Last year's infant formula shortage combined with a widespread mistrust of U.S. food standards has heightened interest in European options, but are they better – or safe? This talk from dietitian Marian Roan, RD, MPH, shines a light on the reasons parents choose these products and how to ensure their babies’ nutritional needs are met. Roan breaks down label terms, provides brand-specific guidance, gives resources for product details, and offers exam-room tips for detecting common pitfalls of using non-U.S. brands.
Again, my name is Marian. I'm one of the dietitians at Oakland, um, Campus, and today I'm gonna talk about European formulas. Now, There's a lot to say about them and it's a little controversial. So I'm going to try to give you as much background information um and where to find some resources so that you feel more informed when your patients come in on, on these formulas that all of our patients come in on. Um, Generally, it's about 20%, 18 to 20% um in some practices, depending on where you practice or um infants that are on these formulas. OK. Um, I, these are all ketogenic diet related, not related to this at all. So my objectives are for you guys to be able to identify the most common European formulas that are used um in the US, the reasons families choose these, review the FDA regulations versus the European regulations, the risks associated with using Um, the European formulas that are not FDA registered and the implications of the formula shortage that we, we had slash have and how that changed the international infant formula availability on the shelves in our, in our retail stores. But first, I wanna say, of course, we all know breastfeeding is best. We have had improvement, um, Over the last years, but as you can see, what I really wanna emphasize is that at birth, 38% of all infants will receive some type of formula. By 6 months, 75%, 75% of all infants will at some point receive some formula in their life. So the big deal is what type of formula are they gonna choose? Here's a list, and I went to one of these websites that sells third-party formula, and here's a list of the formulas that are generally most available to US consumers to purchase. And as you can see, it's hip and holly, and then Leavensworth. Um, we don't see that one as much here, but we see a lot of hip and holly, so that's what we're gonna talk about. So I went and I looked at what they were selling, and I'm highlighting a couple of things that are unique or interesting about this line. Um, one, Notice the language um or the location that is gonna tell you the language that the label is in. So this one is a goat formula in the uh European Union and the, in Europe is the current locations where there are approved goat milk-based formulas. Again, notice that now this is a stage two, so you also have staged formulas. Um, a couple of years ago, maybe it was 85 to 8 years ago, Enfamil tried to introduce staged formulas in the US, stage one and stage 2, and it didn't go over so well. Um So Then the next thing is here, you can see these are hip UK organic formulas, stage 1, stage 2, stage 3. And so this label is going to be in English. The other languages, the other labels are going to be in German. Now, stage one is from 0 to 6 months for all of these formulas, the definition of stage one, and then stage two is 6+ months. I am still trying to figure out what stage 3 is. Um, even on their website, it, it does not clarify. It does not clarify if it's for post preemie discharges. Which is of concern, but again, even I, I could not find information about that, about that one. So even someone who's supposed to know formulas for Their career, I don't know that one. It also could be related to prebiotics, so. Hopefully, I'll have information in the future and come back to you with that one. This is from their website and then, and it's telling people why they need to buy. Hip formula and I really like to read this because you can see the Information and how strongly it's put to the consumer, to the parents of these children. Um, I put in the box, um, Some things that we're gonna address, um, certified to EU standards which are stricter than in North America. So as it says North America, it doesn't say FDA, so It's Putting in Mexico and Canada. This, I'm only gonna compare to the FDA standards. Um, it contains the essentials. All products are sourced from certified distributors. It, and of note, it's made in Germany. It contains DHA and of import, no added sugar or corn syrup and keep that in your head because that's something important. Um. And no synthetic DHA or ARA? Again, it's about how the raw materials and ingredients are produced, the soil, um, the seeds, the The cows that eat this grass, um, natural meadows, no mineral fertilizers, uh, natural grass, they probably have natural gas as well. Uh. So Hip, happy cows, make happy milk. Um, it's not just in. Wisconsin with their cheese. So that's one of the things that