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Goat Milk Formula: New U.S. Approval — What Pediatricians Need to Know · Pediatrics Now: Cases Updates and Discussions for the Busy Pediatric Practitioner

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I'm Holly Wehmint, and this is Pediatrics Now, cases, updates,
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and discussions for the busy pediatric practitioner.
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Click on the link in this podcast for free credit that may include CME,
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MOC, or ethics credit, depending on our topic or podcast.
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Pediatrics Now is brought to you by the Department of Pediatrics at UT Health
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San Antonio and University Health's new Women's and Children's Hospital.
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Goat milk infant formula is now fda
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approved and joining me here in the podcast studio is
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dr cynthia blanco her expertise is
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in neonatal nutrition where she serves as director of neonatal nutrition at
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university health's new women's and children's hospital she's led multiple randomized
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controlled trials over the last 20 years and is a national expert as she has
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served on multiple national and international committees for infants' nutrition,
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including the American Academy of Pediatrics.
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Dr. Blanco, thank you so much for being back on Pediatrics Now.
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Thank you for inviting me. So this is a really hot topic.
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For level setting, what changed in 2023 to 2024 regarding goat milk based infant formula in the U.S.
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And what does meat's FDA requirements actually mean in practice when we're talking
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about nutrient composition, iron, and labeling?
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Well, after the national shortages that we had, the FDA moved to approve various
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infant formulas, one of those including the goat's milk based infant formulas.
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And what it means is that there is additional choices that parents can choose
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from, and the pediatrician needs to be informed of what are the pros,
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the cons, or if it's equally effective and safe as other products.
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Cynthia, what are the pros and cons?
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There are basic differences between goat's milk and cow's milk, for example.
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The basic differences are sometimes in the proteins, for example.
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The content of protein in raw milk versus cow's milk, for example,
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it's pretty similar, but it's very high.
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So we should never use raw products, neither from cows or goats,
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to feed our babies because it can really lead to significant renal dysfunction
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because of the high protein load that this will have.
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But in the basic, you know, amount of or different amino acids and peptides
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that they have in the proteins, there's actually species differences.
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And that is the same when it's compared to human milk.
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In fact, from like, you know, there's lots of different peptides and only about
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10 of those peptides are very similar between cow's milk, goat's milk and human milk.
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Most of the differences in peptides, for example, is the differences that are in the beta casein.
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And some of the literature that we have heard before is that that beta-casein
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can have some potential antimicrobial ACE inhibitor,
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an antioxidant, or immunomodulation.
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But these peptides are, there's only two of them that were very similar to human
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milk, and the clinical relevance of these differences between species is really not known.
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There's been some rodent studies trying to emphasize those differences in between the peptides,
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but there were no significant differences in this immunomodulation or other
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immune properties that is taught.
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So goat milk infant formula is a choice.
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It's not any better than using traditional formula?
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Again, I think that, you know, I can probably go through the differences in
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like the fat and the protein absorption, for example.
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When, you know, the idea of having goat's milk versus cow's milk and when there
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were comparisons, a lot of those comparisons were done with whole milk in adults.
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So because of those comparisons, or they were done also in adult animal models.
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When you compare it as a whole, there are differences.
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But once you break them down, once you break the protein down,
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for example, or once you homogenize it, because that's what is needed in order
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for you to make an infant formula, then those differences disappear.
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For example, one of the biggest differences is the goat milk fat globule,
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right? that it's smaller than cow's milk.
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And that is part of like what we think that that's why that curd,
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you know, improves your digestion because the fat globule is smaller.
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But again, that's only on whole, unpasteurized and unprocessed milk.
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So once you process the milk to make it into in-front formula,
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you have to break it down.
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And once that breakdown occurs, then those differences are gone.
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So we don't really know if really the digestibility is better once the infant
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formula is produced or not.
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And some of the very small studies have not shown any differences in young piglets,
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which is the only data that we have available.
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So more to come. Is it something that you're excited about as an expert in neonatal nutrition?
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I think that sometimes when we have new products, we get really excited.
