FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids

Hi folks.

We're here with Kyle Diamantas as our Head of Human Foods

program and Commissioner Makary for another conversation.

And today we're going to talk about orange.

It's fun, a great topic two Floridians right here.

So we have to talk about oh that's right. Yeah. How are you.

Yeah okay. Yeah.

They were just down in Tampa for,

an activity with the Florida attorney general on 7-OH.

They took some strong action.

So it was good to be back in Florida. Yeah. It's hot.

Yep. But it's great state.

Yeah. Great state.

And, Florida oranges.

What what better topic to talk about.

We just took some action to help, orange juice farmers and,

maybe reduce the sugar a little bit in orange is a pretty interesting topic.

Yeah. So this has gotten a lot of attention.

You know, you never know what what's going to sort of

have a life of its own out there in the world.

But people love this action.

I thought nobody would notice because I thought,

this is kind of a small regulatory change we were making.

But there was a lot of enthusiasm about what you did on orange juice.

So can you explain the FDA's new position? Yeah.

So look, these are part of our broader efforts

on standards of identity that we've talked about before.

We've got about 250 of these standards of identity on the books.

These are essentially, you know, I like to refer to them as sort of recipes.

Right.

They set out, product standards in some cases, some safety standards.

They incorporate, ingredients that might be required.

A lot of like the mixed nuts.

I think you go back to raisin bread, you have a certain percentage of raisins,

frozen cherry pie, which government's got to tell you how what percent batches.

And you must have the number of cherries that have to be in your cherry pie.

And so we have about 250 of these.

We've already taken action recently on, a little over 50 of these,

either to

potentially revoke them, proposed revoke them or to amend some.

And one of the ones we want to amend is pasteurized orange juice

and what we want to do is reduce the Brix level from 10.5 to 10%.

That's essentially the dissolved solids in this.

So largely the sugar content.

What's happened over time is that oranges domestically have become just slightly

less sugary over time due to things like citrus greening and other reasons.

And so we've lost market share domestically for our oranges

to places like Brazil,

where we have to really import oranges now in order to make orange juice.

So by providing a little bit of our orange juice comes from oranges from Brazil,

I think it's a majority of our ones close to 60, 70%.

Okay. Wow.

So we've lost a lot of traction on our domestically grown oranges over the years.

And what this will do is it will help domestic oranges, particularly in Florida,

California, Texas, places that have commercial orange groves,

Arizona to Arizona as well. We just learned Arizona. Yeah.

So what this will allow is our domestic oranges to compete

a little bit better on the on our scale here by lowering the sugar content.

The Brix degree just slightly shouldn't have much impact on taste,

but it will allow a lot more or just to be used for a pasteurized orange juice.

Well, speaking of taste. So maybe. Commissioner, what?

How do you like to take your orange juice?

Pasteurized? Fresh squeezed, cold pressed?

I've, you know, I had really just recently,

a couple years ago learned that orange juice was pasteurized

that is heated up and, and, you know, it goes through a big process.

And it's really it seems like primarily for increasing the shelf life.

And it's one of the reasons why, if you, have ten bottles of orange juice

from the same brand, they all taste identical, right?

Because they've gone through the same and sort of the,

freshly squeezed orange juice.

It might be a little sour one day.

A little sweet might depend on the batch of the oranges in there.

So I'm a little more of.

I like the freshly squeezed, the cold pressed.

You know, no offense to the host that drank the pasteurized

orange juice, but I think there is a bit of a health movement.

You know, I see it with a lot of the MAHA moms that are interested in cold

pressed juices.

Well, we've had a great farmers market here at FDA, once a week.

I know they've been out there doing fresh squeezed orange juice and lemonade,

and I know and I would have brought some from there.

But when I went this morning to to Whole Foods.

And it's interesting to your point on domestic.

So I picked up one orange of every kind of category there was.

Oh, really? And only one was domestic.

Yeah. This one here says Peru.

What's this one?

And that one I love country of origin labeling.

Yeah.

Australia. Australia and this one. Think about it.

We're putting an orange from Australia

on a boat and it comes across the ocean.

And we've got these wonderful orange groves in the United States. One.

And and this is from Chile. Yeah. There we go. It's amazing.

I mean, I grew up in Florida right.

