FDA Direct Ep. 2: No One Thinks it’s a Good Idea for Kids to Consume Petroleum Products
0:00
OK, we're doing this.
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We're doing it.
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Kyle, good to see.
0:03
Good to see you as well.
0:04
Glad to be here.
0:04
Awesome to have you.
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Sanjula, great to have you back and we are lucky to have with us the Deputy Commissioner of the FDA for food, and that is Kyle Diamantas.
0:14
Great to have you, man, Glad to be here.
0:16
This is great.
0:16
It's a new sort of new FDA, new vision for the future and really excited.
0:20
It is one of my favorite topics.
0:22
So I'm so excited to grill you both today.
0:24
So I thought maybe, Marty, why don't you give a little bit of context about why food is such a big kind of priority for you.
0:30
I mean, food has been in the jurisdiction of the FDA, but you're really thinking about it differently.
0:35
Yeah.
0:36
Gosh, food is so important.
0:37
And that's why I think we're so lucky to have Kyle Diamantas with us at the FDA and his expertise.
0:43
You know, we tend to think of the FDA as a drug regulatory body, Drugs and devices, drugs, devices, tobacco.
0:49
People don't really understand that food is a massive part of what we do here, and it's also a big part of healthcare.
0:56
I learned nothing essentially about food in medical school, and I think my experience is not that different from most physicians.
1:04
Where we don't really have an understanding of what ultra processed means of what some of these ingredients are of the data and science behind some of them.
1:15
So I think it's awesome that, that we're able to focus on food.
1:20
You know, my, my personal view is that our childhood obesity and chronic disease epidemic is not a willpower problem.
1:28
We've got 40% of the nation's children now diagnosed with a chronic disease.
1:33
And if you think about it, we're sort of passively blaming the children for their conditions there.
1:39
There was no epidemic like this just a generation or two ago.
1:42
And kids, and I think a lot of it has to do with food.
1:46
I mean, it's crazy that 60 to 70% of caloric intake among Americans and American children is attributed to ultra processed foods.
1:54
How did we get here?
1:56
Right?
1:56
How did we get here?
1:58
Yeah, look, it it's a great question.
2:00
It's true.
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70% of our foods are from ultra processed sources.
2:04
50% of kids don't get their daily intake of fruits, 90% don't get their daily intake of vegetables.
2:10
And the reality is that ultra processed foods, as we're coming to find out they're more palatable, that are more attractive to youth.
2:17
I mean, a fruit roll up is more attractive than a head of broccoli.
2:21
And to your point, it's not a willpower issue and there are signs that this is really systemic from our food supply and under your leadership, we're taking efforts both on both on the pre market and post market side.
2:35
I'm really excited about some of the work in the space.
2:38
And he deserves a lot of credit. Kyle did a lot of the work on the on the removal of petroleum based food dyes.
2:44
I mean Kyle was on the phone and and is with a lot of food manufacturers and helped lead that initiative.
2:49
So thank you for that incredible work.
2:53
I, I don't think anybody out there thinks it's a good idea for kids to be consuming petroleum products.
2:58
I mean, maybe there's somebody out there who thinks that's a good idea, but I think it's, it's a, it's a, it's an issue with a lot of public support.
3:07
It, it is, it's, it's really an issue that has been driven by consumers, moms, parents, people that don't want their children to have these ingredients.
3:15
And we saw a lot of activity from the states over the past couple of years.
3:18
It's it's sort of one of those strange dynamics where California led the way and then West Virginia followed suit.
3:25
You've seen other states pick it up.
3:27
As of right now, I think there's 30 states contemplating legislation on colors.
3:31
And so we're working to step in, create a federal framework to do that.
3:35
And we've had great success.
3:36
And you and I have had meetings the past several weeks.
3:39
We're having large companies reach out to us daily.
3:42
Yesterday, a large retailer of burgers that's based out on the West Coast.
3:47
Can we mention that?
3:48
Yeah, sure.
3:49
In and Out Burger, right.
3:50
Who doesn't love that?
3:51
There it is.
3:52
Great announcement.
3:53
Removing artificial dyes from their milkshakes and lemonade and removing added sugars from their ketchup.
3:58
So a really huge win for the movement.
4:01
That's a step.
4:01
Yeah.
4:02
And, and Danone yogurt, I understand.
