December 6, 2023 • 51 mins
The number of drug overdose deaths involving prescription opioids in 2021 was nearly five times the number in 1999. In 2021, 45 people died each day from a prescription opioid overdose, totaling 17,000 deaths. That does not include well over 100,000 deaths in 2021 from Heroin and fentanyl pouring into the United States due to open borders from the south of Mexico. Mac Haddow has been involved in government relations activities since 1986, when he left as chief-of-staff at the U.S. Department of Health and Human Services to go to the private sector. Today, he is a Lobbyist and advocate in Washington D.C., where he is fighting hard to keep the Natural Herbal supplement Kratom legal and accessible for consumers and patients who are suffering from chronic pain and addiction to opiates.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Intro (00:02):
Get ready to hear the truth, the whole truth, and
nothing but the truth about theUnited States healthcare system
with your host of the medicaltruth podcast, James Egidio.
James Egidio (00:20):
Hi, I'm James Your host of the medical truth
podcast, the podcast that tellsthe truth.
The whole truth and nothing butthe truth about the American
healthcare system.
The number of drug overdosedeaths involving prescription
opioids in 2021 was nearly fivetimes the number in 1999.
In 2021 45 people died each dayfrom a prescription opioid
(00:43):
overdose.
Totaling 17,000 deaths.
That does not include well overa hundred thousand deaths.
In 2021 from heroin and fentanylpouring into the United States
due to open borders from thesouth of Mexico.
My guest has been involved ingovernment relations activities
since 1986 when he left as chiefof staff at the U S department
(01:06):
of health.
And human services to go to theprivate sector.
Today he is a lobbyist andadvocate in Washington, DC.
Where, he is fighting hard tokeep the natural herbal
supplement, Kratom them legaland accessible for consumers and
patients who are suffering fromchronic pain and addiction to
opiates.
(01:26):
It is an honor and a pleasure tohave on the medical truth
podcast.
My guest, Mr.
Mack Haddow.
Mac, how are you doing today?
Welcome to the medical truthpodcast.
Appreciate it.
For the listeners and viewers ofthe medical truth podcast, just
share a little bit about who youare and what you do.
Mac Haddow (01:47):
So my name is Mac Haddow.
I'm the senior fellow on publicpolicy with the American Kratom
Association.
And we're a consumer advocacyorganization that fights to make
sure that quality andmanufactured products are
allowed to be on the marketplacewithout undue restrictions.
James Egidio (02:04):
Nice.
So I know it's specifically forKratom and for the listeners and
viewers, cause we're asconsumers of, let's say,
nutritional supplement products.
A lot of people are.
inundated with so many differentproducts.
what is kratom?
Mac Haddow (02:22):
So kratom is a plant that grows in Southeast Asia
ubiquitously because of climateand soil conditions.
It has recently been introducedinto the United States.
It's grown in some parts ofFlorida and in Hawaii.
The majority of the Kratomoriginates in Indonesia and in
Thailand, about 97 percent ofthe raw materials that are used
(02:43):
in the production of Kraatomproducts originates there.
It is a plant that has forcenturies has been had some
medicinal effects.
People recognize that when theyare working out in the fields,
they chew on a Kratom leaf andit gives them an energy boost
and increased focus.
Traditionally, people will brewit into a tea.
and they'll drink it.
It has a bitter taste.
(03:03):
And so you have to acquire thetaste.
That's principally one oflimitations on why kids don't
like it because it doesn't tastegreat.
And it also has some, it hitsthe same Mu opioid receptors in
the brain as do opioids, forexample.
But it's what's called a partialagonist, which means that it
doesn't have the same effectsnor as powerful in effect, just
(03:24):
hits the same receptor and hearlots of critics, including the
FDA, will say, oh, it hits thesame Mu opioid receptor.
The truth is, and they know it,that things like cheese hit the
same Mu opioid receptors and aton of other products but gets
up.
its effects by going to thesector of the brain that helps
with analgesia, with painrelief.
It also helps with symptoms ofdepression.
(03:46):
It boosts your mood a littlebit.
And so those are things thatmake it very attractive.
And at high doses, people arefinding it to be an effective
option for managing acute andchronic pain and for some that
are struggling with opioidaddictions.
They report that it helped themwith withdrawing from the
opioids and replacing withkratom.
There's a study done by JohnsHopkins University that
(04:07):
documented that.
So there's a, it's one of themedicinal plants that has great,
powerful benefits.
And traditionally, as we've seenin the dietary supplement and
botanical supplement industry inthe United States, The FDA hates
it.
They want to have a control ofit.
They want to ban it.
They want to make sure that theonly access people have is
through a prescriptionmedication.
(04:28):
And of course, that's not theway nature intended it.
It's not the way that we oughtto regulate these kinds of
products.
But nonetheless, the FDAmaintains its very strong anti
kratom position to this day.
James Egidio (04:38):
Yeah, and you mentioned some of the benefits
and I know I had pulled up ainfographic on the use of Kratom
and we're looking at some ofthese here.
As you had mentioned that the,there are a lot of benefits for
pain and for opiate use.
So what you're saying in essenceis that it's got almost like a
(04:59):
dual effect of the pain to wardoff some of the pain or pain,
chronic pain, as well as Beingused maybe as a substitute for
patients that are addicted toopiates or people that are
addicted to opiates,
Mac Haddow (05:13):
correct?
That's correct.
And this particular survey ofadult kratom users was done by
Johns Hopkins University.
It has great data that supportsthe notion for those who are
experiencing these addictions tovery dangerous, highly addictive
and potentially deadly opioidsthat 84 percent I'm sorry, the
(05:33):
87 percent reported that theygot relief from withdrawal
symptoms, which is the hardestpart.
of getting off of an opioid thatyou're addicted to, and 35
percent reported they were freefrom the opioids within a year,
replacing with kratom.
Now that's important because theNational Institutes on Drug
Abuse, which is one of theleading research organizations
(05:53):
in the U.
S.
government, is a strongproponent Of Kratom as a
potential harm reduction tooland they maintain that Kratom
should be available to peoplethat are struggling with these
addictions.
And again, it's about the dose,the amount of serving size you
take of Kratom you probably haveto take more in order to achieve
this particular result.
Most people use it in much lowerserving sizes for that energy
(06:16):
boost.
They pick me up in the morningfor the staving off feelings of
anxiety at a little higher doseand that and feelings of
depression.
So it is really a wonderfulplant that if it's properly
manufactured and labeledappropriately, really does help
people.
Yeah,
James Egidio (06:32):
it's interesting as you're saying this, I'm
thinking to myself why would theFDA?
Get themselves involved withwanting to regulate a natural
herbal supplement such as kratomwhen and especially for pain or
to help people get off ofopiates when we have, uh, an
(06:54):
issue with prescriptionmedications, fentanyl and,
heroin that's coming across ouropen borders.
Mac Haddow (07:02):
Yeah, there are two answers to that question.
First is it's the 64,000question that NIDA asks in the
midst of this crisis we have inAmerica with overdose deaths
that topped 107, 000 last year.
If there's a harm reduction toolavailable, why wouldn't we
encourage its use rather thantrying to ban it?
But the second of the answers isthe one that is probably more
(07:25):
appropriate to discussing whythe FDA takes this position.
The FDA has been an opponent ofdietary and botanical
supplements for decades.
We all remember back in theearly nineties, leading up to
the passage of what was known asthe Dietary Supplement Health
and Education Act, the FDA wastrying to ban all dietary
supplements and vitamins on thepremise that there were products
(07:47):
that were poorly formulated inthe dietary supplement space
that were causing adverse eventsand in some cases deaths.
They were right.
But the solution wasn't to banit.
It is to properly regulate it.
Make sure that those productsare meeting good manufacturing
standards, that they'reformulated with safe ingredients
and not being adulterated inorder to spike the effects of a
(08:08):
product with dangeroussubstances.
That's the solution.
But the FDA always goes to theposition that they want to
regulate it as new drugs.
And if that were true, If theFDA had gotten their way back in
1994, when instead the Congresspassed the DeShay Act, they
would have banned all thesedietary supplements that are
today over a 100 billionindustry.
(08:30):
And more than 80 percent of theAmerican people use dietary
supplements and botanicalsupplements for their health and
wellbeing.
The FDA just has their heads inthe sand.
They, this isn't a battleagainst kratom.
This is a battle that they havesustained over four decades
fighting all botanical anddietary supplements.
Because they just don't likethem and they would rather they
were regulated as new drugs.
James Egidio (08:51):
Yeah, and it sounds like they want to get to
a point where they control itand corner the market in
addition to, let's say, theopiate market that they already
control.
So it sounds like it's just, itsounds like it's more about
control, power and money that'sinvolved then the wellbeing of
the person that's using itresponsibly, because it seems
(09:13):
like anything you can gooverboard with.
You can drink too much coffee.
You can eat too much.
If you had to put a label onfast food McDonald's, you'd have
to ban it, for health reasons.
Mac Haddow (09:25):
exactly right.
And it's interesting, James youbring up a great point because
right now this penchant that theFDA has, in order to put
everything into that bucket ofbeing a prescription medication
and requiring them to go throughthat five to$10 billion.
exercise to prove the safety andefficacy of these kind of
products is a huge lift.
(09:45):
And most dietary supplement andbotanical supplement companies
wouldn't be in the business.
They just are hell bent thatthey're going to make sure that
they control this particularspace.
And they don't.
And it was interesting.
I had a conversation with an FDAofficial.
They won't meet with me here inthe United States, but I was
actually at the U.N..
Commission on Narcotic Drugs inVienna, Austria, and had the
(10:06):
opportunity to meet in an offthe record discussion with an
FDA official who told me thatmost of the people at the FDA
that are comprised of thescientific group that, that
really govern policy, understandthat kratom is probably a
benign, no big deal, but whatthey don't like is that people
are sitting at home selfmedicating themselves with
(10:29):
kratom when they think thatperson for whatever the reason
that person self medicatethemselves should be going to a
doctor.
Now that's an interestingdiscussion, but it strips people
of their freedom.
It strips people of their rightto make the kinds of decisions
about their health and wellbeingand who gave the FDA the power
to make that kind of decision asopposed to simply regulating
products that are presented intothe marketplace to evaluate.
(10:51):
based on their safety andefficacy.
But we know the FDA is notinterested in that because there
is a pathway for what thebotanical supplement pathway
that was passed by the Congress.
And it's been in effect forabout 18 years right now.
During that time period, 800botanical supplement products
have been submitted for reviewby the FDA.
500 of them were able to get aninstitution drug application
(11:15):
review.
So the protocols for the studyto demonstrate their safety.
were met in that 15 or 18 yearperiod of 800 applications, 500
with a qualified protocol forthe study.
to have been approved.
That demonstrates the bias thatthe FDA has.
And it's time for Congress torein in the FDA in this area,
(11:35):
just as they did in 1994 whenthey passed the Dietary
Supplement Health and EducationAct, when they told the FDA, you
can't play this game withdietary supplements, you have to
regulate them appropriately.
And we're hopeful that the nowfederally filed Kratom Consumer
Protection Act will put thoseparameters on the FDA and
require them to do the job thatthey were intended to do.
(11:56):
But I'll tell you right now,when you hear the reports that
people say, Oh Kratom caused thedeath of a loved one or Kratom
caused this adverse event.
In every case that we've beenable to identify, it's always
been because it is anadulterated product or because
of poly drug use.
And Kratom was not the culpritin this situation, but the FDA
(12:18):
refuses to do their job, refusesto do their job to make sure
that happens.
And so you see the string oflawsuits.
that are filed by trialattorneys, which make Kratom the
culprit.
