now they've
developed this addiction andthey're embarrassed in many
cases because they're going,like, how did this happen to me?
(16:19):
And I also speak to a lot ofKratum advocates who have used
Leaf for 15 years.
I mean, you know, leaf has beenaround for 400 years in
Southeast Asia, for 50 years inthe United States, and we
haven't seen this sharp increaseand this like pandemic hit.
(16:39):
There's been some issues, butyou've got 23 million consumers.
90% of those consumers, 95% ofthose consumers are using it
safely.
The further you move away fromthe leaf, that's where the
problems start.
And then when you get to theseconcentrated synthetics, I was
speaking to someone the otherday, they used Pratim Leaf for
15 years, net positive to theirlives.
(17:00):
It really was a game changer forthem.
Three months of using 7hydroxymetryine or synthetic
concentrated 7OH, they were indebt, remortgaged their house,
messed up with their family, andthey were consuming$100,$200 of
the stuff a day.
So it really is very different.
And in some cases, they'reembarrassed because they should
(17:22):
have known better.
In other cases, they were justgiven a free sample and said,
this is the new Kratum.
SPEAKER_00 (17:28):
Wow.
Yeah, that goes back to thepoint you were saying about
these products like Tyaneptineand you know, I I I call them
basically semi-synthetic opioidsof these 70H products.
Is to your point, people getintroduced to them, don't
necessarily know what they are.
And then if it does get banned,it leaves them really high and
dry of like, how do I get help?
(17:51):
And so when we were talkingabout our ban on Kratom, we have
to educate doctors and we haveto educate patients.
So if we're going to do thisright, people have to know where
to land.
And so for me as a doctor inCalifornia, since I've been
working more on Kratom and beenpodcasting about it, I get
emails probably once or twice aweek from somebody in all parts
(18:14):
of the United States, like, Dr.
Grover, you seem like you knowwhat you're doing.
Can you help me?
And when people can see mebecause they're in California,
because that's where I'mlicensed to practice, they are
so grateful that I actually canhelp them by understanding like,
what are you taking?
What are you, what are yougetting from it?
Is it the anti-inflammatoryeffects?
Is it the stimulant effects?
So we actually very thoughtfullysaid the only way we can really
(18:35):
ethically ban Kratom is if weeducate the healthcare provider
so patients can get help.
Because most people tell me, Iasked my doctor and they had to
Google it during the visit.
And then we had to create somepatient-facing information too.
So that comes back to your pointabout tying epine, is that this
this seems to be a repetitivething where a medicine with
(18:56):
maybe a questionable safetyprofile from another country
comes into the U.S.
as an over-the-counter product,and then what do we do about it?
And funny you should mentionthat, because I was at a middle
school 45 minutes ago educatingthe kids about drugs, and a
seventh grader asked me aboutfenibit, which is a Russian
psychiatric medication similarto similar to bacclefin and
(19:18):
benzodazipines that has a prettybad withdrawal syndrome.
SPEAKER_02 (19:21):
Yeah.
So quite a bit to unpack there.
And let me start off by sayingis that we are obviously very
against a broadband on Kratom.
SPEAKER_01 (19:37):
We think that natural Kratom leaf has got a
place in the market.
We believe it needs to beregulated.
There's absolutely no doubtabout it.
Age gates, labeling, etc.
But we believe that it's got aplace in the market and we
believe that it's serving thebetter good.
And we think there's low riskfor kids and those types of
things because it it tastesterrible, it's not a fun
(19:58):
experience.
But as you move further awayfrom it, that that whole
equation changes.
We've seen this time and timeagain where a natural substance
that has got some rewardingactivities or rewarding um
perspectives to it getsadulterated, synthesized, and
turned into something else, andthe baby gets thrown out with
(20:18):
the bathwater.
Cocoa leaf?
Yeah, we said it at the sametime.
Cocoa leaf cocaine.
Cocoa leaf's amazing.
It's an amazing plant, butpeople made crack out of it.
So where do you draw that line?
And I don't think it's aboutthrowing the baby out with the
bathwater.
I think it's exactly what theFDA have recommended to the DEA,
and this is the first time thatthey're doing something like
(20:40):
this.
They said, We've got a problem.
We've got concentrated synthetic70H products on the market.
70H only is a tiny part of theKratum Leaf.
These products are entirelydifferent.
We see the benefit in KratumLeaf.
So how do we deal with this?
Well, we schedule at apercentage.
(21:01):
So we say, well, 70H can only bein 0.04% of the leaf material of
Kratum Leaf.
Anything over and above that isscheduled.
It's out, it's gone.
And that's what they're doing,that's what the Florida AG did.
When it comes to TNeptine, it'sa much simpler case because
you're not talking about anatural substance.
(21:22):
You're talking about somethingthat was created to be a
pharmaceutical.
Then the way that we solve thiscrisis is we need to bring those
individuals to book.
We need to bring the foreignmanufacturers that are importing
it into the country to book, andwe need to bring those
manufacturers who are making itand spreading it into the smoke
shops to book.
(21:43):
Because the secret that no onewill tell you, because no one
knows, is that this is actuallynot being run by 4,000 different
companies.
There's probably five or sixcompanies that are doing this.
And if you went into theirwarehouse or their 10 warehouses
because they operate in theshadows, you will find Delta 8,
(22:07):
Delta 9, Delta 10, you will findFennyBut, you'll find TNeptine,
you will find concentratedsynthetic 70H products and these
other different alkaloidproducts.
Now we're starting to see thembring out hallucinogens.
So you're gonna find the magicmushrooms, the synthetic magic
mushrooms, you're gonna findEboga root and it synthesized
(22:28):
Eboga root.
So it's the same things over andover and over again.
And probably when it comes to TNNeptune, probably the biggest
product was a product calledNeptune's Fix.
Now, Neptune's Fix was put ontothe market, it became quite a
big thing, and then the FDAcottoned onto it because it made
a whole lot of people sick.
(22:49):
And they tested it, and ofcourse it had TN Neptune in,
which was a problem, but it hadalso been contaminated with
Delta 8, Delta 9, Delta 10.
And why do you think that is?
Is because they're all comingfrom the exact same place.
That individual took TNP's fixoff the market and then launched
a brand the next day calledMorpheus's fix.
(23:10):
So they just do it over and overand over again because there
hasn't been enough consequencesfor their action.
TNP's a straight line to thegoal.
You are bringing an unapproveddrug to the market and you're
selling it as a dietarysupplement.
That is federally illegal, andyou can be put in jail for 20
years for doing that.
That's what needs to happen withthese individuals.
(23:33):
Because if the consequences arethere for this behavior, then
people are going to stop doingit because they're not going to
see it as free money.
And I think that that's whatthis new administration is doing
is they're going to say enoughis enough.
They're going to bring it toorder.
And what we're seeing, and it'shopeful, is that they're not
going to throw the baby out ofthe bath water.
(23:55):
There's a place for certainsubstances to be used in certain
ways.
And there's not a place forothers.
And when it comes to any ofthese drugs, if you rarely
because this is also thefrustrating part is these trade
groups and these companies willsay, Oh, well, it's helping so
many people, right?
(24:16):
We've it treats pain, it helpswith opioids, it's actually
helping people get off opioids.
I think it definitely can treatpain.
Certainly 70H, synthetic 70Hcan.
It's a pure opioid.
I think that people do stoptaking traditional opioids when
they take concentrated synthetic70H.
But it's not because they'vesusated off opioids, they've
(24:38):
just switched to a differentvariety.
So the problem hasn't gone away.
It's the same problem.
But that's not the reason whythey launched those products.
They launched those productsbecause they knew they would be
addictive and they knew theywould make a lot of money.
And they have a pathway to go tomarket if they want to, and that
is do your clinical trials, doyour preclinical trials, do your
(24:58):
new drug um application, and putit to market as a
pharmaceutical.
That's what Pfizer has to do.
That's what Bayer has to do.
That's what whoever has to do.
And they skip that step.
SPEAKER_00 (25:09):
Can I just ask?
So I heard you say Iboga, and Ididn't realize that was the
plant behind Ibigaine.
Ibigaine being a substance thatyou can take, it's a
hallucinogen, it's supposed tobe this journey through seeing
your addiction.
So I've had a few patients go toMexico and get treated with
Ibigaine because it's not legalin the US.
(25:30):
Can you talk to me how aresynthetic versions of these
plant-based compounds beingsynthesized?
Like how are they creating asynthetic psilocybin or a
synthetic iboga?
SPEAKER_01 (25:42):
I I don't know the answer to that, to be honest.
I'm not a chemist.
I know very well on synthetic70H and on the Delta 8, Delta 9
side.
I don't know on that side, butit'll be a very similar process.
They're either doing the spicething where they are making it
in a lab, or they're taking thenatural compound and just like
they're doing with synthetic70H, they're figuring out how to
(26:04):
convert it, concentrate it, andmake it more potent.
And I think that's that's whatwe're seeing there.
I mean, the Delta 8, Delta 9,Delta 10 thing is interesting
because so hemp got legalized,and that was for industrial hemp
and CBD, right?
Those are the use cases.
There was a big loophole becausethey only put a concentration
(26:25):
level on one of the deltas, andthe people went, well, it's
below 0.03%, but then they juststack these other new synthetic
cannabinoids on top of it.
But what's fascinating is thatmany of these products are
actually just marijuana.