4:04
Absolutely.
4:05
Yeah.
4:05
They've announced to phase out artificial colors from all of their products by the beginning of next school year.
4:11
And we're seeing continued rolling announcements.
4:13
We've got companies, like I said, reaching out daily wanting to come in and help out on this.
4:18
So we're really excited about the momentum.
4:20
Kyle, what are you hearing in terms of from the companies, what challenges they're anticipating or is everyone just saying, no, we're ready to implement?
4:26
Well, look, I think that that companies realize that there's no turning back given the momentum that's really been driven by the consumer base.
4:34
This has been something that for a couple of years now has sort of trended that way.
4:39
These colors are required to have batch certifications by FDA.
4:43
So we're able to actually trace and track the amount of certifications that come in.
4:48
And they're on a pretty downward slope.
4:50
And so the past couple of years, the number of certifications have declined, consumer demand for natural colors has increased.
4:58
And so I believe companies have really understood that this is where the momentum is going.
5:05
And, you know, there are things to think about in terms of crop yields and potential for minor price increases in the interim.
5:13
But all of those are barriers that innovation can can pretty easily overcome.
5:16
But on the price piece, you know, so I'm a health economist, right?
5:19
And I remember when we were started talking about this a couple of months ago, I went on Amazon and I looked up Fruit Loops in the United States and Fruit Loops in Canada, which fun fact, you know, I grew up in Canada.
5:29
So I was like, oh, I'm interested in how this is different.
5:31
Yeah.
5:32
And Canada uses the natural version of this.
5:34
And so, you know, to the point about people say it may be more expensive.
5:37
I actually, you know, did you know the package amount, the ounces, converted Canadian dollars to U.S.
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dollars.
5:43
And I don't remember the numbers off hand, but it was actually a few cents cheaper per ounce in Canada for the same product as the United States.
5:51
So I'm sure there's some short, you know, short term initial investments that need to be made.
5:55
But from a consumer perspective, it's no guarantee that it's going to actually increase all the product.
5:59
Yeah, that's, that's right.
6:01
And that's what we're hearing and our economists are seeing as well.
6:03
And, and we don't think there's gonna be any sort of inflationary price increase.
6:07
Right. And that's important.
6:08
Of course, affordability of food is important.
6:10
And so we, this is not an issue where we have to take economic predictions on what will happen to food prices.
6:16
We have a living laboratory that is already existing in other countries where these petroleum based food dyes are already out of the food supply.
6:24
And petroleum based dyes are just one step of all the things that we're starting to look at, right.
6:28
So I want to get into kind of where we're going from here.
6:30
But I think before we talk about the future, it was really helpful for me to understand, understand what has been happening right currently.
6:37
And so I'm curious, when you both started here, like, what surprised you about how things were kind of happening?
6:43
What were some of the things you discovered as you were planning to press forward?
6:47
Yeah.
6:47
So, Marty, I don't know if you want to start.
6:49
You know, you and I have talked a little bit about some of the FDA standards of identity.
6:54
You know, these are, these are things that that sort of grew up.
6:56
Is that, is that this thing? That is.
6:58
Yeah.
6:59
So that's, that's -- How many pages is this? That's the Code of Federal Regulation parts 130 through 169, I believe 21 CFR. Seven hundred sixty five pages.
7:07
It's quite robust, quite robust.
7:09
And and these really grew.
7:10
I have an idealistic view.
7:11
I mean, the standards of identity were first developed going back into the late 1930s.
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And the thought was at that time the food supply wasn't very safe.
7:20
Companies, you know, maybe weren't as good of actors as they are now.
7:24
And so the agencies thought, let's put together some standards that sort of govern they're, they're essentially recipes, right?
7:31
So it sets forth what ingredients you can have, what are some optional ingredients and in some cases manufacturing processes.
7:37
But these were really created to try to protect consumers.
7:42
The problem is over time they haven't really adopted to modern technologies, manufacturing processes, changes in ingredients.
7:49
And so we're left in some cases with some of these standards of identity that actually stifle innovation.
7:56
And by my count, I believe we have somewhere around 250 standards of identity currently on the books.
8:02
And in front of us here is as you all see, we've got a couple of great examples of some products that are subject to FDA standards of identity.
8:09
So, Kyle, so this is, this is, standards of identity are basically is the government telling you what is a certain food.