And so I would to parents used to have a produce kind of transportation business.

So we would get crates and crates of fresh oranges.

So we have a tradition until this day, every weekend we do our home,

juicing at home and getting good oranges in DC is not the same

as getting them in Florida. Enjoyed meeting your dad when we were in Tampa?

Yeah, that was the way I was like,

is there an orange grove we can visit while we're down here?

And there was one that's just a little too far for.

Got it.

Our flight delays.

It's a common sense solution.

I mean, this is a regulation that have been on the books

since the 1960s, hadn't been updated since then.

Obviously the, the, standard or the quality of these

is just very much shrunk as a result of citrus reading.

And yeah, tell us a little bit more about citrus greening.

So what's what exactly is citrus?

Citrus greening.

Yeah, it's essentially a disease of sorts that impacts citrus.

It's becoming more prevalent in Florida, as well as other places.

And it just impacts the quality of these oranges.

And it reduces that Brix level very, that the sugar level.

That's right.

Yeah. Yeah.

And so, you know, these these Florida oranges have fallen just below

that standard that we have in place in the standard of identity,

such that millions of oranges in Florida weren't allowed to be used for pasteurized

orange juice because it wouldn't meet the standard of identity.

So by lowering that, we're going to allow these oranges that otherwise wouldn't

be able to be used to now, find themselves in a bottle of pasteurized orange juice.

And is that just related to things like an, oh,

you know, a lot of hurricanes and things like that?

Is that affect?

Oh, Irma, wasn't that a setback?

That's right, that's right.

There's been a lot of setbacks to the Florida citrus industry.

Right. It's been decimated in a lot of ways.

You know, compared to it was a few decades ago.

So any help we can provide to the citrus farmers and to,

common sense solutions that

also help produce a little bit of sugar intake for kids drinking orange juice.

So really, an antiquated kind of definition is really what led to all.

Yeah.

And that again, that goes back to our review of these standards of identity.

Like I said, we've taken action over 50.

We're now looking at more to get another tranche

of standards of identity to potentially take action on.

There are ones that make sense.

Pasteurized orange juice is a good example of one.

We have other ones that do protect consumers.

It helps ensure there's not economic adulteration.

And so, you know, we're not harming we're not demonizing all standards of identity.

But but certainly there's a lot of them that have sort of served their purpose

is they're an example of one that mixed mixed nuts that served its purpose.

Yeah. Well, we have some good dairy standards of identity.

I think pasteurized orange juice is one.

We actually have one for bottled water

that incorporates some EPA safety standards.

So there are ones that serve safety purposes that, are beneficial.

An orange smells good over there.

Does I'm doing a, minor procedure on this orange so the doctor can peel the orange.

Yeah, exactly.

I'm trying to minimize the, amount of waste produced here, but,

Good announcement on 7-OH while you were down there in Florida.

It looks like states are listening and responding

and taking action in response within two weeks of our, announcement.

Yeah, yeah.

You know, we, it was an idea to, to tackle this issue of 7-OH

and as we met with the sort of hardcore scientists

that are subject matter experts in 7-OH and,

all these compounds in this sort of family of opioids,

we basically determined that

the psychoactive effects that people experience,

which is basically the euphoria and the physiologic effects

of an agonist on the mu receptor that's an opioid receptor,

means that things that bind to it and are causing

the effects are technically opioids.

They meet the scientific definition of opioids, which explains

why we've seen deaths and overdoses from these 7-OH products.

And, you know, for people, just as a quick review,

there's there's kratom, which is a leaf,

and it has trace amounts of this opioid called 7-OH.

That's not our focus. We're not targeting kratom.

We are interested in a synthetic concentrated byproduct of the kratom leaf.

And that is 7-OH.

There's actually a little family of molecules,

but that's the most common one.

You see, these are sold in pills or other gummies, stick packs, things like that.

Yeah.

And so people don't know what they're consuming.

And you know, I was so the so we announced that, look, this is an opioid.

We want to take some

action to initiate the scheduling process.

So DEA treats it as a controlled substance.

I mean, it can be up to 13 times more potent than morphine.

And the Journal of Medicinal Chemistry.

And and if you hear the stories out

there of addiction, kids are going down the addiction road, lying,

cheating, stealing all the things that are classically part of the addiction

on the seven.