They've skipped the step of evensynthesizing it, and they're
just putting actual marijuanainto the products because they
(26:47):
can just do it.
And the whole legal marijuanaindustry, which has to go
through dispensaries, has to paytaxes, is completely undercut
because you can just walk into asmoke shop and get something
that is pretty much the samething or acts in the same way.
But even in that space, we'reseeing problems because and this
(27:08):
is a tale as old as time, buttoday's marijuana is not your
grandfather's pot, it is so muchstronger.
And the basic tenet oftoxicology is the poisons in the
dose, and it's just this race tothe top.
How do we make it as strong andas potent as possible to take
(27:29):
out the competition?
And that leads to adverseevents.
Now schizophrenia rates havedoubled because of the strength
of these of these narcotics.
So don't mess with MotherNature.
I think that you know I thinkthat these substances,
particularly that have been usedfor centuries, have a place in
(27:49):
society.
But as soon as you start to messwith them and amp them up and
make them more potent andisolate them, we've got to
realize we're creating somethingnew.
We're creating somethingdifferent and we don't know what
the downstream effects are.
But quick way to understand thedownstream effects is look at
the pharmacology.
And if the pharmacology is thatof a pure opioid, you know
(28:10):
you're gonna what you're gonnaget.
So if I'm thinking about it fromif I'm putting my bad guy hat
on, I'm going, well, I'm gonnago after that because it's gonna
get people addicted.
If I'm putting my regulator haton, I'm going, well, that's
gotta be a bad idea.
We've got to put a stop to it.
And the nuance or the surgeryis, well, how do we do that with
(28:30):
the least amount of damage?
And that's what we're grapplingwith at the moment.
SPEAKER_00 (28:36):
So let me come back to my question because I think I
asked it incorrectly of you.
Is I wasn't asking, like, what'sthe chemical way that they're
synthesizing these novelcompounds?
So let's take a look at THC,right?
So you have the cannabis plant,which I think has like 400
different chemicals in it, andlike I think 60 of which are
cannabinoids.
(28:57):
So are these people that areplanning to take advantage of
loopholes, are they working withchemists to synthesize new
compounds?
Are they extracting existingcompounds?
Or are they just looking in aresearch library of chemicals
and pulling out stuff that waspreviously enlisted as I okay,
(29:20):
that way I figured all all ofthe above.
SPEAKER_01 (29:24):
So the guy that brought concentrated synthetic
70H to the market, he quiteremarkable, but he was on a
podcast about a year agobragging about this.
This is what I did.
And I said, Well, how did youcome up with that idea?
He says, Well, I was reading apaper from from NIDA, a National
Institute of Drug Abuse, and itsaid in there, Cratum Leaf has
(29:48):
got tremendous promise, butseven hydroxymetragynine, if
you're a pharmaceutical company,you should look into it because
it seems like it might be apotential opioid.
We don't know if.
it's safer, if it's moreefficacious.
But this could be something thatcould be turned into a drug and
could be administered to people.
And who knows?
We're looking for saferalternatives.
And he went, Oh, that'sinteresting.
(30:09):
Let me go look.
Has anyone done this?
Patents did it?
No, no one has.
So I did it.
And you're like, well I meanenough said.
So you created a drug and nowyou're selling it on the market.
And then he goes on to say,well, there's no regulations for
this.
And you're like, well, thereabsolutely are regulations for
creating a new drug and puttingthem onto the market.
(30:32):
You just have ignored them.
SPEAKER_00 (30:35):
How was it regulated in terms of a chemical versus
for human consumption?
I mean obviously a new cleaningchemical is going to be
regulated differently than say anew medicine.
So how how do they choose whichloopholes to use?
Or again, it probably is justall of the above, whatever can
make the money, but can you talka little bit about the
(30:56):
difference and how that'sregulated?
SPEAKER_01 (30:58):
Yeah.
So the regulatory structure issuch that you've got medicines
and drugs, then you've got theumbrella of food.
And within the umbrella of foodyou've got traditional foods and
you've got dietary ingredients.
And now there's complex pathwaysfor each of them.
On the medicinal side, you'vegot to do an investigational new
drug approval.
You do all your preclinicaltrials, you show that it's going
(31:21):
to do what you think it's goingto do.
It's not going to kill rats, etcetera, et cetera.
Then you kind of go phase one,phase two, phase three, millions
of dollars, millions of dollars,millions of dollars, you move on
to clinical trials.
And ultimately you've got toprove that your new compound is
safer and more efficacious thanthe incumbent.
If you can get that right afterspending$100 million,$200
(31:44):
million, you then get the rightto sell that product and you get
the right to sell that productand I won't quote the monthly, I
think it's 10 years or 20 years,probably 10 years, and you can
just sell it as your as as yourown product.
You've got control of thatmarket.
After that time then genericscan come into the market.
And then you that's where yousee drug prices drop the
generics come into the marketand often it's the manufacturer
(32:07):
now of the original product thatbrings the generic product to
market because they know what'sgoing to happen.
So that's the medical pathway.
The food and dietary supplementpathway is is different.
So as a dietary supplement ordietary ingredient, you can
either be an old dietaryingredient or a new dietary
ingredient.
So the dische is the regulatoryparadigm for dietary
(32:31):
ingredients.
Old dietary ingredients are anydietary ingredient that was sold
as a dietary supplement prior toOctober 15, 1994.
If you've got one of thosesubstances, you put it into your
product there's no approvalthat's needed.
It's been in the market it'sgrandfathered and it's accepted
to be safe and legal.
Now if you introduce somethingthat has not been in the dietary
(32:54):
supplement market in the UnitedStates prior to 15th of October
1994, it's a new dietaryingredient and you have to file
what's called a new dietaryingredient notification with the
FDA.
Now that includes preclinicaltrials, safety, it's like a mini
approval process.
You submit that to the FDA andin 75 days they will either not
(33:19):
respond and you can go to themarket or they will respond and
say we've got a problem withthis you know you need to do
more work on it.
It cannot go to the market.
So those are your pathways fordietary ingredients.
And for a food you've either gotto be sold in the market in a
form unchemically alteredpre-1958 and you grandfathered
(33:40):
in like a carver would begrandfathered in as a food
product because it's been soldsince 1915.
Or after that you can eithercome to market as a product that
is grass, generally recognizedas safe, or you've got to file a
food additive petition.
On the grass side of things,there are two pathways you can
(34:02):
self-grass or you can submityour grass to the FDA and they
can make a determination.
Now grass relies on scientificconsensus.
So you put all your safetydossier together you submit it
to a board of scientists andthey say yay or nay you can
either self-grass it take it tomarket if the FDA sees a problem
they've got to ask you for yourself-grass you've got to show it
(34:24):
safe or you can submit it to theFDA.
And that's a point of contentionat the moment with with um with
RFK where he's saying well thisseems to have been taken
advantage of as well because ifyou walk into any store in the
United States and you read theback of a product list there's a
lot of different ingredientsmany of them are banned in
(34:46):
Europe.
So there's a problem there aswell and so those are your
different pathways.
What these individuals are doingis they're ignoring everything
and they're just saying it's adietary supplement, labeling it
as a dietary supplement andputting it onto the market and
no new dietary ingredientnotification, no um assumption
(35:07):
of or assurance of safetypre-going to the market.
They're just sticking it in andletting it dry.
SPEAKER_00 (35:14):
So I have to say I'm extraordinarily impressed by
your knowledge of the Americanregulatory system.
This discussion is about the theUnited States but I listened to
a piece from the BBC on ketaminein Europe.
And the fact that there are somany countries close together
and they all view ketaminedifferently has allowed drug
(35:34):
traffickers in Europe to use laxlaws in one country around
ketamine to smuggle ketamine tocountries that have it more
restricted.
So I'm assuming for the peoplethat are distributing these
drugs as dietary supplementsthey need to learn the loopholes
in every country to be able togo after every market or are
they focusing on the UnitedStates I mean from what I
(35:58):
understand is that the UnitedStates for these specific
products is such a big market.
SPEAKER_01 (36:03):
You get the US right you don't have to worry about
global and I you don't see thishuge smoke shop culture in
Europe.
So yes there's a drug culturebut it's done differently and
that's why I call it a bit ofit's gentrified drug dealing.
And that's not to say thateverything in a smoke shop is
bad because it's certainly not Ibelieve people should are
(36:25):
allowed vice and should maketheir own choices.
It's a subsegment of theproducts that are sold in those
shops that is that is thegentrified drug dealing.
And for me it's nitrous oxidefenny button the concentrated
synthetic 7OH Mitrogyne andpseudandoxyl they've got and for
hydroxy now they're bringing inall these mushroom products
(36:48):
that's where the problem is thedelta 8, delta 9 delta 10 sits
in a bit of a middle groundspace because you know you've
got this federal regulation itis a loophole.
There's a lot of arguments to bemade there but I think that
loophole is going to be closedpretty soon here federally and
you're starting to see a bigcrackdown in in states.
I mean Ohio issued an executiveorder just last week outlawing
(37:10):
synthetic intoxicating hemp.
And then it becomes afascinating conversation because
you're going, okay, well are wegoing to do all of it and CBD
and industrial hemp?
Are we going to carve outindustrial hemp and CBD?
Are we going to allowintoxicating low dose beverage
products?
So it becomes a complexconversation.
But the European example isinteresting because you've got
(37:34):
European Union and they've eachgot their own laws and ways they
can control things.
But the European Standardsauthority whether it's EFSA or
the the drug authority actuallyhas full control over the
market.