You don't see them filinglawsuits against the FDA for
their failure to regulateproducts.
You see them saying, Oh, we'regonna go after the creative
manufacturers because that'swhere the deep pocket is.
(12:40):
That's a complete A wrongfulaction by these trial attorneys,
but it's facilitated by the lackof FDA regulation that they
should be involved
James Egidio (12:49):
in.
And meanwhile, they're runningamuck releasing this bio weapon
that they call a vaccine andusing everybody under what I
call experimental useauthorization instead.
Emergency use authorization andpeople are dying left and right
and being injured and not doinga thing about it.
The attorneys are not doing athing about it.
So it seems like to me, thewhole system is rigged with this
(13:11):
whole thing is what it seemslike.
Mac Haddow (13:13):
It certainly is.
And in the case of the trialattorneys, a great example is
that there was a florida casewhere a woman ingested a Kratom
product that was marketedcalling.
It was called space dust.
It was marketed as a superpotent extract.
Of Kratom products the judgeawarded this family 11 and a
(13:34):
half million dollars.
Now, part of the reason he didso is that the manufacturer of
that product didn't show up inorder to defend themselves.
So we don't have a record thatshows us what the autopsy report
showed, or the tox screen.
We'd love to see that becausethat would be illuminate as to
what the actual productcontained.
We don't know if there was anadulterant in the creative
product, or we don't know ifthere was an underlying health
(13:56):
condition that contributed tothat death.
But what we do know is that theFDA refused to regulate a
product that they knew had beenon the market for a year called
space dust.
It came in a plastic pouch wheresomeone wrote with a sharpie
space dust.
And when you flip it over whereyou would expect to see
directions for use labeling thatshowed exactly how it was
(14:17):
manufactured and what thecontents of the product were.
It's blank.
How could that product have beenallowed to be on the marketplace
in the first place?
It was, but the trial attorneysaren't suing the FDA for their
malfeasance.
They're suing, they sued thecompany that did.
Now certainly, that companyshouldn't have been allowed to
market that product on themarket, but the FDA should have
(14:38):
done their job a year before andtaken it off the market.
James Egidio (14:41):
Yeah, and that's what's I'm showing right there
on the screen in that particulararticle where they mentioned
that was an NPR article thatjust broke, right?
Yeah.
And so I think it seems to metoo, that it's a product that's
(15:03):
Effective for what it is as anherbal supplement.
I see it they, I know theyadvertise it and they market it
in a lot of these smoke shops.
And it just seems like thatmaybe that's something that
needs to be changed as far asthe actual reputation of the
product or the marketing of theproduct.
(15:24):
Cause it's sold amongst.
In a lot of smoke shops, Inotice.
Mac Haddow (15:29):
Yeah.
So there's two reasons whythat's true.
First is that it was sold in GNCstores and on Amazon prior to
the FDA coming down hard, makingthe claim that Kratom was going
to be scheduled.
And that, that occurred in 2015and 2016.
So the marketplace shrunkbecause these retailers didn't
want the liability of the FDAcoming in and saying this was a
(15:52):
dangerous product and they wouldbe responsible for that.
So it got withdrawn from thetraditional retail channels.
Now it's been reintroduced intomany of those channels now, and
it continues to grow because therecord of safety for Kratom, if
it's not adulterated, if it'sproperly manufactured and
properly labeled, is actuallyvery good.
So what the FDA's.
Power over the marketplace ischanging.
(16:14):
But that promise in 2016 nevercame to fruition.
They tried.
They went to the DrugEnforcement Administration and
published a notice to scheduleKratom as a schedule one
substance using the emergencypower section.
of the Controlled SubstancesAct.
That was a devious tool becausethey knew they didn't have to
prove much to do that.
That section of the law isdesigned for those products that
(16:36):
are street drugs that areintroduced into the commerce and
they're causing deaths and theyimmediately have to remove them
from the marketplace.
Kratom had been on the marketfor years, since the early
seventies, they use that device,but the DEA in an unprecedented
action they'd never withdrawn ascheduling request like that
from the federal register.
They did in this case.
And they told the FDA, we'regoing to give you from October
(16:59):
13th of 2016 to December 1st toprove your case.
23, 326 people wrote in 99.
1 percent of them.
favored Kratom being allowed onthe marketplace.
147, 000 people signed apetition in the White House.
We the people website sayingdon't ban Kratom.
51 members of the House ofRepresentatives within a 20 day
(17:21):
period signed a letter and thatwas astounding.
Signed a letter to the DEAadministrator and said don't ban
it.
51 51 members, 26 Republicans,25 Democrats.
Very balanced.
13 members of the Senate did thesame thing.
And just to give you a flavor,November 27, 2018.
for the bipartisanship here.
You had on one hand, OrrinHatch, who at the time was one
of the most conservative membersof the United States Senate and
(17:43):
you had Bernie Sanders on theother end signing that letter.
Those are strange politicalbedfellows, except that this was
an issue where the FDAoverreached.
They went too far and they hadto get slapped down.
And that's what the DEA did.
They said we withdrew it.
The FDA never provided.
within that time frame, thedocumentation for the safety and
efficacy evidence that theyclaim proved that kratom
(18:05):
shouldn't be on the marketplace.
They did a year later.
And when they submitted that,they did it when there was an
acting assistant secretary forhealth, they snuck it through
and it was over at the DEA forconsideration when Dr.
Brett Shaw, was confirmed intothat position.
He is the responsible officialto look at new drug app.
I'm sorry, we look at thescheduling under the Controlled
(18:27):
Substance Act.
He reviewed the FDA'sdocumentation and he published a
scathing, unprecedented letterwhich essentially said the FDA
is wrong.
And he pointed out a road mapthat the FDA would have to meet.
Now, this is in 2016 on August16, 2016, I'm sorry, 2018.
(18:48):
He published this letter, gavethe FDA the road map for what
they have to do in order toprove their scientific evidence.
They haven't done a single thingsince then.
Now, when he was asked on aTwitter exchange with Dr.
Scott Gottlieb, the commissionerof the FDA at the time and
Gottlieb challenged his actuallynot banning kratom what Dr.
Juha said was fascinating.
(19:09):
He said, first off, the FDAdoesn't get to schedule, they
get to recommend.
He said, and your evidence anddata was embarrassingly poor
evidence and data and a failureto consider the overall public
health.
Think about that.
You have an independent arbiterevaluating what the FDA did.
The FDA took a third chance atthis.
They went to the UN Commissionon Narcotic Drugs.
(19:31):
They appealed to them to bankratom, much lower standard at
the international level forscheduling of substances.
But they knew that as a treatypartner, we would have, we'd be
obligated if the UN commissionagreed to schedule kratom
internationally.
We would have to follow suit.
They went and gave it their bestshot.
They threw the kitchen sink atit.
There are 12 independentscientists.
(19:52):
who populate a group called theexpert committee on drug
dependence.
They reviewed that.
They looked at all of theevidence and what they did is
they came back and said there isinsufficient evidence, even
though much lower standard forscheduling at the international
level, the FDA is wrong.
They've been smacked down byexperts.
And today you have the lonewolf.
(20:13):
in the federal government in theFDA trying to ban kratom.
And you have the NationalInstitutes on Drug Abuse, which
full throatedly supports peoplehaving access to kratom.
You have the U.
S.
Congress that in the last threeappropriations bills has
encouraged more research andopen access for kratom to the
american people.
The FDA is wrong.
They're isolated and they werejust as wrong on kratom as they
(20:33):
were on dietary supplements whenthey tried to ban them.
Yeah.
Back in 1994.
James Egidio (20:37):
Yeah.
I want to back up for a minutetoo because you mentioned
something very interesting aboutkratom as well.
Not only its effects on pain andgetting off opiates, but also
depression.
And I had just interviewed a fewdays ago, Dr.
Healy, who's an expert onantidepressants and the dangers
of antidepressants.
And I, in fact, just Two daysago, I interviewed Kim Witczak,
(21:00):
whose husband was commit suicideon antidepressants.
And then tomorrow I'minterviewing Dr.
Peter Breggin, who's an expertand was an expert witness for
some of the mass shootings thattook place at some of the
schools with the dangers ofantidepressants.
But you're talking about...
something that's safe andeffective.
And I was watching a video thatyou had mentioned with this
(21:24):
study with the United Nations,with Dr.
Jack Henningfield who had comeup with a lot of anecdotal
evidence, supporting, um, andcomparing kratom to opiates and
its safety and effect efficacy.
So where is the pushback comingfrom with the FDA and who are
(21:47):
the experts on their side thatare supporting this, or is this
just some kind of draconianacross the board, Kratom is
dangerous and we got to regulateit and that's it.
And that's all we know.
Is that what it is?
Mac Haddow (22:00):
Unfortunately, it's closer to the ladder here, where
you have a small group of peopleat the FDA who are not
scientists who just have a biasagainst botanical and dietary
supplements who have loopedKratom him into that bucket and
they want to pursue their effortbecause they think it will build
credibility for them on alldietary supplements, having to
be regulated or banned.
(22:20):
And that's unfortunate, but thetruth is they can't prove it by
the science.
And you referenced Dr.
Henningfield, there wasn't justanecdotal evidence when the
presentation was made.
to the U.
N.
Commission on Narcotic Drugs.
The expert committee on drugdependence.
You had Dr Jack Henningfield whodescribed to them the detailed
analysis and scientific researchthat had been done about kratom,
(22:43):
including on its addiction,liability and safety.
You also had former NIDAscientist, Dr.
Marilyn Eustace, who talkedabout the so called deaths
associated with kratom and shewent through her research that
shows that there's not a toxiclevel that has been identified
by the FDA or anyone else interms of what would cause a
death with kratom.
(23:04):
You also had Dr.
Kirsten Smith, who at the timewas a NIDA scientist.
and worked on Kratom whopresented data about studies
that they had done and anddescribed in fact, the not yet
published, but described howthere is an intoxication study,
a driving study on Kratom andthat it didn't intoxicate or
impair people in driving, whichgoes to the heart of the issue
(23:26):
that the FDA is pushing.
And finally, Dr.
Chris McCurdy made apresentation.
These are four of the leadingscientists in the world who
lined up against the FDA andsaid that they're wrong.
And of course, that goes back towhat Dr.
Joie said, when I spoke to Dr.
Joie after he made his decision,I thanked him, and he said you
need to understand that I am notan advocate for kratom, he said,
(23:48):
I don't know one way or theother, whether it's good or bad,
but I am an advocate for goodscience, he said, and it is an
obligation of the FDA.
to use good science to documentits regulatory decisions.
And in this case, the FDA hasfailed to do that.
They want to take their opinion,interpose it as though it being
the law of the land.
And they want to dictate to theAmerican people that they're
going to do it their way or thehighway.
(24:10):
And we think that the FDA iswrong.
And that's why we're fighting sohard to get the Kratom Consumer
Protection Act passed at thefederal level, mirroring what
we're doing in the States.
We've had 11 States that havepassed the state Kratom Consumer
Protection Act.
And that is all designed toprotect consumers.
Make sure products that areintroduced into the marketplace
are manufactured correctly, notadulterated, properly labeled
(24:31):
and restricted for kids.
And we think that's a model thatought to apply to all Kratom
products.
James Egidio (24:35):
Yeah.
And when you compare apples toapples It seems especially when
you start getting the DrugEnforcement Administration
involved in the game, uh, herewe are in 2023 and they're
relaxing the laws on medicalmarijuana and edibles.
And now they're talking aboutlegalizing or bring, rolling out
(24:57):
psilocybin.
You're talking about people thatare going to purchase these.
Products from say a dispensary,right?