Oh H so they, they can get addicted,

not realizing they're having a gummy at a party.

Right? And then they go down this road.

So when we made this announcement, Florida,

the attorney general there said, hey, we've got some special emergency powers.

We can just go ahead

and make it illegal to try to take it off retail shelves immediately.

We have to go through a process with the DEA federally.

But they went ahead and did this thing, and I went down

and joined the Florida attorney general for a very, very amazing.

Yeah.

And the biggest problem with these products

is that they're they're easily available everyday consumer goods, obviously

not prescription products. Right.

These are things that you can walk

into a vape shop ahead, shop right and purchase these right off the shelves.

It seems like kids are able to purchase these.

So it's a very big problem.

And parents and all don't really know what.

Share some of that. Orange.

Yeah, yeah I think we got to do a little bit

of a taste test here and see if this is our this are us orange.

Yeah.

This is the America First orange right here.

Yeah.

But to the awareness and education about 7-OH

And we've been getting a lot of great feedback of.

Thank you. We had no idea what this was.

I know you got an email I think from a couple of families as well.

Gosh, let me see if I can pull up that email.

Someone who reached out and said,

Let's see, what would I get it from?

Someone reached out and basically said,

this is this is I just have to read it.

We've heard a lot of stories.

I mean, I've seen some news articles that are praising bringing this issue to light

because people don't know it. Right?

It was hiding in plain sight.

That's that's the biggest problem is people

didn't know one what they were buying.

The place is selling these sometimes didn't know what they were selling.

Correct. They thought they were selling just kratom. Yeah.

And so well, they're being marketed as enhanced kratom.

That's right.

Has 500 times the amount of concentration.

And when you don't know what it is, you don't know what to call

it doesn't have a name.

It becomes hard to

track and trace these illnesses and deaths that we've now learned about.

And I think we're

continuing to hear more stories now that we brought this to light.

So after we did that press conference saying

we're going to initiate the scheduling process for 7-OH

as an opioid, as a controlled substance, we, sent letters to the distributors.

You were you actually are the ones, I think, in your division that was involved,

to say, hey, don't distribute this stuff.

We sent a dear doctor letter to doctors to educate them.

And, there was a report on 7-OH that you were involved

in, that it was designed to educate both the scientific community

and the medical community, and school boards and synagogues

and churches and houses of worship and parents alike.

So we did all of those things.

And after we announced it, about two and a half weeks ago, I got this,

this was through a staff member at Health and Human Services.

Please let RFK and the FDA commissioner and others

who participated in today's press conference know personally

how deeply grateful we are for their efforts to ban 7-OH.

Oh, they're talking about concentrated 7-OH.

We're not it's not the trace amounts.

At least we try.

Very tragically, we lost our son

to 7-OH last Sunday.

Although, our son had struggled with addiction

for many years, he was completely clean for five months.

He had a job that he loved and they loved him.

He attended church every week and was being taught by the missionaries.

In fact, his last conversation was with the missionaries

before taking 7-OH pills

before going to sleep, never to wake up.

As I said, he was clean

and free from addictions other than his vape pen.

He called me on May 31st to tell me he had stopped by the vape shop

to buy a vape and was

offered a fruity pill and was told it was kratom.

It turns out it wasn't kratom, it was concentrated 7-OH.

Sometimes it's it's marketed as enhanced credit.

That's right. Yeah.

He said he took the pill and became addicted.

He said he should have done his research.

As I said, the night before he died, he took two

20 milligram pills of 7-OH.

The rapper was by his bedside.

There were no other drugs or alcohol in the house.

We are very focused on eliminating 7-OH.

So no mother has to go through the pain and agony again.

Please let the team know that you can count on us

to help fight this monster in any way.

Including. And are they suggestive on toys?

And that's why we're doing this. It's heartbreaking.

It's heartbreaking.

And, you know, part of the biggest problem and why we hear stories like that

is because these are illegal and illicit.

There's no product standards. Right.

So this could have been represented as a five milligram pill and it's got 100mg.

You know you don't know there's not standards in place to provide

protections and assurances to consumers of these illegal illegal products.

It's not like getting a prescription where you know the exact amount in there.

