Ep 49: Understanding Kratom with Mac Haddow: Science, Politics, and Personal Experience

Mac Haddow, AKA senior fellow and Kratom user, shares his personal story and the ongoing battle for legal access. He exposes the FDA's biased stance and flawed data, highlighting the importance of consumer advocacy. Learn how Kratom has helped millions and how you can get involved to protect this beneficial plant.
In this week's episode of Kratom Stories, Madalyn Sklar interviews Mac Haddow, the senior fellow on public policy for the American Kratom Association (AKA), and a Kratom consumer himself. Mac shares his personal journey with Kratom, revealing how it helps manage chronic pain stemming from past injuries. His introduction to Kratom was unexpected—a vendor offered him a sample, and he experienced a calming effect with an energy boost. This personal experience, combined with seeing Kratom's positive effects on Senator Orrin Hatch (who also used Kratom for pain relief), solidified Mac's advocacy for the plant. He details his extensive experience in politics and how this led him to fight for Kratom's legal status, facing opposition—particularly from within the FDA who are seemingly intent on banning it.
Mac details the FDA's biased view of dietary supplements and how the agency's actions threatened to unjustly ban Kratom based on flawed data and the misunderstanding of the plant's benefits. He recounts the intense fight to prevent the 2016 ban, highlighting the passionate outpouring of support from Kratom consumers that ultimately swayed the DEA, and the ongoing challenges Kratom continues to face due to the FDA’s actions. He emphasizes the importance of consumer voices in advocating for the plant, particularly in the face of local bans fueled by misinformation.
Mac shares advice for new Kratom users, stressing the importance of starting with small doses to find what works best for their needs. Recent FDA research has shown that Kratom is well-tolerated at various dosages, which should be reassuring to those considering using it. He underscores that various user groups—including those seeking energy boosts, mood elevation, and pain relief—all benefit from Kratom. Mac and Madalyn end the show by encouraging listeners to get involved with the American Kratom Association to protect access to this beneficial plant, which has improved the lives of millions.
-RELATED LINKS -
American Kratom Association - website
American Kratom Association - Facebook
Letter from Assistant Secretary for Health, Dr. Brett Giroir
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Please note: The views and experiences shared in this episode are personal and unique to the guest. Kratom, while featured prominently in these stories, is a botanical substance that is unregulated in the U.S. and various countries around the world. The Kratom Stories Podcast and its host, Madalyn Sklar, do not endorse, promote, or encourage the use of Kratom. We simply aim to shed light on personal experiences and narratives related to this plant. If you're considering using Kratom, we strongly urge you to seek professional medical advice, conduct thorough research, and comply with all local laws and guidelines.
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This vendor handed me, it was a
little shot of kratom, and he
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00:00:04,200 --> 00:00:07,080
said try it.
And so I took and selected down
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and I took a double dose and
didn't know it.
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I mean, I should have only taken
half of it.
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But about 20 minutes later, it
hit me.
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And, you know, I felt this calm
feeling and I felt, you know, at
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the same time a little bit of
energy.
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I thought it was an interesting
experience.
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I'm not prone to, you know, just
taking substances like that.
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I don't even like taking pills,
but this was an interesting
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thing.
Welcome to Kratom Stories, a
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weekly podcast where we share
stories of how this amazing
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plant has changed our lives.
I'm your host, Madeleine Sklar.
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Each week I'll bring you a new
episode featuring interviews
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with experts, advocates, and
everyday people who've
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experienced the benefits of
kratom first hand.
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Join me as we dive deeper into
the world of this botanical
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wonder and discover the amazing
stories behind this incredible
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plant.
The Kratom Stories Podcast is
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presented solely for educational
purposes.
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Neither the podcast nor its host
promote or endorse the use of
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kratom, a substance not yet
regulated or approved by the
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FDA.
The views and opinions expressed
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by guests are theirs alone and
do not necessarily reflect those
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of the host or the podcast.
The content is not intended as a
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substitute for professional
medical advice, diagnosis, or
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treatment.
Always seek the advice of your
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physician or other qualified
healthcare provider with any
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questions regarding the use of
kratom.
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So I'm here with Mack Haddow.
So many people in the kratom
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community know who this is.
He is the face of the American
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Kratom Association.
Mack, thank you so much for
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coming on to the Kratom Stories
podcast.
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I'm glad to do it.
This is a a new kind of
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experience for me because we're
not talking policy, although we
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might, but she's talking about
personal experience as kratom.
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It's great.
Yeah, I know, 'cause like you're
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always, yeah, I mean, you're all
about policy.
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You're, you're the senior fellow
on public policy for the
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American Kratom Association.
You do so much to help us as
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consumers keep legal access to
this plant.
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And I just appreciate all that
you do for all of us.
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So thank you.
Well.
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Thank you.
But yeah, I'm eager to hear your
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kratom journey.
So let's start off with you
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telling us a bit about yourself
and life before you ever heard
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about kratom.
Well, I first got involved in
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the political world as a college
student at Brigham Young
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University when I was growing up
in Pittsburgh, PA.
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My stepfather was an abusive
alcoholic.
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The joke in our family was that
when my mother married and he he
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did not know she had five
children at the time and he
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wasn't a happy camper with any
of us.
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And it's one of those
experiences where as you grow up
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in those kinds of tents
surroundings that you look for
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anchors in your life.
And one of the anchors in in my
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life and my brother's lives was
a two people, Jess and Helen
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Hatch, who were the parents of
Oren Hatch.
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And they had come to Pittsburgh
in seeking work during the
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Depression.
Orrin Hatch's father was a, a
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wood wire and leather metal
lather.
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And so he was just looking for
work.
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And he became sort of the the
key person in the Pittsburgh
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area in bringing the religious
view from Mormonism into that
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area.
And our family had converted to
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Mormonism when I was 10 years
old.
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And so Jess and Helen Hatch were
just like surrogate parents to
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me growing up.
So when I was at school at
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Brigham Young University and
Orrin Hatch announced that he
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was going to run for the United
States Senate, I called him up.
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And I said to Warren, what can I
do to help you?
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And he said, well, the most
important thing is you need to
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arrange meetings with delegates
to the state convention.
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Utah has a convention system for
vetting its candidates.
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They now change that a little
bit.
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So there's a pathway to do
actual signatures and primaries.
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But at the time, it was just the
convention.
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And he said, I really need to
win the convention or at least
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come in second so that I can get
into the primary election
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against a fellow Republican.
There were five Republicans that
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had filed.
And so I was assigned and I took
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on the challenge of doing Utah
County, which is the second
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largest county in Utah.
And it's the area where Brigham
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Young University is located.
And so I started calling, and I
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set up these meetings.
And I would call his campaign
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headquarters and say, I got this
state, this state, this state.
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And every time I called, they
said fine, no problem.
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And I after a while, I started
to wonder what is going on?
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There are 29 counties in Utah.
How in the world can I get every
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date?
That's statistically that's just
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not possible.
And finally, I asked the
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scheduler and he said, well, the
truth is you're the only one
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that's working on this.
We don't get any other contacts
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or calls.
And so and I became friends with
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the scheduler who was retired
Air Force Colonel that knew
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Orrin Hatch from his
neighborhood where they lived.
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And he said to me one day said,
look, I made a commitment to my
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wife two years ago before this
campaign we got underway that I
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was going to take her to Hawaii
on a vacation.
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And I've got to do that or I'm
going to get divorced.
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He said, would you come to the
headquarters and just run the
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scheduling operation for a
couple of weeks?
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And so I agreed to do it.
And the first day I was asked to
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go to the airport to pick up a
consultant from the Republican
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National Committee who was
coming out to evaluate the Hatch
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campaign to see if there was any
possibility that he could win.
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And I picked him up at the
airport and on the way to
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downtown Salt Lake, which is
about a 20 minute drive.
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He said to me, what's your
assessment of the campaign?
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I didn't have any assessment of
the campaign.
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All I saw was negatives.
And I said, well, I can tell you
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what I know and I don't know
much, but this is what I
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learned.
And it doesn't look like there's
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much going on.
And he said, fine, thank you.
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And I picked him up to take him
back at the airport about four
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in the afternoon.
And he got in the car and he
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said, it's a lot worse than you
thought.
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He said, this is a disaster of a
campaign.
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He said Hatch is going to ask
you to drive him to Logan
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tomorrow, which is about two
hours from Salt Lake, north of
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Salt Lake.
He's going to ask you to be his
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new campaign manager, he said,
and you need to tell him no.
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I said.
That's easy.
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First off, I'm in school, in my
senior year of college.
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I don't have time to do this, I
said.
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Secondly, I don't know anything
about politics.
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He said, Ah, you don't need to
know anything about politics.
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You just tell him no.
Because the only way that you
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say yes to him is if he agrees
to fire everybody on his
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campaign staff.
And if he'll do that, then you
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tell him yes, and then I'll help
you.
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I'll give you a road map on how
you can at least make it
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credible, He said.
There's no way Hatch can win.
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None.
But he wants, if he wants to
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have a future in politics, he's
going to have to do the
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following things.
And he kind of laid out the road
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map.
Next day, exactly what he had
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asked me to do happened all the
way up to Logan Hatch beat on
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me.
I said, no, I'm not going to do
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it all the way back to his
house.
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And we sat out in front of his
house for till 2:00 in the
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morning and find that he said,
OK, I've got to do this.
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And I hate doing it.
These are all my friends that
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I've recruited to help on the
campaign.
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But if that's what's going to
happen, it's going to happen.
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So next morning, he gets
everybody there, 12 people in
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the room, very small staff.
And he said, I'm making changes.
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Mack is the new campaign
manager.
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They didn't even know me, by the
way.
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He said, and he'll brief you on
what's going to happen next.
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And he walked out.
So I became, they all quit,
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which I would have done too in
their circumstances.
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I would.
I did.
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You know, this is a college kid
that suddenly gets thrust into
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this.
And some of these people were
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older and more experienced than
that.
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You know, all that.
So I became the campaign
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manager.
And through a variety of very
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interesting circumstances, Orrin
Hatch won the seat in the United
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States Senate, toppling a
incumbent that was called the
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safest seat in the US Senate
that year.
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And Hatch beat him and that
suddenly I was thrust into this
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world of politics.
And my first assignment when I
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got to Washington with him was
he said you need to find a good
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dietary supplement store where I
can get supplements that I used
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to maintain my health and
well-being.
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And he gave me a list and I got
on the Metro in DC and I started
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searching.
I got, you know, I, I found out
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some stores and I went looking
for these supplement stores.
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Most of the things that Hatch
had asked me to make sure I
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00:08:13,680 --> 00:08:16,680
could find, I didn't recognize.
I'm a young kid.
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I'm not, I don't need
supplements.
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I don't need this nonsense.
And when I finally found the
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00:08:21,240 --> 00:08:23,000
right location, I reported back
to him.
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But what I saw, and Hatch's
commitment to dietary botanical
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supplements was extraordinary
because his view was the light
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00:08:32,240 --> 00:08:35,559
years ahead of the FDA's view,
because at that time the FDA was
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00:08:35,559 --> 00:08:37,600
demonizing all dietary
supplements.
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And so Hatch started a crusade
against the FDA, and that led
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and culminated in the passage of
the Dietary Supplement Health
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00:08:45,440 --> 00:08:49,280
and Education Act in 1994.
Now, by that time I'd left his
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staff.
I had served the term in the
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Utah Legislature myself.
I had become the chief of staff
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00:08:54,080 --> 00:08:58,880
at HHS and then I was out doing
advocacy work and I was working
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00:08:58,880 --> 00:09:02,240
hard on this Dietary Supplement
Health and Education Act and
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00:09:02,240 --> 00:09:05,200
that passed and it rained in the
FDA.
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00:09:05,440 --> 00:09:12,160
And so Fast forward to 1996 and
on August the 30th I get a call
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00:09:12,360 --> 00:09:14,040
from the American Kratom
Association.
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00:09:14,040 --> 00:09:16,920
Susan Ashe was then the
president of the AKA and she
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00:09:16,920 --> 00:09:20,240
said we need your help.