8:18
That's correct.
8:19
If you want to call something Raisin bread, you've got to have 50 parts per weight Raisin compared to 100 parts per weight weight of flour.
8:27
But if I want to add carrots and nuts and I put fewer raisins and therefore it's not Raisin.
8:32
That's right.
8:32
You've got to hit that threshold in the regulation in order to call it Raisin bread.
8:36
The same thing.
8:37
You know, we've got some delicious breaded shrimp over here right in front of Doctor Makary.
8:43
And we actually have a standard of identity for frozen breaded shrimp and lightly breaded shrimp.
8:48
And if you if it has 65% shrimp, you can call it lightly breaded, But if it's more than 65%, then you can't.
8:56
And so who's, why does the government have to tell you what is breaded shrimp versus non breaded shrimp?
9:04
Yeah.
9:04
And you know, and it's a great question.
9:06
And I think originally some of these were sort of built out of idealistic visions and there was a lot of trade associations that have and continue to push for standards for products.
9:16
But the reality is consumers no longer need that level of protection, right?
9:20
We've got a more robust framework in place.
9:22
Labeling is more robust.
9:24
I mean, I guess I'm wondering like, what are we protecting the American people from like eating a non breaded shrimp thinking it was breaded? Like is that, is that the danger?
9:32
That was the original intent was to protect consumers from economic adulteration, misbranded or adulteration products.
9:42
So it's like the dictionary of food ingredients.
9:45
That's right.
9:46
And some of these, you know, I do want to say some of these we do need because there are quality aspects into it.
9:52
For example, bottled water has a standard of identity that adopts some of the EPA requirements for for tap water.
9:59
And so there are standards of identity we do need, but there's many that have sort of run their course from a consumer protection standpoint.
10:07
And I saw dried eggs in here, whole wheat macaroni products.
10:11
I, I understand the idea of like defining food, but to say that it's a you, you know, you're breaking the law if you call something mixed nuts when they're actually, not mixed. That's right.
10:26
Like there's actually a regulation for mixed nuts.
10:29
Is that right?
10:29
There is.
10:30
So, you know, Sanjula here has a bowl of, of mixed nuts.
10:34
It has two type of mixed nuts.
10:35
And you know, this one, and I took a look at this earlier, this one looks like you can call it mixed nuts because this has four different types of tree nuts in it.
10:43
But over here I'm seeing, I also have a bunch of different ones.
10:45
I'm seeing you have chestnuts, some cashews, different flavor cashews.
10:51
So does that not count?
10:51
So if you called this product mixed nuts, you would be in violation of the standard of identity because you don't have four or more of the required tree nuts.
11:00
But it's a mixture of nuts.
11:02
Well, it doesn't matter, Sanjula, you're, you're now breaking the law.
11:04
What's the penalty?
11:05
Are you?
11:05
I mean, are, is, are we talking jail time? If you have a product with three nuts?
11:07
You know the, the product could be subject to regulatory action by FDA, It could be adulterated or misbranded based on that, that violation.
11:19
So, so certainly companies are at risk if they do not comply with an FDA standard of identity.
11:24
I'm going to prop up these mixed nuts legally mixed nut.
11:27
They're that's correct.
11:28
This is the, can I ... She's got the violative sample over here. But can I brand it like the Sanjula version of ...
11:36
Don't you dare call that mixed. Those are not mixed nuts.
11:37
You've got three types of nuts.
11:38
Oh gosh.
11:39
Now what if you're eating, let's say I'm eating these nuts and it goes from having 4 varieties down to three because I've deleted one type of nut as I'm consuming them.
11:50
Can I say have some mixed nuts or is that.
11:53
Well, I think, I think in that case you can get away with it.
11:56
You know, we're really talking about the, the prepared version that a consumer is going to buy on shelf.
12:00
So once you sort of crack that open, you're, you're on your own there to to pick and choose the cashews or walnuts that you like.
12:07
Interesting.
12:07
Just seems like we have bigger fish, fish to fry in the regulatory domain of the FDA than defining mixed nuts by three versus 4 different types.
12:17
I, I didn't know that was the thing.
12:18
12:19
Well, you know, your point's a good one because in the food space at least we've sort of historically been a reactive agency, right.
12:28
So if you talk about chemicals and food, for example, you know, there's been a lot of talk about GRAS.