So when you buy these illegal products, you know,

who the heck knows what's inside of them, right?

Certainly.

You know, the concentrations can vary widely.

I know many have already been affected,

but I love that we're trying to intervene earlier. Right.

Because public health is about prevention.

And so it's going to be really important to this.

Yeah. That's right. Yeah.

So you've been busy in other areas to Kyle, right?

continue to move in on the eliminating synthetic petroleum based foods.

Yeah. That's right. Yeah. So we oh what's the latest?

What's happening.

Well, so, continuing to work daily weekly with industry.

It's been a tremendous success for us.

As you know, it's been a great initiative.

We are in the process today of launching a website.

This is a tracker, essentially,

that's going to highlight a lot of this work we've been doing.

We want to put it out there

so consumers can see the companies that have made these commitments.

We can hold accountability, right?

That's something we want to do here.

We're going to highlight brands, companies, commitment time.

This is all going to be put forth on an FDA web page.

I believe it's FDA gov backslash dyes.

No, actually we've updated it changes. Yeah.

All right.

Yeah.

So fda.gov backslash natural dye pledge.

There we go. That's why we love Sanjula.

Well it keeps us in line. Yeah.

So really excited about this I think it's a great

a great way to highlight the work that industry's done, the work we've done

and continue to do

and to make sure consumers have complete transparency.

And in this process, yeah, I got a preview of it

and it looks really great.

And I think there's already one company that says Progress Complete,

which is great to start tracking all of this.

It's really important because we want to,

ensure that companies stick to their pledges.

I can't stop eating these, by the way. They're delicious.

I mean, good for you.

That's the, We don't want soft commitments.

We want real commitments.

And, you know, it's funny, we were talking about how we thought

maybe 80% of the companies would would participate

and there'd be a group of stragglers that that just don't want to.

They're not going to play ball.

But I'm I'm surprised no company wants to be an outlier.

That's right.

And it kind of fits the Hawthorne effect.

If you have a bell curve,

if you have an industry that's moved, do you want to be known as the one company

that is insisting on using petroleum based dyes?

So you're absolutely right about that.

We're seeing it.

We have not had any companies come in and say, we're not doing this.

We're not getting on board. We're not supporting it.

They know consumers want it. They know the states want it.

We want it done.

So we're helping them do it. Really. They've been worried about,

potential financial impacts.

If people don't move in unison.

So we're really bringing that federal standard

to help these companies do it in unison.

So there's not competitive advantages and disadvantages.

The consumer movement is just so powerful.

I feel like every day

that's when I'm scrolling on social media and I just keep seeing I mean,

you see like 13 year olds to, you know, moms and grandmas

and they're all kind of posting, you know, these like, buy

or don't buy in the grocery store.

Yeah, I'm trying to scratch cooking and I just have never seen that before.

And actually, last night we were at the baseball game

with a couple of my husband's coworkers, and they had just moved back from Europe,

and they were talking about how it's so different.

They've noticed moving back

the difference and, you know, the snacks and the options that their kids have here.

And, you know, they're like, we're so much more aware about it.

And we're so happy to see the FDA be proactive.

Yeah, I mean, look, the reality is we've dug ourselves in such a deep hole

from a chronic disease standpoint that we can't get out of it

just through federal action.

It does take consumers doing this on their own in a lot of ways.

They've got to become more knowledgeable, buy better foods,

you know, tell their children not to eat those bright colored candies,

you know, go for it. The the Florida.

Well I heard actually to that so to to talking to this family last night

the mom was saying her kids call her house and say, mom,

you shouldn't be eating that, right? Right, right. Yeah.

Like that was unheard of.

I, I've had friends

that have called me and said, you know, my son's refusing to drink.

This, you know, sports beverage now, because there's dyes in it.

And so now I have to, you know, buy these other drinks.

Yeah. I can no longer buy these beverages.

So, you know, we're hearing it all the time as well.

It is largely driven, I would say, by the younger generation

who has more knowledge.

They're more informed.

They want to be part of what they eat.

They don't just want to be a sheep in terms of eating

whatever's in front of them.

So, it's really powerful.

And I do think that it's that consumer piece

that's going to continue to drive the movement.

Yeah, yeah. Don't be a sheep.