The DEA is publishing a notice
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00:09:20,240 --> 00:09:23,960
tomorrow that will ban kratom
and make it a Schedule 1
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00:09:23,960 --> 00:09:26,720
substance.
And we need desperately to get
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00:09:26,720 --> 00:09:28,680
your help.
And we need you to try to lean
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00:09:28,680 --> 00:09:30,600
on Senator Hatch to help us as
well.
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00:09:30,920 --> 00:09:35,360
I told Susan that no chance.
In my experience in working with
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00:09:35,360 --> 00:09:39,760
the FDA, there had never been a
rescission of a Federal Register
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00:09:39,760 --> 00:09:41,520
notice to schedule any
substance.
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00:09:41,520 --> 00:09:44,320
They've never done it before.
And I said the best chance
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00:09:44,320 --> 00:09:48,040
you've got is if they use, which
they typically do, the emergency
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00:09:48,040 --> 00:09:51,120
power section, which gives them
a speedier pathway with no
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00:09:51,120 --> 00:09:53,280
public comment.
They have 30 days after
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00:09:53,280 --> 00:09:55,920
publication, it becomes banned.
I said, but it's only for two
203
00:09:55,920 --> 00:09:57,400
years.
So you could build the case.
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00:09:57,400 --> 00:09:59,200
And she said, well, that we
don't want that.
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00:09:59,400 --> 00:10:01,600
But if that's the best you can
do it, that'll get you on board,
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00:10:01,600 --> 00:10:04,040
then fine, we'll do that.
And of course, I've told people
207
00:10:04,040 --> 00:10:08,080
what I underestimated was that
the advocacy community, the
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00:10:08,080 --> 00:10:11,800
passionate consumers of kratom
stood up and they were counted
209
00:10:12,000 --> 00:10:14,280
and they they reached out and
all this.
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00:10:14,480 --> 00:10:17,360
Now, that being said, that
wasn't my first experience with
211
00:10:17,360 --> 00:10:19,040
Kratom.
I already knew what it was
212
00:10:19,040 --> 00:10:22,200
because in my business, my
brother and a couple of other
213
00:10:22,200 --> 00:10:24,840
guys were partners.
One of the partners had come to
214
00:10:24,840 --> 00:10:28,880
me about a year before and said
I've got this guy that has hired
215
00:10:28,880 --> 00:10:31,920
us and I wasn't working on this
account directly at the time.
216
00:10:32,280 --> 00:10:36,160
It has a product called Kratom
and he really needs to, he's
217
00:10:36,160 --> 00:10:38,680
working with the FDA.
He's trying to get approval to
218
00:10:38,680 --> 00:10:42,320
get through the the new dietary
ingredient notification process
219
00:10:42,640 --> 00:10:44,080
and wants to talk to Orrin
Hatch.
220
00:10:44,080 --> 00:10:46,400
So could you introduce him to
Orrin Hatch, which I did.
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00:10:46,760 --> 00:10:50,360
And we went to lunch before the
meeting and this vendor handed
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00:10:50,360 --> 00:10:53,520
me, it was a little shot of
kratom.
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00:10:53,560 --> 00:10:56,400
And he said try it.
And so I took it and slept it
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00:10:56,400 --> 00:10:59,920
down.
And I was, I took a double dose
225
00:10:59,920 --> 00:11:01,520
and didn't know it.
I mean, I should have only taken
226
00:11:01,520 --> 00:11:03,920
half of it.
But about 20 minutes later it
227
00:11:03,920 --> 00:11:05,800
hit me.
And, you know, I felt this, this
228
00:11:05,800 --> 00:11:08,040
calm feeling and I felt, you
know, at the same time a little
229
00:11:08,040 --> 00:11:09,760
bit of energy.
I thought it was an interesting
230
00:11:09,760 --> 00:11:11,880
experience.
I'm not prone to, you know, just
231
00:11:11,880 --> 00:11:14,680
taking substances like that.
I don't even like taking pills,
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00:11:14,920 --> 00:11:16,520
but this was an interesting
thing.
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00:11:16,520 --> 00:11:20,000
So when we met with Hatch, Hatch
was eager to try it.
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00:11:20,320 --> 00:11:24,160
And he himself had suffered from
age-related kinds of injuries
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00:11:24,160 --> 00:11:26,960
that are arthritis.
And then he had been injured in
236
00:11:26,960 --> 00:11:28,920
a plane crash in St.
George, UT.
237
00:11:28,920 --> 00:11:32,400
A small plane landed in a very
difficult airport, cracked the
238
00:11:32,400 --> 00:11:36,680
plane in two, and Hatch had had
serious back problems from it.
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00:11:36,920 --> 00:11:40,200
And from the moment that he took
kratom in his office the first
240
00:11:40,200 --> 00:11:44,600
time, he became a big advocate
for it and a consumer of it.
241
00:11:44,840 --> 00:11:48,840
And a year later, when we were
in the midst of this battle, I
242
00:11:48,840 --> 00:11:52,360
sat in his office when he picked
up the phone and called the DEA
243
00:11:52,360 --> 00:11:55,440
administrator and said, you will
not schedule Creighton.
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00:11:55,440 --> 00:11:57,120
I will fight you to the death
on.
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00:11:57,120 --> 00:11:59,920
He said, I use it.
It helps me considerably.
246
00:12:00,080 --> 00:12:03,360
I can imagine it's helping
millions of other people, and
247
00:12:03,360 --> 00:12:06,040
you're not going to do this.
And that, of course, was one of
248
00:12:06,040 --> 00:12:09,840
the elements in the decision
that the DEA administrator made
249
00:12:10,120 --> 00:12:13,040
in pulling the recommendation
for scheduling.
250
00:12:13,040 --> 00:12:16,320
So now I have a similar history
of injury.
251
00:12:16,440 --> 00:12:20,040
When I was young and really,
really, really dumb, I was a
252
00:12:20,040 --> 00:12:24,120
motorcycle racer in college and
so I got banged up all the time
253
00:12:24,120 --> 00:12:27,240
on desert bike racing.
And so I have a very bad hip and
254
00:12:27,240 --> 00:12:29,520
so I have this chronic pain.
I have a lot of arthritis in
255
00:12:29,520 --> 00:12:31,640
that hip.
So I was always taking Tylenol
256
00:12:31,640 --> 00:12:33,960
whenever and particularly when I
play golf or something, when I,
257
00:12:34,120 --> 00:12:37,040
when I really had to stretch
those muscles and gin joints.
258
00:12:37,280 --> 00:12:40,600
And so after with Hatches
endorsement, I started using
259
00:12:40,600 --> 00:12:44,480
Kratom from that day forward.
And I, I usually consume at the
260
00:12:44,480 --> 00:12:46,440
time I was doing it probably
five days a week.
261
00:12:46,440 --> 00:12:49,560
As I've gotten a little older, a
lot older, I'm taking it every
262
00:12:49,560 --> 00:12:51,600
day and I take between 4:00 and
6:00 grams a day.
263
00:12:51,600 --> 00:12:55,480
It's not a lot, but it helps me
cut the pain and I can function
264
00:12:55,480 --> 00:12:58,040
fully on it.
And I've been doing that now for
265
00:12:58,040 --> 00:13:01,200
eight years.
And so it's, and it's really, it
266
00:13:01,200 --> 00:13:04,680
has given me a perspective about
how it really can help people.
267
00:13:04,680 --> 00:13:08,000
When I hear the personal
testimonies of people, I can
268
00:13:08,000 --> 00:13:10,640
relate to them because I've
experienced it myself.
269
00:13:10,880 --> 00:13:14,320
And you know, I don't experience
any of the so-called addiction
270
00:13:14,320 --> 00:13:16,960
or the cravings for it.
I don't have any of those kinds
271
00:13:16,960 --> 00:13:20,040
of feelings.
I, I have had on occasion to not
272
00:13:20,040 --> 00:13:22,840
use it for a couple of days or
in one case for a week.
273
00:13:22,840 --> 00:13:25,720
And 1/2 when I went overseas
and, and I just didn't want to
274
00:13:25,720 --> 00:13:28,120
be traveling with him because I
was going to stop me in the
275
00:13:28,120 --> 00:13:31,160
country, Singapore, that it's
not well liked on any drug.
276
00:13:31,400 --> 00:13:34,800
And so, but I've not experienced
any withdrawal symptoms and none
277
00:13:34,800 --> 00:13:38,600
of the classic the kinds of
experiences some people relate
278
00:13:38,600 --> 00:13:41,040
to with drugs where they get
withdrawals.
279
00:13:41,240 --> 00:13:43,520
I don't think I'm addicted to
kratom in any way.
280
00:13:43,720 --> 00:13:46,680
I think my major addiction is
really the caffeine and Diet
281
00:13:46,680 --> 00:13:49,240
Coke, which is my primary
addictive substance.
282
00:13:49,240 --> 00:13:52,600
And the kratomism is not the
same experience at all.
283
00:13:52,600 --> 00:13:57,040
So that's my personal experience
in using kratom and how I got
284
00:13:57,040 --> 00:14:01,000
introduced to it and how it
really is helping me on a daily
285
00:14:01,000 --> 00:14:04,520
basis as I confront these old
age symptoms and this prior
286
00:14:04,520 --> 00:14:08,120
injury from my stupid youth.
What a wild story.
287
00:14:08,120 --> 00:14:11,160
I had no idea you've been a
credium consumer all these
288
00:14:11,160 --> 00:14:12,760
years.
Wow.
289
00:14:12,880 --> 00:14:15,800
And Orrin Hatch too.
I, I, you know, I knew about
290
00:14:15,800 --> 00:14:19,560
the, the Shea Act and, and his
support for dietary supplements.
291
00:14:19,560 --> 00:14:22,440
I did not know he was also a
kratom consumer.
292
00:14:22,440 --> 00:14:26,960
And that really says a lot about
having somebody like him able to
293
00:14:26,960 --> 00:14:31,160
talk to the FDA and, and help
put pressure on when they wanted
294
00:14:31,160 --> 00:14:34,560
to ban this in 2016.
Was this banned that they wanted
295
00:14:34,560 --> 00:14:36,800
to do in 2016?
Did this like just come out of
296
00:14:36,800 --> 00:14:38,920
nowhere?
Like this was just something
297
00:14:38,920 --> 00:14:41,640
that there was like, were there
things leading up to them
298
00:14:41,640 --> 00:14:44,200
wanting to ban Dan Kratom?
Yeah, well, there are two
299
00:14:44,200 --> 00:14:46,560
things.
One is the the FDA has had a
300
00:14:46,560 --> 00:14:50,200
long standing bias, particularly
with one individual who's been
301
00:14:50,200 --> 00:14:53,200
there this whole time for
decades about dietary
302
00:14:53,200 --> 00:14:55,280
supplements and botanical
supplements.
303
00:14:55,280 --> 00:14:58,720
And if the FDA had their way,
they would repeal to shade today
304
00:14:59,000 --> 00:15:02,560
and they tried to nip around the
edges and use regulatory
305
00:15:02,560 --> 00:15:05,480
authorities granted by DSHEA.
And it will be that's adverse to
306
00:15:05,480 --> 00:15:08,160
the to the Dietary Summit and
the kratom community.
307
00:15:08,440 --> 00:15:10,920
So they have just an inherent
bias against them.
308
00:15:11,160 --> 00:15:15,040
But kratom got on their radar
really when they started to hear
309
00:15:15,040 --> 00:15:18,760
reports that smoke shop owners
were getting creative.
310
00:15:18,800 --> 00:15:21,760
They became alchemists and they
started mixing kratom with other
311
00:15:21,760 --> 00:15:24,680
things.
And you started to hear reports
312
00:15:24,680 --> 00:15:27,840
of adverse events.
And not surprisingly, the FDA
313
00:15:27,840 --> 00:15:29,920
started to look at it and so did
the DEA.
314
00:15:30,120 --> 00:15:35,000
And then in 2009, the catalyst
was that you had 9 deaths in a
315
00:15:35,000 --> 00:15:39,160
12 month period in Sweden that
were attributed to 1 product, a
316
00:15:39,320 --> 00:15:42,080
kratom, a powder kratom product
called Krypton.
