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Steven Abrams, Panelist [10:12:53]
There are some basic things like iron, calcium and phosphorus that have a tremendous need to be updating and harmonize as best possible with European and Codex, which are World Health Organization standards.
Our standards for these nutrients in many cases are quite different. And just to give you an example, the iron in infant formula in the United States is much higher than it is allowed to even be in Europe. And the current science supports the European perspective.
So it’s a chance for us to take a look at every nutrient, not just the seed oils and say, do we need to set our limits? Where do we need to look at what needs to be done? And can we harmonize so that the world sees formula in one way and families, as they’re trying to say, well, I want to buy a formula that’s made in Europe can understand that the formulas made in the United States meet those same standards for them.
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Marty Makary, FDA [10:03:16]
We really want to learn from you. We desperately need to innovate in this space and that means regulatory innovation.
So we want to hear your ideas unprompted, unfiltered, tell us exactly what you think needs to be done to improve the health of babies and children in the United States and worldwide through the regulatory authorities that we have.
And I mean that sincerely as moms want to see more options for formula, they want to see formula options without seed oils. They want to see formula options without corn syrup. They want to see formula options without added sugar, and some of those are already on the market.
And in other spaces, we, as a regulatory body can help facilitate some of that innovation.
There’s been almost no change to the monograph for baby formula since 1998, with the exception of adding selenium.
Now, in my view, the field of medical science does not stay stagnant for 26 years in any space. And it’s hard to believe that is the only sort of enlightened moment that we’ve had in understanding how best to nourish children.
There are people who are concerned about the heavy metal levels in formula. And I think for foremost to this entire conversation, we have to acknowledge that we all want the same thing.
There are no malicious actors and we have to see the best in everybody, and this should not be a us versus them with any stakeholder group or any innovator developer or company out there.
This is an expert forum to ask how can we think collectively about what’s best for some of the most vulnerable in our nation.
Gandhi once said that the true measure of any society can be found in how it treats its most vulnerable members, our seniors and our children.
And so, we look forward to your ideas. We are going to take them very seriously.
This is not a horse and pony show where you get to say what you think. And then we ignore it and say that we had a forum. This is a true listening session.
And so we are going to take your ideas and go back to our subject matter experts and the terrific career scientists at the FDA who have been working on this and our policy staff and ask, what can we do differently?
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Tom Brenna, Panelist [10:20:29]
So now I get onto the topic of seed oils. Well, seed oils are one sort of oil. There’s two other kinds of oils, fruit oils and let’s say cows milk fat, and you can maybe think of other ones, but those are the major ones.
And the thing I want to – the one point that I want to make scientifically here is that it’s not just about some problem with seed oils. They’re– it’s not all seed oils are the same.
So in this study, rhesus monkeys, pregnant rhesus monkeys were fed formulas that had all of their fat that came from either soybean oil or from safflower oil, both seed oils on the hit parade these days.
And, so when the infants were born, they were weaned to those essentially formulas where that was the only source of fat and what they measured was visual acuity.
Now visual acuity in humans or primates or pretty much any other mammal is a measure of brain development, not just retinal development. And what you find is that with safflower oil, which is very omega-3 deficient, much less, much slower development of visual acuity, and that’s the lower line there, and I don’t really have a pointer, but if you get to the end there’s a red circle, and that corresponds on the eye chart to about a 2100, on our familiar scale where 2020 is normal vision. But in soybean oil, which has some omega 3, it’s got the plant one, but it has some omega 3. They have a vision at 12 weeks of age of 2050, so much, much better.
And, as it turns out, if you give these same animals a source of omega 3’s, EPA and DHA, so fish oil, classic fish oil, when they get a little bit older, let’s say starting at about a year, the ones that on the lower curve don’t recover. So you’ve gotta get this right early on. That’s another salient point we have to make.
So it’s not just about seed oils, it’s about what we replaced them with. Something like 60 or 70% of the edible oils in the United States are seed oils. And so if we shut it off tomorrow, domestic seed oil, I should say. So, there are things we can do to make it better. There’s no question about that.
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Michael Goran, Panelist [11:05:06]
The FDA regulates these older regulations that we’re talking about, they only regulate the amount of carbohydrate, not the type of carbohydrate. So during the last 20 or 30 years, there’s been all kinds of different types of carbohydrates introduced into infant formula. And in fact, now today, the majority of infant formula sold in the U.S. is made with non lactose sugars, such as sucrose, which is ordinary table sugar. But most of the non lactose formulas are in fact made with corn syrup solids, which is a glucose polymer, meaning it’s a big molecule of glucose, sugars joint together, in one big polymer. So there’s no, there’s no galactose there. So it’s a very different type of sugar, it is handled quite differently in the body.