And there's really no way tocontrol once you eat an edible
of THC to control yourfaculties, uh, based on how it's
(25:20):
released in the body.
Cause it's almost like a timerelease and you're sitting there
driving around intoxicated onTHC.
And it can really wipe somebodyout and they're worried about
Kratom, right?
Same thing with these vaccinesor these bioweapons that are
killing people and injuringpeople.
So they're not really focusingon what's good for the, what's
(25:40):
good for the person for the,that's purchasing these
products.
They're more concerned aboutpower.
and money.
It seems
Mac Haddow (25:51):
like I think that every decision that's made about
a product that has a potentialhealth benefit to the American
people has to be driven by goodscience again, not by the agenda
of a regulatory agency like theFDA that has a long standing
record of going too faroverregulating overreaching.
I don't have an opinion becauseI don't know enough about the
(26:13):
science on some of those othersubstances you referenced, but I
know for certain that the FDA istone deaf, blinded with their
zeal for regulations and banningkratom to not even look at the
data.
There was a study that was donethat looked at it's an animal
study, which is the goldstandard for dietary supplements
where they test against what'scalled the oxycodone protocol.
(26:36):
This is a safety study.
The FDA has developed a protocolto for any substance that wants
to prove that they are notunsafe, that they have to match
it against what they know arethe levels of oxycodone that
will cause and then fill in theblank as to what the adverse
events are.
When this study was done, theresearchers went and went to the
FDA and said, is there anythingthat we're missing on the
(26:58):
published oxycodone studyprotocol that we should include
in our research on kratom?
And the FDA actually made somerecommendations.
they thought they were poisonpills, right?
So they told them you should dothis and this in the end, the
scientists accepted that in thefirst tranche, there were three
tranches of this study.
They know that the first levelof oxycodone levels, they know
exactly what the outcomes are.
(27:19):
And predictably, that's whathappened for Kratom.
The director of the scientificresearch project came back to
the scientist and said, I'mgoing to do this, but you are
wasting your money because Ididn't even see a blip on the
signal safety signal at thatfirst tranche.
He said, you're going to see thesame thing because Kratom just
doesn't have this kind of powerin order to create a problem.
He said, I recommend.
(27:40):
that you let me boost the amountin the second tranche.
Now, if I were making that studyand I wanted an outcome that
hopefully was going to beobviously as good as the
scientists thought, I probablywouldn't have said okay.
But the scientists did becausethey were pursuing the truth
about it.
In the second tranche, whichthey boosted the metrogenin,
which is the alkaloid and kratomlevels to test its safety.
(28:00):
All of the oxycodone animals hadthe predictable reactions to
oxycodone and the kratom at theboosted level.
nothing.
And so the researcher came back,the head researcher and said,
look, you're going to think I'mcrazy, but you're going to see
nothing in Kratom because it'snot boosting any signal here.
So let me put as muchmetrogenin, the alkaloid in
(28:20):
kratom into an aqueous solutionthat I can inject into these
rats, these test rats, and let'ssee what happens there.
Now they boosted that level to400 times what any human could
consume in a day.
And so that's real problemshere, right?
So they did that.
And at the end of the day, Zippofor Kratom the they had some
(28:42):
sedation obviously at that highlevel, but they had the
oxycodone test animals eitherhad major seizures or deaths.
That was predictable.
That's what they know happens atthose levels of oxycodone.
The U S food and drugadministration, when they were
presented with that data, theyhad, as it was described to me,
a group of scientists in theroom and a group of policy
makers.
And when the scientists got thedata and reviewed it, they said
(29:05):
collectively, wow, this changesour perception about Kratom.
The policymaker said meetingover, this is the kind of blind
spot that the FDA has for goodscience.
They don't care about what thescience says.
They only care about theircrusade to ban Kratom, and
that's tragic, and that's whythe US Congress has to step in.
James Egidio (29:26):
Why do you think they're so hell bent on wanting
to ban Kratom?
Mac Haddow (29:30):
It's their first start in going after other
substances because if they canselectively pick out the
substances they want to ban,like kratom.
Then they know if they get a winunder their belts, they're
headed down the road for thenext thing that they want to go
after.
We see them doing probes intothe dietary supplement space now
and they start to pick outproducts and they select them
out and say, these are nowdangerous and so we're not gonna
(29:51):
let you have them on themarketplace anymore.
That's the game the FDA has nowtaken and they're very clever
about it because when they dothese regulatory actions, they
make sure that they don't go towhat's called Final agency
action.
They will put out an alert.
They will scare consumers andretail channels out of the
marketplace.
And then they control themarketplace that way.
(30:12):
That's tragic when it comes toKratom, I hear, and you made the
point earlier maybe we need toimprove the retail channel.
And I agree with that, butultimately.
Ultimately, Dr Jack Henningfieldmade a point that was powerful
in testifying before theLouisiana Legislature when he
was asked by one of thelegislators, Don't you think
it's a bad idea for Kratom to besold in gas station convenience
(30:32):
stores?
And I have not heard theresponse to that question from
Dr Henningfield before.
And he said, No, actually, Ithink it should, as long as it's
properly manufactured andproperly labeled, it ought to be
available in any outlet becausethere are people who are
struggling right now.
We're trying to maintain acuteand chronic pain management and
(30:53):
get off of opioids.
I don't care where they get it,as long as it's a properly
manufactured and properlylabeled product.
And if they don't have thestigma of having to go into a
doctor's office, they don't havethe stigma of trying to go to a
recovery center, and they don'thave the stigma or the financial
resources to take advantage ofthose kinds of treatment
options.
Dr.
Hegel said, I think we need tomake this available.
And I thought that was a prettyastounding point because I
(31:14):
would've agreed and said, yeah,let's get it outta there and
let's put it in thesetraditional, very high-end
retail establishments.
But I, he persuaded me and Ithink that's the right policy as
long as we regulate it so thatit's manufactured properly and
label properly.
James Egidio (31:27):
Yeah.
When I was in the nutritionalsupplement industry, back in the
early 90s, I was doingformulation and design of
products, specialty products.
I remember we were going throughthis scrutiny.
I mentioned this to you offlinewith the industry itself.
And there was a product manyyears ago, back in the early
90s, they were really goingafter the FDA.
(31:48):
And I remembered back then TheFDA was pretty much regulated up
with one desk.
You'd act, you'd actually callthe FDA back then.
You couldn't even reach them.
There weren't, they were sounder unmanned.
It was like a couple of peopleworking for him to regulate that
particular industry.
And there was a product inparticular called ma huang.
It was a Chinese herb whichacted like a Broncodilator and
(32:11):
almost like an ephedrine or atype of stimulant, and they went
after that product.
because it was causing a lot oftachycardia and issues like
that.
But it wasn't even there.
They didn't even stop there.
They were looking to regulatepretty much most products across
the board in the early ninetiesand into the mid nineties.
(32:33):
So there was a lot of back andforth with manufacturers and
marketers of supplements backthen.
I remember that.
Mac Haddow (32:41):
Yeah, in fact, when the F.D.A.
Did that the consumer populationand dietary supplement industry
rose up.
They had over 300, 000 phonecalls that went into the U.
S.
Congress to the white into theCapitol building.
They actually shut down thephone system, so they had to
rebuild and redesign the phonesystem so that today they can
(33:03):
handle that volume of calls.
This is before emails.
There were 900,000 letters thatwere sent.
Now, the result of that you havethe FDA out there saying we have
got to ban all dietarysupplements.
They were unabashed about it.
They built their record over twodecades to get that decision and
the U.
S.
Congress on a unanimous votepassed the DeShay Act, telling
(33:24):
the FDA, no, you're going toregulate them appropriately.
And now is it the perfect pieceof legislation?
No but it was done in order torein in the FDA.
I wish we could, without openingup Pandora's box, go back in and
say.
We made a few mistakes.
We need to tweak this a littlebit, but the FDA would come in
hard and try to ban the dietarysupplements and botanical
supplements.
So we have to live with whatwe've got, but it's far better
(33:46):
than the alternative where theFDA gets to unilaterally make
these decisions to ban productsbecause they don't like them.
It's their regulatory agendathat's the problem.
James Egidio (33:54):
Yeah.
Yeah.
And I know the thing is, andyou're right it's a very
delicate balance in thisindustry too, because CGMPs good
manufacturing practice,certificates of good
manufacturing practice have tobe implemented for
manufacturers, because I do knowfrom being on the manufacturing
(34:15):
and the marketing side ofnutritional supplements, that a
lot of these supplements arewhat they call adulterated.
Yeah.
I know in the market with a lotof herbs that get imported from
Asia and whatnot, and very goodherbs that are very potent and
very effective get adulteratedto where they take the active
(34:37):
ingredient out of the herb inorder to make the tinctures,
which are more concentrated thatcan be sold for a higher cost on
the market and then they'll takethe herb that where they took
the active ingredient out andmake the capsules out of it
Right or and there's noregulation with that.
Okay, or what they did with alot of the products for erectile
(35:00):
dysfunction the naturalsupplements recently in the last
i'd say 10 years Is they wouldsell let's say a supplement on
the market for erectiledysfunction, a natural herbal
supplement, and then they wouldput some sildenafil citrate in
it, right?
Which is the active ingredientin Viagra.
(35:22):
And the FDA got ahold of some ofthose products.
So that's what they're concernedabout.
I know you mentioned too, wheresome of the, these products,
Kratom products were taintedwith.
What was it?
Some kind of active ingredient.
That was similar to whatTramadol, I believe, or
something like
Mac Haddow (35:39):
that.
Yeah.
These were nine deaths thatoccurred in Sweden.
Yeah.
And in 2011 and all of thoseproducts and the FDA, by the
way, uses those deaths asexamples of a Kratom death, but
all of those deaths, but in apeer reviewed published article
examining the tox screens andthe autopsies revealed that they
(35:59):
were adulterated withOdemethyltramadol.
which is the chemical that'sused in the production of the
opioid tramadol at a toxiclevel.
It wasn't the kratom.
It was this adulterant.
So that's the problem.
And the FDA doesn't care aboutthe facts.
They continue to tell that thereare 44 deaths, the nine that I
just referenced.
I'll give you an example.
We, we FOIA'd FreedomInformation Act request to the
(36:21):
FDA.
They gave us on all 44.
They claim they gave all of themto us except one.
Okay.
They said that one was protectedby HIPAA restriction by the
family.
That's the Privacy Act.
So we couldn't argue with that.
We had an independent forensicstoxicologist review all of the
43, and she came back and saidit was shockingly disappointing
work by the FDA.
They didn't do any duediligence, and that none of
(36:43):
those deaths could be attributedto Kratom itself.
Shortly thereafter, I got a callfrom a reporter from Huffington
Post, and he said you know thatone death they claim is
protected by HIPAA?
He said I have a copy of theautopsy and It's not protected
in any way and I was working Iwas working on a different story
and I asked for an autopsy for adifferent story and I got it
just withheld it because theydidn't want you to see it.
(37:04):
I said, why?
Because the kid died of twogunshot wounds to the chest.
It involved apparently a drugsting where the informant was
ordered out of the car by thepolice along with the seller.
They were, I think the kid wasselling marijuana and the kid,
the informant jumped out, butthe seller did not and he was
(37:26):
ordered out of the car.
He reached for what the policethought was a weapon and they
shot him.
He died of two gunshot wounds tothe chest and that's what's on
the autopsy.
It just shows that earlier inthe day he had drunk a kratom
tea and he had four or fiveother toxic drugs in his system
illegal drugs, right?
He died of two gunshot wounds tothe chest and yet the FDA with a
straight face will say That's akratom death.
(37:47):
These people are off the railsand they don't have any
accountability because they getaway with it.