HIPA is really pushing. Now, holly, holly is the other formula um that is a big Part of the market here in the US. So again, this is straight from the website that I pulled this from. And I put The goat milk-based formulas in the boxes just so that you know that it also has a stage 1, stage 2, stage 3. Now of note, every single Holly formula, the label is in German. There are no English labels. Um The One of the things families really like these formulas is currently there's no goat milk-based infant formula that has been approved by the FDA that's on the market. So, um, if families prefer goat milk, they go to this. There is a powdered goat milk, but it's not an infant formula. Um, there is one nutrient that is a concern, um, that's low in goat milk, that's not low in cow's milk. Um, if you wanna think about that one. It's folate, so the pattern, um, Goat's milk has that added extra for the If families want to give it to their uh toddlers, we don't recommend it, for instance. Now, here again, Holly. Um, this is from the website. Now, one thing that I appreciate that this website does is that they do translate the label into all English and have all the directions in English. But again, they're advertising that It is no chemical fertilizers, biodynamically or organically grown food. Now there's no definition of those. Um So then it's Demeter certified farmers. Um, that's very much a big deal. Um, And They cite a quality control system, guaranteed free from genetically modified ingredients using an EU definition, no artificial colorings or artificial flavorings or artificial preservatives, and no added refined sugar. And I want you to think, keep that in mind that they say no added refined sugar. And um they say no artificial flavorings and no artificial colorings. They don't say no artificial ingredients. Um So here I have, I know this is like list, but um the top two are formulas that are available in the US that are a non-GMO formula and an organic formula. And if you look at the ingredients, I do not see any sugar. I do not see any sucrose. I don't see any corn syrup in this. Um, I just see fancy names for ingredients, chemical names. If you wanna stay. Down in the bottom, straight from the website, so it's a little lighter, is the first one. is an organic one, but I see something that's not. Lactose. And it's called maltodextrin. And That is a synthesized, manufactured, processed, highly processed starch, and it's either from corn or it's from rice, or it's from potatoes. So they just say organic maltodextrin. They don't specify where they got their maltodextrin from. Then that is above lactose. Now, one other thing about maltodextrin, um, If you look at it on a glycemic index, it has a higher glycemic index than sucrose. Supposedly, corn syrup solids have a lower glycemic index than sucrose, so Glycemic index isn't really The greatest way to evaluate sugars, but This, it does Break down very quickly and become a sugar. Now, this is another one. again, the label for the vitamins. Um, for example, it says vitamin E. It doesn't say D alpha tocoferrol acetate or mixed tocoferrols. Uh, and But it also does not have organic maltodextrin. So looking at the labels, um, I think that it's important to really see how labeling makes a difference for the consumer on the ingredients and We have labeling requirements and how those ingredients are, are labeled. So here, the top one is Similac organic. Then it's Pure Bliss by Similac. The one that has organic maltodextrin in it is Holly level one organic, and the bottom one is hip organic. So Just to look at those labels and the names. A lot of families have these perceptions of, of what's in a formula. So a formula recently came out that's called Bobby, um, and it says it's a European style. So again, this is a comparison of a standard Similac formula compared to a Compared to Bobby, and the difference is all the bulk organic, organic, organic, and Um That's, there's, there's other. Types of things. Now, there is a difference in the content that I'm gonna get to later about these two products. But there's, there's no sugar in it. So what families say this is from our clinics, from our families, our personal families, um, or from places we've gone and heard speakers. We choose European formulas because they have higher ingredient quality ingredients. It's organic, there's no corn syrup. Milk is the first ingredient and it seemed way more in line of how we eat than the US options. And then one RD says, I just keep hearing that it's better or that their kids tolerate it better. They seem reassured that the EU has more stringent food supply regulations, and they're very distrust, they're very distrustful of all US institutions. And then, um, one of our GI dietitians went to a conference on app pies, and a speaker said babies tend to tolerate the European formulas better because the milk comes from a two cows, um. I'm not sure how cows become a 2. Qualified. Without