12:33
We had a big post market announcement yesterday where we're going to set up a more robust framework to review chemicals in the food supply and, and FDA has never really handled ingredients or chemicals that way.
12:44
We've sort of only looked in the post market context when we were asked to via a citizen's petition or there's been an outbreak or something that really gave rise to a chemical in the food supply.
12:56
But we're going to move to a proactive process.
12:58
We're not, we're no longer going to be reactive in that space and we're standing up a post market framework so that we can more readily identify chemicals and then review those proactively to get them out of the food where appropriate.
13:09
So in practice, so I asked kind of what surprised you?
13:12
I'm about a month in or so.
13:14
And the thing that has surprised me as a researcher is, you know, I've been spending a lot of time looking at trends in food with your team.
13:20
And you know, you were in some of these meetings with me where we were meeting with a couple of the food experts around a couple of other ingredients.
13:27
And I had asked, you know, can you present, give me a briefing on the data, the latest evidence on X ingredient.
13:34
And you know, I'm just trying to get up to speed to understand what the trends are.
13:37
These are the folks that are really deep on it.
13:39
And I didn't bring it with me, but I got kind of a briefing document of some of the key findings.
13:43
And there were about 20 studies that were highlighted.
13:46
And of those 20, about 15 of them cited studies from before 1990 and many of them were from 1970.
13:56
We are now in 2025, right?
13:58
So Kyle, to your point about being kind of proactive, are we going to change that where we're now we can start looking at evidence in real time when studies are coming out to start saying, OK, these are flags, these are signals.
14:09
Should we be more proactive versus waiting for a 20 year study that is kind of a full, I forget the term, the full, full battery assessment, you know, before we can take action?
14:21
Yeah, no, that's exactly right.
14:22
So the key is that we will use all of the resources we have available.
14:26
You know, we've launched an AI initiative, which is fantastic.
14:29
That's going to be a huge part of our post market work.
14:32
We're going to use it to identify new studies.
14:34
We're going to have a look at consumer demand.
14:36
What are consumers concerned about, what are other countries doing, what's Europe doing, what's Canada doing, what are these other jurisdictions with equivalent standards doing?
14:44
And so we're going to have a full robust process in place so that we can really take a hold of and and make sure that the chemicals in our foods are in fact safe.
14:52
And when they're not, we're going to get them out.
14:55
Look, I I think moms across America love this work.
14:58
And so Congrats, Kyle, This this is great.
15:02
Why don't you enjoy a piece of Raisin bread as a sort of reward for your great work?
15:08
Am I allowed to call it Raisin bread?
15:09
You know, I think this one, you can.
15:10
I think this one meets the standards.
15:11
So we can we can call this one.
15:12
It has enough raisins in it.
15:14
It does.
15:14
It does.
15:14
Yeah.
15:14
At least that's what the label said.
15:17
I've been chewing on these nuts, mixed, I can say mixed nuts because these ones are mixed nuts.
15:22
These are not OK.
15:24
I'm chewing on the mixed nuts.
15:25
They're still mixed, but I'm getting thirsty from these cashews and maybe Caleb hand me some water or Bigfoot around.
15:32
Do you have any water?
15:35
OK, thank.
15:35
Is it OK to drink from that now?
15:38
Can I call it bottled water?
15:39
That is bottled water that would meet the standard of identity and that is appropriate bottled water.
15:43
Now, what are you, what are your plans with these standards of identity?
15:47
Are you going to go through the most egregious sort of overreaching ones and, and make reforms to them?
15:54
Yeah.
15:54
So we're going to look at and analyze the standards of identity.
15:57
There's there's some that we know are for products no longer sold anymore.
16:01
So those are sort of low hanging fruit.
16:03
We're going to go through.
16:03
We're going to see which ones make sense, which ones don't make sense.
16:06
There are some that we still want, There's some that we still need that have quality aspects.
16:10
But yeah, they're going to be something that we that we look at very soon.
16:14
Cool.
16:14
What else are you thinking about?
16:16
So you mentioned GRAS.
16:17
I'm not sure.
16:17
For those who are not familiar, just give a little background on what GRAS is and what's kind of what are some of the challenges with it and what are you trying to do with it?
16:25
Yeah.
16:25
So GRAS is a really fascinating subject.
