FDA Direct: Sounding the Alarm on 7-OH

Okay, let's do this. Okay, Kyle.

Great to see you, Sanjula.

We're talking today about 7-OH.

Whoa! So, 7-OH. What is it?

It is a synthetic opioid.

And that's,
I think, the concerning thing. Right?

These are in vape stores all over America.

And people don't understand
that you can actually go buy

an opioid in a vape store
without a prescription.

And it goes by different names
that people are not aware of.

So, Kyle, you've been leading
a lot of the work on this.

And, tell us a little bit about
the difference between Kratom and -OH.

Yeah. Great question.

So -OH, Hydroxyarginine,
as it's also known.

And a couple other street names out there.

It's a synthetic concentrated product.

So 7-OH is found in kratom
but in very small levels.

Just to trace amounts. Trace amounts.

You know, what
we're seeing here and create a is a leaf.

Is that right?

Kratom is a leaf.

It's been used for thousands of years.

It's a botanical.

You often see
it used in teas and other products.

What these products are
that are the the basis of our action

are these concentrated synthetic products
that just have this -OH

an exceedingly high levels.

It's a very potent opioid,

times stronger than morphine, I think
is the number I've heard folks talk about.

And you know, what's also concerning
is they're being sold in formats

that are that are,

aimed at kids.

So, you see,

you know, strawberry gummies we found.
We have some here I that's there we go.

That was the most eye opening piece.

I mean, look,

these flavors pineapple flavored chews
and they look, look like candy.

That's right, that's right.

And, you know,
these are available, everywhere, right?

From the smallest small town USA

to the largest metropolitan,
every corner shop, gas station, head shop.

These are now readily available.

And it's becoming problematic.

You know, these are also I want to make
clear, not lawful dietary supplements.

And we talk a lot
about dietary supplements and

and those are things we want to promote.

I mean dietary supplements can be a
a core of a healthy, American diet.

A lot of Americans use dietary supplements
to supplement things like calcium,

fiber, taking protein powder
for strength training.

So we want to be very clear

that that these types of products
that we are taking action on and are often

disguised as a food or dietary supplement,
are not lawful dietary supplements.

So we don't want the industry,
the dietary supplement industry

to sort of fall under that cast
because it is a good industry.

We want to promote it.

It's an industry
that we we really respect.

And, has gotten a bad rap.

You know, you always hear
about supplements not being regulated, but

but but certainly they are.

That's amazing that you actually have
an opioid in a gummy.

I mean, no, we're not talking THC.

We're talking an opioid that can be up
to times more potent than morphine.

In that Journal
of Medical Chemistry study.

That was an eye opener to me.

And to think you can just
go down the street and buy it.

I think it's time to sound the alarm
and let parents know.

Let houses of worship
know, let school boards know that it's

you need to educate your kids
about what's down the street,

because these vape stores
are popping up on every corner in America,

and I don't know
any doctor of my group of friends

that has been dead inside them,
you know, to to check out

and see what they're selling
and what the names are that they're,

you know, promoting.

Yeah, they've
they've really flown under the radar.

There's not a lot of consumer
knowledge of these products.

You know, I've talked to people.

We've we've talked with DOJ
and other folks.

And a lot of people say, you know,
what is 7-OH what is this thing?

Yeah.

You talk to friends, Moms and Dads.

They have no knowledge of this stuff.

It's really flown under the radar.

And so to that point then why or why now?

Right?

Like I think the we have this tendency
we've we've been too late.

And so we're trying to get ahead now.

But maybe Commissioner you talk a lot
about kind of why are we acting now.

Well look,
I've been very vocal that we were.

Public health in general
is too late to respond.

So if you look at every single time
a very dangerous public health

introduction happens,
be it with combustible cigarettes,

it took the public health community
about years to respond

and figure it out and organize
and raise awareness about it.

Then you had the different waves
of the opioid epidemic.