317
00:15:42,320 --> 00:15:45,480
And it was sold everywhere in
Europe on the Internet.
318
00:15:45,760 --> 00:15:49,960
And so very popular product.
And 9 deaths in a 12 month
319
00:15:49,960 --> 00:15:53,600
period is a matter of huge
public health concern.
320
00:15:53,640 --> 00:15:56,720
And it resulted in a number of
European countries banning
321
00:15:56,720 --> 00:15:58,680
kratom.
The FDA didn't have that
322
00:15:58,680 --> 00:16:01,120
authority on their own as some
other countries do.
323
00:16:01,280 --> 00:16:04,520
So they initiated an import
alert and they started laying
324
00:16:04,520 --> 00:16:08,040
the foundation for how they
could build the scientific
325
00:16:08,040 --> 00:16:10,800
dossier that would allow them to
schedule kratom.
326
00:16:11,000 --> 00:16:12,760
So it took them longer than they
thought.
327
00:16:13,000 --> 00:16:16,840
Now the one thing that is very
disappointing about all of this
328
00:16:16,840 --> 00:16:21,080
and it shows the bias of the FDA
against dietary supplements and
329
00:16:21,080 --> 00:16:25,000
botanical supplements is that
when this they identified these
330
00:16:25,000 --> 00:16:27,480
9 deaths.
One of the things that the FDA
331
00:16:27,480 --> 00:16:31,680
has an obligation to do is to
survey all of the peer reviewed
332
00:16:31,680 --> 00:16:34,960
public literature on any of
substance of which they have
333
00:16:34,960 --> 00:16:38,200
developed a interest in from a
safety perspective.
334
00:16:38,480 --> 00:16:41,960
So there is a peer reviewed
published article called the
335
00:16:41,960 --> 00:16:45,400
Cronstand Report that was
published in 2011.
336
00:16:45,640 --> 00:16:49,840
So he had the deaths in 2009 and
then you had the FDA
337
00:16:49,840 --> 00:16:52,920
implementing their first import
alert in 2012.
338
00:16:53,320 --> 00:16:57,600
So the significant event between
the death reports and their
339
00:16:57,600 --> 00:17:01,000
import alert was the publication
of the Constand report, which
340
00:17:01,000 --> 00:17:04,880
said that the Krypton powdered
kratom product had been
341
00:17:04,880 --> 00:17:09,040
adulterated with Odess methyl
tramadol, which is the chemical
342
00:17:09,040 --> 00:17:11,079
used to develop the opioid
tramadol.
343
00:17:11,319 --> 00:17:16,480
It is a powerful painkiller.
It is also highly toxic and
344
00:17:16,480 --> 00:17:19,040
deadly if it's not managed
properly.
345
00:17:19,280 --> 00:17:22,560
And the report from these
scientists was that it was the
346
00:17:22,560 --> 00:17:25,920
introduction of that adultery
that was the likely cause of
347
00:17:25,920 --> 00:17:29,280
those deaths.
The FDA had an obligation to
348
00:17:29,720 --> 00:17:32,560
factor that in, but they ignored
it, completely ignored it.
349
00:17:32,720 --> 00:17:36,000
And it's one thing to say that
they maybe missed it when they
350
00:17:36,640 --> 00:17:38,760
did the import alert.
I don't think that's possible,
351
00:17:38,760 --> 00:17:41,720
but they they could argue that.
But there's no question that
352
00:17:41,720 --> 00:17:46,080
when they actually filed the
petition with the DEA to
353
00:17:46,080 --> 00:17:48,800
schedule kratom, they listed
those nine deaths.
354
00:17:49,040 --> 00:17:52,320
So at that point, they had an
absolute affirmative legal
355
00:17:52,320 --> 00:17:55,320
obligation to survey all peer
reviewed public literature, and
356
00:17:55,320 --> 00:17:58,600
they chose to ignore it.
And they use those nine deaths
357
00:17:58,600 --> 00:18:02,000
as one of their hallmark
examples of how creating was
358
00:18:02,000 --> 00:18:04,040
dangerous.
And under the eight factors,
359
00:18:04,240 --> 00:18:07,480
Factor 6 says that they have to
prove that there's an eminent
360
00:18:07,480 --> 00:18:10,040
threat to the safety of the
American people from the use of
361
00:18:10,040 --> 00:18:12,640
this substance.
They used those nine guests as
362
00:18:12,640 --> 00:18:16,120
one of the 33 in their initial
recommendation for scheduling.
363
00:18:16,320 --> 00:18:20,000
It was disingenuous, it was
dishonest, and yet they did.
364
00:18:20,120 --> 00:18:21,920
And they were not held to
account.
365
00:18:22,040 --> 00:18:24,600
Well, they were eventually, but
they weren't held to account the
366
00:18:24,600 --> 00:18:26,200
way that they should have been
at the time.
367
00:18:26,360 --> 00:18:31,440
And it was only because of the
outcry from the 23,000 people
368
00:18:31,600 --> 00:18:34,440
that eventually got their
comments on the record that they
369
00:18:34,440 --> 00:18:37,960
were calling in advance of that,
the DEA public affairs officer
370
00:18:37,960 --> 00:18:40,760
told me at the end of September.
And the deadline was it was
371
00:18:40,760 --> 00:18:43,800
going to and take effect
September 30th after the 30 days
372
00:18:43,800 --> 00:18:46,520
of the publication.
He said that we got more calls
373
00:18:46,520 --> 00:18:50,160
on Kratom than we had on any
other scheduling recommendation
374
00:18:50,160 --> 00:18:52,160
in the past.
And so it he said it was
375
00:18:52,160 --> 00:18:55,520
thousands of calls.
He was quoted later saying 6000
376
00:18:55,520 --> 00:18:57,280
calls.
That's a significant number.
377
00:18:57,520 --> 00:19:02,320
And then you had 23,232 comments
submitted when the when the DEO
378
00:19:02,320 --> 00:19:06,320
opened up their comment period
and you had 147,000 petition
379
00:19:06,320 --> 00:19:09,960
signatures on the White House's
We the People website petition
380
00:19:09,960 --> 00:19:12,840
platform.
That was amazing and all of
381
00:19:12,840 --> 00:19:14,720
that.
And you would think that the FDA
382
00:19:14,720 --> 00:19:17,320
would say, you know what, we
need to look at this.
383
00:19:17,320 --> 00:19:20,040
We need to examine whether this
is the right thing to do or not.
384
00:19:20,320 --> 00:19:23,080
But they didn't care.
And it's largely because of one
385
00:19:23,080 --> 00:19:27,760
guy at the FDA who remains there
to this day, who leads this war
386
00:19:27,760 --> 00:19:29,440
on predom.
And he's influential.
387
00:19:29,600 --> 00:19:33,280
He obviously misled Scott
Gottlieb when he became the FDA
388
00:19:33,280 --> 00:19:36,240
commissioner and he's misleading
Commissioner Caleb today.
389
00:19:36,520 --> 00:19:39,360
And yet he gets away with it.
And it's a tragic, and that's in
390
00:19:39,360 --> 00:19:43,400
it from that standpoint.
Wow, it's so disappointing to
391
00:19:43,400 --> 00:19:47,840
hear that that like one person
there, you know, it is the one
392
00:19:47,840 --> 00:19:51,560
that is trying to keep us from
having legal access to this plan
393
00:19:51,560 --> 00:19:53,960
is it's helping millions of
people around the US.
394
00:19:54,400 --> 00:19:57,160
It's just crazy.
You know, when I saw the
395
00:19:57,160 --> 00:20:00,160
documentary A Leap of Faith, you
know, I discovered Kramer in
396
00:20:00,160 --> 00:20:02,320
2019.
So all this stuff y'all did
397
00:20:02,320 --> 00:20:04,640
prior, it's amazing to learn
about it.
398
00:20:04,640 --> 00:20:07,040
And so I learned a lot about it
in the documentary Leap of
399
00:20:07,040 --> 00:20:09,240
Faith.
And to see that Chris Bell went
400
00:20:09,240 --> 00:20:13,880
on Joe Rogan's podcast and that
prompted a lot of people to get
401
00:20:13,880 --> 00:20:17,760
active and to reach out and say
please don't ban this.
402
00:20:17,760 --> 00:20:20,880
Do you think that helped a lot
with all of those calls and in
403
00:20:20,880 --> 00:20:23,000
2016 to help keep it from
getting banned?
404
00:20:23,000 --> 00:20:25,000
What did that play a big role in
it, you think?
405
00:20:25,480 --> 00:20:28,640
There's no question that the
community, the advocacy
406
00:20:28,640 --> 00:20:33,240
community, consumers rallied.
And I think it was a combination
407
00:20:33,600 --> 00:20:37,000
of that kind of influencer that
was feeding into it.
408
00:20:37,000 --> 00:20:41,080
I think that something that
happened at that time with the
409
00:20:41,080 --> 00:20:44,560
vendor community where they
rallied, they were putting up
410
00:20:44,560 --> 00:20:47,800
handmade signs on their cash
registers telling people to
411
00:20:47,800 --> 00:20:50,560
reach out to the DEA and oppose
this.
412
00:20:50,800 --> 00:20:53,160
You saw this.
I call it an outcry.
413
00:20:53,360 --> 00:20:57,720
It was a passionate outcry from
consumers who were saying a very
414
00:20:57,720 --> 00:21:01,480
simple message, this is helping
me, it's not hurting me, This is
415
00:21:01,480 --> 00:21:03,840
saving my life.
I'm not dying.
416
00:21:04,080 --> 00:21:06,800
And it's that kind of thing when
you look at the options.
417
00:21:06,800 --> 00:21:12,040
And the theme of that messaging
resonates to this day with the
418
00:21:12,040 --> 00:21:15,040
National Institutes of Drug
Abuse Director Nora Volkow.
419
00:21:15,240 --> 00:21:18,200
That's what she says.
This is a valuable, a
420
00:21:18,200 --> 00:21:21,200
potentially valuable harm
reduction tool in our war
421
00:21:21,200 --> 00:21:25,120
against the opioid crisis.
Why wouldn't we let people have
422
00:21:25,120 --> 00:21:28,520
access to a product that
otherwise they're trapped in the
423
00:21:28,520 --> 00:21:33,560
addictions and the actual risk
of death because they are using
424
00:21:33,560 --> 00:21:35,760
opioids?
And that's exactly the message
425
00:21:36,080 --> 00:21:39,400
that the assistant secretary for
Health, Brett Shaw said when he
426
00:21:39,400 --> 00:21:42,920
issued his withdrawal letter,
which I think is the Bible for
427
00:21:42,920 --> 00:21:46,880
any crate of advocate to go read
that because he said that not
428
00:21:46,880 --> 00:21:49,960
only was the evidence and data
that the FDA provided
429
00:21:49,960 --> 00:21:53,560
embarrassingly poor, but then
the the phrase it's often
430
00:21:53,560 --> 00:21:56,400
overlooked and a failure to
consider the overall public
431
00:21:56,400 --> 00:21:59,000
health.
This is about a battle that we
432
00:21:59,000 --> 00:22:02,040
have with people that are
entrapped in this opioid crisis
433
00:22:02,040 --> 00:22:05,160
who are dying.
And we have evidence that proves
434
00:22:05,400 --> 00:22:09,120
that people are able to not even
go down that path because
435
00:22:09,120 --> 00:22:12,200
they're managing their pain with
kratom or they're able to wean
436
00:22:12,200 --> 00:22:15,880
off of those dangerously
addictive and potentially deadly
437
00:22:16,240 --> 00:22:19,600
opioid products with using
kratom, not the kratom as an
438
00:22:19,600 --> 00:22:21,880
opioid.
Kratom doesn't have the same
439
00:22:21,880 --> 00:22:24,280
effects.
Opioids are essential to the
440
00:22:24,280 --> 00:22:26,440
management of pain for many
people.