So if they say something's notallowed it's not allowed.
If they're silent on somethingeach of those European countries
can decide on their own.
But if you make something legalin I don't know Estonia or Czech
(38:00):
Republic, you can then cross itover borders very easily and in
fact I believe and I'd need tocheck this but I remember
reading up on it probably threeyears ago you can sell it online
across the border unless ofcourse it's a scheduled drug in
that member state.
So I was doing a little Googlesearch while you were talking do
(38:21):
you have any insight on why theUS seems to be the world's
biggest drug market well I, youknow what I think that's
probably because it's theworld's biggest market besides
besides China.
So I mean you've got 330 millionpeople you've got a GDP per
capita of I mean what 60$600$7000 so everyone can afford
(38:44):
something.
I come from South Africa and weare a nation of 60 million
people but the majority of thepopulation's making less than
$300 a month.
You know that's like 60-70% ofthe population there isn't a
market for recreation becausethe money's taken up by survival
(39:06):
I think in the United Stateseveryone's got the luxury of
recreation that's a fair answer.
SPEAKER_00 (39:13):
I have wondered that myself I mean because I I think
when I look at addiction as anaddiction doctor, addiction at
its core is using something tofeel different.
And I realize that there isthere's nuance to that right you
might be tired and you knowchewing leaf cratom in the
afternoon picks you up and youcan go to do your thing.
(39:34):
You can also be depressed andtake an antidepressant from a
doctor.
Addiction is where really takingsomething to feel different goes
off the rails and we see thethree C's of addiction cravings,
compulsive use and consequences.
But usually what I do as anaddiction doctor is I help
people understand what are youusing, why are you using it,
what are you feeling, and howcan I get you on my medicines
(39:57):
instead of whatever you'rebuying and I just wonder if
there's some sort of just kindof mental health issue in
America that's different inother countries.
I don't know.
I've always wondered what it isabout the United States I I I
don't want to talk out of turn.
SPEAKER_01 (40:16):
I mean I've I I've traveled a lot probably a
hundred countries maybe more andeach country's different and
each culture's different there'sa a big culture of consumption
in the United States it's a bigbig consumer culture and that's
what keeps the economy tickingthat's what keeps people people
(40:36):
going forward that's what drivesthe entrepreneurial spirit but
it is very distinct walking intothe United States and you just
need to get off the plane andwalk into the first coffee shop
and there are 40 different typesof coffee that you can drink all
with different flavors and whichsyrup do you want and this and
(40:57):
that and you know you walk intoa coffee shop in Italy it's like
do you want espresso?
Do you want a cappuccino notafter 11 o'clock it's comp you
don't drink a cappuccino after11.
You've got very simple optionsand in the US options are
ubiquitous and you know coffeeis a great example and there's
(41:17):
nothing wrong with coffee butcoffee's a psychoactive
substance that gives you energymakes you feel different and it
is addictive.
You get withdrawals when youstop it I don't know if you've
ever stopped drinking coffee butI can't because the headaches
are too bad.
SPEAKER_00 (41:31):
My my wife gets really bad caffeine withdrawal
headaches.
SPEAKER_01 (41:34):
Yeah go ahead sorry and you know the the the health
consequences of of caffeineconsumption aren't aren't you
know detrimental I don't believeand you know so it's cool and
the same with nicotine you knowthe whole nicotine culture's
changed so much we can maybe getinto that that there's a
different culture of consumptionin the United States for better
(41:55):
and for worse.
And I think that that's got alot to do with it.
People are looking to consumethey're looking to experiment
they more risk loving and theconsequences of making a mistake
aren't so severe.
When you in Africa theconsequence of making a mistake
(42:16):
are sick is significant.
So people won't change a brandof toothpaste or brand of soap
because the cost of making amistake to something that they
don't like is not worth itbecause they have to go buy
another one and they can'tafford to do that.
So you're very risk averse.
And I think that that riskaversion isn't so prevalent in
(42:38):
the United States or any youknow wealthy nation.
SPEAKER_00 (42:41):
The other thing I would say as an American myself
is we like to get stuff overwith quickly the so-called
culture of instantgratification.
And we see it as Americanphysicians is, you know, people
really want quick fixes andwe've talked about this with
some of the addiction doctorsthat I work with here in the US
(43:01):
that I can see why people findKratom to go see a doctor you
have to make an appointmentthere's a wait time you have to
see if your insurance will coverit.
You go see the doctor they mightrecommend something different
than what you think you need.
And then if they do write theprescription that you want, you
have to go to a pharmacy, oops,it's out of stock and oh your
insurance has a copay oops needsprior authorization.
(43:23):
Like it could be six weeksbefore you're actually able to
get what you need you walk intoa smoke shop and you pick up
your you know your favoritebrand of Kratom and you're in
and out in two minutes.
So I think uniquely forAmericans I I I think there's
also that instant gratificationculture of just we we want to
get it over with quickly.
And and I I didn't realize youknow the the economic
(43:46):
differences between us and othercountries of just having so much
financial freedom that thatmakes very good sense too.
SPEAKER_01 (43:53):
Yeah the financial freedom aspect is something that
hits me in the face actually tobe quite frank when I travel
anywhere that's a first worldcountry it's just so so
different for the majority ofthe population.
And you know your typicalAfrican would kill for a$15 an
hour job in a McDonald's theywouldn't believe that's
(44:15):
possible.
So it is it is very verydifferent and America is one of
the greatest nations in theworld and it's very affluent and
and the best things have comefrom America in many cases.
And a lot of those things havebeen driven by the need to
deliver quickly and beinstantaneous and and these are
all good things.
It's increased productivity etcyou look at Amazon you can now
get your stuff in 24 hours youknow or even less and that's a
(44:39):
great thing.
So like with everything there'sthe good and the bad and I do
think that that America'sheading into a space of real
change and I think that's good.
People are becoming a lot moreaware of the things that they're
(44:59):
putting into the bodyparticularly when it comes to
food because food since the Idon't know 80s has been
poisoning us.
And I'm not gonna get on mysoapbox now but you know I think
about things that my parentsgave me when I grew up I would
never give my kids that nowbecause I know what's in it you
(45:20):
know but they had no idea.
They had no idea they're likewell it's from you know
Kellogg's or Monsante orwhatever it must be okay.
SPEAKER_00 (45:29):
They must have done their research yeah yeah no it's
yes I mean I grew up eatingFruit Loops and Applejacks and
all this stuff as did my wifeand we do not serve it do not
serve it to my daughter.
SPEAKER_01 (45:39):
What is if anything the GKC working on in terms of
trying to combat this sort ofstuff yeah so we are very very
focused on this the these issuesand again we understand we're in
a an interesting spot because wesee the good and we see the bad
and we see it directly in frontof our face and we've just got
(46:02):
to be very honest with whatwe're seeing and what we want
what we want.
And what we want is amarketplace particularly for
Kraton that supports naturalcreatum leaf products that are
safe that are well labeled thathave been manufactured in a GPFP
facility that have a basis forsafety and are not too potent
(46:24):
because potency is whereeverything gets killed.
Everything gets killed inpotency.
Traditionally we know this ishow Kratum has been consumed
this is how much it's beenconsumed.
It's interesting you talk to theMalaysian scientists and that
study Kratum for a living or theIndonesian scientists and you
say to them well you know do yousee this?
Do you see that?
And they go like no what are youtalking about?
(46:44):
Like no you know people enjoy itand sometimes they you know take
too much of it but we don't seeany of the stuff that's
happening here and that'sbecause of how much it's changed
and it's become more potent.
So stay within those ranges ofwhat is appropriate for use what
is safe what is backed by thescience and then broad based
education.
(47:04):
But it becomes really difficultto do that education when
everyone's saying well Kratumit's got to be what is it leaf
kratum is it a concentratedextract is it an isolate is it a
synthetic let's risk stratifyand you will do this in your
practice too you risk stratifyand then you go forward.
Regulations need to be aboutrisk stratification and then
(47:27):
going forward.
So we're very active ineducating a huge amount of
effort we are investing inscience ourselves so we're
spending a tremendous amount oftime and money in making sure
the science gets done we've gotto know what we don't know so
that we can better educate andregulate and and then
regulations.
So we are very supportive of theFDA action very very supportive
(47:51):
and we're still working on astate and a local level to
educate and pass regulationsthat get the bad products out,
keep the good products in, butin a safe regulated environment.
We've also got to allow peopleto be adults but when you cross
that line into creatingsomething new that mimics a
synthetic controlled substancethat's got to stop.
(48:14):
And one thing we've got tofigure out is well what do we do
with these people theseindividuals that have fallen
victim to this nefariousbehavior by these companies and
sometimes they get forgottenabout and we don't want to
forget about them either.
We want to be able to offer themhelp and point them in the right
direction to get the help thatthey need.
(48:36):
So it's a it's a humanexperience but we can't take out
that there are bad actors thatare doing certain things and
those products shouldn't havebeen on the market in the first
place.
SPEAKER_00 (48:50):
Yeah.
I'm gonna make a a comment thatmight actually sound funny in
America in 2025, but I wouldlike to give credit to my
congressman most Americans don'thave a ton of faith in the
government right now, but ourlocal congressman's office
actually reached out to me as anaddiction medicine doctor and
said can you help us withtyaneptine?
So there Yeah so they'reactually very aware of mu opioid
(49:12):
agonism I was actually reallyimpressed.