You had heroin and cocaine and crack,

and then you had prescription opioids.

And it's almost like
we didn't learn our lesson.

We were behind the eight ball time
and time again.

And then fentanyl hits us again.
We're behind the eight ball. So

I'm hoping we

don't get caught flat footed again.

We got blindsided with the other waves
of the opioid epidemic.

I'm not saying this will be the next wave
of the opioid epidemic, but it could be.

And we don't understand it.
Nobody knows what's going on.

So when I've asked my friends,
my physician friends,

scientific friends, and ask them,

what is kratom?

Well, first of all, kratom
is different from -OH.

It's a neon
sign on most vape stores in America

with a K kratom,

and they don't know anything
about the difference between kratom

and then the concentrated
synthetic byproduct.

-OH so they don't know either.

Now, some physicians
have some health concerns with kratom.

Some of that some people describe those
as minimal health concerns.

Some say there's health benefits.

We're not talking about kratom.

We're not targeting kratom.

We're not trying to educate the world
about kratom.

And we're right now focused on this

dangerous synthetic concentrated
byproduct called -OH.

That is, an opioid binds to the opioid
receptor, defining it as an opioid.

And it's in drinks and it's tablets
and chewables in these gummies.

So I think this is a time and that's why
you were involved in the report.

Yeah.

So I think, you know, as a researcher,
I did some market research.

So I went into some of these stores.

I didn't know anything about it.

And I think the reason it's important
to talk about the kratom distinction

is because a lot of time
these products are marketed as kratom.

Really, you go into these stores, enhance
it's kratom and it's actually like five.

I've seen some studies around % times
more than the natural

kind of trace amount. Right?

And so we don't know
what's in these products.

The average consumer wouldn't know. Right?

Like you
just see this on the people selling them.

No no they don't either in fact.

And you know
I talked to some of these store owners

and they're saying, oh, like, you know,
this is the the better version, right?

And they're promoting the -OH but
it's on the same shelf as kratom, right?

So you wouldn't really know
the difference.

And then you read these flavors in like,
you don't think anything of it.

And so, the team here,
the FDA, did a really phenomenal

job on, publishing a consumer
kind of guide, if you will.

And so it's just highly
everybody should read it.

Yeah. We have an FDA site.

It's like fda.gov/-OH
and are all these resources there.

And so one of them is a guide
for parents and teachers.

And it's for the lay audience.

And it's it's pictures.

You can
you can see what these products look like.

You can understand
kind of what the issues are.

And then there's a scientific report

for the clinical community
to really understand, you know,

all the risks and harms
associated with that.

So that's one of the

bunch
of different things the FDA is doing.

Kyle, do you want to explain
some of the other things we're doing?

Yeah, a lot of work in the food space.
So food dies.

You know, it feels like
we started that two years ago.

In reality,
it was a little over three months ago.

You've been doing a lot.

I should
I should clarify, you're doing it.

You're doing a million things
outside of the -OH.

But, I mean,
what else are we doing on -OH, yeah.

Great. Great question.

Before we get into the other
all the other things. Yeah.

So we sent a number of warning letters
to companies that are illegally marketing

these products, making clear
that these are not lawful food

additives or dietary substances
or dietary ingredients.

We're also, you know, working
we saw the the referral,

the eight factor analysis
to DEA to ask them to schedule this.

That's huge hack what that means like
when we say scheduling this.

Yeah.

So what we're hoping is
that DEA will take a look and add

it as a controlled substance
to the controlled substances list

so that can be properly regulated.

Because it lives in a no man.

That's right. It lives in a no man's land.

A lot of these are labeled, as,
you know, dietary supplements or foods.

They're not, but they're sold that way.

And because it's not scheduled,

they can they can technically,
you know, be found on store shelves.

There's not that enforcement hook
from a control, CSA perspective.

So that's what we're looking for.

We're trying to bring awareness largely
and then ask DEA to take some action

with respect to scheduling.