16:27
For those that don't know, GRAS stands for generally recognized as safe and and these are really are fundamental regulations for foods that started in the 1950s.
16:36
And that framework that was created, created a food additive petition process that essentially said if you want to introduce a new ingredient, you've got to submit a food additive petition to FDA.
16:47
The problem is that same law also created this caveat and basically said if you're a generally recognized as safe ingredient, you can just come out of the market.
16:58
You don't have to go through this robust FDA review and approval process like milk and cheese.
17:03
That's correct.
17:03
I mean, remember this is the 1950s, there weren't this prevalent use of additives, simulsifiers, preservatives, binders, all of these things that we now find in our modern food supply.
17:14
And unfortunately, the GRAS, you know, loophole as it's become known, sort of swallowed the rules such that the overwhelming majority of substances now entering the market come through the self GRAS pathway as opposed to the food additive petition pathway.
17:29
So the secretary has directed us here at FDA to address that, to take steps to close the grass loophole.
17:34
And that's something we're we're working on and, and really excited about.
17:37
It's something that's been a major effort for us the past couple months and we'll have more to come later this year.
17:43
So the GRAS standard was really created back in the 50s or so to incorporate existing whole foods that people just, it was obvious that there was no need to regulate them because they were, you know, cheese and things we've been eating for centuries, salt. They've been around for millennia, generations.
18:06
But then ... and back then they didn't have regulations.
18:09
They didn't, they thought there's no need to create a regulation around what salt is or cheese because they want, they were concerned about sort of new chemicals in the ...
18:20
So they said if it, if it's, if it's been around for millennia, then we don't, we can generally recognize it as safe.
18:27
But it sounds like over the last few decades, it's that the loophole is now in the interpretation of GRAS as any highly engineered food chemical that's put in the food supply.
18:40
And they're saying, well, that's GRAS too.
18:42
That's generally recognized ,,,
18:43
Yeah, that's exactly right.
18:45
And, and the problem is that there's really two pathways for GRAS.
18:49
There's a there's a pathway where you can voluntarily notify FDA and sort of get a tacit sign off of the ingredient as being GRAS.
18:57
But the other pathway is the, the self affirmed GRAS pathway where companies can essentially hire an expert panel that they convene to make a determination that an ingredient's safe and they don't have to do anything with that data.
19:10
They don't have to provide it to FDA.
19:12
They don't have to make it publicly available.
19:14
They just have to maintain that data, you know, within their own records and they can go to market with the ingredient based on that expert panel's determination.
19:22
And so it's, it's become a problem where we at FDA don't have good records of what's in our food supply.
19:29
How many ingredients are out there?
19:31
Have they been self GRAS'd?
19:32
Are they being self GRAS'd appropriately to meet the relevant science standards?
19:36
And so we're working quickly to address those issues and, and make sure that that moving forward, any new ingredients that are in our food supply are coming to FDA.
19:45
And then we'll look at ways to address ingredients that have already been self GRAS'd as well.
19:49
So Kyle, what's happening in other countries, right?
19:51
Like, why are we so behind on this?
19:53
Because this is personal to me.
19:55
And I don't know if I've shared the story with either of you, but I have personally, you know, 15 years ago, I was in and out of every specialist you could think of and they were giving me pills because they could not figure out what was happening with me.
20:07
And in the end, I was just getting sicker.
20:08
And I realized just self diagnosed.
20:10
No one told me this, but just being a researcher, look into it.
20:13
It was the food, right?
20:14
And I was realizing that I couldn't handle the gluten because of how things were being processed, although I wasn't celiac
20:19
and dairy was giving me issues, and so I started having to do a lot of work myself, right?
20:25
And this, you talk about kids, but this is happening in adults too.
20:28
And our system isn't designed to kind of investigate.
20:31
We're just medicating for these things that are attributed to food.
20:34
But when I travel internationally, I can eat things there that I can't eat here.
20:39
So what do we get?
20:41
Like, is it the GRAS part that has led us to this state and that other countries don't have that policy?
20:46
Like, what's the difference?
20:47
I mean, I think it's a combination of a lot of things.
20:49
You know, we go back to the ultra processed foods example, right?
20:52
You know, we're there, there was a large drive
20:54
decades ago to make more shelf stable foods.
20:57
You know, we really thought about food security.
20:58
Let's have products that can sit on the shelf a lot longer.