SPEAKER_01 (49:14):
Fantastic yeah so if I can just ask is there anything
specific that the Global Creatumcoalition is doing around these
other substances like tyaneptinelike Fenibit Yeah so we are
involved with a few otherorganizations that are taking
this on in a at a more globalperspective as a more bucket of
of product so looking at nitrousoxide looking at TNT looking at
(49:37):
Fenibat and looking at what athow we appropriately deal with
these products it's complicatedbecause they're already illegal.
This is the crazy part it'salready illegal and it's not
illegal because there's aquestion around well is it
adulterated it's illegal becauseit's not a dietary ingredient
(49:59):
it's a drug and you're sellingit on the market.
So you know when it comes to a anatural botanical there's a much
bigger conversation that needsto be had but when it comes to a
drug that's been made in a labconversation's over have you do
you have your new drugapplication?
No, you're out.
So there's a lot of activitythat's happened on T-11 over the
(50:23):
last seven years.
It feels weird that it's stillgoing on but there's I think
about 11 states now that havebanned it and there's never
anyone standing in a way in theway of that ban.
It's just so obvious.
And there's a a federal billthat seeks to deal with TN1 that
I think should get somemovement.
And then again I think you'reseeing an FDA that is taking
(50:44):
this very seriously if youlisten to anything that that RFK
or Commissioner McCarry havesaid is they've said the focus
of the administration is on gasstation heroin.
And what is gas station heroin?
Well it started with TNF.
So it's very much in their focusand I think that any action
that's being taken in the stateto deal with TNF and and
(51:06):
schedule it is something that wewould support.
SPEAKER_00 (51:09):
Well as always Matthew I learn a ton every time
that I speak to you.
So thank you so much for yourexpertise we're almost out of
time anything else that youwanted to add on this subject no
just thank you.
I I really appreciate you firstof all the work that you do
being open to listen to to usand and share thoughts and yeah
I just appreciate you having meon awesome thank you so much
(51:36):
before we wrap up a huge thankyou to the Montage Health
Foundation for backing mymission to create fun, engaging
education on addiction and ashout out to the nonprofit
Central Coast OverdosePrevention for teaming up with
me on this podcast.
Our partnership helps me get theword out about how to treat
addiction and prevent overdoses.
(51:57):
To those healthcare providersout there treating patients with
addiction you're doinglife-saving work and thank you
for what you do.
For everyone else tuning inthank you for taking the time to
learn about addiction it's afight we cannot win without
awareness and action there'sstill so much we can do to
improve how addiction is treatedtogether we can make it happen.
(52:18):
Thanks for listening andremember treating addiction
saves lives.
Welcome to the Addiction Medicine Made Easy
podcast.
Hey there, I'm Dr.
Casey Grover, an addictionmedicine doctor based on
(00:20):
California's Central Coast.
For 14 years, I worked in theemergency department, seeing
countless patients strugglingwith addiction.
Now, I'm on the other side ofthe fight, helping people
rebuild their lives when drugsand alcohol take control.
Thanks for tuning in.
Let's get started.
Today's episode is abouttyaneptine and the so-called
(00:44):
legal high market.
Let's unpack this a bit.
First of all, what are legalhighs?
Well, they are what they soundlike.
They are substances that arelegal and are not controlled
substances, but they arepsychoactive and can be just as
strong as illegal drugs,alcohol, and controlled
substances.
And speaking of so-called legalhighs, what the heck is
(01:07):
tioneptine?
Well, tioneptine is an atypicaltricyclic antidepressant that is
not available to be prescribedby doctors here in the United
States, but it is used in someother countries in the world.
In addition to being anantidepressant, it turns out
that it also activates theopioid receptor.
So, here in the United States,given that we have a huge
(01:30):
problem with opioids andtherefore a big market of people
who want to buy opioids,tyaneptine started showing up in
gas stations and smoke shops asa supplement that people could
buy, and it was being sold as alegal high.
And this situation has led toTyaneptine getting the nickname
Gas Station Heroin here in theUnited States.
(01:52):
And there are other substanceslike this here in the US.
We did an episode on Fenibutback in 2023, which is a Russian
psychiatric medication that isnot available to be prescribed
by doctors here in the US.
It's actually very similar tobaclefin and benzodiazepines,
and yet it's available here inthe US in smoke shops as a
(02:13):
supplement.
You can imagine this is a bigproblem, right?
We have medications that theU.S.
medical system does not deem tobe useful enough to approve for
doctors to prescribe here, andyet you can get them at a smoke
shop without a prescription as asupplement.
So, in today's episode, we catchup again with Matthew Lowe from
(02:35):
the Global Kratom Coalition.
But we won't just be speakingabout Kratom.
We will be speaking about howbusinesses of questionable
legitimacy are skirting U.S.
laws that regulate medicationsto bring medications from other
countries onto the shelves ofsmoke shops here in the US as
supplements.
And we will also talk about7-hydroxymetrigynine and how
(02:58):
it's essentially a novelsynthetic opioid, which comes
from Kratom.
We will talk about what Matthewand his coalition think we need
to do about it, and I'll giveyou a few points before we start
to give you some context forthis interview.
First, my recommendation as adoctor is that people not use
Kratom as it has the potentialto cause harm, addiction, and
(03:20):
dependence.
Matthew's perspective as aKratom user is that we should
keep Kratom in its natural form,which is leaf kratom, as it's
fairly weak and therefore therisk of using Kratom is low.
I don't know if I agree, but Icertainly see his point.
Second, regarding Kratom, in theUnited States, the Food and Drug
(03:40):
Administration, or FDA, has madea recommendation to the Drug
Enforcement Administration, theDEA, that 7-hydroxymetriene
should be made a controlledsubstance, as it's again
essentially a novel opioid.
Matthew and I both agree thatthis is a great thing.
And finally, a point aboutcannabis.
(04:01):
Matthew mentions Delta 8, Delta9, and Delta 10 throughout the
episode.
Let's unpack this a bit.
It turns out that the THC thatwe get from the cannabis plant
that we use to get high isactually technically named Delta
9 tetrahydrocannabinol.
Marijuana and hemp are twodifferent forms of the cannabis
(04:21):
plant.
Hemp naturally contains lessthan 0.3% Delta 9 THC, and as
you can imagine, it's thereforeregulated differently.
It's often grown to makecommercial items such as paper,
rope, plastic, textiles, andmore.
It's actually not even acontrolled substance.
And unfortunately, and this is atheme in this episode, this
(04:42):
opened a loophole.
Manufacturers started extractingDelta 8 THC and Delta 10 THC
from the hemp plant and sellingthem as cannabis products.
As you can guess from the names,Delta-8 THC, Delta 9 THC, and
Delta 10 THC are very similar,and they actually produce very
(05:03):
similar effects in humans.
But because Delta 8 THC andDelta 10 THC are derived from
hemp, there is so much lessregulation.
It's a bit of a mess, and themarket is being flooded with
Delta 8 and Delta 10 products.
And with that, buckle yourseatbelt because we are going to
be learning about legal highs,the American food and drug
(05:25):
regulation system, and how drugdistributors are constantly
taking advantage of loopholeshere in the US to bring more and
more drugs to the market, oftensold in smoke shops.
All right.
Well, I am so glad to welcomeyou back again to the Addiction
Medicine Made Easy podcast.
Why don't you remind ourlisteners who you are and what
(05:47):
you do?
SPEAKER_01 (05:48):
Thank you, Dr.
Grove.
It's good to see you again.
My name is Matthew Lowe.
I'm the executive director ofthe Global Kratum Coalition.
SPEAKER_00 (05:57):
Now we're going to talk about tie-inptine today,
also known as Gas StationHeroin.
What makes you as the GlobalKratom Coalition interested in
such a product?
SPEAKER_01 (06:06):
Yeah, it's a good question.
And I think it it comes down towhere these products are coming
from.
So you can walk into a gasstation or a smoke shop, really,
anywhere in the United Statesand get substances that are not
natural, that in some countriesin relation to TNP are the
(06:28):
prescription drugs, and you canbuy them over the counter for$5,
$10,$20 without giving your IDforward, without getting a
prescription.
And I always ask myself thequestion how and why is this
happening?
You don't see this anywhere elsein the world.
You see it in the United States.
(06:49):
And it's not just TN Neptine,it's TN Neptine, it's nitrous
oxide, it's synthetic umalkaloid products, it's delta 8,
delta 9, delta 10, and whichevernew synthetic um hemp product
comes onto the market.
And if you dig a bit deeper andyou go through the layers, it's
a coordinated drug traffickingring, really is what we're
(07:12):
seeing.
It's a gentrified drugtrafficking rink because these
drug traffickers have figuredout that they can find
substances or develop substancesthat mimic scheduled narcotics,
wrap them up in nice packaging,call them, you know, names like
perks or Zazar Red or Tia orNeptune's Fix.
(07:35):
Call them a dietary supplementand sell them in these shops.
And I want to be very clear,that's not legal.
What they're doing is not legal.
It's highly illegal.
But they've got away with it forso long that there's no
consequences for that action.
So you see these individuals gofrom substance to substance to
substance, knowing thateventually it's going to catch
(07:57):
up to them and the products aregoing to get going to get
scheduled or gonna get banned,but they've already moved on to
the next thing.
So it's it's it's an interestingpoint in time because I think
people have started to realizethis is what's going on.
