In this Contemporary Pediatrics interview, Ari Brown, MD, FAAP, details the benefits of goat milk-based infant formula, discusses FDA authorized Kabrita goat milk-based infant formula, and highlights misconceptions associated with goat milk-based formula.
Interview transcript (edited for clarity):
Ari Brown, MD, FAAP:
I'm Dr. Ari Brown and I am a pediatrician, I've been in practice for 28 years in Austin, Texas. I also have worked extensively over the years with the American Academy of Pediatrics being a very active member, and I am also the author of the baby411 book series.
Thank you, Dr. Brown, so much for taking the time to speak with us. Today we're discussing goat milk-based infant formula. Recently, I've found there's been a lot of discussions going on, maybe a little bit of back and forth, if you will. First, can you explain the indicated use for the Kabrita goat milk-based infant formula following its FDA market authorization?
Sure. This has been a really long road. Kabrita as a company has been working 10 years to reach the long-term FDA authorization that it recently received in June of 2023. It is now in addition to other goat milk formulas that are not fully FDA authorized yet a first line option for complete nutrition for a baby's first year. So now the FDA and the American Academy of Pediatrics both list goat, cow, and soy as acceptable bases for infant formula. Specifically, the FDA long-term authorization for Kabrita as the first and only goat milk-based infant formula FDA approved, means that it qualifies with appropriate growth, the appropriate nutrients and safety for infant's first year as well as the consistent supply.
Dr. Brown, with that kind of long timeline, what does this authorization really mean? Of course, we understand it can be used, it's marketable, but with that timeline, what does that really mean for the pediatric population and the goat milk-based infant formula market?
Well, it took a long time to get there because it was considered a new product to the market. Because the FDA regulates this so tightly, every ingredient had to be generally recognized as safe initially in that process, and then it had to go through the rigorous clinical trials to prove both growth and safety for that product. So that entire process really does take a long time. Once it receives that long term authorization, it also means that there's going to be annual inspections to ensure that the product remains safe. So to answer your question about how does this affect our market, it's actually a really big deal because as we all experienced the infant formula shortage and 2022, [which] really exposed the vulnerability of our infant formula supply in the United States, where literally overnight we lost 40% of our infant formula supply because the market has been limited to such a small number of manufacturers. That impacted about 3 million babies across the United States. So having another product that is available and absolutely appropriate nutrition for a baby's first year is a really big deal and it's a welcome addition for families, because that is never something anyone ever wants to be in a situation, where they do not have food to feed their baby.
What are some of the benefits of goat milk-based infant formula compared to cow milk formula? Can you touch on some of the misconceptions, or what you believe are misconceptions for lack of a better phrase, and what a general pediatrician or provider should know about goat milk-based infant formula?
Sure. I think it's important to first of all normalize the concept of using goat milk as a base for infant formula, and that it is a perfectly acceptable form of nutrition. It's new to the United States, so it's new to American families, and it's new to American pediatricians, but worldwide, it's been used for decades. This is really not something new. It's just new to us. The potential advantage for goat milk-based infant formula is tolerability. Because goat milk itself more closely resembles human milk, both in its protein composition, and the volume and diversity of prebiotics that occur naturally more in goat milk than in cow milk base formula, there are some advantages to the potential that it's easier to digest because it's more closely resembling human milk. I think the misconceptions are many. First is just taste, and so I think people think it's going to taste "goat-y," for lack of a better word. But the reality is that taste tests have been done and surprisingly, goat milk tends to taste creamier than cow milk-based formula. So it tastes pretty good. The other big one, as pediatricians, I think we were all trained that unmodified goat milk doesn't have enough folic acid in it. And that's true, but we're not feeding our babies goat milk. We're also not feeding our babies cow milk. These are modified products and it's a chemical formula that becomes the baby formula, right? Goat milk infant formula contains all of the essential nutrients. When a product is FDA authorized, it has to meet the 30 essential nutrients in the Infant Formula Act. So goat milk-based baby formula has exactly what babies need to grow and thrive. I'd say the final one is that this product coming to market, this is not a niche product, something that pediatricians might recommend when a baby doesn't do well with a cow milk based product. It actually is perfectly acceptable as a first line product equally to a cow milk-based product or a soy milk-based product.
I want to ask about the clinical trials, if I can. Can you explain the make up of the trial? What were the primary outcomes, results? How do these results support those stringent FDA regulations, and ultimately lead to the clearance.
I encourage people to have an open mind and really think about, "well, why is cow milk based infant formula what we've historically recommended, and why aren't we looking at other options." That was that was my journey on this experience. Nutritionally, it's absolutely fine, babies grow on it and so why not? Also, if I get fewer phone calls, why not right? So my goal is for babies to be happy, and their parents to be happy, too. The final thing I'll say is that I've watched my patient's parents on this journey, and I watched, increasingly, families going through unregulated sources to bootleg European baby formula. The data shows [approximately] 14% of parents in the United States actually sought unregulated European infant formula. I kind of scratch my head about it and thought "why are people going to such great lengths and spending a lot of money to import this these products," and I think that what parents are seeking is high quality ingredients for their babies. So I think this is an interesting option. The reason why this product could reach so great and why I'm excited about it is because it's been done right. The FDA has given it long-term authorization, and all of the ingredients are the highest quality products that I think really do help with tolerability. So I hope people will look at it, and we'll see what they think.