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At the end of the day, I think it's important for the pediatrician to advise
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the public that there's a lot of thoughts and processes that we think these
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new products are going to help us with our baby's digestion, reflux,
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tolerance, but we have to go back to the basics.
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Is there a good study that has
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actually shown those differences with these particular products or not?
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And that's between that and ensuring that there's safety and ensuring that the
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products that the public is utilizing that are FDA approved,
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because in that approval,
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as the double checking that the mineral content, for example,
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it's up to the standards of infant formulas,
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some of the products are not approved and they're being purchased from the outside
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and they might not meet those standards.
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For example, goat's milk has to get additional folic acid added.
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And we have to ensure that all the minerals and the protein content is up to date.
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Also, the excitement comes from.
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You know, then we go into the different products to try to improve different disease processes.
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And those products sometimes may not be the best approach because then we're
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changing lactose for a different carbohydrate.
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So we have to really look into, is that carbohydrate really the one thing that
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is going to make a difference?
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And when that carbohydrate, like known as lactose, gets exchanged for corn syrup,
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is that exciting, right? Just because it's a new product.
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So, and again, I'm not saying that that's what is happening with goat's milk,
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but we just have to look into the actual content of each one of the products.
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And every time there's a new product, then this becomes a little harder to discern
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because we have so many products available in the market.
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We could know more. Could it be better once more human babies are trying this?
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Or do you want to say anything there?
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I think that, you know, as the availability of goat's milk infant formula.
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It's more prevalent in the United States.
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Perhaps we're going to be able to compare head-to-head with cow's milk-based
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products. because in the past, cows-based milk products have been the ones that
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have been compared in between, right?
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But it's the addition of all these other different novel ingredients.
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There's a lot of different novelty coming out, right?
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Adding this extra osteoporotein and or adding different components into the
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milk, is that going to make it or break it?
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So I think that we're going to know more as time goes on, and we can really
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do comparisons in regards to tolerability, digestibility, and long-term allergy.
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In which clinical scenarios is goat milk-based standard formula a reasonable
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first-line option versus when you'd steer families to a hydrolysate or amino acid formula?
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We thought that goat's milk was going to be a better product for allergies,
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and the basis of that came from one prior study where they said.
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Did comparisons of long-term eczema, for example, and then things got extrapolated as hypoallergenic.
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That study was not powered to detect major differences in between the two groups.
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So there still needs to be more studies in that regards,
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but there's really no studies doing comparisons or assessing that it is better
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tolerated for infants that have protein milk allergy.
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In fact, there's some reports that patients that had no cow's milk allergy,
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they actually did have goat's milk protein allergy.
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If a patient has allergy to a protein product that is non-hydrolyzed,
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then the first-line therapy should be hydrolyzed or completed amino acid-based formulas.
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The type of protein or the type of species that the protein comes from has nothing
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to do with that hypoallergenic capability of the protein once it's broken down.
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So we have to really advise our parents if this is an issue,
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right, that we had a strong family history and we also have the evidence that
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this patient has protein milk allergy,
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then a hypoallergenic formulation needs to be used and tested.
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So that's the most important part. Correct.
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Any nuance for non-IGE presentations and how do you cancel during diagnostic
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elimination challenge?
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I think those have to be referred to a pediatric gastroenterologist and need
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to be carefully assessed because those disease processes, you know,
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can lead to really significant food allergies.
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So I think that is just something that sometimes we assume that because we got
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exposed to a certain product, we have an allergy, but that may not be the case.
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Cynthia, do you want to talk about protein profiles, whey-cassian ratio,
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fat blend, including B-palamate, lactose content, and added components in current U.S.
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Goat milk formulas versus cow milk formulas? I think that, you know,
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with the products that we have now and that we have available.
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That content gets pretty evened out in between the different products to try to mimic human milk.
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And so therefore, weight gets added into it.
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So then it can have that higher weight to casein ratio like human milk does
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for better tolerability.
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And also, goat's milk is known to have less DHA amounts, but it's known to have higher MCT oils.