some genetic modification, um, in some way. So in the media, and this is from a blog. Um, and I have the source, Picky Eater blog. Um, it's for 6 reasons, and I don't go into the 6 reasons because essentially they're the same. Um, but The subtitle is, If you don't know about hip, Polly, Levin's Work, and Kenda Mill, which I'll go into in a minute, you're missing out on the best baby formulas on the market. So the blogs are saying these formulas are the best. Now, one of the things is that we had a formula shortage from Formula contamination as well as supply chain issues. And of course, that would lead to families having low confidence in the safety of our formulas. And the FDA expanded what formulas can be imported from zero to Many more. And one of the ones that was approved. Because it met all the FDA requirements was Kendamil. So Kendamil. is manufactured in the UK and It was approved. Hip, Holly, and Levin's were, were not. So having it put in those That category, it's a little bit of a, of If you look at how it meets criteria, it Those other three do not meet FDA criteria. They were not approved. So this is actually a great article this is a great article. It, it is actually kind of the print release of a, of a lit literature published article um that was published in the Journal of Uh, the, the Journal of Pediatric Gastro. Uh, nutrition. And I cited that, I typed that out incorrectly on the next couple of slides. But, um, It is very well done and so I recommend you Googling. And you could probably find New York Times and Infant European baby formula. So if the FDA finds these formulas in customs, they will detain them. Because they're not FDA approved. So here's the literature. So I put, this is not the Journal of Parental and Internal Nutrition. I apologize. Um It's JPGN. So this article was in 2019, so it's pre-pandemic. And the objective was to compare non-FDA registered imported formulas, AKA PIP, Poly, etc. with FDA infant formula guidelines. So, what they did was they identified vendors and blogs, looked through Google and DocDo to try to get something that wasn't tailored by previous searches. Um, Then they contacted the vendors to look at, OK, who is buying what, what's your biggest supply, as well as looking at the blocks, what's most frequently recommended in the brand, as well as the type, because there are hydrolyzed formula types. There's goat milk and there's the regular milk. And as you saw there are 3 pages of of hip milks, it seems to be a smaller supply of holly. And then they compared Those formulas with the FDA infant formula guidelines. So the infant formula act. is a is what the FDA It uses to enforce these or it writes the guidelines, and the guidelines are based on labels, manufacturing, um, pra practices, and that all the formula that is presented to them, um, it requires a lot of documents and data, shows that it supports adequate growth for these infants. So there are quite a few companies that That will label their formula as use over one. And because they don't wanna go through the paperwork to label it and, and do this work. So, uh, many specialized formulas for special conditions do not have an infant formula for that reason is that they don't wanna go through the work. Or the uh uh formula is Uh, not considered balanced, um, and so that would be difficult to get through. There's also the individual nutrient requirements. Now, the FDA import alert is where if the formula is caught in customs, they'll pull it. So The first goal was they looked at the reasons why. Overall, from the blogs that they identified for the bloggers to recommend a non-FDA approved formula. So 85% of the reasons are these top 3. There were stricter standards, higher quality ingredients, and there were no pesticides. Or chemicals like the organic standard was higher. Now, I really, this is smaller percent, but I think they're of. importance to think about, um, especially if you get The really difficult to appease baby that's colicky, um, and doesn't seem to be tolerating a lot of formula. 7.5% mentioned gut balance. And so it's the idea of what probiotic, prebiotics, the type of milk that's used. Um, I'm surprised that they mentioned colic, to be quite honest. I feel that a lot of are on the shelf. Infant formulas talk a lot about colic. Um, I, I'm also surprised that 2%. reported they felt that the nutrition was more specialized because it was available in stages after Infamil tried staged formula a few years back and it completely failed. Um, 2% were interested in the goat milk option, and 2% feel that formula companies in the US have too strong a ties to pharmaceutical companies, and they see that all in that medical pharmacy. Formula complex. OK. So, I'm just gonna briefly go over, I recommend pulling this article as well as reading the FDA, uh, I'm sorry, the US, the NY Times kind of interview with it, um, and having that. In a PDF folder on your computer as a reference because there's a lot of little tiny details that were not really described in this article that the newspaper article describes better. So first, labeling. One of the reasons why These formulas are not approved by the FDA is that they are not labeled by the FDA standards. So the FDA lists a minimal nutrient content guaranteed by the expiration date, and, and all of the FDA guidelines were updated most recently in 2015. Now, the European Food and Safety Authority, EFSA is who's in charge of It's similar to our FDA. They require average nutrient content. And two things changed in 2014. 