They think when it says it, thatit must be right.
And you and I have been in thissphere long enough to know that
the FDA ain't always right.
And the FDA will frequently saythings that are blatantly not
true in order to achieve aregulatory agenda that they want
to accomplish.
James Egidio (38:08):
Yeah.
Yeah.
And it's interesting.
It sounds eerily familiar to Dr.
Scott Jensen, who I interviewedseveral months ago about the
whole thing with COVID wherehe's a he's out of Minnesota.
He's been a physician there,2016 family physician of the
year, and he was instructed bythe hospital that he worked at
(38:28):
to report COVID deaths, nomatter whether it was COVID or
not.
And he blew the whistle.
And they were looking to takeaway his license for that, so
it's a coverup and that, thatwas going to be one of my next
questions is that when you lookat some of the suspected deaths
from Kratom or may have beencaused by Kratom, what are some
(38:50):
of the things that need to betaken into consideration that
may have been overlooked?
Mac Haddow (38:55):
So the first thing is that there's never been a
toxic level of metronidine orany of the other alkaloids in
the natural plant or it's.
metabolites that's beenidentified as toxic.
So any death that is reported bya medical examiner who typically
just follow the FDA, there's ametrogeny intoxication needs to
be examined.
(39:17):
Excuse me.
So we need to do that.
So we look at those deaths.
We've collected every publiclyavailable autopsy intoxicant
report On these deaths.
And what we're finding is thatnone of them are caused by
Kratom alone.
They're always polydrug use, orthere are other underlying
health factors that cause thedeath.
We think, the investigationsneed to be made.
(39:38):
These are tragic circumstancesfor families that lose a loved
one to an overdose or to someother unknown event.
And they like to blame Kratombecause the trial attorneys are
encouraging it, right?
They wanna collect these.
cases that they can go and suethe child attorneys aren't suing
the FDA for failure to regulate.
They're suing the manufacturers.
And first off, I thinkmanufacturers should act
(40:01):
responsibly.
They should meet the standards,even if the FDA doesn't require
it right now.
They don't.
They should meet FDArequirements for GMP regulations
and they should label theirproducts absolutely.
And anybody that doesn't,they're at risk in the
marketplace and they should bepenalized.
And while my heart goes out tofamilies that have lost family
members, finding a trialattorney dragging them into
this.
This quagmire of saying, oh,this was a Kratom death with the
(40:24):
flimsiest of evidence.
And I say Flimsiest, and itmakes no sense to us.
We had a call from a from acoroner in the state of Idaho
who volunteered to us that hehad a death.
That he had reported on of ayoung man.
It was in, in Bannock County,Idaho.
And the young man had gone intoa bar, had become intoxicated,
had he had weed and othersubstance in his system,
(40:46):
including kratom by the way.
He had drunk a Kratom tea, verylow level Kratom had walked out
drunk into the middle of winter.
tripped and fell into a ditchand passed out, and he died of
hypothermia.
Now, when the tox screen waspublished, it showed among these
other substances, a very highalcohol content level in his
blood showed the othersubstances that he was obviously
taking, and it showed kratom ina very low level.
(41:09):
He said the FDA called him upand said, we need you to change
the cause of death tomitragynine intoxication.
He said, why would I do that?
It had nothing to do with thedeath.
Yes, but Mitragynine showed upon the tox screen and we need to
highlight Kratom deaths.
He said, I'm not gonna do that.
They said we want to talk toyour superior.
He said, I'm the duly electedcoroner in Bannon County, Idaho.
(41:32):
I am the superior.
I'm not doing it.
They said we're gonna report youthen to the Medical Examiner's
Association of Idaho.
He said, Hey, hang on.
I'll get the director on thephone.
It's not a problem.
He put them on hold, tried toconnect them.
We went back, the FDA hung up.
This is their game.
These people have no businesstrying to put their thumb on the
scale and tip the scales againstKratom.
(41:54):
They have no business doingthat, but that's the only way
they can make their case.
And that's really unfortunate.
James Egidio (41:58):
It is.
I remember there was a time whenwe were doing we were getting
patients off of opiates with theuse of suboxone.
And when we would have a patientcome in and we would screen the
patient, they were on multiplemedications that they were being
prescribed, or they were usingheroin to get on the suboxone.
(42:19):
So they, they were polypharmacy,they were using Xanax, they were
using heroin.
It's just, it's a multitude ofmedications that they're using.
But I can remember back then wewould even go as far as saying,
Hey, look, what even worksbetter than that is the Suboxone
is the Kratom.
(42:40):
And they were getting such greatresults from Kratom as opposed
to suboxone.
And they were even getting offthe heroin.
With the use of Kratom,
Mac Haddow (42:52):
yeah, you've highlighted one of the problems
in our dealing with theseaddiction liability and trying
to find a better space.
We substitute.
One addiction for another andand that's unfortunate because
suboxone is a product.
It is has its own downsides Itdoes toxic and I think that
should be our goal we shouldfind what's best for the
(43:12):
individual the best treatmentprotocol for them as they
struggle through this andCertainly do not lock the door
on something that could helpthem that just because the FDA
doesn't like it And I thinkthat's why night is so
supportive of us as we goforward here.
This has been to my mind one ofthe biggest challenges we have
in the healthcare space.
As you look at the opioidaddiction crisis, when you have
(43:33):
a product that can help, that'sa lifeline, we should use it.
And Dr.
Nora Volko of the the NationalInstitute on Drug Abuse agrees.
Why is GFK the outlier?
James Egidio (43:45):
I want to share with the listeners and viewers
of the Medical Truth Podcast acouple videos of some of the
people who have benefited fromKratom through your
organization.
Video (43:58):
The pain was just so bad that I couldn't work.
I couldn't even get out of bedon certain days.
I love to travel.
I love to be around mygrandkids.
I love to hike.
All the things that I loved todo in my life, I couldn't do
anymore because of the pain.
The doctors wanted to put me onsynthetic medications.
I started off two every fourhours and then within a month I
(44:19):
tripled that because they justquit working.
I'm trained to think thepharmaceuticals are the only way
to go.
And when I was introduced toKratom I didn't think that it
was going to work because it'sjust a plant.
But then I tried Kratom.
And I literally sat and cried inmy car because for the first
time in years, I didn't feelpain.
(44:41):
I was able to think clearly,this stuff is amazing.
I have not felt this level ofcalm and this level of being
pain free in years.
Having this all natural planthas literally given me my life
back.
I can live.
So I want to I can be thatmedical professional that I need
to be and I can work with aclear head and I can work at the
(45:04):
level I need to because I'm nolonger in pain without this
plant.
I honestly don't think I wouldbe here.
I would tell the legislators.
Please listen to us.
This plant is saving lives forthose of us with chronic pain.
It's giving these people backtheir lifestyle that they had
before they got sick.
Go to ProtectKratom.
(45:24):
org to send a message to yourelected official about Kratom.
I have severe pain in my lowerback.
And there's times when if I didnot have the pain medication, I
would want to put a gun to myhead.
Doctors will tell you, you'regoing to be on pain medication
for the rest of your life.
But it's just not sustainable.
You start building up atolerance.
(45:46):
You need more to relieve morepain.
You just keep moving up andyou're still in pain.
As a scientist, I just didn'tthink it was going to work.
And it was just a plant.
Just a ground up leaf and I waslike, this is not going to be
able to take away my pain.
Because I was on such a highdose of morphine at the time.
(46:07):
And when I took it, it did.
It blew my mind.
I couldn't believe that theKratom actually worked.
With Kratom, my quality of lifeis like I was a 20 year old
without any back problems atall.
Things that I enjoy, like goingout hiking with my dogs, going
RVing across country, I couldn'tdo that on pain medicine.
And with Kratom, it totally gaveme back my life.
(46:30):
I love Kratom because it's aplant, it's all natural, and
it's taking away my pain.
It is a miracle.
It's pretty awesome.
Kratom saves lives.
Contact your elected officials.
Help protect Kratom in Colorado.
Worked 13 years in lawenforcement from corrections
officer to police officer.
I was attached to a gang taskforce for the state of Missouri.
(46:52):
I was going to interview twogang members in a jail.
I was attacked by an inmate witha knife for three minutes and I
was basically left to die.
It just compacted in my mind.
And I was having panic attacks.
I was puking in a trash canbefore I went to work every day.
It was said at that point that Iwas unemployable.
(47:14):
I was just in an absolute pit ofdespair.
I was diagnosed with posttraumatic stress disorder and
major depression.
I gave my life to lawenforcement and when that was
taken away from me, I was just,I was totally devastated.
I saw a therapist.
I saw Different doctors, I tookprescriptions and nothing helped
until I found Kratom.
(47:35):
It has been an absolute lifechanger for me.
I'm able to get out of bed inthe morning.
I'm motivated, I have energy,and I feel normal.
I wasn't stony or in a fog.
I'm a law enforcement officer.
I do not want to take drugs ornarcotics.
Kratom is a plant.
It's related to coffee.
I feel like my life's purpose isback and I have a lot of
(47:58):
interest and still helpingpeople.
So I started an armed securityagency and it's been doing
extremely well.
We are keeping the criticalinfrastructure of a town that
was drastically affected bycategory one.
FEMA disaster.
I'm able to help people and I'mable to contribute to society
and create them, help make thatpossible.
If they did take this away, youwere going to affect 5 million
(48:22):
people across the country, justlike me, that are in
Professional careers that aregoing to have no other options.
Kratom saves lives and it helpedme get my life back, which
allowed me to overcome posttraumatic stress so that I can
come out here and perform myduties efficiently and
effectively.
Legislators, please protectpure, safe Kratom.
(48:43):
Go to protectkratom.
org to send a message to yourelected official about Kratom.
James Egidio (48:48):
There we go.
I
Mac Haddow (48:49):
can't say any better than that.
That was fabulous.
James Egidio (48:53):
We have to keep this stuff out of the hands of
the government as far asregulation is concerned.
It's so important.
And, it's so interesting aboutthat is that when you look at
these are functioning people,these are real people.
Real careers that are have, I'msure are married and have
(49:14):
families.
And when they're going throughthat chronic pain, it affects
the marriage, it affectseverything, it affects your
entire life, it affects yoursleep cycle, everything.
Mac Haddow (49:26):
No question about it.
And I think that the time hascome for everyone.
Whether you take creative or notreally isn't the issue.
If you love freedom, if you knowthat the FDA shouldn't be
allowed to arbitrarily issuethese kinds of edicts without
good science behind it, thenit's time to stand up and say
enough.
And that's why we're askingeveryone to join us in the
federal creative ConsumerProtection Act and in the states
(49:49):
where you're KCPA hasn't passedyet.
We need to help.
So we and I appreciate your timehere, James, letting me come on
and talk about this very
James Egidio (49:55):
much.
Absolutely.
And I'll continue.
And I want you to keep usupdated listeners and viewers.
I'm going to also be posting alot of information, content, and
I'd like to have you come backon the show.
Maybe we could even get DrHenningfield back on and we can
talk about the physiologicaleffects of the of the, of kratom
and go from there.
(50:16):
Thank you.
Great idea.
We can help facilitate thatthing.
I'm here to support you on allthis.
And again, your website is goahead.
Mac Haddow (50:23):
It's a www.KratomAnswers.Org.
www.ProtectKratom.org andwww.AmericanKratom.Org.
Yeah.
All of the
James Egidio (50:31):
resources and I'll post all those links on the free
resources page of the medicaltruth podcast.
But I really appreciate yourtime Mac for coming on to the
medical truth podcast.
Thank you so much.
Mac Haddow (50:43):
We're grateful
James Egidio (50:43):
as well.
Thank you.