And you've seen some responses
to those warning letters. Right?

We have. We have a number of companies have
already taken products off the market.

We've seen some recalled activities.

We've seen a couple websites taken down.

So we're encouraged
by what we've seen so far.

You know, our enforcement

ability is relatively small
compared to agencies like DOJ.

But, you know, we're doing what we can
within our authority,

and we're happy with the feedback
we've seen. It's not enough.

And we'll continue to take action
where we can.

But so far it's it's been a success.

So on -OH
we're trying to get the word out.

We are putting out this report
that everybody should read.

We have been going on media talking about
it, trying to educate the public.

We have recommended that it be scheduled
as a controlled substance by the DEA.

And so the DEA was at our announcement
a few days ago.

You sent out letters to the distributors

letting them know that we don't want -OH
in these synthetic, controlled forms

distributed to vape stores
in the United States.

And we're doing this podcast on it.

So it's doing everything we can.
Basically.

I've also written a letter to the medical
professionals letting them know as well.

Yeah.

So I wrote a Dear Doctor letter,
using a lot of the information

that your team had gathered and, trying
to let doctors know this is out there.

And, look,
there's a bunch of different names.

It's very hard

to create a lexicon to educate the public,
but we have to have some lexicon.

I mean, some of it has the name
Seven Omega.

It's a little sort of cutesy name,
or it's just called OH or hydroxy drugs.

And to your point, people,
you know, confuse it

with kratom, concentrated kratom.

We know it's not, but it's true.

There's not
there's a lot of different names for it.

There's not certainly a lexicon,
that we've arrived on,

but but certainly it's, it's something
that that's going by a lot of different.

And it's not just in the vape
shops. Right?

It's online and it's in gas stations.

And I think that's
what's really scary about it

compared to the other waves
of the opioid crisis. Right.

It used to be it's kind of a fun picture

in the education guide, where it's like
it used to be kind of the back alley.

You know,
you go to your dealer right at night.

This isn't happening
in broad daylight. Right?

And you could be well-intended thinking
you're buying a candy or an energy shot.

And, and people think
they're buying kratom.

They think it's kratom in a tea
that's in another form,

not knowing that in fact, this is
something totally different from kratom.

This is so the kratom leaf has been used
for how long?

In humanity.

Several thousand years to our
our understanding usually like in a tea

that in Southeast Asia.
That's where it originated.

And I understand there's ground up
kratom leaf again that's all kratom.

We are focused on concentrated

synthetic -OH,
which is a synthetic byproduct.

So again, so that a bunch of times
because I think that's

that's the take away message.

It's an important distinction.

It's a really important distinction.

And you know you're at a party
and they pass these things around.

You think anybody knows the concentration
of the synthetic concentrated.

-OH share let's say Kyle is

celebrating the Miami Dolphins
after one of their.

Is that your team in frequent injuries?

Yeah I mean very infrequent of late.

They don't you know.

And when they win it's you know those
infrequent times you want to celebrate.

You could be at a party.

Somebody is passing this stuff around.

Well that's that's part of the problem

with these unregulated substances
is there's no quality control.

You have no I mean, one of these tablets,
you know, could have five times as much,

-OH, which is the one next to it.

You know, the labeling can't be trusted
on these types of products.

So they do pose a real threat
in that regard.

I mean, I just can't get over
how I mean, they're appealing, right?

If I didn't know anything about kratom or

-OH and I'm just seeing these
on the shelves, right?

I've even seen some.
I wish I had brought them here today.

Like they look like ice cream cones.
That's right.

We've seen those.

And the flavoring, you know,
they're they're geared towards children.

Strawberry, cherry, pineapple.

Certainly flavors and colors
that are illustrative to children.

Yeah. And when we say opioid
we can't forget them. Right?

There is high abuse
addiction potential here.

And we see that happening.

That's funny because it's funny
you say that after our event

where we talked about this
and announced this initiative

and all the things
that you've been working on,

there were a flurry of emails

and communications where people said,
you know, my kid died from this.