And you've seen the number ofsmoke shops go from X number to
(08:17):
4X, 5X, 10X over a period offive years.
And I think legislators,regulators are catching on and
are making an impact.
So really the people that getlost in this are the are the
consumers because consumers aregetting tricked.
And in some cases, and this iswhere a problem lies, is they're
(08:39):
getting addicted.
And in the case of TNF team,that is very, very much the
case.
And they're getting addicted,and then it gets taken away, and
they're left without an option.
And it's not their fault thatthey started taking the product
and now they're left without anoption.
It shouldn't have been there inthe first place.
So it leaves a bit of a socialconundrum.
So education, I think, iseverything.
(09:00):
And you could say to the averageperson, well, what is TNP?
And they go, I I've got no idea.
I've got no idea what that is.
And that's because you shouldn'tknow what it is unless your
doctor prescribed it to you andyou live in France.
So TNP specifically is aatypical antidepressant.
It was developed in France inthe 1960s and was given to
(09:22):
people for severe depression,for anxiety, etc.
But it doesn't work like anormal SSRI.
It gives you the same effects atthe right dose levels, but it
actually works and attaches tothe opioid receptors in a very
pure manner.
So with that comes a therapeuticdose, which is beneficial to
(09:44):
people, but they build theirtolerance, they start to consume
too much, they become addicted,and that's where the problems
start.
So even in those countries whereTNeptine is a prescribed drug,
there's countries that havebanned it.
Italy has banned TNP becausethey saw the issues that were
coming from the use of an opioidover and over and over again.
(10:06):
And we know that story withopioids.
Not saying that opioids are bad,but if set in an uncontrolled
environment, you will consumetoo much, and that's where the
problems start, particularly ifyou've got a proclivity for
substance use disorder.
SPEAKER_00 (10:25):
Yeah, it's very interesting.
Let's unpack a number of thethings that you said.
So, you know, Matthew, I learnedfrom you on our first episode
that as a Kratom advocate, youwant better labeling.
And people tell me, you know,Dr.
Grover, we want to ban Kratom.
What are your thoughts?
And I said, Well, what would aban on Kratom actually do?
(10:48):
And the way I explained it tothem is some people have a
substance use disorder and theygo on the internet and they read
about it and they find thatKratom is a substance that acts
like an opioid and they seek itout knowing that it acts like an
opioid.
Where I see a Kratom ban beingbeneficial is the consumer who
does not have a substance usehistory and reads on the package
(11:12):
that it helps with energy orhelps with mood.
And because the package doesn'tshow it's an opioid and that
it's habit forming, thatconsumer then three weeks later
doesn't understand why they feelso sick when they stop Kratom.
So my guess is that the GKC'sperspective would be why don't
we just label Kratom better?
And then we don't necessarilyhave to ban it.
(11:33):
Like if you go buy a pack ofcigarettes as an adult, you know
what you're getting.
SPEAKER_01 (11:38):
Well, I think it's so labeling is a very important
piece of this puzzle, but it'snot a solvable.
And I think productcategorization at the first
instance is the most important.
And something that we alwaystalk about when it comes to
Kratum is well, what are youtalking about?
You say Kratom to me, what areyou talking about?
(11:58):
True.
Show me the product, show me theproduct you took.
Because I'm gonna guess that ifyou've gotten into a really bad
problem with Kratum, it's notthe natural leaf.
The natural leaf is low potency,50% of that leaf is fiber.
50% of the leaf is fiber.
That is an incredible amount offiber.
(12:20):
You can you can get your yourdaily fiber dose from consuming
your Kratum.
25% of that leaf isantioxidants.
Only 2% of those leaf arenaturally occurring kratom
alkaloids.
And the interesting part aboutnatural creatum leaf is it is a
partial muopioid agonist, butit's also got serotonergic and
adrotinergic um activity.
(12:41):
So there's a modulating effectof that consumption of that
kratum leaf in terms of yourexperience with it.
And because of the fiber contentand the low potency, it's very
hard to over-consume the leaf.
And I'm not in any way sayingthat it's not habit forming.
It is habit forming, absolutely.
But that habit forming, and it'sshown in the survey data, it's a
(13:04):
mild to moderate severity of usedisorder in the people that it's
prevalent in.
And if you map that across arelative landscape, and then you
look at the the outcomes of thataddiction, it's very similar to
a caffeine addiction in thatit's highly physical.
Now, that's the leaf.
(13:25):
Then you can get a kratomextract, which has stripped all
the fiber out, stripped all theantioxidants out.
It's high, a lot more potent,big concentration.
You can consume a lot more ofit.
Now, of course, the risk factorchanges.
And then what we've seen morerecently in the last two years
is the introduction of syntheticisolate alkaloids.
(13:47):
So 7-hydroxyometriganine orconcentrated synthetic
7-hydroxyometriene is the talkof the moment because then FDA
stood up and said, enough isenough.
And this is in direct relationto what I was speaking about
before.
Enough is enough.
Stop poisoning Americans withthese drugs.
And these synthetic 70H productsare a perfect example of that
(14:11):
because you had an individual,one individual in the in the US,
I'll I'll have you, and thenit's kind of expanded, that
figured out oh, there's this onetiny little alkaloid that's
0.04% of the weight of the leafmaterial and creatine leaf
called 7-hydroxymetraganine.
Now, 7-hydroxymetraganine in theleaf, if you pick it off the
tree, isn't even in the leaf.
(14:32):
You dry the leaf, it becomesapparent in small amounts.
Now, in the leaf material, it'spharmacologically uh irrelevant.
And a lot of science and studybeing done around this because
it is such a strong alkaloid.
It on its own is a full opioidagonist 13 times more potent
than morphine.
So someone looked at it andsaid, well, what is if I could
(14:52):
isolate it and concentrate it?
I could have an opioid.
And I could claim it's tradeum,or I could claim it's natural.
And that's what they did.
They isolated, they took anextract, they didn't isolate it,
so it's not some like theybasically took an extract, they
added heat, light, and poolchemicals, pool shock.
And they converted themitragynine into
(15:14):
7-hydroxymitrogynine, turned itinto a tablet, and put it on the
shelves, calling it Kratum,which it's not, doesn't have the
fiber, doesn't have theantioxidants, doesn't have the
49 other alkaloids.
Put it onto the shelf at$6 apill.
And on top of that, and this isthe most nefarious part, they
called it perks.
They called it oxy.
(15:34):
They called it roxy, they calledit cosmic lewds.
They knew exactly what they weredoing.
It was a dog whistle, twoindividuals with opioid-seeking
behavior.
And guess what?
It went like a freight train.
It went from zero dollars twoyears ago to nine billion
dollars today and leftdevastation in its wake.
(15:56):
And it's really sad because youspeak to individuals and they
just didn't know what they weregetting themselves into.
They saw this brightly coloredpackaging and it wasn't labeled
appropriately, they startedtaking it, and now they've
developed this addiction andthey're embarrassed in many
cases because they're going,like, how did this happen to me?
(16:19):
And I also speak to a lot ofKratum advocates who have used
Leaf for 15 years.
I mean, you know, leaf has beenaround for 400 years in
Southeast Asia, for 50 years inthe United States, and we
haven't seen this sharp increaseand this like pandemic hit.
(16:39):
There's been some issues, butyou've got 23 million consumers.
90% of those consumers, 95% ofthose consumers are using it
safely.
The further you move away fromthe leaf, that's where the
problems start.
And then when you get to theseconcentrated synthetics, I was
speaking to someone the otherday, they used Pratim Leaf for
15 years, net positive to theirlives.
(17:00):
It really was a game changer forthem.
Three months of using 7hydroxymetryine or synthetic
concentrated 7OH, they were indebt, remortgaged their house,
messed up with their family, andthey were consuming$100,$200 of
the stuff a day.
So it really is very different.
And in some cases, they'reembarrassed because they should
(17:22):
have known better.
In other cases, they were justgiven a free sample and said,
this is the new Kratum.
SPEAKER_00 (17:28):
Wow.
Yeah, that goes back to thepoint you were saying about
these products like Tyaneptineand you know, I I I call them
basically semi-synthetic opioidsof these 70H products.
Is to your point, people getintroduced to them, don't
necessarily know what they are.
And then if it does get banned,it leaves them really high and
dry of like, how do I get help?
(17:51):
And so when we were talkingabout our ban on Kratom, we have
to educate doctors and we haveto educate patients.
So if we're going to do thisright, people have to know where
to land.
And so for me as a doctor inCalifornia, since I've been
working more on Kratom and beenpodcasting about it, I get
emails probably once or twice aweek from somebody in all parts
(18:14):
of the United States, like, Dr.
Grover, you seem like you knowwhat you're doing.
Can you help me?
And when people can see mebecause they're in California,
because that's where I'mlicensed to practice, they are
so grateful that I actually canhelp them by understanding like,
what are you taking?
What are you, what are yougetting from it?
Is it the anti-inflammatoryeffects?
Is it the stimulant effects?
So we actually very thoughtfullysaid the only way we can really
(18:35):
ethically ban Kratom is if weeducate the healthcare provider
so patients can get help.
Because most people tell me, Iasked my doctor and they had to
Google it during the visit.
And then we had to create somepatient-facing information too.
So that comes back to your pointabout tying epine, is that this
this seems to be a repetitivething where a medicine with
(18:56):
maybe a questionable safetyprofile from another country
comes into the U.S.
as an over-the-counter product,and then what do we do about it?