And, this I think has occurred through a series of concerning situations, mostly due to misunderstanding by the public, as well as advertising and marketing claims, based on the concept of lactose intolerance in babies. So these are often sold as gentle formulas or marketed towards fussy babies, but actually this– the fact is that almost all full term babies can digest lactose, which is the only carbohydrate energy source in breast milk.
Now, in addition, um, emerging research just quite recently, probably in the last five or 10 years is beginning to show that these non lactose carbohydrates in formula are linked to a number of different outcomes, including alteration of the infant microbiome, which is the colonization of gut of microbes in the gut changes and taste and food preference because these glucose polymers from corn syrup are much sweeter than lactose and also a study that we published a couple of years ago in collaboration with WIC, so it was a very large population, showing an increased risk of obesity in children who were fed formula made with corn syrup versus traditional formula made with lactoses.
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Michael Goran, Panelist [11:10:02]
I think there should be consideration just like the EU is doing to determine an allowable level of glucose polymers that that would be okay to deal with, to deal with as a, and or a required level of lactose should be determined.
It’s very hard for consumers to know, other than looking at the ingredient list on the back of the product, whether either lactose or milk sugar would be listed as an ingredient or something like corn syrup, it would be listed as the ingredient. There’s no other labeling law.
I think there should be consideration if there is lactose intolerance. I don’t know why there was a decision made to go straight to corn syrup to resolve that issue. That’s not what adults with lactose intolerance would do. So there should– could be a consideration to break apart the lactose into the residual sugars of glucose and galactose, as probably a healthier issue than using corn syrup.
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Steven Abrams, Panelist [11:16:17]
There are a lot of issues involved in this regulation. So for example, labeling approaches and legalities are different in Europe than they are in the United States about average versus minimum content. So I think that we can’t just take European or EFSA guidelines and just turn them into the U.S., and that’s why the FDA is here, but I think the FDA does need to reach out the content experts people in– I mean, we have people about fat. We have people involved in carbohydrates. We have people involved in minerals, people involved in oligosaccharides. And I think each of those are kind of their own scientific groups and interacting with established groups, which include groups like American Society for Nutrition, American Academy of Pediatrics is helpful. But I think ultimately there are topic experts that are going to be need to be reached out to it. We can’t– I think there’s a lot to be gained from trying to harmonize as much as possible with European guidelines. I think that would be tremendously valuable for everyone, but there are differences in how we regulate formulas and how we label them and that need to be addressed in doing that.
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Tim Sentongo, Panelist [11:27:21]
We do have pretty compelling data that shows that excess protein is a big contributor to rapid weight gain because the infant formulas have the same caloric density. The different components are matched differently. Some fats are blended, some carbohydrates have corn starch syrup, others are lactose. But the big differences at that time between breast milk and infant formula is breast milk has about 1.4 grams of protein per a hundred calories. Whereas standard infant formulas have more than that. And the guidelines give a ranges higher as 4.5 grams of protein per a hundred calories.
So you can just see that that excess protein intake, clearly programs – has something to do with the programming of how children grow in the first couple of years of life. And if you follow these children, you realize that if you’re over– if you’re very big in the first three years of your life, you’ll likely be bigger overweight during your preschool years during your school age years. And if you enter adolescence as being overweight, that probability of turning that around is gets less and less and less again with all the additional environmental things that in our diets and that we choose to make, that programming continues.
So clearly the protein data I think is compelling enough. I think the Europeans, I think have had, I think they have more tighter. They have a narrow range of proteins that they recommend. And that’s also one of the reasons I believe why cows milk, which has a much high protein content is really discouraged in infants.
Of course at another age is encouraged, but even in a controlled amount, because you take too much of it, ultra protein, those kids really get very overweight.
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Steven Abrams, Panelist [11:35:50]
So the FDA over decades has created an immense and overwhelming process to make sure that that formula is safe and it’s been extremely effective, but the formula shortage has pointed out that there are times when we needed to bring in formulas that did not go through the full FDA process. Many of which had safely been used overseas for many, many years with excellent testing done using overseas guidance.
So I think there is the opportunity for us to take a look and that’s what the NASEM panel did and say, how do we make sure that we maintain that absolute level of excellence of FDA review of formula, but also add certain types of flexibility. Do we really need six visits? Do we really need for the growth studies? Do we really need to not enroll anyone who is not only on formula by two weeks of age, all sorts of very strict kind of rules that may be flexible as we bring upon new sources of protein, different types of energy and those sorts of things.
And that’s what the FDA I think can really take a look at with the scientific world and take a look at what the European experience has been.
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Andrea Gilbaugh, Panelist [11:42:16]
So formula companies marketing is part of the confusion. It confuses healthcare professionals, it confuses families. So if there are limitations on the marketing that they were allowed to do, I think education would be easier for healthcare professionals.
They say some really dramatic things like designed to reduce crying in 24 hours. So if that’s on a can of formula and you’re thinking, okay, well I’m breastfeeding, but if this is designed to reduce crying in 24 hours, maybe I should try this because my baby keeps crying.