21:01
And I don't think we really realized as a country that the things we were putting in the products to achieve that were potentially harming us as well.
21:08
The preservatives, the additives.
21:11
And so, you know, when you do travel to places like Europe that you talk about and, and there's not the prevalence of ultra processed foods there, you do hear a lot of anecdotal stories like that, Sanjula.
21:21
So, you know, I think it's, it's an issue that is larger than GRAS.
21:25
It's it's larger than just a willpower example as you talked about, Commissioner.
21:30
And so, you know, it's a it's a larger issue that FDA and our other counterparts of HHS have to tackle and, and we are taking steps to do so.
21:38
You know, it seems like there's .., I never like it when I see the tribalism in understanding the evolution of food because when they put preservatives in food to make the increase of shelf life, it was with good intention and nobody understood what the health implications might be in the short term.
21:56
You couldn't do that.
21:57
You when you introduce something new in the marketplace, you really can't know that 10 year, 20 year outcomes of what that intervention is.
22:06
And it may not be any one thing, but you look at the cumulative burden of all these chemicals and, and stripping the flour of the fiber and chopping it up so that it's basically functioning as sugar.
22:19
It's got a high glycemic index.
22:21
And so it's sometimes the ultra processing that is actually converting healthy foods to unhealthy foods.
22:29
And we have, you know, these situations like you described, Sanjula, in your own experience, and I've seen this in the hospital, We order the kitchen sink of tests.
22:40
Somebody's got chronic abdominal pain, Nothing works.
22:43
Nobody can figure it out.
22:44
They get ping ponged from doctor to doctor.
22:47
Every specialist sees them.
22:49
Nobody's got anything really satisfying as a diagnosis.
22:53
We have these sort of wastebasket umbrella diagnoses, like abdominal pain of unknown etiology or, you know, bacterial overgrowth syndrome.
23:02
Basically, we have no idea, right?
23:03
Something's going on in the gut.
23:05
And then you hear that somebody went overseas for a study abroad to Europe and they're cured.
23:12
They have no more pain.
23:14
And it's like, what is that, right?
23:16
And it's, that's not a definitive concrete set of medical evidence, but that is an experience that should ignite our intellectual curiosity, just as you did on your own when you said, look, I don't know what's causing...
23:31
I'm not officially celiac, but the gluten seems to do this.
23:35
And people can kind of deduce, you know, that something's going on.
23:39
It's crazy.
23:40
I mean, it just happened recently.
23:41
So I've been doing dealing with this for 15 years, kind of eliminating gluten, not really doing the breads or anything.
23:46
Just about 6-7 months ago, I was in Australia and we're at this place and the chef said you should try our, you know, sourdough bread.
23:54
And I said I can't, you know, I haven't had a gluten in 15 years.
23:57
They said no, no sourdough is, is good.
24:00
It's low gluten content, you'll be OK.
24:03
And I looked at our schedule and I said, OK, if in case I get sick, I, I kind of want to try it because he's making a convincing argument.
24:09
Let me try it, but let me make sure if in case I get sick, you know, I'm not going to ruin some plan we have later, you know, in the day.
24:14
So I tried it and I'm waiting for hours when I'm going to get that bellyache, when I'm going to get the headache, something. Nothing.
24:21
And the rest of that trip, it was like after 15 years, I got to eat high quality bread again.
24:26
And that's really when I started realizing it's the, to your point, Marty, the processing of some of our grains and what we're doing.
24:33
And maybe it's not gluten at all, right?
24:35
It's the processing part.
24:36
And so connecting all these dots, I mean, that's why I'm so excited to be doing this with the two of you because I don't think most Americans know this, right?
24:43
And it's a lot of effort.
24:45
I consider myself to be a very informed person.
24:47
I go out of my way to do this research, but it's really hard to come up with this.
24:51
And yeah, look, I think we have a generational opportunity here at FDA, specifically in the food sector, right.
24:57
Where we've got consumer demand that's supporting us.
25:00
We've got a secretary supportive of our efforts.
25:03
You've been incredibly supportive of our efforts in food.
25:05
And you know, I really view food regulation, food policy is a non political issue, right?
25:11
It it should be bipartisan.
25:12
I think it largely is when we talk about food policy and, and what we want to do at FDA, we're not talking about Republican kids and Democratic kids.
25:20
We're just talking about kids, right.