Nobody even knows what it is.

Or we had a loved one
go down that road of addiction, of lying

and cheating and stealing and, you know,

eventually kids from good families

become a different person, all because of
the substance that takes a hold of him.

And let's be honest, most abuse,

crises happen

because of the availability
of the abuse substance.

So it's directly proportional, right?

In the more it's ubiquitous.

That's right. More abuse
you're going to have. Yeah, right.

So that was the beginning of the week of,
you know, the big let's see.

It's Friday today.
So that was the beginning of the week.

You know, well before we leave
that topic on vape stores, remember,

to % of the vaping products
and vape stores.

That's right, are illegal.

And so we're trying to get the word out
to the vape shop owners.

Here's the list of FDA approved
straight vaping products.

There's the whole universe
of vaping products.

We don't even know what's in there.

Yeah.

They're very they're designed
to be very attractive for kids.

So that's another thing
people should know about.

Parents should know about.

Yeah, yeah.

Also wrote a letter on Tianeptine,
you know, a month or two ago,

a similar product available
in gas stations and, and vape shops.

So that's another one
that folks should be aware of.

And so I learned about that from the
for the first time from you.

And that's basically
what's called gas station heroin.

Although of course at -OH is also called
gas station heroin.

But that's that is sort of its own drug.

That's right.

A very different but similar type drug
that's widely available

in the same locations
that you'll find -OH and,

and one that consumers and parents
should really be aware of as well.

So the theme is

there are a lot of these very dangerous,
harmful products just kind of popping up.

And I think your team
is being very proactive in trying.

Yeah. Out of it.

You know,
it's always a cat and mouse game, right?

And you see it with other things
like certain cannabinoids,

where really there's a segment of industry
that that does sort of tarnish

some of the really good work
in the dietary

supplement space, in the food space where,

by and large, the majority of folks that
operate in that space do the right thing,

have the right processes in place,
follow GMPs,

submit structure notifications to FDA.

Use proper ingredients.

But there are, you know, segments of it
that put out products like this

and then wrongly label them
as dietary supplements, and they do give

the industry a bit of a black eye.

So we want to bring awareness

to those products, but also awareness
to the overwhelming majority

of industries selling dietary supplements
that that does things the right way

and sells products
that are part of a, personal care regimen.

Yeah. So there's a group of, kratom,

manufacturers, if you will,

farmers, distributors and retailers
that are selling the kratom leaf.

And again, that is not our focus.

Our focus is the synthetic concentrated
form.

Yeah.

So with that
you may want to switch to. Yeah.

I mean, so that was
that was a big announcement.

Sorry. This

I didn't know
he may be out the door right. Yeah.

Like I think
it's been a busy productive week.

So we also made a trip over to New York.

We had a CEO for him.

She thinks we're talking about New York.

So. Terry McLaurin.
Oh. I didn't hear what you said.

Washington Commanders wants to.

He's announced he wants to be traded.

So he's making I think, $million.

And the open market for someone of
his stature is about $million, geez.

And, we will see if Washington
pays him or not.

But he's now demanded a trade.

So we picked the wrong profession.
We should have an athlete.

I don't know if he floated
going to the Baltimore Ravens.

Or you would like that. You would.
You would love him.

I would, you know, I love him.

First of all, they're all God's children.
I love them all.

But we got Zay Flowers and Rashod Bateman
and they are incredible weapons.

And so I worry
that we spend a lot too much money

towards, you know, the total allotment
that you can spend if we got them.

Yeah.

Yeah, I love them.

Look, I hope he stays in, in Washington.

I don't know if I'm allowed to say that.

I hope he finds a nice nest or somewhere.

I think Washington needs him, I think so
they're they're set for a good year.

If they can keep him around.

They got in the Deebo
Samuel from the ers as well. So.

The new stadium is now in jeopardy.

I heard.