1 is that it includes DHA. FDA does not require DHA to be an infant formulas, but Essentially all infant formulas have DHA in it. European formulas have higher DHA. Levels than US formulas. How also At that time, iron levels of the, in the formula were decreased. Her new recommendations, like they also have kind of like the USDA guidelines. So they have lower recommendations. Now, around that time, AAP came out with a paper on iron, concern for iron deficiency and iron needs for infants, and so all of the US formulas have higher iron. Neat levels. So with the labeling, these formulas are not labeled. Low iron mayonnaise supplement. So that's why they're not compliant. Or one OK. So that's one safety thing to think about. The other thing is that the definition for hypoallergenic is different. So for the US it's just essentially hydrolyzed protein. For the EU it's partially or Extensionally hydrolyzed protein. So, We sometimes use The extensively hydrolyzed protein for cow's milk protein allergy before we get to the Complete amino acid powder. But if a family is wanting to use the hypoallergenic holly version. It may only be partialized, partially hydroglyzed, and so that is not appropriate and may continue to be a problem for the infant. Other thing is quality. Now, both have quality controls. Manage batch bacturing processes from field to delivery. Um However, When people are purchasing this formula, On the black market, essentially, cause it's illegal to sell in the US. It's through a third party seller, and that's outside any sort of chain of control that the formula company has. So there is a contamination risk and also there is a risk of if there's a recall of the formula, um, Or if something happens within that shipment. Minimal to no notification could occur. It's sort of who takes responsibility. So Pretty much every single country that makes formula. We'll have some contamination at some point. There's humans involved all the time. Um, we just had a huge one and 2017, France had one, they had to recall from 80 countries. Uh Now, 2016 and 2017, the FDA received six adverse events from these formulas including diarrhea, positive salvanella, etc. etc. And um They aren't able to follow up really on this. So the challenge is if an EU recall happens to these formulas abroad, it may not reach the US consumer or the third-party vendor in a timely manner. So That is one of the most critical safety concerns. Now, the FDA issued a recall of Hip and Hawley in 2021, and it was recalled for mislabeled. Low iron content. And the low iron content was that it was not needing 1 mg of iron per 100 calories. It was meeting the iron content requirements of the EU, but those are lower than that of the US. So, The FDA said, do not use this. We, these are not. Recommended Um, one of the groups, so one of the third-party vendors, it looks like Abel Group, um, did not submit the paperwork as well. So this is someone that the FDA was able to clamp down on. What's different though is that in the Similac recall, families were able to get refunded. Here, they had to toss it, and this formula is not cheap. So where do you find out about implant formula? What do you do to find um this information? For your patience. Also, now that we have Some international formulas being sold at Target and on the shelves. Um, the FDA has a full infant formula. Uh Area where you can go in um and find information for you, information for parents, um, and it, it has um Great PDFs that you can use to show correct formula mixing and Direct parents towards what? For example, Which formulas are recalled at the time. So this is a One that was posted in September 23rd, so just over a week ago. And it's for a Oat milk staged formula that was made in the US I believe, but sold in the US but the company didn't submit. Any of the paperwork, so it's illegal. And And that's why it's being pulled off the market. So, These are some of the things where if you have a kid come baby come in on an infant formula you've never heard of, or if the family is asking about a formula you've never heard of, this is one of the places where you can go. Um, I got to this just from the formula page. So, what in the world do we do? Like, what are the pitfalls of the international formulas because they are different. The first thing is definitely read the label because the mixing instructions are different