25:22
And I, to borrow a line from the secretary, kids should have 1000 dreams, but a sick kid has 1.
25:28
And that's to get healthy.
25:29
And if we can take meaningful steps to help our children be better, eat better, live better lives, end chronic diseases, then it makes it all worth it.
25:39
And, and, you know, and I don't know if you looked, looked at polling numbers, I hate to even use that term, but there was incredible bipartisan support over this issue of healthy food in America.
25:51
And so it is, it does sort of cross, you know, across America and every parent seems to connect with this.
26:00
And you look at the chronic disease rates in Europe.
26:02
And I'm not saying it's, you know, any one ingredient or petroleum based food dyes, but you'll get the cumulative burden of what goes down the gastrointestinal tract in the United States.
26:14
I mean, all of it all, you know, the pro inflammatory things, the chemicals, the thing molecules that do not appear in nature.
26:22
And we could go down a long detailed description of what those are, but it probably is creating some degree of inflammation in the GI tract and maybe an immune response.
26:33
Why do we see one in five to one in six women now developing an autoimmune disease in their lifetime?
26:42
You go to Europe, the rates are lower, life expectancy is higher.
26:47
And when you have this sort of inflammatory reaction in your gut, you don't feel well.
26:52
And when you're a kid, it may just manifest as depression, right?
26:57
They're just kind of feeling blah a lot of the times.
27:00
And we've got, you know, antidepressants.
27:03
The more antidepressants we prescribe, the more depression there is.
27:07
I'm not suggesting it's causative, but we're not getting at the root issue.
27:10
And so that may be, Yeah, well, you know, I'm really excited about the new research program we're doing with NIH that you and the secretary announced a couple weeks ago.
27:21
Incredible opportunity.
27:22
This is something that that FDA and advocates have been aiming for for a long time.
27:27
We finally got it off the ground and we're going to answer some of those questions.
27:31
That's going to be the drive nutrition research.
27:33
What are ultra processed foods?
27:35
What's the impact on those?
27:36
What's the impact on maternal and fetus health?
27:40
Really excited for this and I know it's something you've been passionate about and working hard on.
27:43
And of course, we're going to use gold standard science there and use our friends at NIH to do so.
27:48
Question on the research part there.
27:50
So Marty, you've talked a lot about kind of different standards for drugs and new therapies and how you're thinking about common sense and gold standard science when it comes to nutrition in this research.
27:59
To your point about inflammation, my understanding is that historically, sometimes to be able to take action on an ingredient, you have to show causation between this one specific ingredient.
28:09
And it has to be, you know, something as extreme as cancer versus maybe there was gut inflammation, right?
28:14
Things that are precursors to before you develop that cancer.
28:17
So how are you thinking about kind of the, the standards for research and evidence when it comes to evaluating, you know, nutrition?
28:25
Well, first of all, that is our, our motto at the FDA is gold standard science and common sense.
28:32
And that is a theme in all the reforms and actions that we're implementing.
28:36
And a lot of great ideas come from the amazing employees and staff scientists at the FDA.
28:42
They there are issues that they've wanted to champion in the past, but may not have had support.
28:46
And so we are listening to them and getting these good ideas.
28:49
But look, if we are waiting for a 10 year randomized controlled trial on each petroleum based dye in children and what it does, it's not feasible, we're never going to do it.
29:00
It's unethical.
29:01
Who thinks it's appropriate to inject kids with petroleum in a randomized trial fashion and who's going to consent to it?
29:09
And so we have to use common sense when you have a family say that their kid has had this incredibly abnormal aggressive behavior or severe attention deficit disorder, and then they cut out all the petroleum based food dyes and the kids behavior then becomes normal.
29:30
And then they reintroduce the food dyes because it's, let's be honest, it's hard to keep them out down the road and the kid regresses to that behavior.
29:39
That is data, OK?
29:40
It's not a randomized controlled trial.
29:42
It's not level 1 evidence.
29:43
But we can learn from those experiences.
29:46
And when there's a lot of those experiences and studies like The Lancet study that did a randomized trial and did show an association between attention deficit disorder and petroleum based food dyes, we can say, look, we're going to err on the side of safety.
30:00
We're not, you know, coming in as absolutists and saying this is definitely an association medically proven.