441
00:22:26,640 --> 00:22:29,720
But when you're addicted to them
and you're not man in your pain
442
00:22:29,720 --> 00:22:33,080
anymore, you are fighting a full
blown addiction that traps you
443
00:22:33,360 --> 00:22:36,440
into a very dangerous situation,
then it's got to stop.
444
00:22:36,480 --> 00:22:40,360
And that's what I think Doctor
Zuwa was recognizing that there
445
00:22:40,360 --> 00:22:42,400
are people out there that are
struggling that don't have
446
00:22:42,400 --> 00:22:44,560
access to traditional
treatments.
447
00:22:44,880 --> 00:22:48,320
When I talked to Doctor Jawah
and thanked him when I found out
448
00:22:48,320 --> 00:22:51,320
about his withdrawal letter, he
said to me, he said, Mac, he
449
00:22:51,320 --> 00:22:55,000
said I am not a kratom advocate.
He said, I don't know whether
450
00:22:55,000 --> 00:22:56,600
kratom is good or bad.
I have no idea.
451
00:22:56,920 --> 00:22:59,320
He said I tended to agree with
the FDA when I first heard about
452
00:22:59,320 --> 00:23:00,920
it because they're smart and
they know what they're doing.
453
00:23:01,160 --> 00:23:03,200
He said, but in this case, the
FDA was wrong.
454
00:23:03,440 --> 00:23:07,000
He said, I'm an advocate for
good science and I can recognize
455
00:23:07,000 --> 00:23:09,720
bad science when I see it.
And that's what I saw in the
456
00:23:10,120 --> 00:23:13,480
evidence and data that was
presented by the FDA in an
457
00:23:13,480 --> 00:23:16,520
attempt to do one of the most
monumental decisions under the
458
00:23:16,520 --> 00:23:20,200
Controlled Substances Act, the
death penalty under a schedule
459
00:23:20,200 --> 00:23:23,600
one for a substance like kratom.
He said it made no sense to him.
460
00:23:23,920 --> 00:23:28,640
So that's where we were in 2016.
You would think that the FDA
461
00:23:28,880 --> 00:23:34,200
would recognize that criticism
and self examine themselves and
462
00:23:34,200 --> 00:23:36,840
try to figure out how they can
properly regulate.
463
00:23:37,240 --> 00:23:39,920
They refuse to.
They still want to ban it, and
464
00:23:39,920 --> 00:23:43,120
they persist in that to this
day, despite the many, many
465
00:23:43,120 --> 00:23:46,800
setbacks that they have, even by
their own scientific research
466
00:23:47,040 --> 00:23:49,800
and even when they are called
out by a federal judge.
467
00:23:50,040 --> 00:23:53,360
They just did it earlier this
year saying show me the
468
00:23:53,360 --> 00:23:55,960
evidence, and they refuse to
show up to do that.
469
00:23:56,200 --> 00:24:00,520
The FDA is so wrong on the
science that it's embarrassing.
470
00:24:00,560 --> 00:24:02,640
And they should stand down and
they should find a way to
471
00:24:02,640 --> 00:24:05,320
regulate this product so that it
really, truly does protect the
472
00:24:05,320 --> 00:24:07,000
American people.
Agreed.
473
00:24:07,000 --> 00:24:10,800
As a regular daily kratom
consumer, I I would love to see
474
00:24:10,800 --> 00:24:13,520
regulations.
I would love to see the KCPA all
475
00:24:13,520 --> 00:24:16,880
across the US.
You know it, it is in my state
476
00:24:16,880 --> 00:24:19,480
of Texas, which I really
appreciate as a consumer.
477
00:24:19,760 --> 00:24:22,320
I would love to see this for
everyone because we want to know
478
00:24:22,320 --> 00:24:26,720
what we're getting is safe and
in following the guidelines of
479
00:24:26,800 --> 00:24:29,600
of what is safe kratom.
Absolutely.
480
00:24:29,600 --> 00:24:31,520
And and there's a pathway to do
that.
481
00:24:31,800 --> 00:24:36,600
The FDA doesn't have to take
this regulatory harsh pathway
482
00:24:36,600 --> 00:24:39,160
that they're taking.
It's just ingrained in them.
483
00:24:39,160 --> 00:24:42,720
Their DNA is that they are going
to fight against any product
484
00:24:42,720 --> 00:24:44,520
that they believe should be a
drug.
485
00:24:44,800 --> 00:24:48,840
And they know that for kratom,
that's not possible unless the
486
00:24:48,840 --> 00:24:53,160
molecule or the alkaloid is
converted into a chemical
487
00:24:53,560 --> 00:24:56,640
version of it, which can then be
patented because they know the
488
00:24:56,640 --> 00:25:00,800
kratom is not patentable and
there's no interest by anyone in
489
00:25:00,800 --> 00:25:04,880
the pharma community.
But for changing the alkaloid
490
00:25:04,920 --> 00:25:09,600
and and, you know, synthesizing
it into a dose level of kratom
491
00:25:09,600 --> 00:25:11,960
that would have a much more
powerful effect for a
492
00:25:11,960 --> 00:25:14,920
therapeutic benefit.
The FDA just doesn't, they don't
493
00:25:14,920 --> 00:25:17,120
believe in dietary supplements.
They don't believe in botanical
494
00:25:17,120 --> 00:25:18,720
supplements.
And in fact, they hate them.
495
00:25:18,920 --> 00:25:22,920
And kratom is just their cause
dejour today that we need to
496
00:25:22,920 --> 00:25:25,720
fight back on.
And I think I see a pathway for
497
00:25:25,720 --> 00:25:28,880
the future which they're going
to get overwhelmed by their own
498
00:25:28,880 --> 00:25:32,560
ineptitude on this issue, just
like they did themselves in on
499
00:25:32,560 --> 00:25:35,160
dietary supplements in general.
Well, I think it helps
500
00:25:35,160 --> 00:25:38,800
tremendously knowing that we
have you on our side, Mac, as a
501
00:25:38,800 --> 00:25:43,480
fellow kratom consumer who has
amazing influence in DC, who
502
00:25:43,480 --> 00:25:47,320
gets across all over the US,
speaking with all these
503
00:25:47,360 --> 00:25:50,920
potential bands that come up, it
seems like almost every day
504
00:25:50,920 --> 00:25:53,920
you're like traveling, you're
somewhere, you're popping up in
505
00:25:53,920 --> 00:25:57,720
a live stream or talking about
it, letting us in a webinar,
506
00:25:57,720 --> 00:26:01,280
letting us know what's going on.
I'm just I never was that
507
00:26:01,280 --> 00:26:04,440
involved in politics but once I
started as a kratom consumer in
508
00:26:04,440 --> 00:26:09,120
2019 join the American Crime
Association like right away and
509
00:26:09,360 --> 00:26:13,440
have been blown away at how much
goes on in government all the
510
00:26:13,440 --> 00:26:16,000
time when it comes to this plant
is mind blowing.
511
00:26:16,320 --> 00:26:18,760
Yeah, it truly is.
And it's fascinating to see the
512
00:26:18,800 --> 00:26:23,800
evolution of the understanding
of politicians and regulators
513
00:26:23,800 --> 00:26:27,400
about kratom because that big
hill to climb is when the FDA
514
00:26:27,400 --> 00:26:29,280
says something's bad, it must be
true.
515
00:26:29,520 --> 00:26:32,600
We should have the faith in the
FDA to do the right thing all of
516
00:26:32,600 --> 00:26:34,840
the time.
Unfortunately, we can't.
517
00:26:35,040 --> 00:26:36,800
This isn't the first time
they've made a mistake.
518
00:26:36,800 --> 00:26:39,720
It just happens to be the the
one that's most important to us
519
00:26:39,720 --> 00:26:42,400
right now.
But the bottom line is that the
520
00:26:42,400 --> 00:26:46,520
FDA has an affirmative statutory
obligation to tell the truth and
521
00:26:46,520 --> 00:26:47,720
they're not doing that right
now.
522
00:26:48,240 --> 00:26:51,840
The perfect example is to look
at the FDA and kratom web page
523
00:26:51,840 --> 00:26:53,440
that's up on their website right
now.
524
00:26:53,840 --> 00:26:58,440
They declare on that website,
and it is the basis for actions
525
00:26:58,440 --> 00:27:01,920
by regulators around the
country, including in this in
526
00:27:01,920 --> 00:27:05,720
the state of Ohio, in state of
Washington and New Mexico.
527
00:27:06,040 --> 00:27:09,560
It's growing because they look
at that website and it says that
528
00:27:09,560 --> 00:27:13,040
no kratom product is allowed for
sale that's formulated or
529
00:27:13,040 --> 00:27:15,280
treated as.
And then they list a whole bunch
530
00:27:15,280 --> 00:27:19,240
of jargon that makes people
believe that that must mean all
531
00:27:19,240 --> 00:27:21,440
kratom is illegal and it does
not.
532
00:27:21,720 --> 00:27:25,760
But most importantly, the FDA's
obligation to tell the truth on
533
00:27:25,760 --> 00:27:29,040
it.
It has a an important guardrail.
534
00:27:29,040 --> 00:27:32,800
And that is that in order to
make that declaration, they are
535
00:27:32,800 --> 00:27:36,920
required under the under the
statutes that they have to go
536
00:27:36,920 --> 00:27:38,400
through the Administrative
Procedures Act.
537
00:27:38,400 --> 00:27:40,840
They have to go through
rulemaking, which allows for
538
00:27:40,840 --> 00:27:43,680
public comment.
It would allow for scientists to
539
00:27:43,680 --> 00:27:46,560
step up and say, oh, you're
wrong on this or you're right,
540
00:27:46,560 --> 00:27:49,520
depending on the perspective.
It would require public comment
541
00:27:49,520 --> 00:27:53,280
to be able to say, here's the
consumer experience that I have
542
00:27:53,480 --> 00:27:56,200
that you need to listen to.
They did not do any of that.
543
00:27:56,200 --> 00:27:59,800
And yet they're taking this
affirmative stance against
544
00:27:59,800 --> 00:28:03,000
kratom, saying that it's illegal
for sale in the United States.
545
00:28:03,000 --> 00:28:05,880
And unfortunately, some of the
local jurisdictions are getting
546
00:28:05,880 --> 00:28:08,520
duped by it.
I just got notice about one over
547
00:28:08,520 --> 00:28:12,200
the weekend in Albuquerque, NM,
where a local health authority
548
00:28:12,440 --> 00:28:17,120
came in and relied upon the
FDA's position and claiming the
549
00:28:17,120 --> 00:28:20,120
kratom is not legal for sale.
What's happening in Las Vegas
550
00:28:20,120 --> 00:28:22,840
right now?
There were representatives and
551
00:28:22,840 --> 00:28:26,240
investigators from the Southern
Nevada Health District that went
552
00:28:26,240 --> 00:28:30,840
to a trade show in Las Vegas
over the weekend and shut down 5
553
00:28:30,840 --> 00:28:32,320
kratom booths at that trade
show.
554
00:28:32,560 --> 00:28:36,200
The trade show business is huge
in Las Vegas and they're now
555
00:28:36,200 --> 00:28:39,360
interfering with that business.
And so I think that's going to
556
00:28:39,360 --> 00:28:41,760
cause an outcry from some of the
people at the Chamber of
557
00:28:41,760 --> 00:28:44,200
Commerce and others who are very
concerned that they're just
558
00:28:44,200 --> 00:28:46,560
overreacting.
And they cite the FDA.
559
00:28:46,800 --> 00:28:49,720
The Ohio Department of
Agriculture did the same thing.
560
00:28:50,000 --> 00:28:55,120
This is a pernicious outcome of
a policy that is driven by the
561
00:28:55,120 --> 00:28:59,080
bias of the FDA, not facts, not
any evidence, because we already
562
00:28:59,080 --> 00:29:01,720
know the evidence is not there.
And they cannot even prove their
563
00:29:01,720 --> 00:29:03,880
claim that it's dangerous in a
court of law.
564
00:29:04,040 --> 00:29:05,720
They just like to bluster their
way through.
565
00:29:05,720 --> 00:29:08,760
So the FDA has got to be held
accountable going forward
566
00:29:08,760 --> 00:29:12,240
because our lives, our lives are
the ones that are in the
567
00:29:12,240 --> 00:29:14,240
balance.
