Many bottle-fed infants rely mostly or solely on formula for their nutrition. So if you've heard that a European formula brand is somehow better or more beneficial, you might be tempted to buy one of these imported options online.
It's a move that more families are making these days as they navigate the current formula shortage and past recalls. Parents, too, are seeking out European formulas because of rumors that the products are made of higher quality ingredients or are better formulated to treat problems like colic or other digestive issues.
But the fact is, there's no evidence that European formulas are healthier for babies. And the lack of regulation around some imported formulas means that it's harder for parents to know exactly what they're buying. That can ultimately make it tougher to ensure that a product is both nutritious and safe for your baby.
"If you can find your regular formula or a U.S.-based alternative from your pediatrician or a formula exchange, I'd stick with that," says Micah Resnick, M.D., a board-certified pediatrician at Cincinnati Children's Hospital in Cincinnati, Ohio, and member of the What to Expect Medical Review Board. Here's a look at why, plus how to find safe formula if you are considering buying an imported product.
Is European baby formula safe for use in the U.S.?
Selling and importing baby formula from Europe is normally illegal. It can also be unsafe. Prior to the formula shortage, both the U.S. Department of Agriculture (USDA) and the American Academy of Pediatrics (AAP) took a stance against feeding your infant imported baby formula.[1]
Now with formula in short supply, the AAP and USDA are urging families to avoid buying imported formula online and seek out FDA-regulated infant formulas instead.
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Imported formulas ordered online from other countries are generally not reviewed by the FDA, which is a requirement for all infant formulas sold in the U.S. Because these imported formulas have not been checked, they may not meet U.S. standards for quality, nutrition or packaging. They also run the risk of potentially being contaminated or stored improperly during shipping.
There have been some changes in light of the current formula shortage, though. Beginning in mid-May, the Food and Drug Administration (FDA) announced guidance allowing for certain European formulas to be imported and made available for purchase in the U.S.[2] The move is designed to ease supply issues and increase availability of infant formula nationwide.
Only formulas that meet the FDA's adjusted guidelines can be imported, to ensure that European formulas sold in the U.S. have been produced and stored safely and provide adequate nutrition. Once an imported formula has passed the regulatory process, it becomes available to buy here in the U.S.
These regulatory changes offer a lifeline for families who are scrambling to find food for their infants.
"It is stressful for families to look and search for infant formula, so having another option offers peace of mind.," says Kyle Monk, M.D., a pediatrician at Cedars-Sinai Medical Center in Los Angeles, California and member of the What to Expect Medical Review Board.
That said, many experts agree that there's nothing about European baby formulas that makes them worth seeking out, despite what you may have read or heard. So if you can find formula manufactured in the U.S., you should use it. According to the AAP, there's no scientific evidence showing that imported formulas are better for babies compared to the options sold here in the U.S.[3]
"Using another U.S. brand or another alternative, like U.S.-made formula you received from your pediatrician or a formula exchange, is better than using a European brand," says Gina Posner, M.D., F.A.A.P., a pediatrician at MemorialCare Medical Group in Fountain Valley, California and member of the What to Expect Medical Review Board.
Risks of buying European baby formula
Wondering what, specifically, makes European formula a riskier choice? There are several things to consider, according to experts. Some of the possible downsides:
The FDA does not normally permit the sale of most foreign formulas
Formulas legally sold in the U.S. are subject to strict regulations to ensure that the products meet quality, labeling and nutrition standards. During the formula shortage, the FDA has temporarily adjusted some of these standards to allow for more imported formulas.
If you see a European brand on store shelves in the coming weeks, you can rest assured that it has gone through the FDA's adjusted regulatory process, explains Lauren Crosby, M.D., F.A.A.P., a pediatrician at La Peer Pediatrics in Beverly Hills, California and member of the What to Expect Medical Review Board.
But products that have been sold or imported illegally haven't been evaluated by the FDA for these standards, making it difficult to guarantee their safety, though many have been evaluated by comparable agencies in the European Union (EU).
They may not meet U.S. nutrition standards
The FDA's nutrient specifications for formula are carefully designed to meet infant nutritional needs. But research on European formulas has shown that many popular European brands don't necessarily contain all the specific required nutrients on their labels.[4]
Many imported formulas don't deliver as much iron as their U.S. counterparts, for instance. This may put infants at risk of iron deficiency.
They could be tainted or stored improperly
There have been reports of infant sickness or death occurring from tainted formulas manufactured outside of the U.S. There's also no guarantee that illegally imported formulas have been shipped or stored properly, which could potentially cause formula to become spoiled.
For some experts, this issue is even more of a concern now, during the shortage. "Now I'd be even more cautious of bad actors entering the space, who might be trying to take advantage of desperate families," Resnick says.