So I know in addition to the food dyes, there has been some work.

There was a unified agenda was published. Yeah.

So the Unified Agenda came out on Friday.

What is a unified agenda? It's essentially yeah.

So the unified agenda is essentially an agenda that has all of the regulatory

work the federal government anticipates doing, semiannually.

So it comes out twice a year,

and it will highlight the various regulatory activities.

The one that came out Friday or the big one for us at FDA and foods

is rulemaking on GRAS so generally recognized as safe.

There's been a lot of talk about this.

It's a directive that Secretary Kennedy asked us

to look into and to close the GRAS loophole back in May.

Yeah. So chemicals don't count as GRAS.

That's so essentially what this is going to do.

You know, if you go back to the 1950s

and I think we talked about this a little bit on the last podcast,

the law essentially created this pathway where Congress said,

hey, if you want to be a food additive, you've got to

you've got to file a food additive petition with FDA.

It's got to review the safety.

But that law also said

if you're a substance that's generally recognized as safe, like

so something in the 1950s, we didn't have these complex additives we have now.

That's that's very true.

And the

law said, if you are one of these substances, salt, you know,

baking soda, you don't have to go through the food additive petition process.

You can go through this GRAS process.

And then our regulatory framework developed over time

that allowed companies to do what we call self GRAS affirmation,

which is essentially where companies can convene, an expert panel.

That expert panel makes a GRAS determination, a safety standard.

The companies facilitate these panels.

That's right, that's right. Okay.

The safety standards are essentially the same, but it's done by companies

retaining their own experts to make these conclusions.

These expert panels make these conclusions.

And then the companies go to market.

It's never told to FDA.

It's not put out on, you know, some website somewhere.

So the self GRAS is also much quicker

than the food additive petition process.

Or the GRAS notification process, which is the other pathway

where companies can currently come in voluntarily and ask us to take a look

at their safety standards.

So there's currently those two GRAS processes.

What we're going to do in our new framework

is we're going to eliminate that self GRAS pathway.

And we're going to require mandatory GRAS notifications for all new

and novel substances that want to enter the food supply.

Right.

So we're eliminating that ability for companies to sell GRAS.

We might create some mechanisms.

That that potentially abbreviate the process for, you know,

extending the intended use of a current GRAS substance, like if you want to use

X ingredient and one type of food that,

I don't know, 25, milligrams, for example, do you want to move to 30?

Yeah.

There should be an easier process to do that

than having to submit an entirely new GRAS notification.

So we're thinking of ways to help be efficient with that.

And we're also thinking of ways to address sort of this

backlog of substances that have self GRASed over time.

We think we've got some good ideas in place and a good framework to do that.

The reality is, you know, we don't have a thousand employees reviewing GRAS files.

And how big are these files, by the way?

Are they like hundreds of pages? Yes, sir.

Sir, nothing is nothing small.

Yeah they're they're sizable.

They're sizable.

And the reality is like when when we came in our post-market

our GRAS team, our pre-market team said, you know, we can only review,

you know, a relatively small number of these a year

because of our staffing and the amount of appropriations we have. Right.

And so we are in the in the FY 26 budget.

We're looking to get an increase there to help us do this.

But the reality is we don't have enough money and people and never will,

to look at thousands upon thousands upon thousands of these petitions.

Right.

So we're certainly closing that loophole for all substances moving forward.

And we think we've got a good approach

that will come out and rulemaking to address these substances.

And really, what we want to do there for the GRAS substances

is have full and complete transparency.

We're going to create a website.

It's going to have all of our GRAS substances.

We want to document these self GRAS substances in a way.

And we think we have a good mechanism that we can get that transparency

and document those substances through notification.

And then we'll apply our post-market review to any of these already

self GRASed substances.

So there's stuff that's already been self GRASed.

We're going to apply our new post-market framework to those as

we close that loophole for new substances moving forward. Wow.

Yeah.

So more to come.

You know we can change a little bit between now and then.

But we're really excited about our, our GRAS reform

and, responding to the Secretary's directive.

And if I remember from our, our previous meeting,

we're hiring into that post-market.

Absolutely office. Absolutely.

That's a priority for us.

Nutrition and our food chemical space, both pre-market and post-market,

is where we are focusing, our appropriations and our hiring.