They take this away.
568
00:29:14,440 --> 00:29:16,880
And if they're able to
successfully ban it from the
569
00:29:16,880 --> 00:29:20,120
marketplace, where do people go?
It's what Doctor Zhua said.
570
00:29:20,120 --> 00:29:23,640
They're going to go to more
harmful, potentially more highly
571
00:29:23,640 --> 00:29:26,640
addictive and dangerous products
in order to manage acute and
572
00:29:26,640 --> 00:29:28,560
chronic pain.
There's no excuse for that.
573
00:29:28,760 --> 00:29:32,440
And we hear voices like that,
those in the military that are
574
00:29:32,440 --> 00:29:35,920
saying kratom has saved my life
to me when I was when I was
575
00:29:35,920 --> 00:29:38,720
under the VA scare and I was
addicted to opioids and it was
576
00:29:38,720 --> 00:29:41,040
ruining my life.
We see one after another of
577
00:29:41,040 --> 00:29:42,800
those people that that are doing
that.
578
00:29:42,800 --> 00:29:45,520
And then you have Congressman
Jack Bergman, who speaks up for
579
00:29:45,520 --> 00:29:48,360
veterans as a former Lieutenant
General in the Marine Corps.
580
00:29:48,560 --> 00:29:51,240
And he's passionate about this.
And he says the FDA has got to
581
00:29:51,240 --> 00:29:53,160
come around.
And he points to not just
582
00:29:53,160 --> 00:29:56,080
kratom, but it's psilocybin
where they're proven benefits.
583
00:29:56,240 --> 00:29:59,360
They're available to veterans
are suffering from PTSD and
584
00:29:59,360 --> 00:30:00,720
depression.
That's helping them.
585
00:30:00,760 --> 00:30:04,200
And when you see the suicide
problem among our veterans,
586
00:30:04,360 --> 00:30:08,320
because they're struggling with
these issues that they acquired
587
00:30:08,320 --> 00:30:10,960
as a as a condition of their
service, we should be doing
588
00:30:10,960 --> 00:30:14,120
everything we can to help them.
And when you see the potential
589
00:30:14,120 --> 00:30:17,880
value that psilocybin can have
in that area, the FDA ought to
590
00:30:17,880 --> 00:30:20,240
be leading the charge.
And by the way, they're better
591
00:30:20,320 --> 00:30:22,520
on psilocybin.
They are kratom, by the way, but
592
00:30:22,520 --> 00:30:24,040
they're still not there on
either one of them.
593
00:30:24,080 --> 00:30:27,080
And that's why we need to keep
this fight going and we need to
594
00:30:27,080 --> 00:30:29,280
win in order to protect
consumers.
595
00:30:29,720 --> 00:30:32,280
We really do.
Do you feel like, I mean, for
596
00:30:32,280 --> 00:30:36,960
many of us kratom advocates, we
feel like as Big Pharma that is
597
00:30:37,000 --> 00:30:42,120
in the mix somehow working with
the FDACDC, all of them to like,
598
00:30:42,400 --> 00:30:47,160
no, don't let this amazing
plant, you know, remain as is
599
00:30:47,160 --> 00:30:49,920
and helping all these people
because it's keeping us from,
600
00:30:50,040 --> 00:30:53,240
you know, being in the big
pharma and, you know, having all
601
00:30:53,240 --> 00:30:56,280
these high-powered opioids,
which I took for nine years for
602
00:30:56,280 --> 00:30:59,280
my chronic pain, I would much
rather consume kratom, which is
603
00:30:59,280 --> 00:31:02,680
just a plant.
But I don't know, you're so
604
00:31:02,680 --> 00:31:05,120
involved with all of this stuff.
A lot of us just kind of
605
00:31:05,120 --> 00:31:08,800
speculate that Big Pharma has
got to be somehow meddling in
606
00:31:08,800 --> 00:31:11,600
all of this.
Well, this is a complicated
607
00:31:11,600 --> 00:31:13,480
issue, but here's here's what we
know.
608
00:31:13,680 --> 00:31:18,560
There certainly is an incentive
at the FDA to focus on products
609
00:31:18,560 --> 00:31:20,520
for which they receive user
fees.
610
00:31:20,640 --> 00:31:24,400
When the Prescription Drug User
Fee Act was first passed, it was
611
00:31:24,400 --> 00:31:27,920
intended that it would fill the
gap of being able to fund
612
00:31:28,080 --> 00:31:32,440
resources in terms of equipment
and new technology and people to
613
00:31:32,440 --> 00:31:34,840
run it.
And it was estimated that user
614
00:31:34,840 --> 00:31:38,800
fees for prescription drugs
would account for about 9% of
615
00:31:38,800 --> 00:31:41,560
the review budgets of of Cedar,
which is the Center for Drug
616
00:31:41,560 --> 00:31:44,840
Evaluation and Research.
Today, it's over 70%.
617
00:31:45,080 --> 00:31:49,320
So if you are sitting out there
as a, you know, staffer at the
618
00:31:49,320 --> 00:31:52,600
FDA and you're saying, hey, I'm
stressed in my job, we need more
619
00:31:52,600 --> 00:31:55,400
people, we need more equipment,
we need new technology.
620
00:31:55,440 --> 00:31:58,800
Well, the pathway to that is
increasing user fees and getting
621
00:31:58,800 --> 00:32:01,040
it above where it is right now
is a little bit impossible.
622
00:32:01,040 --> 00:32:04,360
But expanding the products that
can contribute is a whole
623
00:32:04,360 --> 00:32:06,760
different bag, right?
So that's what they want.
624
00:32:06,880 --> 00:32:09,600
And so I think there's an
incentive by the regulators at
625
00:32:09,600 --> 00:32:12,480
the FDA to say, well, let's
increase the pool of those
626
00:32:12,480 --> 00:32:15,240
people or products that are
coming onto the marketplace to
627
00:32:15,240 --> 00:32:17,520
pay us the user fee.
So that's one issue.
628
00:32:17,640 --> 00:32:20,760
The second issue, I think that
it really is pernicious, but
629
00:32:20,760 --> 00:32:24,080
it's there is that they're the
incentives are all on their head
630
00:32:24,200 --> 00:32:27,640
when it comes not just the
financing of the way the FDA
631
00:32:27,640 --> 00:32:31,160
does drug evaluations and
research, but it's also the
632
00:32:31,160 --> 00:32:33,600
companies that are involved in
pain management.
633
00:32:33,760 --> 00:32:38,360
There is no question that they
see kratom as a threat to their
634
00:32:38,360 --> 00:32:40,960
marketplace.
And you've got powerful forces
635
00:32:40,960 --> 00:32:42,480
that are that are crunching
them.
636
00:32:42,640 --> 00:32:45,680
You've got the opioid
prescription restrictions that
637
00:32:45,680 --> 00:32:48,400
everyone believes should have
been put in place.
638
00:32:48,520 --> 00:32:50,960
And government like it typically
does overreaction.
639
00:32:50,960 --> 00:32:53,920
Now the pendulum has come from
the door wide open for opioids
640
00:32:53,960 --> 00:32:55,720
under Scott Gottlieb, by the
way.
641
00:32:55,920 --> 00:32:58,840
And now it's swung back where
they don't have the prescribing
642
00:32:58,840 --> 00:33:02,520
authority for physicians to be
adequate to meet the needs of
643
00:33:02,520 --> 00:33:05,360
people in the pain population.
So they've gone way too far.
644
00:33:05,360 --> 00:33:07,080
And this is the way government
reacts, right?
645
00:33:07,280 --> 00:33:10,000
And you've got these companies
out there that see a restricted
646
00:33:10,120 --> 00:33:12,920
marketplace because they're not
allowed to prescribe these
647
00:33:12,920 --> 00:33:15,000
medications.
And then when they see a product
648
00:33:15,000 --> 00:33:18,200
like kratom that is a direct
competitor to the patient
649
00:33:18,200 --> 00:33:20,080
population, they're going to be
down on kratom.
650
00:33:20,120 --> 00:33:22,640
That's not all pharma.
That's just those companies that
651
00:33:22,640 --> 00:33:25,760
are in this cash game, right?
And by the way, we're not immune
652
00:33:25,760 --> 00:33:27,640
to it.
I see this happening right now
653
00:33:27,640 --> 00:33:30,560
in the kratom world.
You have people in the kratom
654
00:33:30,560 --> 00:33:33,680
world that have products that
they want to have preserved in
655
00:33:33,680 --> 00:33:35,840
the marketplace, but want to,
they want to get rid of
656
00:33:35,840 --> 00:33:39,000
competing products that are not
their same product formulation.
657
00:33:39,080 --> 00:33:41,560
And that's happening right right
now as we sit here today.
658
00:33:41,560 --> 00:33:44,840
I was fighting it this morning
with a vendor who's just hell
659
00:33:44,840 --> 00:33:47,640
bent to eliminate his
competition and he uses every
660
00:33:47,640 --> 00:33:50,800
ruse that he can under the sun.
He's now his latest thing is,
661
00:33:50,840 --> 00:33:53,240
oh, we should eliminate all
products that have any
662
00:33:53,240 --> 00:33:56,120
attraction to children.
His definition of what's
663
00:33:56,120 --> 00:33:59,680
attractive to children is is
completely contrary to what the
664
00:33:59,680 --> 00:34:02,440
the Federal Trade Commission and
the the consumer products
665
00:34:02,440 --> 00:34:05,880
division has for what they
qualify as children's products.
666
00:34:06,000 --> 00:34:10,280
But if you package your product
and you have any logo that is
667
00:34:10,440 --> 00:34:13,800
vaguely resembles an animated
character or a cartoonist
668
00:34:13,800 --> 00:34:16,880
character, then you're out.
If you use a color on the
669
00:34:16,880 --> 00:34:19,600
packaging that might be
attractive to children, you're
670
00:34:19,600 --> 00:34:21,040
out.
This is the kind of nonsense
671
00:34:21,040 --> 00:34:23,880
that we get involved in, and
it's all competition, and that's
672
00:34:23,880 --> 00:34:26,560
unfortunate.
So we see this where the a
673
00:34:26,560 --> 00:34:29,520
couple of the big pain
management companies that are
674
00:34:29,520 --> 00:34:31,920
trying to restrict competition
in the marketplace, we're seeing
675
00:34:31,920 --> 00:34:33,560
in our own house.
And that's got to end.
676
00:34:33,600 --> 00:34:36,040
It's got it's simply, we've just
got to turn our backs to that
677
00:34:36,040 --> 00:34:38,920
and say enough of your nonsense.
We're not going to tolerate it
678
00:34:38,920 --> 00:34:41,040
by the by the big pharma
companies that are in the pain
679
00:34:41,040 --> 00:34:42,760
management business and we're
not going to tolerate it with
680
00:34:42,760 --> 00:34:44,440
creating companies.
They just want to eliminate
681
00:34:44,440 --> 00:34:47,159
competition because there's one
thing that a consumer should
682
00:34:47,159 --> 00:34:49,520
have choices.
As long as that product is
683
00:34:49,520 --> 00:34:52,960
formulated safely, as long as
it's labeled correctly with
684
00:34:52,960 --> 00:34:55,320
directions for use, that's what
we should be doing.
685
00:34:55,440 --> 00:34:58,800
And the idea that we let a
company decide that who the
686
00:34:58,800 --> 00:35:02,280
winners and losers are, using
legislation to try to do it is
687
00:35:02,280 --> 00:35:05,160
just is ridiculous.
And I think that's our next
688
00:35:05,160 --> 00:35:07,720
battle.
Do we have to add to the the
689
00:35:07,720 --> 00:35:11,040
battlefront as we go forward in
2025 when we're working in these
690
00:35:11,040 --> 00:35:14,240
states?
We saw what was proposed in the
691
00:35:14,240 --> 00:35:17,000
state of California by the
Global Kratom Coalition.