The instructions for mixing formula may not be in English
Some European formula labels and instructions for use aren't written in English. Unless you can read the language in which the label and instructions are printed, that can make it difficult to understand the mixing instructions or interpret the expiration date.
The scoop sizes aren't standardized
Different European formulas contain scoops of different sizes. That can make it harder to figure out the amount you need to mix that matches up with the amount of U.S. formula you may have offered your baby in the past.
If there's a recall, you may not be notified
U.S. recalls, while uncommon, are widely publicized when they do occur, making it easy for parents to receive updates. But you're much less likely to hear about a potential recall from a brand manufactured in Europe.
Your pediatrician may not be familiar with the formula
If you have an issue with an imported formula or have questions about it, your pediatrician may not be able to help.
The vast majority of U.S. pediatric providers say they aren't knowledgeable about popular European formula brands and don't know whether the products are FDA-regulated, findings show.
European baby formula brands you should avoid
You should steer clear of using any baby formulas that have been imported from another country unless the formula has been vetted and approved by the FDA. (Again, if you see an imported brand being sold by a major retailer in the near future, you can assume that the formula has received FDA approval, experts say.)
This list, while not all-encompassing, includes some of the most popular European formula brands that U.S. parents are buying:
- HiPP
- Holle
- Lebenswert
- Töpfer
Why American-made baby formulas are safer
Formulas made in the U.S. are safe for all the same reasons that European options may not be. When you buy American-made formula, you can rest assured that the formula is:
- Regulated by the FDA. Again, formulas legally sold in the U.S. are subject to strict regulations to ensure that the products meet quality, labeling and nutrition standards. This ensures that products made by U.S. brands are both safe and meet your baby's nutritional needs. Imported products that receive FDA approval to be sold during the shortage will have also met appropriate safety and nutrition guidelines. "The FDA will also know how the products are being shipped and stored," Posner says.
- In line with U.S. nutrition standards. All U.S. infant formulas must meet strict rules about ingredients to ensure the formula supports healthy growth and development. That means you don't have to worry about whether a formula contains enough of a certain key nutrient, like iron.
- At minimal risk for contamination or spoilage. U.S. formulas and manufacturing facilities are regularly inspected to ensure that standards are being met, which greatly reduces the chances for contaminated or improperly stored formula. And in the rare instance that a recall does occur, you'll most likely hear about it, since recalls are widely publicized in the news.
- Easy-to-follow mixing instructions. When you can easily read and understand the label instructions, you're better able to follow them and avoid giving your baby too much or too little formula.
- A brand your pediatrician is familiar with. Your pediatrician is likely familiar with standard U.S. formula options, so they'll be able to talk with you if you have questions about the formula or if you have concerns that the formula isn't the right fit for your baby.
Tips for buying baby formula in the U.S.
Choosing the best formula for your baby may take some research and thought. But with the right know-how, it's not difficult. If you're planning to formula-feed, keep these tips in mind.
Ask the pediatrician for recommendations
Different formulas work well for different babies. The doctor may have advice based on your baby's individual needs, which can help greatly narrow down your search. (Here are some of our favorite picks.)
One American formula brand called Bobbie is similar to European formulas in some ways but is U.S.-made and regulated, so that might be an option for parents who are set on trying a European formula.
Plus, some European formula brands make U.S. versions that are regulated by the FDA.
Avoid low-iron formulas
All formula-fed infants should drink an iron-fortified formula through their first birthday to prevent iron deficiency, recommends the AAP.[5]
Look for key nutrients
Infant formulas are required to meet established minimums for key vitamins and minerals, but some extras may be worth seeking out.
Formulas fortified with fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA) are thought to be beneficial for brain and eye development, while probiotic- and prebiotic-fortified formulas may support your baby's digestive health and soothe symptoms of colic.
Don't use a specialty formula unless it's needed
Most infants do well on a standard cow's-milk-based formula, and these products tend to be less expensive. Check with your pediatrician if you're considering another option (like soy or goat) to see if it's really necessary first.
Don't switch formulas at the first sign of spit-up
Spitting up doesn't necessarily mean that your baby needs to try another formula. Give your current option at least a week before trying something else, since switching formulas quickly can trigger digestive upset.
It's normal to feel anxious about finding formula right now. While buying a European formula online might seem like a smart way to ensure that your baby gets what she needs, experts agree that you should stick with FDA-approved options sold by major retailers or utilize U.S.-based alternatives from your pediatrician or formula exchanges.
"It can be exhausting to search," Posner acknowledges. But it's still worth it.
Ultimately, European baby formulas aren't actually any better than formulas made by U.S. brands, despite what you may read online or hear from friends. More importantly, giving one to your baby could potentially have downsides when it comes to her health.
Talk with your baby's pediatrician if you have any questions or concerns or are having trouble finding (or using) your formula of choice.