And funny you should mentionthat, because I was at a middle
school 45 minutes ago educatingthe kids about drugs, and a
seventh grader asked me aboutfenibit, which is a Russian
psychiatric medication similarto similar to bacclefin and
(19:18):
benzodazipines that has a prettybad withdrawal syndrome.
SPEAKER_02 (19:21):
Yeah.
So quite a bit to unpack there.
And let me start off by sayingis that we are obviously very
against a broadband on Kratom.
SPEAKER_01 (19:37):
We think that natural Kratom leaf has got a
place in the market.
We believe it needs to beregulated.
There's absolutely no doubtabout it.
Age gates, labeling, etc.
But we believe that it's got aplace in the market and we
believe that it's serving thebetter good.
And we think there's low riskfor kids and those types of
things because it it tastesterrible, it's not a fun
(19:58):
experience.
But as you move further awayfrom it, that that whole
equation changes.
We've seen this time and timeagain where a natural substance
that has got some rewardingactivities or rewarding um
perspectives to it getsadulterated, synthesized, and
turned into something else, andthe baby gets thrown out with
(20:18):
the bathwater.
Cocoa leaf?
Yeah, we said it at the sametime.
Cocoa leaf cocaine.
Cocoa leaf's amazing.
It's an amazing plant, butpeople made crack out of it.
So where do you draw that line?
And I don't think it's aboutthrowing the baby out with the
bathwater.
I think it's exactly what theFDA have recommended to the DEA,
and this is the first time thatthey're doing something like
(20:40):
this.
They said, We've got a problem.
We've got concentrated synthetic70H products on the market.
70H only is a tiny part of theKratum Leaf.
These products are entirelydifferent.
We see the benefit in KratumLeaf.
So how do we deal with this?
Well, we schedule at apercentage.
(21:01):
So we say, well, 70H can only bein 0.04% of the leaf material of
Kratum Leaf.
Anything over and above that isscheduled.
It's out, it's gone.
And that's what they're doing,that's what the Florida AG did.
When it comes to TNeptine, it'sa much simpler case because
you're not talking about anatural substance.
(21:22):
You're talking about somethingthat was created to be a
pharmaceutical.
Then the way that we solve thiscrisis is we need to bring those
individuals to book.
We need to bring the foreignmanufacturers that are importing
it into the country to book, andwe need to bring those
manufacturers who are making itand spreading it into the smoke
shops to book.
(21:43):
Because the secret that no onewill tell you, because no one
knows, is that this is actuallynot being run by 4,000 different
companies.
There's probably five or sixcompanies that are doing this.
And if you went into theirwarehouse or their 10 warehouses
because they operate in theshadows, you will find Delta 8,
(22:07):
Delta 9, Delta 10, you will findFennyBut, you'll find TNeptine,
you will find concentratedsynthetic 70H products and these
other different alkaloidproducts.
Now we're starting to see thembring out hallucinogens.
So you're gonna find the magicmushrooms, the synthetic magic
mushrooms, you're gonna findEboga root and it synthesized
(22:28):
Eboga root.
So it's the same things over andover and over again.
And probably when it comes to TNNeptune, probably the biggest
product was a product calledNeptune's Fix.
Now, Neptune's Fix was put ontothe market, it became quite a
big thing, and then the FDAcottoned onto it because it made
a whole lot of people sick.
(22:49):
And they tested it, and ofcourse it had TN Neptune in,
which was a problem, but it hadalso been contaminated with
Delta 8, Delta 9, Delta 10.
And why do you think that is?
Is because they're all comingfrom the exact same place.
That individual took TNP's fixoff the market and then launched
a brand the next day calledMorpheus's fix.
(23:10):
So they just do it over and overand over again because there
hasn't been enough consequencesfor their action.
TNP's a straight line to thegoal.
You are bringing an unapproveddrug to the market and you're
selling it as a dietarysupplement.
That is federally illegal, andyou can be put in jail for 20
years for doing that.
That's what needs to happen withthese individuals.
(23:33):
Because if the consequences arethere for this behavior, then
people are going to stop doingit because they're not going to
see it as free money.
And I think that that's whatthis new administration is doing
is they're going to say enoughis enough.
They're going to bring it toorder.
And what we're seeing, and it'shopeful, is that they're not
going to throw the baby out ofthe bath water.
(23:55):
There's a place for certainsubstances to be used in certain
ways.
And there's not a place forothers.
And when it comes to any ofthese drugs, if you rarely
because this is also thefrustrating part is these trade
groups and these companies willsay, Oh, well, it's helping so
many people, right?
(24:16):
We've it treats pain, it helpswith opioids, it's actually
helping people get off opioids.
I think it definitely can treatpain.
Certainly 70H, synthetic 70Hcan.
It's a pure opioid.
I think that people do stoptaking traditional opioids when
they take concentrated synthetic70H.
But it's not because they'vesusated off opioids, they've
(24:38):
just switched to a differentvariety.
So the problem hasn't gone away.
It's the same problem.
But that's not the reason whythey launched those products.
They launched those productsbecause they knew they would be
addictive and they knew theywould make a lot of money.
And they have a pathway to go tomarket if they want to, and that
is do your clinical trials, doyour preclinical trials, do your
(24:58):
new drug um application, and putit to market as a
pharmaceutical.
That's what Pfizer has to do.
That's what Bayer has to do.
That's what whoever has to do.
And they skip that step.
SPEAKER_00 (25:09):
Can I just ask?
So I heard you say Iboga, and Ididn't realize that was the
plant behind Ibigaine.
Ibigaine being a substance thatyou can take, it's a
hallucinogen, it's supposed tobe this journey through seeing
your addiction.
So I've had a few patients go toMexico and get treated with
Ibigaine because it's not legalin the US.
(25:30):
Can you talk to me how aresynthetic versions of these
plant-based compounds beingsynthesized?
Like how are they creating asynthetic psilocybin or a
synthetic iboga?
SPEAKER_01 (25:42):
I I don't know the answer to that, to be honest.
I'm not a chemist.
I know very well on synthetic70H and on the Delta 8, Delta 9
side.
I don't know on that side, butit'll be a very similar process.
They're either doing the spicething where they are making it
in a lab, or they're taking thenatural compound and just like
they're doing with synthetic70H, they're figuring out how to
(26:04):
convert it, concentrate it, andmake it more potent.
And I think that's that's whatwe're seeing there.
I mean, the Delta 8, Delta 9,Delta 10 thing is interesting
because so hemp got legalized,and that was for industrial hemp
and CBD, right?
Those are the use cases.
There was a big loophole becausethey only put a concentration
(26:25):
level on one of the deltas, andthe people went, well, it's
below 0.03%, but then they juststack these other new synthetic
cannabinoids on top of it.
But what's fascinating is thatmany of these products are
actually just marijuana.
They've skipped the step of evensynthesizing it, and they're
just putting actual marijuanainto the products because they
(26:47):
can just do it.
And the whole legal marijuanaindustry, which has to go
through dispensaries, has to paytaxes, is completely undercut
because you can just walk into asmoke shop and get something
that is pretty much the samething or acts in the same way.
But even in that space, we'reseeing problems because and this
(27:08):
is a tale as old as time, buttoday's marijuana is not your
grandfather's pot, it is so muchstronger.
And the basic tenet oftoxicology is the poisons in the
dose, and it's just this race tothe top.
How do we make it as strong andas potent as possible to take
(27:29):
out the competition?
And that leads to adverseevents.
Now schizophrenia rates havedoubled because of the strength
of these of these narcotics.
So don't mess with MotherNature.
I think that you know I thinkthat these substances,
particularly that have been usedfor centuries, have a place in
(27:49):
society.
But as soon as you start to messwith them and amp them up and
make them more potent andisolate them, we've got to
realize we're creating somethingnew.
We're creating somethingdifferent and we don't know what
the downstream effects are.
But quick way to understand thedownstream effects is look at
the pharmacology.
And if the pharmacology is thatof a pure opioid, you know
(28:10):
you're gonna what you're gonnaget.
So if I'm thinking about it fromif I'm putting my bad guy hat
on, I'm going, well, I'm gonnago after that because it's gonna
get people addicted.
If I'm putting my regulator haton, I'm going, well, that's
gotta be a bad idea.
We've got to put a stop to it.
And the nuance or the surgeryis, well, how do we do that with
(28:30):
the least amount of damage?
And that's what we're grapplingwith at the moment.
SPEAKER_00 (28:36):
So let me come back to my question because I think I
asked it incorrectly of you.
Is I wasn't asking, like, what'sthe chemical way that they're
synthesizing these novelcompounds?
So let's take a look at THC,right?
So you have the cannabis plant,which I think has like 400
different chemicals in it, andlike I think 60 of which are
cannabinoids.
(28:57):
So are these people that areplanning to take advantage of
loopholes, are they working withchemists to synthesize new
compounds?
Are they extracting existingcompounds?
Or are they just looking in aresearch library of chemicals
and pulling out stuff that waspreviously enlisted as I okay,
(29:20):
that way I figured all all ofthe above.
SPEAKER_01 (29:24):
So the guy that brought concentrated synthetic
70H to the market, he quiteremarkable, but he was on a
podcast about a year agobragging about this.
This is what I did.
And I said, Well, how did youcome up with that idea?
He says, Well, I was reading apaper from from NIDA, a National
Institute of Drug Abuse, and itsaid in there, Cratum Leaf has
(29:48):
got tremendous promise, butseven hydroxymetragynine, if
you're a pharmaceutical company,you should look into it because
it seems like it might be apotential opioid.