692
00:35:17,160 --> 00:35:21,840
They had a bill that drove a
number for enforcement that
693
00:35:21,840 --> 00:35:25,200
would have required for a
registration of a kratom product
694
00:35:25,200 --> 00:35:30,040
at 113, $1000 for the first year
and $83,000 every year
695
00:35:30,040 --> 00:35:32,040
thereafter.
Now that eliminates all the
696
00:35:32,040 --> 00:35:35,440
small to mid sized businesses.
And by the way, for contrast,
697
00:35:35,560 --> 00:35:38,120
the state of Utah, first state
that passed the Credit and
698
00:35:38,120 --> 00:35:41,160
Consumer Protection Act has a
product registration fee of
699
00:35:41,160 --> 00:35:43,960
$260.00.
So where does that come from?
700
00:35:43,960 --> 00:35:47,320
Except that they had the most
onerous regulations known to man
701
00:35:47,400 --> 00:35:50,000
embedded in that bill.
And it's largely why you're
702
00:35:50,000 --> 00:35:52,920
seeing the internal civil war
that's developed in the in the
703
00:35:52,960 --> 00:35:55,520
industry here.
Because I went out, I had the
704
00:35:55,520 --> 00:35:58,840
gall to go out and and testify
to the Senate Appropriations
705
00:35:58,840 --> 00:36:02,400
Committee in the California and
I told them this is going to
706
00:36:02,400 --> 00:36:04,240
decimate the workplace.
You're going to you're going to
707
00:36:04,240 --> 00:36:06,600
restrict product availability,
you're going to destroy
708
00:36:06,600 --> 00:36:08,920
innovation.
You are going to open this
709
00:36:08,920 --> 00:36:11,480
marketplace to one or two
products and that's it.
710
00:36:11,600 --> 00:36:15,200
And you will not allow or serve
the consumers to have access to
711
00:36:15,200 --> 00:36:18,200
products that are helping them.
And and it's all about, Oh well,
712
00:36:18,200 --> 00:36:21,800
I want just a powdered kratom
product and a low MIT content
713
00:36:21,800 --> 00:36:25,000
and not any of these extracts.
And they make extracts the evil
714
00:36:25,200 --> 00:36:28,720
a product line, the good is
extracts have a standardized
715
00:36:28,720 --> 00:36:31,120
dosing form and if they're
properly extracted, where you
716
00:36:31,120 --> 00:36:34,640
can't artificially enhance the
alkaloids power beyond what the
717
00:36:34,880 --> 00:36:37,800
the food grade solvents that are
approved by the FDA allow, which
718
00:36:37,800 --> 00:36:40,480
we do for coffee, we do for all
kinds of products.
719
00:36:40,680 --> 00:36:42,960
We consume extract products
every day.
720
00:36:43,120 --> 00:36:45,800
And yet global credit coalition
wanted to eliminate those.
721
00:36:45,800 --> 00:36:49,440
So that's the tragedy of the
internal battle that we have
722
00:36:49,440 --> 00:36:52,960
because it the consumers are the
losers and when this kind of
723
00:36:52,960 --> 00:36:54,680
thing happens.
And so as I say, it's a new
724
00:36:54,680 --> 00:36:56,800
battlefront we've had to open
up, but we're to do it.
725
00:36:57,040 --> 00:36:59,320
We're going to fight tooth and
nail because the one thing that
726
00:36:59,320 --> 00:37:03,040
we believe in is that consumers
ought to have access to properly
727
00:37:03,040 --> 00:37:05,840
manufactured, properly labeled
products where they can make a
728
00:37:05,840 --> 00:37:08,080
choice.
And that it should be at a price
729
00:37:08,080 --> 00:37:09,560
point that's not going to kill
them.
730
00:37:09,680 --> 00:37:11,280
And that's where they can't buy
it.
731
00:37:11,360 --> 00:37:13,480
And they literally could kill
them in that, in that regard,
732
00:37:13,520 --> 00:37:16,040
because some people desperately
need access to these kratom
733
00:37:16,040 --> 00:37:18,800
products.
And not everybody, not everybody
734
00:37:19,000 --> 00:37:22,400
is going to be helped by a
Metrogen and content product
735
00:37:22,400 --> 00:37:26,160
that said 40 milligrams.
We did a survey, we have kratom
736
00:37:26,160 --> 00:37:30,280
vendors and we have over 10
million servings and we found
737
00:37:30,280 --> 00:37:33,520
that the sweet spot where there
are no adverse events reported
738
00:37:33,520 --> 00:37:36,760
is between 160 and 320
milligrams per day.
739
00:37:36,960 --> 00:37:40,240
Now how, how can you justify
saying we're going to limit the
740
00:37:40,240 --> 00:37:43,200
marketplace to only our low MIT
content products?
741
00:37:43,720 --> 00:37:46,560
And and you know, that's fine by
the way, for them to do that,
742
00:37:46,560 --> 00:37:48,200
but they can't eliminate their
competition.
743
00:37:48,560 --> 00:37:51,880
I believe that the future
marketplace of Kratom, when we
744
00:37:51,880 --> 00:37:55,080
get the FDA back in the box and
we get them properly regulated
745
00:37:55,080 --> 00:37:58,640
Kratom, I think that they'll be
a dramatic expansion of kratom's
746
00:37:58,960 --> 00:38:01,560
product lines in America.
And you're going to see those
747
00:38:01,560 --> 00:38:05,040
low MIT content products being
marketed in Whole Foods because
748
00:38:05,040 --> 00:38:07,920
that's all some people need.
And it will appeal to the quote
749
00:38:07,920 --> 00:38:10,480
soccer moms in the world.
I believe in that.
750
00:38:10,640 --> 00:38:13,080
But I don't think that you
cannibalize the rest of the
751
00:38:13,080 --> 00:38:15,600
industry because that's what you
want to sell, because it's your
752
00:38:15,600 --> 00:38:17,360
product.
And that's the, the real
753
00:38:17,360 --> 00:38:21,440
struggle that I have with
accepting this idea that we can
754
00:38:21,640 --> 00:38:23,400
pick winners and losers by
legislation.
755
00:38:23,640 --> 00:38:26,640
Let's pick it by good science.
Let's pick it by properly
756
00:38:26,640 --> 00:38:29,240
manufactured products.
Let's pick it by properly
757
00:38:29,240 --> 00:38:31,520
labeled products so that the
serving size are clearly
758
00:38:31,520 --> 00:38:34,360
identified.
And the obligation to convey
759
00:38:34,360 --> 00:38:37,920
that information on safety is
the manufacturer's obligation,
760
00:38:38,240 --> 00:38:39,840
because that's what the federal
law says.
761
00:38:39,840 --> 00:38:42,960
If you have a reasonable basis
on the safety of your product
762
00:38:43,080 --> 00:38:46,280
under the conditions of use
prescribed on the label, then
763
00:38:46,280 --> 00:38:48,400
you're good.
And, and why should we be the
764
00:38:48,400 --> 00:38:49,640
ones to interfere with that?
Because.
765
00:38:49,720 --> 00:38:52,720
Because it's a competitive
advantage for one manufacturer
766
00:38:52,720 --> 00:38:55,160
over another.
It's why y'all have my full
767
00:38:55,160 --> 00:38:57,400
support of the American KREM
Association because y'all are
768
00:38:57,400 --> 00:39:00,640
doing things right and I
appreciate all that effort.
769
00:39:00,640 --> 00:39:04,440
And while I personally only
consume the whole leaf kratom
770
00:39:04,440 --> 00:39:06,600
powder, I have no need for the
extracts.
771
00:39:06,600 --> 00:39:10,080
I do believe that they do have
their place for people it, you
772
00:39:10,080 --> 00:39:13,600
know, in some situations,
especially somebody that that's
773
00:39:13,600 --> 00:39:17,240
consume kratom, they understand
it and and I'm totally fine with
774
00:39:17,240 --> 00:39:19,960
that.
But I just don't like the idea
775
00:39:19,960 --> 00:39:22,920
that there's all this division
that's been happening because
776
00:39:22,920 --> 00:39:26,040
you got this other group just
trying to make radical changes
777
00:39:26,040 --> 00:39:28,440
that don't benefit the consumers
overall.
778
00:39:28,720 --> 00:39:31,080
That's a problem.
You know, it's interesting
779
00:39:31,080 --> 00:39:35,240
because one of the things that
we, I thought we agreed on was 7
780
00:39:35,240 --> 00:39:38,920
OH products because those
products are potentially far
781
00:39:38,920 --> 00:39:42,240
more dangerous.
And here we are in a situation
782
00:39:42,240 --> 00:39:44,040
where there's no way to
eliminate them.
783
00:39:44,040 --> 00:39:46,880
Because if you have the standard
that the federal government
784
00:39:47,040 --> 00:39:50,560
requires, they should be allowed
to be in the marketplace if, if
785
00:39:50,560 --> 00:39:52,360
the science proves it, and
that's a big if.
786
00:39:52,480 --> 00:39:55,600
And if the labeling is
sufficient to protect consumers.
787
00:39:55,800 --> 00:39:58,560
It's the same way that Kaaba
Kratin products get on the
788
00:39:58,560 --> 00:40:00,760
marketplace because there's no
peer review publicly public
789
00:40:00,760 --> 00:40:02,960
literature that says those that
combination of products is safe.
790
00:40:03,120 --> 00:40:05,960
I asked the question, I got
rebuked on even getting that
791
00:40:05,960 --> 00:40:08,240
information and here's the
critical problem.
792
00:40:08,240 --> 00:40:11,560
When we confront that issue, how
do we decide what the fair
793
00:40:11,560 --> 00:40:15,080
marketplace evaluation of the
safety of these products is?
794
00:40:15,080 --> 00:40:17,120
It should not be because I don't
like it.
795
00:40:17,120 --> 00:40:20,440
So what we did is we went to the
seven O 8 people and said our
796
00:40:20,440 --> 00:40:22,800
big problem here is you're
calling it kratom because
797
00:40:22,840 --> 00:40:25,600
there's the consumer should know
this is not a kratom product.
798
00:40:25,640 --> 00:40:29,960
So we struck an agreement that
this heart group that represents
799
00:40:29,960 --> 00:40:34,080
a significant percentage of the
70 H community agreed that they
800
00:40:34,080 --> 00:40:37,360
will no longer market their
products as kratom products.
801
00:40:37,480 --> 00:40:39,880
That was a significant step.
That's what the scientists have
802
00:40:39,880 --> 00:40:41,640
been telling us.
You can't let them call it a
803
00:40:41,640 --> 00:40:43,720
kratom product.
We do that and suddenly it's
804
00:40:43,720 --> 00:40:46,640
like we shot our mother because
the Global Kratom Coalition, I
805
00:40:46,640 --> 00:40:49,000
said, oh, my goodness.
I mean, what a terrible decision
806
00:40:49,000 --> 00:40:50,040
that was.
Well, you know what?
807
00:40:50,040 --> 00:40:52,560
I think it was a decision that
we got to 1st and they didn't.
808
00:40:52,640 --> 00:40:55,440
And that's why they demonized it
that hard because we agree.
809
00:40:55,560 --> 00:40:58,200
We agree on the fundamentals,
and yet it wasn't good enough.
810
00:40:58,200 --> 00:40:59,960
It wasn't fun.
Yeah, we didn't give far enough
811
00:40:59,960 --> 00:41:02,920
into it the way that they wanted
to or the way that they would
812
00:41:02,920 --> 00:41:05,120
have done it.
Not a perfect solution because
813
00:41:05,120 --> 00:41:08,080
the perfect solution is for
there to be well developed
814
00:41:08,080 --> 00:41:12,000
science that would document in
human studies, not just on an in
815
00:41:12,000 --> 00:41:13,840
vitro with the animal studies,
none of that.
816
00:41:13,880 --> 00:41:15,920
We need to have good science
that's robust.
817
00:41:15,920 --> 00:41:19,280
And until then, if a company has
that prerequisite that the
818
00:41:19,280 --> 00:41:21,680
federal standard allows, which
is why we have, as I said,
819
00:41:21,680 --> 00:41:24,240
copacrating products, If you
have the science and you have
820
00:41:24,240 --> 00:41:26,280
conditions of use on labeling,
then you should be allowed in
821
00:41:26,280 --> 00:41:29,520
the marketplace until the
documented adverse events you
822
00:41:29,560 --> 00:41:31,640
off the market.