30:05
No, we're just saying when it comes to the health of children, let's learn from different kinds of data and let's err on the side of safety.
30:14
You know, it's interesting to that point, and you know this better than I do, I've seen a couple of large health systems and medical associations put out kind of advisory saying, you know, we recommend these types of populations or patients, you know, avoid A, B and C, right?
30:28
And that's often ahead of some of the things that we know we would say as a regulatory agency.
30:32
And so to your point about these case studies and medical experiences and patient case studies that should count.
30:37
I don't know if it's OK to chat about fluoride for a second if we have a minute, but you know, ingestible fluoride tablets that are currently prescribed for kids as young as six months of age, babies getting ingestible fluoride tablets.
30:54
We took action to say we're going to do a comprehensive safety review and we're going to plan to take steps towards withdrawing these ingestible fluoride tablets from the market.
31:05
In my opinion, they've been on the market illegally.
31:07
They were never FDA approved.
31:09
And we're learning more about fluoride.
31:10
It is damaging the microbiome.
31:12
There are definitive studies now that are showing it's changing the gut microbiome, that is the billion different bacteria that normally live in an equilibrium in the gut.
31:23
And so we know we're altering the gut microbiome.
31:27
There are there's a now a Cochrane review, which is the highest, you know, most respected body of scientific review in clinical medicine always has been that says, and this came out last year that says that there is no evidence that fluoride actually reduces cavities in permanent teeth, which is, you know, sort of the, the, sort of ultimate end point.
31:56
Now it's debatable and you're going to have dental community, you know, folks that say they've seen it or there's there's other studies they point to.
32:07
OK, well, let's let's agree it's debatable.
32:09
Cochrane is a pretty solid, you know, review sourced, but a study came out a few months ago, I think in January in the Journal of the American Medical Association that reviewed 74 studies on fluoride and found what they called an inverse association with lower IQ.
32:29
That is, the more fluoride exposure, the lower the IQ.
32:32
There's an, an idea that it's somehow affecting the learning center of the brain.
32:37
I don't know, it's not my area of expertise, but when you have a JAMA studies, a systematic review showing potential harm and we have clinical evidence now published showing that it alters the microbiome.
32:53
Can we encourage kids to use fluoride in toothpaste and rinses and dental floss and avoiding added sugar, something we don't really talk about instead of ingestible fluoride tablets that that is sort of the big overarching message.
33:12
Makes sense. So what are you most ...
33:13
I mean, there's a lot of cleaning up we need to do, right?
33:15
We're going to focus on that and we have been focused on that.
33:18
But it is there anything that either of you are thinking about in terms of kind of net, you know, we think about food as medicine, right?
33:25
There's a lot of other things we should be thinking about beyond kind of cleaning up what's already out on the market.
33:29
Anything else on kind of your food agenda right now?
33:33
I'm just wondering how I'm going to cook these, these breaded shrimp.
33:37
Can I call it that?
33:37
Breaded.
33:38
Yeah, you can call it.
33:38
Yeah.
33:38
We'll take down the cafeteria after this and see if they can help us out.
33:41
OK.
33:42
By the way, I love nuts.
33:43
I'll just have nuts for lunch sometimes.
33:45
Like it's they're they are high in protein.
33:48
They're amazing.
33:48
And so now I'm going to just ...
33:51
That's what I'm thinking about right now is digging into some of this delicious officially regulated food that is going by the proper terms.
34:01
Well, I'll take you up on your offer and take some of that Raisin bread home.
34:03
That'll, that'll be my, my snack.
34:07
Kyle, we are so lucky to have you.
34:08
Can I call you Kyle?
34:09
Deputy Commissioner Diamantas. Kyle, please.
34:11
We're so lucky to have Kyle as our deputy commissioner in charge of food here.
34:16
You've done a tremendous amount of work.
34:18
The petroleum food dye removal.
34:23
I think it's just one of many very interesting, exciting things that you're working on that you've already demonstrated leadership on.
34:32
And so we're so lucky to have you.
34:34
Thanks, Kyle, for being here.
34:35
I appreciate it.
34:36
Thanks.
34:36
Great to be here.
34:37
It's fun.
34:37
Really appreciate it.
34:37
Thanks, Sanjula.
34:38
Yeah, great.
34:39
We'll do it again.
34:40
And thanks so much, everybody.
34:42
And for now, enjoy your food.