Another thing that they’ve said is just what your baby needs and nothing they don’t. So I think there’s a lot of misleading in the labeling and we need to look at that.
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Tom Brenna, Panelist [11:48:44]
I think we can get on with the business of updating our regulations for fatty acids, and get with the rest of the world. And maybe, if we do it right, we might be able to get ahead of the rest of the world, while we’re at it, that’s the first thing. And those would be the underlying fatty acids.
And the second thing is, if we have a chance to have a detailed discussion, and as the commissioner said, not just walking out of here and saying, gee, we did something, but actually getting together and discussing it, we can do something about the seed oil story, which doesn’t mean, I don’t think getting rid of all seed oils, but giving moms and dads options, which I think is what the point was.
There are currently insufficient historic data to predict whether norovirus GII.17 will remain the dominant genotype and lead to an earlier onset of the norovirus season later this year. In the United States, GII.17 has only circulated at low levels and has never been the dominant norovirus strain. Following the surge of GII.17 strains in Asia and parts of Europe in 2014, the GII.4 Sydney variant re-emerged as the dominant genotype by 2016 with no reports of seasonality change. At this time, there is no clear evidence linking the GII.17 genotype to changes in norovirus seasonality. We will continue to monitor norovirus outbreaks through CaliciNet and will report any early activity or emerging trends through our website https://www.cdc.gov/norovirus/php/reporting/calicinet-data.html.
08 27 26 MAKARY: Moms want more options for baby formula.
They want baby formula options with no corn syrup, no seed oils. They want baby formula options with no added sugar.
And we’ve seen no innovation in the baby formula space since 1998, with the exception of simply adding selenium.
The research has moved and we have now had great learnings in the medical field, but the regulatory obstacles have not allowed companies to really innovate. So we’re going to look at all of it.
We’re going to look at heavy metals in baby formulas, on the– in the supply chain, you know there was a shortage in the last administration, so we’re going to get ahead of it and deliver for moms what they want, which is more options for baby formula.
QUESTION: Yeah, when my daughter was an infant, I relied on this, and I just trusted– she had some tummy issues, and so I had to get this one particular formula. But I didn’t know what was in it, I just listened to the doctors.
Do we have seed oils, do we have heavy metals in our formulas?
MAKARY: Yes, seed oil– it is almost impossible to find baby formula without seed oils and seed oils are not a naturally occurring substance.
You know, in the history of mankind, they did not press seeds and extract the oils and then add a chemical solvent to it, and then bleach it, just to increase the shelf life.
And generally it is– they’re believed to be pro-inflammatory. We don’t want babies with general body inflammation. 40% of our nation’s kids have a chronic condition. Many of those are tied to inflammation and insulin resistance.
Moms want more options and we’re going to deliver.
Checking in to see if you can confirm if it is accurate that FDA Commissioner Makary wrote a letter to Sen Hawley committing to a review of mifepristone. Can you clarify what the review will examine and when it will begin?
On background to an HHS spox: Secretary Kennedy asked Commissioner Makary to review the latest data on mifepristone. Commissioner Makary will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes.
Sarah Gebauer, FDA [00:38:07]
Now that we’ve issued the final rule to update the criteria for the claim, we are continuing our efforts on developing a healthy symbol, and this would be a visual way that manufacturers could demonstrate that their product meets the healthy criteria.
And we’ve conducted consumer research on a potential healthy symbol to help us understand what would really be helpful to consumers. And you can see some symbols that were tested in the middle of the slide. And symbols can be particularly helpful, for example, for people who are less familiar with nutrition information, by having that visual to let consumers know that a product qualifies for the claim.
Finally, we will be working with manufacturers to support implementation of the claim. We see opportunities for using the healthy claim beyond the label and using creative ways to leverage the healthy claim. And we are eager to work with interested groups to support the use of the healthy claim, so that it’s really as impactful and helpful as possible to consumers.
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Sarah Gebauer, FDA [00:48:27]
So as mentioned in the presentation, we have been working on developing a healthy symbol. The symbol would be a standardized graphic, and I showed some examples on the slide that manufacturers could use to show that their products meet the healthy criteria. And so it can really be sort of as that quick visual.
We have conducted two rounds of focus groups and also an experimental study of– related to a healthy symbol, to really learn what would be the most useful for consumers. And we don’t have a specific timeline to share at this point, but again, we are continuing to work on the healthy symbol work.
Robin McKinnon, FDA [00:49:10]
Maybe I can just add on there, Sarah, as well. We know that, because I was involved in some of the early work on the healthy symbol, and we found that people– they were hesitant to engage, especially manufacturers, on the symbol until they had seen the updated criteria.
So now it’s kind of a natural progression, if you like, to have finalized the updated criteria and then to be turning a focus to the– towards the symbol.