Thank you, sir.
Have a good night.
Thanks.
All right.
Thanks for listening to theMedical Truth Podcast.
For the latest episodes, go towww.
medicaltruthpodcast.
com.
You can also find the MedicalTruth Podcast on Rumble, as well
as all the major podcastplatforms like Apple Podcasts,
(51:06):
Spotify, Stitcher, and iHeart.
Get ready to hear the truth, the whole truth, and
nothing but the truth about theUnited States healthcare system
with your host of the medicaltruth podcast, James Egidio.
James Egidio (00:20):
Hi, I'm James Your host of the medical truth
podcast, the podcast that tellsthe truth.
The whole truth and nothing butthe truth about the American
healthcare system.
The number of drug overdosedeaths involving prescription
opioids in 2021 was nearly fivetimes the number in 1999.
In 2021 45 people died each dayfrom a prescription opioid
(00:43):
overdose.
Totaling 17,000 deaths.
That does not include well overa hundred thousand deaths.
In 2021 from heroin and fentanylpouring into the United States
due to open borders from thesouth of Mexico.
My guest has been involved ingovernment relations activities
since 1986 when he left as chiefof staff at the U S department
(01:06):
of health.
And human services to go to theprivate sector.
Today he is a lobbyist andadvocate in Washington, DC.
Where, he is fighting hard tokeep the natural herbal
supplement, Kratom them legaland accessible for consumers and
patients who are suffering fromchronic pain and addiction to
opiates.
(01:26):
It is an honor and a pleasure tohave on the medical truth
podcast.
My guest, Mr.
Mack Haddow.
Mac, how are you doing today?
Welcome to the medical truthpodcast.
Appreciate it.
For the listeners and viewers ofthe medical truth podcast, just
share a little bit about who youare and what you do.
Mac Haddow (01:47):
So my name is Mac Haddow.
I'm the senior fellow on publicpolicy with the American Kratom
Association.
And we're a consumer advocacyorganization that fights to make
sure that quality andmanufactured products are
allowed to be on the marketplacewithout undue restrictions.
James Egidio (02:04):
Nice.
So I know it's specifically forKratom and for the listeners and
viewers, cause we're asconsumers of, let's say,
nutritional supplement products.
A lot of people are.
inundated with so many differentproducts.
what is kratom?
Mac Haddow (02:22):
So kratom is a plant that grows in Southeast Asia
ubiquitously because of climateand soil conditions.
It has recently been introducedinto the United States.
It's grown in some parts ofFlorida and in Hawaii.
The majority of the Kratomoriginates in Indonesia and in
Thailand, about 97 percent ofthe raw materials that are used
(02:43):
in the production of Kraatomproducts originates there.
It is a plant that has forcenturies has been had some
medicinal effects.
People recognize that when theyare working out in the fields,
they chew on a Kratom leaf andit gives them an energy boost
and increased focus.
Traditionally, people will brewit into a tea.
and they'll drink it.
It has a bitter taste.
(03:03):
And so you have to acquire thetaste.
That's principally one oflimitations on why kids don't
like it because it doesn't tastegreat.
And it also has some, it hitsthe same Mu opioid receptors in
the brain as do opioids, forexample.
But it's what's called a partialagonist, which means that it
doesn't have the same effectsnor as powerful in effect, just
(03:24):
hits the same receptor and hearlots of critics, including the
FDA, will say, oh, it hits thesame Mu opioid receptor.
The truth is, and they know it,that things like cheese hit the
same Mu opioid receptors and aton of other products but gets
up.
its effects by going to thesector of the brain that helps
with analgesia, with painrelief.
It also helps with symptoms ofdepression.
(03:46):
It boosts your mood a littlebit.
And so those are things thatmake it very attractive.
And at high doses, people arefinding it to be an effective
option for managing acute andchronic pain and for some that
are struggling with opioidaddictions.
They report that it helped themwith withdrawing from the
opioids and replacing withkratom.
There's a study done by JohnsHopkins University that
(04:07):
documented that.
So there's a, it's one of themedicinal plants that has great,
powerful benefits.
And traditionally, as we've seenin the dietary supplement and
botanical supplement industry inthe United States, The FDA hates
it.
They want to have a control ofit.
They want to ban it.
They want to make sure that theonly access people have is
through a prescriptionmedication.
(04:28):
And of course, that's not theway nature intended it.
It's not the way that we oughtto regulate these kinds of
products.
But nonetheless, the FDAmaintains its very strong anti
kratom position to this day.
James Egidio (04:38):
Yeah, and you mentioned some of the benefits
and I know I had pulled up ainfographic on the use of Kratom
and we're looking at some ofthese here.
As you had mentioned that the,there are a lot of benefits for
pain and for opiate use.
So what you're saying in essenceis that it's got almost like a
(04:59):
dual effect of the pain to wardoff some of the pain or pain,
chronic pain, as well as Beingused maybe as a substitute for
patients that are addicted toopiates or people that are
addicted to opiates,
Mac Haddow (05:13):
correct?
That's correct.
And this particular survey ofadult kratom users was done by
Johns Hopkins University.
It has great data that supportsthe notion for those who are
experiencing these addictions tovery dangerous, highly addictive
and potentially deadly opioidsthat 84 percent I'm sorry, the
(05:33):
87 percent reported that theygot relief from withdrawal
symptoms, which is the hardestpart.
of getting off of an opioid thatyou're addicted to, and 35
percent reported they were freefrom the opioids within a year,
replacing with kratom.
Now that's important because theNational Institutes on Drug
Abuse, which is one of theleading research organizations
(05:53):
in the U.
S.
government, is a strongproponent Of Kratom as a
potential harm reduction tooland they maintain that Kratom
should be available to peoplethat are struggling with these
addictions.
And again, it's about the dose,the amount of serving size you
take of Kratom you probably haveto take more in order to achieve
this particular result.
Most people use it in much lowerserving sizes for that energy
(06:16):
boost.
They pick me up in the morningfor the staving off feelings of
anxiety at a little higher doseand that and feelings of
depression.
So it is really a wonderfulplant that if it's properly
manufactured and labeledappropriately, really does help
people.
Yeah,
James Egidio (06:32):
it's interesting as you're saying this, I'm
thinking to myself why would theFDA?
Get themselves involved withwanting to regulate a natural
herbal supplement such as kratomwhen and especially for pain or
to help people get off ofopiates when we have, uh, an
(06:54):
issue with prescriptionmedications, fentanyl and,
heroin that's coming across ouropen borders.
Mac Haddow (07:02):
Yeah, there are two answers to that question.
First is it's the 64,000question that NIDA asks in the
midst of this crisis we have inAmerica with overdose deaths
that topped 107, 000 last year.
If there's a harm reduction toolavailable, why wouldn't we
encourage its use rather thantrying to ban it?
But the second of the answers isthe one that is probably more
(07:25):
appropriate to discussing whythe FDA takes this position.
The FDA has been an opponent ofdietary and botanical
supplements for decades.
We all remember back in theearly nineties, leading up to
the passage of what was known asthe Dietary Supplement Health
and Education Act, the FDA wastrying to ban all dietary
supplements and vitamins on thepremise that there were products
(07:47):
that were poorly formulated inthe dietary supplement space
that were causing adverse eventsand in some cases deaths.
They were right.
But the solution wasn't to banit.
It is to properly regulate it.
Make sure that those productsare meeting good manufacturing
standards, that they'reformulated with safe ingredients
and not being adulterated inorder to spike the effects of a
(08:08):
product with dangeroussubstances.
That's the solution.
But the FDA always goes to theposition that they want to
regulate it as new drugs.
And if that were true, If theFDA had gotten their way back in
1994, when instead the Congresspassed the DeShay Act, they
would have banned all thesedietary supplements that are
today over a 100 billionindustry.
(08:30):
And more than 80 percent of theAmerican people use dietary
supplements and botanicalsupplements for their health and
wellbeing.
The FDA just has their heads inthe sand.
They, this isn't a battleagainst kratom.
This is a battle that they havesustained over four decades
fighting all botanical anddietary supplements.
Because they just don't likethem and they would rather they
were regulated as new drugs.
James Egidio (08:51):
Yeah, and it sounds like they want to get to
a point where they control itand corner the market in
addition to, let's say, theopiate market that they already
control.
So it sounds like it's just, itsounds like it's more about
control, power and money that'sinvolved then the wellbeing of
the person that's using itresponsibly, because it seems
(09:13):
like anything you can gooverboard with.
You can drink too much coffee.
You can eat too much.
If you had to put a label onfast food McDonald's, you'd have
to ban it, for health reasons.
Mac Haddow (09:25):
exactly right.
And it's interesting, James youbring up a great point because
right now this penchant that theFDA has, in order to put
everything into that bucket ofbeing a prescription medication
and requiring them to go throughthat five to$10 billion.
exercise to prove the safety andefficacy of these kind of
products is a huge lift.
(09:45):
And most dietary supplement andbotanical supplement companies
wouldn't be in the business.
They just are hell bent thatthey're going to make sure that
they control this particularspace.
And they don't.
And it was interesting.
I had a conversation with an FDAofficial.
They won't meet with me here inthe United States, but I was
actually at the U.N..
Commission on Narcotic Drugs inVienna, Austria, and had the
(10:06):
opportunity to meet in an offthe record discussion with an
FDA official who told me thatmost of the people at the FDA
that are comprised of thescientific group that, that
really govern policy, understandthat kratom is probably a
benign, no big deal, but whatthey don't like is that people
are sitting at home selfmedicating themselves with
(10:29):
kratom when they think thatperson for whatever the reason
that person self medicatethemselves should be going to a
doctor.
Now that's an interestingdiscussion, but it strips people
of their freedom.
It strips people of their rightto make the kinds of decisions
about their health and wellbeingand who gave the FDA the power
to make that kind of decision asopposed to simply regulating
products that are presented intothe marketplace to evaluate.
(10:51):
based on their safety andefficacy.
But we know the FDA is notinterested in that because there
is a pathway for what thebotanical supplement pathway
that was passed by the Congress.
And it's been in effect forabout 18 years right now.
During that time period, 800botanical supplement products
have been submitted for reviewby the FDA.
500 of them were able to get aninstitution drug application
(11:15):
review.
So the protocols for the studyto demonstrate their safety.
were met in that 15 or 18 yearperiod of 800 applications, 500
with a qualified protocol forthe study.
to have been approved.
That demonstrates the bias thatthe FDA has.
And it's time for Congress torein in the FDA in this area,
(11:35):
just as they did in 1994 whenthey passed the Dietary
Supplement Health and EducationAct, when they told the FDA, you
can't play this game withdietary supplements, you have to
regulate them appropriately.
And we're hopeful that the nowfederally filed Kratom Consumer
Protection Act will put thoseparameters on the FDA and
require them to do the job thatthey were intended to do.
(11:56):
But I'll tell you right now,when you hear the reports that
people say, Oh Kratom caused thedeath of a loved one or Kratom
caused this adverse event.
In every case that we've beenable to identify, it's always
been because it is anadulterated product or because
of poly drug use.
And Kratom was not the culpritin this situation, but the FDA
(12:18):
refuses to do their job, refusesto do their job to make sure
that happens.
And so you see the string oflawsuits.
that are filed by trialattorneys, which make Kratom the
culprit.
You don't see them filinglawsuits against the FDA for
their failure to regulateproducts.
You see them saying, Oh, we'regonna go after the creative
manufacturers because that'swhere the deep pocket is.
(12:40):
That's a complete A wrongfulaction by these trial attorneys,
but it's facilitated by the lackof FDA regulation that they
should be involved
James Egidio (12:49):
in.