Did you see that? I did,
yeah. I did we'll see what happens there.

It's, it seems like a dicey situation,
a little dicey.

I think the team should be paying
more towards the stadiums.

You know, they get the taxpayers to spend
a lot, and it does benefit the community.

But these, stadium fights
have been going on as long as the league.

That's right.

I think only New England is the,

stadium
where the owner paid for all of it.

Oh, is that right? Yeah. Got it.

No local funding from the government,
from taxpayer dollars.

It's always a dicey issue of taxpayer
funding for stadiums.

But, you know,
the SoFi Field in LA is so beautiful.

If they can do that

at the old RFK Stadium,
little shout out to RFK, our secretary.

Yeah. Then, that'd be amazing.

That'd be a home run.

I'd love to see it back in DC.
I think the team should return.

They're talking about putting up
restaurants and a hotel in that section.

If no one's been to that part of town.

It's been economically struggling.

It's the, right adjacent to where I did
some of my residency

at the old DC General City Hospital.

Oh, well, because, Georgetown

used to farm us out as residents
to staff the trauma unit there.

And, gosh,
I had some stories about that place.

It was just gunshot victim after gunshot
victim.

And, so,

that was a much rougher part of town,
but it's

it would be good to see a nice stadium.

Agreed. Down there. Agreed.

Yeah. One that's METRO accessible
and all. That's right.

Yeah. Great. Metro stop right there.
Yeah, exactly.

I did not hear you earlier, so,

Sorry. I started talking about dies.

Yeah, I know I missed that.

So, Rashod Bateman,

great segue to hormone replacement
therapy and perimenopausal women.

So what a transition.

Yeah, yeah.

We talked about that time.

Yeah, we've already talked,
but we still getting a lot of great,

feedback on that. And,

it's it's exciting.

You know, these women's issues have not
gotten the attention they deserve.

Yeah.

And so just by having a discussion,
just by inviting in some experts

to talk about whatever they believe,

are important issues
that should be heard on these issues,

it's created
a great national conversation.

That's been the fun part about this job
is seeing how we talk about these issues,

and then everybody
is having a broader dialog.

And that's that's what public health

is all about.
Creating conversation and debate

depending on it, regardless
of where it ends up.

It's always a good thing.

We should be having these debates, asking
these questions, asking tough questions

and talking about it.

My Mom started talking to me about it
and I had no idea.

She doesn't follow any of this,
and she was, oh, I did HRT a while back.

And this my doctor scared me away from it

and this and I'm like,
oh wow, this is really relevant.

I'm sorry.

Yeah, I'm
sorry. Women had been taught out of it.

So I think it's also part of the larger
MAHA movement or MAHA push,

where consumers just want to know
more about their health care.

They're asking their doctors
more questions.

They're reading food labels more, right.

They're more focused on self-care
and understanding. You know,

what they're doing to their body,
what they're putting into their body.

And I think it's great
to have that level of consumer awareness

and focus on these issues that we,

you know, we've been passionate
about for so long. Yeah.

Yeah.

I mean, that's the, you know, controversy.

Yeah. Yeah. Can be good.

And like we're not trying to,

you know, have people,
you know, be at each other's throats.

But let's have a healthy discourse
about all these topics.

And you get these topics going.

And they take on a life of their own
social media, hospitals, grand rounds,

on, you know, rounding in the hospital
when you're talking as physicians.

So, anybody can obviously join
the conversation in, in the modern world.

Right?

There's
no censorship of different opinions.

And I think these conversations are good
and healthy. Yeah. Yeah.

So so what else is going on?

It sounds like you went to New York
this week.

Had a nice CEO event there.

Great event in New York.

Yeah.

Talked to the a lot of drug developers
and try to ask them,

as we have with the other four sessions,

what can we be doing to create
a better user interface?

What reforms
do you think need to happen at the FDA?

How can we partner with drug makers
and drug developers,

but yet keep the scientific review
impeccably independent?