We don't know if.
it's safer, if it's moreefficacious.
But this could be something thatcould be turned into a drug and
could be administered to people.
And who knows?
We're looking for saferalternatives.
And he went, Oh, that'sinteresting.
(30:09):
Let me go look.
Has anyone done this?
Patents did it?
No, no one has.
So I did it.
And you're like, well I meanenough said.
So you created a drug and nowyou're selling it on the market.
And then he goes on to say,well, there's no regulations for
this.
And you're like, well, thereabsolutely are regulations for
creating a new drug and puttingthem onto the market.
(30:32):
You just have ignored them.
SPEAKER_00 (30:35):
How was it regulated in terms of a chemical versus
for human consumption?
I mean obviously a new cleaningchemical is going to be
regulated differently than say anew medicine.
So how how do they choose whichloopholes to use?
Or again, it probably is justall of the above, whatever can
make the money, but can you talka little bit about the
(30:56):
difference and how that'sregulated?
SPEAKER_01 (30:58):
Yeah.
So the regulatory structure issuch that you've got medicines
and drugs, then you've got theumbrella of food.
And within the umbrella of foodyou've got traditional foods and
you've got dietary ingredients.
And now there's complex pathwaysfor each of them.
On the medicinal side, you'vegot to do an investigational new
drug approval.
You do all your preclinicaltrials, you show that it's going
(31:21):
to do what you think it's goingto do.
It's not going to kill rats, etcetera, et cetera.
Then you kind of go phase one,phase two, phase three, millions
of dollars, millions of dollars,millions of dollars, you move on
to clinical trials.
And ultimately you've got toprove that your new compound is
safer and more efficacious thanthe incumbent.
If you can get that right afterspending$100 million,$200
(31:44):
million, you then get the rightto sell that product and you get
the right to sell that productand I won't quote the monthly, I
think it's 10 years or 20 years,probably 10 years, and you can
just sell it as your as as yourown product.
You've got control of thatmarket.
After that time then genericscan come into the market.
And then you that's where yousee drug prices drop the
generics come into the marketand often it's the manufacturer
(32:07):
now of the original product thatbrings the generic product to
market because they know what'sgoing to happen.
So that's the medical pathway.
The food and dietary supplementpathway is is different.
So as a dietary supplement ordietary ingredient, you can
either be an old dietaryingredient or a new dietary
ingredient.
So the dische is the regulatoryparadigm for dietary
(32:31):
ingredients.
Old dietary ingredients are anydietary ingredient that was sold
as a dietary supplement prior toOctober 15, 1994.
If you've got one of thosesubstances, you put it into your
product there's no approvalthat's needed.
It's been in the market it'sgrandfathered and it's accepted
to be safe and legal.
Now if you introduce somethingthat has not been in the dietary
(32:54):
supplement market in the UnitedStates prior to 15th of October
1994, it's a new dietaryingredient and you have to file
what's called a new dietaryingredient notification with the
FDA.
Now that includes preclinicaltrials, safety, it's like a mini
approval process.
You submit that to the FDA andin 75 days they will either not
(33:19):
respond and you can go to themarket or they will respond and
say we've got a problem withthis you know you need to do
more work on it.
It cannot go to the market.
So those are your pathways fordietary ingredients.
And for a food you've either gotto be sold in the market in a
form unchemically alteredpre-1958 and you grandfathered
(33:40):
in like a carver would begrandfathered in as a food
product because it's been soldsince 1915.
Or after that you can eithercome to market as a product that
is grass, generally recognizedas safe, or you've got to file a
food additive petition.
On the grass side of things,there are two pathways you can
(34:02):
self-grass or you can submityour grass to the FDA and they
can make a determination.
Now grass relies on scientificconsensus.
So you put all your safetydossier together you submit it
to a board of scientists andthey say yay or nay you can
either self-grass it take it tomarket if the FDA sees a problem
they've got to ask you for yourself-grass you've got to show it
(34:24):
safe or you can submit it to theFDA.
And that's a point of contentionat the moment with with um with
RFK where he's saying well thisseems to have been taken
advantage of as well because ifyou walk into any store in the
United States and you read theback of a product list there's a
lot of different ingredientsmany of them are banned in
(34:46):
Europe.
So there's a problem there aswell and so those are your
different pathways.
What these individuals are doingis they're ignoring everything
and they're just saying it's adietary supplement, labeling it
as a dietary supplement andputting it onto the market and
no new dietary ingredientnotification, no um assumption
(35:07):
of or assurance of safetypre-going to the market.
They're just sticking it in andletting it dry.
SPEAKER_00 (35:14):
So I have to say I'm extraordinarily impressed by
your knowledge of the Americanregulatory system.
This discussion is about the theUnited States but I listened to
a piece from the BBC on ketaminein Europe.
And the fact that there are somany countries close together
and they all view ketaminedifferently has allowed drug
(35:34):
traffickers in Europe to use laxlaws in one country around
ketamine to smuggle ketamine tocountries that have it more
restricted.
So I'm assuming for the peoplethat are distributing these
drugs as dietary supplementsthey need to learn the loopholes
in every country to be able togo after every market or are
they focusing on the UnitedStates I mean from what I
(35:58):
understand is that the UnitedStates for these specific
products is such a big market.
SPEAKER_01 (36:03):
You get the US right you don't have to worry about
global and I you don't see thishuge smoke shop culture in
Europe.
So yes there's a drug culturebut it's done differently and
that's why I call it a bit ofit's gentrified drug dealing.
And that's not to say thateverything in a smoke shop is
bad because it's certainly not Ibelieve people should are
(36:25):
allowed vice and should maketheir own choices.
It's a subsegment of theproducts that are sold in those
shops that is that is thegentrified drug dealing.
And for me it's nitrous oxidefenny button the concentrated
synthetic 7OH Mitrogyne andpseudandoxyl they've got and for
hydroxy now they're bringing inall these mushroom products
(36:48):
that's where the problem is thedelta 8, delta 9 delta 10 sits
in a bit of a middle groundspace because you know you've
got this federal regulation itis a loophole.
There's a lot of arguments to bemade there but I think that
loophole is going to be closedpretty soon here federally and
you're starting to see a bigcrackdown in in states.
I mean Ohio issued an executiveorder just last week outlawing
(37:10):
synthetic intoxicating hemp.
And then it becomes afascinating conversation because
you're going, okay, well are wegoing to do all of it and CBD
and industrial hemp?
Are we going to carve outindustrial hemp and CBD?
Are we going to allowintoxicating low dose beverage
products?
So it becomes a complexconversation.
But the European example isinteresting because you've got
(37:34):
European Union and they've eachgot their own laws and ways they
can control things.
But the European Standardsauthority whether it's EFSA or
the the drug authority actuallyhas full control over the
market.
So if they say something's notallowed it's not allowed.
If they're silent on somethingeach of those European countries
can decide on their own.
But if you make something legalin I don't know Estonia or Czech
(38:00):
Republic, you can then cross itover borders very easily and in
fact I believe and I'd need tocheck this but I remember
reading up on it probably threeyears ago you can sell it online
across the border unless ofcourse it's a scheduled drug in
that member state.
So I was doing a little Googlesearch while you were talking do
(38:21):
you have any insight on why theUS seems to be the world's
biggest drug market well I, youknow what I think that's
probably because it's theworld's biggest market besides
besides China.
So I mean you've got 330 millionpeople you've got a GDP per
capita of I mean what 60$600$7000 so everyone can afford
(38:44):
something.
I come from South Africa and weare a nation of 60 million
people but the majority of thepopulation's making less than
$300 a month.
You know that's like 60-70% ofthe population there isn't a
market for recreation becausethe money's taken up by survival
(39:06):
I think in the United Stateseveryone's got the luxury of
recreation that's a fair answer.
SPEAKER_00 (39:13):
I have wondered that myself I mean because I I think
when I look at addiction as anaddiction doctor, addiction at
its core is using something tofeel different.
And I realize that there isthere's nuance to that right you
might be tired and you knowchewing leaf cratom in the
afternoon picks you up and youcan go to do your thing.
(39:34):
You can also be depressed andtake an antidepressant from a
doctor.
Addiction is where really takingsomething to feel different goes
off the rails and we see thethree C's of addiction cravings,
compulsive use and consequences.
But usually what I do as anaddiction doctor is I help
people understand what are youusing, why are you using it,
what are you feeling, and howcan I get you on my medicines
(39:57):
instead of whatever you'rebuying and I just wonder if
there's some sort of just kindof mental health issue in
America that's different inother countries.
I don't know.
I've always wondered what it isabout the United States I I I
don't want to talk out of turn.
SPEAKER_01 (40:16):
I mean I've I I've traveled a lot probably a
hundred countries maybe more andeach country's different and
each culture's different there'sa a big culture of consumption
in the United States it's a bigbig consumer culture and that's
what keeps the economy tickingthat's what keeps people people
(40:36):
going forward that's what drivesthe entrepreneurial spirit but
it is very distinct walking intothe United States and you just
need to get off the plane andwalk into the first coffee shop
and there are 40 different typesof coffee that you can drink all
with different flavors and whichsyrup do you want and this and
(40:57):
that and you know you walk intoa coffee shop in Italy it's like
do you want espresso?