And meanwhile, they're runningamuck releasing this bio weapon
that they call a vaccine andusing everybody under what I
call experimental useauthorization instead.
Emergency use authorization andpeople are dying left and right
and being injured and not doinga thing about it.
The attorneys are not doing athing about it.
So it seems like to me, thewhole system is rigged with this
(13:11):
whole thing is what it seemslike.
Mac Haddow (13:13):
It certainly is.
And in the case of the trialattorneys, a great example is
that there was a florida casewhere a woman ingested a Kratom
product that was marketedcalling.
It was called space dust.
It was marketed as a superpotent extract.
Of Kratom products the judgeawarded this family 11 and a
(13:34):
half million dollars.
Now, part of the reason he didso is that the manufacturer of
that product didn't show up inorder to defend themselves.
So we don't have a record thatshows us what the autopsy report
showed, or the tox screen.
We'd love to see that becausethat would be illuminate as to
what the actual productcontained.
We don't know if there was anadulterant in the creative
product, or we don't know ifthere was an underlying health
(13:56):
condition that contributed tothat death.
But what we do know is that theFDA refused to regulate a
product that they knew had beenon the market for a year called
space dust.
It came in a plastic pouch wheresomeone wrote with a sharpie
space dust.
And when you flip it over whereyou would expect to see
directions for use labeling thatshowed exactly how it was
(14:17):
manufactured and what thecontents of the product were.
It's blank.
How could that product have beenallowed to be on the marketplace
in the first place?
It was, but the trial attorneysaren't suing the FDA for their
malfeasance.
They're suing, they sued thecompany that did.
Now certainly, that companyshouldn't have been allowed to
market that product on themarket, but the FDA should have
(14:38):
done their job a year before andtaken it off the market.
James Egidio (14:41):
Yeah, and that's what's I'm showing right there
on the screen in that particulararticle where they mentioned
that was an NPR article thatjust broke, right?
Yeah.
And so I think it seems to metoo, that it's a product that's
(15:03):
Effective for what it is as anherbal supplement.
I see it they, I know theyadvertise it and they market it
in a lot of these smoke shops.
And it just seems like thatmaybe that's something that
needs to be changed as far asthe actual reputation of the
product or the marketing of theproduct.
(15:24):
Cause it's sold amongst.
In a lot of smoke shops, Inotice.
Mac Haddow (15:29):
Yeah.
So there's two reasons whythat's true.
First is that it was sold in GNCstores and on Amazon prior to
the FDA coming down hard, makingthe claim that Kratom was going
to be scheduled.
And that, that occurred in 2015and 2016.
So the marketplace shrunkbecause these retailers didn't
want the liability of the FDAcoming in and saying this was a
(15:52):
dangerous product and they wouldbe responsible for that.
So it got withdrawn from thetraditional retail channels.
Now it's been reintroduced intomany of those channels now, and
it continues to grow because therecord of safety for Kratom, if
it's not adulterated, if it'sproperly manufactured and
properly labeled, is actuallyvery good.
So what the FDA's.
Power over the marketplace ischanging.
(16:14):
But that promise in 2016 nevercame to fruition.
They tried.
They went to the DrugEnforcement Administration and
published a notice to scheduleKratom as a schedule one
substance using the emergencypower section.
of the Controlled SubstancesAct.
That was a devious tool becausethey knew they didn't have to
prove much to do that.
That section of the law isdesigned for those products that
(16:36):
are street drugs that areintroduced into the commerce and
they're causing deaths and theyimmediately have to remove them
from the marketplace.
Kratom had been on the marketfor years, since the early
seventies, they use that device,but the DEA in an unprecedented
action they'd never withdrawn ascheduling request like that
from the federal register.
They did in this case.
And they told the FDA, we'regoing to give you from October
(16:59):
13th of 2016 to December 1st toprove your case.
23, 326 people wrote in 99.
1 percent of them.
favored Kratom being allowed onthe marketplace.
147, 000 people signed apetition in the White House.
We the people website sayingdon't ban Kratom.
51 members of the House ofRepresentatives within a 20 day
(17:21):
period signed a letter and thatwas astounding.
Signed a letter to the DEAadministrator and said don't ban
it.
51 51 members, 26 Republicans,25 Democrats.
Very balanced.
13 members of the Senate did thesame thing.
And just to give you a flavor,November 27, 2018.
for the bipartisanship here.
You had on one hand, OrrinHatch, who at the time was one
of the most conservative membersof the United States Senate and
(17:43):
you had Bernie Sanders on theother end signing that letter.
Those are strange politicalbedfellows, except that this was
an issue where the FDAoverreached.
They went too far and they hadto get slapped down.
And that's what the DEA did.
They said we withdrew it.
The FDA never provided.
within that time frame, thedocumentation for the safety and
efficacy evidence that theyclaim proved that kratom
(18:05):
shouldn't be on the marketplace.
They did a year later.
And when they submitted that,they did it when there was an
acting assistant secretary forhealth, they snuck it through
and it was over at the DEA forconsideration when Dr.
Brett Shaw, was confirmed intothat position.
He is the responsible officialto look at new drug app.
I'm sorry, we look at thescheduling under the Controlled
(18:27):
Substance Act.
He reviewed the FDA'sdocumentation and he published a
scathing, unprecedented letterwhich essentially said the FDA
is wrong.
And he pointed out a road mapthat the FDA would have to meet.
Now, this is in 2016 on August16, 2016, I'm sorry, 2018.
(18:48):
He published this letter, gavethe FDA the road map for what
they have to do in order toprove their scientific evidence.
They haven't done a single thingsince then.
Now, when he was asked on aTwitter exchange with Dr.
Scott Gottlieb, the commissionerof the FDA at the time and
Gottlieb challenged his actuallynot banning kratom what Dr.
Juha said was fascinating.
(19:09):
He said, first off, the FDAdoesn't get to schedule, they
get to recommend.
He said, and your evidence anddata was embarrassingly poor
evidence and data and a failureto consider the overall public
health.
Think about that.
You have an independent arbiterevaluating what the FDA did.
The FDA took a third chance atthis.
They went to the UN Commissionon Narcotic Drugs.
(19:31):
They appealed to them to bankratom, much lower standard at
the international level forscheduling of substances.
But they knew that as a treatypartner, we would have, we'd be
obligated if the UN commissionagreed to schedule kratom
internationally.
We would have to follow suit.
They went and gave it their bestshot.
They threw the kitchen sink atit.
There are 12 independentscientists.
(19:52):
who populate a group called theexpert committee on drug
dependence.
They reviewed that.
They looked at all of theevidence and what they did is
they came back and said there isinsufficient evidence, even
though much lower standard forscheduling at the international
level, the FDA is wrong.
They've been smacked down byexperts.
And today you have the lonewolf.
(20:13):
in the federal government in theFDA trying to ban kratom.
And you have the NationalInstitutes on Drug Abuse, which
full throatedly supports peoplehaving access to kratom.
You have the U.
S.
Congress that in the last threeappropriations bills has
encouraged more research andopen access for kratom to the
american people.
The FDA is wrong.
They're isolated and they werejust as wrong on kratom as they
(20:33):
were on dietary supplements whenthey tried to ban them.
Yeah.
Back in 1994.
James Egidio (20:37):
Yeah.
I want to back up for a minutetoo because you mentioned
something very interesting aboutkratom as well.
Not only its effects on pain andgetting off opiates, but also
depression.
And I had just interviewed a fewdays ago, Dr.
Healy, who's an expert onantidepressants and the dangers
of antidepressants.
And I, in fact, just Two daysago, I interviewed Kim Witczak,
(21:00):
whose husband was commit suicideon antidepressants.
And then tomorrow I'minterviewing Dr.
Peter Breggin, who's an expertand was an expert witness for
some of the mass shootings thattook place at some of the
schools with the dangers ofantidepressants.
But you're talking about...
something that's safe andeffective.
And I was watching a video thatyou had mentioned with this
(21:24):
study with the United Nations,with Dr.
Jack Henningfield who had comeup with a lot of anecdotal
evidence, supporting, um, andcomparing kratom to opiates and
its safety and effect efficacy.
So where is the pushback comingfrom with the FDA and who are
(21:47):
the experts on their side thatare supporting this, or is this
just some kind of draconianacross the board, Kratom is
dangerous and we got to regulateit and that's it.
And that's all we know.
Is that what it is?
Mac Haddow (22:00):
Unfortunately, it's closer to the ladder here, where
you have a small group of peopleat the FDA who are not
scientists who just have a biasagainst botanical and dietary
supplements who have loopedKratom him into that bucket and
they want to pursue their effortbecause they think it will build
credibility for them on alldietary supplements, having to
be regulated or banned.
(22:20):
And that's unfortunate, but thetruth is they can't prove it by
the science.
And you referenced Dr.
Henningfield, there wasn't justanecdotal evidence when the
presentation was made.
to the U.
N.
Commission on Narcotic Drugs.
The expert committee on drugdependence.
You had Dr Jack Henningfield whodescribed to them the detailed
analysis and scientific researchthat had been done about kratom,
(22:43):
including on its addiction,liability and safety.
You also had former NIDAscientist, Dr.
Marilyn Eustace, who talkedabout the so called deaths
associated with kratom and shewent through her research that
shows that there's not a toxiclevel that has been identified
by the FDA or anyone else interms of what would cause a
death with kratom.
(23:04):
You also had Dr.
Kirsten Smith, who at the timewas a NIDA scientist.
and worked on Kratom whopresented data about studies
that they had done and anddescribed in fact, the not yet
published, but described howthere is an intoxication study,
a driving study on Kratom andthat it didn't intoxicate or
impair people in driving, whichgoes to the heart of the issue
(23:26):
that the FDA is pushing.
And finally, Dr.
Chris McCurdy made apresentation.
These are four of the leadingscientists in the world who
lined up against the FDA andsaid that they're wrong.
And of course, that goes back towhat Dr.
Joie said, when I spoke to Dr.
Joie after he made his decision,I thanked him, and he said you
need to understand that I am notan advocate for kratom, he said,
(23:48):
I don't know one way or theother, whether it's good or bad,
but I am an advocate for goodscience, he said, and it is an
obligation of the FDA.
to use good science to documentits regulatory decisions.
And in this case, the FDA hasfailed to do that.
They want to take their opinion,interpose it as though it being
the law of the land.
And they want to dictate to theAmerican people that they're
going to do it their way or thehighway.
(24:10):
And we think that the FDA iswrong.
And that's why we're fighting sohard to get the Kratom Consumer
Protection Act passed at thefederal level, mirroring what
we're doing in the States.
We've had 11 States that havepassed the state Kratom Consumer
Protection Act.
And that is all designed toprotect consumers.
Make sure products that areintroduced into the marketplace
are manufactured correctly, notadulterated, properly labeled
(24:31):
and restricted for kids.
And we think that's a model thatought to apply to all Kratom
products.
James Egidio (24:35):
Yeah.
And when you compare apples toapples It seems especially when
you start getting the DrugEnforcement Administration
involved in the game, uh, herewe are in 2023 and they're
relaxing the laws on medicalmarijuana and edibles.
And now they're talking aboutlegalizing or bring, rolling out
(24:57):
psilocybin.
You're talking about people thatare going to purchase these.
Products from say a dispensary,right?
And there's really no way tocontrol once you eat an edible
of THC to control yourfaculties, uh, based on how it's
(25:20):
released in the body.
Cause it's almost like a timerelease and you're sitting there
driving around intoxicated onTHC.
And it can really wipe somebodyout and they're worried about
Kratom, right?
Same thing with these vaccinesor these bioweapons that are
killing people and injuringpeople.