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So then those are formulations that are known that the companies address and
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they make the products to be quite similar or better adapted.
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Or closer to what the breast milk has. What about preterm or late-term preterm
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SGA or infants with complex medical needs?
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Any data or reasons to avoid or consider goat milk formula?
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I think those babies are going to be discharged from the NICU with special formulas.
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Those special formulas are usually made for babies that have higher needs of
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minerals, for example, the calcium and phosphorus, and especially premature babies,
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their bones continue to get, you know.
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Their osteopenia of prematurity tends to continue to get better and better with
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additional supplements.
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So those babies are better served by having those premature formulas that are
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specially designed for them.
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If in the future we have goat's milk-based infant formulas that have a particular
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content for the minerals that premature babies require,
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then the protein base has nothing to do with that mineral content.
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So what we need to look for as pediatricians is how small were our babies?
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Is it a very preterm baby or is it a late preterm baby?
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The requirements for bone health are different, and perhaps if it was a late
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preterm baby with minimal concerns during the NICU course,
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then a term infant formula will be completely adequate, whether it is cow's
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milk-based or goat's milk-based, it really has no differences between them.
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But if you have a very small, complex, premature baby that spent a lot of time
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in the NICU with a lot of medications that caused, you know,
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a lot of losses in calcium,
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then you need to continue to replenish those long-term.
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And since there's really not enough data to support that tolerance from the
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different types of proteins,
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you need to get your families back around into focusing on that mineral content,
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which is what the need for this baby is.
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This is all so fascinating, and it's such an honor to be here in the podcast
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studio with you, Cynthia.
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What are some of the top misconceptions you're hearing, such as goat milk cures reflux?
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Is it easier to digest for all babies, good for cow milk allergies?
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We've talked about the cow milk allergies. What about reflux?
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Reflux is something that is very frustrating for everyone, particularly with
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parents. there's really no data to date.
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Any formula that can cure reflux or medications or, you know,
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any type of additive that you can add to the baby's nutrition that could cure reflux.
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The main cure is time.
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And you have to really emphasize that over time, the more you expose the babies
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to all kinds of different formulations.
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You may be really changing quite a bit the intestinal health because you're
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exposing them, again, to different sources of lactose or carbohydrates.
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Instead of lactose, you expose them to corn syrups instead of different oils,
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and you expose them to safflower oil, to corn oil. We don't know much about
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those early exposures either.
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So I try to avoid trying to change formulas many times for reflux because then
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at the end of the day, time is what is going to be the best case scenario.
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If your baby has such reflux that it's not able to grow and you have faltering
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growth, that's when you really need to worry about it.
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And that is when you really then perhaps will need to refer that patient to
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pediatric gastroenterology to do additional testing for allergic components
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or allergic reactions, for example,
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or to aid into this reflux that is a benign condition as long as the baby is growing.
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And the developmental stage of that intestine is going to reach that time where
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the sphincter is going to tighten up and it's going to get better.
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That's great advice. My son, when he was a baby, he had reflux and it was so frustrating.
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And it was only time that helped.
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It seemed like he would spit up everything after I breastfed him,
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but he was meeting all of his milestones and doing well.
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And that is another thing, right? We haven't talked much about human milk, breast milk.
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That is the best nutrition for any baby.
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And we should really try to emphasize that we need to continue with breastfeeding
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as long as we can and utilization and maximization of human milk.
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Instead of switching a baby that otherwise was healthy and thriving because
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of the spit-ups or because of the significant reflux,
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we should never switch a baby from human milk to any other formulations unless
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we absolutely have to for specific allergic reactions or components or intestinal disease.
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For example, we have babies that have short bowel syndrome.
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May not be able to tolerate even breast milk.
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But then there's specific formulations where everything is really broken down
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to make sure that that short amount of intestine can absorb those nutrients as much as possible.
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And that should be the only time where we really need to change to a different formulation.
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Any advice for pediatricians what to say if a new mom is saying,
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Well, I'm just using formula. I want to use formula because I'm exhausted.