And we got some great ideas.

I was I keep thinking,
we're going to hear the same ideas.

Said no, it was that right. Amazing.

Yeah,
a lot of a lot of very formative feedback.

So yeah, make a huge list.

Taking it back to the drawing board.
Great.

Trying to think well yeah.

So I was top five
and we have two more cities coming up.

Oh that's great.
Yeah yeah. So what's the next stop?

So I think Raleigh and then Atlanta.

Okay. Is that the order? Yeah.

Yeah. Well, not to bounce around too much.

We've got some other food stuff
going on. Ultra processed foods.

RFI went out.

That's something we've really been
focused on and talking a lot about.

So what's an RFI?

So Request for Information
She keeps us in check.

That's right.

Well they have we have a diverse audience
and everyone's always like you guys

sometimes say technical things I write down.
So you know ultra processed foods.

It's it's sort of an amorphous term
that everybody's heard of.

Everybody has a different
their own interpretation of it.

Right. Yeah.

There's a lot of different ways
it's been defined over the years.

The state of California has got a process
going on to try to define it.

And we thought, look, we could be
a national leader in this space.

You know, there's a patchwork
that's developed,

in the States
and other places on a definition.

We can provide that federal clarity
if we're able to come up

with a good definition.

But we want to do it the right way.

We want to have full engagement
by industry, all stakeholder groups.

So we said, let's put out an RFI
request for information.

So let's put out a series of questions
and ask people to answer those and inform

us so that we can make the best decision
as we move forward in the process.

And, you know,
if we're going to be realistic, it's

going to be difficult
probably to come up with a definition

because everybody has different ideas
and thoughts on on what it should mean,

you know, should it be
focused on additives, should it be focused

on only certain additives that don't have
a functional or safety benefit?

Should it be focused on nutrient density?

Should it be focused on
actual processing steps?

I mean, I think that that generally,
like you cut corn off of a cob,

put it in the can,
throw some salt in there, heat it up

that's processed,
but it's not ultra processed.

Right, right, right.

Or you put some green beans in a bag
and freeze them.

Yeah. Cut a cucumber. Yeah.

Like that's a processing step.
But it's not ultra processed.

That's right.

And so we have to be thoughtful
in how we define it.

We have to understand the impacts of that.

I think there's a lot of research
opportunity if a definition is created.

But and we've talked a lot about this
before, like, we're not

we're not trying to ban, you know, people
from eating cupcakes and cheeseburgers.

So have your Ding Dongs.

Yeah.

Yeah, I've had some ultra processed food
at at the Ravens Stadium in the past.

There we go. There we go.
Have you had at the Commanders game?

Have you had any?

Yeah. Yeah yeah.

So look we want to define these things.

We want there to be more choices.

We want food companies to offer different
choices, better alternatives.

But we're not trying to outright,

you know, ban people
from from eating certain foods.

And, you know, we're seeing this

incredible movement in the United States
now with the SNAP waivers.

So the food assistance program, SNAP,
it's a it's a state program,

but the government oversees
that and can grant waivers.

So states
now are saying we don't want taxpayer

dollars
going to sugary junk food

and junk food to
they don't want it going to that food.

And we don't want it
going to sugary drinks.

So they can be in labs,
labs of innovation,

and they can just make decisions.

So what we can do
is try to provide some guidance.

And even if it's not perfect, even
if we don't get the definition perfect

because let's let's be honest,
this is a big task.

That's
why nobody's tried it before, right?

If we can try to provide some guidance,

we can create the conversation
and through iterations.

That's right. Something. That's right.

Yeah. And that's sort of our goal.

And MAHA, you know, people always say
What is MAHA from a food perspective.

And you know what I like to say
and we've talked about this is that MAHA,

and if you look at historically
at successful societal movements,

they don't happen in a year or two years
or even a single administration.

Oftentimes
these are things that take a decade

or more to have a really successful
societal movement.