So they're not really focusingon what's good for the, what's
(25:40):
good for the person for the,that's purchasing these
products.
They're more concerned aboutpower.
and money.
It seems
Mac Haddow (25:51):
like I think that every decision that's made about
a product that has a potentialhealth benefit to the American
people has to be driven by goodscience again, not by the agenda
of a regulatory agency like theFDA that has a long standing
record of going too faroverregulating overreaching.
I don't have an opinion becauseI don't know enough about the
(26:13):
science on some of those othersubstances you referenced, but I
know for certain that the FDA istone deaf, blinded with their
zeal for regulations and banningkratom to not even look at the
data.
There was a study that was donethat looked at it's an animal
study, which is the goldstandard for dietary supplements
where they test against what'scalled the oxycodone protocol.
(26:36):
This is a safety study.
The FDA has developed a protocolto for any substance that wants
to prove that they are notunsafe, that they have to match
it against what they know arethe levels of oxycodone that
will cause and then fill in theblank as to what the adverse
events are.
When this study was done, theresearchers went and went to the
FDA and said, is there anythingthat we're missing on the
(26:58):
published oxycodone studyprotocol that we should include
in our research on kratom?
And the FDA actually made somerecommendations.
they thought they were poisonpills, right?
So they told them you should dothis and this in the end, the
scientists accepted that in thefirst tranche, there were three
tranches of this study.
They know that the first levelof oxycodone levels, they know
exactly what the outcomes are.
(27:19):
And predictably, that's whathappened for Kratom.
The director of the scientificresearch project came back to
the scientist and said, I'mgoing to do this, but you are
wasting your money because Ididn't even see a blip on the
signal safety signal at thatfirst tranche.
He said, you're going to see thesame thing because Kratom just
doesn't have this kind of powerin order to create a problem.
He said, I recommend.
(27:40):
that you let me boost the amountin the second tranche.
Now, if I were making that studyand I wanted an outcome that
hopefully was going to beobviously as good as the
scientists thought, I probablywouldn't have said okay.
But the scientists did becausethey were pursuing the truth
about it.
In the second tranche, whichthey boosted the metrogenin,
which is the alkaloid and kratomlevels to test its safety.
(28:00):
All of the oxycodone animals hadthe predictable reactions to
oxycodone and the kratom at theboosted level.
nothing.
And so the researcher came back,the head researcher and said,
look, you're going to think I'mcrazy, but you're going to see
nothing in Kratom because it'snot boosting any signal here.
So let me put as muchmetrogenin, the alkaloid in
(28:20):
kratom into an aqueous solutionthat I can inject into these
rats, these test rats, and let'ssee what happens there.
Now they boosted that level to400 times what any human could
consume in a day.
And so that's real problemshere, right?
So they did that.
And at the end of the day, Zippofor Kratom the they had some
(28:42):
sedation obviously at that highlevel, but they had the
oxycodone test animals eitherhad major seizures or deaths.
That was predictable.
That's what they know happens atthose levels of oxycodone.
The U S food and drugadministration, when they were
presented with that data, theyhad, as it was described to me,
a group of scientists in theroom and a group of policy
makers.
And when the scientists got thedata and reviewed it, they said
(29:05):
collectively, wow, this changesour perception about Kratom.
The policymaker said meetingover, this is the kind of blind
spot that the FDA has for goodscience.
They don't care about what thescience says.
They only care about theircrusade to ban Kratom, and
that's tragic, and that's whythe US Congress has to step in.
James Egidio (29:26):
Why do you think they're so hell bent on wanting
to ban Kratom?
Mac Haddow (29:30):
It's their first start in going after other
substances because if they canselectively pick out the
substances they want to ban,like kratom.
Then they know if they get a winunder their belts, they're
headed down the road for thenext thing that they want to go
after.
We see them doing probes intothe dietary supplement space now
and they start to pick outproducts and they select them
out and say, these are nowdangerous and so we're not gonna
(29:51):
let you have them on themarketplace anymore.
That's the game the FDA has nowtaken and they're very clever
about it because when they dothese regulatory actions, they
make sure that they don't go towhat's called Final agency
action.
They will put out an alert.
They will scare consumers andretail channels out of the
marketplace.
And then they control themarketplace that way.
(30:12):
That's tragic when it comes toKratom, I hear, and you made the
point earlier maybe we need toimprove the retail channel.
And I agree with that, butultimately.
Ultimately, Dr Jack Henningfieldmade a point that was powerful
in testifying before theLouisiana Legislature when he
was asked by one of thelegislators, Don't you think
it's a bad idea for Kratom to besold in gas station convenience
(30:32):
stores?
And I have not heard theresponse to that question from
Dr Henningfield before.
And he said, No, actually, Ithink it should, as long as it's
properly manufactured andproperly labeled, it ought to be
available in any outlet becausethere are people who are
struggling right now.
We're trying to maintain acuteand chronic pain management and
(30:53):
get off of opioids.
I don't care where they get it,as long as it's a properly
manufactured and properlylabeled product.
And if they don't have thestigma of having to go into a
doctor's office, they don't havethe stigma of trying to go to a
recovery center, and they don'thave the stigma or the financial
resources to take advantage ofthose kinds of treatment
options.
Dr.
Hegel said, I think we need tomake this available.
And I thought that was a prettyastounding point because I
(31:14):
would've agreed and said, yeah,let's get it outta there and
let's put it in thesetraditional, very high-end
retail establishments.
But I, he persuaded me and Ithink that's the right policy as
long as we regulate it so thatit's manufactured properly and
label properly.
James Egidio (31:27):
Yeah.
When I was in the nutritionalsupplement industry, back in the
early 90s, I was doingformulation and design of
products, specialty products.
I remember we were going throughthis scrutiny.
I mentioned this to you offlinewith the industry itself.
And there was a product manyyears ago, back in the early
90s, they were really goingafter the FDA.
(31:48):
And I remembered back then TheFDA was pretty much regulated up
with one desk.
You'd act, you'd actually callthe FDA back then.
You couldn't even reach them.
There weren't, they were sounder unmanned.
It was like a couple of peopleworking for him to regulate that
particular industry.
And there was a product inparticular called ma huang.
It was a Chinese herb whichacted like a Broncodilator and
(32:11):
almost like an ephedrine or atype of stimulant, and they went
after that product.
because it was causing a lot oftachycardia and issues like
that.
But it wasn't even there.
They didn't even stop there.
They were looking to regulatepretty much most products across
the board in the early ninetiesand into the mid nineties.
(32:33):
So there was a lot of back andforth with manufacturers and
marketers of supplements backthen.
I remember that.
Mac Haddow (32:41):
Yeah, in fact, when the F.D.A.
Did that the consumer populationand dietary supplement industry
rose up.
They had over 300, 000 phonecalls that went into the U.
S.
Congress to the white into theCapitol building.
They actually shut down thephone system, so they had to
rebuild and redesign the phonesystem so that today they can
(33:03):
handle that volume of calls.
This is before emails.
There were 900,000 letters thatwere sent.
Now, the result of that you havethe FDA out there saying we have
got to ban all dietarysupplements.
They were unabashed about it.
They built their record over twodecades to get that decision and
the U.
S.
Congress on a unanimous votepassed the DeShay Act, telling
(33:24):
the FDA, no, you're going toregulate them appropriately.
And now is it the perfect pieceof legislation?
No but it was done in order torein in the FDA.
I wish we could, without openingup Pandora's box, go back in and
say.
We made a few mistakes.
We need to tweak this a littlebit, but the FDA would come in
hard and try to ban the dietarysupplements and botanical
supplements.
So we have to live with whatwe've got, but it's far better
(33:46):
than the alternative where theFDA gets to unilaterally make
these decisions to ban productsbecause they don't like them.
It's their regulatory agendathat's the problem.
James Egidio (33:54):
Yeah.
Yeah.
And I know the thing is, andyou're right it's a very
delicate balance in thisindustry too, because CGMPs good
manufacturing practice,certificates of good
manufacturing practice have tobe implemented for
manufacturers, because I do knowfrom being on the manufacturing
(34:15):
and the marketing side ofnutritional supplements, that a
lot of these supplements arewhat they call adulterated.
Yeah.
I know in the market with a lotof herbs that get imported from
Asia and whatnot, and very goodherbs that are very potent and
very effective get adulteratedto where they take the active
(34:37):
ingredient out of the herb inorder to make the tinctures,
which are more concentrated thatcan be sold for a higher cost on
the market and then they'll takethe herb that where they took
the active ingredient out andmake the capsules out of it
Right or and there's noregulation with that.
Okay, or what they did with alot of the products for erectile
(35:00):
dysfunction the naturalsupplements recently in the last
i'd say 10 years Is they wouldsell let's say a supplement on
the market for erectiledysfunction, a natural herbal
supplement, and then they wouldput some sildenafil citrate in
it, right?
Which is the active ingredientin Viagra.
(35:22):
And the FDA got ahold of some ofthose products.
So that's what they're concernedabout.
I know you mentioned too, wheresome of the, these products,
Kratom products were taintedwith.
What was it?
Some kind of active ingredient.
That was similar to whatTramadol, I believe, or
something like
Mac Haddow (35:39):
that.
Yeah.
These were nine deaths thatoccurred in Sweden.
Yeah.
And in 2011 and all of thoseproducts and the FDA, by the
way, uses those deaths asexamples of a Kratom death, but
all of those deaths, but in apeer reviewed published article
examining the tox screens andthe autopsies revealed that they
(35:59):
were adulterated withOdemethyltramadol.
which is the chemical that'sused in the production of the
opioid tramadol at a toxiclevel.
It wasn't the kratom.
It was this adulterant.
So that's the problem.
And the FDA doesn't care aboutthe facts.
They continue to tell that thereare 44 deaths, the nine that I
just referenced.
I'll give you an example.
We, we FOIA'd FreedomInformation Act request to the
(36:21):
FDA.
They gave us on all 44.
They claim they gave all of themto us except one.
Okay.
They said that one was protectedby HIPAA restriction by the
family.
That's the Privacy Act.
So we couldn't argue with that.
We had an independent forensicstoxicologist review all of the
43, and she came back and saidit was shockingly disappointing
work by the FDA.
They didn't do any duediligence, and that none of
(36:43):
those deaths could be attributedto Kratom itself.
Shortly thereafter, I got a callfrom a reporter from Huffington
Post, and he said you know thatone death they claim is
protected by HIPAA?
He said I have a copy of theautopsy and It's not protected
in any way and I was working Iwas working on a different story
and I asked for an autopsy for adifferent story and I got it
just withheld it because theydidn't want you to see it.
(37:04):
I said, why?
Because the kid died of twogunshot wounds to the chest.
It involved apparently a drugsting where the informant was
ordered out of the car by thepolice along with the seller.
They were, I think the kid wasselling marijuana and the kid,
the informant jumped out, butthe seller did not and he was
(37:26):
ordered out of the car.
He reached for what the policethought was a weapon and they
shot him.
He died of two gunshot wounds tothe chest and that's what's on
the autopsy.
It just shows that earlier inthe day he had drunk a kratom
tea and he had four or fiveother toxic drugs in his system
illegal drugs, right?
He died of two gunshot wounds tothe chest and yet the FDA with a
straight face will say That's akratom death.
(37:47):
These people are off the railsand they don't have any
accountability because they getaway with it.
They think when it says it, thatit must be right.
And you and I have been in thissphere long enough to know that
the FDA ain't always right.
And the FDA will frequently saythings that are blatantly not
true in order to achieve aregulatory agenda that they want
to accomplish.
James Egidio (38:08):
Yeah.
Yeah.
And it's interesting.
It sounds eerily familiar to Dr.