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And just in case the baby's not getting enough to have that extra option, more must be better.
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Usually then i would advise
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to you know the moms to get additional support because for example at university
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hospital we have a special place that we call mother's place that was really
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very well thought out when we
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opened the women's and children's we provide additional lactation support,
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additional support with maximization of the human milk when your baby is still
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in the NICU, for example,
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dietary support for the moms.
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So I think that there's a lot more that we can do for our breastfeeding mothers
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to support them throughout that time instead of getting so frustrated and adding
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the additional formula to ensure that the baby is eating enough.
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Because the first few days of life, mom's breast milk is very highly dense in calories.
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So even smaller amounts will be enough for the baby to be able to gain weight
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and to grow and to thrive.
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And you have to look for the additional signs and symptoms that they're getting
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dehydrated for the pediatrician to be able to communicate with the moms.
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Is it overstating it to say breast
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milk is pretty magical if you just look at what it can do for a baby?
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I don't think so. That's what I do for a living. And I have studied breast milk for a very long time.
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And I always tell the moms that breast milk is the medication that we give and
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provide for all babies in the NICU.
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We are now training our new generation of physicians by also training them in
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regards of like nutrition,
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doing rotations and electives with our dieticians and showing them how the magic
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happens in Mother's Place where we have all the dieticians and the dietary techs
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maximizing that breast milk for the hospital stay.
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But that can also happen at home, and we have to be able to teach moms on how
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to maximize that breast milk, how to store it,
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where to store it, and how to really handle all of that magical product.
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And that special program sounds amazing. Let's look at some cases or a way for
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pediatricians to coach a patient.
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So, for example, a two-month-old with fussiness and loose stools on cow milk
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formula, the parents request switching to goat milk formula.
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What workup or watch and wait strategy do you recommend before or after switching?
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So I always recommend, and this is something that has been published in the
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past by some of the leading papers in the country, especially for like reflux or allergies,
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colic, discomfort, diarrhea, that every time you're trying a different formula
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or a product, you need to give it a try for at least two weeks.
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And if this new formula that you're trying does not work, then you should go
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back to a regular term formula.
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So if you, as a pediatrician, when you're doing this, try to really emphasize
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that this is usually something that is transient.
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As long as the baby's gaining weight appropriately and not having any other symptoms.
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Babies have watery stools sometimes and some days are better than others.
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So you can talk to them about a trial.
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And if that does not make it better, then to go back to the original formula
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instead of trying multiple formulations every single time, because that adds
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to the frustration, right?
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So then just have that one-on-one parent understanding that this might be just
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a developmental change that over time will get better as long as you consider
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as a pediatrician that this is not a disease process,
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that the baby's not sick, that this is something that is just transient,
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then either continue the formulation that
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the baby's on or have an agreement that you
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will try one formula for two weeks and if
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not then you're going to go back because if you continue to have different formulas
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over formulas over formulas and nothing helps then that adds also to the distrust
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of that bond that you have with the family because then they're going to be
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thinking well what my pediatrician recommended didn't work,
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instead of having, well,
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my pediatrician thinks that this is going to get better with time,
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but we're trying something just in case, but it's not working.
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So we're going back to where we were before.
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What about this? A breastfed four-month-old needs supplementing.
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Mom prefers a, quote, gentler goat milk formula.
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How do you choose a product and set expectations on stooling, gas?
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I think, again, you remind your family that goat milk is a choice,
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and it's the same as cow's milk-based products.
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If they ask you, is one safer or better than the other?
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I really don't think we have enough data to ensure the parents that this is the case.
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We can say that there's really been most of the studies that have been hundreds
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of thousands to millions of babies being studied with cow's milk-based formulas.
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And so far there's been really
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less like less than in the
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thousand babies studied with goat milk formula so then the knowledge that we
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have with cow's milk based products is so much larger then you can really provide
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a little bit more guidance compared to what we know from goat's milk products,
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just because it hasn't been studied long enough and with enough number of babies for a very long time.