But what they do have is leadership
and sort of concrete underpinnings.

And so we want to stand up
those really pillars of the MAHA movement.

It's things like GRAS, you know,
that's something we're going to tackle,

GRAS reform. We want to be able to remind
everybody about GRASs.

I know you talked about it before. Yeah.

So generally recognized it's safe.

It's sort of the pre-market side of food
additives right.

So if you want to get in a new ingredient
on the market

historically
you have to file a food additive petition.

The way the law developed

going back in the s,
if I can give like the minute version

is that Congress basically said, okay,
you want to add something new to foods,

you got to file a food additive

petition submitted to FDA, let FDA review
all the data and approve it.

Unfortunately,
the law also had a carve out

that recognized this GRAS
generally recognized as safe substances,

and at the time
it was things like salt baking soda,

not these more novel
ingredients we see today.

But the law

said, if you are a generally recognized
as safe ingredient,

you don't have to go through the food
additive process.

Unfortunately, over time,
our regulatory landscape developed

that that GRAS process
really became the tail

that wag the dog much more
so than the food additive process.

And so,

you know, over time, it's
also developed to allow companies

to self grass ingredients
where essentially self GRAS.

So yeah.

So what it, it
it's the same safety standard. In theory.

They have to meet the same standard
that they would, if they came to FDA.

But they can do it on their own
by hiring their own panel.

And they don't have to make
that information publicly available.

So, you know, it does
it does impact transparency,

which is something that's big
for this administration.

So we want to close that GRAS loophole.

We're going to do that.
It has to be reformed.

And then on the back end you know
we're standing up a greater post-market

review framework.

So once the barn door is sort of closed,
we can then incrementally take a look

at some food additives over time,

do it with science, do it evidence based
and make determinations that way.

So I think that GRAS
and standing up a post-market

framework are two of the major
key pillars to tomorrow.

And look we're going to roll those out.

They're going to take time.

But but really
when you look back at ten years

and there's a more robust
framework in place for additives,

you know, I think I think people will
look back and say that was a key to MAHA.

Yeah, we've already made good progress
with the petroleum based food dyes,

and you're building off of that framework.
That's right.

You're really crushing it, Kyle.

And the thing I love about the petroleum
based food dye removal

is the way that you also expedited

the approvals of natural food dyes
from natural ingredients, because normally

the FDA would approve one of those
every couple of years or every five years.

And you've approved how many?

Like four we've got we've got four out
in the past three months.

We've got a couple more in flight.

We're going to try to get out

and look, we're not we're not skimping on
the science or data that I want to make.

I want to make sure people understand
that we are doing the exact same review,

the same level of science.

What we are able to do

is ask, ask more people to look at it,
put more effort into it instead of having,

you know, one person look at it,
you know, for one week out of the month,

we may have a team of or looking at it
more robust prioritization.

Speed it up and prioritize the review.

That's
something industry has asked us for.

You know, we've been in conversations.

We're industry says, yeah,
now that you've put that out,

we're able to make an announcement
and shift to one of these colors.

So we've got a few more in the queue

and we really think that that's
a big part of the movement as well.

That's awesome. What are you hearing
from food companies or.

Well, so

far, you know the conversations on food
dyes have been great.

You know, we've been
in a lot of these meetings together.

They've answered the call.

I think we do have to give them credit
for the work they're doing.

And it's it's it's sort of a storm,
you know, a perfect storm in some ways

in our ability to do this
because there's other factions of play.

The consumer demand is a huge drive.

Yeah, some of the state laws.

But these food companies
are incredibly sophisticated and smart.

They respond to consumer demands.

And the consumers
have been calling for this.

Consumers are also calling for simpler
ingredients.

In general.

They're calling for less added sugar.

And I think the food companies
realize that

if they want to,
you know, continue to have robust sales,

they do have to be responsive to consumers
so we can play a role in that by being

and setting federal standards

and helping that transition
from a federal perspective.