Do you want a cappuccino notafter 11 o'clock it's comp you
don't drink a cappuccino after11.
You've got very simple optionsand in the US options are
ubiquitous and you know coffeeis a great example and there's
(41:17):
nothing wrong with coffee butcoffee's a psychoactive
substance that gives you energymakes you feel different and it
is addictive.
You get withdrawals when youstop it I don't know if you've
ever stopped drinking coffee butI can't because the headaches
are too bad.
SPEAKER_00 (41:31):
My my wife gets really bad caffeine withdrawal
headaches.
SPEAKER_01 (41:34):
Yeah go ahead sorry and you know the the the health
consequences of of caffeineconsumption aren't aren't you
know detrimental I don't believeand you know so it's cool and
the same with nicotine you knowthe whole nicotine culture's
changed so much we can maybe getinto that that there's a
different culture of consumptionin the United States for better
(41:55):
and for worse.
And I think that that's got alot to do with it.
People are looking to consumethey're looking to experiment
they more risk loving and theconsequences of making a mistake
aren't so severe.
When you in Africa theconsequence of making a mistake
(42:16):
are sick is significant.
So people won't change a brandof toothpaste or brand of soap
because the cost of making amistake to something that they
don't like is not worth itbecause they have to go buy
another one and they can'tafford to do that.
So you're very risk averse.
And I think that that riskaversion isn't so prevalent in
(42:38):
the United States or any youknow wealthy nation.
SPEAKER_00 (42:41):
The other thing I would say as an American myself
is we like to get stuff overwith quickly the so-called
culture of instantgratification.
And we see it as Americanphysicians is, you know, people
really want quick fixes andwe've talked about this with
some of the addiction doctorsthat I work with here in the US
(43:01):
that I can see why people findKratom to go see a doctor you
have to make an appointmentthere's a wait time you have to
see if your insurance will coverit.
You go see the doctor they mightrecommend something different
than what you think you need.
And then if they do write theprescription that you want, you
have to go to a pharmacy, oops,it's out of stock and oh your
insurance has a copay oops needsprior authorization.
(43:23):
Like it could be six weeksbefore you're actually able to
get what you need you walk intoa smoke shop and you pick up
your you know your favoritebrand of Kratom and you're in
and out in two minutes.
So I think uniquely forAmericans I I I think there's
also that instant gratificationculture of just we we want to
get it over with quickly.
And and I I didn't realize youknow the the economic
(43:46):
differences between us and othercountries of just having so much
financial freedom that thatmakes very good sense too.
SPEAKER_01 (43:53):
Yeah the financial freedom aspect is something that
hits me in the face actually tobe quite frank when I travel
anywhere that's a first worldcountry it's just so so
different for the majority ofthe population.
And you know your typicalAfrican would kill for a$15 an
hour job in a McDonald's theywouldn't believe that's
(44:15):
possible.
So it is it is very verydifferent and America is one of
the greatest nations in theworld and it's very affluent and
and the best things have comefrom America in many cases.
And a lot of those things havebeen driven by the need to
deliver quickly and beinstantaneous and and these are
all good things.
It's increased productivity etcyou look at Amazon you can now
get your stuff in 24 hours youknow or even less and that's a
(44:39):
great thing.
So like with everything there'sthe good and the bad and I do
think that that America'sheading into a space of real
change and I think that's good.
People are becoming a lot moreaware of the things that they're
(44:59):
putting into the bodyparticularly when it comes to
food because food since the Idon't know 80s has been
poisoning us.
And I'm not gonna get on mysoapbox now but you know I think
about things that my parentsgave me when I grew up I would
never give my kids that nowbecause I know what's in it you
(45:20):
know but they had no idea.
They had no idea they're likewell it's from you know
Kellogg's or Monsante orwhatever it must be okay.
SPEAKER_00 (45:29):
They must have done their research yeah yeah no it's
yes I mean I grew up eatingFruit Loops and Applejacks and
all this stuff as did my wifeand we do not serve it do not
serve it to my daughter.
SPEAKER_01 (45:39):
What is if anything the GKC working on in terms of
trying to combat this sort ofstuff yeah so we are very very
focused on this the these issuesand again we understand we're in
a an interesting spot because wesee the good and we see the bad
and we see it directly in frontof our face and we've just got
(46:02):
to be very honest with whatwe're seeing and what we want
what we want.
And what we want is amarketplace particularly for
Kraton that supports naturalcreatum leaf products that are
safe that are well labeled thathave been manufactured in a GPFP
facility that have a basis forsafety and are not too potent
(46:24):
because potency is whereeverything gets killed.
Everything gets killed inpotency.
Traditionally we know this ishow Kratum has been consumed
this is how much it's beenconsumed.
It's interesting you talk to theMalaysian scientists and that
study Kratum for a living or theIndonesian scientists and you
say to them well you know do yousee this?
Do you see that?
And they go like no what are youtalking about?
(46:44):
Like no you know people enjoy itand sometimes they you know take
too much of it but we don't seeany of the stuff that's
happening here and that'sbecause of how much it's changed
and it's become more potent.
So stay within those ranges ofwhat is appropriate for use what
is safe what is backed by thescience and then broad based
education.
(47:04):
But it becomes really difficultto do that education when
everyone's saying well Kratumit's got to be what is it leaf
kratum is it a concentratedextract is it an isolate is it a
synthetic let's risk stratifyand you will do this in your
practice too you risk stratifyand then you go forward.
Regulations need to be aboutrisk stratification and then
(47:27):
going forward.
So we're very active ineducating a huge amount of
effort we are investing inscience ourselves so we're
spending a tremendous amount oftime and money in making sure
the science gets done we've gotto know what we don't know so
that we can better educate andregulate and and then
regulations.
So we are very supportive of theFDA action very very supportive
(47:51):
and we're still working on astate and a local level to
educate and pass regulationsthat get the bad products out,
keep the good products in, butin a safe regulated environment.
We've also got to allow peopleto be adults but when you cross
that line into creatingsomething new that mimics a
synthetic controlled substancethat's got to stop.
(48:14):
And one thing we've got tofigure out is well what do we do
with these people theseindividuals that have fallen
victim to this nefariousbehavior by these companies and
sometimes they get forgottenabout and we don't want to
forget about them either.
We want to be able to offer themhelp and point them in the right
direction to get the help thatthey need.
(48:36):
So it's a it's a humanexperience but we can't take out
that there are bad actors thatare doing certain things and
those products shouldn't havebeen on the market in the first
place.
SPEAKER_00 (48:50):
Yeah.
I'm gonna make a a comment thatmight actually sound funny in
America in 2025, but I wouldlike to give credit to my
congressman most Americans don'thave a ton of faith in the
government right now, but ourlocal congressman's office
actually reached out to me as anaddiction medicine doctor and
said can you help us withtyaneptine?
So there Yeah so they'reactually very aware of mu opioid
(49:12):
agonism I was actually reallyimpressed.
SPEAKER_01 (49:14):
Fantastic yeah so if I can just ask is there anything
specific that the Global Creatumcoalition is doing around these
other substances like tyaneptinelike Fenibit Yeah so we are
involved with a few otherorganizations that are taking
this on in a at a more globalperspective as a more bucket of
of product so looking at nitrousoxide looking at TNT looking at
(49:37):
Fenibat and looking at what athow we appropriately deal with
these products it's complicatedbecause they're already illegal.
This is the crazy part it'salready illegal and it's not
illegal because there's aquestion around well is it
adulterated it's illegal becauseit's not a dietary ingredient
(49:59):
it's a drug and you're sellingit on the market.
So you know when it comes to a anatural botanical there's a much
bigger conversation that needsto be had but when it comes to a
drug that's been made in a labconversation's over have you do
you have your new drugapplication?
No, you're out.
So there's a lot of activitythat's happened on T-11 over the
(50:23):
last seven years.
It feels weird that it's stillgoing on but there's I think
about 11 states now that havebanned it and there's never
anyone standing in a way in theway of that ban.
It's just so obvious.
And there's a a federal billthat seeks to deal with TN1 that
I think should get somemovement.
And then again I think you'reseeing an FDA that is taking
(50:44):
this very seriously if youlisten to anything that that RFK
or Commissioner McCarry havesaid is they've said the focus
of the administration is on gasstation heroin.
And what is gas station heroin?
Well it started with TNF.
So it's very much in their focusand I think that any action
that's being taken in the stateto deal with TNF and and
(51:06):
schedule it is something that wewould support.
SPEAKER_00 (51:09):
Well as always Matthew I learn a ton every time
that I speak to you.
So thank you so much for yourexpertise we're almost out of
time anything else that youwanted to add on this subject no
just thank you.
I I really appreciate you firstof all the work that you do
being open to listen to to usand and share thoughts and yeah
I just appreciate you having meon awesome thank you so much
(51:36):
before we wrap up a huge thankyou to the Montage Health
Foundation for backing mymission to create fun, engaging
education on addiction and ashout out to the nonprofit
Central Coast OverdosePrevention for teaming up with
me on this podcast.
Our partnership helps me get theword out about how to treat
addiction and prevent overdoses.
(51:57):
To those healthcare providersout there treating patients with
addiction you're doinglife-saving work and thank you
for what you do.
For everyone else tuning inthank you for taking the time to
learn about addiction it's afight we cannot win without
awareness and action there'sstill so much we can do to
improve how addiction is treatedtogether we can make it happen.
(52:18):
Thanks for listening andremember treating addiction
saves lives.
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