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Someone may say, well, in Europe, we've used it for a long time,
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but there's still not a lot of data that has been formally presented and published
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in peer-reviewed journals with comparisons between goat and cow's milk or even
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within goat's milk formulations.
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There's just not as much of a robust amount of data when you compare one versus
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the other, but it's still a choice.
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I would not argue about one being gentler than the other because of what we discussed.
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Once the protein and the fat globules are homogenized to make their formulations.
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That gentle digestion goes away. A six-week-old with suspected cow's milk protein allergy.
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Parents ask about goat milk formula.
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We've talked a lot about the cow's milk protein allergy. What's your evidence-based
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counseling and alternative plan?
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There has been only one randomized prospective trial where they reported as
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a secondary outcome the number of patients that develop eczema in one group versus the other group.
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And it was about 10% difference in between the two different groups.
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It was like 14% versus 23% in a study, and that was probably done about like 10, 11 years ago.
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There was no statistical significance in between those groups,
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but again, it was just more of a trend, and I would just not recommend stating
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that that is actually a fact, because we don't know.
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In regards to the heme-positive stools or babies that have potentially a cow's milk protein allergy,
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it can equally develop with goat's milk and it can be a protein milk allergy
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to just a non-human product.
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And even human milk, they can develop protein allergy just because it's not
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completely hydrolyzed.
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So if that is the case and you think this baby has a protein milk allergy,
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then my recommendation will be to go to a hydrolysate product.
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What other forms of formula are not okay? Donkey formula, camel?
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So there's been new products in the market that you can obtain from outside
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of the United States where that protein-based formula is, or the base formula
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comes from other animal sources.
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None of them are FDA approved currently and none of them are well studied.
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So I will stay away from those products and I will encourage the pediatricians
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to discuss with the families of all the unknowns.
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And a lot of them might not be complete in the nutrient content to support healthy growth.
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Because in all of the infant formulas, you have to add different vitamins and additional minerals,
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and you have to stabilize some of that protein content to make sure that they
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are adequate for the infant intestine.
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That is different than the toddler, and it's very different than the older child or adult.
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If the pediatrician gets the question from the mom in his or her exam room,
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well, if this was your baby, what would you do?
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Do you have any advice there? Like, what do you say?
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I always give the advice to the parents and also my trainees that I always respond
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that I am not in your situation.
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I can only tell you from my expert opinion as a pediatrician,
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this is what the evidence suggests and this is what my recommendation is.
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But at the end of the day, the choice is yours.
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And bottom line, if breastfeeding is an option, that's the magical one.
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Absolutely. We should never...
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Try to modify or exchange that precious human milk for any other product.
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The digestibility, the immune properties, the properties for long-term neurodevelopment
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are just so superior compared to formulas.
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And we know that now, after so many studies, so even in premature infants that
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have short bowel syndrome or term infants that have lost their bowel,
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our current approach is human milk.
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We really have moved away from using amino acid-based formulas, even on those children.
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So many of them, they will transition over time if there's not enough breast milk available.
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But breast milk, at the end of the day, is the most gentle and powerful infant
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product available in the market.
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And then the new mom may not be getting those messages on social media and elsewhere
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about the importance and how amazing breast milk is.
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Absolutely. So then we need to emphasize that in our pediatrics office.
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Hopefully, we will have more tools and literature available for the pediatricians soon.
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So then you can utilize and navigate this very complex infant formula world
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where almost every other week,
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there's something new that we hadn't heard about and some additional,
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novel ingredient that it gets added into the mix that we didn't know about.
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So I'm hopeful that pretty soon
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we're going to have something that the pediatrician's office can rely on.
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And we will have an episode with Dr. Blanco on our sister podcast,
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Pediatrics Now for Parents.
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So if you want to mention that to your patients, that can be found wherever you listen.
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And there they can learn more about goat milk infant formula.
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Dr. Cynthia Blanco with UT Health San Antonio and University Health,
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thank you so much for being here today on Pediatrics Now. Thank you for inviting me.