And Chris McCurdy said something
823
00:41:31,640 --> 00:41:34,040
fascinating in our congressional
briefing.
824
00:41:34,120 --> 00:41:37,120
And at the end of his statement,
he said that the forensics labs
825
00:41:37,120 --> 00:41:41,440
in America do not test for the
difference between Metrogeny and
826
00:41:41,440 --> 00:41:44,320
seven hydroxymetrogeny or
spiciosalatine or any of the
827
00:41:44,320 --> 00:41:46,600
other subalkaloids that are
enhanced and concentrated.
828
00:41:46,600 --> 00:41:49,240
So we don't know what those
deaths really are.
829
00:41:49,440 --> 00:41:52,520
That's significant.
And I that I learned something
830
00:41:52,520 --> 00:41:56,040
that that day when I heard that.
And so we're actively looking at
831
00:41:56,040 --> 00:42:00,040
how we can promote better
standards for these and six labs
832
00:42:00,040 --> 00:42:02,360
to make sure we can
differentiate what the content
833
00:42:02,360 --> 00:42:05,400
of those products really are.
That would be amazing.
834
00:42:05,680 --> 00:42:07,800
Would love to see that happen
for sure.
835
00:42:07,800 --> 00:42:09,760
I know we got people listening
to this going.
836
00:42:09,760 --> 00:42:11,760
I didn't even really know much
about American Crane
837
00:42:11,760 --> 00:42:13,560
Association.
We have a lot of people that are
838
00:42:13,560 --> 00:42:15,960
newer to kratom in our
community.
839
00:42:16,640 --> 00:42:19,800
How can people get involved?
You know, luckily for me, I
840
00:42:19,800 --> 00:42:22,560
discovered you guys very early
on in my cranium journey,
841
00:42:22,680 --> 00:42:25,360
probably through a Google
search, I imagine surprisingly.
842
00:42:25,720 --> 00:42:27,760
But I was like, oh, there's an
advocacy group.
843
00:42:27,760 --> 00:42:29,600
This is awesome.
And I immediately joined and
844
00:42:29,600 --> 00:42:32,960
I've been getting the emails
ever since in 2019 all the way
845
00:42:32,960 --> 00:42:35,440
to now.
And it's how I stay informed of
846
00:42:35,560 --> 00:42:38,240
all the stuff that goes on in
this community, especially all
847
00:42:38,240 --> 00:42:41,160
the legal issues.
And it's what got me to come out
848
00:42:41,160 --> 00:42:44,520
to Washington, DC last year when
y'all had the big congressional
849
00:42:44,760 --> 00:42:47,160
briefing on Capitol Hill, which
was amazing, amazing to come
850
00:42:47,160 --> 00:42:51,480
meet you in person, other kratom
vendors, other researchers, as
851
00:42:51,480 --> 00:42:54,360
well as fellow advocates.
And we have such a strong
852
00:42:54,360 --> 00:42:56,080
community here.
But it was all because I
853
00:42:56,080 --> 00:42:58,480
discovered American KREM
Association.
854
00:42:58,480 --> 00:43:02,520
So for those are not as familiar
with, I'm sure they are now
855
00:43:02,520 --> 00:43:05,040
after listening to you because I
mean, you're explaining so much
856
00:43:05,040 --> 00:43:07,800
of what y'all do, but how can
people get involved?
857
00:43:07,800 --> 00:43:10,480
They're listening that really
have no idea they could be
858
00:43:10,480 --> 00:43:12,040
involved.
Well, thank you for that
859
00:43:12,040 --> 00:43:15,520
question because we need every
kratom consumer to stand up.
860
00:43:15,840 --> 00:43:19,200
We're seeing the challenge that
the FDA is now initiating at the
861
00:43:19,200 --> 00:43:21,160
local level.
We're seeing more and more of
862
00:43:21,160 --> 00:43:23,960
these bans pop up and everybody
citing the FDA.
863
00:43:24,080 --> 00:43:26,880
And it's clear that the FDA is
pumping that disinformation
864
00:43:26,880 --> 00:43:28,800
campaign out there.
They have allies.
865
00:43:28,800 --> 00:43:30,840
They've got the trial attorneys
that are doing the same thing
866
00:43:30,840 --> 00:43:32,280
and the creating danger
awareness group.
867
00:43:32,520 --> 00:43:34,480
And you know, they're
weaponizing their grief.
868
00:43:34,680 --> 00:43:37,960
All of us feel great empathy for
anyone who's lost a loved one.
869
00:43:38,080 --> 00:43:40,760
But the bottom line, it should
be the truth that is based on
870
00:43:40,800 --> 00:43:43,760
what their advocacy is.
And I suspect, and I know in
871
00:43:43,760 --> 00:43:46,800
many cases that the trial
attorneys of LED these families
872
00:43:46,800 --> 00:43:48,920
down the Primrose path to look
for the payday.
873
00:43:49,080 --> 00:43:52,560
And there really isn't what
they're claiming, but they're
874
00:43:53,000 --> 00:43:55,640
certainly, it's tragic and and I
get that, but you can't
875
00:43:55,640 --> 00:43:57,280
weaponize your grief to the
point where you're just
876
00:43:57,280 --> 00:44:00,200
spreading disinformation.
So we need kratom consumers to
877
00:44:00,200 --> 00:44:02,800
stand up in these local
communities more now than ever.
878
00:44:02,840 --> 00:44:05,800
You can go to americankratom.org
and you can just sign up.
879
00:44:05,880 --> 00:44:08,400
Go to protectkratom.org and you
can sign up.
880
00:44:08,560 --> 00:44:12,240
We're always looking for those
new voices, bodies to fill seats
881
00:44:12,240 --> 00:44:15,120
to stand up before a microphone.
And by the way, I know that's
882
00:44:15,120 --> 00:44:17,960
hard.
I've sat and watched hundreds
883
00:44:17,960 --> 00:44:20,720
and hundreds of people stand
before a microphone and I can,
884
00:44:20,720 --> 00:44:23,080
and I'm sitting behind them and
I can see their knees shaking
885
00:44:23,080 --> 00:44:25,320
and I can see that they're
terrified at this.
886
00:44:25,480 --> 00:44:29,040
But those powerful testimonies
that come through because they
887
00:44:29,040 --> 00:44:32,040
are obviously uncomfortable
doing it, but yet willing to
888
00:44:32,040 --> 00:44:34,840
share it with public officials,
it makes a huge difference.
889
00:44:35,000 --> 00:44:39,000
I can talk policy all day long
and I will be countering against
890
00:44:39,120 --> 00:44:43,200
what the public official was
looking at on his iPad on, you
891
00:44:43,200 --> 00:44:46,560
know, Googling the kratom horror
show on Google.
892
00:44:46,800 --> 00:44:50,960
Nothing, nothing can replace
that consumer standing up and
893
00:44:50,960 --> 00:44:54,000
saying this is how it's impacted
my life and how it saved my
894
00:44:54,000 --> 00:44:55,520
life.
It's helped me, It's got me back
895
00:44:55,520 --> 00:44:57,920
into society.
And I hear so many of those
896
00:44:57,920 --> 00:44:59,920
stories.
So we need every kratom
897
00:44:59,920 --> 00:45:01,520
advocate.
We need to set aside our
898
00:45:01,520 --> 00:45:03,320
differences.
And I know that there are people
899
00:45:03,320 --> 00:45:05,520
that say, oh, the AKA should do
things differently.
900
00:45:05,520 --> 00:45:07,080
We're not perfect.
We've made mistakes.
901
00:45:07,200 --> 00:45:09,800
I wish I could take back a
couple of decisions that we made
902
00:45:09,800 --> 00:45:12,200
early on and they certainly were
trying.
903
00:45:12,320 --> 00:45:15,880
And we may not in every
implementation of decisions or
904
00:45:15,880 --> 00:45:18,800
even well-intentioned may not be
as good at as we need to be, but
905
00:45:18,800 --> 00:45:21,760
we'll overcome that with voice.
People that stand up, willing to
906
00:45:21,760 --> 00:45:24,680
set aside the petty differences
and let's really, let's really
907
00:45:24,680 --> 00:45:25,800
do the right thing for one
another.
908
00:45:25,800 --> 00:45:27,920
I think that's the key.
Absolutely.
909
00:45:27,920 --> 00:45:30,920
Well, it's just amazing all the
stuff y'all do.
910
00:45:30,920 --> 00:45:34,920
And as a consumer, I appreciate
it and I always do everything I
911
00:45:34,920 --> 00:45:38,400
can to help.
Always sharing my testimony
912
00:45:38,400 --> 00:45:40,960
wherever people are directing us
to share it.
913
00:45:40,960 --> 00:45:45,480
For legislators, anybody that
where kratom becomes this issue
914
00:45:45,480 --> 00:45:47,640
all of a sudden and they need to
hear our stories.
915
00:45:47,640 --> 00:45:50,680
You know, when I was in DC for
the congressional briefing last
916
00:45:50,680 --> 00:45:55,000
December last year, I did go to
see my House Rep and, and I tell
917
00:45:55,000 --> 00:45:58,000
people like, look, you don't
have to go to DC to do this.
918
00:45:58,120 --> 00:46:03,240
You're House Rep has and you
know, they have a location in
919
00:46:03,240 --> 00:46:06,680
your city that in addition to
the one in DC and the one at the
920
00:46:06,680 --> 00:46:10,000
state level, the senators have
one at your state capitol.
921
00:46:10,080 --> 00:46:14,800
But because I wanted to come to
DC and meet everybody and attend
922
00:46:14,880 --> 00:46:17,560
the congressional briefing, it's
like, OK, well, while I'm here,
923
00:46:17,680 --> 00:46:19,840
I'm going to go try to meet the
senators, go try to meet the
924
00:46:19,840 --> 00:46:22,560
House Rep, see how far I get.
Didn't get anywhere with
925
00:46:22,560 --> 00:46:24,920
senators.
But the House Rep, I got to sit
926
00:46:24,920 --> 00:46:26,560
down with an aide like
unannounced.
927
00:46:26,560 --> 00:46:29,640
I showed up and got to sit down
with the aide that that handles
928
00:46:29,640 --> 00:46:33,680
our FDA issues and she was
really interested in hearing my
929
00:46:33,680 --> 00:46:35,840
story.
And it was really cool to like
930
00:46:35,960 --> 00:46:39,280
have somebody listen that didn't
know anything about Kratom.
931
00:46:39,600 --> 00:46:43,040
And while I could have done this
locally in my city, I thought,
932
00:46:43,040 --> 00:46:45,120
you know, maybe that add a
little oomph to it.
933
00:46:45,120 --> 00:46:48,080
You know, that, hey, I happen to
be in town and, you know, while
934
00:46:48,080 --> 00:46:51,320
I'm here, I'd love to meet with
somebody to talk about this.
935
00:46:51,320 --> 00:46:54,080
And it was just a lot of
validation to be able to get
936
00:46:54,080 --> 00:46:59,360
your story heard by people in
power that can change our lives.
937
00:46:59,720 --> 00:47:03,120
But there's no question and then
let me let me tell you that the
938
00:47:03,200 --> 00:47:06,520
influencers in the community and
and you know, I'm I'm an
939
00:47:06,520 --> 00:47:10,920
observer in most cases of the
way social media has transformed
940
00:47:10,920 --> 00:47:14,800
public advocacy.
And if I were going to name, and
941
00:47:14,800 --> 00:47:17,480
we have at the AKA, by the way,
as you know, that name the
942
00:47:17,480 --> 00:47:21,480
heroes, it's that that Madeleine
at the Kratom stories podcast
943
00:47:21,480 --> 00:47:25,240
and it's the Kratom Gals podcast
and it's it's Mike over the
944
00:47:25,240 --> 00:47:27,400
Kratom guy show.
