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Written by Anna Baboval, 7th grade teacher and mom to threenager, Harrison.
Demand for European “black market formula” has been soaring in the United States. These EU baby formulas come from countries like Germany and the Netherlands, where standards are thought to be higher, better, and closer to breastmilk. They are not FDA regulated, but have become widely available through several third party distributor sites that are frequented by hundreds of thousands of parents here in the US. In a sharp turn of events, it appears that as of last week several of the top third party distribution websites are no longer functioning, siting maintenance issues. Parents aren’t able to order, and many have expressed that pending orders were never received and it’s unclear if they will be shipped or refunded at all.
Kim Chappell, head of marketing at Bobbie, sat down virtually with formula experts, Mallory Whitmore, aka @theformulamom, who is all about guilt and shame-free feeding support as an Infant Feeding Tech and Dr. Anthony Porto. Dr. Porto is a board-certified pediatrician and pediatric gastroenterologist and co-author of The Pediatrician’s Guide to Feeding Babies and Toddlers to break down this black market shut down. You can listen to the full IG live here.
While the facts about what is going on are very murky, with no word from the FDA or the site owners, stuck in the middle are the parents desperate to get the formula of their choice for the babies. Whitmore and Dr. Porto break down what they have learned and what this may mean for the future of these black market EU formula distributors and American made baby formula brands.
Where has the EU formula gone?
Mallory: About a week ago, I started to get DMs asking for quality sources of EU formula. Then I started to get more and then a network of suppliers went down for maintenance. More and more retailers are starting to change how they operate. We’re at this tipping point where the ability to get European formulas is going to get more difficult.
Kim: Were you surprised to see this? Based on what you know about this black market?
Dr. Porto: Yes and no.
Is it safe to us European formula? If it’s FDA approved then it’s okay. What happens to those formulas when they leave the manufacturer in Europe until they get into our babies? Extreme (weather) can break down nutrients. Also recalls— we are unaware of them. This is the largest effect.
Why are parents using them? They want organic, grass fed formula that has more lactose.
Kim: The usage of these formulas has gotten to new heights. The USDA guidelines flagged them and said we do not think you should use these. Also, a 2019 article from NYTimes dove into the black market. People wanted something that they cannot get in the US.
There are so many parents that are high and dry, unable to get the formula of their choice.
Mallory: It is within a parents right to import formula from Europe, but directly from Europe. Now we are seeing these (distribution) warehouses in the US and that is where it gets a little more grey.
The FDA has always been aware of parents bringing in formulas but is now just now they are realizing how many are operating in undisclosed warehouses.
Will the European formula websites re-open?
Kim: It’s been noted in publicly shared email correspondence from one of these sites to customers last week that the FDA was shutting down their US warehouses. Will these sites come back online but ship product directly from Europe?
Dr. Porto: The risk will still be there because we do not know how they are kept/stored.
There is going to be a change where you need to buy things in bulk so that it comes directly from Europe to your household. This is the biggest change we’ve seen, too.
What is the risk associated with black market EU formulas?
Kim: This is not a scare tactic that is happening— there really is a risk. We have spoken to a mom who accidentally diluted her baby’s formula for months because she got the directions in German wrong and another mom whose baby got botiulism from EU formula and had to be hospitalized. Can you explain the supply chain process?
Dr. Porto: This really comes back to the Infant Formula Act of 1980. There was a decrease in chloride in formula, which caused a disease that a doctor in Tennessee was able to piece together after seeing multiple cases. However, it still took months to get the formula off the shelves and ultimately more kids were affected.
When we say outside the chain, once it leaves, is it being kept at extreme temperatures? Is it being properly used? How is it being imported? And then the recall effect. We don’t know what is happening with controls and testing. The recall is really the biggest factor. (Parents in the US won’t know about an EU recall until months later, or maybe not at all.)
Kim: WIll this create an even bigger black market? This seems like it could get more dangerous for parents.
Mallory: An additional risk for shipping is the boxes that they are shipped in and arrive already damaged.
Will this lead to an evolution of US made baby formulas?
Kim: The tension for parents is why can’t we just evolve our nutrition standards to meet what parents want? Do you think this will lead to change to those industry standards?
Dr. Porto: It’s hard to know, but I hope so. Every book says breast milk is best. I believe that infant feeding is a personal choice and there shouldn’t be any guilt. What’s important to understand is that we hope there is an update, there has not been an update.
Formula in the United States adds ingredients because it’s found in breast milk but we don’t really know what the benefits are. Take DHA for example. It took 20 years of getting the data to discover that high levels of DHA is very important to infant brain development. This seems like an ingredient that should be mandated and at high levels. Nothing is dangerous, but why are we including extra ingredients we don’t need?
Kim: The only way to understand as a parent how much DHA is in a formula is to call the 1-800 number to ask how much is in there. In the EU the minimum is 20 mg.
Mallory: A lot of parents don’t know how difficult the FDA makes it for a new brand or different formula. It is a million dollar process to go through the regulatory hurdles, but it is more difficult than the average parent understands.
Will people start switching to American baby formulas?
Kim: We really feel for the parents. We are getting DMs from parents that placed EU orders and don’t know if they’re going to receive their orders. We are offering two free cans of organic Bobbie formula to help make the formula transition. These parents are so stressed out and their babies are crying in the background. Even if these sites come back online, what is the value of reliability? Could this keep happening?
Dr. Porto: Time will tell. It could keep happening. When a parent finds the right formula, any deviation or change can be an adjustment and that is the last thing that we want as a parent. This is your child’s full source of nutrition in the first 6 months of life. To me choosing a formula that you know you’ll be able to have access to is important because that switch is going to be challenging.
Kim: Do you think there will be a lot of people switching?
Mallory: I think right now in the last week there is this scramble for formula to get it quickly and at a decent price. I think they will realize it is not sustainable (to keep using EU formula). I really feel for parents. I am nervous about it. I am seeing things about shipments being seized at the border. I want parents to realize that if things look bad this week, it may look worse next week given what we’re seeing with the first few suppliers.
Advice for switching infant formulas
Kim: I want to touch on the idea if you are thinking about switching. It’s not an overnight process, it can really take about a full week to adapt to a new formula. Any advice on switching?
Mallory: Give yourself and your baby grace during that transition time. There might be an increase in digestive symptoms and your baby might not like the taste. A lot of parents will try it once or twice and then switch again. That is really hard on a new digestive system. Really try to stick with it for a few days.
Dr. Porto: I completely agree. Really try to stick with that new formula as much as possible. Some people do well with mixing a little of each, but I say go for it with the new one. You might want to do a 50/50 mix for a day or so if they are really reluctant.
Kim: Mallory made a great IG post about 5 days ago on ideas for switching and what might be great US formula options for you if you are thinking of switching. I think that will be helpful to everybody.
Mallory: Just encourage parents to be patient. There is not a lot written in stone. We’re trying to figure out what is going to get easier and what is going to get harder. Just try to keep an open mind.
Dr. Porto: Think about what is important to you as to what the protein source and the carbohydrate source to aid in making the switch. Talk to your pediatrician and they will be able to offer you specific guidance.
Kim: If any of you are interested in making the switch to Bobbie, check out our IG post for information on how to do that. We would love to be able to support you guys crossing the pond.