And I think sort of the convening
a power power approach

that that you've talked about is one

that makes a lot of sense
for some of these areas,

a lot of trash
talking to Mars in the media.

I heard you were having very productive
conversations with them and still are.

Yeah. And, they did signal that they are.

That's right.

Playing ball.

And so it is amazing how, you know,
the media will sort of polarize

every issue that.

Yeah, even though there's incredible
consensus, even among

most food makers now in the United States,
they want to get to the same thing.

And if you look at the history of sugar,

when the medical community
would start warning about the downsides

of just a very high glycemic
index in your body, then, you know, for

prolonged periods of time, the food makers
responded after nutrition labels to say,

we are low
in sugar and then they would advertise it.

Then they would say, buy our product,

not our competitors,
because we are lower in added sugar.

And so that's the healthy market
that we want to see and remember.

When the nutrition labels came out,
everybody was saying,

oh, this is the downfall of Western
civilization

and people are going to die and layoffs
and food prices are going to spike.

None of that happened.

Yeah, eventually they added sugar
or they added a daily requirement,

which, you know,
no one knew what that number was.

But at least now you had a benchmark.

And then good things happened.
That's right.

Yeah.

And look guys, you know,

people have said, oh well does that move
the needle on addressing chronic disease.

The reality
it does because on average products

that use these dyes have % more added
sugar than products that don't.

And so when you give consumers a more even
playing field from a visual perspective,

you know,

there's an incremental change there will
they will pick a healthier product.

So it doesn't directly lower
things like added sugar consumption.

And there's a lot of research around

how these colors make
the food more attractive.

And that leads to overeating.

That's for consumption,
which is the caloric intake.

That's right.

There is good evidence that shows
that these dyes lead to overconsumption

behaviors, and that directly correlates
to things like obesity and diabetes risk.

So I think the point on consumer
demand, though, with your societal shift

part, is just so fascinating,
because now every time I look at social

media, you see, you know,
just all these, you know, influencers

or everyday consumers talking about it
and it's really amazing.

Yeah, I mean,
consumers are driving the MAHA movement,

and it's been fascinating
to watch what they've been able to do.

And my feed is always like,
you know, different people

going to the grocery store and being like,
you know, buy this or don't buy this.

And it's like,
let's read the labels together.

And it's like, wow.

It's in teaching people to read labels,
we're seeing a shift back to,

and a lot of ways, fresh produce, eggs,
you know, sort of American state eggs.

Yeah. Yeah, absolutely.

You know, it's National Farmers
Market Week next week, is that right?

That's right.

So so our friends at USDA

have a great American farmers
market on the National Mall here in D.C.

we'll be there Monday for MAHA Monday.

So folks that are local
should stop by and check it out.

There will be a cooking class.

Oh, are you leading this? I'm not.

There's also goat yoga, from what I hear.

What is goat yoga? You're doing good.

Yeah, I think it's literally yoga
with the goat standing on.

Okay, okay.

Yeah, I won't be doing that one either,
but, it's available for people attending.

Speaking of, Miami
and the Miami Dolphins, my uncle lives

just north of Miami and loves eggs,
and he's

He's been eating them his whole life
and his doctors for a period of time.

I think it was like a year
period of his life,

When he came to the United States,

the American doctors were like,
stop eating eggs are bad for you.

And so the poor guy didn't
get like his livelihood for years.

And finally his son became a doctor.

And he's like, that's dogma eat the eggs.

And he's back to enjoying eggs.
And he's

He won.

You know, at that point you won.

That's right, that's right.

Full circle. Yeah.

Eggs, great products, fresh produce.

All part of a healthy American diet.

Awesome.

Great time to get to where
I think we're meeting with a bunch

of scientific reviewers
now, Kyle, thanks for having us.

You're doing a great job.

Well, thanks for having me.
Really appreciate it.

Great to see. All right,
folks, thanks. We'll do it again.