I mean, all these people that
945
00:47:27,400 --> 00:47:30,720
are influencers and people that
are not necessarily fans of
946
00:47:30,720 --> 00:47:32,080
ours.
Brian Gallagher is a great
947
00:47:32,080 --> 00:47:34,080
example.
I mean, his heart's in the right
948
00:47:34,080 --> 00:47:35,960
place.
He's pushing hard to get the
949
00:47:35,960 --> 00:47:38,560
right story out about kratom.
We can have disagreements and we
950
00:47:38,560 --> 00:47:41,120
can have we have personal
feelings of animosity.
951
00:47:41,120 --> 00:47:43,920
That's fine that we should set
those aside if to the extent we
952
00:47:43,920 --> 00:47:46,000
can and not take the things
personal.
953
00:47:46,360 --> 00:47:49,640
We're all human beings and we
all come to the table here, to
954
00:47:49,640 --> 00:47:52,440
the battlefield, actually, with
different perspectives.
955
00:47:52,440 --> 00:47:54,360
And we may not agree on
everything together, but we
956
00:47:54,360 --> 00:47:57,600
should agree on the common goal,
which clearly is to keep this
957
00:47:57,600 --> 00:48:00,120
plant legal.
And by whatever means that is
958
00:48:00,120 --> 00:48:02,600
necessary to do that.
Whether it means coming to
959
00:48:02,600 --> 00:48:05,120
Washington DC and what you did
and visiting with your
960
00:48:05,240 --> 00:48:08,080
congressional representatives,
whether it's getting on a phone
961
00:48:08,080 --> 00:48:11,200
call with them or emailing them,
or going out to these local
962
00:48:11,400 --> 00:48:13,600
jurisdictions where kratom is
under threat.
963
00:48:13,720 --> 00:48:16,280
Those are the battlefields that
we need to be there with.
964
00:48:16,360 --> 00:48:19,200
There's many of the weapons that
we can and our weapons are our
965
00:48:19,200 --> 00:48:21,520
voices and our personal
testimonials.
966
00:48:21,520 --> 00:48:24,120
And so I'm, I'm in awe of the
work that you do.
967
00:48:24,120 --> 00:48:26,920
It's selfless.
It's something that makes a huge
968
00:48:26,920 --> 00:48:29,920
difference in keeping people
informed and motivating people
969
00:48:29,920 --> 00:48:32,840
and reassuring people that their
voice really does matter.
970
00:48:32,840 --> 00:48:36,440
So I'm grateful, and the AKA is
deeply grateful for all the work
971
00:48:36,440 --> 00:48:39,320
that you and your colleagues do.
Well, we all appreciate it and
972
00:48:39,320 --> 00:48:41,600
none of us set out to be
influencers in the Kratin
973
00:48:41,600 --> 00:48:44,000
community.
We're just all super passionate
974
00:48:44,000 --> 00:48:47,040
about how this plant has changed
our lives and we we want to
975
00:48:47,200 --> 00:48:51,280
share that enthusiasm we have
with anybody that will listen
976
00:48:51,280 --> 00:48:53,680
because it's been incredibly
life saving.
977
00:48:53,760 --> 00:48:56,560
When I get the kratom gals
together each week for our live
978
00:48:56,560 --> 00:48:59,000
stream, we always, it always
seems to come up in the
979
00:48:59,000 --> 00:49:03,280
conversation how we all don't
take this plan for granted that
980
00:49:03,280 --> 00:49:05,480
our lives have been transformed
because of it.
981
00:49:05,480 --> 00:49:08,960
We all suffer from chronic pain
and several of the gals, you
982
00:49:08,960 --> 00:49:11,880
know, also in addition had some
addiction issues.
983
00:49:11,880 --> 00:49:15,400
And because of this plant, our
lives have been completely
984
00:49:15,400 --> 00:49:17,880
changed for the better.
And it's just amazing.
985
00:49:17,880 --> 00:49:20,280
And we just, we don't want to
hold that in, you know, we want
986
00:49:20,280 --> 00:49:23,520
people to know.
And it's just so validating to
987
00:49:23,520 --> 00:49:26,120
get this message out in a
variety of ways.
988
00:49:26,120 --> 00:49:29,600
Social media helps tremendously,
Podcasts like this, live streams
989
00:49:29,600 --> 00:49:32,120
like the kratom gals.
And it's something that anybody
990
00:49:32,120 --> 00:49:34,320
can do.
So I really hope in all the
991
00:49:34,320 --> 00:49:38,520
stuff I'm doing that inspires
others to do things as well and
992
00:49:38,520 --> 00:49:42,520
just get their story out there
in whatever way they can is
993
00:49:42,520 --> 00:49:44,680
incredibly important.
We'll definitely get the link to
994
00:49:44,680 --> 00:49:48,560
the AKA and protect kratom.org
on the website.
995
00:49:48,560 --> 00:49:51,840
Make sure people know they can
easily just go click on the link
996
00:49:51,840 --> 00:49:54,360
to sign up.
My last question for you, Mac.
997
00:49:54,360 --> 00:49:56,480
This is such an amazing
conversation, by the way.
998
00:49:56,480 --> 00:49:58,960
But knowing everything you know
now about kratom, you know a
999
00:49:58,960 --> 00:50:01,000
lot.
You've been in this for quite a
1000
00:50:01,000 --> 00:50:02,440
while.
What advice would you give to
1001
00:50:02,440 --> 00:50:06,000
someone who was just getting
started in their own kratom
1002
00:50:06,000 --> 00:50:06,480
journey?
Yeah.
1003
00:50:07,160 --> 00:50:10,880
I think that as new products
have come on a landscape here
1004
00:50:10,880 --> 00:50:14,920
and into the market, consumers
need to be careful about, you
1005
00:50:14,920 --> 00:50:17,360
know, their experience with
kratom and start slow.
1006
00:50:17,720 --> 00:50:20,320
As I said, the first time I took
it, I took twice as much as I
1007
00:50:20,320 --> 00:50:22,240
should have and it hit me a
little harder.
1008
00:50:22,360 --> 00:50:26,000
I learned from that experience.
But now you can take other
1009
00:50:26,000 --> 00:50:28,680
people's experiences and learn
from that and start slow.
1010
00:50:28,680 --> 00:50:32,800
Find out what that right spot is
for the kind of experience that
1011
00:50:32,800 --> 00:50:36,560
you're seeking with kratom and
take time to just feel it out.
1012
00:50:36,560 --> 00:50:39,200
Experiment with it to find that
right serving size.
1013
00:50:39,360 --> 00:50:42,480
The serving sizes that are
recommended in packaging today
1014
00:50:42,480 --> 00:50:46,320
rightfully should be cautious.
So you need to observe that and
1015
00:50:46,320 --> 00:50:49,280
then find the right spot.
I think that the reassuring
1016
00:50:49,280 --> 00:50:54,320
thing that is certainly a
milestone in our safety journey
1017
00:50:54,320 --> 00:50:56,760
with kratom is the FDA dose
finding study.
1018
00:50:56,920 --> 00:50:59,400
Because the FDA has demonized
kratom to the point where they
1019
00:50:59,400 --> 00:51:02,000
believed and they told the
clinicians who were part of
1020
00:51:02,000 --> 00:51:04,480
their dose finding study and
that's where they take start at
1021
00:51:04,480 --> 00:51:08,000
1g and they escalated up until
they see a serious adverse
1022
00:51:08,000 --> 00:51:09,720
event.
They predicted that they were
1023
00:51:09,720 --> 00:51:12,400
going to see serious adverse
events at 6 grams.
1024
00:51:12,400 --> 00:51:15,120
Now remember that was 6 grams
taken in a 5 minute period.
1025
00:51:15,280 --> 00:51:18,400
So they literally predicted
people would be flopping on the
1026
00:51:18,400 --> 00:51:21,680
floor and riding into seizures
at that level in that short
1027
00:51:21,680 --> 00:51:24,040
period of time.
They blew right past 6 grams.
1028
00:51:24,040 --> 00:51:27,120
They got to 8, they got to 10,
they got the 12 grams consumed
1029
00:51:27,120 --> 00:51:31,240
in a 5 minute period and they
saw a mild, not considered
1030
00:51:31,240 --> 00:51:35,560
serious in any way, adverse
event by both the kratom human
1031
00:51:35,560 --> 00:51:37,960
subjects and the placebos
because you were consuming that
1032
00:51:37,960 --> 00:51:40,560
plant material in a 5 minute
period at 12 grams, it's a lot
1033
00:51:40,560 --> 00:51:42,320
of material.
So they got nauseous and that's
1034
00:51:42,320 --> 00:51:45,480
when the FDA said, okay, well,
the scientists said enough and
1035
00:51:45,480 --> 00:51:47,680
the FDA agreed.
They said that kratom is well
1036
00:51:47,680 --> 00:51:50,960
tolerated at all dose levels.
So I think that's instructive to
1037
00:51:50,960 --> 00:51:54,840
people that now we have this
affirmation from the FDA that
1038
00:51:54,840 --> 00:51:58,840
kratom is not dangerous.
And so you take the responsibly
1039
00:51:58,840 --> 00:52:02,440
manufactured products and you,
you know, obviously feel it out,
1040
00:52:02,440 --> 00:52:05,480
you're going to be fine and and
find what you need it for.
1041
00:52:05,560 --> 00:52:08,680
My wife uses it in order to they
have the boost of damaging
1042
00:52:08,680 --> 00:52:10,880
increase focus.
I use it for pain.
1043
00:52:11,360 --> 00:52:13,680
I don't have problem, at least I
don't think I have problem
1044
00:52:13,680 --> 00:52:16,200
focusing.
Some people may think I do but I
1045
00:52:16,200 --> 00:52:18,640
use it for pain others you know,
depending on that experience
1046
00:52:18,640 --> 00:52:21,680
you're looking for they about
1/3 of the American population
1047
00:52:21,680 --> 00:52:24,640
according to studies done of
consumer behaviors by the
1048
00:52:24,640 --> 00:52:27,200
University of Florida
demonstrates that people use
1049
00:52:27,200 --> 00:52:30,520
kratom as a replacement for a
cup of coffee or for the energy
1050
00:52:30,520 --> 00:52:33,920
boost and increase focus.
Another third, use it for mood
1051
00:52:33,920 --> 00:52:36,520
boosting and fighting back
feelings of depression.
1052
00:52:36,640 --> 00:52:39,640
And then that third tranche of
people at higher doses are using
1053
00:52:39,640 --> 00:52:42,520
it to manage acute and chronic
pain and to deal with opioid
1054
00:52:42,520 --> 00:52:45,520
addictions.
Those, whatever you are on that
1055
00:52:45,520 --> 00:52:48,960
journey, whatever your need is,
then appropriately dose yourself
1056
00:52:48,960 --> 00:52:51,960
to that point and I think you'll
have a very positive experience
1057
00:52:51,960 --> 00:52:53,960
with kratom.
Excellent advice.
1058
00:52:53,960 --> 00:52:56,360
Thank you back so much for
spending time with us and
1059
00:52:56,360 --> 00:53:00,000
sharing your journey with kratom
and how we can all get involved
1060
00:53:00,000 --> 00:53:01,840
as consumers.
I appreciate it.
1061
00:53:02,240 --> 00:53:04,080
And this has been my pleasure.
Thank you so much.
1062
00:53:07,840 --> 00:53:10,640
Thank you for listening.
You can get more information at
1063
00:53:10,640 --> 00:53:14,520
kratomstoriespodcast.com,
including show notes from this
1064
00:53:14,520 --> 00:53:15,080
episode.

Senior Fellow on Public Policy with the American Kratom Association
I enter the political world serving as the campaign manager for Orrin Hatch's first Senate campaign in 1976. I worked for Senator Hatch for a year, then worked on then Governor Ronald Reagan's campaign, and following his winning the Presidency, I served as the Chief of Staff at the U.S. Department of Health and Human Services. After leaving the government, I have worked in the dietary and botanical supplement industry as a lobbyist fighting the FDA's war on natural products. In 2016, I was asked to join the kratom battle with the American Kratom Association, and have served in that role since then.