Right.

And and I'm asking questions, even though I know the answer because

I think people like hearing this. That's.

So where do we stand on the dietary guidelines

that, your your team's involved in rewriting?

Yeah, we've got a little bit of involvement.

You know, it's a, it's a, directive driven by, OASH

So the office of the Assistant secretary for health

out of the HHS and USDA, they've been working day and night.

I get updates every once in a while or questions that, that come in from them.

I think they're they've got a great work product that they're working on.

Timings to be determined.

Certainly it'll be, you know, this year sooner rather than later.

Won't be it won't be December 31st.

That's that's for sure.

But I think they're doing a great job.

We're helping out where we can in the process, and we'll continue to do so.

But I think it's going to be a really great work product that comes out great.

Well, gosh, Kyle D you're just crushing it.

I mean, every year.

Share it. Bump into an update. It's.

Yeah, just,

you've been here less than six months and looked at all

the stuff that you've been doing.

So we're trying to strike while the iron is hot.

So, the foods is a it's a good area.

You know, it's a lot of this stuff is common sense, right?

It's hard to object to cleaning up the food supply.

These are 80, 20, 90, ten issues.

And so we're really happy to do it for American. Yeah.

Who thinks it's a great idea

to be importing all of our oranges from Brazil and Australia and Peru?

I mean, we have all these orange groves in the United States.

I mean, these are common sense things.

I think a lot of a lot of the America

first stuff is and we're certainly we're committed to that.

We had our pre-check program for domestic manufacturing of,

drug manufacturing facilities.

That is, if you're going to build in the United States, we're going to help.

We're not just going to be a stingy librarian

and start our inspection after you've built the center, the, the,

the plant, we're going to be involved

in that design phase, or at least we're going to offer.

We're going to be available for more communications.

As you build our inspectors can be a part of that and get started early

so that when you're done with the construction,

you can immediately start with the FDA approval seal.

And so that's a program we called pre-check.

It's in America.

It's designed to move manufacturing to the United States.

It's national security issue.

So I think a lot of this America first stuff that applies to food and drugs

is common stuff.

Any updates on the commissioner's voucher program?

How's that going? Oh, it's going great. Great. Yeah.

So I think we're going to have some announcements very soon.

We've been going through the applications.

We've also asked, these divisions at the FDA

involved in drugs to submit a product they believe,

should get the national priority review, right.

So we're, it's so they were excited, very excited.

Oh, they're very excited.

And I think they're struggling like, hey,

we got three products here that could work for this.

So we told them they could submit to two.

And this initial round if they feel like there's a tie.

But otherwise we're asking each division to submit one.

Some divisions may not have one right now at this point in time,

but they said rolling process over and work through the first wave of these.

Yeah, it's a pilot program.

And, you know, we're going to need to hammer some stuff out.

It may be a little clunky.

We're sort of creating a new process, but we got to try new things.

That's right.

And that's what you're doing with food

and that's what you're doing by going to the nationals game.

Oh, sure.

Did you say you were just there?

Yeah, yeah, there was a game last night.

Who did they play? the Phillies. okay.

Yeah, yeah, that's my old team.

Yeah. You know Pennsylvania guy. Oh, yeah.

True. Yeah.

Good. Well, we're having,

FDA night at National Stadium, right?

You got to start practicing your pitch.

Oh. Oh, you got the precision.

Is that right?

I don't know, I don't know anything about that.

Hopefully she's joking. I don't know, no, I want to say I would love to.

What. Right. Wouldn't that be a great way? Yeah.

That's how you get people there.

I'll say after Fauci's performance, I'm afraid to go up there.

You know, there's been some funny ones over the years.

If you don't do it right, like you're a meme forever, that's the risk, right?

And filling out the first and second part, we don't want that.

Oh, so we don't think we have a date on that yet?

I don't think so.

And I'm probably not even supposed to have announced it yet.

But here we are.

You know what?

We're unfiltered right here at FDA direct.

I think that's what we call it.

Yes, a conversation is great.

I'm going to go back to eating some more orange.

Yeah.

You guys don't mind. Nice. Good American orange.

Yeah. Great.

Well, let's land here then. Great.

So, great to see you guys.

We'll do it again, folks. Thanks for your time.