and It may not be the same country to country or brand to brand. So typically, It is 1 scoop to 1 ounce or 30 mLs, but don't assume because sometimes it's one scoop to 31.7 mLs depending on how much water to add. Also, the use by date is written as day, month, and year, not month, day, year. So that's something to look at with the families and to note with the families. Also, If you have a newborn come in being fed stage 2, they're not being given adequate nutrients. So you want to make sure that if the family's going to use it, then you need to have the baby on stage 1. Also, it is not intended for preterm or very low birth weight infants because of the low iron. And At the minimum Also, the ingredients are labeled as the average of what it would be, not the nutrients at what it is at the final right before it expires. So you don't exactly know exactly. What Your micronutrient content is and for premium and even if they're on a standard formula, that is of concern, especially of growth faltering. So what we do here is we do a lot of harm reduction counseling. Um, Again This is within the context. A lot of them have had trauma around the medical system, um, And Find out why they've had, they choose HIPA-HOLI, um. There are sometimes that they are able to be directed to another international formula or to Bobby that is cleared by the FDA appropriately labeled, has gone through all of those review processes that are in place to protect babies from Any possible thing that could go wrong. Um, for example, Kendamil, um, and Nestle Nan are both European manufactured formulas that have met the requirements of labeling for both the EU and The FDA and are available over the counter. They're also cheaper. So here, the FDA does have a list of formulas that have acted to be Continued on the market after the formula shortage. Now this is just a screenshot, um. You can Google FDA international formulas available and you'll be able to click through to get it. Um, But again, the things I want to point out is if you look at the Ireland, Abbott Nutrition, they are not taking steps to keep their SIM advanced from Ireland on the market because they make their own US version. OK. The next thing, this is further down the list, um, again, The Optimil from New Zealand is not continuing. Now, Actonel does not have enough iron in it. And so it was labeled. Um, see, first infant milk has a note on the iron content. Um And so that is going to be labeled low iron. Like the Similac 60/40 powdered formula that we use for children with endocrine or, or renal concerns and electrolyte concerns. So that will notify everyone who's involved that A supplement may be needed. So this is a, a partial of a PDF of a handout the FDA has. I wish that there was more helpful information on there about, you know, the scoop number could be different. But really, this just helps people. Convert milliliters to fluid ounces and temperatures and And that sort of thing. Um, it does show that the scoop is smaller, a little bit. Um, But it also leaves a lot of responsibility on us, you know, talk, if there's questions about anything, just talk to your baby's healthcare provider, uh, which I always enjoy when I'm going to them for answers. Um, so again, here's a summary of different considerations, and these are What we as a department and uh myself have, have looked at. Um, typically, if you have a child on HIP or HOLY, there is lower iron content. It may or may not be below their needs. So they may need monitoring or you may wanna put them on an iron supplement as prophylaxis. It's up to you. Um, this is also why we don't recommend it for pre-infants. What To have a family. No, tell you or show you how they mix the formula. Uh, we find that there are formula mixing problems even with the one scoop to 2 ounces. One of the things that we check when we have a baby that's not tolerating feeds or comes in hyponatremic is how the family has mixed the formula. So if you have a family that has, especially Holly where the labels in German and they haven't clicked around to see the instructions, now, in general, they do, but if you have a new baby, sometimes um Putting 2 and 2 together, it's just really hard. Sleep deprivation, it's very easy to go back to old habits of 1 scoop and 2 ounces instead of 1 to 1. So, um, You can even show that and document that that's what they did. I am a fan of documentation. Documentation has helped me in the past. But also, if you wanna increase the calorie concentration, all the recipes that you have on file. are not for these formulas cause they're based on scoops, scoop size for the US based formula. So you, you wanna contact your dietitian, uh, your clinical nutrition office for those types of recipes, um, to be converted. Again, monitoring of growth and development and also note that if they're labeled hypoallergenic, it does not mean the same thing. So um caution with Using them in suspected cow's milk protein allergy.