Scott Jensen, who I interviewedseveral months ago about the
whole thing with COVID wherehe's a he's out of Minnesota.
He's been a physician there,2016 family physician of the
year, and he was instructed bythe hospital that he worked at
(38:28):
to report COVID deaths, nomatter whether it was COVID or
not.
And he blew the whistle.
And they were looking to takeaway his license for that, so
it's a coverup and that, thatwas going to be one of my next
questions is that when you lookat some of the suspected deaths
from Kratom or may have beencaused by Kratom, what are some
(38:50):
of the things that need to betaken into consideration that
may have been overlooked?
Mac Haddow (38:55):
So the first thing is that there's never been a
toxic level of metronidine orany of the other alkaloids in
the natural plant or it's.
metabolites that's beenidentified as toxic.
So any death that is reported bya medical examiner who typically
just follow the FDA, there's ametrogeny intoxication needs to
be examined.
(39:17):
Excuse me.
So we need to do that.
So we look at those deaths.
We've collected every publiclyavailable autopsy intoxicant
report On these deaths.
And what we're finding is thatnone of them are caused by
Kratom alone.
They're always polydrug use, orthere are other underlying
health factors that cause thedeath.
We think, the investigationsneed to be made.
(39:38):
These are tragic circumstancesfor families that lose a loved
one to an overdose or to someother unknown event.
And they like to blame Kratombecause the trial attorneys are
encouraging it, right?
They wanna collect these.
cases that they can go and suethe child attorneys aren't suing
the FDA for failure to regulate.
They're suing the manufacturers.
And first off, I thinkmanufacturers should act
(40:01):
responsibly.
They should meet the standards,even if the FDA doesn't require
it right now.
They don't.
They should meet FDArequirements for GMP regulations
and they should label theirproducts absolutely.
And anybody that doesn't,they're at risk in the
marketplace and they should bepenalized.
And while my heart goes out tofamilies that have lost family
members, finding a trialattorney dragging them into
this.
This quagmire of saying, oh,this was a Kratom death with the
(40:24):
flimsiest of evidence.
And I say Flimsiest, and itmakes no sense to us.
We had a call from a from acoroner in the state of Idaho
who volunteered to us that hehad a death.
That he had reported on of ayoung man.
It was in, in Bannock County,Idaho.
And the young man had gone intoa bar, had become intoxicated,
had he had weed and othersubstance in his system,
(40:46):
including kratom by the way.
He had drunk a Kratom tea, verylow level Kratom had walked out
drunk into the middle of winter.
tripped and fell into a ditchand passed out, and he died of
hypothermia.
Now, when the tox screen waspublished, it showed among these
other substances, a very highalcohol content level in his
blood showed the othersubstances that he was obviously
taking, and it showed kratom ina very low level.
(41:09):
He said the FDA called him upand said, we need you to change
the cause of death tomitragynine intoxication.
He said, why would I do that?
It had nothing to do with thedeath.
Yes, but Mitragynine showed upon the tox screen and we need to
highlight Kratom deaths.
He said, I'm not gonna do that.
They said we want to talk toyour superior.
He said, I'm the duly electedcoroner in Bannon County, Idaho.
(41:32):
I am the superior.
I'm not doing it.
They said we're gonna report youthen to the Medical Examiner's
Association of Idaho.
He said, Hey, hang on.
I'll get the director on thephone.
It's not a problem.
He put them on hold, tried toconnect them.
We went back, the FDA hung up.
This is their game.
These people have no businesstrying to put their thumb on the
scale and tip the scales againstKratom.
(41:54):
They have no business doingthat, but that's the only way
they can make their case.
And that's really unfortunate.
James Egidio (41:58):
It is.
I remember there was a time whenwe were doing we were getting
patients off of opiates with theuse of suboxone.
And when we would have a patientcome in and we would screen the
patient, they were on multiplemedications that they were being
prescribed, or they were usingheroin to get on the suboxone.
(42:19):
So they, they were polypharmacy,they were using Xanax, they were
using heroin.
It's just, it's a multitude ofmedications that they're using.
But I can remember back then wewould even go as far as saying,
Hey, look, what even worksbetter than that is the Suboxone
is the Kratom.
(42:40):
And they were getting such greatresults from Kratom as opposed
to suboxone.
And they were even getting offthe heroin.
With the use of Kratom,
Mac Haddow (42:52):
yeah, you've highlighted one of the problems
in our dealing with theseaddiction liability and trying
to find a better space.
We substitute.
One addiction for another andand that's unfortunate because
suboxone is a product.
It is has its own downsides Itdoes toxic and I think that
should be our goal we shouldfind what's best for the
(43:12):
individual the best treatmentprotocol for them as they
struggle through this andCertainly do not lock the door
on something that could helpthem that just because the FDA
doesn't like it And I thinkthat's why night is so
supportive of us as we goforward here.
This has been to my mind one ofthe biggest challenges we have
in the healthcare space.
As you look at the opioidaddiction crisis, when you have
(43:33):
a product that can help, that'sa lifeline, we should use it.
And Dr.
Nora Volko of the the NationalInstitute on Drug Abuse agrees.
Why is GFK the outlier?
James Egidio (43:45):
I want to share with the listeners and viewers
of the Medical Truth Podcast acouple videos of some of the
people who have benefited fromKratom through your
organization.
Video (43:58):
The pain was just so bad that I couldn't work.
I couldn't even get out of bedon certain days.
I love to travel.
I love to be around mygrandkids.
I love to hike.
All the things that I loved todo in my life, I couldn't do
anymore because of the pain.
The doctors wanted to put me onsynthetic medications.
I started off two every fourhours and then within a month I
(44:19):
tripled that because they justquit working.
I'm trained to think thepharmaceuticals are the only way
to go.
And when I was introduced toKratom I didn't think that it
was going to work because it'sjust a plant.
But then I tried Kratom.
And I literally sat and cried inmy car because for the first
time in years, I didn't feelpain.
(44:41):
I was able to think clearly,this stuff is amazing.
I have not felt this level ofcalm and this level of being
pain free in years.
Having this all natural planthas literally given me my life
back.
I can live.
So I want to I can be thatmedical professional that I need
to be and I can work with aclear head and I can work at the
(45:04):
level I need to because I'm nolonger in pain without this
plant.
I honestly don't think I wouldbe here.
I would tell the legislators.
Please listen to us.
This plant is saving lives forthose of us with chronic pain.
It's giving these people backtheir lifestyle that they had
before they got sick.
Go to ProtectKratom.
(45:24):
org to send a message to yourelected official about Kratom.
I have severe pain in my lowerback.
And there's times when if I didnot have the pain medication, I
would want to put a gun to myhead.
Doctors will tell you, you'regoing to be on pain medication
for the rest of your life.
But it's just not sustainable.
You start building up atolerance.
(45:46):
You need more to relieve morepain.
You just keep moving up andyou're still in pain.
As a scientist, I just didn'tthink it was going to work.
And it was just a plant.
Just a ground up leaf and I waslike, this is not going to be
able to take away my pain.
Because I was on such a highdose of morphine at the time.
(46:07):
And when I took it, it did.
It blew my mind.
I couldn't believe that theKratom actually worked.
With Kratom, my quality of lifeis like I was a 20 year old
without any back problems atall.
Things that I enjoy, like goingout hiking with my dogs, going
RVing across country, I couldn'tdo that on pain medicine.
And with Kratom, it totally gaveme back my life.
(46:30):
I love Kratom because it's aplant, it's all natural, and
it's taking away my pain.
It is a miracle.
It's pretty awesome.
Kratom saves lives.
Contact your elected officials.
Help protect Kratom in Colorado.
Worked 13 years in lawenforcement from corrections
officer to police officer.
I was attached to a gang taskforce for the state of Missouri.
(46:52):
I was going to interview twogang members in a jail.
I was attacked by an inmate witha knife for three minutes and I
was basically left to die.
It just compacted in my mind.
And I was having panic attacks.
I was puking in a trash canbefore I went to work every day.
It was said at that point that Iwas unemployable.
(47:14):
I was just in an absolute pit ofdespair.
I was diagnosed with posttraumatic stress disorder and
major depression.
I gave my life to lawenforcement and when that was
taken away from me, I was just,I was totally devastated.
I saw a therapist.
I saw Different doctors, I tookprescriptions and nothing helped
until I found Kratom.
(47:35):
It has been an absolute lifechanger for me.
I'm able to get out of bed inthe morning.
I'm motivated, I have energy,and I feel normal.
I wasn't stony or in a fog.
I'm a law enforcement officer.
I do not want to take drugs ornarcotics.
Kratom is a plant.
It's related to coffee.
I feel like my life's purpose isback and I have a lot of
(47:58):
interest and still helpingpeople.
So I started an armed securityagency and it's been doing
extremely well.
We are keeping the criticalinfrastructure of a town that
was drastically affected bycategory one.
FEMA disaster.
I'm able to help people and I'mable to contribute to society
and create them, help make thatpossible.
If they did take this away, youwere going to affect 5 million
(48:22):
people across the country, justlike me, that are in
Professional careers that aregoing to have no other options.
Kratom saves lives and it helpedme get my life back, which
allowed me to overcome posttraumatic stress so that I can
come out here and perform myduties efficiently and
effectively.
Legislators, please protectpure, safe Kratom.
(48:43):
Go to protectkratom.
org to send a message to yourelected official about Kratom.
James Egidio (48:48):
There we go.
I
Mac Haddow (48:49):
can't say any better than that.
That was fabulous.
James Egidio (48:53):
We have to keep this stuff out of the hands of
the government as far asregulation is concerned.
It's so important.
And, it's so interesting aboutthat is that when you look at
these are functioning people,these are real people.
Real careers that are have, I'msure are married and have
(49:14):
families.
And when they're going throughthat chronic pain, it affects
the marriage, it affectseverything, it affects your
entire life, it affects yoursleep cycle, everything.
Mac Haddow (49:26):
No question about it.
And I think that the time hascome for everyone.
Whether you take creative or notreally isn't the issue.
If you love freedom, if you knowthat the FDA shouldn't be
allowed to arbitrarily issuethese kinds of edicts without
good science behind it, thenit's time to stand up and say
enough.
And that's why we're askingeveryone to join us in the
federal creative ConsumerProtection Act and in the states
(49:49):
where you're KCPA hasn't passedyet.
We need to help.
So we and I appreciate your timehere, James, letting me come on
and talk about this very
James Egidio (49:55):
much.
Absolutely.
And I'll continue.
And I want you to keep usupdated listeners and viewers.
I'm going to also be posting alot of information, content, and
I'd like to have you come backon the show.
Maybe we could even get DrHenningfield back on and we can
talk about the physiologicaleffects of the of the, of kratom
and go from there.
(50:16):
Thank you.
Great idea.
We can help facilitate thatthing.
I'm here to support you on allthis.
And again, your website is goahead.
Mac Haddow (50:23):
It's a www.KratomAnswers.Org.
www.ProtectKratom.org andwww.AmericanKratom.Org.
Yeah.
All of the
James Egidio (50:31):
resources and I'll post all those links on the free
resources page of the medicaltruth podcast.
But I really appreciate yourtime Mac for coming on to the
medical truth podcast.
Thank you so much.
Mac Haddow (50:43):
We're grateful
James Egidio (50:43):
as well.
Thank you.
Thank you, sir.
Have a good night.
Thanks.
All right.
Thanks for listening to theMedical Truth Podcast.
For the latest episodes, go towww.
medicaltruthpodcast.
com.
You can also find the MedicalTruth Podcast on Rumble, as well
as all the major podcastplatforms like Apple Podcasts,
(51:06):
Spotify, Stitcher, and iHeart.
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